Active Pharmaceutical Ingredient

Roxatidine Acetate — CAS 78628-28-1

Also known as: Altat; Roxit; TZU-0460

GMP Certified IP / BP / EP / USP H2 Receptor Antagonist / Antiulcer Agent Aurangabad, India
Roxatidine Acetate API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Roxatidine Acetate IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 78628-28-1

Product Overview

Roxatidine Acetate is a high-purity Active Pharmaceutical Ingredient (API) classified under H2 Receptor Antagonist / Antiulcer Agent. Mediocon Inc manufactures GMP-compliant Roxatidine Acetate at its state-of-the-art facility in Aurangabad, Maharashtra, India, supplying pharmaceutical companies worldwide with consistent quality and full regulatory documentation.

Therapeutic Applications
  • Gastric ulcer and duodenal ulcer treatment
  • Gastroesophageal reflux disease (GERD)
  • H2 histamine receptor blockade
  • Reduction of gastric acid secretion

Technical Specifications

ParameterSpecification
CAS Number78628-28-1
Molecular FormulaC₁₉H₂₈N₂O₄
Molecular Weight352.44 g/mol
GradeIP / BP / EP / USP
CategoryH2 Receptor Antagonist / Antiulcer Agent
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 NoROX/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 / EP / 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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