Description

Estradiol Impurity 1 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 containing estradiol. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The reliable identification and quantification of this impurity are essential for maintaining drug efficacy and meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in estradiol Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, and GC methods to monitor impurity levels during manufacturing and stability studies.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure analytical procedures are performing as intended.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of impurity identity and supporting the establishment of specification limits.
• Stability Studies: Used to track the formation of degradation products in estradiol formulations under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Employed in metabolic studies, pharmacokinetic research, and the synthesis of related steroid compounds.

Basic Information

Product Name	Estradiol Impurity 1
CAS No.	57780-81-1
Molecular Formula	C18H24O2
Molecular Weight	272.38 g/mol
Synonyms	1,3,5(10)-Estratrien-3,17β-diol-6,7-dione; Estra-1,3,5(10)-triene-3,17β-diol-6,7-dione; 6,7-Diketoestradiol; Estradiol-6,7-dione; 17β-Estradiol-6,7-dione; Estradiol Diketone Impurity
EINECS	Contact for details

Quality Control

Every batch of Estradiol Impurity 1 is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC for purity, IR and NMR for structural confirmation, and residual solvent analysis. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications aligned with ICH guidelines. Our quality commitment ensures material suitable for use as a reference standard in regulated environments.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

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)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
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.