??????????
??????? K3 ???? ???? ????? ??????
?????
(?) ????? ?????: ??????? ?????? (???? ????????, ???, ?????? ?????? ???????); ???? ?????? (???? ????, ????????? ???????); ?????????????? ??? ?????????? (???? ???? ??, ?????? ?????, ????, ??????? ????? ??????? ??? ??? ???????); ???? ??? ???????? ?????? (???? ?? ????, ????????? ?????, ?? ??? ???? ???????)?
(?) ????? ?????: ?????? ??? ??????? ???? ????????; ??????????? ??? ??????????? ???????????; ????????? ????? ? ?????????? ?????????? ?????? ??? ???????; ????????? ?????? ?????, ???? ??? ????? ??????? ?????; ?????? ???? ???????? ??????; ????? ????????? ?????? ??????? ????? ????????????? ??????? ??????????? ?????? ??????? ??? ???? ??????? ???? ??? ??? ?????? ??? ??? ??????-????????? ??? ?????? ???? ??????? ???; ???????????? ????????????????, ????????
(?) ???????????????? ?????: ??????????? ??????, ??????? ??, ??????? ?, ???????????????? ?????????????? ??????? ??????? ????????? ??????????
???????
?????
?. ??????? K3 ???? ?????? ?????? ??????? ??? ??? ??????? K3 ?????????????? ????????? ???????? ???? ?????
?. ??????? K3 ????? ??????? ???? ?????? ??????? K3 ??? ????????????? ???????? ???? ???????????? ?????? ??? ???? ?????????? ????????????? ???? ????????? ?????
?. ??????? K3 ????? ?????????????? ?????? ???, ?? ???????? ?????????????? ??????? ???? ????, ???? ???????????? ???????? ???????? ???? ???? ??? ?????? ???????????? ????????? ??????????? ??????? ????
?. ??????? K3 ??????????? ???????????? ??????? ???, ??????? ???? ???????, ??????, ????? ??????????????, ????? ???? ???????? ???????? ?????
?????? ?????
????? | ????????????? | |
???????? ???? ?????????? | ?. ???-??????: ??????? ???? ????????? ??????????????? ???? ?????? | |
2. HPLC-MS: ??????? ???? ?? ?????? ???? ??? ?????? ?????? ????? ??? ????????? ??????????????? ???? ??????? | ||
?. IR: IR ?? ???? ????????? ??????????????? ???? ?????? | ||
????????? (HPLC) | ≥??.?% | |
????????? ?????? | ????????? ??? ????????? | EP/USP/BP ??? ???? ??? |
?-????????? ??? ????????? | ≤?.??% | |
??? ?????? | ≤?.??% | |
?????? ??? | EP/USP/BP ??? ???? ??? | |
??????? ???? ????? | ≤?.?% | |
?? | ≤?.?% | |
???? ??? | ≤?.?% | |
???? ???? | ≤?? ?????? | |
??????? | ??.?%~???.?% (???/??????/???? ??? ????????) | |
???????????????????? ???????? | ||
??? ????? ?????? | ≤???? ??????/????? | |
????? ??? ???? | ≤??? ??????/????? | |
?. ?????? | ????????? | |
????????? | ????????? | |
??. ??????? | ????????? | |