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
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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
还可用于制备标准、标准储备和系统适用性溶液，用于根据以下美国药典各论通过液相色谱法和紫外检测器进行检测：
- 甘精胰岛素注射液
- 甘精胰岛素
- 〈121〉 胰岛素测定
Analysis Note
存储类别
11 - Combustible Solids
flash_point_f
Not applicable
flash_point_c
Not applicable
法规信息
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