| ≥1 piece |
|
ITEM
|
STANDARD
|
RESULTS
|
|
Identification
|
Positive
|
Complies
|
|
Melting point of
insoluble saccharin ° C
|
226-230
|
226.5-229.2 º C
|
|
Appearance
|
White crystal
|
White crystal
|
|
Content %
|
99.0-101.0
|
99.54
|
|
Loss on drying %
|
≤ 15
|
13.36
|
|
Ammonium Salts ≤
|
0.0025
|
0.0020
|
|
Arsenic % ≤
|
0.0002
|
0.0001
|
|
Benzoate and salicylate
|
No precipitate or violet color appears
|
Complies
|
|
Heavy metals ≤
|
0.001
|
0.0005
|
|
Free acid or alkali
|
Complies with BP/USP/EP
|
Complies
|
|
Readily carbonizable
substances
|
Not more intensely colored than reference
|
Complies
|
|
P-Toluene sulfonamide ≤
|
10ppm
|
7ppm
|
|
O-Toluene sulfonamide ≤
|
10ppm
|
7ppm
|
|
selenium ≤
|
30 ppm
|
6ppm
|
|
Related substance
|
Complies with BP/USP/EP
|
Without
|
|
Clarity and color of solution.
|
Colorless, clear
|
Colorless, clear
|
|
Organic volatiles
|
Complies with BP/USP/EP
|
Without
|
|
PH value
|
Complies with BP/USP/EP
|
7.0
|
|
Benzoic acid- sulfonamide
|
≤ 25ppm
|
20ppm
|
|
CONCLUSION: Complies with BP2000/USP30/EP-E954
SHELF LIFE: 3 YEARS
|
||