Active Pharmaceutical Ingredient

Isoniazid

Also known as: INH, Isoniazid

CAS: 54-85-3 Antitubercular Agent IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Isoniazid API — Mediocon Inc
Isoniazid — Pharmaceutical Grade API

Product Overview

CAS No: 54-85-3  |  MF: C₆H₇N₃O  |  MW: 137.14 g/mol

Isoniazid is a pharmaceutical-grade active ingredient classified as a Antitubercular Agent. Mediocon Inc supplies high-purity Isoniazid API conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Key Features

  • Essential first-line antitubercular agent (WHO EML)
  • Inhibits mycolic acid synthesis in M. tuberculosis
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation

Applications

  • Active tuberculosis (TB) treatment
  • Latent TB infection (LTBI) prophylaxis
  • Multi-drug TB regimens (HRZE)
  • Oral tablet and injectable formulations

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameIsoniazid
Also Known AsINH, Isoniazid
CAS Number54-85-3
Molecular FormulaC₆H₇N₃O
Molecular Weight137.14 g/mol
CategoryAntitubercular Agent
AppearanceWhite to off-white crystalline powder
SolubilityFreely soluble in water; slightly soluble in ethanol
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay≥98.0% (as per pharmacopoeia)
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement
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