|
TEST |
USP |
EP |
|
CHARACTERS |
White Free flowing powder |
A white or almost white, crystalline powder, soluble in water, very slightly soluble in methanol, practically insoluble in methylene chloride. |
|
IDENTIFICATION |
IR spectra concordant with reference sample.
It gives reaction of sodium .
|
IR spectra concordant with reference sample.
It gives reaction of sodium .
|
|
APPEARANCE OF SOLUTION |
----- |
Solution S is clear and not more intensely coloured than reference solution B7 or BY7 . |
|
PH |
----- |
4.0 to 5.0 |
|
4-AMINOBUTANOIC ACID ( TLC) |
----- |
Not more than 0.5 per cent. |
|
CHROMATOGRAPHIC PURITY INDIVIDUAL IMPURITY TOTAL IMPURITY
|
NMT 0.1%
NMT 0.5%
|
Not more than 0.5 per cent. |
|
PHOSPHATE AND PHOSPHITEY
|
Phosphate is not greater than 0.5 per cent; Phosphite is not greater than 0.5 per cent. |
Phosphate is not greater than 0.5 per cent; Phosphite is not greater than 0.5 per cent. |
|
HEAVY METALS
|
Not more than 0.001% |
NMT 20 ppm |
|
LOSS ON DRYING
|
Between 16.1% to 17.1% W/W |
16.1 per cent to 17.1 per cent. |
|
ASSAY |
98.0% to 102.0% w/w |
98.0 per cent to 102.0 per cent w/w |
