| Product Name: | Ibuprofen | |
| Shelf Life: | 4 years | |
| Items | Specifications | Results |
| Description | White or off-white powder | Conforms |
| Identification | a)IR Spectrum :Must Comply | Conforms |
| b)HPLC: Retention Time Must Comply | Conforms | |
| Optical Rotation | -0.10º— +0.10º | +0.00º |
| Clarity of Solution | a)1% Solution in water: Clear | Conforms |
| b)1% Solution in methanol: Clear | Conforms | |
| Ibuprofen Related Substances(by HPLC) | a) 2-(4-butylphenyl) propionic acid: | Not detected |
| Not More Than 0.1%(area%) | ||
| b) Any other individual Impurity: | 0.04% | |
| Not More Than 0.1%(area%) | ||
| c)Total Impurity: | 0.07% | |
| Not More Than 0.3%(area%) | ||
| Lysine Related Substances(by TLC) | Any maximum impurity: Not more than0.1% | Conforms |
| pH | pH of 1% aqueous solution:6.2-7.0 | 6.59 |
| Heavy Metals | Not More Than 10ppm | <10ppm |
| Residue on ignition | Not More Than 0.1% | 0.01% |
| Water | Not More Than 0.5% | 0.16% |
| Assay | a)Lysine content (by titration): | 100% |
| 98.5-101.5% | ||
| b) Ibuprofen content (by HPLC): | 100.3% | |
| 98.5-101.5% | ||
| Residual Solvents(by GC) | Ethanol: Not More Than 1000ppm | 22ppm |
| Conclusion: The product meets the above specifications. | ||