Bt pha tim cefazolin

Cefazolini pro injectione

 

Bt pha tim cefazolin l bt kt tinh v khun ca cefazolin natri ng trong l thu tinh nt kn. Ch pha vi nc v khun tim ngay trc khi dng.

Ch phm phi t cc yu cu quy nh trong chuyn lun chung v Thuc tim, thuc tim truyn (Ph lc 1.19) v cc yu cu sau y:

 

Hm lng cefazolin, C14H14N8O4S3, phi t t 90,0 n 105,0% so vi hm lng ghi trn nhn.

 

Tnh cht

Tinh th hoc bt kt tinh mu trng ng.

 

inh tnh

A. Trn sc k phn nh lng, thi gian lu ca pic chnh trong dung dch th phi tng ng vi thi gian lu ca pic cefazolin natri trong dung dch chun.

B. Ch phm phi c phn ng c trng ca ion natri (Ph lc 8.1).

 

Gii hn acid - kim

pH ca dung dch ch phm 10% trong nc khng c carbon dioxyd (TT) t 4,0 n 6,0 (Ph lc 6.2).

 

trong ca dung dch

Dung dch ch phm 10,0% trong nc khng c carbon dioxyd (TT) phi trong. hp th ca dung dch trn bc sng 430 nm khng qu 0,15 (Ph lc 4.1).

 

Nc

Khng c qu 6,0% (Ph lc 10.3).

Dng 0,3 g ch phm.

 

Cc cht lin quan

Xc nh bng phng php sc k lp mng (Ph lc 5.4).

Bn mng: Silicagel GF254, hot ho 100OC trong 1 gi.

Dung mi khai trin: Acid acetic glacial - nc aceton - ethyl acetat (10 : 10 : 20 : 50).

Dung dch (1): Ha tan mt lng thch hp ch phm trong nc c dung dch c nng cefazolin 5,0%.

Dung dch (2): Pha long 1 th tch dung dch (1) thnh 25 th tch vi nc.

Dung dch (3): Pha long 3 th tch dung dch (1 ) thnh 200 th tch vi nc.

Cch tin hnh: Chm ring bit ln bn mng mi dung dch trn 50 ml trong lung kh nitrogen. Sau khi trin khai sc k, ly bn mng ra, kh nhit phng. Kim tra di nh sng t ngoi bc sng 254 nm. Kim tra li bng cch t bn mng trong bnh bo ho hi iod cho ti khi cc vt xut hin r nht v quan st. Trn sc k , bt k mt vt ph no ca dung dch (1) u khng c m hn vt ca dung dch (2) (4%) v khng c c qu 1 vt m hn vt ca dung dch (3) (1,5%).

 

Ni c t vi khun

Tin hnh theo Php th ni c t vi khun (Ph lc 13.2).

Ho tan mt lng ch phm trong nc BET(TT) thu c dung dch c nng cefazolin 10 mg/ml (dung dch A). Nng gii hn ni c t ca dung dch A l 1,5 n v trong 1 ml. Gi tr pha long ti a ca dung dch A c tnh t nhy ca thuc th Lysat dng trong php th.

 

nh lng

Tin hnh bng phng php sc k lng (Ph lc 5.3).

Pha ng: Hn hp acetonitril (TT) - dung dch c cha dinatri hydrophosphat khan 0,277% v acid citric 0,186% (10 : 90).

Dung dch th: Cn thuc trong 10 l tnh khi lng trung bnh ca thuc, trn u. Ho tan mt lng ch phm trong nc c dung dch c nng cefazolin chnh xc khong 0,1%.

Dung dch chun: Dung dch cefazolin natri chun 0,1% trong nc.

Dung dch phn gii: Dung dch c cha cefazolin natri chun 0,01% v cefuroxim natri chun 0,005% trong nc.

iu kin sc k:

Ct thp khng g (25 cm 4,6 mm), c nhi pha tnh C, (5 mm n 10 mm) (Spherisorb ODS 1 l thch hp).

Detector quang ph t ngoi t bc sng 270 nm.

Tc dng: 1,0 ml/pht.

Th tch tim: 20 ml.

Cch tin hnh:

Kim tra kh nng thch hp ca h thng sc k: Tim dung dch phn gii iu chnh nhy ca detector sao cho chiu cao ca pic t t nht 50% chiu cao thang o. Php th ch c gi tr khi h s phn gii gia pic ca cefazolin v cefuroxim khng nh hn 2,0. iu chnh nng acetonitril trong pha ng t yu cu trn, nu cn.

Tim ln lt dung dch chun v dung dch th.

Tnh hm lng cefazolin, C14H14N8O4S3 , trong mt n v ch phm t din tch pic thu c trn sc k ca dung dch chun v dung dch th, v vo hm lng cefazolin, C14H14N8O4S3, ca cefazolin natri chun tnh hm lng cefazolin trong mt n v ch phm theo khi lng trung bnh ca thuc v so vi lng ghi trn nhn.

 

Bo qun

ni kh, trnh nh sng, nhit khng qu 30OC.

 

Loi thuc

Khng sinh cephalosporin th h 1

 

Hm lng thng dng

250 mg, 500 mg, 1000 mg