3 in the flip PDF version. For solid oral dosage forms, a pilot scaleFormal Stability Studies — Long-term and accelerated is generally, at a minimum, one-tenth that of a full pro-(and intermediate) studies undertaken on primary or com- duction scale or 100,000 tablets or capsules, whichever ismitment batches according to a prescribed stability pro- larger.tocol to establish or confirm the retest period of a drug Primary Batch — A batch of a drug substance or drugsubstance or the shelf life of a drug product. intermediate storage condition. It is shaped to remainor from a laminated material. Manufacturers who supply a rawthere is a special performance function built into the drug material or an intermediate packaging component shouldproduct (e.g., a counter cap), it is of importance for any inform their customers of any intended changes to formu-dosage form or route of administration to show that the lations or manufacturing procedures and should updatecontainer closure system performs that function properly. Powder for Reconstitution..................................................................................................................................... 55XVIII. age statements. The data may showhandling). limit for the mean curve intersects the acceptance crite- rion. If term excursions outside the label storage conditions, suchanalysis shows that the batch-to-batch variability is small, as might occur during shipping. Fiberscontents to become superpotent and microbiological con- and even insects often appear as debris in containers,tamination. Fordrugs, preservation, taste masking, viscosity, flavoring, example, if a better packaging material that impartsappearance, and stability (chemical, physical, and micro- greater safety and shelf life is available, the FDA wouldbiological), raw materials, equipment, the compounding like this to be used (not for the purpose of shelf life, butprocedures (often the order of mixing), and finally the for the safety factors). A single primary stability batch of the drugclinical formulation studies. Drug Products Packaged in Impermeable Containers.................................................................................. 11 C. Drug Products Packaged in Semipermeable Containers.............................................................................. 11 D. Drug Products Intended for Storage in a Refrigerator................................................................................. 12 E. Drug Products Intended for Storage in a Freezer ........................................................................................ 13 F. Drug Products Intended for Storage below –20˚C....................................................................................... 13IV. 7, 8 Handbook of Pharmaceutical Formulations: Liquid Products In general, a drug substance should be evaluated under to the authorities if requested. Intrauterine systems are held in placemarketed in a sifter-top container. If used, fillers,to establish safety. RH, relative humidity.A. Stabilizing Suspensions......................................................................................................................................... 58PART IIManufacturing Formulations ................................................................................ 59Abacavir Sulfate Oral Solution........................................................................................................................................ 61Acetaminophen Rectal Solution....................................................................................................................................... 61Acetaminophen Drops...................................................................................................................................................... 62Acetaminophen Oral Suspension ..................................................................................................................................... 63Acetaminophen Suspension ............................................................................................................................................. 64Acetaminophen Syrup for Children................................................................................................................................. 64Acetaminophen Syrup ...................................................................................................................................................... 65Acetaminophen Syrup ...................................................................................................................................................... 66Acetaminophen, Chlorpheniramine, and Pseudoephedrine Syrup .................................................................................. 67Acyclovir Oral Suspension .............................................................................................................................................. 68Acyclovir Oral Suspension .............................................................................................................................................. 68Adapalene Solution .......................................................................................................................................................... 69Albendazole Oral Suspension .......................................................................................................................................... 70Albendazole Suspension .................................................................................................................................................. 71Albuterol Inhalation Solution........................................................................................................................................... 71Alpha-Bisabolol Aqueous Mouthwash Solution.............................................................................................................. 72Alpha-Bisabolol Buccal or Topical Solution................................................................................................................... 72Alpha-Bisabolol Ethanolic Mouthwash Solutio .............................................................................................................. 72Alpha-Bisabolol Mouthwash Solution............................................................................................................................. 73, Aluminum Chloride Solution........................................................................................................................................... 73Aluminum Hydroxide and Magnesium Hydroxide Suspension ..................................................................................... 74Aluminum Hydroxide and Magnesium Hydroxide Suspension ..................................................................................... 75Aluminum Hydroxide and Magnesium Hydroxide Suspension ..................................................................................... 75Aluminum Hydroxide and Magnesium Hydroxide Suspension ..................................................................................... 76Aluminum Hydroxide and Magnesium Hydroxide Suspension ..................................................................................... 76Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone Suspension .............................................................. 77Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone Suspension .............................................................. 77Aluminum Hydroxide and Magnesium Carbonate Dry Syrup ....................................................................................... 78Aminacrine Hydrochloride Topical Solution................................................................................................................... 78Aminolevulinic Acid HCl for Topical Solution, 20% ..................................................................................................... 79Amoxacillin Powder for Suspension ............................................................................................................................... 79Amoxacillin–Clavulanate Syrup ...................................................................................................................................... 80Ampicillin Powder for Suspension .................................................................................................................................. 81Ampicillin Powder for Suspension .................................................................................................................................. 81Ampicillin and Cloxacillin Oily Suspension................................................................................................................... 82Amprenavir Capsules ....................................................................................................................................................... 82Amprenavir Oral Solution................................................................................................................................................ 83Anise Oil Solution ...........................................................................................................................................................83Antipyrine and Benzocaine Elixir.................................................................................................................................... 