The pharmaceutical evaluation of different products of water-soluable vitamin for injection

Key words: 
• water-soluable vitamin /
• injection /
• pharmaceutical evaluation

Abstract: Objective :To evaluate the quality of three different products of water-soluable vitamin for injection(prouducted by AV, BV and CV respectively)and to make a reference for clinical application. Methods : several indicators were compared, such as the physical and chemical properties of the products, the pH, the solubility, the difference at the load capacity, the insoluble particles, the transparency clarity , the content and the toxin produced by certain bacteria according to the quality standards of the same kind prouducts at home and abroad Results :The color of sample varies from light yellow to brown yellow,even the color is diffent at spot.The pH values were between 5.6 -6.1.The powder and injection preparation dissolved in five minutes.The results of the tests of the transparency clarity, the difference at the load capacity and the toxin produced were complied with the Chinese Pharmacopoeia about the request of the injection.The amount of sub-visible particles whose size was larger than 10 or 25μm were accordence with the Chinese Pharmacopoeia.But The amount of sub-visible particles were different among products made in different manufacturers.For the content of vitamin or preservative,just three batches which made in AV were accordence with the standard of MOH among batches .Individual batch numbers that prouducted by the others could not meet the standard requests of the Ministry of Heal. Conclusion : On the whole,the quality is not too bad,but the quality of product made by different manufacturers has some difference.