ISONIAZID

Isoniazidum

 

 

 

 

 

 

C6H7N3O P.t.l: 137,14

Isoniazid la pyridin-4-carbohydrazid, phai cha t 99,0 en 101,0% C6H7N3O, tnh theo che pham a lam kho.

Tnh chat

Bot ket tinh trang hay tinh the khong mau, khong mui.

De tan trong nc, hi tan trong ethanol 96%, kho tan trong cloroform, rat kho tan trong ether.

nh tnh

Co the chon mot trong hai nhom nh tnh sau:

Nhom I: B va C.

Nhom II: A va C.

A. Pho hong ngoai (Phu luc 4.2) cua che pham phai phu hp vi pho hong ngoai cua isoniazid chuan hoac pho hong ngoai oi chieu cua isoniazid chun (ĐC).

B. Hoa tan 0,1 g che pham trong 2 ml nc, them dung dch nong cua 0,10 g vanilin (TT) trong 10 ml nc, e yen va co thanh ong nghiem bang mot ua thuy tinh, se co tua vang, tua nay sau khi ket tinh lai bang 5 ml ethanol 70% va say kho 100 105 oC, co iem chay t 226 231 oC (Phu luc 6.7).

C. iem chay: 170 174 oC (Phu luc 6.7).

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 ml vi cung dung moi.

Dung dch S phai trong (Phu luc 9.2) va khong c co mau am hn mau mau VN7 (Phu luc 9.3, phng phap 2).

pH

pH cua dung dch S t 6,0 en 8,0 (Phu luc 6.2).

Hydrazin va tap chat lien quan

Xac nh bang phng phap sac ky lp mong (Phu luc 5.4).

Ban mong: Silica gel GF254 (TT).

He dung moi: Nc - aceton - methanol - ethyl acetat (10 : 20 : 20 : 50).

Dung dch th: Hoa tan 1,0 g che pham trong hon hp ong the tch aceton (TT) va nc va pha loang thanh 10,0 ml vi cung dung moi.

Dung dch oi chieu: Hoa tan 50,0 mg hydrazin sulfat (TT) trong 50 ml nc va pha loang thanh 100,0 ml bang aceton (TT). Lay 10,0 ml dung dch nay, them 0,2 ml dung dch th va pha loang thanh 100,0 ml bang hon hp ong the tch aceton (TT) va nc.

Cach tien hanh: Cham rieng biet len ban mong 5 ml moi dung dch tren. Trien khai ban mong en khi dung moi i c 15 cm. e kho ban mong ngoai khong kh va quan sat di anh sang t ngoai bc song 254 nm. Bat ky vet phu nao ngoai vet chnh cua dung dch th khong c am mau hn vet cua dung dch oi chieu (0,2%). Phun ban mong bang dung dch dimethylamino benzaldehyd (TT1). Quan sat di anh sang ban ngay. Dung dch oi chieu xuat hien them vet tng ng vi hydrazin. Vet tng ng vi hydrazin cua dung dch th khong c am mau hn vet tng ng vi hydrazin cua dung dch oi chieu (0,05%).

Kim loai nang

Khong c qua 10 phan trieu (Phu luc 9.4.8).

Lay 2,0 g che pham th theo phng phap 3. Dung 2 ml dung dch ch mau 10 phan trieu (TT) e chuan b mau oi chieu.

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

Can chnh xac khoang 0,250 g che pham, hoa tan trong nc va pha loang thanh 100,0 ml vi cung dung moi. Lay 20,0 ml dung dch tren, them 100 ml nc, 20 ml acid hydrocloric (TT), 0,2 g kali bromid (TT) va 0,05 ml dung dch o methyl (TT). nh lng t t bang dung dch kali bromat 0,1 N (C), lac lien tuc cho ti khi mau o bien mat. Song song tien hanh mau trang trong cung ieu kien nh tren.

1 ml dung dch kali bromat 0,1 N (C) tng ng vi 3,429 mg C6H7N3O.

Bao quan

Trong lo thuy tinh nut kn, tranh anh sang.

Loại thuốc

Phong va phoi hp vi cac thuoc khac e ieu tr lao.

Che pham

Vien rimifon 150 mg, nang isoniazid thuoc tiem, siro.