Sodium dihydrogen phosphate monohydrate, EMPROVE® EXPERT BP, USP suitable for use as excipient, SAFC®
Supplier: EMD MILLIPORE – PCS CA EXCEP
Synonyms:
Sodium Phosphate Monobasic hydrate
, Sodium dihydrogen orthophosphate monohydrate
, Sodium phosphate monobasic monohydrate
, Monosodium phosphate
1.06349.9025
1.06349.9025
1.06349.1000
1.06349.9051
1.06349.1000
1.06349.9014
1.06349.9013
1.06349.9013
1.06349.9051
CA1.06349.9013EA
3612.01
CAD
EM1.06349.9051
EM1.06349.1000
CA1.06349.9013
CA1.06349.9025
CA1.06349.1000
EM1.06349.9013
CA1.06349.9051
EM1.06349.9025
EM1.06349.9014
Sodium dihydrogen phosphate monohydrate, EMPROVE® EXPERT BP, USP suitable for use as excipient, SAFC®
Sodium dihydrogen phosphate monohydrate
Sodium dihydrogen phosphate monohydrate suitable for use as excipient EMPROVE® exp BP, USP.
Certifications: Specified acc. to EMEA/CHMP/SWP/4446/2000. Corresponds to BP, USP.
Formula:
NaH₂PO₄·H₂O MW: 137.99 g/mol Melting Pt: 100 °C Density: 2.04 g/cm³ (20 °C) |
MDL Number:
MFCD00149208 CAS Number: 10049-21-5 Merck Index: 13,08734 |
Specification Test Results
pH Value | 4.1 - 4.5 (50 g/l, H2O, 25 °C) |
Bulk Density | 880 kg/m3 |
Solubility | 850 g/l |
LD 50 oral |
LD50 Rat |
LD 50 dermal |
LD50 Rabbit |
Storage | Store at 15 to 25 °C |
Assay (Alkalimetric, calculated on dried substance) | 98.0 - 100.5% |
Identity | Passes Test |
Appearance of Solution | Passes Test |
Insoluble Substances | ≤0.2% |
pH-value (5%; water) | 4.2 - 4.5 |
Chloride (Cl) | ≤ 0.014% |
Sulphate (SO4) | ≤0.03% |
Heavy metals (as Pb) | ≤0.001% |
Al (Aluminium) | ≤0.0002% |
As (Arsenic) | ≤0.0002% |
Fe (Iron) | ≤0.001% |
Aluminium, Calcium and related elements | Passes Test |
Reducing substances | Passes Test |
Residual solvents (ICH Q3C) | excluded by manufacturing process |
Loss on drying (130 °C) | 11.5 - 14.5% |
Water | 10.0 - 15.0% |
Endotoxins | ≤2.5 I.U./g |
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