Description

Ibuprofen Related Compound (2,3-Dihydroxypropyl 2-(4-Isobutylphenyl)Propanoate) CAS NO 64622-21-5 is a high-purity chemical reference standard and a key process-related substance in the synthesis of the widely used non-steroidal anti-inflammatory drug (NSAID), ibuprofen. Its primary value lies in serving as a critical marker for quality control and analytical method development in pharmaceutical manufacturing, ensuring the purity and safety of the final API. This compound is essential for pharmaceutical R&D laboratories, analytical testing facilities, and manufacturers requiring rigorous impurity profiling and regulatory compliance documentation.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of related substances in ibuprofen active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, GC, or LC-MS methods to monitor process impurities and degradation products.
• Pharmaceutical Research & Development: Employed in metabolic studies, stability testing, and impurity pathway investigation during ibuprofen synthesis process optimization.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability standard and for preparing spiked samples to ensure the accuracy and precision of impurity testing in compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control over the manufacturing process.
• Academic Research: Used in universities and research institutes for studies on NSAID chemistry, pharmacology, and analytical techniques.

Basic Information

Product Name	Ibuprofen Related Compound (2,3-Dihydroxypropyl 2-(4-Isobutylphenyl)Propanoate)
CAS No.	64622-21-5
Molecular Formula	C16H24O4
Molecular Weight	280.36 g/mol
Synonyms	2,3-Dihydroxypropyl 2-(4-Isobutylphenyl)propanoate; Ibuprofen Diol Ester; Ibuprofen Impurity (Diol Ester); 1,2,3-Propanetriol, 1-[2-(4-isobutylphenyl)-1-oxopropoxy]-2-hydroxy-; Propanoic acid, 2-(4-isobutylphenyl)-, 2,3-dihydroxypropyl ester; Ibuprofen Related Substance; Ibuprofen Process Impurity; Ibuprofen Degradant
EINECS	Contact for details

Quality Control

Our Ibuprofen Related Compound is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and specific impurity profiling, to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific results, chromatograms, and traceability data. Our quality commitment aligns with the standards expected for materials used in GMP environments and regulatory filings.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of water vapor. For long-term storage, consider storing under an inert atmosphere.

Specification

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

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