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Stearic Acid

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Stearic acid, 1-Heptadecanecarboxylic acid, C18:0, Cetylacetic acid, NSC 25956, NSC 261168, Octadecanoic acid, Stearophanic acid
Linear Formula:
CH3(CH2)16COOH
CAS Number:
57-11-4
Molecular Weight:
284.48
Beilstein:
608585
EC Number:
200-313-4
MDL number:
MFCD00002752
PubChem Substance ID:
329823135

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to Ph. Eur. S1340000
traceable to USP 1621008

vapor pressure

1 mmHg ( 173.7 °C)

API family

stearic acid

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

bp

361 °C (lit.)

mp

67-72 °C (lit.)

application(s)

cleaning products
cosmetics
food and beverages
personal care
pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

CCCCCCCCCCCCCCCCCC(O)=O

InChI

1S/C18H36O2/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-18(19)20/h2-17H2,1H3,(H,19,20)

InChI key

QIQXTHQIDYTFRH-UHFFFAOYSA-N

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General description

Stearic acid is a saturated fatty acid, which is a long aliphatic chain containing a carboxyl group at one end and a methyl group at the other. Pharmaceutically, it is used as a lubricant in tablet and capsule formulations and as an emulsifying and solubilizing agent in topical formulations.
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.

Application

Stearic acid may be used as a pharmaceutical reference standard for the determination of the analyte in raw material, food and pharmaceutical formulations by gas chromatography.
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 (PhEur) 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 LRAA7125 in the slot below. This is an example certificate only and may not be the lot that you receive.

Recommended products

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

Storage Class Code

11 - Combustible Solids

WGK

nwg

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificates of Analysis (COA)

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Stearic acid
Pharmacopeia, US
United States Pharmacopeia/National Formulary, 29(2), 6068-6068 (2018)
Novel method for quantification of individual free fatty acids in milk using an in-solution derivatisation approach and gas chromatography-mass spectrometry
Amer B, et al.
International dairy journal, 32(2), 199-203 (2013)
Qualitative and quantitative determination of the fatty acids by gas-liquid chromatography
James AT
Methods of Biochemical Analysis, 1-59 (1960)
Handbook of Pharmaceutical Excipients, 6th Edition
Handbook of Pharmaceutical Excipients 6th edition Pharmaceutical Press, 697-699 (2009)
Ulla Hoppu et al.
Journal of pediatric gastroenterology and nutrition, 41(3), 335-338 (2005-09-01)
Breast milk fatty acids may have immunomodulatory properties related to the development of atopic disease. The aim of this study was to assess the impact of the breast milk fatty acid composition on the development of atopic dermatitis (AD) in
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