Active Pharmaceutical Ingredient

Norethistrone

Also known as: Norethisterone; Primolut N; NET

CAS: 68-22-4ProgestinIP / BP / USPGMP CertifiedAurangabad, Maharashtra, India
Norethistrone API — Mediocon Inc
Norethistrone — Pharmaceutical Grade Progestin API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

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

Norethistrone is a high-purity Progestin supplied by Mediocon Inc as an Active Pharmaceutical Ingredient (API) conforming to IP / BP / USP specifications. Manufactured at our GMP-certified facility in Aurangabad, Maharashtra, India, it meets the stringent quality requirements of global pharmaceutical manufacturers.

Norethistrone (Norethisterone) is a synthetic progestogen used in contraceptive formulations, hormone replacement therapy, and the treatment of gynecological disorders including endometriosis, menorrhagia, and amenorrhea.

Key Features

  • High-purity pharmaceutical grade API
  • IP / BP / EP / USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing facility

Applications

  • Oral contraceptive formulations
  • Hormone replacement therapy (HRT)
  • Endometriosis treatment
  • Dysmenorrhea and menorrhagia 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 NameNorethistrone (Norethisterone)
Also Known AsNorethisterone; Primolut N; NET
CAS Number68-22-4
Molecular FormulaC₂₀H₂₆O₂
Molecular Weight298.42 g/mol
CategoryProgestin / Active Pharmaceutical Ingredient
AppearanceWhite to off-white crystalline powder
SolubilityPractically insoluble in water; soluble in alcohol, acetone, and chloroform
GradeIP / BP / 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
Batch No.NOR/24032026
Mfg DateMAR 2026
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement
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