PHR1444

Sodium Stearyl Fumarate

Pharmaceutical Secondary Standard; Certified Reference Material

• Sinônimo(s): Sodium stearyl fumarate, (E)-2-Butenedioic acid monooctadecyl ester sodium salt, Sodium octadecyl fumarate
• Fórmula empírica (Notação de Hill): C₂₂H₃₉NaO₄
• Número CAS: 4070-80-8
• Peso molecular: 390.53
• Código UNSPSC: 41116107
• NACRES: NA.24

Propriedades

• grau: certified reference material; pharmaceutical secondary standard
• Nível de qualidade: 300
• Agency: traceable to Ph. Eur. S0808000; traceable to USP 1614705
• família API: sodium stearyl fumarate
• 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
• InChI: 1S/C22H40O4.Na/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-20-26-22(25)19-18-21(23)24;/h18-19H,2-17,20H2,1H3,(H,23,24);/q;+1/p-1/b19-18+;
• chave InChI: STFSJTPVIIDAQX-LTRPLHCISA-M

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. Sodium Stearyl Fumarate is a water soluble lubricant, which is widely used in the pharmaceutical industry for the compression of tablets. Its ability to reduce friction, adhesion to the punches, tablet strength and the disintegration time was investigated.

Aplicação

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.

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 LRAC3332 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Informações de segurança

• Código de classe de armazenamento: 11 - Combustible Solids
• Classe de risco de água (WGK): WGK 3
• Ponto de fulgor (°F): Not applicable
• Ponto de fulgor (°C): Not applicable