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
• 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

Properties

• 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)

Description

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.

Safety Information

• 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
• Storage Class Code: 8A - Combustible, corrosive hazardous materials
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable