Description

Loxoprofen Related Compound 1 is a high-purity chemical reference standard, identified by CAS NO 1091621-63-4. This compound is essential for ensuring the quality, safety, and efficacy of the non-steroidal anti-inflammatory drug (NSAID) Loxoprofen sodium through rigorous analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. This standard supports critical compliance with international pharmacopeial guidelines.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific impurities in Loxoprofen sodium active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, ensuring accuracy and specificity.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine batch release testing within pharmaceutical QC laboratories to monitor impurity levels against established specifications.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of Loxoprofen.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and ICH requirements.
• Research and Development: Utilized in pharmaceutical R&D for synthesizing and studying the metabolic pathways and pharmacokinetics of Loxoprofen and its related substances.

Basic Information

Product Name	Loxoprofen Related Compound 1
CAS No.	1091621-63-4
Molecular Formula	C15H18O3
Molecular Weight	246.30 g/mol
Synonyms	2-[4-[(2-Oxocyclopentyl)methyl]phenyl]propanoic Acid; Loxoprofen Impurity; Loxoprofen Related Substance 1; Loxoprofen EP Impurity C; Loxoprofen Sodium Related Compound A; (±)-2-[4-[(2-Oxocyclopentyl)methyl]phenyl]propionic Acid; Loxoprofen Ketone Metabolite
EINECS	Contact for details

Quality Control

Every batch of Loxoprofen Related Compound 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with ICH Q3A, Q3B, and relevant pharmacopeial standards (USP, EP, JP). Comprehensive Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

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)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w
Assay (on dried basis)	98.0% - 102.0%

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