PROCAIN HYDROCLORID

Procaini hydrochloridum

C13H20N2O2. HCl P.t.l: 272,8

Procain hydroclorid la 2-(diethylamino)ethyl-4-aminobenzoat hydroclorid, phai cha t 99,0 en 101,0% C13H20N2O2. HCl, tnh theo che pham a lam kho.

Tnh chat

Tinh the khong mau hay bot ket tinh trang.

Rat de tan trong nc, tan trong ethanol 96%, hi tan trong cloroform, thc te khong tan trong ether.

nh tnh

Co the chon mot trong hai nhom nh tnh sau:

Nhom I: A, C, D, E, F.

Nhom II: A, B, E.

A. iem chay: 154 en 158 oC (Phu luc 6.7).

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

C. Lay khoang 5 mg che pham, them 0,5 ml acid nitric boc khoi (TT), boc hi cho ti kho tren cach thuy. e nguoi roi hoa tan can trong 5 ml aceton (TT), them 1 ml dung dch kali hydroxyd 0,1 M trong ethanol (TT). Ch co mau o nau xuat hien.

D. Lay 0,2 ml dung dch S, them 2 ml nc, 0,5 ml dung dch acid sulfuric 1M (TT), lac va them 1 ml dung dch kali permanganat 0,1% (TT). Mau bien mat ngay.

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

F. Pha loang 1 ml dung dch S thanh 100 ml bang nc. 2 ml dung dch nay cho phan ng ac trng 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 50 ml bang cung dung moi.

Dung dch S phai trong (Phu luc 9.2) va khong mau (Phu luc 9.3, phng phap 2).

pH

Pha loang 4 ml dung dch S thanh 10 ml vi nc khong co carbon dioxyd (TT). pH cua dung dch nay t 5,0 - 6,5 (Phu luc 6.2).

Tap chat lien quan

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

Ban mong: Silica gel GF254 (TT).

Dung moi khai trien: Dibutyl ether - hexan - acid acetic bang (80 : 16 : 4).

Dung dch th: Hoa tan 1,0 g che pham trong nc va pha loang thanh 10 ml bang cung dung moi.

Dung dch oi chieu: Hoa tan 50 mg acid 4-aminobenzoic trong nc va pha loang thanh 100 ml bang cung dung moi. Pha loang 1 ml dung dch nay thanh 10 ml vi nc .

Cach tien hanh: Cham rieng re len ban mong 5 ml moi dung dch tren. Trien khai sac ky en khi dung moi i c 10 cm, lay ban mong ra va lam kho 105 oC trong 10 phut. Quan sat ban mong di anh sang t ngoai bc song 254 nm. Bat ky vet phu nao tren sac ky o thu c t dung dch th khong c am mau hn vet tren sac ky o thu c t dung dch oi chieu (0,05%). Vet chnh cua dung dch th nam tren ng xuat phat.

Kim loai nang

Khong c qua 5 phan trieu (Phu luc 9.4.8).

Hoa tan 1,0 g che pham trong nc va pha loang thanh 25,0 ml, loc. Lay 10 ml dch loc tien hanh theo phng phap 5. Dung 2 ml dung dch ch mau 1 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 0,400 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 27,28 mg C13H20N2O2. HCl.

Bao quan

Che pham c bao quan trong chai lo nut kn, tranh anh sang.

Tac dung

Gay te cuc bo