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

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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

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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

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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

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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

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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

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Other Monographs with Safety Issues

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

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Others

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