Description

Carprofen Impurity 1 is a specified impurity and degradation product of the non-steroidal anti-inflammatory drug (NSAID) Carprofen. This compound is of critical importance in the pharmaceutical industry for analytical method development, stability studies, and quality control of Carprofen active pharmaceutical ingredients (APIs) and finished drug products. It is an essential reference standard for manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Carprofen-related impurities in compliance with ICH Q3A/B guidelines.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles in Carprofen API and formulations.
• Stability Indicating Studies: Used in forced degradation studies to understand the degradation pathways of Carprofen and establish shelf-life specifications.
• Quality Control & Batch Release: Serves as a system suitability standard in the routine QC testing of Carprofen to ensure batch-to-batch consistency and regulatory compliance.
• Regulatory Submissions: Essential for compiling impurity data in Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings for market approval.
• Research & Development: Used in pharmaceutical R&D to study the metabolism, pharmacokinetics, and toxicological profile of Carprofen impurities.

Basic Information

Product Name	Carprofen Impurity 1
CAS No.	114041-33-7
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 Related Compound A; Carprofen Impurity A; UNII-5V6W3TZ8Q2; Carprofen Carboxylic Acid Impurity
EINECS	Contact for details

Quality Control

Every batch of Carprofen Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC/UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

Storage

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

Specification

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

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