Description

Ibuprofen Impurity 60 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 required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling.

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 finished dosage forms.
• Analytical Method Development: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity levels in compliance with ICH Q3A/B guidelines.
• Quality Control & Assurance: Serves as a system suitability standard in quality control laboratories to ensure the accuracy and precision of impurity testing procedures.
• Stability Studies: Employed in forced degradation and long-term stability studies of ibuprofen to understand impurity formation pathways and shelf-life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Research & Development: Used in academic and industrial R&D to study the metabolism, pharmacokinetics, and toxicological profile of ibuprofen-related substances.

Basic Information

Product Name	Ibuprofen Impurity 60
CAS No.	89878-75-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ibuprofen Related Compound 60; Ibuprofen Impurity F; 2-[4-(2-Methylpropyl)phenyl]propanoic Acid Impurity 60; Ibuprofen Process Impurity; 1-(4-Isobutylphenyl)ethanol; α-Methyl-4-(2-methylpropyl)benzenemethanol; 4-Isobutyl-α-methylbenzyl Alcohol
EINECS	Contact for details

Quality Control

Every batch of Ibuprofen Impurity 60 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request, providing detailed results for identity, purity, and related substances as per current pharmacopoeial methodologies.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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