83Apraclonidine Hydrochloride Ophthalmic Solution........................................................................................................ 83Ascorbic Acid Solution .................................................................................................................................................... 84Atovaquone Suspension ................................................................................................................................................... 84Azelastine Hydrochloride Nasal Spray............................................................................................................................ 85Azithromycin Suspension ................................................................................................................................................ 86Azithromycin Suspension ................................................................................................................................................ 86Azulene Solution .............................................................................................................................................................. 87Barium Sulfate Oral Suspension.......................................................................................................................................87Beclomethasone Dipropionate Inhalation Aerosol .......................................................................................................... 88Beclomethasone Dipropionate and Salbutamol Sulfate Nasal Spray ............................................................................. 88Benzethonium Chloride Solution..................................................................................................................................... 88Benzethonium Chloride and Benzocaine Topical Anesthetic ......................................................................................... 89Benzocaine and Tetracaine Topical Solution................................................................................................................... 89Benzyl Benzoate Solution................................................................................................................................................ 89Beta-Estradiol Vaginal Solution ....................................................................................................................................... 89Betamethasone Syrup....................................................................................................................................................... 90Bismuth Carbonate Suspension ....................................................................................................................................... 90Bismuth Subsalicylate Suspension................................................................................................................................... 90Bromazepam Drops ..........................................................................................................................................................91Bromhexine Hydrochloride Syrup — Alcohol Free ....................................................................................................... 92Bromhexine Hydrochloride Syrup ................................................................................................................................... 93Budesonide Inhaler ..........................................................................................................................................................94Butamirate Citrate Syrup ................................................................................................................................................. 94Caffeine Citrate Oral Solution ......................................................................................................................................... 95Calcipotriene Solution...................................................................................................................................................... 95Calcitonin Nasal Spray..................................................................................................................................................... 95Calcium Carbonate and Guar Gum Suspension.............................................................................................................. 96Calcium Iodide and Ascorbic Acid Syrup ....................................................................................................................... 97Carnitine and Coenzyme Q Solution............................................................................................................................... 97Cefaclor Suspension ......................................................................................................................................................... 98Cefadroxil Monohydrate Oral Suspension ...................................................................................................................... 98Cefpodoxime Proxetil Oral Suspension........................................................................................................................... 98Cefpodoxime Proxetil for Oral Suspension..................................................................................................................... 99Cefuroxime Axetil Suspension......................................................................................................................................... 99Cetrizine Hydrochloride Syrup ........................................................................................................................................ 99, Chlophedianol, Ipecac, Ephedrine, Ammonium Chloride, Carbinoxamine, and Balsam Tolu Syrup ......................... 100Chloramphenicol Opthalmic Solution ........................................................................................................................... 101Chloramphenicol Palmitate Oral or Topical Emulsion ................................................................................................. 101Chloroxylenol Surgical Scrub ........................................................................................................................................ 101Chlorpheniramine Maleate Syrup .................................................................................................................................. 102Ciclopirox Topical Solution ............................................................................................................................................103Cimetidine Syrup.............................................................................................................................................................103Ciprofloxacin Hydrochloride and Hydrocortisone Otic Suspension............................................................................. 104Cisapride Suspension .....................................................................................................................................................105Citalopram Hydrobromide Oral Solution ...................................................................................................................... 106Clarithromycin Suspension ............................................................................................................................................ 106Clindamycin Phosphate Topical Solution...................................................................................................................... 107Clotrimazol Topical Solution ........................................................................................................................................ 107Codeine Phosphate and Acetaminophen Elixir ............................................................................................................. 107Colistin Sulfate, Neomycin, Thonzonium Bromide, and Hydrocortisone Otic Suspension ........................................ 107Cotrimoxazole Oral Suspension..................................................................................................................................... 108Cromolyn Sodium Nasal Spray ..................................................................................................................................... 109Cromolyn Sodium Oral Concentrate ............................................................................................................................. 109Cyclosporin Oral Solution ............................................................................................................................................. 109Cyclosporine Soft Gelatin Capsules .............................................................................................................................. 110Desmopressin Acetate Nasal Spray ................................................................................................................................110Dexamethasone Elixir .................................................................................................................................................... 110Dextromethorphan Solution ........................................................................................................................................... 110Dextromethorphan and Chlorpheniramine Maleate Solution........................................................................................ 