Description

Carprofen Ep Impurity B is a specified impurity and degradation product of the non-steroidal anti-inflammatory drug (NSAID) Carprofen. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method validation and quality control. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Carprofen API and its finished dosage forms.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of Carprofen-related impurities.
• Critical component in analytical method development and validation (HPLC, LC-MS) for Carprofen API and pharmaceutical formulations.
• Used in stability studies to monitor degradation pathways and establish shelf-life specifications.
• Essential for quality control (QC) and quality assurance (QA) laboratories to meet pharmacopeial standards (e.g., EP, USP).
• Supports regulatory submissions (e.g., CMC sections for FDA, EMA) by providing impurity profiling data.
• Valuable for research and development in veterinary and human pharmaceuticals to understand drug metabolism and degradation.

Basic Information

Product Name	Carprofen Ep Impurity B
CAS No.	52263-68-0
Molecular Formula	C15H12ClNO2
Molecular Weight	273.71 g/mol
Synonyms	6-Chloro-α-methyl-9H-carbazole-2-acetic Acid; 2-(6-Chloro-9H-carbazol-2-yl)propanoic Acid; Carprofen Impurity B; Carprofen Related Compound B; Carprofen EP Impurity B; Carprofen Carbazole Impurity; (RS)-2-(6-Chloro-9H-carbazol-2-yl)propionic Acid
EINECS	Contact for details

Quality Control

Every batch of Carprofen Ep Impurity B is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C to ensure maximum stability.

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%

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