PHR1444

Sodium Stearyl Fumarate

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Sodium stearyl fumarate, (E)-2-Butenedioic acid monooctadecyl ester sodium salt, Sodium octadecyl fumarate
• Empirical Formula (Hill Notation): C₂₂H₃₉NaO₄
• CAS Number: 4070-80-8
• Molecular Weight: 390.53
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to Ph. Eur. S0808000; traceable to USP 1614705
• API family: sodium stearyl fumarate
• 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.: 2-30°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+;
• InChI key: STFSJTPVIIDAQX-LTRPLHCISA-M

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. 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.

Application

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

Safety Information

• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable