|
TEST |
USP |
BP / EP |
|
CHARACTERS |
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A white powder, slightly soapy to the touch, soluble in water and in alcohol, very slightly soluble in ether. An aqueous solution froths copiously when shaken |
IDENTIFICATION
UV ABSORPTION
IR
CHLOROFORM TEST
TEST FOR CHLORIDES
|
Ultraviolet absorption: should confirm with USP reference standard.
IR spectra concordant with reference sample.
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Complies with the test for chloride
|
Examined between 240 nm and 300 nm, the solution shows an absorption maximum at 259 nm and 2 shoulders at about 254 nm and at about 265 nm.
IR spectra concordant with reference sample
The chloroform layer becomes blue.
Solution S gives reaction of chlorides.
|
|
APPEARANCE OF SOLUTION |
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Solution S is not more opalescent than reference suspension II and is colourless |
|
ACIDITY |
Not more than 2.5 ml is required for neutralization. |
Not more than 2.5 ml is required for neutralization. |
|
AMINE AND AMINE SALTS |
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By potentiometric titration the volume of titrant is not greater than 5.0 ml. |
|
WATER
|
4.5% to 5.55w/w |
4.5 % to 5.5% w/w
|
|
SULPHATED ASH
|
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Not more than 0.2 per cent |
|
LOSS ON DRYING
|
NMT 0.5% |
NMT 0.5 % w/w |
|
SULPHATED ASH |
----- |
NMT 0.10% |
|
MELTING RANGE |
80º to 84ºC |
----- |
|
RESIDUE ON IGNITION |
Not more than 0.2 per cent, |
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|
HEAVY METALS |
NMT 0.002% |
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|
PYRIDINE |
The odour of pyridine is not immediately perceptible. |
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|
ASSAY |
99.0 %to 102.0 %w/w |
96.0 % to 101.0 %w/w |
