1、美国药典 USP 标准品USP 认证药物成分概述鉴于人们日益关注药物成分的质量和稳定性，USP 为活性药物成分 (API) 和药物辅料提供严格的认证计划。这项服务向制造厂商、监管机构和客户保证带有醒目的 USP 认证标记的原料药和辅料具有稳定的高质量。什么是 USP 药物成分认证？USP 认证药物成分标记USP 药物成份认证计划有助于公司达到最优质量管理实践。USP 专家向原料药厂商提供符合药品生产质量管理规范 (GMP) 的审查、文件审核、实验室测试和持续进行的变更报告以及监督服务。USP 认证标记代表什么？USP 将 USP 认证标记授予那些完全符合 USP 认证标准的公司和药物成分：认证
2、标准包括通过药品生产质量管理规范 (GMP) 的审查，全面的文件审核以及药物纯度和效力的测试。USP 认证标记可用于经认证成分的外包装及其分析证书，证实药品的质量和完整性。经 USP 认证的药物成分也将获颁 USP 合格证书 目前市场上质量最高，最全面的认证。购买经 USP 认证成分的药品制造厂商可以确信：成分的质量在各个批次中保持一致；成分达到标签或证书上有关特性、效力、纯度和质量的分析说明标准；成分严格按照国际公认的药品生产质量管理规范 (GMP) 对原料药和辅料的规定进行生产；并且达到可接受污染物限制要求。什么是认证流程？审核第一年要求达成四项工作内容，审核期间则视每种成分而有所不同：1
3、. 生产制造和质量控制文件的评估和审核2. 在制造厂商提供的期间内进行药品生产质量管理规范 (GMP) 审查3. 全面的实验室测试4. 监督和认证后审核，包括跟踪监控和变更报告为确保 USP 合格证书的完整性，在审核期间每年要执行以下工作内容：1. 评估和审核公司递交的年度报告中包含的文件2. 审查 审核期间需要进行关注于以前风险领域的自我审计。USP 可全权决定进行额外审查3. 对指定批次进行实验室测试1096702 Carprofen Related Compound A (50 mg) (carbazole)F0F276 1 86-74-81102974 Cetrimonium Brom
4、ide (1 g) F0F316 1 57-09-01134211 Cladribine Related Compound A (20 mg) (2-methoxy-2-deoxyadenosine)F0F244 1 24757-70-81188709 Diclofenac Potassium (200 mg) F0F269 1.000 mg/mg (dr) 1 15307-81-01224664 Docosyl Ferulate (50 mg) F0E143 0.99 mg/mg (ai) 1 101927-24-61287358 Gabapentin Related Compound D
5、(20 mg) (1-(3-oxo-2-aza-spiro4.5dec-2-ylmethyl)-cyclohexyl)aceticacid)F0F246 0.99 mg/mg (ai) 1 n/f1295724 Glyceryl Distearate (500 mg) F0F284 1 1323-83-71304209 Heptane (1.2 mL/ampule; 3 ampules) F0E211 0.99 mg/mg (ai) 1 142-82-51347700 Irbesartan (200 mg) F0F293 0.998 mg/mg (ai) 1 138402-11-6134780
6、2 Isobutyl acetate (1.2 mL/ampule; 3 ampules) F0E246 1.00 mg/mg (ai) 1 110-19-01350104 Isopropyl Acetate (1.2 mL/ampule; 3 ampules) F0E225 1.00 mg/mg (ai) 1 108-21-41482014 Oxandrolone Related Compound A CIII (20 mg) (17beta-hydroxy-17alpha-methyl-2-oxa-5alphaandrost-7-en-3-one)F0F137 1.00 mg/mg (ai
7、) 1 n/f1482036 Oxandrolone Related Compound C CIII (20 mg)(17,17-dimethyl-18-nor-2-oxa-5alpha-androst-13-en-3-one)F0F135 0.99 mg/mg (ai) 1 n/f1504933 Pentane (1.2 mL/ampule; 3 ampules) F0E196 1.00 mg/mg (ai) 1 109-66-01544304 Pirbuterol Acetate (200 mg) (AS) F0F256 1 65652-44-01547302 Polyoxyl 10 Ol
