1342059
USP
Insulin glargine
United States Pharmacopeia (USP) Reference Standard
About This Item
Produits recommandés
Qualité
pharmaceutical primary standard
Famille d'API
insulin
Forme
powder
Fabricant/nom de marque
USP
Application(s)
pharmaceutical (small molecule)
Format
neat
Température de stockage
−20°C
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Description générale
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
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
Remarque sur l'analyse
Autres remarques
Produit(s) apparenté(s)
Code de la classe de stockage
11 - Combustible Solids
Classe de danger pour l'eau (WGK)
nwg
Point d'éclair (°F)
Not applicable
Point d'éclair (°C)
Not applicable
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