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USP Seeks Submission of Proposals for Monograph Improvement

In an effort to improve drug product, drug substance, and excipient monographs to current scientific/regulatory standards, USP is seeking submission of proposals for improved methods for inclusion in the following USP-NF monographs to replace the current procedures that may be deficient, flawed, or unsafe. The submissions should include data and other information recommended in the USP Guideline for Submission of Request for Revision to USP-NF. Each submission should include analytical validation data, data demonstrating that the procedure is stability indicating (if applicable), and results of analysis from three commercial batches.

Please forward your submission(s) by email to or mail to:
Karen A. Russo, Ph.D.
Vice President, Small Molecules
Department of Standards Development
United States Pharmacopeia
12601 Twinbrook Parkway
Rockville, MD 20853

Contact Dr. Russo for details of submission at the above email address or at +1-301-816-8379.

MONOGRAPHS NEEDING UPDATE

Current Procedure: Titration Assays;
Need Stability-indicating Assay Procedures


Drug Products
  1. Acetylcholine Chloride for Ophthalmic Solution
  2. Aminobenzoic Acid Topical Solution
  3. Aminophylline Injection
  4. Aminophylline Oral Solution
  5. Aminophylline Rectal Solution
  6. Aminophylline Suppositories
  7. Aminophylline Tablets
  8. Apomorphine Hydrochloride Tablets
  9. Aromatic Ammonia Spirit
  10. Benzocaine Cream
  11. Benzocaine Ointment
  12. Benzocaine Otic Solution
  13. Benzocaine Topical Solution
  14. Bromodiphenhydramine Hydrochloride Elixir*
  15. Bromodiphenhydramine Hydrochloride Oral Solution
  16. Brompheniramine Maleate Elixir*
  17. Brompheniramine Maleate Oral Solution
  18. Caffeine and Sodium Benzoate Injection
  19. Carbamide Peroxide Topical Solution
  20. Carbinoxamine Maleate Tablets
  21. Codeine Phosphate Injection
  22. Codeine Phosphate Tablet
  23. Codeine Sulfate Tablets
  24. Echothiophate Iodide for Opthalmic Solution
  25. Epinephrine Injection
  26. Fluphenazine Enanthate Injection
  27. Fructose and Sodium Chloride Injection
  28. Ganciclovir for Injection
  29. Glycerin Ophthalmic Solution
  30. Hydralazine Hydrochloride Injection
  31. Hydrocodone Bitartrate Tablets
  32. Iodine Topical Solution
  33. Isoniazid Oral Solution
  34. Isoniazid Syrup
  35. Levorphanol Tartrate Injection
  36. Levorphanol Tartrate Tablets
  37. Lidocaine Hydrochloride Jelly
  38. Lidocaine Oral Topical Solution
  39. Magnesium Sulfate Injection
  40. Menadiol Sodium Diphosphate Injection
  41. Menadiol Sodium Diphosphate Tablets
  42. Meperidine Hydrochloride Oral Solution
  43. Meprobamate Oral Suspension
  44. Methylbenzethonium Chloride Lotion
  45. Oral Rehydration Salts
  46. PEG 3350 and Electrolytes for Oral Solution
  47. Pilocarpine Ocular System
  48. Potassium and Sodium Bicarbonates and Citric Acid Effervescent Tablets for Oral Solution
  49. Potassium Bicarbonate and Potassium Chloride Effervescent Tablets for Oral Solution
  50. Potassium Bicarbonate and Potassium Chloride for Effervescent Oral Solution
  51. Potassium Chloride in Dextrose and Sodium Chloride Injection
  52. Potassium Chloride in Dextrose Injection
  53. Potassium Chloride in Sodium Chloride Injection
  54. Potassium Chloride, Potassium Bicarbonate, and Potassium Citrate Effervescent Tablets for Oral Solution
  55. Potassium Citrate and Citric Acid Oral Solution
  56. Potassium Gluconate and Potassium Chloride for Oral Solution
  57. Potassium Gluconate and Potassium Chloride Oral Solution
  58. Potassium Gluconate, Potassium Citrate, and Ammonium Chloride Oral Solution
  59. Primaquine Phosphate Tablets
  60. Procaine and Tetracaine Hydrochlorides and Levonordefrin Injection
  61. Ringer's Injection
  62. Salicylic Acid Plaster
  63. Scopolamine Hydrobromide Ophthalmic Ointment
  64. Scopolamine Hydrobromide Ophthalmic Solution
  65. Scopolamine Hydrobromide Tablets
  66. Sodium Acetate Solution
  67. Sodium Chloride Injection
  68. Sodium Chloride Ophthalmic Ointment
  69. Sodium Chloride Ophthalmic Solution
  70. Sodium Chloride Tablets
  71. Sodium Citrate and Citric Acid Oral Solution
  72. Sodium Lactate Injection
  73. Sodium Lactate Solution
  74. Sodium Nitrite Injection
  75. Sodium Salicylate Tablets
  76. Strong Iodine Solution
  77. Sulfadiazine Sodium Injection
  78. Sulfapyridine Tablets
  79. Sulfisoxazole Acetyl Oral Suspension
  80. Theophylline Sodium Glycinate Tablets
  81. Tromethamine for Injection

