Description

Ibuprofen Ester Impurity CAS NO 87553-98-8 is a high-purity reference standard critical for the analytical profiling and quality control of Ibuprofen active pharmaceutical ingredients (APIs) and related formulations. This compound serves as a key marker for identifying and quantifying process-related impurities, ensuring final product safety and compliance with stringent pharmacopeial guidelines. It is an essential material for pharmaceutical R&D laboratories, quality assurance (QA) departments, and contract research organizations (CROs) engaged in method development, validation, and stability studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of specific ester-related impurities in Ibuprofen API during stability-indicating method development.
• Analytical Method Validation: Serves as a critical system suitability standard to validate HPLC, UPLC, and GC methods for impurity detection in accordance with ICH Q2(R1) guidelines.
• Quality Control & Release Testing: Employed in routine QC laboratories to establish acceptance criteria and monitor batch-to-batch consistency of Ibuprofen raw material and finished dosage forms.
• Regulatory Submissions: Provides essential impurity characterization data required for Drug Master Files (DMFs), Common Technical Documents (CTDs), and submissions to agencies like the FDA and EMA.
• Stability Studies: Acts as a reference point for tracking the formation of degradation products under various stress conditions (hydrolysis, oxidation) as per ICH Q1A(R2).
• Process Chemistry Optimization: Helps chemical development scientists identify and eliminate the source of this impurity during the synthesis and purification stages of Ibuprofen manufacturing.

Basic Information

Product Name	Ibuprofen Ester Impurity
CAS No.	87553-98-8
Molecular Formula	C19H28O4
Molecular Weight	320.43 g/mol
Synonyms	Ibuprofen Ester; Ibuprofen Related Compound Ester; Propanoic acid, 2-[4-(2-methylpropyl)phenyl]-, 1-methylethyl ester; Isopropyl 2-(4-isobutylphenyl)propionate; Ibuprofen Isopropyl Ester; Ibuprofen Impurity E (Ester); Ibuprofen Process Impurity (Ester); 2-(4-Isobutylphenyl)propionic Acid Isopropyl Ester
EINECS	Contact for details

Quality Control

Every batch of Ibuprofen Ester Impurity (CAS 87553-98-8) is manufactured and analyzed under a strict quality management system. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using validated chromatographic (HPLC, GC) and spectroscopic (IR, NMR, MS) methods to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with cGMP and ICH guidelines.

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); the container must be kept tightly sealed in a dry environment to prevent absorption of water vapor.

Specification

Item	Specification
Appearance	White to off-white solid
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 unspecified impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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