111Dextromethorphan Liquid .............................................................................................................................................. 112Dextromethorphan Liquid ...............................................................................................................................................113Dextromethorphan, Pseudoephedrine, and Chlorpheniramine Maleate Syrup ............................................................. 114Dextrose, Levulose, and Phosphoric Acid Solution ...................................................................................................... 114Diclofenac Oral Solution ............................................................................................................................................... 115Diazepam Rectal Solution.............................................................................................................................................. 115Didanosine for Oral Solution......................................................................................................................................... 116Digoxin Capsules ........................................................................................................................................................... 116Digoxin Elixir Pediatric ................................................................................................................................................. 116Dihydroergotamine Mesylate Drops .............................................................................................................................. 117Diphenhydramine and Ammonium Chloride Syrup...................................................................................................... 118Diphenhydramine Hydrochloride Liquid....................................................................................................................... 119Dornase Alfa Inhalation Solution .................................................................................................................................. 119Doxercalciferol Capsules ............................................................................................................................................... 119Dyphylline, Guaifenesin Elixir ...................................................................................................................................... 119Electrolyte Lavage Solution ........................................................................................................................................... 120Erythromycin Drops....................................................................................................................................................... 121Erythromycin Topical Solution ...................................................................................................................................... 122Estradiol Nasal Spray..................................................................................................................................................... 122Ethchlorvynol Gelatin Capsule 200 mg ........................................................................................................................ 123Eucalyptol Solution ........................................................................................................................................................ 123Eucalyptus and Mint Emulsion...................................................................................................................................... 124Fentanyl Citrate Nasal Spray ......................................................................................................................................... 124Ferrous Sulfate Oral Solution ........................................................................................................................................ 125Ferrous Sulfate Oral Syrup ............................................................................................................................................ 126Fluconazole Oral Suspension......................................................................................................................................... 126Flunisolide Spray............................................................................................................................................................ 126Fluocinonide Topical Solution ....................................................................................................................................... 126Fluorouracil Solution...................................................................................................................................................... 127Fluorouracil Topical Solution ........................................................................................................................................ 127Fluticasone Suspension Spray........................................................................................................................................ 127, Furosemide Syrup .......................................................................................................................................................... 127Gabapentin Oral Solution............................................................................................................................................... 128Galantamine Hydrobromide Oral Solution.................................................................................................................... 128Glucose, Fructose, and Phosphoric Acid Antiemetic Solution ..................................................................................... 128Gramicidin Opthalmic Solution ..................................................................................................................................... 128Guaifenesin, Pseudoephedrine, Carbinoxamine, and Chlophedianol Drops ................................................................ 129Haloperiodol Oral Liquid............................................................................................................................................... 130Heparin Nasal Spray ...................................................................................................................................................... 130Hydrocodone Bitartarate Elixir...................................................................................................................................... 130Hydrocodone Polistirex Extended-Release Suspension ................................................................................................ 131Hydromorphone Hydrochloride Oral Liquid................................................................................................................. 131Hydroxyzine Pamoate Oral Suspension ........................................................................................................................ 131Hyoscine Butylbromide Syrup....................................................................................................................................... 132Hyoscyamine Sulfate Elixir ........................................................................................................................................... 132Ibuprofen Topical Solution............................................................................................................................................. 132Ibuprofen Pediatric Suspension ..................................................................................................................................... 133Ibuprofen Solution.......................................................................................................................................................... 134Ibuprofen Suspension ..................................................................................................................................................... 134Ibuprofen Suspension, Sugar Free ................................................................................................................................. 134Insulin Inhalation Spray ................................................................................................................................................. 135Ipratropium Bromide Inhalation Solution ..................................................................................................................... 135Ipratropium Bromide Nasal Spray................................................................................................................................. 135Iron Infant Drops............................................................................................................................................................ 136Iron Polystyrene and Vitamin C Syrup.......................................................................................................................... 137Isoproterenol Sulfate and Calcium Iodide Syrup ......................................................................................................... 138Isotretinoin Capsules ...................................................................................................................................................... 