Description

Lynestrenol Ep Impurity C is a specified impurity and degradation product of the synthetic progestin Lynestrenol. This compound is critical for pharmaceutical quality control and analytical method development, ensuring the safety and efficacy of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for use as a certified reference standard in chromatographic analysis.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Lynestrenol Ep Impurity C in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, and GC methods for impurity profiling and stability-indicating assays.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., EP, USP, ICH Q3B).
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific degradation product.
• Regulatory Submissions: Provides critical data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control.
• Research & Development: Used in synthetic chemistry R&D to understand degradation pathways and improve the synthesis and purification processes of Lynestrenol.

Basic Information

Product Name	Lynestrenol Ep Impurity C
CAS No.	5225-38-7
Molecular Formula	C20H28O
Molecular Weight	284.44 g/mol
Synonyms	19-Norpregna-1,3,5(10)-trien-20-yn-17-ol; Lynestrenol Impurity C; Lynestrenol EP Impurity C; Lynestrenol Related Compound C; 17α-Ethynyl-19-nor-1,3,5(10)-estratrien-17β-ol; 17α-Ethynylestra-1,3,5(10)-trien-17β-ol; Org-2969 Impurity C
EINECS	Contact for details

Quality Control

Our Lynestrenol Ep Impurity C is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency, suitable for use as a reference standard. Each batch is characterized and tested using advanced analytical techniques including HPLC, GC, NMR, and Mass Spectrometry. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile, supporting compliance with EP, USP, and ICH guidelines.

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 prevent potential oxidation.

Specification

Item	Specification
Appearance	White to off-white powder
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 Q3C

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