Potassium dihydrogen phosphate, crystallised, EMPROVE® EXPERT Ph. Eur., BP, JPC, NF for biopharmaceutical production, SAFC®

Supplier: EMD MILLIPORE – PCS CA EXCEP

Certificates

Supplier: EMD MILLIPORE – PCS CA EXCEP

Certificates

About this item

Synonyms: Monopotassiumphosphate,Potassium phosphate monobasic,Monobasic Potassium Phosphate

Formula:KH₂PO₄

MW:136.09 g/mol

MDL Number:MFCD00011401

CAS Number:7778-77-0

:Length:

:Width:

:Height:

:Ø

:Thickness:

:Boiling Pt:

:Melting Pt:

:Melting Pt: 253 °C

:Flash Pt:

:M.W. 136.09 g/mol

:253

:100

:12,07829

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Specification Test Results

Assay (alkalimetric, calculated on dried substance):
98.0 - 100.5 %
Assay (alkalimetric; dried substance):
≥ 99.0 %
Identity:
passes test
Appearance of solution:
passes test
Insoluble substances:
≤ 0.2 %
pH-value (2 %; water):
4.2 - 4.6
pH-value (5 %; water):
4.2 - 4.5
Carbonate:
passes test
Condensed phosphate:
passes test
Chloride (Cl):
≤ 0.009 %
Fluoride (F):
≤ 0.0010 %
Sulfate (SO₄):
≤ 0.017 %
Heavy metals (as Pb):
≤ 0.0010 %
Al (Aluminium):
≤ 0.0005 %
As (Arsenic):
≤ 0.0002 %
Fe (Iron):
≤ 0.0010 %
Na (Sodium):
≤ 0.1 %
0:
passes test
Pb (Lead):
≤ 0.0004 %
Endotoxins:
≤ 2.5 I.U./g
Total aerobic microbial count:
≤ 100 CFU/g
Total yeast and mould count:
≤ 100 CFU/g
DNases (Exo- and endonucleases) (not detectable):
passes test
RNases (not detectable):
passes test
Proteases (not detectable):
passes test
Residual solvents (ICH Q3C):
excluded by manufacturing process
Reducing substances:
passes test
Loss on drying (105 °C):
≤ 0.5 %
Loss on drying (130 °C):
≤ 1.0 %
SAFC®, Potassium dihydrogen phosphate, crystallised, EMPROVE® EXPERT Ph. Eur., BP, JPC, NF for biopharmaceutical production: