Loxoprofen Impurity 57964-61-1
WhatsAPP: +86 17320513646
E-mail: anna@molcoo.com
Loxoprofen, a prodrug-type nonsteroidal anti-inflammatory drug (NSAID), exerts analgesic, anti-inflammatory, and antipyretic effects via metabolic conversion to its active trans-OH form. In pharmaceutical R&D and quality control, impurity reference standards are critical for ensuring drug safety and efficacy. This documentation provides high-purity Loxoprofen impurity reference standards, covering major degradation products and process-related impurities (e.g., Impurity A, B, C), suitable for forced degradation studies, analytical method validation, and ICH Q3A/Q3B compliance.
Technical Specifications
| Parameter | Details |
|---|
| Purity | ≥98.0% (HPLC area normalization), single impurity ≤0.1% |
| Structural Confirmation | ¹H-NMR, ¹³C-NMR, MS, and HPLC spectra provided for structural elucidation |
| Packaging | 10mg/vial (customizable to 25mg, 50mg) |
| Stability | Inert gas packaging, stored at -20°C (dark), shelf life ≥3 years |
| Compliance | Aligned with ChP, USP, EP pharmacopoeias; includes CoA and DSC support |
Applications
Forced Degradation Studies: Simulate degradation under light, heat, and acid/base conditions to establish impurity profiles.
Method Validation: Support HPLC/UPLC method development for specificity, linearity, and LOQ/LOD studies.
Genotoxic Impurity Screening: Assess mutagenic potential per ICH M7 guidelines.
Drug Metabolism Research: Track metabolic pathways of Loxoprofen in vivo.
Representative Impurities
| Impurity Code | Chemical Name | CAS No. | Molecular Formula | Molecular Weight | Key Properties |
|---|
| Impurity A | Loxoprofen Acid (Active Metabolite) | 68767-14-6 | C₁₅H₁₈O₃ | 246.30 | Trans-OH configuration, core anti-inflammatory structure |
| Impurity B | Loxoprofen Ethyl Ester (Process Impurity) | 81623-55-0 | C₁₇H₂₂O₄ | 290.35 | Prodrug ester, less stable than parent drug |
| Impurity C | Loxoprofen Epoxide (Degradation Impurity) | 112853-53-5 | C₁₅H₁₆O₃ | 244.28 | Potential genotoxic impurity, strict control required |
| Impurity D | Loxoprofen Amide (Synthetic Intermediate) | 157293-95-3 | C₁₄H₁₇NO₂ | 231.29 | Used for synthetic route optimization |
Quality Assurance
Full Traceability: Multi-step QC (ID, LC-MS, KF) for each batch.
Spectral Library: Electronic spectra package with retention time and peak annotations.
Custom Synthesis: Isotope-labeled (e.g., ¹³C, D₃) or positional isomers available upon request.
WhatsAPP: +86 17320513646
E-mail: anna@molcoo.com
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