Description

Gestodene Ep Impurity K is a high-purity reference standard and synthetic intermediate of significant importance in pharmaceutical development and quality control. This compound is critical for the accurate identification, quantification, and monitoring of process-related impurities in the synthesis of Gestodene, a key active pharmaceutical ingredient (API) used in hormonal contraceptives. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product safety, efficacy, and compliance with stringent pharmacopeial standards such as USP and EP.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for HPLC, LC-MS, and GC-MS analysis in method development and validation.
• Quality Control & Assurance: Used for the identification and quantification of specific process-related impurities in Gestodene API batches to meet ICH guidelines.
• Research & Development: Employed in synthetic route optimization and impurity profiling studies during Gestodene process development.
• Regulatory Compliance: Essential for preparing documentation and analytical data for regulatory submissions (e.g., FDA, EMA) to demonstrate impurity control.
• Stability Studies: Used as a marker to track impurity formation in stability testing of Gestodene drug substances and finished products.

Basic Information

Product Name	Gestodene Ep Impurity K
CAS No.	1421283-61-5
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 Impurity K; Gestodene EP Impurity K; Gestodene Related Compound K; 11-Methylene Gestodene; Gestodene 11-Methylene Impurity; Gestodene Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Gestodene Ep Impurity K is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and conformity with in-house specifications aligned with pharmacopeial expectations. 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 a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

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%
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.