PROCAINAMID HYDROCLORID

Procainamidi hydrochloridum

C13H21N3O. HCl P.t.l: 271,8

Procainamid hydroclorid la 4-amino-N-[2-(diethylamino)ethyl]-benzamid hydroclorid, phai cha t 98,0 en 101,0% C13H21N3O. HCl, tnh theo che pham a lam kho.

Tnh chat

Bot ket tinh mau trang hay vang rat nhat, de hut am.

Rat tan trong nc, de tan trong ethanol 96%, kho tan trong aceton, thc te khong tan trong ether.

nh tnh

Co the chon mot trong hai nhom nh tnh sau:

Nhom I: C, D.

Nhom II: A, B, D, E.

A. iem chay: 166 en 170 0C (Phu luc 6.7).

B. Hoa tan 10,0 mg che pham trong dung dch natri hydroxyd 0,1 M (TT) va pha loang thanh 100,0 ml vi cung dung moi. Pha loang 10,0 ml dung dch nay thanh 100,0 ml bang dung dch natri hydroxyd 0,1 M. Pho hap thu t ngoai (Phu luc 4.1) cua dung dch nay t 220 en 350 nm cho mot cc ai hap thu bc song 273 nm. A (1%, 1 cm) bc song cc ai phai t 580 en 610.

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

D. Pha loang 1 ml dung dch S thanh 5 ml vi nc. Dung dch nay cho phan ng A cua ion clorid (Phu luc 8.1).

E. Pha loang 1 ml dung dch S thanh 2 ml bang nc. 1 ml dung dch nay cho phan ng cua amin thm bac nhat (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 25,0 ml vi cung dung moi.

Dung dch S phai trong (Phu luc 9.2) va co mau khong c am hn mau mau N6 (Phu luc 9.3, phng phap 2).

pH

Dung dch S phai co pH t 5,6 en 6,3 (Phu luc 6.2).

Tap chat lien quan

Khong c qua 0,5%.

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

Ban mong: Silica gel GF254 (TT).

Dung moi khai trien: Acid acetic bang - nc - butanol (15 : 30 : 60).

Dung dch th: Hoa tan 0,10 g che pham trong ethanol 96% (TT) va pha loang thanh 10 ml vi cung dung moi.

Dung dch oi chieu: Pha loang 1 ml dung dch th thanh 200 ml bang ethanol 96% (TT).

Cach tien hanh: Cham rieng biet len ban mong 5 ml moi dung dch tren. Trien khai sac ky en khi dung moi i c 12 cm. e kho ban mong trong luong khong kh lanh. Quan sat di anh sang t ngoai bc song 254 nm.

Tren sac ky o, bat ky vet phu nao cua dung dch th cung khong c am mau hn vet cua dung dch oi chieu.

Kim loai nang

Khong c qua 20 phan trieu (Phu luc 9.4.8).

Lay 1,0 g che pham va tien hanh 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

Hoa tan 0,250 g che pham trong 50 ml dung dch acid hydrocloric 2 M (TT), them 3 g kali bromid (TT), lam lanh trong nc a va chuan o cham bang dung dch natri nitrit 0,1 M (C). Xac nh iem ket thuc bang phng phap chuan o o ampe (Phu luc 10.1).

1 ml dung dch natri nitrit 0,1 M (C) tng ng vi 27,18 mg C13H21N3O. HCl.

Bao quan

ng trong o ng kn, tranh anh sang.

Loai thuoc

Chong loan nhp.

Che pham

Thuoc tiem, vien nen.