SORBITOL

Sorbitolum

 

C6H14O6 P.t.l: 182,2

Sorbitol la Dglucitol (D-sorbitol), phai cha t 97,0 en 102,0% C6H14O6, tnh theo che pham khan.

Tnh chat

Bot ket tinh mau trang, hay gan nh trang, a hnh.

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

nh tnh

A. Hoa tan 0,5 g che pham trong hon hp gom 5 ml anhydrid acetic (TT) va 0,5 ml pyridin (TT) bang cach lam nong, e yen 10 phut. o hon hp tren vao 25 ml nc, e yen trong nc a 2 gi va loc. Lay tua, ket tinh lai trong mot lng nho ethanol 96% (TT) va say kho trong chan khong, iem chay cua tua thu c phai khoang 98 oC en 104 oC (Phu luc 6.7).

B. Phng phap sac ky lp mong (Phu luc 5.4).

Ban mong: Silica gel G (TT).

Dung moi khai trien: Propanol - ethyl acetat - nc (70 : 20 : 10).

Dung dch th: Hoa tan 25 mg che pham trong nc va pha loang thanh 10 ml vi cung dung moi.

Dung dch oi chieu (1): Hoa tan 25 mg sorbitol chuan (C) trong nc va pha loang thanh 10 ml vi cung dung moi.

Dung dch oi chieu (2): Hoa tan 25 mg manitol chuan (C), 25 mg sorbitol chuan (C) trong nc va pha loang thanh 10 ml vi cung dung moi.

Cach tien hanh: Cham rieng biet len ban mong 2 ml moi dung dch tren. Trien khai
sac ky en khi dung moi i c khoang 17 cm. Lay ban mong ra, e kho ngoai khong kh va phun dung dch acid 4 - aminobenzoic (TT). e kho ban mong trong luong khong kh lanh en khi aceton bay het. Say ban mong 100 C trong 15 phut. e nguoi va phun dung dch natri periodat 0,2%. e kho ban mong trong luong khong kh lanh. Say ban mong 100 C trong 15 phut.

Vet chnh tren sac ky o cua dung dch th phai co v tr, mau sac va kch thc
tng ng vi vet chnh tren sac ky o thu c cua dung dch oi chieu (1).

Phep th ch co gia tr khi sac ky o cua dung dch oi chieu (2) co 2 vet tach ro
rang rieng biet.

C. Hoa tan 5,00 g che pham va 6,4 g dinatri tetraborat (TT) trong 40 ml nc, e
yen 1 gi, thnh thoang lac, va pha loang thanh 50,0 ml bang nc. Loc neu
can. Goc quay cc rieng t +4,0 en +7,0o tnh theo che pham khan (Phu luc 6.4).

o trong va mau sac cua dung dch

Hoa tan 5,0 g che pham trong nc va pha loang thanh 50 ml vi cung dung moi.

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

o dan ien

Hoa tan 20,0 g che pham trong nc khong co carbon dioxyd (TT) va pha loang thanh 100,0 ml vi cung dung moi. o o dan ien cua dung dch o c khi khuay t nhe khong c qua 20 mS.cm-1 (Phu luc 6.10).

ng kh

Khong c qua 0,2% tnh theo glucose.

Hoa tan 5,0 g che pham trong 6 ml nc bang cach un nong nhe. e nguoi, them 20 ml dung dch ong - citrat (TT) va vai vien bi thuy tinh. un nong sao cho sau 4 phut th soi va un soi tiep 3 phut. Lam nguoi nhanh va them 100 ml dung dch acid acetic 2,4% (tt/tt) (TT) , 20,0 ml dung dch iod 0,05 N (C). Va lac va them 25 ml hon hp acid hydrocloric - nc (6 : 94). Khi tua tan het, chuan o iod tha bang dung dch natri thiosulfat 0,05 N (C) dung 1 ml dung dch ho tinh bot (TT) lam ch th, cho vao cuoi phep chuan o. The tch dung dch natri thiosulfat 0,05 N (C) tieu thu khong c t hn 12,8 ml.

Tap chat lien quan

Tien hanh phng phap sac ky long nh mo ta phan nh lng.

Tiem dung dch oi chieu (2). ieu chnh o nhay cua he thong sao cho chieu cao cua pic sorbitol phai t nhat la 50% cua thang o.

