Active Pharmaceutical Ingredient

Norethisterone

Also known as: Primolut N; Aygestin

CAS: 68-22-4 Progestogen / Hormonal Contraceptive IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Norethisterone API — Mediocon Inc
Norethisterone — Pharmaceutical Grade API

Product Overview

CAS No: 68-22-4  |  MF: C₂₀H₂₆O₂  |  MW: 298.42 g/mol

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

Norethisterone is a synthetic progestogen used in hormonal contraceptives, hormone replacement therapy, and treatment of gynecological disorders.

Key Features

  • Progestogen hormone API
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Oral contraceptives
  • Hormone replacement therapy
  • Endometriosis treatment
  • Menstrual disorders

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 NameNorethisterone
Also Known AsPrimolut N; Aygestin
CAS Number68-22-4
Molecular FormulaC₂₀H₂₆O₂
Molecular Weight298.42 g/mol
CategoryProgestogen / Hormonal Contraceptive
AppearanceWhite to off-white crystalline powder
SolubilityPractically insoluble 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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