Description

Progesterone Impurity 1 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety and efficacy of pharmaceutical products by enabling the accurate identification and quantification of related substances. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of steroid-based APIs and finished drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the analysis of Progesterone Active Pharmaceutical Ingredients (APIs) and finished formulations.
• Method Development and Validation: Essential for developing and validating chromatographic methods (HPLC, GC) to monitor impurities in compliance with ICH Q3B guidelines.
• Quality Control (QC) Testing: Employed in routine QC laboratories to establish impurity profiles and ensure batch-to-batch consistency of Progesterone.
• Stability Studies: Used to track the formation of degradation products in Progesterone drug substances and products under various stress conditions.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity data for drug master files.
• Research and Development: Serves as a key material in pharmaceutical R&D for studying the metabolism, synthesis pathways, and degradation chemistry of Progesterone.

Basic Information

Item	Details
Product Name	Progesterone Impurity 1
CAS No.	37717-13-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Progesterone Related Compound A; 6β-Hydroxyprogesterone; 6β-Hydroxy-4-pregnene-3,20-dione; 6β-Hydroxypregn-4-ene-3,20-dione; 6β-OH-Progesterone; (6β)-6-Hydroxypregn-4-ene-3,20-dione; Pregn-4-ene-3,20-dione, 6-hydroxy-, (6β)-
EINECS	Contact for details

Quality Control

Our Progesterone Impurity 1 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the stringent requirements for a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
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.