Description

Conjugated Estrogens Ep Impurity I is a specified impurity used in the quality control and analytical testing of conjugated estrogens drug substances and products. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and compliance with stringent pharmacopeial standards. It serves as a key reference standard for method development, validation, and routine batch analysis in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Conjugated Estrogens USP/EP.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles in active pharmaceutical ingredients (APIs).
• Quality Control & Assurance: Used in-house by QC laboratories to confirm the impurity limits of drug substances and finished dosage forms meet pharmacopeia specifications.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and dossiers.
• Stability Studies: Employed to track the formation of degradation products in conjugated estrogens under various stability-indicating conditions.
• Research & Development: Utilized in pharmaceutical R&D for studying the metabolism, degradation pathways, and synthesis of estrogen-based compounds.

Basic Information

Product Name	Conjugated Estrogens Ep Impurity I
CAS No.	15370-49-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Equilin Impurity; 3-Hydroxyestra-1,3,5(10),7-tetraen-17-one; Estra-1,3,5(10),7-tetraene-3,17-diol; Delta7,9-Dehydroestrone; 7-Dehydroestrone; Conjugated Estrogens Related Compound I; EP Impurity I of Conjugated Estrogens
EINECS	Contact for details

Quality Control

Our Conjugated Estrogens Ep Impurity I is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity and identity confirmation, to ensure it meets the exacting standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances.

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 low-humidity environment to maintain stability and purity.

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 impurity: ≤ 1.0% 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.