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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
110.153890552389457238867193887218389114038900400.09
210.193963142396780539654740.09
单位质量响应值RSD%判断
383255.17389153.481.08数据可信
供试品溶液-2024091313批-shui(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1892706-89270620.80524.4625.3420.8024.4625.34
21085995-108599525.30925.31
31125909-112590926.23926.24
4601558-60155814.01914.02
51292389-129238930.11930.12
61298753-129875330.26830.27
10min12070967-207096748.26453.5915.9348.3153.6415.94
22413816-241381656.25456.31
32498435-249843558.22658.28
41663953-166395338.77938.81
52647506-264750661.70061.77
62501634-250163458.30158.37
15min12911249-291124967.84770.717.9768.0070.887.99
23090043-309004372.01472.19
33194427-319442774.44674.63
42600138-260013860.59660.71
53233024-323302475.34675.55
63174928-317492873.99274.19
20min13195336-319533674.46876.764.0974.7777.104.13
23291919-329191976.71877.06
33393474-339347479.08579.44
43078063-307806371.73571.99
53422601-342260179.76480.14
63382081-338208178.82079.18
30min13505022-350502281.68582.841.7282.1583.341.78
23567506-356750683.14183.65
33601617-360161783.93684.46
43456777-345677780.56080.97
53613656-361365684.21784.77
63582226-358222683.48484.02
45min13612144-361214484.18185.351.7584.8386.031.80
23639361-363936184.81685.51
33729513-372951386.91787.63
43573167-357316783.27383.86
53725090-372509086.81487.55
63693688-369368886.08286.80
60min13747644-374764487.33988.051.5688.1888.921.61
23749398-374939887.38088.27
33842088-384208889.54090.45
43692230-369223086.04886.82
53838842-383884289.46590.39
63797713-379771388.50689.42
极限13835033-383503389.37690.081.4190.4191.161.45
23841982-384198289.53890.62
33933367-393336791.66792.77
43787232-378723288.26289.23
53911846-391184691.16692.29
63883071-388307190.49591.61
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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
110.153885741389395338925713893950390010138932630.14
210.193963439397377839686080.19
单位质量响应值RSD%判断
383572.71389461.041.08数据可信
供试品溶液-2024091313批-shui(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1451401-45140110.51124.4431.2810.5124.4431.28
21121262-112126226.11026.11
31290132-129013230.04230.04
41080289-108028925.15625.16
5970973-97097322.61022.61
61382244-138224432.18732.19
10min11352805-135280531.50252.0721.7131.5352.1221.72
22419548-241954856.34256.40
32589315-258931560.29560.36
42321777-232177754.06554.12
52051379-205137947.76947.82
62680552-268055262.42062.49
15min12110130-211013049.13766.4213.6249.2366.5913.65
23038992-303899270.76770.95
33106279-310627972.33472.53
42978533-297853369.35969.53
52749849-274984964.03464.19
63130905-313090572.90773.12
20min12782548-278254864.79575.047.1065.0075.367.15
23335985-333598577.68378.02
33319332-331933277.29577.66
43308945-330894577.05377.38
53176178-317617873.96174.26
63411404-341140479.43979.81
30min13493217-349321781.34482.831.6881.6983.311.74
23582532-358253283.42483.94
33553758-355375882.75483.29
43593889-359388983.68884.19
53482711-348271181.09981.56
63635503-363550384.65785.21
45min13825487-382548789.08187.802.4189.6188.472.40
23714932-371493286.50787.21
33716269-371626986.53887.26
43745811-374581187.22687.91
53691011-369101185.95086.59
63929458-392945891.50292.24
60min13970672-397067292.46290.372.0893.1991.232.05
23854843-385484389.76590.66
33832337-383233789.24190.15
43873709-387370990.20491.09
53773493-377349387.87088.70
63979805-397980592.67593.61
极限14054816-405481694.42192.161.7695.3593.221.73
23938175-393817591.70592.80
33929782-392978291.51092.62
43943325-394332591.82592.91
53859587-385958789.87590.90
64019278-401927893.59494.74