*Monographs currently named as Elixir will be renamed as Oral Solution



Drug Substances
  1. Acetylcholine Chloride
  2. Alfentanil Hydrochloride
  3. Amiloride Hydrochloride
  4. Aminobenzoate Potassium
  5. Aminobenzoate Sodium
  6. Aminobenzoic Acid
  7. Aminophylline
  8. Amoxapine
  9. Anileridine
  10. Anileridine Hydrochloride
  11. Antazoline Phosphate
  12. Antipyrine
  13. Apomorphine Hydrochloride
  14. Apraclonidine Hydrochloride
  15. Aspirin
  16. Atropine
  17. Atropine Sulfate
  18. Aurothioglucose
  19. Azatadine Maleate
  20. Azathioprine
  21. Baclofen
  22. Bendroflumethiazide
  23. Benoxinate Hydrochloride
  24. Benzocaine
  25. Benzonatate
  26. Benztropine Mesylate
  27. Betaxolol Hydrochloride
  28. Bethanechol Chloride
  29. Biperiden
  30. Biperiden Hydrochloride
  31. Bretylium Tosylate
  32. Bromocriptine Mesylate
  33. Bromodiphenhydramine Hydrochloride
  34. Brompheniramine Maleate
  35. Bumetanide
  36. Bupivacaine Hydrochloride
  37. Buprenorphine HCl
  38. Butalbital
  39. Butamben
  40. Butorphanol Tartrate
  41. Calamine
  42. Carbachol
  43. Carbamide Peroxide
  44. Carbinoxamine Maleate
  45. Carisoprodol
  46. Chloral Hydrate
  47. Chloroprocaine Hydrochloride
  48. Chlorpheniramine Maleate
  49. Clemastine Fumarate
  50. Clonidine Hydrochloride
  51. Clorazepate Dipotassium
  52. Clozapine
  53. Codeine
  54. Codeine Phosphate
  55. Codeine Sulfate
  56. Cyclizine Hydrochloride
  57. Cyclobenzaprine Hydrochloride
  58. Cyproheptadine Hydrochloride
  59. Demecarium Bromide
  60. Desipramine Hydrochloride
  61. Dexbrompheniramine Maleate
  62. Dexchlorpheniramine Maleate
  63. Dextromethorphan
  64. Diclofenac Sodium
  65. Dihydroxyacetone
  66. Diphenhydramine Citrate
  67. Diphenoxylate Hydrochloride
  68. Dipyridamole
  69. Disopyramide Phosphate
  70. Doxapram Hydrochloride
  71. Doxylamine Succinate
  72. Emedastine Difumarate
  73. Ephedrine
  74. Ephedrine Hydrochloride
  75. Ephedrine Sulfate
  76. Epinephrine
  77. Epinephrine Bitartrate
  78. Ethacrynic Acid
  79. Ethyl Chloride
  80. Etodolac
  81. Eucatropine Hydrochloride
  82. Eugenol (need Assay and specs)
  83. Famotidine
  84. Fentanyl Citrate
  85. Ferric Sulfate
  86. Fluphenazine Decanoate
  87. Fluphenazine Enanthate
  88. Flurazepam Hydrochloride
  89. Flurbiprofen
  90. Fructose
  91. Furosemide
  92. Glycopyrrolate
  93. Guanabenz Acetate
  94. Haloperidol
  95. Hydromorphone Hydrochloride
  96. Hydrous Benzoyl Peroxide
  97. Hydroxyamphetamine Hydrobromide
  98. Hydroxyzine Hydrochloride
  99. Isoflurane
  100. Isometheptene Mucate
  101. Isopropamide Iodide
  102. Isoproterenol Hydrochloride
  103. Isotretinoin
  104. Ketoprofen
  105. Levmetamfetamine
  106. Levonordefrin
  107. Levorphanol Tartrate
  108. Lithium Carbonate
  109. Lithium Hydroxide
  110. Loxapine Succinate
  111. Magnesium Sulfate
  112. Mannitol
  113. Maprotiline Hydrochloride
  114. Mazindol
  115. Meclizine Hydrochloride
  116. Meclofenamate Sodium
  117. Menadiol Sodium Diphosphate
  118. Menadione
  119. Mephobarbital
  120. Mepivacaine Hydrochloride
  121. Meprobamate
  122. Mesoridazine Besylate
  123. Metaraminol Bitartrate
  124. Metformin Hydrochloride
  125. Methacholine Chloride
