Description

Equilenin 17β-Dihydro 17α-Ethinyl Impurity 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, particularly in the development and manufacturing of steroidal drugs. It is primarily needed by pharmaceutical R&D laboratories, quality control (QC) departments, and contract research organizations (CROs) for method validation, impurity profiling, and stability studies.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating sensitive analytical methods, such as HPLC and LC-MS, to monitor process-related impurities.
• Quality Control & Assurance: Serves as a critical benchmark in QC laboratories to ensure batch-to-batch consistency and compliance with stringent pharmacopeial standards (e.g., USP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products in steroidal compounds under various stress conditions.
• Regulatory Submissions: Provides necessary data on impurity identity and levels for regulatory filings with agencies like the FDA and EMA.
• Research & Synthesis: Used in chemical research as an intermediate or a marker to study synthetic pathways and optimize manufacturing processes for related steroidal molecules.

Basic Information

Product Name	Equilenin 17β-Dihydro 17α-Ethinyl Impurity
CAS No.	1357266-17-1
Molecular Formula	C20H24O2
Molecular Weight	296.41 g/mol
Synonyms	17α-Ethynyl-17β-hydroxyestra-1,3,5(10),6,8-pentaen-3-ol; 17α-Ethynyl-17β-hydroxy-1,3,5(10),6,8-estrapentaen-3-ol; 17β-Hydroxy-17α-ethynylestra-1,3,5(10),6,8-pentaen-3-one Impurity; Equilenin 17α-Ethynyl-17β-ol Impurity; 17α-Ethynyl-17β-hydroxyequilenin; 17β-Hydroxy-17α-ethynyl-1,3,5(10),6,8-estrapentaen-3-one; 17α-Ethynyl-17β-hydroxyestra-1,3,5(10),6,8-pentaen-3-one
EINECS	Contact for details

Quality Control

Our Equilenin 17β-Dihydro 17α-Ethinyl Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and structural confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data (HPLC/LC-MS) are provided and traceable to primary standards. The quality system adheres to cGMP principles and relevant ICH guidelines.

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 product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a desiccated environment and handled under appropriate conditions to prevent degradation.

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 single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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