138Itraconazole Oral Solution ............................................................................................................................................. 138Kaolin, Pectin, and Aluminum Hydroxide Suspension................................................................................................. 139Kaolin–Pectin Suspension .............................................................................................................................................140Ketoprofen Topical Solution .......................................................................................................................................... 140Ketotifen Syrup .............................................................................................................................................................. 141Lamivudine Oral Solution.............................................................................................................................................. 141Levalbuterol Hydrochloride Inhalation Solution ........................................................................................................... 141Levocarnitine Oral Solution ........................................................................................................................................... 141Linezolid for Oral Suspension ....................................................................................................................................... 142Lithium Carbonate Solution........................................................................................................................................... 142Lithium Citrate Syrup .................................................................................................................................................... 142Lomustine Nasal Spray .................................................................................................................................................. 142Loracarbef for Oral Suspension .................................................................................................................................... 142Loratidine Syrup ........................................................................................................................................................... 143Mafenide Acetate Topical Solution................................................................................................................................ 143Magaldrate Instant Powder for Dry Syrup .................................................................................................................... 144Magaldrate Suspension .................................................................................................................................................. 144Magaldrate with Simethicone Suspension..................................................................................................................... 145Mebendazole Oral Suspension....................................................................................................................................... 146Mebendazole Suspension ............................................................................................................................................... 147Megestrol Acetate Oral Suspension............................................................................................................................... 147Menthol and Benzocaine Solution................................................................................................................................. 148Menthol Mouthwash .......................................................................................................................................................148Mesalamine Rectal Suspension Enema ......................................................................................................................... 149Mesalamine Rectal Suspension...................................................................................................................................... 149Metformin Liquid........................................................................................................................................................... 149Metoclopramide Oral Solution....................................................................................................................................... 150Metoclopramide Syrup................................................................................................................................................... 151Metronidazole Suspension ............................................................................................................................................. 152, Minoxidil Solution ......................................................................................................................................................... 153Mint Oil Solution ........................................................................................................................................................... 153Mint–Menthol Mouthwash............................................................................................................................................. 153Mometasone Furoate Nasal Spray ................................................................................................................................. 154Monosulfiram Solution................................................................................................................................................... 154Multivitamin and Calcium Syrup .................................................................................................................................. 155Multivitamin Drops ........................................................................................................................................................ 156Multivitamin Syrup ........................................................................................................................................................ 156Multivitamin Syrup ........................................................................................................................................................ 157Multivitamin with Fluoride Infant Drops ...................................................................................................................... 158Nafarelin Acetate Nasal Solution................................................................................................................................... 159Nevirapine Suspension ................................................................................................................................................... 159Nicotine Spray................................................................................................................................................................ 159Nimesulide Suspension ...................................................................................................................................................160Nimodipine Capsules ..................................................................................................................................................... 160Nitroglycerin Lingual Spray .......................................................................................................................................... 160Norephedrine Syrup .......................................................................................................................................................161Nystatin Oral Suspension............................................................................................................................................... 162Nystatin Suspension ....................................................................................................................................................... 163Naproxen Suspension ..................................................................................................................................................... 163Ofloxacin Otic Solution ................................................................................................................................................. 163Omeprazole Solution.......................................................................................................................................................164Phenylpropanolamine Controlled-Release Capsule....................................................................................................... 164Ondansetron Hydrochloride Dihydrate Oral Solution................................................................................................... 165Orciprenaline Sulfate and Clobutinol Hydrochloride Syrup......................................................................................... 165Oxitropium and Formeterol Nasal Spray........................................................................................................................165Oxycodone Hydrochloride Oral Concentrate Solution ................................................................................................. 165Oxymetazoline Hydrochloride Congestion Nasal Spray............................................................................................... 166Oxymetazoline Hydrochloride Nasal Solution .............................................................................................................. 