PHR1431

Clopidogrel-Bisulfat

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(e): (S)-(2-Chlorphenyl)(6,7-dihydro-4H-thieno[3,2-c]pyridin-5-yl)-essigsäure-methylester -hydrogensulfat
• Empirische Formel (Hill-System): C₁₆H₁₆ClNO₂S · H₂SO₄
• CAS-Nummer: 120202-66-6
• Molekulargewicht: 419.90
• Beilstein: 9967887
• MDL-Nummer: MFCD00876395
• UNSPSC-Code: 41116107
• PubChem Substanz-ID: 329822595
• NACRES: NA.24

Eigenschaften

• Qualität: certified reference material; pharmaceutical secondary standard
• Qualitätsniveau: 300
• Agentur: traceable to Ph. Eur. Y0001333; traceable to USP 1140430
• API-Familie: clopidogrel
• Analysenzertifikat (CofA): current certificate can be downloaded
• Verpackung: pkg of 1 g
• Methode(n): HPLC: suitable; gas chromatography (GC): suitable
• Anwendung(en): pharmaceutical (small molecule)
• Format: neat
• Lagertemp.: 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
• InChIKey: FDEODCTUSIWGLK-RSAXXLAASA-N
• Angaben zum Gen: human ... P2RY12(64805)

Beschreibung

Allgemeine Beschreibung

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.[1] It is reported to have exhibited clinical efficacy greater than that of aspirin, during large phase III trials.[2]

Anwendung

Clopidogrel Bisulfate may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by various chromatography,[3][1][4] spectrophotometric and spectrodensitometric [2] 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.

Hinweis zur Analyse

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

Sonstige Hinweise

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.

Fußnote

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.

Sicherheitshinweise

• Piktogramme: GHS05,GHS09
• Signalwort: Danger
• H-Sätze: H314,H411
• P-Sätze: P260 - P273 - P280 - P303 + P361 + P353 - P304 + P340 + P310 - P305 + P351 + P338
• Gefahreneinstufungen: Aquatic Chronic 2 - Eye Dam. 1 - Skin Corr. 1B
• Lagerklassenschlüssel: 8A - Combustible corrosive hazardous materials
• WGK: WGK 3
• Flammpunkt (°F): Not applicable
• Flammpunkt (°C): Not applicable