8、eyl Ether (1 mL) F0E078 1 9004-98-21576402 Propyl Acetate (1.2 mL/ampule; 3 ampules) F0E220 1.00 mg/mg (ai) 1 109-60-41609024 Salicylic Acid Related Compound B (100 mg) (4-hydroxyisophthalic acid)F0F272 0.99 mg/mg (ai) 1 636-46-41667905 Tizanidine Hydrochloride (200 mg) F0F226 0.997 mg/mg (ai) 1 644
9、61-82-11672206 Topiramate (200 mg) F0F297 0.996 mg/mg (ai) 1 97240-79-41672210 Topiramate Related Compound A (25 mg)(2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose)F0F279 1 20880-92-61042500 L-Arginine (200 mg) G2E280 1.000 mg/mg (dr) 2 G-1 (06/07)G (09/00)74-79-31081002 Butalbital CIII (2
10、00 mg) I0F204 0.999 mg/mg (ai) 2 H0C054 (12/07)G2B077 (07/04)G-2 (06/03)G (05/02)77-26-91091006 Capreomycin Sulfate (250 mg) G1F191 890 ug/mg (dr) 2 G (11/07)F (06/01)1405-37-41091221 Captopril Disulfide (100 mg) H0F251 0.99 mg/mg (ai) 2 G1B066 (12/07)G (01/04)64806-05-91095506 Carbidopa (400 mg) J0
11、F258 0.926 mg/mg (ai) 2 I (09/07)H (10/99)38821-49-71111103 Chlorhexidine Acetate (500 mg) H0F199 0.997 mg/mg (an) 2 G0E008 (11/07)F0C281 (02/06)56-95-11140430 Clopidogrel Bisulfate (125 mg) G0F282 0.988 mg/mg (ai) 2 F0E115 (11/07) 120202-66-61185020 Diazepam Related Compound A (25 mg) (2-Methyl-ami
12、no-5-chlorobenzophenone)I1F077 1.00 mg/mg (ai) 2 I (12/07)H-1 (11/02)H (04/00)1022-13-51186000 Diazoxide (200 mg) H0F314 0.999 mg/mg (ai) 2 G1C017 (11/07)G (12/03)364-98-71205003 Diltiazem Hydrochloride (200 mg) J0F005 0.999 mg/mg (dr) 2 I (11/07) 33286-22-51271733 Fluconazole Related Compound C (10
13、 mg) (1,1-(1,3-phenylene)di(1H-1,2,4-triazole)G0F202 0.99 mg/mg (ai) 2 F0D082 (12/07) n/f1287008 Furosemide (125 mg) K0F188 0.997 mg/mg (dr) 2 J1B131 (10/07)J (10/03)54-31-91288500 Gemfibrozil (200 mg) H1F285 0.997 mg/mg (ai) 2 H (11/07) 25812-30-01314009 Hydrochlorothiazide (200 mg) J0F070 0.997 mg
14、/mg (ai) 2 I (11/07)H (05/02)58-93-51329800 Hydroxypropyl Cellulose (200 mg) G0F066 0.999 mg/mg (dr) 2 F-1 (07/07) 9004-64-21336205 Ifosfamide (500 mg) H0F233 1.000 mg/mg (an) 2 G1C371 (12/07)G (03/06)F-1 (11/00)F (02/99)3778-73-21336806 Imidurea (200 mg) I0F180 2 H (09/07)G (10/99)39236-46-91342106