166Oxymetazoline Moisturizing Nasal Spray..................................................................................................................... 166Oxymetazoline Nasal Spray............................................................................................................................................167Oxymetazoline Sinus Nasal Spray................................................................................................................................. 167Oxymetazoline Nasal Solution........................................................................................................................................167Pheniramine Maleate Syrup ........................................................................................................................................... 168Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, and Scopolamine Hydrobromide Elixir ............................... 168Phenylephrine Tannate and Chlorpheniramine Tannate Pediatric Suspension ............................................................. 168Phenylephrine Tannate and Pyrilamine Tannate Suspension ........................................................................................ 168Phenylpropanolamine, Chlorpheniramine, Dextromethorphan, Vitamin C Syrup........................................................ 169Phenytoin Suspension .................................................................................................................................................... 170Pipenzolate Methyl Bromide and Phenobarbital Drops................................................................................................ 171Podofilox Solution.......................................................................................................................................................... 171Polidocanol Wound Spray.............................................................................................................................................. 172Polyvinyl Pyrrolidone–Iodine Gargle Solution ............................................................................................................. 172Polyvinyl Pyrrolidone–Iodine Gargle Solution Concentrate......................................................................................... 173Polyvinyl Pyrrolidone–Iodine Liquid Spray.................................................................................................................. 173Polyvinyl Pyrrolidone–Iodine Mouthwash and Gargle Solution Concentrate ............................................................ 174Polyvinyl Pyrrolidone–Iodine Scrub.............................................................................................................................. 174Polyvinyl Pyrrolidone–Iodine Solution ......................................................................................................................... 175Polyvinyl Pyrrolidone–Iodine Solution ......................................................................................................................... 175Polyvinyl Pyrrolidone–Iodine Solution ......................................................................................................................... 175Polyvinyl Pyrrolidone–Iodine Solution ......................................................................................................................... 176Polyvinyl Pyrrolidone–Iodine Solution ......................................................................................................................... 176Polyvinyl Pyrrolidone–Iodine Surgical Scrub ............................................................................................................... 177Polyvinyl Pyrrolidone–Iodine Surgical Scrub ...............................................................................................................177Polyvinyl Pyrrolidone–Iodine Vaginal Douche Concentrate......................................................................................... 177, Polyvinyl Pyrrolidone–Iodine Viscous Solution............................................................................................................ 178Prednisone Oral Solution ...............................................................................................................................................178Prednisolone Sodium Phosphate Oral Solution............................................................................................................. 178Prednisolone Syrup ........................................................................................................................................................ 178Progesterone Capsules .................................................................................................................................................. 178Promethazine Hydrochloride Syrup............................................................................................................................... 179Promethazine and Codeine Syrup.................................................................................................................................. 180Promethazine and Dextromethorphan Syrup................................................................................................................. 180Promethazine Rectal Solution........................................................................................................................................ 180Promethazine Rectal Solution........................................................................................................................................ 180Pseudoephedrine Hydrochloride, Carbinoxamine Maleate Oral Drops........................................................................ 181Pseudoephedrine and Carbinoxmine Drops................................................................................................................... 182Pseudoephedrine Hydrochloride Syrup ......................................................................................................................... 183Ribavirin Inhalation Solution......................................................................................................................................... 184Risperidone Oral Solution ............................................................................................................................................ 184Ritonavir Capsules ......................................................................................................................................................... 184Ritonavir Oral Solution .................................................................................................................................................. 184Ritonavir and lopinavir Oral Solution ........................................................................................................................... 184Rivastigmine Tartarate Oral Solution............................................................................................................................. 184Salbutamol Aerosol ........................................................................................................................................................ 185Salbutamol Syrup Sugar Free ........................................................................................................................................ 186Salbutamol Syrup ........................................................................................................................................................... 186Salicylic Acid Collodion ................................................................................................................................................ 187Salmeterol Xinafoate Inhalation Aerosol....................................................................................................................... 187Scopolamine Nasal Spray .............................................................................................................................................. 188Sertraline Hydrochloride Oral Concentrate ................................................................................................................... 188Sertraline Hydrochloride Solution ................................................................................................................................. 188Simethicone Drops ......................................................................................................................................................... 189Sirolimus Solution.......................................................................................................................................................... 190Sodium Chloride Nasal Drops ....................................................................................................................................... 190Stavudine for Oral Suspension ...................................................................................................................................... 190Sucralafate Suspension................................................................................................................................................... 191Sulfacetamide Sodium and Sulfur Cleanser and Suspension........................................................................................ 