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USP原料藥、相關(guān)雜質(zhì)、生物制劑-相關(guān)技術(shù)文章

更新時(shí)間:2024-07-15      瀏覽次數(shù):141

USP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、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)

分析方法的開發(fā),驗(yàn)證和轉(zhuǎn)移

通過測(cè)試未在各論中列出的雜質(zhì)來進(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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