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%
110.531060641060261060051058561059821059870.08
210.551058651059291058970.05
单位质量响应值RSD%判断
10065.2410037.630.20数据可信
长期6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%
5min171471-7147163.80351.6214.8963.8051.6214.90
251118-5111845.63445.63
355197-5519749.27549.27
452346-5234646.73046.73
551260-5126045.76045.76
665528-6552858.49758.50
10min198093-9809387.56973.9014.1087.9274.1814.09
278722-7872270.27670.53
374632-7463266.62566.90
477038-7703868.77369.03
571315-7131563.66463.92
696868-9686886.47586.80
15min1103932-10393292.78183.2410.3093.6283.9310.32
296291-9629185.96086.60
385861-8586176.64977.29
488987-8898779.44080.08
580740-8074072.07772.69
6103634-10363492.51593.32
20min1107916-10791696.33889.368.6697.6990.528.68
2108172-10817296.56697.69
392329-9232982.42383.49
497022-9702286.61387.70
588456-8845678.96679.97
6106713-10671395.26496.58
30min1109567-10956797.81292.385.1599.7094.045.20
2105978-10597894.60896.27
395910-9591085.62087.15
4106467-10646795.04496.61
598022-9802287.50588.95
6104945-10494593.68595.53
45min1107519-10751995.98391.973.0398.4294.143.15
2103093-10309392.03294.22
398426-9842687.86689.87
4103478-10347892.37694.47
5100970-10097090.13792.07
6104673-10467393.44395.81
60min1106040-10604094.66393.022.8997.6395.702.97
2102749-10274991.72594.42
3100033-10003389.30091.79
4106956-10695695.48198.09
5102028-10202891.08193.52
6107367-10736795.84898.74
极限1109248-10924897.52796.061.26101.0299.261.32
2108407-10840796.77699.98
3105491-10549194.17397.16
4107847-10784796.27699.41
5108063-10806396.46999.41
6106559-10655995.12698.55
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%
110.531061321060061061771058961060281060480.11
210.551065371065941065660.04
单位质量响应值RSD%判断
10071.0410101.040.22数据可信
长期6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%
5min150907-5090745.28941.829.0345.2941.829.03
250448-5044844.88144.88
348026-4802642.72642.73
439384-3938435.03835.04
547974-4797442.68042.68
645309-4530940.30940.31
10min181688-8168872.67469.172.7872.9369.412.79
277907-7790769.31069.56
376198-7619867.78968.03
475818-7581867.45167.65
576598-7659868.14568.38
678318-7831869.67569.90
15min191476-9147681.38181.042.9382.0481.662.89
288536-8853678.76679.40
392239-9223982.06082.67
495651-9565185.09685.67
588798-8879878.99979.61
689872-8987279.95480.57
20min199206-9920688.25887.961.7989.3789.031.77
299617-9961788.62489.70
397266-9726686.53287.60
4101853-10185390.61391.66
597158-9715886.43687.49
698124-9812487.29688.35
30min1103436-10343692.02292.801.6993.6294.361.66
2105585-10558593.93395.50
3102014-10201490.75792.31
4104532-10453292.99794.54
5106940-10694095.13996.67
6103356-10335691.95093.49
45min1106988-10698895.18295.331.8297.2997.401.79
2109131-10913197.08899.17
3106637-10663794.86996.92
4108037-10803796.11598.18
5108467-10846796.49798.56
6103660-10366092.22194.27
60min1105352-10535293.72693.641.1696.3696.241.11
2102942-10294291.58294.21
3105233-10523393.62096.20
4105656-10565693.99796.59
5105902-10590294.21596.81
6106450-10645094.70397.27
极限1107264-10726495.42793.931.1798.5997.061.15
2106222-10622294.50097.63
3104034-10403492.55495.66
4105798-10579894.12397.24
5104252-10425292.74895.87
6105947-10594794.25597.34
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%
