Ceftriaxon pha THuc tim

Ceftriaxoni pro injectine

Ceftriaxon pha thuc tim l bt kt tinh v khun ca ceftriaxon natri ng trong l thu tinh nt kn. Ch pha vi dung mi 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 ceftriaxon, C18H18N8O7S3 phi t t 92,0 n 108,0% so vi hm lng ghi trn nhn.

Tnh cht

Tinh th hoc bt kt tinh trng ng.

nh tnh

A. Ph hng ngoi (Ph lc 4.2) ca ch phm phi ph hp vi ph hng ngoi ca ceftriaxon natri chun.

B. Trong php th nh lng, trn sc k ca dung dch th phi cho pic c thi gian lu tng ng vi thi gian lu ca pic ceftriaxon trong sc k ca dung dch ceftriaxon natri chun.

C.   C phn ng c trng ca ion natri (Ph lc 8.1).

Gii hn acid-kim

Dung dch 10% ch phm (kl/tt) trong nc khng c carbon dioxyd (TT) phi c pH t 6,0 n 8,0 (Ph lc 6.2).

trong ca dung dch

Dung dch 1,2% ch phm trong nc khng c carbon dioxyd (TT) phi trong ( Ph lc 9.2).

Tp cht lin quan

Tin hnh bng phng php sc k lng nh trong mc nh lng, vi thi gian sc k t nht l 2 ln thi gian lu ca pic chnh. Din tch ca bt k pic ph no trn sc k ca dung dch th u khng c ln hn din tch ca pic chnh trn sc k ca dung dch th long (1%) v tng din tch ca tt c cc pic ph trn sc k ca dung dch th khng c ln hn 5 ln din tch ca pic chnh trn sc k ca dung dch th long (5%). B qua bt k pic no c din tch nh hn 10% din tch pic chnh trn sc k ca dung dch th long.

Nc

Khng c qu 11,0%. ( Ph lc 10.3).

Dng 0,2 g ch phm.

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 ceftriaxon 10 mg/ml (dung dch A). Nng gii hn ni c t ca dung dch A l 2,0 n v ni c t 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: Ho tan 2 g tetradecylammoni bromid (TT) v 2 g tetraheptilammoni bromid (TT) trong mt hn hp gm 440 ml nc v 55 ml dung dch m phosphat pH 7,0 (TT) v 5 ml dung dch m citrat pH 5,0 ( iu ch bng cch ho tan 20,17 g acid citric (TT) trong 800 ml nc, iu chnh ti pH 5,0 bng dung dch natri hydroxyd 10N (TT) v pha long bng nc ti 1000 ml), sau trn u vi 500 ml acetonitril (TT).

Dung dch th: Cn thuc trong 10 l tnh khi lng trung bnh ca thuc trong mt n v ch phm, trn u. Cn chnh xc mt lng ch phm, ho tan trong pha ng c dung dch c nng ceftriaxon 0,030%.

Dung dch chun: Dung dch ceftriaxon natri chun 0,030% trong pha ng.

Dung dch phn gii: L dung dch cha ceftriaxon chun 0,0050% v ceftriaxon natri E-isomer chun 0,0050% trong pha ng.

Dung dch th long: Pha long mt th tch dung dch th thnh 100 th tch với pha ng.

iu kin sc k:

Ct thp khng g (25 cm 4,6 mm) c nhi pha tnh C (5 mm)(Lichrosphere RP-18 l thch hp).

Detector quang ph t ngoi t bc sng 254 nm.

Tc dng: 1,5 ml/pht.

Th tch tim: 20 ml.

Cch tin hnh:

Tin hnh sc k i vi dung dch phn gii, iu chnh nhy ca detector sao cho chiu cao ca cc pic t nht bng 50% ca thang o. Php th ch c gi tr khi h s phn gii gia hai pic chnh ca dung dch phn gii khng nh hn 3,0.

Tin hnh sc k ln lt i vi dung dch chun v dung dch th.

Tnh hm lng ceftriaxon, C18H18N8O7S3, trong mt n v ch phm dựa vo din tch pic trn sc k thu c ca dung dch chun v dung dch th v hm lng C18H18N8O7S3 ca ceftriaxon natri chun.

1 mg ceftriaxon natri (C18H18N8O7S331/2 H2O) tng ng vi 0,8383 mg ceftriaxon (C18H18N8O7S3).

Bo qun

Ni kh ro, nhit khng qu 30 0C.

Loi thuc

Khng sinh cephalosporin th h 3.

Hm lng thng dng

250 mg, 500 mg v 1000 mg, tnh theo ceftriaxon.

Nu tim bp th khi dng thng phi pha thuc trong mi l bng mt ng thuc tim lidocain (3,5 ml, cha 35 mg lidocain C14H22N2O.HCl.H2O ).