非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.651815023181226218115051813140181214318128150.08
29.711821281182176018215200.02
单位质量响应值RSD%判断
187856.48187592.170.10数据可信
供试品溶液-2024112621批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1383411-38341118.38230.6124.7118.3830.6124.72
2686157-68615732.89632.90
3504504-50450424.18724.19
4742286-74228635.58735.59
5767311-76731136.78736.79
6746902-74690235.80835.81
10min11107218-110721853.08359.638.4153.1259.708.43
21211581-121158158.08658.16
31146698-114669854.97655.03
41366202-136620265.49965.58
51302938-130293862.46662.55
61327650-132765063.65163.73
15min11453417-145341769.68172.603.9069.8472.803.92
21490684-149068471.46771.67
31459580-145958069.97670.15
41607357-160735777.06177.29
51522858-152285873.01073.23
61551349-155134974.37674.60
20min11619390-161939077.63879.943.1677.9580.303.16
21624071-162407177.86278.22
31692177-169217781.12781.46
41747673-174767383.78884.18
51625487-162548777.93078.31
61696224-169622481.32181.71
30min11789921-178992185.81486.262.2186.3086.802.22
21771759-177175984.94385.48
31773513-177351385.02785.54
41872120-187212089.75490.34
51771921-177192184.95185.51
61816147-181614787.07187.64
45min11896453-189645390.92191.212.1291.6091.942.13
21886176-188617690.42891.15
31876298-187629889.95590.66
41974746-197474694.67595.46
51862492-186249289.29390.04
61918982-191898292.00192.76
60min11944667-194466793.23393.712.3994.1194.642.40
21933695-193369592.70693.63
31934227-193422792.73293.63
42043729-204372997.98298.97
51910527-191052791.59692.54
61961277-196127794.02994.99
极限11972194-197219494.55294.632.2595.6495.772.26
21946398-194639893.31694.45
31949778-194977893.47894.58
42053249-205324998.43899.65
51930093-193009392.53493.68
61990844-199084495.44696.62
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.651812069181828618206311818279181724818173030.18
29.711801668182337418125210.85
单位质量响应值RSD%判断
188321.55186665.400.63数据可信
供试品溶液-b批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1857906-85790641.18234.7513.9241.1834.7613.92
2780160-78016037.45037.45
3553409-55340926.56526.57
4705807-70580733.88133.88
5734775-73477535.27135.27
6712013-71201334.17834.18
10min11338093-133809364.23260.883.6364.3260.963.63
21299448-129944862.37762.46
31211950-121195058.17758.24
41276935-127693561.29661.37
51237856-123785659.42059.50
61245411-124541159.78359.86
15min11532635-153263573.57073.012.5873.8073.222.57
21567631-156763175.25075.47
31552429-155242974.52174.71
41468962-146896270.51470.73
51523292-152329273.12273.33
61480626-148062671.07471.28
20min11644312-164431278.93179.582.7879.3379.952.77
21712106-171210682.18682.57
31703006-170300681.74982.10
41601515-160151576.87777.25
51672778-167277880.29880.67
61612687-161268777.41377.78
30min11780115-178011585.45086.383.2086.0286.933.19
21839695-183969588.31088.88
31868572-186857289.69690.23
41712054-171205482.18382.72
51831155-183115587.90088.45
61765353-176535384.74285.28
45min11865612-186561289.55491.493.5590.3292.233.53
21967973-196797394.46895.24
31984926-198492695.28296.02
41810696-181069686.91887.64
51934865-193486592.87993.63
61871136-187113689.81990.55
60min11892852-189285290.86294.043.6491.8294.983.62
22033266-203326697.60298.58
32032120-203212097.54798.49
41875248-187524890.01790.93
51999423-199942395.97896.93
61920852-192085292.20693.13
极限11904237-190423791.40894.924.4792.5796.074.44
22057934-205793498.78699.98
32074706-207470699.591100.75
41867651-186765189.65290.77
52032769-203276997.57898.74
61926922-192692292.49793.63
