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%