Active Pharmaceutical Ingredient

Insulin

Also known as: Human Insulin / Humulin / Novolin

CAS: 11061-68-0 Peptide Hormone / Antidiabetic IP / BP / EP / USP Bulk Supply Available
Insulin API Manufacturer India | Mediocon Inc
Insulin — Pharmaceutical Grade API

Product Overview

CAS No: 11061-68-0  |  MF: C₂₅₇H₃₈₃N₆₅O₇₇S₆  |  MW: ~5808 g/mol

Insulin is a peptide hormone produced by the beta cells of the pancreas and is the primary hormone responsible for regulating blood glucose levels. Pharmaceutical-grade human insulin and its analogues are used in the management of Type 1 and Type 2 diabetes mellitus. Mediocon Inc supplies IP/BP/EP/USP compliant insulin API.

Key Features

  • Pharmaceutical-grade human insulin
  • IP/BP/EP/USP compliant quality
  • Available in regular and analogues forms
  • Full regulatory documentation provided

Applications

  • Type 1 diabetes mellitus management
  • Type 2 diabetes mellitus (insulin-dependent stage)
  • Hyperglycemic emergencies (DKA, HHS)
  • Parenteral nutrition protocols

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 NameInsulin
Also Known AsHuman Insulin / Humulin / Novolin
CAS Number11061-68-0
Molecular FormulaC₂₅₇H₃₈₃N₆₅O₇₇S₆
Molecular Weight~5808 g/mol
CategoryPeptide Hormone / Antidiabetic
AppearanceWhite or Almost White Powder
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay97.0% – 103.0%
Loss on DryingNMT 5.0%
Heavy MetalsNMT 20 ppm
pH7.0 – 7.8 (neutral solution)
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement
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