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PHR1431

Clopidogrel Bisulfate

Name: Clopidogrel Bisulfate
Brand: SIAL

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

(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

Empirical Formula (Hill Notation):

C₁₆H₁₆ClNO₂S · H₂SO₄

CAS Number:

120202-66-6

Molecular Weight:

419.90

Beilstein:

9967887

MDL number:

MFCD00876395

UNSPSC Code:

41116107

PubChem Substance ID:

329822595

NACRES:

NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to Ph. Eur. Y0001333
traceable to USP 1140430

API family

clopidogrel

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

SMILES string

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

Gene Information

human ... P2RY12(64805)

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Related Categories

Analytical Reference Standards

Certified Reference Materials

Pharmacopeia & Metrological Institute Standards

General description

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.

Application

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.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

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.

Footnote

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.

related product

Product No.

Description

Pricing

1140430

Clopidogrel bisulfate, United States Pharmacopeia (USP) Reference Standard

1140586

1140597

1140600

PHR1992

PHR1991

PHR1990

Pictograms

GHS05,GHS09

Signal Word

Danger

Hazard Statements

H314,H411

Precautionary Statements

P260 - P273 - P280 - P303 + P361 + P353 - P304 + P340 + P310 - P305 + P351 + P338

Hazard Classifications

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

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

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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)

Spectrophotometric and spectrodensitometric determination of Clopidogrel Bisulfate with kinetic study of its alkaline degradation.

Zaazaa HE, et al.

Talanta, 78(3), 874-884 (2009)

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)

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)

Point-of-care measurements of platelet inhibition after clopidogrel loading in patients with acute coronary syndrome: comparison of generic and branded clopidogrel bisulfate.

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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