15、 Insulin Human (100 mg) I1F270 26.6 USP InsulinHuman Units/mg(ai)2 I0C383 (11/07)H1A031 (07/05)H (11/02)G (04/00)11061-68-01379106 Megestrol Acetate (500 mg) I1F281 0.999 mg/mg (an) 2 I (10/07)H (05/00)595-33-51392705 Mesalamine (200 mg) I0F121 1.000 mg/mg (dr) 2 H0C341 (12/07)G1B001 (06/05)G (01/03
16、)F-1 (03/00)89-57-61436006 Methylprednisolone Acetate (200 mg) I0F082 0.998 mg/mg (dr) 2 H0D148 (10/07)G-2 (05/05)G-1 (02/00)53-36-11449518 Nabumetone (200 mg) G0F312 0.997 mg/mg (ai) 2 F0C072 (11/07) 42924-53-81454008 Nandrolone CIII (50 mg) G0F291 1.00 mg/mg (ai) 2 F4D144 (10/07)F-3 (04/05)434-22-
17、01460000 Neostigmine Methylsulfate (200 mg) J0F167 1.000 (dr) 2 I (11/07)H (07/00)51-60-51470004 Norethindrone Acetate (100 mg) K0F227 0.996 mg/mg (ai) 2 J1E102 (11/07)J0B072 (09/06)I (04/03)H (06/99)51-98-91478582 Ondansetron Hydrochloride (300 mg) G1F249 0.993 mg/mg (an) 2 G0D154 (11/07)F0C222 (05
18、/05)103639-04-91478593 Ondansetron Related Compound A (50 mg)(3(Dimethylamino)methyl-1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-one hydrochloride)F1F240 2 F0C191 (10/07) 119812-29-21500273 Paroxetine Related Compound F (10 mg) (trans(-)-1-Methyl-3-(1,3-benzodioxol-5-yloxy)methyl-4-(4-fluorophenyl)pip
19、eridine)G0F221 1.00 mg/mg (ai) 2 F0D237 n/f1501108 Penicillamine Disulfide (200 mg) I0F234 1.00 mg/mg (dr) 2,3 H (10/07)G (07/00)20902-45-81554670 Praziquantel Related Compound C (50 mg) (2-(Nformylhexahydrohippuroyl)-1,2,3,4-tetrahydroisoquinolin-1-one)G0F288 1.00 mg/mg (dr) 2 F-2 (08/07)F-1 (06/00
20、)n/f1606503 Rutin (100 mg) G1F308 2 G0C355 (11/07)F (09/05)153-18-41000601 Acebutolol Hydrochloride (125 mg) F-1 34381-68-51001003 Acenocoumarol (200 mg) G0D300 F (10/05) 152-72-71001502 Acepromazine Maleate (250 mg) F-2 F-1 (05/02) 3598-37-61002505 Acesulfame Potassium (200 mg) F0C136 55589-62-3100
21、3009 Acetaminophen (400 mg) J2C423 0.996 mg/mg (dr) J-1 (04/06)J (05/02)I (05/99)103-90-21004001 Acetanilide Melting Point Standard (500 mg)(Approximately 114 degrees)M0A029 L (06/04)K (02/00)103-84-41005004 Acetazolamide (2 g) J1E041 0.997 mg/mg (dr) J (02/06) 59-66-51005706 Glacial Acetic Acid (1.
