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更新時(shí)間：2024-07-15 
瀏覽次數(shù)：157USP原料藥、相關(guān)雜質(zhì)、生物制劑、輔料、植物性治療藥物、聚合物、近紅外和溶出度校正片、顯微照片
美國(guó)藥典委員會(huì) (USP) 是一家非營(yíng)利性科研機(jī)構(gòu)，為quan世界生產(chǎn)、經(jīng)銷(xiāo)、使用的藥品、食品成分和膳食補(bǔ)充劑的質(zhì)量、純度、鑒定和濃度設(shè)立標(biāo)準(zhǔn)。USP 的標(biāo)準(zhǔn)在美國(guó)由藥品與食品管理局 (FDA) 強(qiáng)制實(shí)施，quan世界有 140 多個(gè)國(guó)家地區(qū)也在制定和采用這些標(biāo)準(zhǔn)。
USP 標(biāo)準(zhǔn)物質(zhì)是特性ji強(qiáng)的物理樣本，被制藥及相關(guān)行業(yè)用來(lái)進(jìn)行各種測(cè)試，以幫助驗(yàn)證藥品（藥品、生物制劑和輔料）、食物補(bǔ)充劑和食品成分的特性、效力、質(zhì)量和純度。
USP提供 3500多種標(biāo)準(zhǔn)物質(zhì)，包括原料藥、相關(guān)雜質(zhì)、生物制劑、輔料、植物性治療藥物、聚合物、近紅外和溶出度校正片、顯微照片等。
在早期配方可行性研究期間的分析測(cè)試
在工藝研發(fā)過(guò)程中的深入研究以證明重結(jié)晶時(shí)的損耗
比較保留時(shí)間/光譜做峰鑒定或確認(rèn)
確定相對(duì)響應(yīng)因子
確定加速試驗(yàn)研究中產(chǎn)生的降解雜質(zhì)
識(shí)別在ICH穩(wěn)定性條件下形成的未知雜質(zhì)
確定參比藥物中存在的雜質(zhì)
分析方法的開(kāi)發(fā)，驗(yàn)證和轉(zhuǎn)移
通過(guò)測(cè)試未在各論中列出的雜質(zhì)來(lái)進(jìn)行活性藥物成分(API)或藥品的放行
USP品牌部分產(chǎn)品訂購(gòu)信息：
Casno | 貨號(hào) | 規(guī)格 | 品名 |
157283-68-6 | 1673001 | 3ml | Travoprost (3 mL) (COLD SHIPMENT REQUIRED) |
1004001 | EA | Acetanilide Melting Point Standard (1g) (Approximately 114 degrees) N-乙酰ben胺 | |
979-92-0 | 1012112 | EA | S-Adenosyl-L-Homocysteine (50 mg) |
61-19-8 | 1012178 | EA | 5'-Adenylic Acid (500 mg) 5'-腺嘌呤核苷酸 |
56-41-7 | 1012509 | EA | L-Alanine (200 mg) L-丙氨酸(99%). |
1012688 | EA | Alcohol Determination--Alcohol (5 mL/ampule; 5 ampules) | |
1012768 | EA | Alcohol (1.2 mL/ampule; 5 ampules) 乙醇，無(wú)水 | |
41372-20-7 | 1041008 | EA | Apomorphine Hydrochloride (250 mg) |
170729-80-3 | 1041904 | EA | Aprepitant (150 mg) |
121-30-2 | 1057507 | EA | Benzothiadiazine Related Compound A (100 mg) (4-Amino-6-chloro-1,3-benzenedisulfonamide) 4-氨基-6-氯-1,3-苯二磺酰胺 |
107-43-7 | 1065695 | EA | Betaine (1 g) 無(wú)水甜菜堿(98%) |
58-85-5 | 1071508 | EA | Biotin (200 mg) 生物素 |
980-71-2 | 1078008 | EA | Brompheniramine Maleate (125 mg) |
137-08-6 | 1087009 | EA | Calcium Pantothenate (200 mg) (Vitamin B5) 泛酸鈣 |
145040-37-5 | 1087803 | EA | Candesartan Cilexetil (100 mg) 坎地沙坦酯 |
154361-50-9 | 1090706 | EA | Capecitabine (200 mg) 卡培他濱 |
1090739 | EA | Capecitabine Related Compound C (10 mg) (2',3'-O-carbonyl-5'-deoxy-5-fluoro-N4-(pentyloxycarbonyl)cytidine) (COLD SHIPMENT REQUIRED) | |
67-97-0 | 1131009 | EA | Cholecalciferol (30 mg/ampule; 5 ampules) (Vitamin D3) 維生素D3 |
2586-89-9 | 1148500 | EA | Copovidone (100 mg) |
