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Merck
CN

1621008

USP

硬脂酸

United States Pharmacopeia (USP) Reference Standard

别名:

1-十八碳烷酸, C18:0, NSC 25956, NSC 261168, 十八烷酸, 硬脂酸

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线性分子式:
CH3(CH2)16COOH
化学文摘社编号:
57-11-4
分子量:
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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相关类别

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

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.

存储类别

11 - Combustible Solids

flash_point_f

392.0 °F - Cleveland open cup

flash_point_c

200 °C - Cleveland open cup

历史批次信息供参考:

分析证书(COA)

Lot/Batch Number

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Sodium Stearate
United States Pharmacopeia, 39(3), 6024-6024 (2023)
Palmitic Acid
United States Pharmacopeia, 42(3), 5918-5918 (2019)
Aluminum Monostearate
United States Pharmacopeia, 44(4), 5612-5612 (2019)
Stearic acid
United States Pharmacopeia, 34(5), 3146-3146 (2020)
S M Grundy
The American journal of clinical nutrition, 60(6 Suppl), 986S-990S (1994-12-01)
Stearic acid is a long-chain saturated fatty acid. However, in contrast with other saturated fatty acids, stearic acid apparently does not raise serum cholesterol concentrations. Studies carried out three decades ago provided strong suggestive evidence that this was the case.
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