110.531058921059481058151058791058561058780.05
210.551059501060051059780.04
单位质量响应值RSD%判断
10054.8910045.310.07数据可信
长期6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%
5min133493-3349329.90340.7722.9329.9040.7722.93
242418-4241837.87237.87
351074-5107445.60045.60
436848-3684832.89932.90
547826-4782642.70042.70
662323-6232355.64455.64
10min171528-7152863.86270.347.0964.0370.577.14
276666-7666668.44968.66
378900-7890070.44470.70
477907-7790769.55769.74
579029-7902970.55970.80
688685-8868579.18079.49
15min186364-8636477.10881.645.3777.6382.265.41
289226-8922679.66380.25
392836-9283682.88783.53
491593-9159381.77782.35
588361-8836178.89179.52
6100272-10027289.52690.27
20min196966-9696686.57488.614.4887.5289.684.49
298474-9847487.92088.95
3102453-10245391.47392.58
4101849-10184990.93491.96
591873-9187382.02783.09
6103887-10388792.75394.00
30min199978-9997889.26393.873.6090.6995.433.64
2104047-10404792.89694.42
3106565-10656595.14496.76
4107585-10758596.05597.58
5102261-10226191.30192.82
6110360-11036098.532100.29
45min1106205-10620594.82395.191.6296.7597.271.67
2103682-10368292.57094.61
3106617-10661795.19197.33
4107203-10720395.71497.78
5106990-10699095.52497.55
6108978-10897897.29999.61
60min1105313-10531394.02695.671.2196.4898.281.30
2107505-10750595.98398.54
3106984-10698495.51898.19
4106563-10656395.14297.74
5107282-10728295.78498.35
6109257-10925797.548100.40
极限1105782-10578294.44595.341.1597.4298.491.13
2109111-10911197.417100.50
3106768-10676895.32598.53
4106649-10664995.21998.34
5105791-10579194.45397.55
6106635-10663595.20798.60
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%
110.531054711055551055311054901054571055010.04
210.551056041057821056930.12
单位质量响应值RSD%判断
10019.0910018.290.01数据可信
长期6月-供试品溶液批-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%
5min115513-1551313.89420.9125.7713.8920.9125.76
230058-3005826.92126.92
328934-2893425.91425.91
424536-2453621.97521.98
524135-2413521.61621.62
616923-1692315.15715.16
10min148077-4807743.05951.5711.1343.1451.6911.16
266877-6687759.89760.05
360195-6019553.91254.06
459761-5976153.52453.65
557032-5703251.07951.20
653537-5353747.94948.03
15min175340-7534067.47669.893.6267.7970.293.68
282618-8261873.99574.48
380033-8003371.68072.12
478016-7801669.87370.29
576376-7637668.40468.81
675836-7583667.92168.27
20min194645-9464584.76783.911.3585.4684.701.37
294995-9499585.08085.97
393543-9354383.78084.62
494489-9448984.62785.43
592709-9270983.03383.82
691763-9176382.18582.91
30min1103202-10320292.43092.722.3893.5993.972.37
2107415-10741596.20497.57
3101010-10101090.46791.77
4102680-10268091.96393.24
5101408-10140890.82492.07
6105406-10540694.40495.59
45min1106423-10642395.31594.961.0096.9996.741.00
2106569-10656995.44697.35
3106094-10609495.02196.83
4106676-10667695.54297.33
5103916-10391693.07094.82
6106501-10650195.38597.09
60min1107353-10735396.14895.471.7398.3597.771.68
2107375-10737596.16898.60
3104183-10418393.30995.65
4107392-10739296.18398.50
5104500-10450093.59395.86
6108801-10880197.44599.68
极限1106999-10699995.83195.911.4198.5798.741.43
2110043-11004398.557101.52
3106098-10609895.02497.88
4105997-10599794.93497.79
5106980-10698095.81498.60
6106407-10640795.30198.08
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