Active Pharmaceutical Ingredient

Hepatitis B Immunoglobulin

Also known as: HBIG, HepB-IG

CAS: N/A Passive Immunisation Agent / Biologic IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Hepatitis B Immunoglobulin API — Mediocon Inc
Hepatitis B Immunoglobulin — Pharmaceutical Grade API

Product Overview

CAS No: N/A  |  MF: Biological (Immunoglobulin G)  |  MW: ~150,000 g/mol

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

Key Features

  • Human-derived passive immunisation against Hepatitis B
  • Post-exposure prophylaxis agent
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation

Applications

  • Post-exposure prophylaxis for Hepatitis B
  • Newborns of HBsAg-positive mothers
  • Prevention of Hepatitis B recurrence post-liver transplant
  • Injectable biologic 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 NameHepatitis B Immunoglobulin
Also Known AsHBIG, HepB-IG
CAS NumberN/A
Molecular FormulaBiological (Immunoglobulin G)
Molecular Weight~150,000 g/mol
CategoryPassive Immunisation Agent / Biologic
AppearanceClear to pale yellow sterile solution / lyophilized powder
SolubilitySoluble in water (biological)
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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