Sodium dihydrogénophosphate dihydraté 98.0-100.5% (alcalimétrie, calculée sur la substance anhydre), EMPROVE® EXPERT JPE, BP, Ph. Eur., USP for biopharmaceutical production, SAFC®
Marques : MERCK PRODUCTION CHEMICALS
Ratings:
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Total Evaluation: 0
Moyenne des Notes : 0.0 sur 5
Synonyme(s):
Sodium phosphate monobasique dihydraté, Sodium phosphate monopotassique dihydraté
1.37018.5000
1.37018.9012
1.37018.1000
1.37018.9025
1.37018.5000EA
424
EUR
1.37018.5000
1.37018.9012
1.37018.1000
1.37018.9025
Sodium dihydrogénophosphate dihydraté 98.0-100.5% (alcalimétrie, calculée sur la substance anhydre), EMPROVE® EXPERT JPE, BP, Ph. Eur., USP for biopharmaceutical production, SAFC®
Sodium dihydrogénophosphate dihydraté
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Formule:
NaH₂PO₄·2H₂O Poids moléculaire: 156.01 g/mol Point d'ébullition: ∼650 °C (1013 hPa) Point de fusion: 60 Densité: 1.91 g/cm³ (20 °C) Température de stockage: Température ambiante |
Numéro MDL:
MFCD00149209 Numéro CAS: 13472-35-0 EINECS: 231-449-2 REACH: 01-2119489796-13 Indice Merck: 12,08806 |
Résultats des tests de spécification
| Assay (alkalimetric, calculated on dried substance) | 98.0 - 100.5 % |
| Assay (alkalimetric; dried substance) | 98.0 - 101.0 % |
| Identity | passes test |
| Appearance of solution | passes test |
| In water insoluble matter (calculated on dried substance) | ≤ 0.15 % |
| pH-value (1 %, water) | 4.1 - 4.7 |
| pH-value (5 %; water) | 4.2 - 4.5 |
| pH-value (5.7 %; water) | 4.1 - 4.5 |
| Chloride (Cl) | ≤ 0.005 % |
| Hydrogenphosphate (HPO₄) | ≤ 0.5 % |
| Sulfate (SO₄) | ≤ 0.01 % |
| Heavy metals (as Pb) | ≤ 0.0005 % |
| Al, Ca and other elements detectable with ammonia | passes test |
| As (Arsenic) | ≤ 0.0002 % |
| Fe (Iron) | ≤ 0.0010 % |
| Residual solvents (ICH Q3C) | excluded by production process |
| Substances reducing potassium permanganate (as O) | passes test |
| Loss on drying (130 °C) | 22.0 - 24.0 % |
| Endotoxins | ≤ 2.5 I.U./g |
| Total aerobic microbial count | ≤ 1E+02 CFU/g |
| Total yeast and mould count | ≤ 1E+02 CFU/g |
| E.coli (absent in 1g) | passes test |
| Pseudomonas aeruginosa (absent in 1g) | passes test |
| Staphylococcus aureus (absent in 1g) | passes test |
| Salmonella species (absent in 10g) | passes test |
| Bile tolerante gram negative bacteria (absent in 1g) | passes test |
| Candida albicans (absent in 1g) | passes test |
| DNases (Exo- and endonucleases) (not detectable) | passes test |
| RNases (not detectable) | passes test |
| Proteases (not detectable) | passes test |
| 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, USP, JPE |
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