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%
19.531790877179015317898271788246178793817894080.08
29.641839279183709518381870.09
单位质量响应值RSD%判断
187765.79190683.301.10数据可信
供试品溶液-2024112422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%
5min1717801-71780134.14233.069.3434.1433.069.34
2565770-56577026.91126.91
3713414-71341433.93433.93
4746577-74657735.51135.51
5705053-70505333.53633.54
6721841-72184134.33534.33
10min11262711-126271160.06160.495.0660.1460.565.06
21147307-114730754.57254.63
31294214-129421461.56061.64
41322918-132291862.92563.00
51310912-131091262.35462.43
61292368-129236861.47261.55
15min11509482-150948271.79971.742.1372.0171.952.14
21446057-144605768.78268.96
31520220-152022072.31072.52
41537755-153775573.14473.36
51522494-152249472.41872.63
61513840-151384072.00672.22
20min11647575-164757578.36878.061.2378.7478.421.25
21605704-160570476.37676.71
31657440-165744078.83779.21
41660318-166031878.97479.35
51643882-164388278.19278.57
61631460-163146077.60177.97
30min11811201-181120186.15085.280.7586.6985.820.76
21777883-177788384.56685.07
31796834-179683485.46786.02
41803996-180399685.80886.36
51787805-178780585.03885.59
61779794-177979484.65785.20
45min11937893-193789392.17791.330.7492.9192.060.74
21910610-191061090.87991.57
31918480-191848091.25391.99
41936875-193687592.12892.88
51911918-191191890.94191.68
61904700-190470090.59891.33
60min12006597-200659795.44594.650.7296.3895.580.73
21972007-197200793.79994.69
31981546-198154694.25395.19
41996050-199605094.94395.90
52004148-200414895.32896.27
61979208-197920894.14295.08
极限12071302-207130298.52297.600.6999.6798.740.69
22048008-204800897.41498.52
32051358-205135897.57498.72
42060261-206026197.99799.16
52051601-205160197.58598.74
62029216-202921696.52097.66
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%
19.531793202179354217944411793519179128617931980.07
29.641843916184880118463580.19
单位质量响应值RSD%判断
188163.48191530.911.26数据可信
供试品溶液-2024112422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%
5min1534130-53413025.32327.6715.5825.3227.6715.59
2600932-60093228.49028.49
3676765-67676532.08632.09
4661466-66146631.36031.36
5429970-42997020.38520.38
6598202-59820228.36128.36
10min11260515-126051559.76160.415.3259.8260.475.33
21273250-127325060.36560.43
31345016-134501663.76863.84
41352569-135256964.12664.20
51171584-117158455.54555.59
61242166-124216658.89158.95
15min11554644-155464473.70673.562.6673.9073.762.68
21537765-153776572.90673.10
31589233-158923375.34675.56
41604510-160451076.07076.28
51490377-149037770.65970.83
61533177-153317772.68872.88
20min11687010-168701079.98279.432.0980.3379.792.10
21660471-166047178.72379.08
31702213-170221380.70281.08
41717361-171736181.42181.80
51619141-161914176.76477.09
61666309-166630979.00079.36
30min11918142-191814290.94088.472.2491.4789.002.24
21829449-182944986.73587.27
31874692-187469288.88089.44
41878284-187828489.05089.61
51804581-180458185.55686.05
61891020-189102089.65490.18
45min11980389-198038993.89193.141.7994.6293.871.80
21936423-193642391.80692.53
31975648-197564893.66694.42
42006999-200699995.15295.91
51910092-191009290.55891.24
61978188-197818893.78694.52
60min12040860-204086096.75895.691.6297.7096.631.63
21992283-199228394.45595.39
32038438-203843896.64397.61
42061535-206153597.73898.71
51982831-198283194.00794.89
61994447-199444794.55795.50
极限12091023-209102399.13697.861.64100.2999.011.64
22036868-203686896.56897.71
32077171-207717198.47999.66
42110180-2110180100.044101.23
52025033-202503396.00797.10
62044717-204471796.94198.09
