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diwodorofosforan sodu dihydrat 98,0-100,5 alkalimetry on anhydrous substance, EMPROVE® EXPERT JPE, BP, Ph. Eur., USP for biopharmaceutical production, SAFC®

Dostawca: MERCK PRODUCTION CHEMICALS

Synonim: Phosphoric acid (sodium hydrate), Sodium phosphate monobasic dihydrate, Sodium dihydrogen orthophosphate dihydrate

1.37018.5000 1.37018.9012 1.37018.1000 1.37018.9025
1.37018.5000EA 0 PLN
1.37018.5000 1.37018.9012 1.37018.1000 1.37018.9025
diwodorofosforan sodu dihydrat 98,0-100,5 alkalimetry on anhydrous substance, EMPROVE® EXPERT JPE, BP, Ph. Eur., USP for biopharmaceutical production, SAFC®
diwodorofosforan sodu dihydrat
Formuła: NaH₂PO₄·2H₂O
MW: 156.01 g/mol
Temp. Wrzenia: ∼650 °C (1013 hPa)
Temp. topnienia: 60
Gęstość: 1.91 g/cm³ (20 °C)
Temperatura przechowywania: Temperatura otoczenia
Numer MDL: MFCD00149209
Numer CAS: 13472-35-0
Numer WE (dawny EINECS): 231-449-2
REACH: 01-2119489796-13
Klasyfikacja Merck : 12,08806

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Wyniki testów specyfikacyjnych

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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