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

Supplier: MilliporeSigma

Synonyms: Sodium Phosphate Monobasic hydrateSodium dihydrogen orthophosphate monohydrateSodium dihydrogenorthophosphate monohydrateSodium phosphate monobasic monohydrateSodium dihydrogen orthophosphate 1-hydrateSodium orthophosphate monobasic monohydrateMonosodium phosphateSodium dihydrogen phosphate 1-hydrate

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
EM1.06349.9051EA 4918 USD
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.


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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