Xylometazolin Hydroclorid

Xylomethazolini hydrochloridum

 

C16H24N2. HCl P.t.l: 280,8

Xylometazolin hydroclorid la 2-[4-(1,1-dimethylethyl)-2,6-dimethylbenzyl]-4,5-dihydro-1H-imidazol hydroclorid, cha t 99,0 en 101,0 % C16H24N2. HCl, tnh theo che pham a lam kho.

Tnh chat

Bot ket tinh mau trang hoac gan nh trang. De tan trong nc, trong ethanol 96% va methanol, thc te khong tan trong ether.

nh tnh

Co the chon 1 trong 2 nhom nh tnh sau:

Nhom 1: A, E.

Nhom 2: B, C, D, E.

A.      Pho hong ngoai cua che pham phai phu hp vi pho hong ngoai cua xylometazolin hydroclorid chuan (C) (Phu luc 4.2).

B.       Kiem tra sac ky o thu c trong phep th tap chat lien quan: Vet chnh trong sac ky o cua dung dch th (2) phai tng ng ve v tr, mau sac, kch thc so vi vet chnh tren sac ky o cua dung dch oi chieu (1).

C.       Hoa tan khoang 0,5 mg che pham trong 1 ml methanol (TT), them 0,5 ml dung dch natri nitroprusiat 5% va mi pha, them tiep 0,5 ml dung dch natri hydroxyd 2%. e yen hon hp trong 10 phut, them 1 ml dung dch natri bicarbonat 8%. Mau tm xuat hien.

D.      Hoa tan 0,2 g che pham trong 1 ml nc, them 2,5 ml ethanol 96% (TT) va 2 ml dung dch natri hydroxyd 1 M. Tron eu va quan sat di anh sang UV 365 nm. Dung dch khong co huynh quang, hoac co huynh quang tng ng vi dung dch mau trang pha trong cung ieu kien. Phan ng nh tnh nay ch co gia tr khi mot dung dch pha trong cung ieu kien dung naphtazolin hydroclorid chuan (C) thay the che pham cho huynh quang xanh dng ro ret.

E.       Che pham phai cho phan ng (A) cua phep th ion clorid (Phu luc 8.1)

o trong va mau sac cua dung dch

Dung dch S: Hoa tan 2,5 g che pham trong nc khong co carbon dioxyd (TT) va pha loang thanh 50,0 ml vi cung dung moi.

Dung dch S phai trong suot (Phu luc 9.2), va khong c co mau am hn mau mau V6 (Phu luc 9.3, phng phap 2).

Gii han acid - kiem

Hoa tan 0,25 g che pham trong nc khong co carbon dioxyd (TT) va pha loang thanh 25 ml vi cung dung moi. Them 0,1 ml dung dch o methyl (TT) va 0,1 ml dung dch acid hydrocloric 0,01 M (C). Dung dch co mau o. Khong c dung qua 0,2 ml dung dch natri hydroxyd 0,01 M (C) e chuyen mau cua chat ch th sang mau vang.

Tap chat lien quan

Kiem tra bang phng phap sac ky lp mong (Phu luc 5.4).

Ban mong: Silica gel G (TT).

Dung moi khai trien: Amoniac am ac - methanol (5 : 100).

Dung dch th (1): Hoa tan 0,2 g che pham trong methanol (TT) va pha loang thanh 5 ml vi cung dung moi.

Dung dch th (2): Pha loang 1 ml dung dch th (1) thanh 10 ml bang methanol.

Dung dch oi chieu (1): Hoa tan 20,0 mg xylometazolin hydroclorid chuan (C) trong methanol (TT) va pha loang thanh 5 ml vi cung dung moi.

Dung dch oi chieu (2): Hoa tan 4,0 mg tap chat chun A cua xylometazolin (ĐC) trong methanol (TT), va pha loang thanh 50,0 ml vi cung dung moi.

Dung dch oi chieu (3): Pha loang 1 ml dung dch th (2) thanh 50 ml bang methanol (TT).

Cach tien hanh:

Cham rieng re 5 l moi dung dch len ban mong. Trien khai sac ky en khi dung moi i c 10 cm. e kho ban mong. Trong mot bnh sac ky khac, ay bnh at mot a e tao kh bay hi co cha mot hon hp nc - acid hydrocloric 25% - dung dch kali permanganat 1,5% (1 : 1 : 2). ay kn bnh sac ky, va e yen trong 15 phut. Cho ban sac ky a lam kho vao bnh sac ky tren va ay kn lai. e ban mong tiep xuc vi hi clor trong 5 phut. Lay ban mong ra ngoai va at vao luong khong kh lanh cho en khi uoi het kh clor d va lp silicagel pha di vet cham khong c co mau xanh khi nho 1 giot dung dch kali iodid (TT) va dung dch ho tinh bot co kali iodid (TT). Phun ban mong vi dung dch ho tinh bot co kali iodid (TT). Tren sac ky o, vet nao thu c t dung dch th (1) tng ng vi tap chat A cua xylometazolin, khong c am mau hn vet chnh tren sac ky o thu c t dung dch oi chieu (2) (0,2%). Bat c vet nao trong sac ky o thu c t dung dch th (1), khac vi chat chnh, va vet tng ng vi tap chat A cua xylometazolin khong c am mau hn so vi vet chnh tren sac ky o thu c t dung dch oi chieu (3) (0,2%).

Ghi chu:

Tap chat A: N-(2-aminomethyl)-2-[4-(1,1-dimethylethyl)-2,6-dimethylphenyl]acetamid.

Mat khoi lng do lam kho

Khong c qua 0,5% (Phu luc 9.6).

(1,000 g; 100 105 oC).

Tro sulfat

Khong c qua 0,1 % (Phu luc 9.9, Phng phap 2).

Dung 1,0 g che pham .

nh lng

Hoa tan 0,200 g che pham trong 25 ml acid acetic khan (TT) va them 10 ml anhydrid acetic (TT). Chuan o bang dung dch acid percloric 0,1 M (C), xac nh iem ket thuc bang phng phap chuan o o ien the (Phu luc10.2)

1 ml dung dch acid percloric 0,1M (C) tng ng vi 28,08 mg C16H25ClN2.

Bao quan

Bao quan tranh anh sang.

Loai thuoc

ong van alpha-adenoceptor.

Che pham

Thuoc nho mui.