Vin nn clarithromycin

Tabellae Clarithromycini

L vin nn bao phim cha clarithromycin.

Ch phm phi p ng cc yu cu trong chuyn lun Thuc vin nn mc vin bao (Ph lc 1.20) v cc yu cu sau y:

 

Hm lng clarithromycin, C38H69NO13,phi t 90,0 n 110,0% so vi hm lng ghi trn nhn.

 

Tnh cht

Vin mu trng hoc trng ng hoc c mu ng u.

 

nh tnh

Trong phn nh lng, pic chnh trn sc k ca dung dch th phi c thi gian lu tng ng vi thi gian lu ca pic clarithromycin trn sc k ca dung dch clarithromycin chun.

 

Nc

Cn chnh xc khong 0,25 g bt vin, sy trong chn khng di p sut 5 mm Hg 110 OC trong 3 gi, lng mt i khng qu 6,0% ( Ph lc 9.6).

 

ho tan ( Ph lc 11.4 )

Mi trng ho tan: 900 ml dung dch m natri acetat 0,1 M.

Cch pha dung dch m natri acetat 0,1 M: Ho tan 13,61 g natri acetat trihydrat (TT) trong 1000 ml nc, iu chnh n pH 5,0 bng acid acetic 0,1N (TT).

Thit b: Kiu cnh khuy.

Tc quay : 50 vng/pht.

Thi gian: 30 pht.

Cch tin hnh:

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

Pha ng, dung dch chun, dung dch phn gii v iu kin sc k thc hin nh trong phn nh lng.

Dung dch th : Ly mt phn dung dch mi trng sau khi ha tan, lc, b 20 ml dch lc u, pha long dch lc vi pha ng thu c dung dch c nng clarithromycin khong 125 mg/ ml.

Yu cu: Khng c t hn 80,0% lng clarithromycin, C38H69NO13,so vi lng ghi trn nhn c ho tan trong 30 pht.

 

nh lng

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

Pha ng: Hn hp ca methanol (TT) v dung dch kali dihydrophosphat 0,067 M (65: 35), iu chnh n pH 4,0 bng acid phosphoric (TT). Lc qua mng 0,45 mm. iu chnh t l dung mi nu cn.

Dung dch th: Cn 20 vin, tnh khi lng trung bnh, nghin thnh bt mn. Cn chnh xc mt lng bt vin tng ng vi 0,2 g clarithromycin vo bnh nh mc 50 ml, thm khong 35 ml methanol (TT), lc trong 30 pht ri thm methanol (TT) va ; lng. Ly 3,0 ml dch trn thm pha ng va 100,0 ml, trn u v lc qua mng 0,5 mm.

Dung dch chun: Cn chnh xc mt lng clarithromycin chun pha trong methanol (TT), lc, siu m nu cn c dung dch gc c nng clarithromycin chun chnh xc khong 625 mg/ ml. Pha long 10,0 ml dung dch ny thnh 50,0 ml bng pha ng, trn u. Lc qua mng 0,5 mm. (Dung dch c nng clarithromycin chun chnh xc khong 125 mg/ ml.)

Dung dch phn gii: Pha cht lin quan A (6,11 di o-methyl erythromycin A, C39H71NO13 ) ca clarithromycin trong methanol (TT) c dung dch c nng khong 625 mg/ ml. Ly 10,0 ml dung dch ny v 10,0 ml dung dch chun vo bnh nh mc 50 ml, thm pha ng n vch v trn u.

iu kin sc k:

Ct thp khng g (15 cm 4,6 mm) cha pha tnh C (5 mm).

Nhit duy tr khong 50OC.

Detector quang ph t ngoi, t bc sng 210 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: Tin hnh sc k vi dung dch phn gii, thi gian lu tng i ca clarithromycin khong 0,75 v ca cht lin quan A ca clarithromycin l 1,0. phn gii gia pic ca clarithrromycin v cht lin quan A ca clarithromycin phi khng nh hn 2,0.

Tin hnh sc k vi dung dch chun, t pic ca clarithromycin tnh ra s a l thuyt ca ct khng c nh hn 750; h s i xng khng nh hn 0,9 v khng qu 2; lch chun tng i ca din tch pic clarithromycin t 6 ln tim lp li khng ln hn 2,0%.

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

Tnh hm lng clarithromycin, C38H69NO13,trong mt vin da vo din tch pic thu c t sc k ca dung dch chun v dung dch th v hm lng C38H69NO13 trong clarithromycin chun.

 

Bo qun

Trong ng kn, nhit khng qu 30OC.

 

Loi thuc

Khng sinh

 

Hm lng thng dng

250 mg, 500 mg.