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Merck
CN

PHR1431

Clopidogrel Bisulfate

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
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329822595
MDL number:
MFCD00876395
Beilstein/REAXYS Number:
9967887

Key Documents

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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

SMILES string

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

InChI key

FDEODCTUSIWGLK-RSAXXLAASA-N

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. Y0001333, traceable to USP 1140430

Quality Level

300

Gene Information

human ... P2RY12(64805)

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

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Related Categories

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 and EP 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.
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.

pictograms

CorrosionEnvironment
GHS05,GHS09

signalword

Danger

hcodes

H314,H411

Hazard Classifications

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

Storage Class

8A - Combustible corrosive hazardous materials

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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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)
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)
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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