Description

Ibuprofen Impurity 7 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of ibuprofen-based pharmaceutical products. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, impurity profiling, and stability studies.

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 drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels in compliance with ICH guidelines.
• Quality Control and Assurance (QC/QA): Employed in routine quality control testing to ensure ibuprofen batches meet stringent pharmacopeial specifications (e.g., USP, EP, BP) for impurity limits.
• Stability Studies: Used to track the formation and growth of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the impurity profile of ibuprofen.
• Research and Development: Facilitates chemical and metabolic pathway studies related to ibuprofen synthesis, degradation, and in-vivo behavior.

Basic Information

Product Name	Ibuprofen Impurity 7
CAS No.	69363-33-3
Molecular Formula	C13H18O2
Molecular Weight	206.28 g/mol
Synonyms	2-[4-(2-Methylpropyl)phenyl]propanoic Acid (Ibuprofen) Related Compound; Ibuprofen Related Substance 7; 1-Isobutyl-4-(1-hydroxy-1-methylethyl)benzene; 4-(2-Methylpropyl)-α,α-dimethylbenzenemethanol; Ibuprofen Alcohol; Ibuprofen Impurity C (EP); Ibuprofen Impurity F (USP); Ibuprofen EP Impurity C
EINECS	Contact for details

Quality Control

Every batch of Ibuprofen Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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