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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
110.151959257196261819539261959561195471419580150.19
210.191993887199344519936660.02
单位质量响应值RSD%判断
192907.88195649.261.00数据可信
供试品溶液-2024092211批-shui(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1364491-36449116.88616.4645.9316.8916.4645.95
2496058-49605822.98122.98
3142130-1421306.5856.58
4492904-49290422.83522.84
5469861-46986121.76821.77
6166268-1662687.7037.70
10min1999933-99993346.32449.3229.8546.3649.3629.86
21371010-137101063.51663.57
3674889-67488931.26631.28
41342220-134222062.18262.23
51291229-129122959.81959.87
6708937-70893732.84332.86
15min11401464-140146464.92668.9215.1965.0769.0715.23
21686553-168655378.13478.33
31212730-121273056.18356.27
41680386-168038677.84878.04
51690424-169042478.31378.49
61254430-125443058.11558.20
20min11732211-173221180.24980.405.1780.5380.705.24
21805987-180598783.66784.03
31609324-160932474.55674.76
41802522-180252283.50683.87
51817096-181709684.18284.54
61645247-164524776.22076.44
30min11891339-189133987.62188.171.3288.0888.651.40
21920950-192095088.99389.54
31867029-186702986.49586.87
41917714-191771488.84389.39
51934065-193406589.60090.14
61888181-188818187.47587.86
45min11981756-198175691.81092.320.6692.4792.990.72
21996655-199665592.50093.25
31979796-197979691.71992.29
41995044-199504492.42593.17
52015308-201530893.36494.11
61987803-198780392.09092.67
60min12034321-203432194.24594.240.5695.1195.120.60
22035466-203546694.29895.25
32027427-202742793.92694.70
42025341-202534193.82994.78
52055468-205546895.22596.17
62026905-202690593.90294.69
极限12051508-205150895.04195.260.5696.1196.350.59
22055790-205579095.24096.40
32047640-204764094.86295.84
42048731-204873194.91396.07
52078337-207833796.28497.44
62055555-205555595.22996.23
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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
110.151975514197733919717171975659197541919751300.11
210.191990318199009819902080.01
单位质量响应值RSD%判断
194594.09195309.910.26数据可信
供试品溶液-2024092211批-shui(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1413417-41341719.08618.9436.0819.0918.9436.08
2563964-56396426.03626.04
3205535-2055359.4899.49
4256868-25686811.85811.86
5499252-49925223.04823.05
6522046-52204624.10024.10
10min11255705-125570557.97051.9726.2158.0152.0226.22
21356156-135615662.60762.67
3670432-67043230.95130.97
4836425-83642538.61438.64
51309959-130995960.47560.53
61326319-132631961.23061.28
15min11661268-166126876.69371.6814.5576.8671.8314.58
21707300-170730078.81879.02
31366211-136621163.07263.16
41178078-117807854.38654.50
51707337-170733778.82079.01
61695279-169527978.26378.45
20min11771572-177157281.78580.526.2882.1380.836.33
21830895-183089584.52484.90
31674722-167472277.31477.54
41554033-155403371.74371.98
51809705-180970583.54683.91
61823456-182345684.18184.54
30min11887008-188700887.11487.472.4587.6487.962.52
21942777-194277789.68990.25
31850799-185079985.44385.84
41833797-183379784.65885.05
51908083-190808388.08788.63
61945542-194554289.81790.37
45min11958221-195822190.40291.311.8891.1292.001.94
22016524-201652493.09493.85
31942798-194279889.69090.28
41942379-194237989.67190.25
51979667-197966791.39292.13
62028074-202807493.62794.38
60min11993009-199300992.00892.971.7092.9393.861.76
22052585-205258594.75895.72
31981736-198173691.48892.28
41986804-198680491.72292.50
52008665-200866592.73193.68
62059711-205971195.08796.05
极限12077652-207765295.91693.831.6797.0494.921.69
22024626-202462693.46894.64
32008174-200817492.70893.70
42003161-200316192.47793.46
52072143-207214395.66196.81
62008585-200858592.72793.90
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