Diosmine
City: LV, Marupe
Please avoid sudden changes in temperature and humidity, as they may affect the condition of derivative ingredients and tablets.
The shelf life begins from the date of manufacture at the factory.
Taking into account logistical and transportation stages, the remaining shelf life of the product is always shorter than the full shelf life.
We ship products to our customers with a remaining shelf life of no less than 70%.
Identification
Analysis Item | Specification | Result |
IR spectrum | Should be concordant with reference standard spectrum | Conforms |
Principal peak (chromatogram) | Similar in retention time and size to reference | Conforms |
Specific Tests
Analysis Item | Specification | Result |
Water | NMT 6>% | 3.19>% |
Residue on ignition | NMT 0.2>% | 0.08% |
Iodine | NMT 0.1% | Conforms |
Heavy metals | NMT 20ppm | Conforms |
Pyridine | NMT 200ppm | 63ppm |
Related Substances
Impurity | Specification | Result |
Impurity A | NMT 0.5% | 0.08% |
Impurity B | NMT 4.0% | 0.37% |
Impurity C | NMT 3.0% | 2,59% |
Impurity D | NMT 0.6% | ND |
Impurity E | NMT 3.0% | 2.74% |
Impurity F | NMT 2.0% | 0.19% |
Unspecified impurities (each) | NMT 0.4% | 0.8% |
Total impurities | NMT 8.5% | 6.05% |
Assay
Analysis Item | Specification | Result |
Assay (on dried basis) | NLT 90.0% and NMT 102.0% | 92.24% |
Microbiological Tests
Analysis Item | Specification | Result |
Total plate count | NMT 1000 cfu/g | Conforms |
Yeasts and molds | NMT 100 cfu/g | Conforms |
Escherichia Coli | Negative in 1g | Conforms |
Salmonella | Negative in 10g | Conforms |
Staphylococcus Aureus | Negative in 1g | Conforms |