I-037

Ibuprofen Impurity B (PhEur) solution

100 μg/mL in acetonitrile: water (9:1) (as free acid), certified reference material, ampule of 1 mL, Cerilliant^®

• Empirical Formula (Hill Notation): C₁₃H₁₇O₂ · Na
• Molecular Weight: 228.26
• MDL number: MFCD08275581
• UNSPSC Code: 12352200

Properties

• grade: certified reference material
• form: liquid
• feature: Snap-N-Spike^®/Snap-N-Shoot^®
• packaging: ampule of 1 mL
• manufacturer/tradename: Cerilliant^®
• concentration: 100 μg/mL in acetonitrile: water (9:1) (as free acid)
• technique(s): gas chromatography (GC): suitable; liquid chromatography (LC): suitable
• application(s): pharmaceutical (small molecule)
• format: single component solution
• storage temp.: −20°C

Description

General description

Ibuprofen Impurity B (PhEur) is a major impurity formed during the manufacturing of ibuprofen active pharmaceutical ingredient (API). Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) and was first developed to be used in the treatment of rheumatism. It exhibits chirality and structurally belongs to the class of 2-arylpropionic acids (2-APA). It hinders the activity of cyclooxygenase enzymes in the synthesis of prostaglandins and is used in the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gouty arthritis, and dysmenorrhoea. The S-(+)-enantiomer has been found to have more contribution in the anti-inflammatory activities of the compound than its R-(+)-enantiomer.[1][2][3][4]
This solution-based Certified Reference Material is suitable for use in ibuprofen monograph testing methods by HPLC in applications such as API release testing or pharmaceutical research. I

Ibuprofen Impurity B (PhEur) is a major impurity found in pharmaceutical manufacturing of ibuprofen active pharmaceutical ingredients (API). This solution-based Certified Reference Material is suitable for use in ibuprofen monograph testing methods by HPLC in testing applications such as API release testing or pharmaceutical research.

Application

Ibuprofen may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography techniques.[5]

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Legal Information

CERILLIANT is a registered trademark of Merck KGaA, Darmstadt, Germany

Snap-N-Shoot is a registered trademark of Cerilliant Corporation

Snap-N-Spike is a registered trademark of Merck KGaA, Darmstadt, Germany

Analyte

Ibuprofen Impurity B, Pharmaceutical Secondary Standard; Certified Reference Material

Safety Information

• pictograms: GHS02,GHS07
• signalword: Danger
• hcodes: H225,H302 + H312 + H332,H319
• pcodes: P210 - P280 - P301 + P312 - P303 + P361 + P353 - P304 + P340 + P312 - P305 + P351 + P338
• Hazard Classifications: Acute Tox. 4 Dermal - Acute Tox. 4 Inhalation - Acute Tox. 4 Oral - Eye Irrit. 2 - Flam. Liq. 2
• Storage Class: 3 - Flammable liquids
• wgk_germany: WGK 2
• flash_point_f: 35.6 °F - closed cup
• flash_point_c: 2 °C - closed cup