22、5 mL/ampule; 3 ampules)(AS)F0D002 99.9% (ai) 64-19-71006007 Acetohexamide (250 mg) H G-1 (06/99) 968-81-01006506 Acetohydroxamic Acid (200 mg) F-1 F (03/03) 546-88-31006801 Acetone (1.5 mL/ampule; 3 ampules) F0D028 0.997 mg/mg (ai) 67-64-11007000 Acetophenazine Maleate (200 mg) F-1 5714-00-11008501
23、Acetylcholine Chloride (200 mg) H0F091 1.000 mg/mg (dr) G (03/07) 60-31-11009005 Acetylcysteine (200 mg) H1B169 H (01/04) 616-91-11009901 Acetyltributyl Citrate (500 mg) G0C120 F (05/04) 77-90-71009923 Acetyltriethyl Citrate (500 mg) G0E085 F-1 (01/07)F (05/02)77-89-41011007 Acitretin (200 mg) F0E26
24、6 0.998 mg/mg (ai) 55079-83-91011018 Acitretin Related Compound A (20 mg)(2Z,4E,6E,8E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid) F0E264 69427-46-91011029 Acitretin Related Compound B (20 mg) (ethyl(all-E)-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,
25、8-tetraenoate) F0E265 54350-48-01012065 Acyclovir (300 mg) J0C149 I (06/04) 59277-89-31012076 Acyclovir Related Compound A (50 mg) (AS) (2-(2-amino-6-oxo-1,6-dihydro-9H-purin-9-yl)-methoxyethyl acetate) F0F010 n/f1012134 Ademetionine Disulfate Tosylate (500 mg) F0D073 97540-22-21012101 Adenine (200
26、mg) G2D279 1.000 mg/mg (dr) G-1 (12/05) G (06/00) 73-24-51012123 Adenosine (200 mg) G0C295 F1B058 (01/05) F (04/03) 58-61-71012190 Adipic Acid (100 mg) F0D318 124-04-91012145 Agigenin (25 mg) F n/f1012203 Agnuside (25 mg) F0D397 0.88 mg/mg (ai) 11027-63-71012495 Beta Alanine (100 mg) F0F111 1.00 mg/
27、mg (ai) 107-95-91012509 L-Alanine (200 mg) G0E002 1.00 mg/mg (ai) F-2 (08/06) F-1 (04/01) 56-41-71012553 Albendazole (200 mg) H0E240 0.996 mg/mg (dr) G (10/06)F-1 (01/00)54965-21-81012600 Albuterol (200 mg) I H (12/00) 18559-94-91012633 Albuterol Sulfate (200 mg) J I (04/00) 51022-70-91012757 Alclom
28、etasone Dipropionate (300 mg) I0C302 0.992 mg/mg (ai) H (09/07)G (01/00)66734-13-21012768 Alcohol (1.2 mL/ampule; 5 ampules) F0D030 64-17-51012772 Dehydrated Alcohol (1.2 mL/ampule; 5 ampules)F0D031 64-17-51012699 Alcohol DeterminationAcetonitrile (5 mL/ampule;5 ampules)F0C419 2% v/v (ai) n/f1012688
29、 Alcohol DeterminationAlcohol (5 mL/ampule;5 ampules)F0C399 1.96% v/v (ai) n/f1012780 Alendronate Sodium (200 mg) G0D288 0.834 mg/mg (ai) F0B315 (02/06) 121268-17-51012906 Alfentanil Hydrochloride CII (500 mg) F0B016 70879-28-61012939 Allantoin (200 mg) F0C169 97-59-61012950 Alliin (25 mg) F 556-27-
30、41013002 Allopurinol (250 mg) J0C186 I-1 (01/05)I (07/02)315-30-01013024 Allopurinol Related Compound A (50 mg) (3-Amino-4-carboxamidopyrazole Hemisulfate)G F-3 (05/02)F-2 (04/99)n/f1013057 S-Allyl-L-Cysteine (25 mg) F n/f1014005 Alphaprodine Hydrochloride CII (250 mg) F 561-78-41015008 Alprazolam C
