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%
110.531066361069581068541068821071911069040.19
210.551080991083661082320.18
单位质量响应值RSD%判断
10152.3310258.960.74数据可信
中间条件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%
5min156649-5664949.80851.7911.8649.8151.7911.86
264391-6439156.61556.62
346445-4644540.83640.84
463234-6323455.59855.60
557983-5798350.98150.98
664716-6471656.90156.90
10min185354-8535475.04774.586.0175.3274.865.99
293421-9342182.14082.45
381604-8160471.75071.98
481958-8195872.06172.37
587309-8730976.76677.05
679281-7928169.70770.02
15min197408-9740885.64583.254.0686.3483.954.03
298031-9803186.19386.96
395379-9537983.86184.49
490868-9086879.89580.60
597429-9742985.66486.37
688998-8899878.25178.95
20min1102597-10259790.20887.754.7791.3888.914.72
2100837-10083788.66089.91
3103322-10332290.84591.94
495684-9568484.13085.28
5104060-10406091.49492.68
692277-9227781.13482.27
30min1105634-10563492.87891.253.9294.5592.903.87
2105338-10533892.61894.36
3108500-10850095.39896.99
4100983-10098388.78990.41
5105141-10514192.44594.14
697096-9709685.37186.96
45min1102900-10290090.47490.961.4792.6693.121.46
2103815-10381591.27993.54
3104960-10496092.28594.41
4100747-10074788.58190.69
5104669-10466992.03094.24
6103641-10364191.12693.19
60min1101283-10128389.05291.632.4291.7494.302.37
2103702-10370291.17993.94
3106351-10635193.50896.15
4102500-10250090.12292.73
5108044-10804494.99797.72
6103409-10340990.92293.49
极限1105749-10574992.97994.241.2196.1697.421.13
2106522-10652293.65996.93
3107282-10728294.32797.49
4106865-10686593.96097.07
5107122-10712294.18697.43
6109579-10957996.34799.42
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%
110.531064601068301066051065291063901065630.16
210.551060401063811062100.23
单位质量响应值RSD%判断
10119.9410067.300.37数据可信
中间条件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%
5min169744-6974462.00159.5520.4862.0059.5520.48
258273-5827351.80451.80
351932-5193246.16746.17
468418-6841860.82260.82
591554-9155481.39081.39
662002-6200255.11955.12
10min196904-9690486.14682.628.7186.4982.948.72
278521-7852169.80470.09
392853-9285382.54582.80
489941-8994179.95680.29
5100966-10096689.75790.21
698413-9841387.48887.79
15min196728-9672885.99088.125.9086.8188.905.93
290986-9098680.88581.56
397987-9798787.10987.82
497213-9721386.42187.20
5106815-10681594.95795.91
6104987-10498793.33294.12
20min199040-9904088.04591.144.7089.3592.424.74
295601-9560184.98886.11
3104181-10418192.61593.81
4101408-10140890.15091.41
5108709-10870996.64098.12
6106223-10622394.43095.74
30min1101003-10100389.79091.553.9591.5893.334.00
296196-9619685.51787.11
3104521-10452192.91794.63
4102492-10249291.11492.88
5107268-10726895.35997.37
6106390-10639094.57996.41
45min199627-9962788.56791.333.1090.8693.623.15
298488-9848887.55489.63
3104231-10423192.66094.89
4102227-10222790.87893.15
5106113-10611394.33396.88
6105714-10571493.97896.34
60min199951-9995188.85591.172.3591.6493.972.42
299570-9957088.51691.07
3104425-10442592.83295.58
4102179-10217990.83593.61
5105350-10535093.65496.72
6103867-10386792.33695.22
极限1109172-10917297.05295.281.10100.3398.591.12
2105861-10586194.10997.16
3106591-10659194.75898.02
4107775-10777595.81099.09
5107192-10719295.29298.88
6106497-10649794.67498.07
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%
