Quality of medicinal maltose as a excipient in the production of blood products: a comparative study

Objective To comprehensively compare the quality and filtration efficiency of medicinal maltose between two domestic manufacturers(B, C) and one foreign manufacturer(A), compare their product quality as an excipient for intravenous immunoglobulin(IVIG), so as to determine the feasibility and substitutability of maltose as an excipient for IVIG from different manufacturers. Methods Quality inspection and comparison of maltose from different manufacturers, small-scale filtration tests, and product quality comparision of IVIG(pH4) were conducted. Results The comparis on results showed that there was no significant difference in the quality of medicinal maltose between manufacturer B and A, and there was no significant difference in the quality of IVIG (pH4) produced. The quality of manufacturer C did not meet the requirements. Conclusion There is no significant difference in the quality of medicinal maltose produced by manufacturer B and A, which can be used for the production of IVIG (pH4).