Description

Ethinylestradiol Impurity J is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of active pharmaceutical ingredients (APIs) by enabling the accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in the synthesis and quality assurance of steroid-based drugs.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Ethinylestradiol Impurity J in drug substances and products.
• Method Development and Validation: Essential for developing and validating analytical methods, such as HPLC and UPLC, in compliance with ICH guidelines.
• Quality Control (QC) Testing: Serves as a system suitability standard in routine QC labs to monitor the performance of chromatographic systems for impurity profiling.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed to track the formation of this specific impurity during forced degradation and long-term stability studies of drug products.
• Research and Development: Used in R&D to study the synthetic pathways, degradation mechanisms, and purification processes for Ethinylestradiol.

Basic Information

Item	Detail
Product Name	Ethinylestradiol Impurity J
CAS No.	15071-66-6
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 J; EE Impurity J; Ethinyl Estradiol Related Compound J; 3,17β-Dihydroxy-19-nor-17α-pregna-1,3,5(10)-trien-20-yne; 17α-Ethynylestra-1,3,5(10)-triene-3,17β-diol Impurity
EINECS	Contact for details

Quality Control

Every batch of Ethinylestradiol Impurity J is manufactured and tested under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including HPLC purity, identity confirmation (IR, NMR), and specified impurity limits. Certificates of Analysis (COA) detailing batch-specific results are available upon request, ensuring full traceability and compliance with ICH Q3A, Q3B, and relevant pharmacopeial 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 should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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