Description

Lynestrenol Ep Impurity B is a specified impurity of the active pharmaceutical ingredient Lynestrenol, a synthetic progestogen. This high-purity reference standard is critical for pharmaceutical research, development, and quality control, enabling accurate identification, quantification, and monitoring of this specific impurity. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable materials for method validation, stability studies, and ensuring compliance with stringent regulatory guidelines for drug substance purity.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Lynestrenol.
• Method Development and Validation: Critical for developing and validating analytical methods, particularly HPLC and LC-MS, for impurity profiling.
• Quality Control and Assurance (QC/QA): Used in-house by API manufacturers and finished dosage form producers to monitor and control impurity levels against established specifications.
• Stability Studies: Employed to track the formation and increase of this specific degradation product under various stress conditions.
• Regulatory Compliance and Filing: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Research and Development: Facilitates studies on the degradation pathways and chemical behavior of Lynestrenol during synthesis and formulation.

Basic Information

Product Name	Lynestrenol Ep Impurity B
CAS No.	58311-09-4
Molecular Formula	C20H28O
Molecular Weight	284.44 g/mol
Synonyms	19-Nor-17α-pregna-1,3,5(10)-trien-20-yn-17-ol; Lynestrenol Impurity B; Lynestrenol Related Compound B; 17α-Ethynyl-19-norandrosta-1,3,5(10)-trien-17β-ol; 17α-Ethynyl-19-nor-1,3,5(10)-estratrien-17β-ol; 17α-Ethynylestra-1,3,5(10)-trien-17β-ol (19-nor); Org-2969 Impurity B
EINECS	Contact for details

Quality Control

Our Lynestrenol Ep Impurity B is manufactured and handled under strict quality management protocols. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR) and purity determination by advanced chromatographic techniques (HPLC). We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results for identity, assay, and impurity profile. Our quality systems are designed to support compliance with cGMP and ICH Q3A/B guidelines for pharmaceutical impurities.

Storage

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

Specification

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