items |
acceptance criteria |
results |
|
character |
appearance: white to almost white powder |
a white powder |
|
identification |
infrared absorption spectrophotometry :the ir spectrum is consistent with that obtained with dirithromycin crs |
|
|
the retention time of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation as obtained in the assay |
|
||
test |
chromatographic purity |
9-(s)-erythromycylamine ; no more than 1.5% |
0.2precent |
any other individual impurity : not more than 1.0% |
less than 1.0percent |
||
total impurities : not more than 4.0 percent |
2.2 percent |
||
dirithromycin 16s-epimer |
not more than 1.5percent |
0.7precent |
|
acetonitrile |
not more than 0.1 percent |
less than 0.1 percent |
|
heavy metals |
not more than 20ppm |
less than 20ppm |
|
water |
not more than 1.0 percent |
0.5 percent |
|
assay |
dirithromycin contains not less than 96.0% percent and not more than 102.0 percent consisting of the 16r-and 16s-epimers .calculated on the anhydrous basis |
97.6 percent |
|
conclusion |
this batch of dirithromycin meets the specification of usp31 |