Nang amoxicilin

Capsulae Amoxicillini

L nang cng c cha amoxicilin trihydrat.

Ch phm phi p ng cc yu cu trong chuyn lun Thuc nang (Ph lc 1.13) v cc yu cu sau y:

Hm lng amoxicilin, C16H19N3O5S, t 90,0 n 120,0% so vi lng ghi trn nhn (tnh theo loi khan).

Tnh cht

Nang cng, bt thuc trong nang mu trng ng, khng mi hay gn nh khng mi.

nh tnh

Ch phm phi p ng cc yu cu trong chuyn lun Vin nn amoxicilin.

Nc

Khng c qu 14,5% ( Ph lc 10.3).

Dng khong 0,100 g bt thuc.

ho tan ( Ph lc 11.4 )

Mi trng ho tan: 900 ml nc.

Thit b: Kiu gi quay.

Tc quay : 100 vng/pht.

Thi gian: 60 pht.

Cch tin hnh: Ly mt lng dung dch mi trng sau khi ha tan, lc, b 10 ml dch lc u, pha long nu cn. o hp th bc sng cc i 272 nm (Ph lc 4.1), trong cc o dy 1 cm, mu trng l nc. So snh vi dung dch amoxicilin trihydrat chun trong nc c nng tng ng. Tnh hm lng ca amoxicilin.

Yu cu: Khng c t hn 80,0% lng amoxicilin, C16H19N3O5S, so vi lng ghi trn nhn c ho tan trong 60 pht.

nh lng

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

Dung dch A: Ho tan 13,6 g kali dihydrophosphat (TT) trong 2000 ml nc, iu chnh ti pH = 5,0 0,1 vi dung dch kali hydroxyd 45%.

Pha ng : Hn hp Dung dch A v acetonitril (TT) t l (96 : 4). iu chnh t l acetonitril t iu kin sc k yu cu (nu cn).

Dung dch chun: Pha amoxicilin trihydrat chun trong dung dch A c nng amoxicilin chnh xc khong 1,2 mg/ml (ch dng trong vng 6 gi).

Dung dch th: Cn thuc trong tng nang ca 20 nang, tnh khi lng trung bnh, trn u, ri nghin thnh bt mn. Cn chnh xc mt lng bt vin tng ng khong 0,200 g amoxicilin, pha trong dung dch A va 200,0 ml; lc siu m ho tan v lc qua mng lc khng qu 1 mm (ch dng trong vng 6 gi).

iu kin sc k:

Ct thp khng g (25 cm 4 mm) c nhi pha tnh C (3 n 10 mm).

Detector quang ph t ngoi t bc sng 230 nm.

Tc dng: 1,5 ml/pht.

Th tch tim: 10 ml.

Cch tin hnh:

Kim tra kh nng thch hp ca h thng: Tim dung dch chun, h s dung lng phi nm trong khong 1,1 n 2,8. S a l thuyt ca ct khng nh hn 1700; h s i xng khng ln hn 2,5 v lch chun tng i ca cc din tch pic t 6 ln tim lp li mu chun khng ln hn 2,0%.

Tim ring bit dung dch th v dung dch chun .

Tnh hm lng amoxicilin, C16H19N3O5S , trong nang t din tch pic trn sc k ca dung dch chun v dung dch th, v hm lng C16H19N3O5S trong amoxicilin trihydrat chun.

 

Bo qun

ni mt, trong ng kn, trnh nh sng.

Loi thuc

Khng sinh nhm beta lactam

Hm lng thng dng

250 mg, 500 mg, tnh theo amoxicilin khan.