Description

Progesterone Impurity 6 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of progesterone-based pharmaceutical products by serving as a known impurity marker. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The product is supplied with comprehensive analytical data to support compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of impurities in Progesterone Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and GC methods in quality control laboratories.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) to demonstrate thorough impurity characterization.
• Stability Studies: Employed as a marker to monitor degradation pathways and establish shelf-life for progesterone formulations.
• Research & Development: Used in synthetic chemistry R&D to study the formation and fate of related substances during process optimization.
• Quality Control Testing: Acts as a system suitability standard and for routine batch release testing of progesterone to ensure it meets pharmacopeial monographs (USP, EP, BP).

Basic Information

Product Name	Progesterone Impurity 6
CAS No.	2526-82-1
Molecular Formula	C21H30O2
Molecular Weight	314.46 g/mol
Synonyms	Pregn-4-ene-3,20-dione, 17-(acetyloxy)-; 17α-Acetoxyprogesterone; 17α-Hydroxyprogesterone 17-acetate; 17-Acetoxyprogesterone; 17α-AP; 17α-Hydroxy-4-pregnene-3,20-dione acetate; Progesterone Related Compound 6
EINECS	Contact for details

Quality Control

Every batch of Progesterone Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, GC) and spectroscopic (IR, NMR, MS) techniques to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with cGMP, ICH Q3A/B guidelines, and relevant pharmacopeias (USP, EP).

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant use within the primary container.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches 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
Water Content (KF)	≤ 0.5%

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