Xylometazolin hydroclorid - XYLOMETAZOLIN HYDROCLORID...

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XYLOMETAZOLIN HYDROCLORID Xylomethazolini hydrochloridum C 16 H 24 N 2 . HCl P.t.l: 280,8 Xylometazolin hydroclorid laø 2-[4-(1,1-dimethylethyl)-2,6-dimethylbenzyl]-4,5- dihydro-1 H -imidazol hydroclorid, chöùa töø 99,0 ñeán 101,0 % C 16 H 24 N 2 . HCl, tính theo cheá phaåm ñaõ laøm khoâ. Tính chaát Boät keát tinh maøu traéng hoaëc gaàn nhö traéng. Deã tan trong nöôùc, trong ethanol 96% vaø methanol,thöïc teá khoâng tan trong ether. Ñònh tính Coù theå choïn 1 trong 2 nhoùm ñònh tính sau: Nhoùm 1: A, E. Nhoùm 2: B, C, D, E. A. Phoå hoàng ngoaïi cuûa cheá phaåm phaûi phuø hôïp vôùi phoå hoàng ngoaïi cuûa xylometazolin hydroclorid chuaån (ÑC) (Phuï luïc 4.2). B. Kieåm tra saéc kyù ñoà thu ñöôïc trongpheùp thöû taïp chaát lieânquan: Veát chính trongsaéc kyù ñoà cuûa dung dòch thöû (2) phaûi töông ñöông veà vò trí, maøu saéc, kích thöôùc so vôùi veát chínhtreân saéc kyù ñoàcuûa dung dòchñoái chieáu (1). C. Hoøa tan khoaûng 0,5 mg cheá phaåm trong 1 ml methanol (TT) , theâm 0,5 ml dung dòch natri nitroprusiat 5% vöøa môùi pha, theâm tieáp 0,5 ml dung dòch natri hydroxyd 2% . Ñeå yeân hoãn hôïp trong 10 phuùt, theâm 1 ml dung dòch natri bicarbonat 8% . Maøu tím xuaát hieän. D. Hoøa tan 0,2 g cheá phaåm trong 1 ml nöôùc , theâm 2,5 ml ethanol 96% (TT) vaø 2 ml dung dòch natri hydroxyd 1 M. Troän ñeàu vaø quan saùt döôùi aùnh saùng UV 365 nm. Dung dòch khoâng
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