Micro-source detection official website - drug quality research, impurity research, structural confirmation, biological drug analysis, methodological development and verification
As a chemical raw material, chloroacetic acid is widely used in pesticides, pharmaceuticals and chemical products, and is an anionic starch ether, non-toxic and odorless. It is a product that is easier to use than CMC, and can be widely used in thickening, stability, oil resistance, ink absorption, water resistance, filter aid and other aspects. Because its process, the carboxymethylating agent uses chloroacetic acid, so the chloroacetic acid content in it also needs to be determined.
The 2020 edition of the Pharmacopoeia adds the determination of the content of chloroacetic acid in sodium carboxyl starch as follows:
Micro-source detection verifies the specificity, accuracy, precision, detection limit, quantitative limit, linearity, range and durability of the method according to the methods provided by the current pharmacopeia.
Test Results:
Micro-source detection makes corresponding judgments on the verification results: the recovery rate of the sample standard-labeled solution is between 80 and 115%, the detection limit signal-to-noise ratio is greater than 3.0, the linear correlation coefficient r is greater than 0.99, the quantitative limit signal-to-noise ratio is greater than 10.0, the peak area RSD in the 6-pin quantitative limit solution is less than 20%, the repeatable RSD is less than 10%, the accuracy recovery rate is 80~115%, the peak area change rate of solution stability is less than 20%, and the durability test result change rate is less than 20%. Meet the requirements of the 9101 Guiding Principles.