Active Pharmaceutical Ingredient

Miglustat

Also known as: Zavesca; NB-DNJ

CAS: 72599-27-0 Enzyme Inhibitor / Lysosomal Storage Disease IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Miglustat API — Mediocon Inc
Miglustat — Pharmaceutical Grade API

Product Overview

CAS No: 72599-27-0  |  MF: C₇H₁₃NO₄  |  MW: 163.19 g/mol

Miglustat is a pharmaceutical-grade active ingredient classified as Enzyme Inhibitor / Lysosomal Storage Disease. Mediocon Inc supplies high-purity Miglustat API conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Key Features

  • Glucosylceramide synthase inhibitor
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Gaucher disease type 1 (substrate reduction therapy)
  • Niemann-Pick disease type C
  • Lysosomal storage disorder management

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 NameMiglustat
Also Known AsZavesca; NB-DNJ
CAS Number72599-27-0
Chemical Name(2R,3R,4R,5S)-1-butyl-2-(hydroxymethyl)piperidine-3,4,5-triol
Molecular FormulaC₇H₁₃NO₄
Molecular Weight163.19 g/mol
CategoryEnzyme Inhibitor / Lysosomal Storage Disease
AppearanceWhite crystalline powder
SolubilityFreely soluble in water
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
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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