Quality Evaluation and Discussion on the Current Quality Standard of Vitamin C Injection

OBJECTIVE To evaluate the quality of Vitamin C injection, and offer some suggestions on the current quality standards according to the exploratory results. METHODS On the basis of current quality standards, exploratory research methods were used to examine samples, analysis the results form the different methods. RESULTS The 309 batches of samples were tested under the current standard, with a pass rate of 100%. Exploratory research showed that 6 of 68 batches of samples’ related substances were more than 1.0%, 1 of 23 batches of samples’ content was below the limits determined by HPLC. The UV absorption and color of solution was positively correlated, but had no linear ralationship. All of the tested samples’ related substances were exceeded 1.0% when their colour were equal to NO.5 yellow standard colorimetric solution. One of the colored substances was probably assosiated by vitamin C and its degradation pruducts. Samples with thioglycolic acid as antioxidant had stronger cytotoxicity than samples with hydrochloride cysteine as antioxidants. CONCLUSION The quality of Vitamin C injection can basically meet the current standards, but the current standards need to be further improved by adding check items of related substances, improving limits of absorption value for color check, establishing a highly specific method for the determination of content.