Description

Desogestrel Related Compound B (15 Mg) (3-Hydroxy-Desogestrel) is a high-purity pharmaceutical reference standard and synthetic intermediate. This compound is critically important for quality control and analytical method development in the production of active pharmaceutical ingredients (APIs). It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories for use as a certified reference material (CRM) in HPLC, LC-MS, and other chromatographic assays to ensure the purity, safety, and efficacy of final drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quantitative and qualitative analysis of Desogestrel and related progestin APIs.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Pharmaceutical Impurity Profiling: Serves as a known impurity (Related Substance B) for monitoring and controlling the impurity profile during API synthesis and formulation.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing characterized material for stability studies and specification setting.
• Research & Development: Utilized in synthetic chemistry R&D for the study of metabolic pathways and the synthesis of novel steroid derivatives.
• Quality Assurance/Quality Control (QA/QC): A critical tool for in-process testing and release testing of bulk pharmaceuticals to meet pharmacopeial standards (USP, EP).

Basic Information

Product Name	Desogestrel Related Compound B (15 Mg) (3-Hydroxy-Desogestrel)
CAS No.	70805-85-5
Molecular Formula	C22H30O2
Molecular Weight	326.48 g/mol
Synonyms	3-Hydroxy-desogestrel; 13-Ethyl-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-17-ol; 13-Ethyl-11-methylidene-18,19-dinor-17α-pregn-4-en-20-yn-17-ol; Desogestrel Impurity B; Desogestrel Related Substance B; 17-Hydroxy-13-ethyl-11-methylene-18,19-dinorpregna-4-en-20-yn-3-one; 3-Oxo-desogestrel
EINECS	Contact for details

Quality Control

Our Desogestrel Related Compound B is manufactured under strict quality systems to ensure it meets the exacting requirements for a pharmaceutical reference standard. Each batch is subjected to comprehensive analytical testing, including identity confirmation by spectroscopic methods (IR, NMR) and purity determination by validated chromatographic methods (HPLC). A detailed Certificate of Analysis (COA) is provided, which includes batch-specific data on assay, related substances, and residual solvents, supporting compliance with ICH guidelines and pharmacopeial expectations.

Storage

Preserve in the original, tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%

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