Description

Loxoprofen Impurity C CAS NO 1551612-94-2 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 routine quality control testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Loxoprofen Sodium impurities in accordance with ICH guidelines.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and GC methods for impurity profiling of Loxoprofen Sodium API and finished dosage forms.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine pharmaceutical quality control laboratories to monitor batch-to-batch consistency.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., DMF, CMC sections) by providing necessary impurity data for FDA, EMA, and other global health authority submissions.
• Stability Studies: Employed in forced degradation and long-term stability studies of Loxoprofen formulations to track impurity formation over time.
• Research & Development (R&D): Used in pharmacokinetic, metabolic, and toxicological studies to understand the impurity's profile and behavior.

Basic Information

Product Name	Loxoprofen Impurity C
CAS No.	1551612-94-2
Molecular Formula	C15H18O3
Molecular Weight	246.30 g/mol
Synonyms	Loxoprofen Related Compound C; Loxoprofen EP Impurity C; Loxoprofen Sodium Impurity C; 2-[4-[(2-Oxocyclopentyl)methyl]phenyl]propanoic Acid; (RS)-2-[4-[(2-Oxocyclopentyl)methyl]phenyl]propanoic Acid; Loxoprofen Keto Impurity; Loxoprofen Impurity 3
EINECS	Contact for details

Quality Control

Our Loxoprofen Impurity C is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized and controlled against comprehensive specifications, including identity, purity, and impurity profile. A detailed Certificate of Analysis (COA) is provided, which includes data from HPLC, NMR, and MS analyses, ensuring full traceability and compliance with current pharmacopeial (EP, USP) and ICH 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). 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 an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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