110.531072831073161072241067931067281070690.27
210.551059961062881061420.20
单位质量响应值RSD%判断
10168.0010060.850.75数据可信
中间条件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%
5min156435-5643550.06842.8115.8150.0742.8115.81
239197-3919734.77534.77
339828-3982835.33435.33
455696-5569649.41249.41
546566-4656641.31241.31
651795-5179545.95145.95
10min181655-8165572.44268.897.7172.7269.127.74
272558-7255864.37264.56
368806-6880661.04361.24
484051-8405174.56874.84
576982-7698268.29668.53
681835-8183572.60272.86
15min189116-8911679.06180.484.1679.7481.104.18
290844-9084480.59481.15
385178-8517875.56876.10
494417-9441783.76484.45
589313-8931379.23679.85
695403-9540384.63985.30
20min196718-9671885.80687.382.0386.9388.452.02
2100252-10025288.94189.94
398396-9839687.29488.25
4100127-10012788.83089.98
595510-9551084.73485.78
699954-9995488.67789.81
30min1101028-10102889.62991.992.2591.2393.542.20
2105816-10581693.87795.37
3103883-10388392.16293.60
4102046-10204690.53392.18
5102351-10235190.80392.32
6106989-10698994.91896.54
45min1107851-10785195.68394.770.9897.7896.830.95
2107791-10779195.62997.64
3105686-10568693.76295.71
4106037-10603794.07396.22
5107643-10764395.49897.52
6105917-10591793.96796.12
60min1106928-10692894.86495.310.8497.4997.900.76
2107703-10770395.55198.10
3107806-10780695.64398.12
4106373-10637394.37197.04
5108882-10888296.59799.15
6106875-10687594.81797.49
极限1107715-10771595.56295.001.6098.7198.121.59
2107054-10705494.97598.05
3104145-10414592.39595.40
4107195-10719595.10198.30
5109436-10943697.089100.18
6106946-10694694.88098.08
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%
110.531066961070811069281066341074371069550.31
210.551057101058271057680.08
单位质量响应值RSD%判断
10157.1710025.400.93数据可信
中间条件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%
5min134170-3417030.38527.9111.7330.3827.9111.73
232502-3250228.90128.90
324683-2468321.94921.95
433409-3340929.70829.71
529621-2962126.34026.34
633952-3395230.19130.19
10min163616-6361656.56957.222.4256.7457.382.42
267027-6702759.60259.76
362844-6284455.88256.00
464173-6417357.06457.23
565239-6523958.01258.16
663220-6322056.21756.38
15min180972-8097272.00274.873.9472.4975.343.94
289827-8982779.87680.37
381931-8193172.85573.29
485800-8580076.29576.78
581966-8196672.88673.35
684669-8466975.28975.77
20min197453-9745386.65787.902.4087.5488.792.40
2101333-10133390.10791.04
397344-9734486.56087.40
4101928-10192890.63791.54
599036-9903688.06588.94
695991-9599185.35786.26
30min1103163-10316391.73594.772.4693.1096.152.41
2104439-10443992.86994.31
3107563-10756395.64796.97
4107326-10732695.43796.85
5110634-11063498.37899.74
6106338-10633894.55895.93
45min1106456-10645694.66395.991.7796.5497.901.74
2106983-10698395.13297.08
3106731-10673194.90796.76
4107146-10714695.27697.22
5111361-11136199.025100.93
6109045-10904596.96598.86
60min1106355-10635594.57395.931.8796.9798.361.84
2106837-10683795.00297.48
3106191-10619194.42796.80
4107075-10707595.21397.68
5109824-10982497.658100.12
6110972-11097298.679101.12
极限1107111-10711195.24595.713.3598.1798.683.25
2106058-10605894.30997.32
3106018-10601894.27397.17
4104100-10410092.56895.57
5108039-10803996.07199.07
6114472-114472101.791104.78
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