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250
标示量(mg)40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%
19.531800257180085218007361800907179977818005060.03
29.641824547182525818249020.03
单位质量响应值RSD%判断
188930.33189305.190.15数据可信
供试品溶液-2024112321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%
5min1378048-37804817.99122.6521.0017.9922.6521.00
2503577-50357723.96523.96
3446552-44655221.25121.25
4362606-36260617.25617.26
5542049-54204925.79625.80
6622563-62256329.62729.63
10min11089929-108992951.86955.327.3151.9155.377.33
21232797-123279758.66858.72
31151351-115135154.79254.84
41036678-103667849.33549.37
51244146-124414659.20859.27
61219442-121944258.03358.10
15min11466433-146643369.78769.334.4969.9469.514.50
21496239-149623971.20571.39
31389016-138901666.10266.27
41363312-136331264.87965.03
51514974-151497472.09772.29
61511431-151143171.92872.12
20min11639290-163929078.01374.877.6578.3275.197.64
21640205-164020578.05678.40
31399710-139971066.61166.93
41438783-143878368.47168.76
51659056-165905678.95479.30
61661946-166194679.09179.45
30min11828395-182839587.01285.094.2887.5085.584.28
21839334-183933487.53388.05
31642058-164205878.14578.61
41764306-176430683.96284.41
51823699-182369986.78987.31
61829814-182981487.08087.61
45min11963049-196304993.42092.401.0294.1093.081.04
21937127-193712792.18792.90
31941915-194191592.41593.05
41905967-190596790.70491.33
51946350-194635092.62693.34
61954648-195464893.02193.74
60min12074469-207446998.72395.981.6499.6196.871.64
22006380-200638095.48396.40
32020379-202037996.14996.99
41972749-197274993.88294.71
52009510-200951095.63196.55
62017985-201798596.03596.97
极限12081768-208176899.07097.601.11100.1798.701.13
22057945-205794597.93699.06
32030957-203095796.65297.71
42018770-201877096.07297.11
52053997-205399797.74998.88
62062339-206233998.14699.29
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250
标示量(mg)40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%
19.531815188181522618142261813800181380418144490.04
29.641840111184033918402250.01
单位质量响应值RSD%判断
190393.39190894.710.19数据可信
供试品溶液-2024112321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%
5min1570945-57094526.95323.7823.4026.9523.7823.41
2362085-36208517.09317.09
3447823-44782321.14121.14
4646662-64666230.52830.53
5394376-39437618.61818.62
6600483-60048328.34828.35
10min11273487-127348760.11956.398.1960.1856.458.20
21107668-110766852.29152.33
31183714-118371455.88155.93
41296118-129611861.18861.26
51052707-105270749.69749.74
61253566-125356659.17959.24
15min11521941-152194171.84969.743.9672.0469.923.98
21447211-144721168.32168.47
31475983-147598369.67969.85
41537308-153730872.57472.78
51378059-137805965.05665.21
61503689-150368970.98771.18
20min11656308-165630878.19276.761.8878.5477.091.90
21616843-161684376.32976.63
31628372-162837276.87377.20
41650464-165046477.91678.28
51571350-157135074.18174.48
61632020-163202077.04577.40
30min11810722-181072285.48184.760.8986.0185.260.92
21798745-179874584.91685.39
31798976-179897684.92785.42
41809787-180978785.43785.98
51769005-176900583.51283.97
61784862-178486284.26184.78
45min11925259-192525990.88990.430.5991.6191.120.61
21922709-192270990.76891.43
31914196-191419690.36691.05
41926406-192640690.94391.67
51900175-190017589.70490.35
61903952-190395289.88390.59
60min11984506-198450693.68693.330.6494.6094.220.63
21993444-199344494.10794.97
31977761-197776193.36794.25
41980760-198076093.50994.44
51966423-196642392.83293.68
61958831-195883192.47393.38
极限12033998-203399896.02295.690.5997.1596.790.57
22037603-203760396.19297.27
32007226-200722694.75895.85
42023524-202352495.52796.67
52037738-203773896.19997.25
62021952-202195295.45396.57
