Description

Progesterone Impurity 3 (Progesterone Ep Impurity C) is a specified impurity of the steroid hormone progesterone, identified by CAS No. 14510-23-7. This compound is critical for pharmaceutical quality control and analytical method development, ensuring the purity and safety of progesterone-based drug substances and products. It is primarily required by research institutions, analytical laboratories, and pharmaceutical manufacturers engaged in the development, validation, and regulatory compliance of steroid hormone APIs and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in progesterone active pharmaceutical ingredients (APIs).
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to meet ICH Q3A/B guidelines.
• Quality Control & Assurance: Serves as a system suitability standard and for routine batch testing in QC laboratories to monitor impurity profiles.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Employed to track the formation of degradation products in progesterone formulations under various stress conditions.
• Research & Synthesis: Used in chemical research to study the metabolism, degradation pathways, and synthesis of progesterone and related steroids.

Basic Information

Product Name	Progesterone Impurity 3 (Progesterone Ep Impurity C)
CAS No.	14510-23-7
Molecular Formula	C21H30O2
Molecular Weight	314.46 g/mol
Synonyms	Progesterone EP Impurity C; 17α-Hydroxy-6β-methylpregn-4-ene-3,20-dione; 6β-Methyl-17α-hydroxyprogesterone; 6β-Methyl-17α-hydroxypregn-4-ene-3,20-dione; 17α-Hydroxy-6β-methyl-4-pregnene-3,20-dione; Pregn-4-ene-3,20-dione, 17-hydroxy-6-methyl-, (6β,17α)-; Progesterone Related Compound C (EP)
EINECS	Contact for details

Quality Control

Our Progesterone Impurity 3 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets high-purity standards suitable for use as a reference material. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

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