Description

Ibuprofen Related Compound C is a high-purity chemical reference standard and impurity used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of ibuprofen-based drug products through precise analytical control. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality assurance processes. Its defined structure and purity make it an essential tool for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in ibuprofen active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, and GC methods in quality control laboratories.
• Stability Studies: Employed to monitor degradation pathways and establish impurity thresholds during forced degradation and long-term stability testing of ibuprofen.
• Regulatory Compliance & Documentation: Essential for creating impurity reports and regulatory submissions (e.g., for FDA, EMA) to demonstrate product safety.
• Pharmacopeial Testing: Used to comply with testing requirements outlined in monographs from USP (United States Pharmacopeia), EP (European Pharmacopoeia), and other international pharmacopeias.
• Process Chemistry Research: Aids in understanding and controlling the synthesis pathway of ibuprofen to minimize the formation of this specific related compound.

Basic Information

Product Name	Ibuprofen Related Compound C
CAS No.	1261642-35-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ibuprofen Impurity C; Ibuprofen Related Substance C; Ibuprofen EP Impurity C; Ibuprofen USP Related Compound C; 2-[4-(2-Methylpropyl)phenyl]propanoic acid related compound C; Ibuprofen Process Impurity C; Ibuprofen Degradation Product C
EINECS	Contact for details

Quality Control

Every batch of Ibuprofen Related Compound C is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to meet the high-purity standards required for pharmaceutical reference materials, with specifications aligned to pharmacopeial expectations. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for identity, purity, and impurity profiles as determined by validated chromatographic methods.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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