  126. Methadone Hydrochloride
  127. Methimazole
  128. Methotrimeprazine
  129. Methoxyflurane
  130. Methyclothiazide
  131. Methylbenzethonium Chloride
  132. Methyldopa
  133. Methylphenidate Hydrochloride
  134. Methysergide Maleate
  135. Metoclopramide Hydrochloride
  136. Metoprolol Fumarate
  137. Metoprolol Tartrate
  138. Metyrosine
  139. Milrinone
  140. Nadolol
  141. Naloxone Hydrochloride
  142. Naproxen
  143. Naproxen Sodium
  144. Neostigmine Bromide
  145. Neostigmine Methylsulfate
  146. Nicotine
  147. Nifedipine
  148. Nimodipine
  149. Norepinephrine Bitartrate
  150. Nortriptyline Hydrochloride
  151. Noscapine
  152. Oxaprozin
  153. Oxazepam
  154. Oxprenolol Hydrochloride
  155. Oxtriphylline
  156. Oxymorphone Hydrochloride
  157. Padimate
  158. Pamabrom
  159. Papaverine Hydrochloride
  160. Paraldehyde
  161. Pentazocine
  162. Pentazocine Hydrochloride
  163. Perphenazine
  164. Phendimetrazine Tartrate
  165. Pheniramine Maleate
  166. Phenoxybenzamine Hydrochloride
  167. Phentermine Hydrochloride
  168. Phentolamine Mesylate
  169. Phenylephrine Hydrochloride
  170. Phenylpropanolamine Bitartrate
  171. Phenylpropanolamine Hydrochloride
  172. Phenyltoloxamine Citrate
  173. Physostigmine
  174. Physostigmine Salicylate
  175. Physostigmine Sulfate
  176. Pilocarpine Hydrochloride
  177. Piperazine
  178. Potassium Bicarbonate
  179. Potassium Carbonate
  180. Potassium Chloride
  181. Potassium Iodide
  182. Potassium Nitrate
  183. Prilocaine Hydrochloride
  184. Primaquine Phosphate
  185. Procaine Hydrochloride
  186. Prochlorperazine
  187. Prochlorperazine Edisylate
  188. Prochlorperazine Maleate
  189. Procyclidine Hydrochloride
  190. Promethazine Hydrochloride
  191. Propafenone Hydrochloride
  192. Proparacaine Hydrochloride
  193. Propoxycaine Hydrochloride
  194. Propylthiouracil
  195. Protriptyline Hydrochloride
  196. Pseudoephedrine Hydrochloride
  197. Pseudoephedrine Sulfate
  198. Ptocarbazine Hydrochloride
  199. Pyridostigmine Bromide
  200. Pyrilamine Maleate
  201. Quazepam
  202. Quinidine Gluconate
  203. Resorcinol Monoacetate
  204. Salicylamide
  205. Scopolamine Hydrobromide
  206. Secobarbital
  207. Sodium Acetate
  208. Sodium Chloride
  209. Sodium Citrate
  210. Sodium Iodide
  211. Sodium Nitrite
  212. Sodium Nitroprusside
  213. Sodium Salicylate
  214. Spironolactone
  215. Succinylcholine Chloride
  216. Sulfacetamide
  217. Sulfacetamide Sodium
  218. Sulfadiazine Sodium
  219. Sulfadoxine
  220. Sulfamethazine
  221. Sulfapyridine
  222. Sulfathiazole
  223. Sulfisoxazole Acetyl
  224. Sulindac
  225. Sulisobenzone
  226. Tamoxifen Citrate
  227. Terbutaline Sulfate
  228. Tetracaine
  229. Tetrahydrozolin Hydrochloride
  230. Thiethylperazine Maleate
  231. Thioridazine
  232. Thioridazine Hydrochloride
  233. Timolol Maleate
  234. Tocainide Hydrochloride
  235. Tolazoline Hydrochloride
  236. Tolmetin Sodium
  237. Tretinoin
  238. Triamterene
  239. Trifluoperazine Hydrochloride
  240. Triflupromazine
  241. Triflupromazine Hydrochloride
  242. Trihexyphenidyl Hydrochloride
  243. Triprolidine Hydrochloride
  244. Tromethamine
  245. Tubocurarine Chloride
  246. Verapamil Hydrochloride
  247. Zinc Acetate


