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PHR1431

Supelco

Clopidogrel Bisulfate

Pharmaceutical Secondary Standard; Certified Reference Material

Sinonimo/i:

(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

Formula empirica (notazione di Hill):
C16H16ClNO2S · H2SO4
Numero CAS:
Peso molecolare:
419.90
Beilstein:
9967887
Numero MDL:
Codice UNSPSC:
41116107
ID PubChem:
NACRES:
NA.24

Grado

certified reference material
pharmaceutical secondary standard

Livello qualitativo

agenzia

traceable to Ph. Eur. Y0001333
traceable to USP 1140430

Famiglia di API

clopidogrel

CdA

current certificate can be downloaded

Confezionamento

pkg of 1 g

tecniche

HPLC: suitable
gas chromatography (GC): suitable

applicazioni

pharmaceutical (small molecule)

Formato

neat

Temperatura di conservazione

2-8°C

Stringa SMILE

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
FDEODCTUSIWGLK-RSAXXLAASA-N

Informazioni sul gene

human ... P2RY12(64805)

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Descrizione generale

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.

Applicazioni

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.

Risultati analitici

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

Altre note

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.

Nota a piè di pagina

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.

Pittogrammi

CorrosionEnvironment

Avvertenze

Danger

Indicazioni di pericolo

Classi di pericolo

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

Codice della classe di stoccaggio

8A - Combustible corrosive hazardous materials

Classe di pericolosità dell'acqua (WGK)

WGK 3

Punto d’infiammabilità (°F)

Not applicable

Punto d’infiammabilità (°C)

Not applicable


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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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