10016-20-3 | 1154558 | EA | Alpha Cyclodextrin (500 mg) α-水合環(huán)糊精 |
17465-86-0 | 1154591 | EA | Gamma Cyclodextrin (200 mg) γ-環(huán)糊精 |
68-41-7 | 1158005 | EA | Cycloserine (250 mg) D-(+)-環(huán)絲氨酸 |
3734-33-6 | 1171003 | EA | Denatonium Benzoate (200 mg) |
84-66-2 | 1193505 | EA | Diethyl Phthalate (200 mg) 鄰苯二甲酸二乙酯(99%) |
1200000 | EA | Digoxin (250 mg) 地gao辛 | |
154598-52-4 | 1234103 | EA | Efavirenz (200 mg) |
1235503 | EA | Endotoxin (10,000 USP Endotoxin Units) (COLD SHIPMENT REQUIRED) | |
153439-40-8 | 1270377 | EA | Fexofenadine Hydrochloride (200 mg) 鹽酸非索非那定 |
76811-98-8 | 1270388 | EA | Fexofenadine Related Compound A (25 mg) (4-[1-oxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-alpha,alpha-dimethyl benzeneacetic acid) |
129332-29-2 | 1285964 | EA | Fluvastatin Related Compound B (15 mg) ([R*,S*-E]-(+/-)-7-[3-(4-fluorophenyl)-1-methylethyl-1H-indol-2-yl]-3,5-dihydroxy-6-heptenoic acid 1,1, dimethylethyl ester) |
59-30-3 | 1286005 | EA | Folic Acid (500 mg) (Vitamin M or Vitamin Bc) 葉酸水合物 |
1286129 | EA | Formoterol Fumarate Resolution Mixture (20 mg) | |
9003-07-0 | 1311306 | EA | Homopolymer Polypropylene (3 Strips) |
58-93-5 | 1314009 | EA | Hydrochlorothiazide (200 mg) 雙氫氯噻嗪 |
50-03-3 | 1317007 | EA | Hydrocortisone Acetate (200 mg) 乙酸氫化可的松 |
74431-23-5 | 1337809 | EA | Imipenem Monohydrate (100 mg) |
92339-11-2 | 1343517 | EA | Iodixanol (200 mg) |
138402-11-6 | 1347700 | EA | Irbesartan (200 mg) 厄貝沙坦 |
748812-53-5 | 1347711 | EA | Irbesartan Related Compound A (25 mg) (1-pentanoylamino-cyclopentanecarboxylic acid [2\'-(1H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-amide) |
64519-82-0 | 1349626 | EA | Isomalt (200 mg) |
54-85-3 | 1349706 | EA | Isoniazid (200 mg) 異煙酸肼 |
124750-99-8 | 1370462 | EA | Losartan Potassium (150 mg) 氯沙坦鉀 |
90-64-2 | 1375058 | EA | Mandelic Acid (500 mg) DL-扁桃酸/苯基乙醇酸 |
69-65-8 | 1375105 | EA | Mannitol (1.5 g) 甘露醇 |
1115-70-4 | 1396309 | EA | Metformin Hydrochloride (200 mg) 鹽酸二jia雙胍 |
1441232 | EA | Metoprolol Related Compound A (20 mg) ((+/-)1-(ethylamino)-3-[4-(2-methoxyethyl)phenoxy]-propan-2-ol) | |
1441243 | EA | Metoprolol Related Compound B (100 mg) ((+/-)1-Chloro-2-hydroxy-3-[4-(2-methoxyethyl)phenoxy]-propane) | |
1441254 | EA | Metoprolol Related Compound C (15 mg) ((+/-)4-[2-Hydroxy-3-(1-methylethyl) aminopropoxy]benzaldehyde hydrochloride) | |
