Description

Gestodene Ep Impurity F is a specified impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient Gestodene. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions involved in the development and production of hormonal contraceptives and related steroid-based therapies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Gestodene Ep Impurity F in drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing, validating, and transferring HPLC, UPLC, or GC methods in quality control laboratories.
• Stability Studies & Impurity Profiling: Employed to monitor impurity levels in stability samples to assess drug product shelf-life and degradation pathways.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Process Chemistry Research: Used in research to understand and control the formation of this impurity during the synthesis and purification of Gestodene.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability and calibration standard in routine batch release testing of Gestodene API.

Basic Information

Product Name	Gestodene Ep Impurity F
CAS No.	267650-77-1
Molecular Formula	C21H26O2
Molecular Weight	310.43 g/mol
Synonyms	13-Ethyl-17-hydroxy-11-methylene-18,19-dinor-17α-pregna-4,15-dien-20-yn-3-one; Gestodene EP Impurity F; Gestodene Impurity F; Gestodene Related Compound F; (17α)-13-Ethyl-17-hydroxy-11-methylene-18,19-dinorpregna-4,15-dien-20-yn-3-one
EINECS	Contact for details

Quality Control

Every batch of Gestodene Ep Impurity F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated analytical methods such as HPLC, NMR, and MS to ensure compliance with pharmacopeial standards (e.g., EP, USP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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