Description

Promestriene Impurity 2 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing Promestriene. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in drug development and production.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of impurities in Promestriene Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and GC methods to establish specificity, accuracy, and detection limits for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure product consistency meets pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Aids in the identification of degradation products formed during the stability testing of Promestriene formulations under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and properties of this specific impurity.

Basic Information

Product Name	Promestriene Impurity 2
CAS No.	499985-15-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Promestriene Related Compound; Promestriene Process Impurity; Promestriene Degradant; 3,17-Dihydroxy-1,3,5(10)-estratrien-16-yl 3-hydroxy-2-methylpropanoate Impurity; Estriol 16α-(3-hydroxy-2-methylpropionate) Impurity; 16α-(3-Hydroxy-2-methyl-1-oxopropoxy)-1,3,5(10)-estratriene-3,17-diol
EINECS	Contact for details

Quality Control

Our Promestriene Impurity 2 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and traceability is provided with every shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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