Mazdutide API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Mazdutide API

Mazdutide is a long-acting synthetic oxyntomodulin analogue that acts as a dual glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) agonist. It is a peptide-based pharmaceutical compound developed for metabolic diseases, particularly obesity and type 2 diabetes.

Mazdutide is also known by the development codes IBI-362 and LY3305677. It is administered by subcutaneous injection and has been approved in China.

Mazdutide API Manufacturer in India

Mazdutide is a specialized peptide pharmaceutical API requiring controlled peptide synthesis, purification and comprehensive analytical characterization.

Important quality attributes include identity, peptide purity, assay, related peptides, aggregation, residual solvents, water content, peptide mapping and biological activity.

Chemical Information

CAS Number: 2259884-03-0
Molecular Formula: C210H322N46O67
Molecular Weight: 4563.06 g/mol
Synonyms: IBI-362, IBI362, LY3305677, OXM-3
Development Code: IBI-362 / LY3305677
Drug Class: Dual GLP-1/Glucagon Receptor Agonist
Therapeutic Class: Metabolic Agent
Therapeutic Area: Obesity / Type 2 Diabetes
Molecule Type: Synthetic Peptide

The FDA Global Substance Registration System lists CAS 2259884-03-0 for Mazdutide. The molecular formula and mass have some database discrepancies; the formula C210H322N46O67 and molecular weight 4563.06 g/mol are consistent with commonly reported structural records.

Mechanism of Action

Mazdutide is a dual agonist of GLP-1 and glucagon receptors.

Its activity includes:

  • GLP-1 receptor activation
  • Glucagon receptor activation
  • Enhancement of glucose-dependent insulin secretion
  • Reduction of appetite
  • Regulation of energy metabolism
  • Promotion of weight loss
  • Improvement of metabolic parameters

The combination of GLP-1 and glucagon receptor activity is intended to provide complementary effects on glucose regulation, appetite and energy expenditure.

Pharmaceutical Applications

Mazdutide is used/developed for:

  • Obesity management
  • Chronic weight management
  • Type 2 diabetes research and treatment
  • Metabolic disease research
  • GLP-1 receptor research
  • Glucagon receptor research
  • Peptide drug development

Dosage Form Applications

Mazdutide is developed as a subcutaneous injectable peptide pharmaceutical and is administered on a long-acting dosing schedule.

Physical and Biological Characteristics

Mazdutide is a modified peptide molecule derived from the oxyntomodulin concept. Its structure incorporates peptide modifications and a lipid-containing conjugate designed to extend pharmacological duration.

As a peptide API, critical quality attributes include:

  • Peptide identity
  • Peptide sequence
  • Purity
  • Related peptides
  • Degradation products
  • Aggregates
  • Oxidation products
  • Acylation profile
  • Water content
  • Residual solvents
  • Biological potency

Manufacturing Process

A controlled Mazdutide API manufacturing process may involve:

  1. Selection of qualified amino-acid raw materials
  2. Solid-phase peptide synthesis
  3. Controlled incorporation of modified amino acids
  4. Peptide-chain assembly
  5. Site-specific lipid conjugation
  6. Cleavage and deprotection
  7. Purification by preparative chromatography
  8. Removal of process-related impurities
  9. Concentration
  10. Lyophilization or controlled drying
  11. Analytical characterization
  12. Pharmaceutical-grade packaging

Quality Control Testing

Typical Mazdutide peptide API testing may include:

  • HPLC identification
  • LC-MS characterization
  • Peptide mapping
  • Assay
  • Related peptides
  • Purity
  • Aggregates
  • Degradation products
  • Residual solvents
  • Water content
  • Acylation profile
  • Endotoxin
  • Bioburden
  • Microbial quality
  • Biological potency
  • Stability testing

Storage

Mazdutide peptide API should be stored under validated temperature and humidity conditions, protected from moisture, excessive heat and light. Because peptide stability can be sensitive to environmental conditions, final storage requirements should follow the manufacturer's validated stability data.

Pharmaceutical Research

Mazdutide is relevant to research involving:

  • GLP-1 receptor agonism
  • Glucagon receptor agonism
  • Oxyntomodulin analogues
  • Obesity
  • Type 2 diabetes
  • Weight management
  • Metabolic disorders
  • Peptide therapeutics
  • Incretin-based drug development

Mazdutide API Summary

Mazdutide is a long-acting dual GLP-1 and glucagon receptor agonist and synthetic peptide. It has CAS Number 2259884-03-0, commonly reported molecular formula C210H322N46O67, and molecular weight 4563.06 g/mol. It is primarily associated with obesity, weight management and metabolic-disease applications.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 2.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 10 ppm
pH (1% Solution) 2.0 – 4.0
Individual Impurity NMT 0.5%
Water Content NMT 2.0%
Get Bulk Quote via WhatsApp