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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. | ||
