Testing Items | Specifications | Results |
Appearance | White powder | Conforms |
Identification | Meet the requirement | Conforms |
Nitrates | ≤0.50% | 0.04% |
Related substances | Isosorbide ≤0.20% | 0.02% |
Isosorbide 2-nitrate ≤0.25% | 0.023% | |
Isosorbide dinitrate ≤0.25% | 0.042% | |
Any other single impurity ≤0.10% | 0.0003% | |
Total impurities ≤0.50% | 0.07% | |
Heavy metals | ≤10ppm | <10ppm |
Assay | 66.5%~73.5% | 68.6% |
Conclusion: The Product Conforms to CP/USP. |