Description

Insulin Glargine is a long-acting, biosynthetic human insulin analog designed to provide a stable, peakless basal insulin level for up to 24 hours. This product is critical for the effective management of diabetes mellitus, offering patients improved glycemic control with a reduced risk of hypoglycemia compared to traditional NPH insulin. It is an essential active pharmaceutical ingredient (API) primarily required by global pharmaceutical manufacturers for the formulation of injectable diabetes treatments.

Application

• Primary Active Pharmaceutical Ingredient (API) in long-acting basal insulin formulations.
• Manufacturing of prefilled insulin pens and vials for subcutaneous injection.
• Use in combination therapy with rapid-acting insulins for comprehensive diabetes management.
• Critical component in biosimilar development and manufacturing.
• Research and development of novel insulin delivery systems and sustained-release mechanisms.
• Reference standard in analytical laboratories for quality control and regulatory testing.

Basic Information

Product Name	Insulin Glargine
CAS No.	160337-95-1
Molecular Formula	C267H404N72O78S6
Molecular Weight	6063.0 g/mol
Synonyms	HOE 901; Insulin, 21A-Gly-30Ba-L-Arg-30Bb-L-Arg-human; Lantus (Brand Name); Basaglar (Brand Name); Toujeo (Brand Name); Long-Acting Insulin Analog; Gly(A21)-Arg(B31)-Arg(B32) human insulin
EINECS	Contact for details

Quality Control

Our Insulin Glargine is manufactured under strict cGMP (current Good Manufacturing Practice) guidelines to ensure the highest standards of purity, identity, and biological activity. Each batch is subjected to a comprehensive battery of tests including HPLC for purity and related substances, peptide mapping, and biological potency assays. Certificates of Analysis (COA) detailing full compliance with relevant pharmacopeial standards (e.g., USP, EP) are provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store unopened vials at 2°C to 8°C (refrigerated, do not freeze). Once reconstituted or transferred, follow the specific handling and storage instructions provided in the product's regulatory filing. The material is hygroscopic (moisture-sensitive) and must be protected from humidity during handling.

Specification

Item	Specification
Appearance	White or almost white powder
Identification (HPLC)	Conforms to reference standard
Identification (Peptide Map)	Conforms to reference standard
Assay (HPLC)	95.0% - 105.0%
Related Substances (HPLC)	Total impurities: NMT 5.0% Any single impurity: NMT 2.0%
Biological Potency	27.5 IU/mg to 35.0 IU/mg
Water Content (KF)	NMT 10.0%
Bacterial Endotoxins	Less than 10 IU/mg
Sterility (if supplied sterile)	Sterile

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.