Melting Range, ۫۫
șC
Loss on drying, % w/w
Insoluble, mg/kg
Heavy Metals,(as pb),mg/kg.
Iron, mg/kg
Lead, mg/kg
Chlorides, % W/v
Sulfate, % w/v
Arsenic, mg/kg
Sulphated Ash/
Residue on lgnition, % w/w
PH Value
Organic volatile impurities
Assay, % w/w
Purity
Other Alkaloids/Related Substance
Chromatographic Purity HPLC
Microbiological Test
Standard Plate Count
Yeast/mold
E. coil
Salmonella
|
235-237.5
Passes Test
Passes Test
Passes Test
Passes Test
NIL
Passes Test
Passes Test
NIL
< 0.1
Neutral
Passes Test
99.0-100.5
>99%
Passes Test
Passes Test
Passes Test
Passes Test
Negative
Negative
|
235.0-237.5 (IP/BP/EP/JP/USP/FCC)
Max. 0.5 (IP/BP/EP/JP/USP/FCC)
Max. 50mg/kg
Max. 10 (IP/BP/EP/JP/USP)
Max. 10
Max. 1 (FCC)
Max. 0.011% (JP)
Max0.024% (BP/EP/JP)
Max.3 (IP/USP)
Max0.01%(IP/BP/EP/JP/USP/FCC)
5.5-6.5 (IP/BP/EP/JP/USP/FCC)
(EP/JP/USP/FCC)
98.5-101.0 (IP/BP/EP/JP/USP/FCC)
(IP/BP/EP/JP/USP/FCC)
>0.1% each & total impurity (EP/USP)
Less than 100CFU/gram
Less than 10 CFU/gram
/25 grams
/100 grams
|
