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Production and Evaluation of the stability of Tetrathiomolibdate Capsules (Non GMP study)

Production and Evaluation of the stability of Tetrathiomolibdate Capsules (Non GMP study)
四硫钼酸盐胶囊的生产及稳定性评价(非GMP研究)
批准号:
9568967
负责人:
ROBERT GIANNINI
金额:
$1.75万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2017
资助国家:
美国
项目状态:
已结题
起止时间:
2017-06-19 至 2018-06-18

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中文摘要
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英文摘要
To determine the effect of Argon gas on the stability and shelf life of Tetrathiomolibdate capsules the following experimental design is suggested: 1. Buy two 50 gram bottles of Tetrathiomolibdate from Sigma/Aldrich. 2. Using one bottle produce 150 mg strength capsules and place 25 capsule in suitable size bottle along with cotton coil and seal them with induction seal and label them as “control group.” 3. Using the other bottle under argon gas purge and produce 150 mg strength capsules and place 25 capsules in suitable size bottles along with cotton coil and the purge the bottles with argon gas long enough to deplete as much oxygen as possible from the bottle and seal them with induction sealer and label them as “test group.” 4. Free capsules will be used for the initial assay (only assay) using the published spectrophotometric method. 5. Place two bottles of each group in the -20oC, 2-8oC, and Controlled Room Temperature and assay two bottles each group separately (four assay results) at 3 months and 6 months’ time point.
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