Excipients
  1. Fructose
  2. Magnesium Sulfate
  3. Mannitol
  4. Potassium Bicarbonate
  5. Potassium Carbonate
  6. Potassium Chloride
  7. Sodium Acetate
  8. Sodium Chloride
  9. Sodium Citrate

Current Procedure: Titrations With Mecruric Acetate;
Need Stability-indicating Assay Procedures (Also requires replacement of unsafe reagent—Mercury)


Drug Substances:
  1. Biperiden Hydrochloride
  2. Carbachol
  3. Chlorpromazine Hydrochloride
  4. Cyclobenzaprine Hydrochloride
  5. Demecarium Bromide
  6. Desipramine Hydrochloride
  7. Doxapram Hydrochloride
  8. Flurazepam Hydrochloride
  9. Maprotiline Hydrochloride
  10. Methacholine Chloride
  11. Methylphenidate Hydrochloride
  12. Neostigmine Bromide
  13. Nortriptyline Hydrochloride
  14. Procyclidine Hydrochloride
  15. Protriptyline Hydrochloride
  16. Pyridostigmine Bromide
  17. Trifluoperazine Hydrochloride
  18. Triflupromazine Hydrochloride

Current Procedure: Microbiological Assays;
Need Stability-indicating Assay Procedures


Drug Products
  1. Bacitracin and Polymyxin B Sulfate Topical Aerosol
  2. Bacitracin for Injection
  3. Bacitracin Ointment
  4. Bacitracin Zinc and Polymyxin B Sulfate Ointment
  5. Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment
  6. Bacitracin Zinc Ointment
  7. Bleomycin for Injection
  8. Colistin and Neomycin Sulfates and Hydrocortisone Acetate Otic Suspension
  9. Colistin Sulfate for Oral Suspension
  10. Erythromycin Estolate and Sulfisoxazole Acetyl Oral Suspension
  11. Erythromycin Ethylsuccinate and Sulfisoxazole Acetyl for Oral Suspension
  12. Erythromycin Ethylsuccinate Injection
  13. Erythromycin Ethylsuccinate Oral Suspension
  14. Erythromycin Ethylsuccinate Tablets
  15. Erythromycin Lactobionate for Injection
  16. Gentamicin and Prednisolone Acetate Ophthalmic Ointment
  17. Gentamicin Injection
  18. Gentamicin Sulfate Ointment
  19. Nafcillin Sodium Capsules
  20. Nafcillin Sodium for Oral Solution
  21. Nafcillin Sodium Tablets
  22. Neomycin and Polymyxin B Sulfates Cream
  23. Neomycin for Injection
  24. Neomycin Sulfate and Dexamethasone Sodium Phosphate Ophthalmic Ointment
  25. Neomycin Sulfate and Dexamethasone Sodium Phosphate Ophthalmic Solution
  26. Neomycin Sulfate and Flurandrenolide Lotion
  27. Neomycin Sulfate and Gramicidin Ointment
  28. Neomycin Sulfate and Hydrocortisone Acetate Lotion
  29. Neomycin Sulfate and Hydrocortisone Acetate Ophthalmic Suspension
  30. Neomycin Sulfate Cream
  31. Neomycin Sulfate Ointment
  32. Neomycin Sulfate Oral Solution
  33. Neomycin Sulfate Tablets
  34. Nystatin and Triamcinolone Acetonide Ointment
  35. Oxytetracycline and Nystatin Capsules
  36. Oxytetracycline and Nystatin for Oral Suspension
  37. Oxytetracycline Calcium Oral Suspension
  38. Oxytetracycline Hydrochloride and Hydrocortisone Acetate Ophthalmic Suspension
  39. Oxytetracycline Hydrochloride and Hydrocortisone Ointment
  40. Oxytetracycline Hydrochloride and Polymyxin B Sulfate Ointment