1486464-40-7 | 1441265 | EA | Metoprolol Related Compound D (50 mg) ((+/-)N,N-bis-[2-hydroxy-3-[4-(2-methoxyethyl)phenoxy]propyl](1-methylethyl) amine hydrochloride) |
98418-47-4 | 1441298 | EA | Metoprolol Succinate (200 mg) |
577953-88-9 | 1446815 | EA | Montelukast Dicyclohexylamine (150 mg) |
1446837 | EA | Montelukast for Peak Identification (20 mg) | |
577953-88-9 | 1446848 | EA | Montelukast Racemate (20 mg) |
151767-02-1 | 1446859 | EA | Montelukast Sodium (50 mg) 孟魯司特鈉 |
98-92-0 | 1462006 | EA | Niacinamide (500 mg) 煙酰胺 |
132539-06-1 | 1478301 | EA | Olanzapine (200 mg) |
204255-11-8 | 1479304 | EA | Oseltamivir Phosphate (200 mg) 磷酸奧斯他韋 |
57-10-3 | 1492007 | EA | Palmitic Acid (500 mg) 棕櫚酸(98%) |
92-84-2 | 1525707 | EA | Phenothiazine (500 mg) 吩噻嗪，99% |
25322-68-3 | 1546580 | EA | Polyethylene Glycol 6000 (1 g) 聚乙二醇M.W.6000 |
9002-88-4 | 1546707 | EA | High Density Polyethylene (3 strips) 高密度聚乙烯 |
7447-40-7 | 1548190 | EA | Potassium Chloride (1 g) 氯hua鉀 |
24634-61-5 | 1548407 | EA | Potassium Sorbate (1 g) 山梨酸鉀[生物學(xué)研究用] |
53-03-2 | 1559006 | EA | Prednisone (250 mg) |
53-03-2 | 1559505 | EA | Prednisone Tablets (30 tablets) |
1570406 | EA | 1-Propanol (1.2 mL/ampule; 3 ampules) 1-丙醇 | |
13345-51-2 | 1578554 | EA | Prostaglandin B1 (25 mg) ((13E,15S)-15-Hydroxy-9-oxoprosta-8(12),13-dien-1-oic Acid) |
207671-44-1 | 1597005 | EA | Quinine Sulfate (500 mg) 硫酸奎寧 |
1598450 | EA | Ranitidine Resolution Mixture (20 mg) | |
83-88-5 | 1603006 | EA | Riboflavin (500 mg) 維生素 B2 |
153-18-4 | 1606503 | EA | Rutin (100 mg) 蕓香苷三水合物 |
79902-63-9 | 1612700 | EA | Simvastatin (200 mg) 辛伐他汀 |
7647-14-5 | 1613804 | EA | Sodium Chloride (1 g) 氯化鈉(99+%) |
9063-38-1 | 1614669 | EA | Sodium Starch Glycolate Type A (400 mg) 羧甲淀粉鈉 |
57-50-1 | 1623637 | EA | Sucrose (100 mg) 蔗糖 |
144701-48-4 | 1643419 | EA | Telmisartan (200 mg) 替米沙坦 |
1026353-20-7 | 1643437 | EA | Telmisartan Related Compound B (15 mg) (4'-[(1,7'-dimethyl-2'-propyl-1H,1'H-2,5'-bibenzo[d]imidazol-1'-yl)methyl]biphenyl-2-carboxylic acid) |
206184-49-8 | 1643601 | EA | Tenofovir (15 mg) |
7695-91-2 | 1667701 | EA | Alpha Tocopheryl Acetate (250 mg) (Vitamin E Acetate) (COLD SHIPMENT REQUIRED) 維生素E醋酸酯 |
77-86-1 | 1698002 | EA | Tromethamine (125 mg) 三羥甲基氨基甲wan |
73-22-3 | 1700501 | EA | L-Tryptophan (200 mg) L-色氨酸 |
124832-27-5 | 1707839 | EA | Valacyclovir Hydrochloride (200 mg) 伐昔洛韋鹽酸鹽水合物 |
99-66-1 | 1708707 | EA | Valproic Acid (500 mg) 2-正丙基正戊suan |
137862-53-4 | 1708762 | EA | Valsartan (350 mg) 纈沙坦 |