31、IV (200 mg) H1C133 H (06/05) 28981-97-71016000 Alprostadil (25 mg) H1F110 0.991 mg/mg (ai) H (06/07) 745-65-31017105 Altretamine (500 mg) F 645-05-61017502 Dried Aluminum Hydroxide Gel (200 mg) F2B120 F-1 (01/04) 21645-51-21017364 Aluminum Sulfate (2 g) (AS) F0D342 55.3 % (ai) 17927-65-01018505 Aman
32、tadine Hydrochloride (200 mg) H1D207 0.998 mg/mg (ai) H (02/06)G (04/01)665-66-71019202 Amcinonide (200 mg) H0D346 0.995 mg/mg (ai) G0B260 (06/06)F-1 (03/04)51022-69-61019417 Amifostine Disulfide (25 mg) F0C152 112901-68-51019508 Amikacin (300 mg) J0E226 0.981 mg/mg (an) I (10/06)H (08/00)37517-28-5
33、1019701 Amiloride Hydrochloride (500 mg) H 17440-83-41019712 Amiloride Related Compound A (30 mg) (AS)(Methyl 3,5-diamino-6-chloropyrazine-2-carboxylate)F0E287 1458-01-11019756 Aminobenzoate Potassium (200 mg) F-1 F (06/01) 138-84-11019767 Aminobenzoate Sodium (200 mg) F 55-06-61019803 Aminobenzoic
34、Acid (200 mg) (p-aminobenzoic acid)H1C083 H (10/04)G (10/00)150-13-01020008 Aminobutanol (500 mg) G-1 G (06/99) 96-20-81021000 Aminocaproic Acid (200 mg) G0D101 0.997 mg/mg (dr) F-4 (09/05) 60-32-21022808 2-Amino-5-chlorobenzophenone (25 mg) J0F197 1.00 mg/mg (ai) I (09/07)H-1 (01/03)719-59-51025205
35、 Aminoglutethimide (200 mg) F 125-84-81025307 m-Aminoglutethimide (100 mg) G F (05/01) n/f1025351 Aminohippuric Acid (200 mg) F-1 61-78-91025806 2-3-Amino-5-(n-methylacetamido)-2,4,6-triiodobenzamido-2-deoxy-d-glucose (25 mg)F n/f1025908 Aminopentamide Sulfate (200 mg) F0B273 60-46-81021204 4-Aminop
36、henol (100 mg) F0F099 0.99 mg/mg (ai) 123-30-81026004 m-Aminophenol (300 mg) F 591-27-51026401 Aminosalicylic Acid (125 mg) F-1 F (03/99) 65-49-61026605 3-Amino-2,4,6-triiodobenzoic Acid (50 mg) G 3119-15-11027007 5-Amino-2,4,6-triiodo-N-methylisophthalamic Acid (50 mg)F-1 2280-89-91027302 Amiodaron
37、e Hydrochloride (200 mg) F0D257 0.995 mg/mg (ai) 19774-82-41028000 Amitraz (200 mg) F0C042 (08/07) 33089-61-11029002 Amitriptyline Hydrochloride (200 mg) J0A004 I (03/03) 549-18-81029501 Amlodipine Besylate (350 mg) G0F133 0.997 mg/mg (an) F0D167 (06/07) 111470-99-61029909 Ammonio Methacrylate Copol
38、ymer Type A (100 mg)F-1 F (06/01) 33434-24-11029910 Ammonio Methacrylate Copolymer Type B (100 mg) F2C082 F-1 (06/05)F (05/00)33434-24-11029942 Ammonium Carbonate (2 g) (AS) F0D102 33.3% NH3 (ai) 8000-73-51029953 Ammonium Chloride (200 mg) F0C134 12125-02-91029986 Ammonium Phosphate Dibasic (1 g) (A
39、S) F0D104 100.0 % (ai) 7783-28-01030001 Amobarbital CII (200 mg) F-2 57-43-21031004 Amodiaquine Hydrochloride (500 mg) H0B238 G-1 (04/03) 6398-98-71031401 Amoxapine (200 mg) G1D375 1.000 mg/mg (dr) G (03/07) F-1 (04/02)14028-44-51031503 Amoxicillin (200 mg) J0C043 I (07/04) 61336-70-71032007 Amphote
40、ricin B (125 mg) J3C246 1009 ug/mg (dr) J-2 (01/05)J-1 (07/02)1397-89-31033000 Ampicillin (200 mg) K0D139 998 ug/mg (dr) J-1 (05/07)J (12/01)69-53-41033203 Ampicillin Sodium (125 mg) G-1 G (10/99) 69-52-31033407 Ampicillin Trihydrate (200 mg) G1D147 G (08/05) 7177-48-21034002 Amprolium (200 mg) G0C3
