Sodium dihydrogen phosphate dihydrate 98.0-100.5% (alkalimetric, calculated on anhydrous substance), EMPROVE® EXPERT Ph. Eur., BP, USP, JPE, SAFC®
Supplier: MERCK PRODUCTION CHEMICALS
Ratings:
(No Reviews)
Total Ratings: 0
Avg. Ratings: 0.0 out of 5
1.37018.5000
1.37018.9012
1.37018.1000
1.37018.9025
1.37018.5000EA
179
GBP
1.37018.5000
1.37018.9012
1.37018.1000
1.37018.9025
Sodium dihydrogen phosphate dihydrate 98.0-100.5% (alkalimetric, calculated on anhydrous substance), EMPROVE® EXPERT Ph. Eur., BP, USP, JPE, SAFC®
Sodium dihydrogen phosphate dihydrate
Formula:
NaH₂PO₄·2H₂O Boiling Pt: ∼650 °C (1013 hPa) Melting Pt: 60 °C Density: 1.91 g/cm³ (20 °C) Storage Temperature: Ambient |
MDL Number:
MFCD00149209 CAS Number: 13472-35-0 EINECS: 231-449-2 REACH: 01-2119489796-13 Merck Index: 12,08806 |
Specification Test Results
Assay (alkalimetric, calculated on dried substance) | 98.0 - 100.5 % |
Assay (alkalimetric; dried substance) | 98.0 - 101.0 % |
Identity | passes test |
Appearance of solution | passes test |
In water insoluble matter (calculated on dried substance) | ≤ 0.15 % |
pH-value (1 %, water) | 4.1 - 4.7 |
pH-value (5 %; water) | 4.2 - 4.5 |
pH-value (5.7 %; water) | 4.1 - 4.5 |
Chloride (Cl) | ≤ 0.005 % |
Hydrogenphosphate (HPO₄) | ≤ 0.5 % |
Sulfate (SO₄) | ≤ 0.01 % |
Heavy metals (as Pb) | ≤ 0.0005 % |
Al, Ca and other elements detectable with ammonia | passes test |
As (Arsenic) | ≤ 0.0002 % |
Fe (Iron) | ≤ 0.0010 % |
Residual solvents (ICH Q3C) | excluded by production process |
Substances reducing potassium permanganate (as O) | passes test |
Loss on drying (130 °C) | 22.0 - 24.0 % |
Endotoxins | ≤ 2.5 I.U./g |
Total aerobic microbial count | ≤ 1E+02 CFU/g |
Total yeast and mould count | ≤ 1E+02 CFU/g |
E.coli (absent in 1g) | passes test |
Pseudomonas aeruginosa (absent in 1g) | passes test |
Staphylococcus aureus (absent in 1g) | passes test |
Salmonella species (absent in 10g) | passes test |
Bile tolerante gram negative bacteria (absent in 1g) | passes test |
Candida albicans (absent in 1g) | passes test |
DNases (Exo- and endonucleases) (not detectable) | passes test |
RNases (not detectable) | passes test |
Proteases (not detectable) | passes test |
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*). | |
Corresponds to Ph Eur, BP, USP, JPE |
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