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Merck

1621008

USP

Stearic acid

United States Pharmacopeia (USP) Reference Standard

Sinónimos:

1-Heptadecanecarboxylic acid, C18:0, Cetylacetic acid, NSC 25956, NSC 261168, Octadecanoic acid, Stearophanic acid

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Fórmula lineal:
CH3(CH2)16COOH
Número CAS:
57-11-4
Peso molecular:
284.48
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329751146
MDL number:
MFCD00002752
Beilstein/REAXYS Number:
608585

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InChI key

QIQXTHQIDYTFRH-UHFFFAOYSA-N

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)

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)

USP Biologics
pharmaceutical (small molecule)

format

neat

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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.  ​

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

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.

Other Notes

Sales restrictions may apply.
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.

Clase de almacenamiento

11 - Combustible Solids

flash_point_f

392.0 °F - Cleveland open cup

flash_point_c

200 °C - Cleveland open cup

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Certificados de análisis (COA)

Lot/Batch Number

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Aluminum Monostearate
United States Pharmacopeia, 44(4), 5612-5612 (2019)
Sodium Stearate
United States Pharmacopeia, 39(3), 6024-6024 (2023)
Deliang Zhou et al.
Journal of pharmaceutical sciences, 103(6), 1664-1672 (2014-03-22)
The purpose of this study is to identify critical physicochemical properties of hydroxypxropyl methylcellulose (HPMC) that impact the dissolution of a controlled release tablet and develop a strategy to mitigate the HPMC lot-to-lot and vendor-to-vendor variability. A screening experiment was
Sarah E E Berry
Nutrition research reviews, 22(1), 3-17 (2009-05-16)
The position of fatty acids in the TAG molecule (sn-1, sn-2 and sn-3) determines the physical properties of the fat, which affects its absorption, metabolism and distribution into tissues, which may have implications for the risk of CHD. The TAG
A M Turpeinen et al.
Arteriosclerosis, thrombosis, and vascular biology, 18(2), 316-322 (1998-03-04)
The effects of stearic acid (C18:0) and trans-fatty acids (trans-FAs) on measures of platelet function and prostacyclin (PGI2) production are poorly understood in humans. In this controlled dietary study, platelet function and endothelial PGI2 production were studied in healthy humans
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