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ITEMS
STANDARD
RESULTS
Characters
White or almost white crystalline granule and powder
A white crystalline granule and powder
Identification
(1) The spectrum obtained with the substance to be examined corresponds with that obtained with reference standard
(2) Should meet the requirement under water
Comforms
Appearance of solution
≤reference suspension II
(1 mol/L hydrochloric acid)
≤reference suspension II
(2 mol/L ammonia)
≤Reference suspension I
≤Reference suspension I
PH
3.5~5.5
4.4
Specific optical rotation
+280~ +305
+296
Related substances
Any impurity≤1.0%
0.26%
Dimethylaniline
≤20ppm
Complies
(not used in process)
Water
12.0%~15.0%
13.3%
Sulphated ash
≤0.5%
0.07%
Bulk density
0.45g/ml - 0.65g/ml
0.57g
/ml
Tapped density
≥0.65g/ml
0.76g
/ml
Assay
96.0%~102.0% C16H19N3O4S
(calculated on the anhydrous basis)
99.7%
Ampicillin sodium+ Sulbactam sodium (2:1) Sterileone kind of semi synthetic penicilline product (antibiotic)
Ampicillin sodium+ Sulbactam sodium (2:1) Sterile
one kind of semi synthetic penicilline product
appearance: a white powder
sterility: conforms
PH:8.0-10.0
bacterial endotoxins: 0.17EU/mg max.
Ampicillin: 563μg/mg min
sulbactam:280μg/mg min
packing:5kg/tin & 2tin/carton
pharmacopeia standard: USP29
ITEMS
STANDARD
RESULTS
Characters
White or almost white crystalline powder
A white crystalline powder
Identification
complies
conforms
Appearance of solution
1 mol/L HCL≤ 2#
2 mol/L NH3·H2O≤2#
1#
1#
PH
3.5~5.5
4.5
Specific optical rotation
+280°~ +305°
+297
°
Related substances
Individual impurity≤1.0%
0.26%
Water
12.0%~15.0%
13.6%
N,N-Dimethylaniline
≤20ppm
conforms
(not used in process)
Sulphated ash
≤0.5%
0.10%
Assay (HPLC)
(calculated on anhydrous basis)
96.0%~102.0% C16H19N3O4S
99.0%
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