Description

Desogestrel Related Compound (3-α-Hydroxy Desogestrel) is a high-purity reference standard and pharmaceutical intermediate, specifically identified as a key related substance of the progestin Desogestrel. Its precise characterization is critical for ensuring the quality, safety, and efficacy of active pharmaceutical ingredients (APIs) and finished drug products. This compound is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in quality control, method development, and regulatory compliance for hormonal contraceptives and other steroidal medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of 3-α-Hydroxy Desogestrel in Desogestrel API and finished dosage forms.
• Impurity Profiling and Control: Essential for monitoring and controlling this specific related substance during the synthesis and purification of Desogestrel to meet pharmacopeial limits (e.g., USP, EP).
• Analytical Method Development and Validation: Serves as a critical component in developing and validating stability-indicating HPLC, UPLC, or GC methods for steroidal compounds.
• Stability Studies: Employed in forced degradation and long-term stability studies to understand the degradation pathways of Desogestrel-based products.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Used in metabolic studies and the synthesis of novel steroidal derivatives for pharmacological evaluation.

Basic Information

Product Name	Desogestrel Related Compound (3-α-Hydroxy Desogestrel)
CAS No.	70805-84-4
Molecular Formula	C22H30O2
Molecular Weight	326.48 g/mol
Synonyms	3α-Hydroxy Desogestrel; 13-Ethyl-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-17-ol; 3α-Hydroxy-13-ethyl-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-17-ol; 3α-Hydroxydesogestrel; Desogestrel Impurity; Desogestrel Related Substance A; 17α-Ethynyl-3α-hydroxy-11-methylene-18,19-dinor-17α-pregn-4-ene
EINECS	Contact for details

Quality Control

Our Desogestrel Related Compound is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, related substance profiling, and structural confirmation via spectroscopic methods (IR, NMR, MS). We provide full traceability and Certificates of Analysis (COA) that detail all test results against stringent in-house specifications, supporting compliance with cGMP and ICH guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C to maximize stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.