ITEMS OF TEST
|
STANDARD
|
RESULTS OF ANALYSIS
|
Appearance
|
White to almost white crystalline powder
|
Almost white crystalline powder
|
Identification
|
A: Infrared absorption
B: Ultraviolet absorption C: Thin-layer chromatographic identification |
Conforms
Conforms Conforms |
Loss of drying
|
NMT 0.50%
|
0.31%
|
Melting range
|
136 -142
|
/
|
Heavy metals
|
NMT 20ppm
|
<20ppm
|
Residue on ignition
|
NMT 0.10%
|
0.05%
|
3-Amino-1-propanol
|
NMT 0.50%
|
0.18%
|
Acetone
|
NMT 0.020%
|
Negative
|
Isopropyl alcohol
|
NMT 0.20%
|
Negative
|
Chromatographic purity
|
Total impurities: NMT1.00%Single impurity: NMT0.50%
|
Conforms
Conforms |
Assay
|
Not less than 98.00% and not more than 102.00%
|
99.64%
|
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