137862-87-4 | 1708773 | EA | Valsartan Related Compound A (10 mg) (N-valeryl-N-D-valine) |
1708784 | EA | Valsartan Related Compound B (10 mg) (N-butyryl-N--L-valine) | |
137863-20-8 | 1708795 | EA | Valsartan Related Compound C (10 mg) (N-valeryl-N--L-valine benzyl ester) |
127-47-9 | 1716002 | EA | Retinyl Acetate (Vitamin A) (10 ampuls x 0.5 g) 乙酸維生素A 凝膠, powder, 500,000 I.U./g |
7361-61-7 | 1720407 | EA | Xylazine (200 mg) 賽拉嗪 |
39831-55-5 | 1019494 | EA | Amikacin Sulfate (100 mg) |
165800-03-3 | 1367561 | EA | Linezolid (200 mg) |
83857-96-9 | 1370473 | EA | Losartan Related Compound A (20 mg) (2-Butyl-4-chloro-1H-imidazole-5-carbaldehyde) |
163222-33-1 | 1269028 | 250mg | Ezetimibe (250 mg) |
1269039 | 20mg | Ezetimibe System Suitability Mixture (20 mg) | |
654671-77-9 | 1612903 | EA | Sitagliptin Phosphate (200 mg) |
76646-91-8 | 1623783 | EA | Sulbactam Related Compound E (15 mg) ((2S,5R)-6,6-Dibromo-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid 4,4-dioxide) |
301-02-0 | 1545034 | EA | Plastic Additive 12 (100 mg) (Oleamide) |
1006062-27-6 | 1370484 | EA | Losartan Related Compound B (20 mg) (2-Butyl-4-chloro-(1--1H-imidazol-5-yl)methyl acetate) |
6683-19-8 | 1544938 | EA | Plastic Additive 2 (200 mg) (pentaerythrityl tetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]) |
31570-04-4 | 1544964 | EA | Plastic Additive 5 (200 mg) (Tris(2,4-di-tert-butylphenyl) phosphite) |
5451-09-2 | 1025715 | EA | Aminolevulinic Acid Hydrochloride (200 mg) |
1370510 | EA | Losartan Related Compound E (20 mg) (5-[4'-(-2H-tetrazol-2-yl)methyl]-4-chloro-1H-imidazol-1-yl}methyl)biphenyl-2-yl]tetrazol, potassium salt) | |
114798-36-6 | 1370495 | EA | Losartan Related Compound C (20 mg) (2-Butyl-4-chloro-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-imidazol-5-carbaldehyde) |
112-84-5 | 1545045 | EA | Plastic Additive 13 (100 mg) (Erucamide) |
23315-18-6 | 1623749 | EA | Sulbactam Related Compound A (15 mg) ((2S)-2-Amino-3-methyl-3-sulfinobutanoic acid) |
24158-88-1 | 1623794 | EA | Sulbactam Related Compound F (15 mg) ((2S,5R)-6,6-Dibromo-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid) |
36150-00-2 | 1213136 | EA | Dinoprostone Related Compound C (20 mg) ((E)-7-hept-5-enoic acid) |
1370509 | EA | Losartan Related Compound D (20 mg) (5-[4'-(-1H-tetrazol-1-yl)methyl]-4-chloro-1H-imidazol-1-yl}methyl)biphenyl-2-yl]tetrazol, potassium salt) | |
