Description

Carprofen Ethyl Ester (Carprofen Impurity) is a key chemical reference standard and impurity used in the pharmaceutical development and quality control of the non-steroidal anti-inflammatory drug (NSAID) Carprofen. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in analytical methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in API synthesis, method validation, and regulatory compliance activities.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Carprofen and its related substances.
• Impurity Profiling & Control: Essential for identifying, monitoring, and controlling Carprofen Ethyl Ester as a specified impurity during Active Pharmaceutical Ingredient (API) manufacturing and stability studies.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, and GC methods to ensure accurate impurity detection and quantification.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity identity, levels, and toxicological assessment.
• Research & Development: Utilized in synthetic chemistry research for studying Carprofen metabolism, degradation pathways, and the synthesis of novel derivatives.
• Quality Assurance/Quality Control (QA/QC): Integral for in-process testing and release testing of Carprofen API batches to confirm they meet pharmacopeial or internal specifications.

Basic Information

Product Name	Carprofen Ethyl Ester (Carprofen Impurity)
CAS No.	52262-89-2
Molecular Formula	C17H16ClNO3
Molecular Weight	317.77 g/mol
Synonyms	6-Chloro-α-methyl-9H-carbazole-2-acetic Acid Ethyl Ester; Ethyl 2-(6-Chloro-9H-carbazol-2-yl)propanoate; Carprofen Ethyl Ester; Carprofen Related Compound; Carprofen Impurity; Carprofen EP Impurity; Carprofen USP Impurity; 2-(6-Chloro-9H-carbazol-2-yl)propionic Acid Ethyl Ester
EINECS	Contact for details

Quality Control

Our Carprofen Ethyl Ester is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity assay by HPLC, and control of related impurities. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with specified standards. We support compliance with ICH Q3A/B guidelines for impurities in new drug substances and products.

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 under inert atmosphere to prevent potential degradation.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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