White or almost white, crystalline powder, colourless crystals or granules. Odorless, has a strongly acid taste. Very soluble in water, freely soluble in ethanol.
Pass
Identification
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Pass Test
Pass
Appearanceofsolution
----
Pass Test
Pass
Assay
%
99.5~100.5
99.9
Water
%
≤0.5
0.1
Readily Carbonisable Substances
----
Pass Test
Pass
SulphatedAsh
(Residue on Ignition)
%
≤0.05
0.02
Sulfate
mg/kg
≤150
<150
Oxalate
mg/kg
≤100
<100
Lead
mg/kg
≤0.5
<0.5
Arsenic
mg/kg
≤1
<1
Mercury
mg/kg
≤1
<1
Aluminum
mg/kg
≤0.2
<0.2
Heavy Metals (as Pb)
mg/kg
≤10
<10
Bacterialendotoxins
IU/mg
<0.5
<0.5
Conclusion: The product is in conformity with BP/USP/FCC/E330.