Sodium dihydrogen phosphate monohydrate, EMPROVE® EXPERT BP, USP suitable for use as excipient, SAFC®
Supplier: MilliporeSigma
Synonyms:
Sodium phosphate monobasic monohydrate, Sodium dihydrogen orthophosphate monohydrate, Monosodium phosphate monohydrate, Sodium dihydrogenorthophosphate monohydrate, Sodium orthophosphate monobasic monohydrate
1.06349.9051
1.06349.9013
1.06349.9014
1.06349.1000
1.06349.9025
EM1.06349.9051EA
4918
USD
EM1.06349.9051
EM1.06349.9013
EM1.06349.9014
EM1.06349.1000
EM1.06349.9025
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.
Certificaciones: 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) 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 > 2000 mg/kg |
LD 50 dermal | LD50 Rabbit > 7940 mg/kg |
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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