Description

Pranoprofen Impurity 5 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) Pranoprofen. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity in Pranoprofen API and its finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for Pranoprofen analysis.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine QC testing to ensure Pranoprofen batches meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Used to track the formation and level of this impurity during forced degradation and long-term stability studies of Pranoprofen formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research and Development: Facilitates chemical and pharmacological research to understand the formation, properties, and potential impact of this impurity.

Basic Information

Product Name	Pranoprofen Impurity 5
CAS No.	145986-74-9
Molecular Formula	C15H13NO3
Molecular Weight	255.27 g/mol
Synonyms	Pranoprofen Related Compound 5; Pranoprofen EP Impurity 5; Pranoprofen USP Impurity 5; 2-[3-Chloro-4-(2-oxocyclopentylmethyl)phenyl]propanoic Acid; 3-Chloro-α-methyl-4-(2-oxocyclopentylmethyl)benzenacetic Acid; Pranoprofen Impurity C (Potential); Pranoprofen Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Pranoprofen Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity screening using advanced analytical techniques like HPLC, GC, and NMR to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual 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.