Urée 98.0-102.0% (par HPLC), crystallin, EMPROVE® ESSENTIAL Ph. Eur., BP, USP, JP, SAFC®
Marques : MERCK PRODUCTION CHEMICALSTotal Evaluation: 0
Moyenne des Notes : 0.0 sur 5
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 Point d'ébullition: 197 °C (1013 hPa) Point de fusion: 132,7 °C Densité: 1,34 g/cm³ (20 °C) Température de stockage: Température ambiante |
Numéro MDL:
MFCD00008022 Numéro CAS: 57-13-6 EINECS: 200-315-5 REACH: 01-2119463277-33 Indice Merck: 13,09935 |
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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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