  41. Oxytetracycline Hydrochloride and Polymyxin B Sulfate Topical Powder
  42. Oxytetracycline Hydrochloride and Polymyxin B Sulfate Vaginal Inserts
  43. Oxytetracycline Hydrochloride and Polymyxin B Sulfate Vaginal Tablets
  44. Paromomycin Oral Solution
  45. Paromomycin Sulfate Capsules
  46. Paromomycin Sulfate Syrup
  47. Penicillin G Potassium for Oral Solution
  48. Polymyxin B for Injection
  49. Polymyxin B Sulfate and Bacitracin Zinc Topical Aerosol
  50. Polymyxin B Sulfate and Bacitracin Zinc Topical Powder
  51. Polymyxin B Sulfate and Hydrocortisone Otic Solution
  52. Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution
  53. Sisomicin Sulfate Injection
  54. Tetracycline Hydrochloride and Nystatin Capsules
  55. Troleandomycin Capsules
  56. Vancomycin Hydrochloride Capsules
  57. Vancomycin Hydrochloride for Injection
  58. Vancomycin Hydrochloride for Oral Solution
  59. Vancomycin Injection


Drug Substances
  1. Bacitracin
  2. Bacitracin Zinc
  3. Bleomycin Sulfate
  4. Gentamicin Sulfate
  5. Gramicidin
  6. Neomycin Sulfate
  7. Oxytetracycline Calcium
  8. Paromomycin Sulfate
  9. Penicillamine
  10. Polymyxin B Sulfate
  11. Sisomicin Sulfate
  12. Sterile Erythromycin Gluceptate
  13. Sterile Erythromycin Lactobionate
  14. Sterile Vancomycin Hydrochloride
  15. Troleandomycin
  16. Tyrothricin
  17. Vancomycin
  18. Vancomycin Hydrochloride

Current Procedure: UV Assays;
Need Stability-indicating Assay Procedures



Drug Products
  1. Acetazolamide Injection
  2. Dioxybenzone and Oxybenzone Cream
  3. Eucatropine Hydrochloride Ophthalmic Solution
  4. Mercaptopurine Tablets
  5. Monobenzone Cream
  6. Tetrahydrozoline Hcl Opthalmic Solution
  7. Tretinoin Topical Solution
  8. Tretinoin Gel
  9. Tropicamide Ophthalmic Solution


Drug Substances
  1. Acetazolamide
  2. Dacarbazine
  3. Dioxybenzone
  4. Mercaptopurine
  5. Oxybenzone

Current Procedures: Barbiturate Assays;
Need Stability-indicating Assays



Drug Products
  1. Butabarbital Sodium Oral Solution
  2. Butabarbital Sodium Tablets
  3. Pentobarbital Oral Solution
  4. Secobarbital Elixir*
  5. Secobarbital Oral Solution
*Monographs currently named as Elixir will be renamed as Oral Solution

Current Procedures: Spectrohotometric Assays
Need Stability-indicating Assays


  1. Diethylstilbestrol Injection
  2. Diethylstilbestrol Diphosphate

Current Procedures: Miscelleneous Issues, including column not available, reagent not available, use of unsafe reagent, others; Need replacement procedures



Drug Products
  1. Aminophylline Injection
  2. Aminophylline Oral Solution
  3. Aminophylline Rectal Solution
  4. Aminophylline Suppositories
  5. Aminophylline Tablets
  6. Aromatic Ammonia Spirit
  7. Diethylstilbestrol Diphosphate Injection
  8. Epinephrine Injection
  9. Estradiol Injectable Suspension
  10. Fructose and Sodium Chloride Injection
  11. Lidocaine Hydrochloride Jelly
  12. Lidocaine Oral Topical Solution


