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PHR1444

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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

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About This Item

Empirical Formula (Hill Notation):
C22H39NaO4
CAS Number:
Molecular Weight:
390.53
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

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

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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.

Storage Class

11 - Combustible Solids

wgk_germany

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable


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Certificates of Analysis (COA)

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Evaluation of sodium stearyl fumarate as a tablet lubricant
Holzer WA and Sjogren J
International Journal of Pharmaceutics, 2(3-4), 145-153 (1979)

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