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About This Item
grade
pharmaceutical primary standard
API family
insulin
form
powder
manufacturer/tradename
USP
application(s)
USP Biologics
pharmaceutical (small molecule)
format
neat
storage temp.
−20°C
General description
Insulin glargine for Peak Identification is a reference material composed of well-characterized peptide fragments or analogs of insulin glargine. It is used in chromatographic methods to identify and assign peaks during impurity and degradation product analysis.
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
- Insulin Glargine Injection
Analysis Note
Other Notes
Storage Class
11 - Combustible Solids
flash_point_f
Not applicable
flash_point_c
Not applicable
Regulatory Information
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