Active Pharmaceutical Ingredient

Nalbuphine

Also known as: Nubain

CAS: 20594-83-6 Opioid Agonist-Antagonist IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Nalbuphine API — Mediocon Inc
Nalbuphine — Pharmaceutical Grade API

Product Overview

CAS No: 20594-83-6  |  MF: C₂₁H₂₇NO₄  |  MW: 357.44 g/mol

Mirtazapine is a pharmaceutical-grade active ingredient classified as Opioid Agonist-Antagonist. Mediocon Inc supplies high-purity Nalbuphine conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Key Features

  • Mixed opioid agonist-antagonist
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Moderate to severe pain management
  • Surgical analgesia and sedation
  • Opioid-induced pruritus treatment

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 NameNalbuphine
Also Known AsNubain
CAS Number20594-83-6
Chemical Name17-(cyclobutylmethyl)-4,5α-epoxymorphinan-3,6α,14-triol
Molecular FormulaC₂₁H₂₇NO₄
Molecular Weight357.44 g/mol
CategoryNaSSA Antidepressant
AppearanceWhite to off-white powder
SolubilitySlightly 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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