Active Pharmaceutical Ingredient

Nizatidine — CAS 76963-41-2

Also known as: Axid; Tazac; LY-139037

GMP Certified I.P. / B.P. / E.P. / U.S.P. H₂ Receptor Antagonist / Antiulcer Agent Aurangabad, India
Nizatidine API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Nizatidine I.P. / B.P. / E.P. / U.S.P.  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 76963-41-2

Product Overview

Nizatidine is a high-purity Active Pharmaceutical Ingredient (API) classified as a H₂ Receptor Antagonist / Antiulcer Agent. Manufactured by Mediocon Inc in Aurangabad, Maharashtra, India at a GMP-certified facility, it is supplied in bulk for pharmaceutical formulations worldwide. CAS No: 76963-41-2.

Therapeutic Applications
  • Duodenal ulcer treatment and prevention
  • Gastric ulcer healing
  • Gastroesophageal reflux disease (GERD)
  • Zollinger-Ellison syndrome
  • NSAID-induced gastric injury prevention

Technical Specifications

ParameterSpecification
CAS Number76963-41-2
Molecular FormulaC₁₂H₂₁N₅O₂S₂
Molecular Weight331.46 g/mol
GradeI.P. / B.P. / E.P. / U.S.P.
CategoryH₂ Receptor Antagonist / Antiulcer Agent
AppearanceWhite to off-white crystalline powder
SolubilitySlightly soluble in water; soluble in methanol
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 NoNIZ25030021
Mfg DateMAR 2025
Exp DateFEB 2030
Packing25 kg HDPE drums / as per requirement

Quality & Compliance

  • GMP Certified manufacturing facility in Aurangabad, Maharashtra, India
  • Full pharmacopoeial compliance: I.P. / B.P. / E.P. / U.S.P. 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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