BT PHA TIM Amoxicilin

Amoxicillini pro injectione

 

Bt pha tim amoxicilin l bt kt tinh v khun ca amoxicilin 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 amoxicilin, C16H19N3O5S , phi t t 90,0 n 105,0% so vi hm lng ghi trn nhn.

Tnh cht

Bt kt tinh trng hoc trng ng.

inh tnh

A.     Ph hng ngoi (Ph lc 3.2).

Ph hng ngoi ca ch phm phi ph hp vi ph hng ngoi ca amoxicilin natri chun.

B.     Phng php sc k lp mng (Ph lc 5.4).

Bn mng: Silica gel G, hot ho 100 OC trong 1 gi.

Dung mi khai trin: Aceton - dung dch amoni acetat 15,4% (TT) c iu chnh n pH 5,0 vi acid acetic bng (TT) (10 : 90).

Dung dch th: Ho tan mt lng ch phm trong dung dch natri hydrocarbonat 4,2% (TT) c dung dch c nng amoxicilin 0,25%.

Dung dch chun: Dung dch amoxicilin trihydrat chun 0,25% trong dung dch natri hydrocarbonat 4,2% (TT).

Dung dch i chiu:Pha dung dch c cha amoxicilin trihydrat chun v ampicilin trihydrat chun trong dung dch natri hydrocarbonat 4,2% (TT) c nng mi cht l 0,25%.

Cch tin hnh: Chm ring bit ln bn mng 2 ml mi dung dch trn. Trin khai sc k ti khi dung mi i c khong 15 cm, ly bn mng ra, kh nhit phng. Cho vo bnh cha hi iod pht hin cc vt.

Vt chnh trn sc k ca dung dch th phi tng ng v v tr, mu sc, kch thc vi vt trn sc k ca dung dch chun. Php th ch c gi tr khi 2 vt ca dung dch i chiu c tch ri r rng.

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

Gii hn acid - kim

Pha ch phm trong nc c dung dch cha 10% amoxicilin ri xc nh pH, phi t 8,0 n 10,0 (Ph lc 6.2).

Nc

Khng c qu 4,0% (Ph lc 10.3). Dng 0,3 g ch phm.

Ni c t vi khun

Ho tan mt lng ch phm trong nc BET(TT) thu c dung dch c nng amoxicilin 10 mg/ml (dung dch A). Gii hn ni c t ca dung dch A l 2,5 n v ni c t trong 1 ml. Tin hnh th nghim s dng gi tr pha long cc i ca dung dch A c tnh t nhy ca thuc th Lysat s dng trong th nghim (Ph lc 13.2).

Cht phn hu

Cn chnh xc mt lng ch phm tng ng 0,24 g amoxicilin, thm 25 ml dung dch m boric pH 9,0 v 0,5 ml dung dch anhydrid acetic (TT), khuy trong 3 pht. Thm 10 ml dung dch m acetat pH 4,6 v chun ngay bng dung dch thu ngn (II) nitrat 0,02N (C) bng phng php in th (Ph lc 10.2).

1 ml dung dch thu ngn (II) nitrat 0,02 N tng ng vi 7,748 mg cht phn hu (tnh theo amoxicilin natri, C16H18N3NaO5S ).

Ch phm khng c c qu 9,0% cht phn hu, tnh theo amoxicilin natri, C16H18N3NaO5S.

nh lng

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

Pha ng: Hn hp pha ng A v pha ng B (92 : 8).

Pha ng A: Trn 1 th tch acetonitril (TT) vi 99 th tch dung dch c nng 25% (tt/tt) ca dung dch kali dihydrophosphat 0,2 M (TT) c iu chnh ti pH 5,0 bng dung dch natri hydroxyd 2M (TT).

Pha ng B: Trn 20 th tch acetonitril (TT) vi 80 th tch dung dch c nng 25% (tt/tt) ca dung dch kali dihydrophosphat 0,2 M (TT) c iu chnh ti pH 5,0 bng dung dch NaOH 2 M (TT).

Dung dch th: Cn thuc trong 10 l tnh khi lng trung bnh ca thuc trong mt n v ch phm, trn u ri cn chnh xc mt lng ch phm tng ng vi khong 60 mg amoxicilin vo bnh nh mc 100 ml, thm 80 ml pha ng A, lc trong 15 pht sau lc siu m trong 1 pht ri thm pha ng A va n vch, trn u v lc.

Dung dch chun: Dung dch amoxicilin trihydrat chun 0,070% trong pha ng A.

Dung dch phn gii: Dung dch c cha 0,003% amoxicilin trihydrat chun v 0,0004% cefadroxil chun trong pha ng A.

iu kin sc k:

Ct thp khng g (25 cm 4,6 mm) c nhi pha tnh C (5 mm) (ct Hypersil ODS l thch hp).

Tc dng: 1,0 ml/pht.

Detector quang ph t ngoi t bc sng 254 nm.

Th tch tim: 50 ml.

Cch tin hnh:

Tim dung dch phn gii. Th nghim ch c gi tr khi h s phn gii gia 2 pic amoxicilin v cefadroxil khng nh hn 2. iu chnh thnh phn ca pha ng t yu cu phn gii trn (nu cn).

Tim ln lt dung dch chun v dung dch th.

Tnh hm lng amoxicilin, C16H19N3O5S , trong mt n v ch phm theo khi lng trung bnh t din tch pic trn sc k ca dung dch chun v dung dch th, v vo hm lng C16H19N3O5S trong amoxicilin trihydrat chun (C).

Bo qun

Trnh m, nhit khng qu 25OC.

Loi thuc

Khng sinh nhm beta lactam

Hm lng thng dng

250 mg, 500 mg, 1000 mg, tnh theo amoxicilin.