Sodium dihydrogen phosphate monohydrate, EMPROVE® EXPERT USP, BP excipient_suitable, SAFC®
Supplier: EMD MILLIPORE – PCS CA EXCEP
Synonyms:
Sodium phosphate monobasic monohydrate, Sodium dihydrogen orthophosphate monohydrate, Monosodium phosphate monohydrate, Sodium dihydrogenorthophosphate monohydrate, Sodium orthophosphate monobasic monohydrate
1.06349.9013
1.06349.9051
1.06349.1000
1.06349.9025
CA1.06349.9013EA
4237.91
CAD
CA1.06349.9013
CA1.06349.9051
CA1.06349.1000
CA1.06349.9025
Sodium dihydrogen phosphate monohydrate, EMPROVE® EXPERT USP, BP excipient_suitable, 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 Density: 2.04 g/cm³ (20 °C) Storage Temperature: Ambient |
MDL Number:
MFCD00149208 CAS Number: 10049-21-5 EINECS: 231-449-2 Merck Index: 13,08734 |
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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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