Description

Ethynylestradiol Impurity M is a designated reference standard and impurity used in the pharmaceutical development and quality control of synthetic estrogen compounds. This compound is critical for ensuring the purity, safety, and efficacy of active pharmaceutical ingredients (APIs) and finished drug products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Ethynylestradiol and related steroid APIs.
• Impurity Profiling & Identification: Essential for identifying and quantifying this specific impurity during the stability testing and shelf-life determination of pharmaceutical formulations.
• Method Development & Validation (HPLC/GC): Serves as a critical component in developing and validating analytical methods to meet ICH Q2(R1) and pharmacopeial guidelines (USP, EP).
• Quality Control (QC) Testing: Employed in routine batch release testing of steroid-based APIs to ensure compliance with strict impurity thresholds.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to synthesize purer forms of the parent drug compound.

Basic Information

Product Name	Ethynylestradiol Impurity M
CAS No.	1818-11-7
Molecular Formula	C20H24O2
Molecular Weight	296.40 g/mol
Synonyms	19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol; 17α-Ethynyl-1,3,5(10)-estratriene-3,17β-diol Impurity M; EE Impurity M; 17α-Ethynylestra-1,3,5(10)-triene-3,17β-diol related compound M; Ethinylestradiol Impurity M; 19-Nor-17α-pregna-1,3,5(10)-trien-20-yn-3,17-diol
EINECS	Contact for details

Quality Control

Every batch of Ethynylestradiol Impurity M is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. Keep the container sealed to protect the material from moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%

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