Description

Loteprednol Impurity CAS NO 207670-57-3 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Loteprednol Etabonate. This compound is critical for ensuring the safety and efficacy of the final ophthalmic drug product by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analytical testing of Loteprednol Etabonate active pharmaceutical ingredient (API) and finished drug products.
• Method Development and Validation: Used in developing and validating chromatographic methods (HPLC, UPLC) for impurity profiling and stability studies.
• Quality Control (QC) Testing: Essential for routine batch release testing in pharmaceutical manufacturing to monitor impurity levels against regulatory specifications (ICH Q3A/B).
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research and Development: Used in synthetic chemistry research to understand degradation pathways and to synthesize purer batches of the main API.

Basic Information

Product Name	Loteprednol Impurity
CAS No.	207670-57-3
Molecular Formula	C₂₄H₃₁ClO₇
Molecular Weight	466.95 g/mol
Synonyms	Loteprednol Etabonate Impurity; Loteprednol Related Compound; Chloromethyl (1R,4aS,4bR,6aS,7R,9aS,10aS,10bS)-7-[(Acetyloxy)methyl]-1,4b-dihydroxy-8-methylene-9a-(2-methyl-1-oxobutoxy)-4a,6a,8,10a-tetramethyl-1,2,3,4,4a,4b,5,6,6a,7,9a,10,10a,10b-tetradecahydrobenzo[f]azulene-3-carboxylate; (11β,17α)-17-[(Ethoxycarbonyl)oxy]-11-hydroxy-3-oxoandrosta-1,4-diene-2-carboxylic Acid Methyl Ester Impurity; Loteprednol Etabonate EP Impurity; Loteprednol Etabonate USP Impurity
EINECS	Contact for details

Quality Control

Our Loteprednol Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards. The quality management system supports compliance with cGMP and relevant pharmacopeial guidelines (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

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)	Single unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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