Description

Norgestimate CAS NO 35189-28-7 is a synthetic progestin steroid, widely recognized for its high selectivity and favorable metabolic profile. This compound is a critical active pharmaceutical ingredient (API) in modern hormonal contraceptive formulations. It is primarily utilized by pharmaceutical manufacturers in the development and production of oral contraceptives and hormone replacement therapies. Its reliable performance and established safety profile make it a cornerstone in women's healthcare products.

Application

• Active Pharmaceutical Ingredient (API) in combination oral contraceptive pills.
• Hormone Replacement Therapy (HRT) formulations for managing menopausal symptoms.
• Pharmaceutical Intermediates for the synthesis of other steroid-based therapeutics.
• Research & Development of novel hormonal treatments and delivery systems.
• Reference Standard for quality control and analytical testing in pharmaceutical laboratories.
• Clinical Trial Material for new drug development programs.

Basic Information

Product Name	Norgestimate
CAS No.	35189-28-7
Molecular Formula	C23H31NO3
Molecular Weight	369.50 g/mol
Synonyms	(+)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one oxime acetate; 17α-Ethynyl-17β-hydroxy-13-ethyl-4-gonen-3-one oxime acetate; (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one oxime acetate; DL-Norgestimate; Norgestimate (USP); (±)-Norgestimate; 35189-28-7; Wyeth 4574
EINECS	Contact for details

Quality Control

Our Norgestimate is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards such as USP and EP. Each batch undergoes comprehensive analytical testing including HPLC assay, related substances analysis, residual solvent screening, and identity confirmation. A detailed Certificate of Analysis (COA) is provided with every shipment to ensure full traceability and quality assurance for our pharmaceutical partners.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Water (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.