1342059

Insulin glargine

United States Pharmacopeia (USP) Reference Standard

• CAS Number: 160337-95-1
• MDL number: MFCD23160755
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: pharmaceutical primary standard
• API family: insulin
• form: powder
• manufacturer/tradename: USP
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: −20°C

Description

General description

Insulin glargine is a long-acting recombinant human insulin analog produced in *E. coli*. It differs from native insulin by a glycine substitution and additional arginine residues, leading to altered solubility and extended activity. The USP standard supports identity testing, potency assays, and impurity profiling in insulin glargine formulations.

The USP biologics proteins category provides critical standards and reference materials necessary for the development and manufacturing of therapeutic proteins. These proteins, which can be naturally derived or genetically engineered, are essential in treating various diseases and conditions, ensuring that they meet quality, safety, and efficacy standards.

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.

Application

Insulin glargine USP reference standard suitable for use in specified USP compendial tests and assays.

Also used to prepare standard, standard stock and system suitability solutions for assay by liquid chromatography in conjunction with a UV detector according to the given below monographs of United States Pharmacopeia (USP):

• Insulin Glargine Injection
• Insulin Glargine
• 〈121〉 Insulin Assays

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 the USP Biologics program.

Sales restrictions may apply.

Safety Information

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