Item
Acceptance criteria
Result
Character
Appearance: White or almost white powder
white powder
Solubility: freely soluble in water, sparingly soluble in methanol, practically insoluble in methylene chloride.
complies
Identification
Infrared absorption spectrophotometry: corresponds to Sumatriptan succinate CRS
complies
ph
4.5—5.3
4.8
Absorbance
Maximum 0.1
0.05
Impurity
Impurity A: not more than 0.6 %
Impurity H: not more than 0.3 %
0.2%
0.1 %
Related substances
Impurity B,C or D:
each impurities not more than 0.5%
0.2%
Impurity E or any other impurity:
each impurities not more than 0.1%
Less than 0.1%
Total other impurities: not more than 0.6 %
0.2%
water
Not more than 1.0 %
0.1%
Sulphated ash:
Not more than 0.1%
0.02%
Residual solvents
Methanol: not more than 3000ppm
520ppm
Acetonitrite: not more than 100ppm
Not detected
Isopropyl Alcohol: not more than 100ppm
Not detected
Choroform: not more than 60ppm
Not detected
Assay(Anhydrous substance)
97.5% - 102.0%
99.3%
Conclusion: This batch of Sumatriptansuccinatemeets the specification of EP7.0