Drug Substances
  1. Aminophylline
  2. Bromocriptine Mesylate
  3. Clemastine Fumarate
  4. Cyproheptadine Hydrochloride
  5. Dexbrompheniramine Maleate
  6. Dexchlorpheniramine Maleate
  7. Diphenhydramine Citrate
  8. Doxylamine Succinate
  9. Emedastine Difumarate
  10. Ephedrine
  11. Ephedrine Hydrochloride
  12. Ephedrine Sulfate
  13. Epinephrine
  14. Epinephrine Bitartrate
  15. Ethyl Chloride
  16. Fructose
  17. Isoflurane
  18. Isoproterenol Hydrochloride
  19. Mepivacaine Hydrochloride
  20. Methoxyflurane
  21. Oxtriphylline
  22. Tamoxifen Citrate

Current Procedure: Monographs having Limits for Ordinary Impurities using TLC; Need modern procedure(s) and limits consistent with the USP guideline



Drug Substances
  1. Acetazolamide
  2. Acyclovir
  3. Alclometasone Dipropionate
  4. Aminobenzoate Potassium
  5. Aminobenzoate Sodium
  6. Aminobenzoic Acid
  7. Anileridine
  8. Antipyrine
  9. Apomorphine Hydrochloride
  10. Benoxinate Hydrochloride
  11. Benzocaine
  12. Betamethasone
  13. Betamethasone Acetate
  14. Biperiden
  15. Biperiden Hydrochloride
  16. Butoconazole Nitrate
  17. Carbachol
  18. Carbinoxamine Maleate
  19. Cyclizine Hydrochloride
  20. Danazol
  21. Dextromethorphan
  22. Dextromethorphan Hydrobromide
  23. Diethylcarbamazine Citrate
  24. Diethylstilbestrol Diphosphate
  25. Diflunisal
  26. Dihydrocodeine Bitartrate
  27. Diphenoxylate Hydrochloride
  28. Ephedrine
  29. Ephedrine Hydrochloride
  30. Ephedrine Sulfate
  31. Estradiol Valerate
  32. Estrone
  33. Ethambutol Hydrochloride
  34. Ethinyl Estradiol
  35. Eucalyptol
  36. Fentanyl Citrate
  37. Eugenol
  38. Fluphenazine Decanoate
  39. Fluphenazine Enanthate
  40. Fluphenazine Hydrochloride
  41. Flurandrenolide
  42. Glycopyrrolate
  43. Halcinonide
  44. Hydromorphone Hydrochloride
  45. Hydroxyamphetamine Hydrobromide
  46. Hydroxychloroquine Sulfate
  47. Hydroxyprogesterone Caproate
  48. Indomethacin
  49. Isopropamide Iodide
  50. Levmetamfetamine
  51. Levorphanol Tartrate
  52. Mazindol
  53. Meclofenamate Sodium
  54. Menadione
  55. Mesoridazine Besylate
  56. Methadone Hydrochloride
  57. Methamphetamine Hydrochloride
  58. Methdilazione Hydrochloride
  59. Methimazole
  60. Methohexital
  61. Methylphenidate Hydrochloride
  62. Methysergide Maleate
  63. Naphazoline Hydrochloride
  64. Naproxen
  65. Naproxen Sodium
  66. Nitrofurazone
  67. Norethynodrel
  68. Nortriptyline Hydrochloride
  69. Noscapine
  70. Oxandrolone
  71. Oxtriphylline
  72. Oxymorphone Hydrochloride
  73. Pentazocine
  74. Pentazocine Hydrochloride
  75. Perphenazine
  76. Phenazopyridine Hydrochloride
  77. Phenelzine Sulfate
  78. Phenmetrazine Hydrochloride
  79. Phenoxybenzamine Hydrochloride
  80. Phensuximide
  81. Pilocarpine Hydrochloride
  82. Pimozide
  83. Prazosin Hydrochloride
  84. Prednisolone
  85. Primidone
  86. Procainamide Hydrochloride
  87. Prochlorperazine
  88. Prochlorperazine Edisylate
  89. Prochlorperazine Maleate
  90. Proparacaine Hydrochloride
  91. Propylthiouracil
  92. Pseudoephedrine Hydrochloride
  93. Pseudoephedrine Sulfate
  94. Pyridostigmine Bromide
  95. Pyrimethamine
  96. Resorcinol
  97. Rimantadine Hydrochloride
  98. Salicylamide
  99. Spironolactone
  100. Sulconazole Nitrate
  101. Sulfabenzamide
  102. Sulfacetamide Sodium
  103. Sulfadiazine
  104. Sulfamethazine
  105. Sulfamethizole
  106. Sulfathiazole
  107. Sulfisoxazole
  108. Sulfisoxazole Acetyl
  109. Sulindac
  110. Suprofen
  111. Testolactone
  112. Testosterone Enanthate
  113. Tetrahydrozoline Hydrochloride
  114. Thalidomide
  115. Thiethylperazine Maleate
  116. Thiopental Sodium
  117. Thioridazine Hydrochloride
  118. Tolmetin Sodium
  119. Triamterene
  120. Triflupromazine
  121. Trimeprazine Tartrate
  122. Zalcitabine

