Résumé
OBJECTIVE: To evaluate the uncertainty of pH measurement in pharmaceuticals. METHODS: Taking glucose and sodium chloride injection as an example, the uncertainty of pH measurement in pharmaceuticals was evaluate by uncertainty transmission rule's method (GUM) and Monte Carlo method (MCM), and the uncertainties obtained by the two methods were compared. RESULTS: The measurement uncertainty obtained by GUM almost agreed with that by MCM. CONCLUSION: MCM is easy and reliable, and can be used as an alternative method for evaluation of the measurement uncertainty in pharmaceutical analysis.
Résumé
The main significant change of the Chinese Pharmacopoeia (Ch. P) 2015 edition is the development of volume IV for the first time based on integrating the appendices of the Ch. P volume I (traditional Chinese drug), II (chemical drugs) and III (biologics), including the general requirements for preparations, testing methods, guidelines as well as the excipients standards. The Ch. P 2015 volume IV, as the general requirements, is the most important part of Ch. P. The Ch. P 2015 volume IV has made a great progress in improving testing methods, application of advanced analysis technology, strengthening process quality control, improving the control system for excipients as well as establishing the excipients monographs. It will play an important role in improving the overall standards of Ch. P, strengthening the drug quality control and assuring the drug quality.