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101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
110.552044743204625520472752043697204366920451280.08
210.722098377209968620990320.05
单位质量响应值RSD%判断
193851.00195805.220.71数据可信
供试品溶液-250603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%
5min1637821-63782129.43531.218.8129.4431.218.80
2637698-63769829.42929.43
3651520-65152030.06730.07
4769845-76984535.52835.53
5732193-73219333.79033.79
6628741-62874129.01629.02
10min11176263-117626354.28455.592.6854.3555.662.69
21187371-118737154.79754.86
31209303-120930355.80955.88
41266595-126659558.45358.53
51191617-119161754.99355.07
61196093-119609355.19955.26
15min11428080-142808065.90567.151.4366.0967.341.44
21449183-144918366.87967.07
31463602-146360267.54567.74
41490180-149018068.77168.98
51452165-145216567.01767.21
61447164-144716466.78666.97
20min11563364-156336472.14973.741.4272.4874.081.43
21597086-159708673.70574.04
31605684-160568474.10274.44
41633539-163353975.38775.75
51594429-159442973.58273.93
61593047-159304773.51873.85
30min11735128-173512880.07580.901.1380.5781.411.13
21739551-173955180.27980.78
31760562-176056281.24981.75
41787891-178789182.51083.04
51754749-175474980.98181.49
61740511-174051180.32480.82
45min11848655-184865585.31586.811.2385.9987.501.23
21872958-187295886.43687.11
31899249-189924987.64988.34
41912356-191235688.25488.97
51866902-186690286.15786.85
61886283-188628387.05187.73
60min11906777-190677787.99789.631.1288.8690.511.12
21939593-193959389.51190.38
31962041-196204190.54791.43
41967504-196750490.79991.71
51941579-194157989.60390.48
61935544-193554489.32490.20
极限11957573-195757390.34191.891.1991.4092.971.20
21976410-197641091.21092.28
32011359-201135992.82393.91
42022026-202202693.31694.43
51996079-199607992.11893.20
61982881-198288191.50992.58
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101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
110.552038041203854020357212033948203247620357450.13
210.722107345210411321057290.11
单位质量响应值RSD%判断
192961.61196429.941.26数据可信
供试品溶液-250603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%
5min1610347-61034728.18831.1714.4428.1931.1714.44
2773785-77378535.73635.74
3690834-69083431.90531.91
4513464-51346423.71423.71
5707639-70763932.68132.68
6753125-75312534.78234.78
10min11174026-117402654.22157.143.8154.2857.213.82
21260612-126061258.21958.30
31238189-123818957.18457.25
41188979-118897954.91154.96
51268019-126801958.56158.63
61294184-129418459.77059.85
15min11446403-144640366.80068.491.8966.9868.681.90
21497968-149796869.18169.39
31462219-146221967.53067.73
41468478-146847867.81967.99
51505751-150575169.54169.74
61517244-151724470.07170.28
20min11591164-159116473.48574.781.6873.8275.131.68
21633078-163307875.42175.78
31586523-158652373.27173.62
41612973-161297374.49374.82
51637091-163709175.60675.96
61654730-165473076.42176.79
30min11747779-174777980.71882.051.3581.2182.561.36
21782440-178244082.31982.85
31752010-175201080.91481.42
41776933-177693382.06582.56
51787975-178797582.57583.10
61811957-181195783.68284.22
45min11873513-187351386.52587.591.1687.2088.291.16
21894516-189451687.49588.21
31870032-187003286.36487.06
41906141-190614188.03288.71
51908577-190857788.14588.85
61926616-192661688.97889.70
60min11931802-193180289.21790.781.2890.0891.671.28
21972148-197214891.08191.99
31941548-194154889.66790.55
41974186-197418691.17592.04
51973666-197366691.15192.06
62000542-200054292.39293.31
极限11983259-198325991.59492.951.3492.6694.051.34
22018988-201898893.24494.35
31980712-198071291.47692.56
42011270-201127092.88793.96
52035708-203570894.01695.12
62046342-204634294.50795.63
