Description

Gestodene Sulfate Sodium Salt is a high-purity synthetic steroid derivative, specifically the sodium salt of gestodene sulfate. This compound serves as a critical pharmaceutical intermediate and reference standard in the development and quality control of hormonal therapeutics. It is primarily required by research institutions, analytical laboratories, and pharmaceutical manufacturers engaged in the production of advanced contraceptive and hormone replacement therapies. The material is supplied under strict quality protocols to ensure consistency and reliability for sensitive applications.

Application

• Pharmaceutical Intermediate: A key starting material or synthetic precursor in the manufacture of gestodene-based active pharmaceutical ingredients (APIs).
• Reference Standard: Used for analytical method development, validation, and quality control (QC) testing in pharmaceutical laboratories to ensure product purity and identity.
• Biochemical Research: Employed in preclinical and clinical studies to investigate the pharmacokinetics, metabolism, and biological activity of progestin compounds.
• Contraceptive Formulation R&D: Integral to the research and development of new and improved hormonal contraceptive formulations.
• Impurity Profiling: Serves as a known impurity or degradation product standard for stability testing and regulatory filing of gestodene-containing drugs.
• Metabolite Studies: Utilized as a standard in the identification and quantification of sulfate-conjugated metabolites in biological samples.

Basic Information

Product Name	Gestodene Sulfate Sodium Salt
CAS No.	1259126-61-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Gestodene 3-Sulfate Sodium Salt; Gestodene Sodium Sulfate; 13-Ethyl-17-hydroxy-18,19-dinor-17α-pregna-4,15-dien-20-yn-3-one sulfate sodium salt; Sodium Gestodene Sulfate; 17α-Ethynyl-13-ethyl-17-hydroxy-4,15-gonadien-3-one sulfate sodium salt
EINECS	Contact for details

Quality Control

Every batch of Gestodene Sulfate Sodium Salt is manufactured and controlled under a strict quality management system. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and conformity to specified standards. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with each shipment. We support compliance with cGMP, ICH Q7, and other relevant pharmaceutical guidelines for intermediates and reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0%
Single Unknown Impurity	≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤1.0%

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