Kaliumdihydrogenphosphat, kristallisiert, EMPROVE® EXPERT Ph. Eur., BP, JPC, NF für die biopharmazeutische Produktion, SAFC®
Lieferant: MERCK PRODUCTION CHEMICALS
1.37039.5000
1.37039.9029
1.37039.5000EA
827
CHF
1.37039.5000
1.37039.9029
Kaliumdihydrogenphosphat, kristallisiert, EMPROVE® EXPERT Ph. Eur., BP, JPC, NF für die biopharmazeutische Produktion, SAFC®
Kaliumdihydrogenphosphat
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, JPC NF
|
Formel:
KH₂PO₄ Siedepunkt: ∼100 °C (1013 hPa) Melting Pt: 253 °C Dichte: 2.3 g/cm³ (20 °C) Lager Temperatur: Raumtemperatur |
MDL Number:
MFCD00011401 CAS-Nummer: 7778-77-0 EINECS: 231-913-4 REACH: 01-2119490224-41 Merck Index: 13,07744 |
Spezifikation Testergebnisse
| Assay (alkalimetric, calculated on dried substance) | 98.0 - 100.5 % |
| Assay (alkalimetric; dried substance) | ≥ 99.0 % |
| Identity | passes test |
| Appearance of solution | passes test |
| Insoluble substances | ≤ 0.2 % |
| pH-value (2 %; water) | 4.2 - 4.6 |
| pH-value (5 %; water) | 4.2 - 4.5 |
| Carbonate | passes test |
| Condensed phosphate | passes test |
| Chloride (Cl) | ≤ 0.009 % |
| Fluoride (F) | ≤ 0.0010 % |
| Sulfate (SO₄) | ≤ 0.017 % |
| Heavy metals (as Pb) | ≤ 0.0010 % |
| Al (Aluminium) | ≤ 0.0005 % |
| As (Arsenic) | ≤ 0.0002 % |
| Fe (Iron) | ≤ 0.0010 % |
| Na (Sodium) | ≤ 0.1 % |
| 0 | passes test |
| Pb (Lead) | ≤ 0.0004 % |
| Endotoxins | ≤ 2.5 I.U./g |
| Total aerobic microbial count | ≤ 100 CFU/g |
| Total yeast and mould count | ≤ 100 CFU/g |
| DNases (Exo- and endonucleases) (not detectable) | passes test |
| RNases (not detectable) | passes test |
| Proteases (not detectable) | passes test |
| Residual solvents (ICH Q3C) | excluded by manufacturing process |
| Reducing substances | passes test |
| Loss on drying (105 °C) | ≤ 0.5 % |
| Loss on drying (130 °C) | ≤ 1.0 % |
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