Abstract Objective: To evaluate the physical quality properties of sodium carboxymethyl cellulose from different sources. Methods: Based on the concept of the chemical fingerprint for quality control of traditional Chinese medicine products, the physical characterization parameters of sodium carboxymethyl cellulose were constructed by 11 indexes including bulk density, tapped density, particles < 50 μm, size distribution width, size distribution range, Hausner ratio, angle of repose, inter-particle porosity, Carr index, loss on drying, hygroscopicity, and evaluate it. Furthermore, compressibility parameters (i.e. index of parameter, index of parametric profile and index of good compression) were constructed to predict the compressibility characteristics of the excipients. Results: There were significant differences in the powder properties of sodium carboxymethyl cellulose from different sources or different batches of the same product and litter differences in compressibility. Conclusion: The established physical parameter characterization method of sodium carboxymethylcellulose is of great importance to evaluate the quality consistency of powder from different sources, and provides new ideas for the quality evaluation of excipients and the development and process control of oral solid preparations. |