Description

Gestodene - Impurity E is a specified impurity of the active pharmaceutical ingredient Gestodene, a key component in various hormonal contraceptives. This high-purity reference standard is critical for pharmaceutical research, development, and quality control, enabling accurate identification and quantification of this specific impurity. It is primarily used by analytical chemists and quality assurance professionals in the pharmaceutical industry to ensure product safety, efficacy, and regulatory compliance. The compound is supplied with full analytical characterization to support method validation and stability studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Gestodene - Impurity E in active pharmaceutical ingredient (API) batches and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate sensitive analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine quality control testing to monitor impurity levels and ensure they remain within International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies of Gestodene to understand degradation pathways and establish shelf life.
• Regulatory Submissions: Provides necessary data and a characterized sample for inclusion in regulatory filings (e.g., for FDA, EMA) to demonstrate control of impurities.
• Research & Development: Used in synthetic chemistry R&D to study the formation and fate of this impurity during the manufacturing process of Gestodene.

Basic Information

Product Name	Gestodene - Impurity E
CAS No.	2143949-52-2
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 E; Gestodene Related Compound E; Gestodene EP Impurity E; Gestodene USP Impurity E; 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 E is manufactured and controlled under a strict quality management system. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, GC, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality systems are designed to support compliance with cGMP, ICH Q3A/B, and relevant pharmacopoeial guidelines (USP, EP).

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

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

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