Active Pharmaceutical Ingredient

Pirenzepine — CAS 28797-61-7

Also known as: Gastrozepin; LS-519

GMP Certified IP / BP / USP Anticholinergic / Antiulcer Agent Aurangabad, India
Pirenzepine API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Pirenzepine IP / BP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 28797-61-7

Product Overview

Pirenzepine is a selective M1 muscarinic receptor antagonist used for the treatment of peptic ulcers and gastric acid hypersecretion. Unlike non-selective anticholinergics, it preferentially blocks M1 receptors in the gastric mucosa, reducing acid secretion with fewer systemic side effects. Mediocon Inc manufactures Pirenzepine API at its GMP-certified facility in Aurangabad, Maharashtra, India.

Therapeutic Applications
  • Treatment of peptic ulcers (gastric and duodenal)
  • Management of gastric acid hypersecretion
  • Treatment of Zollinger-Ellison syndrome
  • Investigational use in myopia control (ophthalmic)

Technical Specifications

ParameterSpecification
CAS Number28797-61-7
Molecular FormulaC19H21N5O2
Molecular Weight351.40 g/mol
GradeIP / BP / USP
CategoryAnticholinergic / Antiulcer Agent
AppearanceWhite to off-white, crystalline powder
SolubilityFreely soluble in water, sparingly soluble in ethanol, practically insoluble in ether
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Batch NoPIR/24032026
Mfg DateMAR 2026
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement

Quality & Compliance

  • GMP Certified manufacturing facility in Aurangabad, Maharashtra, India
  • Full pharmacopoeial compliance: IP / BP / USP standards
  • Complete documentation: Certificate of Analysis (CoA), MSDS, Certificate of Origin
  • Stringent in-process quality control at every manufacturing stage
  • HPLC purity testing and spectroscopic identification (IR, NMR)
  • Cold-chain and controlled-environment storage facilities available
  • Exported to 40+ countries with full regulatory support
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