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.651829844183061718323431835321182872218313690.15
29.711811931180934818106400.11
单位质量响应值RSD%判断
189779.17186471.681.25数据可信
供试品溶液-2024112621批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1753385-75338536.04533.3622.9136.0533.3622.91
2416770-41677019.94019.94
3790365-79036537.81437.81
4808544-80854438.68438.68
5818034-81803439.13839.14
6596834-59683428.55528.55
10min11314940-131494062.91260.279.5862.9960.349.60
21061164-106116450.77050.81
31308161-130816162.58862.67
41362180-136218065.17265.26
51348969-134896964.54064.63
61162682-116268255.62755.69
15min11545031-154503173.92172.105.1474.1472.315.17
21380637-138063766.05566.21
31519970-151997072.72272.94
41568448-156844875.04175.27
51579116-157911675.55175.78
61448750-144875069.31469.50
20min11676564-167656480.21478.414.8680.6078.784.88
21526492-152649273.03473.34
31622781-162278177.64178.03
41713253-171325381.96982.37
51723443-172344382.45782.85
61571049-157104975.16575.51
30min11811546-181154686.67285.103.9087.2385.643.92
21677368-167736880.25280.72
31745640-174564083.51984.08
41825346-182534687.33287.91
51868563-186856389.40089.98
61743142-174314283.39983.91
45min11912662-191266291.51089.604.5992.2690.334.60
21775208-177520884.93385.58
31813936-181393686.78687.53
41920967-192096791.90792.68
52000504-200050495.71296.49
61812726-181272686.72887.42
60min11947881-194788193.19591.963.5294.1592.893.55
21842610-184261088.15888.99
31875865-187586589.74990.68
41950593-195059393.32494.30
52029872-202987297.11798.11
61885690-188569090.21991.11
极限11975528-197552894.51793.403.6895.6894.533.69
21888772-188877290.36791.40
31873234-187323489.62390.76
41990232-199023295.22196.41
52063780-206378098.74099.95
61921014-192101491.90993.00
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.651833695183924918384911835937183305818360860.16
29.711831519183823718348780.26
单位质量响应值RSD%判断
190267.98188967.870.49数据可信
供试品溶液-b批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1586223-58622327.82535.6616.9427.8235.6616.95
2836322-83632239.69639.70
3866700-86670041.13741.14
4591913-59191328.09528.09
5819972-81997238.91938.92
6806286-80628638.27038.27
10min11168752-116875255.47460.306.2855.5460.386.29
21295561-129556161.49361.58
31331914-133191463.21963.31
41169322-116932255.50155.56
51329062-132906263.08363.17
61328428-132842863.05363.14
15min11447071-144707168.68471.642.6968.8771.862.71
21524851-152485172.37672.60
31539900-153990073.09073.32
41474420-147442069.98270.17
51552767-155276773.70173.93
61517618-151761872.03372.26
20min11571332-157133274.58277.333.1374.9277.703.15
21637243-163724377.71178.10
31703338-170333880.84881.24
41570496-157049674.54374.88
51649023-164902378.27078.66
61644168-164416878.03978.42
30min11723366-172336681.79984.731.9482.3085.271.95
21793765-179376585.14085.70
31827421-182742186.73787.31
41798232-179823285.35285.86
51777203-177720384.35484.92
61790404-179040484.98085.54
45min12014632-201463295.62390.583.3296.3191.313.27
21837577-183757787.22087.97
31929298-192929891.57392.34
41920209-192020991.14291.84
51854770-185477088.03688.79
61893224-189322489.86190.61
60min11876481-187648189.06690.831.9089.9691.761.90
21886551-188655189.54490.49
31953482-195348292.72193.69
41900777-190077790.21991.12
51900204-190020490.19291.14
61963801-196380193.21194.16
极限11924949-192494991.36792.271.7892.4693.401.79
21922234-192223491.23892.38
32001614-200161495.00596.18
41909734-190973490.64491.74
51967948-196794893.40894.56
61937270-193727091.95193.11
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