Description

Progesterone Ep Impurity G is a designated impurity of the pharmaceutical active ingredient Progesterone, a key steroid hormone. This compound is critical for pharmaceutical research and development, specifically in the analytical characterization and quality control of Progesterone-based drug substances and products. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Progesterone Ep Impurity G in drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurities in Progesterone.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity under various stress conditions.
• Quality Control & Batch Release: Serves as a system suitability standard and for setting specification limits in the quality control testing of Progesterone APIs.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Research into Degradation Pathways: Used in research to understand the chemical degradation mechanisms of Progesterone, aiding in formulation optimization.

Basic Information

Product Name	Progesterone Ep Impurity G
CAS No.	2257421-79-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Progesterone EP Impurity G; Progesterone Impurity G (EP); Progesterone Related Compound G; (8R,9S,10R,13S,14S,17S)-17-acetyl-10,13-dimethyl-1,2,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-3-one; Progesterone Degradant G; Progesterone Process Impurity G; Steroid Impurity G
EINECS	Contact for details

Quality Control

Our Progesterone Ep Impurity G is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity assay and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical impurity analysis. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container tightly sealed in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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