191Sulfadiazine and Trimethoprim Veterinary Oral Suspension ........................................................................................ 192Sulfamethoxazole and Trimethoprim Suspension ......................................................................................................... 193Sulfamethoxazole and Trimethoprim Suspension ......................................................................................................... 194Sulfamethoxazole and Trimethoprim Suspension ......................................................................................................... 194Sulfathiazole Veterinary Oral Solution .......................................................................................................................... 194Sulfidoxine Solution .......................................................................................................................................................195Sulfidoxine and Pyrimethamine Suspension ................................................................................................................. 195Sumatriptan Nasal Spray................................................................................................................................................ 196Terfenadine Oral Suspension ......................................................................................................................................... 197Terfenadine Suspension .................................................................................................................................................198Theophylline Sodium Glycinate Elixir .......................................................................................................................... 198Thiabendazole Suspension ............................................................................................................................................. 199Thiothixene Oral Concentrate ........................................................................................................................................ 199Timolol Maleate Opthalmic Drops ................................................................................................................................ 199Tolnafate Foot Care Microemulsion .............................................................................................................................. 199Tolu Balsam Cough Syrup............................................................................................................................................. 200Tretinoin Solution........................................................................................................................................................... 201Triamcinolone Acetonide Nasal Spray .......................................................................................................................... 201Triclosan Oral Solution .................................................................................................................................................. 202Triprolidine and Pseudoephedrine Hydrochloride Syrup .............................................................................................. 203Tulobuterol Syrup........................................................................................................................................................... 204Undecylenic Acid and Chloroxylenol Solution ............................................................................................................. 204, Urea Peroxide Ear Drop................................................................................................................................................. 205Valproic Acid Capsules .................................................................................................................................................. 205Valproic Acid Syrup ....................................................................................................................................................... 205Vancomycin Hydrochloride Oral Solution .................................................................................................................... 205Vitamin A and D Infant Drops ..................................................................................................................................... 206Vitamin A and Vitamin D3 Drops ................................................................................................................................. 207Vitamin A and Vitamin D3 Oral Solution ..................................................................................................................... 207Vitamin A and Vitamin D3 Syrup ................................................................................................................................. 207Vitamin A and Vitamin E Drops.................................................................................................................................... 208Vitamin A and Vitamin E Drops.................................................................................................................................... 208Vitamin A Concentrate, Water-Miscible ........................................................................................................................ 208Vitamin A Drops ............................................................................................................................................................ 209Vitamin B-Complex Syrup............................................................................................................................................. 209Vitamin B-Complex Syrup............................................................................................................................................. 210Vitamin B-Complex Syrup ........................................................................................................................................... 211Vitamin B-Complex and Vitamin C Syrup.................................................................................................................... 211Vitamin B-Complex (without B12) Syrup..................................................................................................................... 212Vitamin B-Complex, A, C, D, and Calcium Drops....................................................................................................... 214Vitamin B-Complex and Iron Syrup.............................................................................................................................. 215Vitamin B-Complex and Vitamin C Syrup.................................................................................................................... 216Vitamin B-Complex, Vitamin C, and Iron Syrup.......................................................................................................... 217Vitamin B-Complex, Vitamin C, and Iron Syrup.......................................................................................................... 218Vitamin B-Complex, A, C, and D Syrup....................................................................................................................... 219Vitamin B-Complex, A, C, D, and E Pediatric Drops .................................................................................................. 220Vitamin C Drops ............................................................................................................................................................ 221Vitamin E and Benzocaine Solution.............................................................................................................................. 221Vitamin E and Benzocaine Solution.............................................................................................................................. 222Vitamin E Capsules........................................................................................................................................................ 222Vitamin E Drops............................................................................................................................................................. 222Vitamin E Drops............................................................................................................................................................. 223Vitamin E Solution with Ethanol................................................................................................................................... 223Vitamin E Solution with Ethanol................................................................................................................................... 223Xylometazoline Hydrochloride Nasal Solution............................................................................................................. 224Xylometazoline Hydrochloride Children’s Nasal Solution ........................................................................................... 224Index ............................................................................................................................................................................... 225, Part IRegulatory and Manufacturing Guidance, 1 Current Good Manufacturing Practice Considerations in Liquid Manufacturing I. 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