Description

Progesterone Ep Impurity F is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound is essential for the identification, qualification, and control of impurities in Progesterone Active Pharmaceutical Ingredient (API) manufacturing. It is primarily used by analytical chemists and quality control professionals in the pharmaceutical and biotechnology industries to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Progesterone API batches.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or GC analytical methods for purity testing.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency of Progesterone.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for impurity specifications.
• Stability Studies: Used as a marker to track the formation of degradation products during forced degradation and long-term stability studies of Progesterone formulations.
• Research & Development: Facilitates process chemistry research aimed at understanding and minimizing impurity formation during API synthesis.

Basic Information

Product Name	Progesterone Ep Impurity F
CAS No.	2257421-78-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Progesterone EP Impurity F; Progesterone Related Compound F; Progesterone Impurity F; (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; 17α-Hydroxyprogesterone Impurity; Progesterone Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Progesterone Ep Impurity F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for identity, assay, purity, and related substances is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, well-ventilated place. For long-term storage, consider storing under inert atmosphere.

Specification

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

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