1621008

Stearic acid

United States Pharmacopeia (USP) Reference Standard

• Synonym(s): 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
• MDL number: MFCD00002752
• UNSPSC Code: 41116107
• PubChem Substance ID: 329751146
• NACRES: NA.24

Properties

• grade: pharmaceutical primary standard
• vapor pressure: 1 mmHg ( 173.7 °C)
• API family: stearic acid
• form: solid
• manufacturer/tradename: USP
• bp: 361 °C (lit.)
• mp: 67-72 °C (lit.)
• solubility: acetone: soluble; benzene: freely soluble; chloroform: freely soluble; ethanol: soluble; ether: freely soluble; propylene glycol: soluble; water: practically insoluble
• density: 0.845 g/cm³
• application(s): pharmaceutical (small molecule)
• format: neat
• 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

Description

General description

Stearic acid, a saturated fatty acid, is essential in biologic drug formulations, where it is used to stabilize emulsions and to prepare lipid-based carriers for drug delivery. Its use in the synthesis of solid lipid nanoparticles helps in enhancing the bioavailability of poorly soluble drugs. Stearic acid also plays a role in improving the pharmacokinetic profile of biologics, contributing to their stability and efficacy in therapeutic applications.

The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia.

Application

Stearic acid USP reference standard, intended for use in specified quality tests and assays as specified in the USP compendia. Also, for use with USP monographs such as:

• Palmitic Acid
• Calcium Stearate
• Sodium Stearate
• Aluminum Monostearate
• Glycerin Suppositories
• Magnesium Stearate

Analysis Note

These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  ​

Other Notes

This product is part of USP Biologics Program.

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pha

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia.

Sales restrictions may apply.

Safety Information

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