Active Pharmaceutical Ingredient

Norgestimate

Also known as: Ortho-Cyclen; Sprintec

CAS: 35189-28-7 Progestogen / Oral Contraceptive IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Norgestimate API — Mediocon Inc
Norgestimate — Pharmaceutical Grade API

Product Overview

CAS No: 35189-28-7  |  MF: C₂₃H₃₁NO₃  |  MW: 369.50 g/mol

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

Norgestimate is a third-generation progestogen used in oral contraceptive formulations, known for its low androgenic activity and favorable lipid profile.

Key Features

  • Third-generation progestogen
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Oral contraceptives
  • Acne vulgaris treatment
  • Dysmenorrhea
  • Hormone therapy

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 NameNorgestimate
Also Known AsOrtho-Cyclen; Sprintec
CAS Number35189-28-7
Molecular FormulaC₂₃H₃₁NO₃
Molecular Weight369.50 g/mol
CategoryProgestogen / Oral 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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