Description

Promestriene Impurity 4 is a specified impurity of the active pharmaceutical ingredient Promestriene, identified by the CAS registry number 69227-81-2. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation, quality control, and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, purification, and quality assurance of Promestriene-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Promestriene active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation (HPLC/GC): Essential for developing, optimizing, and validating chromatographic methods to ensure specificity, accuracy, and precision in impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure drug substance and product specifications meet pharmacopeial standards (e.g., USP, EP).
• Regulatory Compliance & Submission: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Used to track the formation and degradation of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Process Chemistry Research: Aids chemists in understanding and optimizing the Promestriene synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Promestriene Impurity 4
CAS No.	69227-81-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Promestriene Related Compound 4; Promestriene EP Impurity 4; Promestriene USP Impurity 4; 3,17-Dihydroxy-1,3,5(10)-estratrien-16-one; 16-Oxoestradiol; 16-Ketoestradiol; Estra-1,3,5(10)-triene-3,16α,17β-triol Impurity; 69227-81-2
EINECS	Contact for details

Quality Control

Our Promestriene Impurity 4 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assay (HPLC) and identity confirmation (IR/MS/NMR), to ensure it meets the high standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available for review upon request.

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w

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