sulfadiazine tim Thng bo chung

Hnh ng v s dng

Sulfonamid khng khun.

NH NGHA

Sulfadiazine Injection l mt dung dch v trng ca cc dn xut natri ca Sulfadiazine trong nc cho Tim min ph t khng kh ha tan.

Tim ph hp vi cc yu cu nu di ch phm tim v vi cc yu cu sau.

Ni dung ca sulfadiazine, C10H10N4O2S

95,0-105,0% ca s liu cng b.

NHN DNG

Axt mt khi lng tim c cha tng ng vi 0,5 g Sulfadiazine vi 6M axit axetic v b lc. Ph hp th hng ngoi, Ph lc II A, cn, sau khi ra bng nc v sy 105 , l ph hp vi ph ti liu tham kho ca sulfadiazine (RS 325).

KIM TRA

kim

pH, 10,0-11,0 Ph lc V L.

Mu sc ca gii php

Tim c cha tng ng vi 1 g Sulfadiazine trong 4 ml nc khng phi l hn mnh m mu hn dung dch i chiu xp 5, Ph lc IV B, Phng php II.

cht lin quan

Thc hin cc phng php sc k lp mng, Ph lc III A, bng cch s dng sau y cc gii php.

? (1): Pha long mt lng tim c cha tng ng vi 0,5 g Sulfadiazine vi y ca mt hn hp ca 1 khi lng amoniac 13.5m v 9 khi lng methanol sn xut 25 ml.

? (2): Pha long 1 th tch dung dch (1) n 200 lng vi mt hn hp ca 1 th tch 13.5m amoniac v 24 khi lng methanol. iu kin sc k

(a) S dng nh silica ph gel GF 254.

? (b) Giai on di ng l mt hn hp gm 3 khi lng amoniac 6M, 5 th tch nc, 40 khi lng nitromethane v 50 khi lng ca 1,4-dioxan.

? (c) Xy dng n 15 cm.

? (d) khi lng ng dng ca 5 ml cho mi gii php.

? (e) Hy b a, lm kh 100 n 105 v kim tra di nh sng tia cc tm (bc sng 254 nm).

GII HN

Bt kz v tr th trn sc k{ ca dung dch (1) khng c m hn ti ch trong sc k{ ca dung dch (2) (0,5%).

nh lng

mt khi lng cha tng ng vi 0,5 g Sulfadiazine thm mt hn hp ca 75 ml nc v 10 ml dung dch acid hydrochloric, thm 3 g kali bromua, mt m trong bng v chun chm vi 0,1 M natri nitrit VS, khuy lin tc v xc nh im kt thc electrometrically. Mi ml dung dch natri nitrit 0,1 M VS tng ng vi 25,03 mg C10H10N4O2S.

BO QUN Sulfadiazine tim phi c bo v t nh sng.

Ghi nhn

Sc mnh c quy nh trong iu khon ca s lng tng ng ca Sulfadiazine trong mt ph hp liu khi lng.