Urée 98,0-102,0 HPLC_ASSAY_METHOD, Crystalline, EMPROVE® ESSENTIAL USP, JP, Ph. Eur., BP suitable for use as excipient, SAFC®
Fournisseur: MERCK PRODUCTION CHEMICALS
Synonyms:
Carbonyl diamide, Carbamide, Diaminomethanone, Carbonyldiamide
1.08486.9029
1.08486.9525
1.08486.9029EA
0
EUR
1.08486.9029
1.08486.9525
Urée 98,0-102,0 HPLC_ASSAY_METHOD, Crystalline, EMPROVE® ESSENTIAL USP, JP, Ph. Eur., BP suitable for use as excipient, SAFC®
Urée
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.
Formule:
NH₂CONH₂ MW: 60.06 g/mol Point d'ébullition: 197 Point de fusion: 132.7 Densité: 1.34 g/cm³ (20 °C) Température de stockage: Température ambiante |
Numéro MDL:
MFCD00008022 Numéro CAS: 57-13-6 EINECS: 200-315-5 ATTEINDRE: 01-2119463277-33 Merck Index: 13,09935 |
|
Résultats des tests de spécification
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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