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250
标示量(mg)40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%
19.531803342180308618031441804277180366318035020.03
29.641827994182623118271120.07
单位质量响应值RSD%判断
189244.70189534.440.11数据可信
供试品溶液-2024112421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%
5min1485914-48591423.09129.1518.7523.0929.1518.74
2660075-66007531.36831.37
3642654-64265430.54030.54
4763133-76313336.26536.26
5465380-46538022.11522.12
6663286-66328631.52031.52
10min11198477-119847756.95359.633.9057.0059.693.91
21287080-128708061.16361.23
31251002-125100259.44959.52
41323490-132349062.89462.97
51201621-120162157.10257.15
61267016-126701660.21060.28
15min11492344-149234470.91871.271.8571.1071.471.86
21528576-152857672.64072.85
31482657-148265770.45870.66
41533257-153325772.86273.08
51460897-146089769.42369.60
61501292-150129271.34371.55
20min11642434-164243478.05078.301.5578.3978.661.56
21692365-169236580.42380.79
31628214-162821477.37577.73
41658067-165806778.79379.18
51620688-162068877.01777.35
61644513-164451378.14978.51
30min11810070-181007086.01785.400.8086.5385.930.80
21809253-180925385.97886.52
31786592-178659284.90185.43
41810528-181052886.03886.60
51783257-178325784.74285.24
61782422-178242284.70385.24
45min11933866-193386691.89991.421.4292.6092.141.42
21912574-191257490.88891.62
31920947-192094791.28692.00
41972713-197271393.74694.49
51905471-190547190.55091.24
61896899-189689990.14390.87
60min12001916-200191695.13394.000.8496.0494.920.84
21984832-198483294.32195.26
31960330-196033093.15794.08
41988384-198838494.49095.45
51971239-197123993.67594.57
61961101-196110193.19494.12
极限12078529-207852998.77496.821.4099.8997.951.37
22034392-203439296.67797.82
32020218-202021896.00397.13
42028978-202897896.41997.59
52061718-206171897.97599.07
62000566-200056695.06996.20
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250
标示量(mg)40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%
19.531802832180281518039481803535180350618033270.03
29.641825035182455318247940.02
单位质量响应值RSD%判断
189226.34189293.980.03数据可信
供试品溶液-2024112421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%
5min1573903-57390327.29126.5915.7627.2926.5915.75
2497907-49790723.67723.68
3532326-53232625.31425.31
4532771-53277125.33525.34
5489701-48970123.28723.29
6728196-72819634.62834.63
10min11216540-121654057.85158.963.7757.9159.023.78
21201803-120180357.15057.20
31196265-119626556.88756.94
41270484-127048460.41660.47
51236976-123697658.82358.87
61317688-131768862.66162.74
15min11500219-150021971.34171.481.9471.5371.661.96
21477752-147775270.27270.45
31480433-148043370.40070.58
41512967-151296771.94772.14
51490756-149075670.89171.07
61556205-155620574.00374.22
20min11645739-164573978.26178.161.3178.6178.511.32
21622998-162299877.17977.52
31626782-162678277.35977.70
41654954-165495478.69979.05
51631116-163111677.56577.91
61679534-167953479.86880.25
30min11807079-180707985.93385.571.3286.4586.091.33
21787529-178752985.00385.51
31785286-178528684.89785.41
41814205-181420586.27286.80
51768321-176832184.09084.60
61834052-183405287.21687.77
45min11923727-192372791.48091.640.9592.1992.360.96
21914077-191407791.02191.72
31906238-190623890.64891.35
41945066-194506692.49593.21
51920587-192058791.33192.03
61953287-195328792.88693.64
60min11998578-199857895.04094.850.7795.9695.770.78
21985611-198561194.42395.32
31973826-197382693.86394.76
42011578-201157895.65896.58
51986793-198679394.47995.38
62011412-201141295.65096.61
极限12035949-203594996.81796.960.7697.9498.080.77
22027778-202777896.42897.54
32020290-202029096.07297.18
42055148-205514897.73098.86
52034867-203486796.76597.88
62059202-205920297.92299.09
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