Description

Dydrogesterone Ep Impurity C CAS NO 25093-47-4 is a specified impurity associated with the synthetic progestogen, Dydrogesterone. This compound is critical for pharmaceutical research and development, serving as a key reference standard in analytical chemistry. It is primarily utilized by quality control laboratories and regulatory affairs departments to ensure the purity, safety, and efficacy of Dydrogesterone active pharmaceutical ingredients (APIs) and finished drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Dydrogesterone API and formulations.
• Method Development and Validation: Essential for developing and validating sensitive analytical methods, such as HPLC and UPLC, in compliance with ICH Q2(R1) and Q3B guidelines.
• Quality Control & Assurance: Employed in routine batch testing to monitor and control impurity profiles, ensuring product consistency and meeting pharmacopoeial specifications (e.g., EP, USP).
• Stability Studies: Used to track the formation of degradation products under various stress conditions, supporting shelf-life determination and regulatory filings.
• Regulatory Compliance: Supports regulatory submissions (e.g., ANDA, NDA) by providing necessary impurity data for drug master files (DMFs).
• Process Chemistry Research: Aids in optimizing synthesis pathways by identifying and minimizing the formation of this specific impurity during manufacturing.

Basic Information

Product Name	Dydrogesterone Ep Impurity C
CAS No.	25093-47-4
Molecular Formula	C21H28O2
Molecular Weight	312.45 g/mol
Synonyms	(9β,10α)-Pregna-4,6-diene-3,20-dione; 9β,10α-Pregna-4,6-diene-3,20-dione; Dydrogesterone EP Impurity C; Dydrogesterone Related Compound C; 6-Dehydro-9β,10α-progesterone; Isodydrogesterone Impurity C
EINECS	Contact for details

Quality Control

Our Dydrogesterone Ep Impurity C is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS). We provide full traceability and Certificates of Analysis (COA) that detail batch-specific results, ensuring compliance with relevant pharmacopoeial standards and ICH guidelines for impurity standards.

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. For long-term storage, consider desiccant use.

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 unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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