Description

Loteprednol Impurity CAS NO 207670-55-1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the ophthalmic corticosteroid Loteprednol Etabonate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling in active pharmaceutical ingredient (API) production.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) to identify, quantify, and control related substances in Loteprednol Etabonate API batches.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and LC-MS methods for purity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Regulatory Submissions: Essential for preparing documentation for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization.
• Stability Studies: Used as a marker to track the formation of degradation products in stability testing of drug substances and finished formulations.
• Research & Development: Supports synthetic chemistry research for process optimization and impurity synthesis studies.

Basic Information

Product Name	Loteprednol Impurity
CAS No.	207670-55-1
Molecular Formula	C24H31ClO5
Molecular Weight	434.96 g/mol
Synonyms	Loteprednol Related Compound; Chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate; Loteprednol Etabonate Impurity; (11β,17α)-17-[(Ethoxycarbonyl)oxy]-11-hydroxy-3-oxoandrosta-1,4-diene-17-carboxylic Acid Chloromethyl Ester; Loteprednol Etabonate EP Impurity; Loteprednol Etabonate USP Impurity
EINECS	Contact for details

Quality Control

Our Loteprednol Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identification by spectroscopic methods (IR, NMR, MS), and related substance analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive (store away from light).

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 individual impurity ≤ 0.5%
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.