Description

Ibuprofen Impurity 4 is a specified impurity and degradation product of the widely used non-steroidal anti-inflammatory drug (NSAID) Ibuprofen. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, stability studies, and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for quality control and assurance of Ibuprofen API and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Ibuprofen Active Pharmaceutical Ingredient (API) and drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) to monitor impurity profiles.
• Stability and Forced Degradation Studies: Employed to understand the degradation pathways of Ibuprofen and establish shelf-life specifications.
• Quality Control (QC) & Quality Assurance (QA): Used in routine batch testing to ensure Ibuprofen meets pharmacopoeial standards (USP, EP, BP) for impurity limits.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate control over the drug substance's impurity profile.
• Research on Degradation Mechanisms: Supports academic and industrial research aimed at understanding the chemical stability and behavior of Ibuprofen under various conditions.

Basic Information

Product Name	Ibuprofen Impurity 4
CAS No.	123704-98-3
Molecular Formula	C13H18O2
Molecular Weight	206.28 g/mol
Synonyms	1-(4-Isobutylphenyl)ethanol; 4-Isobutyl-α-methylbenzyl alcohol; Ibuprofen Alcohol Impurity; Ibuprofen Impurity B (EP); Ibuprofen Related Compound C; α-Methyl-4-(2-methylpropyl)benzenemethanol; 2-(4-Isobutylphenyl)propan-1-ol
EINECS	Contact for details

Quality Control

Our Ibuprofen Impurity 4 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on purity, impurities, and analytical 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 under inert atmosphere to prevent potential oxidation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.