Appearance( 25ºC) | white flakes |
Active Matter(%) | 50±5 |
PH Value (1% aqueous solution) | 7±1.5 |
Free Amine Content(%) | ≤0.50 |
Solid Content(%) | ≥50.0 |
Availability: | |
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Description | Yellow or orange cryptocrystalline powder. Hygroscopic. | Conforms |
Identification | A. IR-spectrum B. UV-spectrum should have 3 maximums by wavelengths 258 nm, 302 nm and 371 nm.Relation of optical density by 302 nm and 371 nm from 2,8 till 3,3 | Conforms |
Water | Not more than12.0% | 10.1% |
Residue on ignition | Not more than 0.1% | 0.02% |
Chromatographic purity | Total: Not more than 2.0% | 0.7% |
Individual: Not more than 0.5% | 0.32% | |
Specific rotation | Between +19°to +24° | +19.7° |
Residual solvents | Ethanol : not more than 2000ppm Acetone : not more than 1000ppm Ether: not more than 500 ppm | 100ppm 80ppm 0ppm |
Heavy metals | Not more than 20 ppm | Conforms |
Microbiological purity: - Total count of aerobes in 1 gr - Total count of fungus in 1 gr - Escherichia coli in 1 gr | 103 CFU 102 CFU Absence | Conforms Conforms Conforms |
Storage conditions | In the protected from light and moisture place, under temperature not higher than 25 oC | Conforms |
Assay | Between 98.0% to 102.0% | 99.3% |
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