[Screening for the new formulation of 25% ascorbic acid injection and studies on its stability].
Two optimum new formulation of 25% ascobic Acid injection were selected by screening with the method of orthogomal design. To estimate the stability of these new formulations, samples were subjected to accelerated stability test at elevated temperatures. The rats of coloration and variation in the concentration of the new formulation under anaerobic degradation were studied. Experimental results indicate that the rule of coloration of ascorbic acid injection may be represented by the following regression equation T = T(o)-kt2 where To is the initial transmittance of the injection, T denotes the transmittance at time t, and k denotes the regression coefficient. The variation in the concentration of the two new formulations under amaerobic degradation was found to proceed in the pseudo-zero order reaction. The discoloration and content of ascorbic acid for two injections were predicted by accelerated stability test with the classical isothermal method and one-point method respectively. The discoloration shelf-life was about 39 months for R I and 36 months for R II, the content shelf-life about 40 months for R I and 38 months for R II respectively.
Guo
Y
Y
Department of Physical Chemistry, School of Pharmacy, Chengdu.
Chen
X
X
Zhao
Y
Y
Sun
J
J
D000818:Animals; D001205:Ascorbic Acid / Q000737:chemistry; D004304:Dosage Forms; D004355:Drug Stability; D007267:Injections; D051381:Rats
D004304:Dosage Forms; D001205:Ascorbic Acid