Glucagon API | Glucagon Recombinant Pharmaceutical API Manufacturer in India

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Glucagon API

Glucagon is a peptide hormone that plays a major role in maintaining blood glucose levels. It acts primarily on the liver to stimulate glycogen breakdown and glucose production, thereby increasing blood glucose concentrations.

Pharmaceutical Glucagon is produced using recombinant or synthetic peptide manufacturing technologies and is used in emergency treatment of severe hypoglycemia as well as in certain diagnostic procedures.

Glucagon API Manufacturer in India

Glucagon is a specialized peptide pharmaceutical API requiring controlled manufacturing, purification and advanced analytical characterization. Unlike conventional small-molecule APIs, glucagon quality control requires peptide identity, purity, potency, aggregation and related-substance testing.

Chemical Information

CAS Number: 16941-32-5
Molecular Formula: C153H225N43O49S
Molecular Weight: 3482.78 g/mol
Amino Acids: 29
Drug Class: Pancreatic Hormone
Pharmacological Class: Glucose-Raising Agent
Therapeutic Class: Hypoglycemic Emergency Treatment
Therapeutic Area: Endocrinology / Emergency Medicine

Mechanism of Action

Glucagon binds to glucagon receptors, which are G-protein-coupled receptors primarily expressed in the liver. Receptor activation increases intracellular cyclic AMP and activates pathways that promote glycogenolysis and gluconeogenesis, resulting in an increase in blood glucose.

Pharmaceutical Applications

Glucagon is used for the emergency treatment of severe hypoglycemia when oral carbohydrate administration is not possible or appropriate. It is also used in certain diagnostic procedures to temporarily inhibit gastrointestinal motility.

Glucagon in Severe Hypoglycemia

Glucagon provides an important rescue mechanism for patients experiencing severe hypoglycemia, particularly when the individual is unable to safely consume glucose orally. It increases blood glucose by mobilizing hepatic glucose stores.

Physical and Chemical Properties

Glucagon is a 29-amino-acid peptide hormone with a molecular weight of approximately 3.48 kDa. It is a peptide rather than a conventional small-molecule API and therefore requires specialized analytical techniques for characterization.

Quality and Analytical Testing

Glucagon API quality evaluation may include:

  • Peptide identity by LC-MS
  • Peptide mapping
  • HPLC purity
  • Assay/content
  • Related peptides
  • Oxidized glucagon
  • Deamidated/modified peptide impurities
  • Aggregates
  • Water content
  • Residual solvents
  • Bacterial endotoxins
  • Bioburden
  • Biological potency
  • Sterility for applicable sterile drug substance/product

Storage

Glucagon should be stored under controlled pharmaceutical conditions and protected from excessive heat, moisture and light. Exact storage requirements depend on whether the material is supplied as a bulk peptide, lyophilized drug substance or finished pharmaceutical product.

Pharmaceutical Research and Development

Glucagon is an established peptide therapeutic and remains relevant to research involving glucose regulation, pancreatic hormones, metabolic pathways and emergency treatment of hypoglycemia.

Glucagon API Summary

Glucagon is a 29-amino-acid peptide hormone with CAS Number 16941-32-5, molecular formula C153H225N43O49S, and molecular weight 3482.78 g/mol. It acts primarily through hepatic glucagon receptors to increase blood glucose and is used therapeutically for severe hypoglycemia and selected diagnostic applications.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 95.0% – 105.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 10 ppm
pH (1% Solution) 2.5 – 4.5
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Water Content NMT 2.0%
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