Description:
urea chemically pure, crystalline, Ph. Eur. (Pharmacopoea Europaea), USP (United States Pharmacopeia)
Specification:
| appearance | fine white crystals | ||
| identity | passes test | ||
| assay (NH2)2CO | 99,6 | – 100,5 | % |
| loss on drying (water) | ≤ | 0,50 | % |
| water (according to Karl Fischer) | ≤ | 0,20 | % |
| melting point | 132,0 | – 135,0 | oC |
| biuret | ≤ | 0,1 | % |
| appearance of solution | clear and colourless | ||
| alkalinity (0,01 M HCl/0,5g) | ≤ | 0,40 | ml |
| insoluble matter (in C2H5OH) | ≤ | 0,010 | % |
| chloride (Cl–) | ≤ | 70,0 | mg/kg |
| sulphate (SO42-) | ≤ | 100,0 | mg/kg |
| ammonium (NH4+) | ≤ | 500,0 | mg/kg |
| heavy metals (as Pb) | ≤ | 3,0 | mg/kg |
| sulfated ash | ≤ | 0,10 | % |
| iron (Fe) | ≤ | 1,0 | mg/kg |
| arsenic (As) | ≤ | 0,50 | mg/kg |
| copper (Cu) | ≤ | 1,0 | mg/kg |
Packaging:
25 kg card boxes on 750 kg net pallets (30 boxes x 25 kg)
This product complies to the requirements according to ICH (International Conference on Harmonisation) Guideline Impurities: “Residual solvents” (CPMP/ICH/283/95) – Ph. Eur. and/or USP.