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101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
110.554169678416648741639394165434416083641652750.08
210.724261069426421742626430.06
单位质量响应值RSD%判断
394812.80397634.610.51数据可信
供试品溶液-250603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%
5min11057307-105730723.99227.6510.1223.9927.6510.12
21118622-111862225.38425.38
31269384-126938428.80528.80
41402518-140251831.82631.83
51271092-127109228.84428.84
61191744-119174427.04327.04
10min12236797-223679750.75751.323.4150.8151.383.41
22151100-215110048.81348.87
32272910-227291051.57751.64
42365053-236505353.66853.74
52324942-232494252.75852.82
62217373-221737350.31750.38
15min12794819-279481963.42063.670.8363.5963.850.84
22780984-278098463.10663.27
32814353-281435363.86364.04
42844912-284491264.55764.75
52812176-281217663.81464.00
62788557-278855763.27863.45
20min13044325-304432569.08269.780.7269.3970.090.73
23059358-305935869.42369.73
33098680-309868070.31570.64
43096856-309685670.27470.61
53085203-308520370.00970.33
63064977-306497769.55169.86
30min13371153-337115376.49876.620.3876.9677.090.37
23366315-336631576.38876.85
33374040-337404076.56477.04
43370261-337026176.47876.97
53375934-337593476.60777.09
63401419-340141977.18577.65
45min13610141-361014181.92182.150.3382.5582.790.32
23631530-363153082.40783.04
33617310-361731082.08482.73
43606340-360634081.83582.49
53619281-361928182.12982.78
63636006-363600682.50883.15
60min13760855-376085585.34185.290.5286.1586.110.52
23729338-372933884.62685.44
33788664-378866485.97286.80
43756736-375673685.24886.09
53763478-376347885.40186.23
63751323-375132385.12585.95
极限13833364-383336486.98787.400.4387.9988.420.42
23856022-385602287.50188.50
33839384-383938487.12388.14
43843545-384354587.21888.25
53877402-387740287.98689.01
63860760-386076087.60888.62
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101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
110.554261078427404942702914269201426736342683960.12
210.724278998427712642780620.04
单位质量响应值RSD%判断
404587.30399072.950.98数据可信
供试品溶液-250603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%
5min11125912-112591225.19426.3510.9925.1926.3511.00
21021711-102171122.86222.86
31054446-105444623.59423.59
41306983-130698329.24529.25
51230084-123008427.52527.52
61326121-132612129.67429.67
10min12352590-235259052.64251.994.5752.7052.054.58
22230925-223092549.92049.97
32173268-217326848.62948.68
42469100-246910055.24955.31
52336243-233624352.27652.34
62378392-237839253.21953.29
15min12844030-284403063.63963.411.1563.8163.591.16
22803956-280395662.74262.90
32790309-279030962.43662.60
42880647-288064764.45864.65
52839780-283978063.54363.72
62844694-284469463.65363.84
20min13104879-310487969.47569.360.4369.7969.680.44
23095713-309571369.27069.57
33095921-309592169.27569.57
43121895-312189569.85670.19
53098768-309876869.33969.66
63082204-308220468.96869.29
30min13411877-341187776.34575.900.3776.8176.370.36
23399171-339917176.06076.52
33382033-338203375.67776.13
43381599-338159975.66776.15
53396082-339608275.99176.46
63382453-338245375.68676.17
45min13657218-365721881.83581.550.6382.4782.190.61
23675345-367534582.24082.86
33658674-365867481.86782.49
43623396-362339681.07881.73
53636835-363683581.37882.02
63616082-361608280.91481.56
60min13778258-377825884.54384.350.5385.3685.170.53
23790890-379089084.82685.63
33732279-373227983.51484.32
43771528-377152884.39285.23
53770452-377045284.36885.19
63773822-377382284.44485.27
极限13894439-389443987.14387.010.7388.1588.020.71
23905819-390581987.39788.39
33900307-390030787.27488.26
43916065-391606587.62788.65
53877683-387768386.76887.78
63837634-383763485.87286.89
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