Ibuprofen Impurities

General Information

Ibuprofen Impurities and Ibuprofen

Daicel Pharma offers worldwide delivery options for a custom synthesis of Ibuprofen impurities, including impurities such as Ibuprofen Ph. Eur. Impurity G, Ibuprofen Unknown Impurity, 3-Hydroxy-2,2-dimethylpropyl 2-(4-isobutylphenyl)propanoate, Ibuprofen 1,2-Propylene Glycol Esters (Mixture of Regio and Stereo isomers), Ibuprofen 1,2,3-propanetriol esters (mixture of regio and stereo isomers), and so on. These impurities play a vital role in evaluating the purity and safety of Ibuprofen, an active pharmaceutical ingredient.

Ibuprofen [CAS: 15687-27-1], a nonsteroidal anti-inflammatory drug (NSAID) and a propionic acid derivative helps alleviate symptoms related to arthritis, primary dysmenorrhea, and fever. It exhibits analgesic, anti-inflammatory, and antipyretic effects.

Ibuprofen: Use and Commercial Availability  

Ibuprofen, available under various trademarks, Advil, Caldolor, Ibuprohm, Medipren, Nuprin, etc., is a nonsteroidal anti-inflammatory drug (NSAID). It manages and treats inflammatory diseases, rheumatoid disorders, mild to moderate pain, fever, dysmenorrhea, and osteoarthritis. It is available by prescription for more severe conditions and over the counter for mild pain relief.

Ibuprofen Structure and Mechanism of Action

The chemical name of Ibuprofen is α-Methyl-4-(2-methylpropyl) benzene acetic acid. Its chemical formula is C₁₃H₁₈O₂, and its molecular weight is approximately 206.28 g/mol.

Ibuprofen inhibits prostaglandin precursors, such as cyclooxygenase, an enzyme for prostaglandin synthesis.

Ibuprofen Impurities and Synthesis

Ibuprofen can contain impurities that arise from manufacturing processes¹ or storage. The common Ibuprofen impurities include Ibuprofen isomer impurities, related carboxylic acid impurities, organic impurities from starting materials or intermediates, inorganic impurities such as heavy metals or salts, and residual solvents used during synthesis or purification. Regulatory authorities set limits on impurity levels to ensure the safety and quality of Ibuprofen. Manufacturers adhere to strict quality control measures to minimize impurities and meet regulatory standards for the final product.

Daicel Pharma strictly adheres to cGMP standards and operates an analytical facility for the preparation of Ibuprofen impurity standards, such as Ibuprofen Ph. Eur. Impurity G, Ibuprofen Unknown Impurity, 3-Hydroxy-2,2-dimethylpropyl 2-(4-isobutylphenyl)propanoate, Ibuprofen 1,2-Propylene Glycol Esters (Mixture of Regio and Stereo isomers), Ibuprofen 1,2,3-propanetriol esters (mixture of regio and stereo isomers), and so on. We offer deuterium-labeled Ibuprofen compounds, including Ibuprofen-D3, Ibuprofen-D3 S-isomer, Ibuprofen-13CD3, and Ibuprofen-D3 R-isomer, essential for bioanalytical research and BA/BE studies. Our impurities have a detailed Certificate of Analysis (CoA) that provides a comprehensive characterization report. This report includes data obtained through techniques, 1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis². Upon request, we give additional data like 13C-DEPT. We can synthesize unknown Ibuprofen impurities or degradation products and labeled compounds. Each delivery has a comprehensive characterization report.