Description

Carprofen Ep Impurity H CAS NO 92841-23-1 is a critical pharmaceutical reference standard used in the analytical profiling of the non-steroidal anti-inflammatory drug (NSAID) Carprofen. This compound is essential for ensuring the purity, safety, and efficacy of Carprofen active pharmaceutical ingredients (APIs) and finished drug products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific process-related impurities in Carprofen API.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control and Release Testing: Employed in routine QC laboratories to monitor batch-to-batch consistency and ensure compliance with pharmacopeial specifications (e.g., ICH Q3A/B).
• Stability Studies: Acts as a marker to track the formation of degradation products during forced degradation and long-term stability studies of Carprofen 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: Utilized in pharmaceutical R&D to understand the synthesis pathway, degradation pathways, and overall impurity profile of Carprofen.

Basic Information

Product Name	Carprofen Ep Impurity H
CAS No.	92841-23-1
Molecular Formula	C15H12ClNO2
Molecular Weight	273.71 g/mol
Synonyms	6-Chloro-α-methyl-9H-carbazole-2-acetic Acid Impurity H; Carprofen Related Compound H; 2-(6-Chloro-9H-carbazol-2-yl)propanoic Acid; Carprofen Impurity H; Carprofen EP Impurity H; Carprofen USP Impurity H; Carprofen Process Impurity H
EINECS	Contact for details

Quality Control

Every batch of Carprofen Ep Impurity H is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (HPLC, GC, NMR, MS) to ensure they meet the exacting standards for pharmaceutical reference materials. 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.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.