Description

Loteprednol Impurity 7 is a specified impurity and degradation product of the corticosteroid Loteprednol Etabonate. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control processes. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Loteprednol-based ophthalmic formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Loteprednol Etabonate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Crucial for developing and validating stability-indicating HPLC/UPLC methods to monitor degradation pathways in accordance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to establish impurity profiles and ensure API and drug product specifications are met for regulatory filings (e.g., FDA, EMA).
• Stability Studies: Employed to track and quantify the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission documents (e.g., CMC sections, Drug Master Files) by providing definitive impurity characterization data.
• Research on Degradation Pathways: Facilitates chemical research to understand the degradation mechanisms of Loteprednol Etabonate, aiding in formulation optimization.

Basic Information

Item	Details
Product Name	Loteprednol Impurity 7
CAS No.	82034-20-6
Molecular Formula	C24H31ClO7
Molecular Weight	466.95 g/mol
Synonyms	Loteprednol Related Compound 7; 17-[(Chloroacetyl)oxy]-11-hydroxy-3-oxoandrosta-1,4-diene-17-carboxylic Acid Methyl Ester; 11β,17α-Dihydroxy-3-oxopregna-1,4-diene-21-carboxylic Acid γ-Chloromethyl Ester; Loteprednol Etabonate Impurity 7; Loteprednol EP Impurity C; Loteprednol Etabonate Degradant; Loteprednol Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Loteprednol Impurity 7 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive characterization and purity verification using advanced analytical techniques including HPLC, NMR, and MS to ensure it meets the stringent requirements for use as a reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurities. Our quality protocols are designed to support compliance with cGMP and relevant pharmacopoeial guidelines.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.