Insulin Glargine is a recombinant human insulin analog designed to provide prolonged, relatively constant insulin activity. It is a long-acting basal insulin used to improve glycemic control in patients with diabetes mellitus.
Insulin Glargine differs from human insulin by specific amino-acid modifications that alter its solubility and pharmacokinetic profile, allowing it to form a depot after subcutaneous administration and provide extended insulin activity.
Insulin Glargine is a specialized recombinant biological API manufactured using biotechnology-based processes. Production involves recombinant expression, recovery, purification, refolding and extensive characterization of the insulin analog.
Quality control is focused on critical attributes such as identity, purity, potency, related proteins, aggregation, peptide mapping, amino-acid sequence, host-cell impurities, residual DNA and microbial quality.
CAS Number: 160337-95-1
Molecular Formula: C267H404N72O78S6
Molecular Weight: Approximately 6063.4 g/mol
Molecule Type: Recombinant Protein / Insulin Analog
Drug Class: Insulin Analog
Pharmacological Class: Long-Acting Basal Insulin
Therapeutic Class: Antidiabetic Agent
Therapeutic Area: Endocrinology / Diabetes
Insulin Glargine is an analog of human insulin containing three key amino-acid modifications:
These modifications shift the isoelectric characteristics of the molecule and contribute to its prolonged action following subcutaneous administration.
Insulin Glargine binds to insulin receptors on target cells and activates insulin signaling pathways.
Its major physiological effects include:
Through these effects, Insulin Glargine helps reduce elevated blood glucose concentrations.
Insulin Glargine is formulated as a solution at an acidic pH. After subcutaneous injection into physiological tissue, the solution undergoes precipitation, creating a relatively slowly dissolving depot.
This provides a prolonged release of insulin Glargine and supports its role as a basal insulin.
Insulin Glargine is used for glycemic control in:
It may be used alone or together with other glucose-lowering therapies according to the applicable prescribing information.
Manufacturing of Insulin Glargine involves specialized recombinant biotechnology. Typical manufacturing stages can include:
Insulin Glargine quality evaluation may include:
Insulin Glargine drug substance and finished products should be stored according to validated stability data and approved product requirements. Temperature control is particularly important for maintaining protein stability and biological activity.
Insulin Glargine is relevant to research involving:
Insulin Glargine is a recombinant long-acting human insulin analog with CAS Number 160337-95-1 and a molecular weight of approximately 6063.4 g/mol. Its modified amino-acid sequence produces altered solubility characteristics that enable prolonged basal insulin activity following subcutaneous administration.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 5.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |