Description

Gestodene Impurity 1 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 products by serving as a benchmark in quality control testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and production of hormonal contraceptives and other steroid-based therapeutics.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Gestodene Impurity 1 in drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods, such as HPLC and UPLC, in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in Gestodene formulations under various stress conditions.
• 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 and development to understand and control impurity formation during the synthesis and purification of Gestodene.
• Quality Assurance/Quality Control (QA/QC): A critical component in routine batch release testing to ensure pharmaceutical products meet stringent purity specifications.

Basic Information

Product Name	Gestodene Impurity 1
CAS No.	104933-97-3
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 Related Compound A; Gestodene EP Impurity A; Gestodene USP Impurity; 17α-Hydroxy-13-ethyl-11-methylene-18,19-dinorgona-4,15-dien-20-yn-3-one
EINECS	Contact for details

Quality Control

Every batch of Gestodene Impurity 1 is manufactured and handled under strict quality management systems. The product undergoes rigorous analytical testing, including chromatographic purity assays and structural confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and analytical methods. Our quality commitment aligns with cGMP principles to support our global clientele in regulated markets.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive (store away from light).

Specification

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

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