Description

Pelubiprofen Impurity is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Pelubiprofen. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is essential for method development, validation, and stability studies within the pharmaceutical and analytical chemistry sectors.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Pelubiprofen API batches.
• Analytical Method Development: Used in developing and validating HPLC, UPLC, and GC methods for impurity profiling.
• Stability Studies: Employed to monitor the formation of degradation products in Pelubiprofen formulations under various stress conditions.
• Regulatory Compliance & Documentation: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and specifications.
• Research & Development: Utilized in synthetic chemistry research to study the pathways of impurity formation and to develop purification processes.
• Contract Research Organizations (CROs): Supplied to CROs and testing laboratories offering analytical services to the pharmaceutical industry.

Basic Information

Product Name	Pelubiprofen Impurity
CAS No.	63476-54-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pelubiprofen Related Compound; Pelubiprofen Impurity Standard; 2-[4-(2-Oxocyclopentylmethyl)phenyl]propanoic Acid (Related Substance); Pelubiprofen Process Impurity; Pelubiprofen Degradant; API Impurity 63476-54-0; Pelubiprofen Analog
EINECS	Contact for details

Quality Control

Every batch of our Pelubiprofen Impurity is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including characterization by advanced spectroscopic and chromatographic techniques. A detailed Certificate of Analysis (COA) is supplied with each product, confirming identity, purity, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material 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 solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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