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Merck

PHR1431

Supelco

Clopidogrel Bisulfate

Pharmaceutical Secondary Standard; Certified Reference Material

別名:

(S)-Methyl (2-chlorophenyl)(6,7-dihydro-4H-thieno[3,2-c]pyridin-5-yl)acetate hydrogensulfate, CLP

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About This Item

実験式(ヒル表記法):
C16H16ClNO2S · H2SO4
CAS番号:
分子量:
419.90
Beilstein:
9967887
MDL番号:
UNSPSCコード:
41116107
PubChem Substance ID:
NACRES:
NA.24

グレード

certified reference material
pharmaceutical secondary standard

品質水準

認証

traceable to Ph. Eur. Y0001333
traceable to USP 1140430

APIファミリー

clopidogrel

CofA

current certificate can be downloaded

包装

pkg of 1 g

テクニック

HPLC: suitable
gas chromatography (GC): suitable

アプリケーション

pharmaceutical (small molecule)

フォーマット

neat

保管温度

2-8°C

SMILES記法

OS(O)(=O)=O.COC(=O)[C@@H](N1CCc2sccc2C1)c3ccccc3Cl

InChI

1S/C16H16ClNO2S.H2O4S/c1-20-16(19)15(12-4-2-3-5-13(12)17)18-8-6-14-11(10-18)7-9-21-14;1-5(2,3)4/h2-5,7,9,15H,6,8,10H2,1H3;(H2,1,2,3,4)/t15-;/m0./s1

InChI Key

FDEODCTUSIWGLK-RSAXXLAASA-N

遺伝子情報

human ... P2RY12(64805)

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詳細

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
Clopidogrel Bisulfate is a novel antiplatelet agent which is chemically related to ticlopidine. It acts against ischaemic stroke, myocardial infraction as well as vascular disease. It is reported to have exhibited clinical efficacy greater than that of aspirin, during large phase III trials.

アプリケーション

Clopidogrel Bisulfate may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by various chromatography, spectrophotometric and spectrodensitometric techniques.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

アナリシスノート

このような2次標準は、入手可能な場合にはUSP、EP、BPの1次標準にマルチトレーサビリティを提供します。

その他情報

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

脚注

To see an example of a Certificate of Analysis for this material enter LRAC3034 in the slot below. This is an example certificate only and may not be the lot that you receive.

ピクトグラム

CorrosionEnvironment

シグナルワード

Danger

危険有害性情報

危険有害性の分類

Aquatic Chronic 2 - Eye Dam. 1 - Skin Corr. 1B

保管分類コード

8A - Combustible corrosive hazardous materials

WGK

WGK 3

引火点(°F)

Not applicable

引火点(℃)

Not applicable


適用法令

試験研究用途を考慮した関連法令を主に挙げております。化学物質以外については、一部の情報のみ提供しています。 製品を安全かつ合法的に使用することは、使用者の義務です。最新情報により修正される場合があります。WEBの反映には時間を要することがあるため、適宜SDSをご参照ください。

Jan Code

PHR1431-1G-PW:
PHR1431-1G:


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試験成績書(COA)

Lot/Batch Number

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A validated stability-indicating normal phase LC method for clopidogrel bisulfate and its impurities in bulk drug and pharmaceutical dosage form.
Rao DD, et al.
Journal of Pharmaceutical and Biomedical Analysis, 52(1), 160-165 (2010)
Spectrophotometric and spectrodensitometric determination of Clopidogrel Bisulfate with kinetic study of its alkaline degradation.
Zaazaa HE, et al.
Talanta, 78(3), 874-884 (2009)
Stability-indicating liquid chromatography for determination of clopidogrel bisulfate in tablets: Application to content uniformity testing.
Alarfaj NA
Journal of Saudi Chemical Society, 16(1), 23-30 (2012)
Concurrent estimation of clopidogrel bisulfate and aspirin in tablets by validated RP-HPLC method.
Shrivastava PK, et al.
Indian Journal of Pharmaceutical Sciences, 70(5), 667-667 (2008)
Kyoung-Woo Seo et al.
Clinical therapeutics, 36(11), 1588-1594 (2014-09-15)
Platelet-function suppression with antiplatelet therapy is effective in preventing and treating cardiovascular disease. Clopidogrel is a thienopyridine derivative that blocks platelet activation by adenosine diphosphate receptor binding. This study demonstrates the effects of generic clopidogrel bisulfate in comparison to branded

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