Uniformity study of chorionic gonadotropin for injection using near-infrared spectroscopy
Objective:To establish fast and robust uniformity models for chorionic gonadotropin injection(HCG injection)using near-infrared spectroscopy(NIRS),and to rapidly detect and screen HCG injection in different prescription processes.Methods:NIRS qualitative modes for HCG injection produced by manufacturer A were established using the integrating sphere diffuse reflection mode of nondestructive testing.Principal component analysis was used to reconstruct the spectral data for the studies of HCG injection and discriminate different processes.The distance of samples from different manufacturers was studied in the principal component space to evaluate the uniformity of processes.Results:The NIR consistency model of HCG injection produced by manufacturer A was established.The model could distinguish HCG injection produced by manufacturer A from those produced by other manufacturers with the prediction accuracy of 100％.The original samples were also identified correctly,in accordance with the results of principal component analysis model.Conclusion:NIR spectroscopy can be used for rapid screening of HCG injections in stable process,and the established uniformity model can be used for rapid identification of HCG injections from modeling manufacturers and products from other manufacturers,so as to achieve quality control and ensure drug safety.
near-infrared spectroscopyprincipal component analysischorionic gonadotropin for injectionvector normalization methodintegrating sphere diffuse reflectionuniformity test models
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