Description

Loteprednol Impurity 7 is a specified organic compound used as a reference standard in analytical chemistry. This impurity is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient Loteprednol Etabonate. It is primarily required by pharmaceutical manufacturers and analytical laboratories for research, method development, and rigorous quality control processes.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Loteprednol Etabonate API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure compliance with pharmacopeial limits (e.g., ICH Q3A/B guidelines) for impurities.
• Stability Studies: Used to track the formation and level of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in the optimization of synthesis and purification processes to minimize the formation of this impurity.

Basic Information

Item	Details
Product Name	Loteprednol Impurity 7
CAS No.	182068-96-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Loteprednol Related Compound 7; Loteprednol Etabonate Impurity 7; 17α-[(Chloroacetyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-2-carboxylic Acid Methyl Ester; 2-Carbomethoxy-11β,17α-dihydroxy-3-oxoandrosta-1,4-dien-17α-yl Chloroacetate Impurity; Loteprednol Chlorohydrin Impurity; Potential Degradation Product of Loteprednol
EINECS	Contact for details

Quality Control

Every batch of Loteprednol Impurity 7 is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including chromatographic purity and structural confirmation. A detailed Certificate of Analysis (COA) is supplied with each shipment, documenting identity, purity (by HPLC), and other critical parameters in compliance with current industry and regulatory expectations.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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 degradation. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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