Description

Estrone 3-Acetate 1-Methyl Impurity is a specific chemical reference standard used in the analysis and quality control of steroid-based pharmaceuticals. This compound is critical for ensuring the purity and safety of active pharmaceutical ingredients (APIs) and finished drug products by serving as a known impurity marker. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the development, validation, and routine testing of steroid hormone products.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of the 1-methyl impurity in Estrone 3-Acetate and related steroid APIs.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or GC-MS methods to monitor impurities in compliance with ICH Q3A/B guidelines.
• Quality Control (QC) Testing: Serves as a system suitability standard and a calibrant in the routine QC testing of bulk drug substances and finished dosage forms.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of impurity characterization and control strategies.
• Research & Development: Utilized in synthetic chemistry research to study metabolic pathways, degradation products, and the stability of steroid compounds.

Basic Information

Product Name	Estrone 3-Acetate 1-Methyl Impurity
CAS No.	30903-07-2
Molecular Formula	C21H28O3
Molecular Weight	328.45 g/mol
Synonyms	1-Methyl Estrone 3-Acetate; 1-Methyl-3-hydroxyestra-1,3,5(10)-trien-17-one 3-acetate; Estrone 3-acetate, 1-methyl-; 1-Methylestra-1,3,5(10)-triene-3,17-diol 3-acetate 17-one; 3-Acetoxy-1-methylestra-1,3,5(10)-trien-17-one; 1-Methylestrone 3-acetate; Estrone 3-acetate methyl derivative; 1-ME-3-Ac
EINECS	Contact for details

Quality Control

Every batch of Estrone 3-Acetate 1-Methyl Impurity is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with each shipment to support your regulatory and quality assurance needs.

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. For long-term storage, consider desiccant use.

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)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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