Current Procedure: Tests using Packed column GC; Replace With Modern Procedure



Drug Products
  1. Amantadine Hydrochloride Capsules
  2. Atropine Sulfate Ophthalmic Solution
  3. Azeotropic Isopropyl Alcohol
  4. Benzethonium Chloride Tincture
  5. Camphorated Phenol Topical Gel
  6. Chlorambucil Tablets
  7. Ciclopirox Olamine Cream
  8. Clioquinol and Hydrocortisone Cream
  9. Compound Undecylenic Acid Ointment
  10. Dimethy Sulfoxide Gel
  11. Doxepin Hydrochloride Oral Solution
  12. Dyphylline Elixir*
  13. Dyphylline Oral Solution
  14. Echothiophate for Ophthalmic Solution
  15. Ethchlorvynol Capsules
  16. Ether
  17. Guaifenesin and Codeine Phosphate Oral Solution
  18. Lindane Cream
  19. Malathion Lotion
  20. Methohexital Sodium for Injection
  21. Naftifine Hydrochloride Gel
  22. Phenytoin Sodium Injection
  23. Primidone Oral Suspension
  24. Primidone Tablets
  25. Resorcinol and Sulfur Lotion
  26. Scopolamine Hydrobromide Injection
  27. Secobarbital Sodium and Amobarbital Sodium Capsules
  28. Tetracaine and Menthol Ointment
  29. Valproic Acid Capsules
*Monographs currently named as Elixir will be renamed as Oral Solution

Drug Substances
  1. Alprazolam
  2. Amyl Nitrite
  3. Butabarbital
  4. Butorphanol Tartrate (Chrom purity)
  5. Chloroxylenol
  6. Clioquinol
  7. Colestipol Hydrochloride
  8. Cyclomethicone
  9. Desflurane
  10. Dihydroxyaluminum Sodium Carbonate
  11. Dimethy Sulfoxide
  12. Enflurane
  13. Ethchlorvynol
  14. Guanabenz Acetate
  15. Halothane
  16. Ifosfamide
  17. Indomethacin Sodium - Limit of acetone
  18. Isoflurane
  19. Isoflurophate
  20. Isopropyl Alcohol
  21. Isoxsuprine Hydrochloride
  22. Labetalol Hydrochloride
  23. Lanolin
  24. Meperidine Hydrochloride - Chrom. Purity test
  25. Mepivacaine Hydrochloride
  26. Metaproterenol Sulfate
  27. Methoxyflurane
  28. Modified Lanolin
  29. Padimate O
  30. Procyclidine Hydrochloride
  31. Rimantadine Hydrochloride
  32. Sufentanil Citrate (limit of acetone)
  33. Terpin Hydrate
  34. Triazolam
  35. Valproic Acid
  36. Vinblastine Sulfate
  37. Vincristine Sulfate
  38. Warfain Sodium


