Description

Loxoprofen Impurity 33 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 active pharmaceutical ingredient (API) Loxoprofen Sodium. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Loxoprofen Sodium API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to accurately identify and quantify this specific impurity.
• Stability Studies: Employed to monitor the formation of Loxoprofen Impurity 33 in drug products under various stress conditions (e.g., heat, humidity, light).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity data required for drug master files (DMFs).
• Research & Development: Used in R&D laboratories to study the degradation pathways and chemical behavior of Loxoprofen.
• Pharmacopoeial Testing: Aids in compliance testing against pharmacopoeial monographs (e.g., USP, EP, JP) that specify impurity limits.

Basic Information

Product Name	Loxoprofen Impurity 33
CAS No.	1380490-59-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Loxoprofen Related Compound 33; Loxoprofen Sodium Impurity 33; 2-[4-[(2-Oxocyclopentyl)methyl]phenyl]propanoic acid (related compound); Loxoprofen EP Impurity C; Loxoprofen Process Impurity; Loxoprofen Degradant; (RS)-2-[4-[(2-Oxocyclopentyl)methyl]phenyl]propanoic acid
EINECS	Contact for details

Quality Control

Every batch of Loxoprofen Impurity 33 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure it meets the highest standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing all test results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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