Sodium dihydrogen phosphate monohydrate, EMPROVE® EXPERT BP, USP suitable for use as excipient, SAFC®

Supplier: EMD MILLIPORE – PCS CA EXCEP

Synonyms: Sodium Phosphate Monobasic hydrateSodium dihydrogen orthophosphate monohydrateSodium phosphate monobasic monohydrateMonosodium 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
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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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