Description

Ibuprofen Impurity 87 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of ibuprofen-based drug products by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, impurity profiling, and quality control processes. The availability of this well-characterized impurity supports compliance with stringent global pharmacopeial standards.

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 & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurity levels throughout the drug product lifecycle.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed in forced degradation and long-term stability studies to understand the degradation pathways of ibuprofen and establish appropriate shelf-life.
• Quality Control (QC) Testing: Serves as a system suitability standard and for routine batch release testing in pharmaceutical QC laboratories to ensure product purity.
• Research on Degradation Chemistry: Used by academic and industrial researchers to study the formation, structure, and toxicity of ibuprofen-related degradation products.

Basic Information

Product Name	Ibuprofen Impurity 87
CAS No.	60640-80-4
Molecular Formula	C13H18O2
Molecular Weight	206.28 g/mol
Synonyms	2-[4-(2-Methylpropyl)phenyl]propanoic Acid Impurity 87; Ibuprofen Related Compound 87; Ibuprofen Degradation Product; Ibuprofen Process Impurity; 4-Isobutylacetophenone Impurity; (RS)-2-(4-Isobutylphenyl)propionic Acid Impurity 87
EINECS	Contact for details

Quality Control

Every batch of Ibuprofen Impurity 87 is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) containing batch-specific data is provided with each shipment.

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. The container should be opened only under controlled, low-humidity conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 0.5% w/w
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.