693-36-7 | 1545012 | EA | Plastic Additive 10 (100 mg) (dioctadecyl 3,3'-thiodipropionate) |
1716-12-7 | 1614512 | EA | Sodium Phenylbutyrate (200 mg) |
111974-72-2 | 1592704 | EA | Quetiapine Fumarate (100 mg) |
4027-64-9 | 1623772 | EA | Sulbactam Related Compound D (15 mg) (Potassium (2S,5R,6R)-6-bromo-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate) |
2923-18-4 | 1615138 | EA | Sodium Trifluoroacetate (500 mg) |
27676-62-6 | 1544971 | EA | Plastic Additive 6 (200 mg) (1,3,5-Tris(3,5-di-tert-butyl-4-hydroxybenzyl)-s-triazine-2,4,6(1H,3H,5H)-trione) |
921769-65-5 | 1090739-10MG | 10MG | Capecitabine Related Compound C |
9003-39-8 | 1150706-100MG | 100MG | Crospovidone 聚乙烯吡luo烷酮 |
61718-82-9 | 1285909-200MG | 200MG | Fluvoxamine maleate 伏氟沙明馬來(lái)酸鹽 |
56-40-6 | 1295800-200MG | 200MG | Glycine 甘氨酸 |
50-21-5 | 1356734-3X1.5ML | 1.5ML | Lactic acid 乳酸 |
506-44-5 | 1367699-5X30MG | 5X30MG | Linolenyl alcohol |
1115-70-4 | 1396309-200MG | 200MG | Metformin hydrochloride 二jia雙胍 鹽酸鹽 |
98418-47-4 | 1441298-200MG | 200MG | Metoprolol succinate United States Pharmacopeia (USP) Reference Standard |
1500502-1SET | 1SET | Particle Count Set 微粒計(jì)數(shù)集 | |
9002-88-4 | 1546707-3STRIPS | 3STRIPS | High Density Polyethylene 高密度聚乙烯 |
9005-64-5 | 1547925-2G | 2G | Polysorbate 20 聚山梨酯20 |
9003-39-8 | 1551503-100MG | 100MG | Povidone 聚維酮 |
318-98-9 | 1576005-200MG | 200MG | Propranolol hydrochloride United States Pharmacopeia (USP) Reference Standard |
129101-54-8 | 1604858-200MG | 200MG | Rivastigmine tartrate 卡巴拉汀 酒石酸酯 |
8001-21-6 | 1642347-1G | 1G | Sunflower Oil (1 g) |
148553-51-9 | 1559629 | EA | Pregabalin Related Compound A United States Pharmacopeia (USP) Reference Standard |
61312-87-6 | 1559647 | EA | Pregabalin Related Compound C United States Pharmacopeia (USP) Reference Standard |
67-48-1 | 1133547-500MG | 500MG | Choline chloride 氯化膽堿 |
1133977 | 250mg | Cinacalcet Hydrochloride 鹽酸西那卡塞 | |
137-58-6 | 1366002-250MG | 250MG | Lidocaine |
165800-03-3 | 1367561-200MG | 200MG | Linezolid 利奈唑胺 |
1478367 | 100mg | Olmesartan Medoxomil (100 mg) 奧美沙坦酯 | |
849206-43-5 | 1478378 | 20mg | Olmesartan Medoxomil Related Compound A (20 mg) (1--4,4-dimethyl-2-propyl-1H-furo[3,4-d]imidazol-6(4H)-one) 奧美沙坦酯組分A |
9000-70-8 | 1288485-500MG | 500MG | Gelatin 明膠 |
50-03-3 | 1317007-200MG | 200MG | Hydrocortisone Acetate (200 mg) |
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