Description

Ibuprofen Impurity 59 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 for method development, validation, and impurity profiling.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in ibuprofen Active Pharmaceutical Ingredient (API) and finished drug products.
• Essential for analytical method development and validation in accordance with ICH Q2(R1) guidelines.
• Critical component in pharmaceutical quality control (QC) and quality assurance (QA) processes to monitor batch-to-batch consistency.
• Used in stability studies to track impurity formation under various stress conditions.
• Valuable for regulatory submissions (e.g., to FDA, EMA) to establish impurity limits and specifications.
• Supports research and development (R&D) in synthetic chemistry and impurity pathway elucidation.

Basic Information

Product Name	Ibuprofen Impurity 59
CAS No.	89878-72-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ibuprofen Related Compound 59; Ibuprofen Impurity F; Ibuprofen EP Impurity F; Ibuprofen USP Impurity; 2-[4-(2-Methylpropyl)phenyl]propanoic acid impurity; Ibuprofen Process Impurity; Ibuprofen Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Ibuprofen Impurity 59 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and traceability. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against established specifications. We support compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Keep the container sealed to prevent moisture absorption and contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	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.