Excipients
  1. Isopropyl Alcohol
  2. Lanolin
  3. Modified Lanolin

Current Procedure using Open Column LC;
Replace With Updated HPLC Procedure



Drug Products
  1. Aspirin Capsules (Assay)
  2. Aspirin Suppositories (Assay)
  3. Pentazocine and Aspirin Tablets (Assay)
  4. Pentazocine Injection (Assay)
  5. Propoxyphene Hydrochloride, Aspirin, and Caffeine Capsules (Limit of salicylic acid)
  6. Propoxyphene Napsylate and Aspirin Tablets (Limit of salicylic acid)
  7. Tetracycline Hydrochloride for Topical Solution (Assay)

Drug Substances and Excipients Needing FT-IR ID Test



Drug Substances
  1. Dexamethasone Sodium Phosphate
  2. Estradiol Valerate
  3. Eucalyptol
  4. Eugenol
  5. Safflower Oil
  6. Sodium Salicylate


Excipients
  1. Aluminum Monostearate
  2. Amylene Hydrate
  3. Ascorbyl Palmitate
  4. Calcium Stearate
  5. Chlorocresol
  6. Oleic Acid
  7. Oleyl Alcohol
  8. Peppermint
  9. Petrolatum
  10. Phenylethyl alcohol
  11. Polyethylene Glycol Monomethylether
  12. Polyoxyl 40 Hydrogenated Castor Oil
  13. Polysorbate 40
  14. Polysorbate 60
  15. Sesame Oil
  16. White Petrolatum

Need Uniformity of Dosage Units Test


  1. Acetaminophen Suppositories
  2. Halcinonide Topical Solution
  3. Methadone Hydrochloride Oral Concentrate
  4. Oral Solution Containing at Least Three of the Following—Acetaminophen and Salts of Chlorpheniramine, Dextromethorphan, and Phenylpropanolamine
  5. Oxymorphone Hydrochloride Suppositories

Need Dissolution Test


  1. Benzonatate Capsules
  2. Guaifenesin and Pseudoephedrine Hydrochloride Capsules
  3. Guaifenesin, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Capsules
  4. Methadone Hydrochloride Tablets for Oral Suspension
  5. Salsalate Capsules

Safety Issues

Monographs where Benzene (Class 1 Solvent – 2 ppm Limit of Daily Exposure) is used as Reagent



Drug Products
  1. Estrone Injection
  2. Estrone Injectable Suspension
  3. Iodohippurate Sodium I 131 Injection
  4. Mesoridazine Besylate Oral Solution
  5. Norethindrone and Ethinyl Estradiol Tablets
  6. Stanozolol Tablets
  7. Tetracycline Hydrochloride for Topical Solution
  8. Triamcinolone Acetonide Cream
  9. Triamcinolone Acetonide Ointment
  10. Trichlormethiazide Tablets
  11. Butorphanol Tartrate Nasal Solution


Drug Substances
  1. Bromodiphenhydramine Hydrochloride
  2. Butorphanol Tartrate
  3. Epitetracycline Hydrochloride
  4. Methoxsalen
  5. Nitromersol
  6. Oxymetholone
  7. Resorcinol Monoacetate
  8. Testosterone
  9. Biperiden

Monographs where Carbon Tetrachloride (Class 1 Solvent – 4 ppm Limit of Daily Exposure) is used as Reagent



Drug Products
  1. Epinephryl Borate Ophthalmic Solution
  2. Ergotamine Tartrate Inhalation Aerosol
  3. Isoproterenol Hydrochloride and Phenylephrine Bitartrate
  4. Isoproterenol Sulfate Inhalation Aerosol
  5. Amyl Nitrite Inhalant
  6. Terbutaline Sulfate Inhalation Aerosol
  7. Trifluoperazine Hydrochloride Injection


Drug Substances
  1. Cyanocobalamin
  2. Hydroxocobalamin
  3. Amyl Nitrite
  4. Orphenadrine Citrate
  5. Psyllium Husk
  6. Rauwolfia Serpentina

Monographs where 1,1,1-Trichloroethane (Class 1 Solvent – 1500 ppm Limit of Daily Exposure) is used as Reagent


  1. Dydrogesterone
  2. Procaine Hydrochloride
  3. Rauwolfia Serpentina

Other Monographs with Safety Issues


  1. Clidinium Bromide (use of picric acid)
  2. Sodium Monofluorophosphate (use of radioactive thorium nitrate)

Others


  1. Phenylephrine Hydrochloride Nasal Solution (need test for pH)
  2. Propoxyphene Napsylate (need ID test for naphthalenesulfonic acid)