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            北京云肽生物科技有限公司
            中級(jí)會(huì)員 | 第2年

            13269190901

            生化試劑
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            分子生物學(xué)
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            儀器耗材

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

            時(shí)間:2024/7/15閱讀:656
            分享:

            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-{[2'-(1H-tetrazole-5-yl)biphenyl-4-yl]methyl)}D-valine)


            1708784

            EA

            Valsartan Related Compound B (10 mg) (N-butyryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]methyl}-L-valine)

            137863-20-8

            1708795

            EA

            Valsartan Related Compound C (10 mg) (N-valeryl-N-{[2'-(1H-tetrazole-5-yl)biphenyl-4-yl]methyl}-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-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-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'-({2-Butyl-5-[(5-{4'-[(2-butyl-4-chloro-5-hydroxymethyl-1H-imidazol-1-yl)methyl]biphenyl-2-yl}-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-{(1R,2R,3R)-3-Hydroxy-2-[(S,E)-3-hydroxyoct-1-en-1-yl]-5-oxocyclopentyl}hept-5-enoic acid)


            1370509

            EA

            Losartan Related Compound D (20 mg) (5-[4'-({2-Butyl-5-[(5-{4'-[(2-butyl-4-chloro-5-hydroxymethyl-1H-imidazol-1-yl)methyl]biphenyl-2-yl}-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-{[2'-(1H-Tetrazol-5-yl)biphenyl-4-yl]methyl}-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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