41、17 0.991 mg/mg (dr) F-1 (04/05)F (04/02)121-25-51034308 Amrinone (500 mg) G 60719-84-81034320 Amrinone Related Compound A (100 mg) (5-carboxamide3,4-bipyridin-6(1H)-one) F 62749-46-61034341 Amrinone Related Compound B (100 mg) (N-(1,6-dihydro-6-oxo-(3,4-bipyridine)-5-yl)-2-hydroxypropanamide) F-1 F
42、(03/00) n/f1034363 Amrinone Related Compound C (50 mg) (1,6-dihydro-6-oxo-(3,4-bipyridine)-5-carbonitrile) F-1 F (05/00) n/f1034909 Anecortave Acetate (200 mg) F0E298 0.997 mg/mg (ai) 7753-60-81034910 Anecortave Acetate Related Compound A (20 mg) (9(11)-dehydrocortisol) F0E299 10184-70-01035005 Anet
43、hole (2 mL) (AS) F0E023 4180-23-81036008 Anileridine Hydrochloride CII (250 mg) F 126-12-51036507 3-Anilino-2-(3,4,5-trimethoxybenzyl) acrylonitrile (25 mg) (AS) G2D383 G-1 (04/06) 30078-48-91037011 Anisole (1.2 mL/ampule; 3 ampules) F0E216 1.00 mg/mg (ai) 100-66-31038003 Antazoline Phosphate (200 m
44、g) H G-1 (04/02) 154-68-71039006 Anthralin (200 mg) I0B221 H (11/02) 1143-38-01040005 Antipyrine (200 mg) G1F162 0.999 mg/mg (ai) G (08/07) F-4 (09/01) 60-80-01040708 Apigenin-7-glucoside (30 mg) F n/f1041008 Apomorphine Hydrochloride (250 mg) H G (01/03) 41372-20-71041609 Apraclonidine Hydrochlorid
45、e (100 mg) H0B112 (12/07) G (06/03) 73218-79-81042000 Aprobarbital CIII (200 mg) (AS) DISCONTINUED F-1 (02/07) 77-02-11042102 L-Arabinitol (500 mg) F0E311 1.00 mg/mg (an) 7643-75-61042500 L-Arginine (200 mg) G2E280 1.000 mg/mg (dr) 2 G-1 (06/07) G (09/00)74-79-31042601 Arginine Hydrochloride (125 mg
46、) G0B060 F-1 (05/03) 1119-34-21042703 Arsanilic Acid (25 mg) F 98-50-01043003 Ascorbic Acid (1 g) (Vitamin C) Q0B012 P (04/03) 50-81-71043105 Ascorbyl Palmitate (2 g) (AS) F0D326 0.988 mg/mg (ai) 137-66-61043502 Asparagine Anhydrous (200 mg) F0E013 1.00 mg/mg (dr) 70-47-31043513 Asparagine Monohydra
47、te (200 mg) F0E012 1.00 mg/mg (ai) 5794-13-81043706 Aspartame (200 mg) H1B125 H (05/03) 22839-47-01043750 Aspartame Acesulfame (200 mg) F0C137 106372-55-81043728 Aspartame Related Compound A (25 mg) (5-Benzyl-3,6-dioxo-2-piperazineacetic Acid) I0D208 0.99 mg/mg (ai) H (11/05) G-1 (10/99) 5262-10-210
48、43819 Aspartic Acid (100 mg) F0B087 6899-03-21044006 Aspirin (500 mg) H G-1 (11/02) 50-78-21044301 Astemizole (200 mg) F 68844-77-91044403 Atenolol (200 mg) I0F032 0.999 mg/mg (dr) H1C320 (04/07) H (01/05) G (08/01)29122-68-71044651 Atovaquone (200 mg) F0B190 95233-18-41044662 Atovaquone Related Compound A (25 mg) (cis-2-4-(4-chlorophenyl)cyclohexyl-3-hydroxy-1,4-naphthoquinone) F0B188 n/f1044800 Atracurium Besylate (100 mg) F0B143 64228-81-51045009 Atropine Sulfate (500 mg) M0B098 L-2 (04/03) L-1 (06/02)L (10/00)5908-99-61045337 Avobenzone (500
