Description

Loteprednol Impurity 8 is a specified impurity and degradation product associated with the corticosteroid active pharmaceutical ingredient Loteprednol Etabonate. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, stability studies, and quality control protocols. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in ensuring the purity, safety, and efficacy of ophthalmic and other pharmaceutical formulations containing Loteprednol.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Loteprednol Etabonate drug substance and finished products.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Stability and Forced Degradation Studies: Used to understand the degradation pathways of Loteprednol Etabonate under various stress conditions (e.g., heat, light, humidity).
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to ensure drug substance and product batches meet stringent pharmacopeial (USP, EP) impurity limits.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CMC sections) to demonstrate comprehensive impurity control strategies.
• Research on Degradation Mechanisms: Supports fundamental research into the chemical behavior and stability of corticosteroid compounds.

Basic Information

Product Name	Loteprednol Impurity 8
CAS No.	207670-54-0
Molecular Formula	C24H31ClO7
Molecular Weight	466.95 g/mol
Synonyms	Loteprednol Etabonate Impurity 8; Loteprednol Related Compound 8; 17-[(Chloroacetyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17α-carboxylic Acid, 17-Ethyl Ester; 11β,17α-Dihydroxy-3-oxopregna-1,4-diene-21-carboxylic Acid, 17-(Chloroacetate), γ-Lactone; Chloro Loteprednol; Loteprednol Chloroacetate Impurity
EINECS	Contact for details

Quality Control

Our Loteprednol Impurity 8 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC purity assay, related substance analysis, and confirmatory identification tests (IR, MS). We adhere to ICH Q3A/B guidelines for impurity qualification, and our quality system supports the needs of cGMP-compliant pharmaceutical development and manufacturing.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage under inert atmosphere, please contact us for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.5%
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.