Tiem dung dch th, dung dch oi chieu (3) va tien hanh chay sac ky vi thi gian bang 2 lan thi gian lu cua sorbitol. Trong sac ky o cua dung dch th: dien tch cua bat ky pic phu nao, ngoai pic chnh, khong c ln hn dien tch pic chnh trong sac ky o cua dung dch oi chieu (2) (2%) va tong dien tch cua tat ca cac pic phu nay khong c qua 1,5 lan dien tch pic chnh trong sac ky o cua dung dch oi chieu (2) (3%). Bo qua cac pic co dien tch nho hn dien tch pic chnh cua dung dch oi chieu (3) (0,1%).

Ch

Khong c qua 0,5 phan trieu (Phu luc 9.4.4).

Nickel

Khong c qua 1 phan trieu (Phu luc 9.4.10).

Hoa tan che pham trong 150,0 ml hon hp dung moi quy nh.

Nc

Khong c qua 1,5% (Phu luc 10.3).

Dung 1,00 g che pham.

o nhiem khuan

Neu che pham d nh dung e san xuat thuoc tiem phai at yeu cau ve o nhiem khuan: so lng vi khuan hieu kh song lai c khong c qua 100 vi khuan, khong c qua 100 nam moc va men cho moi gam che pham, xac nh bang phng phap a thach (Phu luc 13.6). Che pham khong c co Escherichia coli va Salmonella (Phu luc 13.6).

Noi oc to vi khuan

Neu che pham d nh dung e san xuat thuoc tiem ma khong co phng phap khac thch hp e loai noi oc to vi khuan th phai cha t hn 4 IU/g oi vi thuoc tiem co nong o sorbitol thap hn 100 g/l va cha t hn 2,5 IU/g oi vi thuoc tiem co nong o sorbitol bang hoac cao hn 100 g/l (Phu luc 13.2)

nh lng

Tien hanh bang phng phap sac ky long (Phu luc 5.3)

Pha ong: Nc dung cho sac ky long, a loai bot kh.

Dung dch th: Hoa tan 5,0 g che pham trong 20 ml nc va pha loang thanh 100,0 ml vi cung dung moi.

Dung dch oi chieu (1): Hoa tan 0,50 g sorbitol chuan (C) trong 2 ml nc va pha loang thanh 10,0 ml vi cung dung moi.

Dung dch oi chieu (2): Pha loang 2,0 ml dung dch th va thanh 100,0 ml bang nc.

Dung dch oi chieu (3): Pha loang 5,0 ml dung dch oi chieu (2) va thanh 100,0 ml bang nc.

Dung dch phan giai: Hoa tan 0,5 g sorbitol (TT) va 0,5 g manitol (TT) trong 5 ml nc va pha loang thanh 10,0 ml vi cung dung moi.

ieu kien sac ky:

Cot thep khong g (0,3 m x 7,8 mm) c nhoi nha trao oi cation manh (dang calci) (TT) (9 mm) va gi nhiet o 85 1 oC.

Pha ong: Nc a loai bot kh.

Toc o dong: 0,5 ml/phut.

Detector khuc xa ke c gi nhiet o khong oi.

The tch tiem: 20 ml

Cach tien hanh:

Tiem dung dch phan giai va tien hanh chay sac ky vi thi gian bang 3 lan thi gian lu cua sorbitol.

Sac ky o c ghi trong ieu kien a neu tren th thi gian lu cua sorbitol khoang 27 phut va thi gian lu tng oi so vi sorbitol la: maltitol khoang 0,6, manitol khoang 0,8 va iditol khoang 1,1. Phep th ch co gia tr khi o phan giai gia pic cua sorbitol va pic manitol t nhat la 2 trong sac ky o cua dung dch phan giai.

Tiem dung dch th va dung dch oi chieu (1). Tien hanh chay sac ky vi thi gian bang 2 lan thi gian lu cua sorbitol.

Tnh ham lng % cua D-sorbitol t dien tch cac pic va ham lng cua sorbitol chuan.

Bao quan

Trong o ng kn.

Nhan phai ghi nong o toi a cua noi oc to vi khuan va co thch hp e pha thuoc tiem khong.