0102030405
??????? K3 ?? ???? ????? ??????
???
(1) ???? ??????: ???? ??????? (??? ??????? ?????? ????? ????????? ??? ??? ???)? ???? ???? (??? ?????? ???????? ??? ??? ???)? ???? ????? ???????? (??? ???? ???????? ???????? ???????? ??????????? ??????? ???????? ??????? ??? ??? ???)? ???? ????? ???? (??? ???? ??????? ?????????? ???????? ???????? ????????? ??? ??? ???).
(2) ???? ???????: ???? ??????? ????????? ???? ?????? ?? ?????? ??? ???????? ???? ????? ????? ??????? ?????????? ????????? ???? ?? ?????? ???????? ?????? ???? ?? ????? ???? ?????? ???? ????? ?????? ???? ???? ?????? ??? ????? ????? ?????? ??????? ??? ???????????? ?????? ???? ?????? ?????? ????? ???????? ??????? ?????? ??????? ???????? ??????? ?????? ???? ????? ?????? ??? ??? ???.
(3) ?????? ??????????: ?? ??????? ????????? ?? ????? ??????? ???????????? ???????? ?? ???????? ?? ???????? ??????????? ??? ??? ???.
?????2
???????
1. ??????? K3 ???? ???? ????? ????? ???????? K3 ????? ???????????? ??? ??????.
?. ??????? ?? ????? ?? ??????? ??????. ??? ???? ??? ?? ????? ?????? ??????? ????? ???? ?????? ??????? ????????? ?? ?????.
3. ??????? K3 ???? ?? ????? ???????? ??? ???? ?? ???? ?????? ??????? ????? ????? ????? ???????? ???????? ???? ?????? ??????? ?????? ??????.
4. ?????? ??????? K3 ????? ?? ???????? ????????? ????? ????? ?????? ??? ????? ???????? ??????? ??????? ?????? ??????? ?????? ??? ??? ???.



??????? ??????
??? | ????? | |
????? ???????? ???????? | 1. H-NMR: ?????? ?????? ??????? ?? ???????? ???????? ???????? | |
2. HPLC-MS: ???? ?? ?? ????? ??????? ?????? ???????? ????? ?????? ???????? ?? ??????? ??????? | ||
3. IR: ?????? IR ??????? ?? ?????? ??????? ??????? | ||
?????? (HPLC) | ≥99.0% | |
??????? ??? ????? | ????? ????? ????? | ???? ?????? EP/USP/BP |
????? ????? ??? ????? | ≤0.10% | |
?????? ??????? | ≤0.50% | |
??? ??????? | ???? ?????? EP/USP/BP | |
????? ??? ??????? | ≤1.0% | |
??? | ≤1.0% | |
????? ??? ?????? | ≤0.1% | |
??????? ??????? | ≤10 ??? ?? ??????? | |
??? | 99.0%~101.0%(????? ??????? EP/USP/BP) | |
??????? ?????????????? | ||
?????? ??? ??????? | ≤1000 ???? ????? ???????/?? | |
??????? ?????? | ≤100 ???? ????? ???????/?? | |
????????? ????????? | ???? | |
??????????? | ???? | |
????????? ????????? ??????? | ???? |