Urea 98.0-102.0% (by HPLC), crystalline, EMPROVE® ESSENTIAL USP, JP, Ph. Eur., BP suitable for use as excipient, SAFC®
Fornitore: MERCK PRODUCTION CHEMICALS
Synonyms:
Carbonyl diamide, Carbamide, Diaminomethanone, Carbonyldiamide
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1 to 3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated.
Formula:
NH₂CONH₂ Peso molecolare: 60.06 g/mol Punto di ebollizione: 197 Punto di fusione: 132.7 Densità: 1.34 g/cm³ (20 °C) Temperatura di stoccaggio: Ambiente |
MDL Number:
MFCD00008022 CAS Number: 57-13-6 EINECS: 200-315-5 REACH: 01-2119463277-33 Merck Index: 13,09935 |
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Risultati del test di specificazione
Assay (HPLC) | 98.0 - 102.0% |
Assay (ex N) | 99.0 - 100.5% |
Assay (ex N, Calculated on Dried Substance) | 99.0 - 101.0% |
Identity | Conforms |
In Ethanol (96%) Insoluble Parts | ≤0.04% |
Alkalinity | Passes Test |
Chloride (Cl) | ≤0.007% |
Sulfate (SO₄) | ≤0.010% |
Heavy Metals (as Pb) | ≤0.0010% |
NH₄ (Ammonium) | ≤0.0500% |
Biuret | ≤0.1% |
Organic Impurities (Related compound A) | ≤0.1% |
Organic Impurities (Any Individual Unspecified Impurity) | ≤0.1% |
Organic Impurities (Total Impurities) | ≤2.0% |
Residual Solvents (ICH Q3C) | Excluded by Manufacturing Process |
Sulfated Ash (600 °C) | ≤0.10% |
Loss on Drying (105 °C) | ≤1.0% |
Corresponds to Ph. Eur., BP, JP, USP |
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