| Specifications | |
|---|---|
| Assay (ex N) | 99.0 - 100.5 % |
| Assay (ex N, calc. on dried substance) | 99.0 - 101.0 % |
| Identity | conforms |
| Appearance | Colorless crystals or white, crystalline powder. |
| Appearance of solution (5 %; water) | conforms |
| In ethanol (96 %) insoluble parts | ≤ 0.04 % |
| Alkalinity | passes test |
| Melting point (DSC (differential scanning calorimetry)) | 132.5 - 134.5 °C |
| Chloride (Cl) | ≤ 0.007 % |
| Sulphate (SO₄) | ≤ 0.010 % |
| Heavy metals (as Pb) | ≤ 0.0010 % |
| NH₄ (Ammonium) | ≤ 0.0500 % |
| Biuret | ≤ 0.1 % |
| Residual solvents (ICH Q3C) | excluded by manufacturing process |
| Sulfated ash (600 °C) | ≤ 0.10 % |
| Loss on Drying (105°C) | ≤ 1.0 % |
| Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*). Corresponds to Ph. Eur., BP, JP, USP |
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Key Spec Table
| CAS # | EC Number | Hill Formula | Chemical Formula | Molar Mass | Grade Value |
|---|---|---|---|---|---|
| 57-13-6 | 200-315-5 | CH₄N₂O | CO(NH₂)₂ | 60.06 g/mol | Ph Eur,BP,USP,JP |
| Description | |
|---|---|
| Catalogue Number | 108486 |
| Synonyms | Carbamide, Carbonyl diamide, Diaminomethanone, Carbonyldiamine |
| Product Information | |
|---|---|
| CAS number | 57-13-6 |
| EC number | 200-315-5 |
| Grade | Ph Eur,BP,USP,JP |
| Hill Formula | CH₄N₂O |
| Chemical formula | CO(NH₂)₂ |
| Molar Mass | 60.06 g/mol |
| HS Code | 3105 10 00 |
| Structure formula Image | |
| Applications | |
|---|---|
| Application | Urea cryst., suitable for use as excipient EMPROVE® exp Ph Eur,BP,USP,JP. Urea CAS No. 57-13-6, EC Number 200-315-5. Urea MSDS (material safety data sheet) or SDS here. |
| Physicochemical Information | |
|---|---|
| Density | 1.34 g/cm3 (20 °C) |
| Melting Point | 133 °C |
| pH value | 9 (100 g/l, H₂O, 20 °C) |
| Vapor pressure | <0.1 hPa (20 °C) |
| Bulk density | 720 - 760 kg/m3 |
| Solubility | 1000 g/l |
| Toxicological Information | |
|---|---|
| LD 50 oral | LD50 Rat 8471 mg/kg |
| LD 50 dermal | LD50 Rat 8200 mg/kg |
| Safety Information according to GHS | |
|---|---|
| RTECS | YR6250000 |
| Storage class | 10 - 13 Other liquids and solids |
| WGK | WGK 1 slightly water endangering |
| Disposal | 3 Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C. |
| Storage and Shipping Information | |
|---|---|
| Storage | Store at +15°C to +30°C. |
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