Description

Desogestrel Impurity CAS NO 201360-83-0 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of Desogestrel, a key active pharmaceutical ingredient (API) in hormonal contraceptives. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Desogestrel API and finished drug products.
• Analytical Method Development: Essential for developing and validating sensitive HPLC, UPLC, or GC methods to monitor impurity levels in compliance with ICH Q3A/B guidelines.
• Quality Control & Assurance (QC/QA): Serves as a primary standard in in-house QC laboratories to ensure batch-to-batch consistency and purity of Desogestrel.
• Regulatory Compliance & Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive characterization data for impurity specifications.
• Stability Studies: Employed to track the formation of degradation products in Desogestrel formulations under various stress conditions.
• Research & Development: Used in synthetic chemistry R&D to understand degradation pathways and to synthesize purer forms of the API.

Basic Information

Product Name	Desogestrel Impurity
CAS No.	201360-83-0
Molecular Formula	C22H30O2
Molecular Weight	326.48 g/mol
Synonyms	13-Ethyl-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-17-ol; 13-Ethyl-11-methylenegon-4-en-17α-ol; 11-Methylene-13-ethyl-18,19-dinor-17α-pregn-4-en-20-yn-17-ol; 11-Methylenedesogestrel; Desogestrel Related Compound; Desogestrel Impurity Standard; Desogestrel EP Impurity; Desogestrel USP Impurity
EINECS	Contact for details

Quality Control

Our Desogestrel Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We support compliance with ICH guidelines, USP, and EP monographs.

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 material 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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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