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%
19.533626086362367236230213614910361134236198060.18
29.643687178368612336866500.03
单位质量响应值RSD%判断
379832.74382432.570.49数据可信
供试品溶液-2024112521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%
5min1956811-95681122.59419.607.9222.5919.607.92
2835506-83550619.73019.73
3769549-76954918.17218.17
4811640-81164019.16619.17
5801610-80161018.92918.93
6803948-80394818.98518.98
10min12119168-211916850.04251.237.8250.0951.277.81
22010737-201073747.48247.53
32356924-235692455.65755.70
42023984-202398447.79547.84
52404158-240415856.77256.81
62101481-210148149.62549.67
15min12746391-274639164.85467.373.2665.0167.533.26
22740337-274033764.71164.86
32937411-293741169.36469.53
42859198-285919867.51767.67
52959252-295925269.88070.05
62876256-287625667.92068.07
20min13083160-308316072.80674.151.3073.1174.451.30
23101770-310177073.24673.54
33146907-314690774.31174.63
43172257-317225774.91075.21
53189173-318917375.30975.63
63146006-314600674.29074.59
30min13485346-348534682.30382.870.8982.7783.340.88
23492549-349254982.47382.93
33471888-347188881.98682.47
43550328-355032883.83884.30
53517070-351707083.05283.54
63538193-353819383.55184.02
45min13693674-369367487.22387.390.7387.8788.050.73
23711205-371120587.63788.28
33669290-366929086.64787.31
43748096-374809688.50889.16
53697701-369770187.31887.99
63685116-368511687.02187.67
60min13821851-382185190.25090.610.9891.0991.460.97
23889548-388954891.84892.68
33806131-380613189.87890.74
43875903-387590391.52692.37
53831342-383134290.47491.34
63797472-379747289.67490.52
极限13975434-397543493.87693.901.3594.9294.961.34
23988842-398884294.19395.23
33917428-391742892.50793.56
44070609-407060996.12497.18
53973025-397302593.81994.89
63934068-393406892.89993.95
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%
19.533644974364175936395203638600363715036404010.09
29.643707942370872337083320.02
单位质量响应值RSD%判断
381993.81384681.740.50数据可信
供试品溶液-2024112521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%
5min1415871-4158719.76412.2132.819.7612.2132.81
2444978-44497810.44710.45
3823795-82379519.34119.34
4621523-62152314.59214.59
5387392-3873929.0959.10
6425978-42597810.00110.00
10min11852772-185277243.50044.346.7543.5244.366.76
21738133-173813340.80840.83
32075136-207513648.72148.76
41976228-197622846.39846.43
51917528-191752845.02045.04
61770435-177043541.56741.59
15min12683106-268310662.99561.185.2863.1161.305.28
22376754-237675455.80255.92
32668374-266837462.64962.80
42713295-271329563.70363.84
52697065-269706563.32263.44
62495668-249566858.59458.71
20min13055142-305514271.72969.403.9171.9969.663.92
22750712-275071264.58264.82
32991974-299197470.24670.54
43010094-301009470.67270.95
53035234-303523471.26271.52
62891388-289138867.88568.13
30min13367643-336764379.06677.112.1279.4877.522.13
23162916-316291674.26074.64
33302542-330254277.53877.98
43295469-329546977.37277.81
53319519-331951977.93778.36
63256948-325694876.46876.86
45min13666480-366648086.08384.471.1586.6885.061.16
23547530-354753083.29083.84
33590020-359002084.28784.91
43589193-358919384.26884.87
53619356-361935684.97685.57
63573409-357340983.89784.46
60min13754095-375409588.14086.590.9088.9287.370.90
23667209-366720986.10086.83
33680104-368010486.40387.21
43667356-366735686.10386.90
53677913-367791386.35187.13
63682339-368233986.45587.21
极限13895131-389513191.45189.251.2892.4390.221.28
23799445-379944589.20490.13
33796117-379611789.12690.12
43780159-378015988.75289.74
53784230-378423088.84789.82
63754287-375428788.14489.09
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