Description

Progesterone 20-Hydroxy Impurity is a specified impurity of the steroid hormone progesterone, identified by CAS No. 151122-70-2. This compound is critical for pharmaceutical quality control, serving as a reference standard to ensure the purity and safety of progesterone-based drug substances and products. It is primarily required by analytical laboratories, research institutions, and pharmaceutical manufacturers engaged in method development, validation, and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of 20-Hydroxy Progesterone in progesterone Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Employed in routine QC testing to establish acceptance criteria and ensure batch-to-batch consistency of progesterone.
• Stability Studies: Used to track the formation of degradation products in progesterone under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Synthesis: Serves as an intermediate or analytical marker in steroid chemistry research and process development.

Basic Information

Product Name	Progesterone 20-Hydroxy Impurity
CAS No.	151122-70-2
Molecular Formula	C21H30O3
Molecular Weight	330.46 g/mol
Synonyms	20α-Hydroxyprogesterone; 20α-Hydroxypregn-4-ene-3,20-dione; 20α-OHP; 20α-Dihydroprogesterone; Pregn-4-ene-3,20-dione, 20-hydroxy-, (20α)-; 20-Hydroxy Progesterone Impurity; Progesterone 20α-Hydroxy Impurity
EINECS	Contact for details

Quality Control

Every batch of our Progesterone 20-Hydroxy Impurity is manufactured and analyzed under strict quality management systems. The product is characterized using advanced spectroscopic and chromatographic techniques to ensure identity, purity, and stability. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing results for assay, related substances, and residual solvents. Our quality standards align with current pharmacopeial requirements, supporting use in GMP-regulated environments.

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 prevent degradation.

Specification

Item	Specification
Appearance	White to off-white 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
Loss on Drying	≤ 0.5%

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