Salmon calcitonin nasal spray Stability.doc

 PAGE \* MERGEFORMAT 12 Salmon calcitonin nasal spray Stability [Abstract] Objective To study the salmon calcitonin nasal spray stability, the validity period for the development of reasonable, provide the basis for storage conditions. Methods HPLC, were determined in the light, high temperature, high humidity conditions for 5 d and 10 d, at 25 under the conditions of accelerated testing for 6 months, in (5 + -3) under the conditions placed on three months of salmon calcitonin nasal spray in the content, the content material, etc. . Results salmon calcitonin nasal spray at 40 , 25 and high light conditions, and its related substances are changed significantly in the (5 + -3) and high humidity will not change significantly, The pH of the storage conditions, the amount of such value and appearance of the equipment was no significant change. Conclusion salmon calcitonin in the tentative 24-month validity period, the appropriate storage conditions for the low temperature (2 ~ 8 ), dark storage. [Keywords:] salmon calcitonin; nasal spray; stability; related substances Abstract: Objective To investigate the stability of salmon calcitonin nasal spray to establish the useful life and storage conditions.Method HPLC was used to determine the salmon calcium nasal’s content and related substances, which were placed five days and ten days under the conditions of high temperature , high humidity and strong light respectively, half a year under the condition of 25 , three months under the condition of (5 + -3) . Result The contents of salmon calcium in nasal spray declined under the 40 , 25 , strong light condition and related substances increased obviously. While there were no obvious changes in relevant substances under the conditions of (5 + -3) and high humidity, and in the pH, appearances and capacities under all tested conditions.Conclusion The useful life of the salmon calcium nasal spray is tentatively set for two years and the storage should be at low t