PHR1405

Capecitabine

Pharmaceutical Secondary Standard; Certified Reference Material

• Sinônimo(s): Capecitabine, CAP, 5′-Deoxy-5-fluoro-N-[(pentyloxy)carbonyl]cytidine, Ro-9-1978
• Fórmula empírica (Notação de Hill): C₁₅H₂₂FN₃O₆
• Número CAS: 154361-50-9
• Peso molecular: 359.35
• Número MDL: MFCD00930626
• Código UNSPSC: 41116107
• ID de substância PubChem: 329823378
• NACRES: NA.24

Propriedades

• grau: certified reference material; pharmaceutical secondary standard
• Nível de qualidade: 300
• Agency: traceable to Ph. Eur. Y0001642; traceable to USP 1090706
• família API: capecitabine
• Certificado de análise (CofA): current certificate can be downloaded
• embalagem: pkg of 1 g
• técnica(s): HPLC: suitable; gas chromatography (GC): suitable
• aplicação(ões): pharmaceutical (small molecule)
• Formato: neat
• temperatura de armazenamento: 2-30°C
• cadeia de caracteres SMILES: O[C@H]1[C@@H](O)[C@H](N2C(N=C(NC(OCCCCC)=O)C(F)=C2)=O)O[C@@H]1C
• InChI: 1S/C15H22FN3O6/c1-3-4-5-6-24-15(23)18-12-9(16)7-19(14(22)17-12)13-11(21)10(20)8(2)25-13/h7-8,10-11,13,20-21H,3-6H2,1-2H3,(H,17,18,22,23)/t8-,10-,11-,13-/m1/s1
• chave InChI: GAGWJHPBXLXJQN-UORFTKCHSA-N
• Informações sobre genes: human ... TYMS(7298)

Descrição

Descrição geral

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.
Capecitabine is an orally administered drug belonging to the class of fluoropyrimidine carbamates. It converts into 5-fluorouracil (5-FU) at the tumor tissues by exploiting the high intratumoral concentrations of thymidine phosphorylase.

Aplicação

Capecitabine may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography and spectrophotometric 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.

Ações bioquímicas/fisiológicas

Capecitabine is an anti-cancer drug, a prodrug of doxifluridine, metabolized to 5-fluorouracil at the tumor site. The activation of capecitabine follows a pathway with three enzymatic steps and two intermediary metabolites, 5′-Deoxy-5-fluorocytidine (5′-DFCR) and 5′-Deoxy-5-fluorouridine (5′-DFUR), to form 5-fluorouracil.

Nota de análise

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

Outras notas

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 de rodapé

To see an example of a Certificate of Analysis for this material enter LRAA2199 in the slot below. This is an example certificate only and may not be the lot that you receive.

Informações de segurança

• Pictogramas: GHS08
• Palavra indicadora: Danger
• Frases de perigo: H341,H350,H360FD
• Declarações de precaução: P201 - P308 + P313
• Classificações de perigo: Carc. 1B - Muta. 2 - Repr. 1B
• Código de classe de armazenamento: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• Classe de risco de água (WGK): WGK 3
• Ponto de fulgor (°F): Not applicable
• Ponto de fulgor (°C): Not applicable