Description

Desogestrel Ep Impurity B is a specified impurity of the active pharmaceutical ingredient Desogestrel, a key component in various hormonal contraceptives. This high-purity reference standard is critical for pharmaceutical research, development, and quality control processes to ensure drug safety and efficacy. It is primarily used by analytical laboratories and pharmaceutical manufacturers for method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Desogestrel in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly HPLC and LC-MS, for impurity profiling.
• Quality Control and Assurance: Used in routine QC testing to monitor and control the levels of this specific impurity, ensuring batches meet stringent pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to identify and quantify degradation products that may form under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control.
• Research and Development: Utilized in synthetic chemistry R&D to understand and minimize the formation of this impurity during the manufacturing process of Desogestrel.

Basic Information

Product Name	Desogestrel Ep Impurity B
CAS No.	54024-12-3
Molecular Formula	C22H30O
Molecular Weight	310.47 g/mol
Synonyms	13-Ethyl-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-17-ol; 11-Methylene-13-ethyl-18,19-dinor-17α-pregn-4-en-20-yn-17-ol; 3-Deoxy-11-methylene-13-ethyl-18,19-dinor-17α-pregn-4-en-20-yn-17-ol; Desogestrel Impurity B; Desogestrel EP Impurity B; Desogestrel Related Compound B; 11-Methylene-13-ethylgon-4-en-17α-ol
EINECS	Contact for details

Quality Control

Every batch of Desogestrel Ep Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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