阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.561059971062901066611058141060381061600.31
210.531060571062921061740.16
单位质量响应值RSD%判断
10053.0310083.000.22数据可信
加速3月-供试品溶液-2023111721批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min141248-4124836.76241.309.7036.7641.309.70
242225-4222537.63337.63
351981-5198146.32846.33
445999-4599940.99641.00
551330-5133045.74745.75
645264-4526440.34140.34
10min179622-7962270.96271.214.4371.1771.444.43
275932-7593267.67467.88
385191-8519175.92676.18
476330-7633068.02868.26
579975-7997571.27771.53
682325-8232573.37173.60
15min194611-9461184.32181.184.9984.9281.804.98
289489-8948979.75680.34
396337-9633785.85986.54
483712-8371274.60775.21
592920-9292082.81483.46
689431-8943179.70480.34
20min198198-9819887.51887.733.9388.5888.803.93
295232-9523284.87585.90
3102758-10275891.58292.74
496160-9616085.70286.72
5103576-10357692.31193.42
694676-9467684.37985.45
30min1105834-10583494.32494.030.9995.8895.591.03
2104679-10467993.29494.79
3107372-10737295.69497.36
4104875-10487593.46994.97
5105587-10558794.10395.73
6104672-10467293.28894.83
45min1111090-11109099.00893.523.87101.0995.603.80
2100761-10076189.80291.82
3103812-10381292.52194.72
4105998-10599894.47096.49
5107316-10731695.64497.79
6100595-10059589.65491.72
60min1107266-10726695.60093.622.6598.2396.232.62
299874-9987489.01291.53
3106503-10650394.92097.63
4106907-10690795.28097.82
5105621-10562194.13496.81
6104097-10409792.77595.34
极限1108177-10817796.41294.152.9499.5797.282.89
2104969-10496993.55396.56
3107534-10753495.83999.08
4107232-10723295.56998.64
5106196-10619694.64697.85
699741-9974188.89391.97
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.561050571059191061561062731057211058250.46
210.531057471059371058420.13
单位质量响应值RSD%判断
10021.3110051.470.22数据可信
加速3月-供试品溶液-2023111821批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min154947-5494749.12544.4421.7149.1344.4421.71
249220-4922044.00544.01
365445-6544558.51158.51
452868-5286847.26747.27
540677-4067736.36736.37
635048-3504831.33531.33
10min188887-8888779.46972.3316.9279.7472.5816.93
283424-8342474.58574.83
397722-9772287.36887.69
486579-8657977.40677.67
562627-6262755.99256.19
666171-6617159.16059.33
15min197870-9787087.50182.639.1288.2183.289.19
294324-9432484.33084.99
399884-9988489.30190.11
498454-9845488.02388.72
579485-7948571.06371.58
684526-8452675.57076.07
20min1104816-10481693.71190.687.0994.9191.787.17
2102080-10208091.26492.39
3110596-11059698.878100.18
4104493-10449393.42294.60
590118-9011880.57081.48
696446-9644686.22787.15
30min1107733-10773396.31996.571.9498.0498.182.06
2108606-10860697.09998.73
3108941-10894197.39999.25
4111224-11122499.440101.14
5106133-10613394.88896.24
6105430-10543094.26095.66
45min1111737-11173799.89898.451.44102.15100.601.57
2110959-11095999.203101.38
3110858-11085899.112101.51
4110438-11043898.737100.99
5109470-10947097.87299.75
6107270-10727095.90597.83
60min1108731-10873197.21194.352.19100.0297.042.15
2107965-10796596.52699.25
3103925-10392592.91495.86
4103080-10308092.15994.96
5104236-10423693.19295.62
6105249-10524994.09896.56
极限1105313-10531394.15594.701.9897.5197.921.85
2107593-10759396.19399.45
3102343-10234391.50094.96
4108305-10830596.830100.14
5105739-10573994.53697.48
6106276-10627695.01698.00
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数5000
标示量(mg)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.561057301051831060961065891060781059350.50
210.531054811048651051730.42
单位质量响应值RSD%判断
10031.729987.940.31数据可信
加速3月-供试品溶液-2023111921批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min151352-5135246.03337.3518.2546.0337.3518.25
239507-3950735.41535.41
331098-3109827.87727.88
449782-4978244.62644.63
539087-3908735.03835.04
639169-3916935.11235.11
10min197007-9700786.95970.0816.3787.2270.2916.38
274467-7446766.75466.95
357972-5797251.96752.12
483644-8364474.98075.23
575516-7551667.69467.89
680473-8047372.13872.33
15min1104391-10439193.57881.3411.0894.3281.9411.12
286576-8657677.60978.18
374534-7453466.81467.26
496307-9630786.33287.00
589477-8947780.20980.78
693151-9315183.50384.10
20min1102372-10237291.76985.007.8493.0386.057.89
287659-8765978.58079.58
386172-8617277.24778.06
4100986-10098690.52691.67
590730-9073081.33282.35
6100985-10098590.52591.59
30min1101084-10108490.61492.585.1592.3894.105.16
2103565-10356592.83894.27
394468-9446884.68385.93
4108700-10870097.44199.09
5108689-10868997.43198.90
6103175-10317592.48894.05
45min1104844-10484493.98596.212.5996.2698.242.61
2106292-10629295.28397.23
3104428-10442893.61295.33
4109628-10962898.273100.46
5107236-10723696.12998.14
6111525-11152599.974102.05
60min1110551-11055199.10097.922.48101.89100.492.54
2105186-10518694.29196.77
3107705-10770596.54998.78
4112630-112630100.964103.70
5111136-11113699.625102.17
6108218-10821897.00999.64
极限1106157-10615795.16294.684.5698.5197.794.59
2105948-10594894.97497.98
396194-9619486.23189.00
4107839-10783996.66999.96
5107868-10786896.69599.79
6109697-10969798.335101.51
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