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%
110.561085881085191087631085711086211086120.09
210.531085121087171086140.14
单位质量响应值RSD%判断
10285.2310314.720.21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%
5min151988-5198845.29046.219.8745.2946.219.87
245355-4535539.51239.51
360877-6087753.03453.03
452370-5237045.62345.62
556452-5645249.17949.18
651214-5121444.61644.62
10min172305-7230562.99072.557.6863.2472.817.64
291000-9100079.27679.50
384921-8492173.98174.28
480450-8045070.08670.34
584182-8418273.33773.61
686820-8682075.63575.88
15min192969-9296980.99282.186.8681.5982.846.81
2100170-10017087.26587.92
390776-9077679.08179.79
484757-8475773.83874.48
594748-9474882.54283.22
6102600-10260089.38290.05
20min199118-9911886.34988.423.6487.4089.543.65
2106174-10617492.49693.64
3101696-10169688.59489.74
495596-9559683.28084.33
5103151-10315189.86291.00
6103251-10325189.94991.11
30min1107341-10734193.51294.922.7895.0496.532.76
2113706-11370699.057100.72
3110620-11062096.36998.01
4108339-10833994.38295.90
5104798-10479891.29792.94
6108940-10894094.90596.57
45min1108419-10841994.45194.752.1696.5096.892.12
2112881-11288198.338100.55
3107019-10701993.23295.40
4109287-10928795.20797.25
5108871-10887194.84596.99
6106127-10612792.45594.65
60min1111599-11159997.22295.671.9799.8098.331.91
2110730-11073096.46599.22
3105642-10564292.03294.72
4109880-10988095.72498.29
5109881-10988195.72598.40
6111165-11116596.84499.55
极限1110247-11024796.04495.041.3699.1698.241.28
2110033-11003395.85799.15
3107437-10743793.59696.80
4110860-11086096.57899.68
5108447-10844794.47697.68
6107556-10755693.69996.94
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%
110.561085881085521088351082951085671085670.18
210.531084621085111084860.04
单位质量响应值RSD%判断
10280.9710302.560.15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%
5min173108-7310863.74048.0420.1263.7448.0420.12
238450-3845033.52333.52
356317-5631749.10149.10
452587-5258745.84945.85
553547-5354746.68646.69
656605-5660549.35249.35
10min199765-9976586.98175.3611.0487.3475.6311.08
271199-7119962.07662.26
391589-9158979.85380.13
482712-8271272.11472.37
585119-8511974.21274.47
688230-8823076.92477.20
15min1101180-10118088.21582.037.7289.0582.717.76
283097-8309772.44972.98
394713-9471382.57783.29
490336-9033678.76179.42
592408-9240880.56781.24
6102754-10275489.58790.29
20min1103447-10344790.19288.113.3891.5289.253.44
295330-9533083.11584.05
398494-9849485.87387.05
4103191-10319189.96891.06
5102104-10210489.02190.14
6103780-10378090.48291.68
30min1104389-10438991.01391.972.1992.8493.602.14
2104158-10415890.81292.21
3106448-10644892.80894.46
4105912-10591292.34193.93
5109309-10930995.30296.92
6102672-10267289.51691.22
45min1111319-11131997.05594.532.9299.3996.682.97
2103570-10357090.29992.20
3111965-11196597.61899.79
4109651-10965195.60197.71
5106948-10694893.24495.39
6107098-10709893.37595.57
60min1107379-10737993.62093.771.1696.4996.431.06
2109203-10920395.21097.61
3108388-10838894.49997.21
4106151-10615192.54995.19
5108046-10804694.20196.86
6106117-10611792.51995.24
极限1106259-10625992.64394.831.5796.0498.021.49
2108633-10863394.71397.64
3110423-11042396.27499.51
4107365-10736593.60896.76
5109444-10944495.42098.60
6110509-11050996.34999.58
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%
110.561087171085011086821081411082491084580.24
210.531080291077021078660.22
单位质量响应值RSD%判断
10270.6410243.680.19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%
5min146987-4698741.10442.578.3741.1042.578.36
244954-4495439.32639.33
349820-4982043.58343.58
449878-4987843.63443.63
555590-5559048.63048.63
644738-4473839.13739.14
10min185581-8558174.86773.066.4575.1073.296.43
283099-8309972.69572.91
384191-8419173.65173.89
490617-9061779.27279.51
583530-8353073.07273.34
674060-7406064.78865.01
15min194563-9456382.72481.794.8883.3782.434.87
297428-9742885.23085.85
393349-9334981.66282.31
498824-9882486.45287.13
590238-9023878.94179.62
686543-8654375.70876.29
20min1101631-10163188.90789.503.1490.0190.603.16
2102907-10290790.02491.12
3101553-10155388.83989.94
4105387-10538792.19393.36
5105546-10554692.33293.45
696810-9681084.69085.69
30min1106361-10636193.04594.731.3094.6496.321.27
2110425-11042596.60098.20
3107514-10751494.05495.65
4108566-10856694.97496.65
5107776-10777694.28395.91
6109061-10906195.40796.88
45min1106700-10670093.34296.192.1995.4698.312.17
2112053-11205398.024100.16
3107701-10770194.21796.34
4112880-11288098.748100.95
5110423-11042396.59998.75
6109950-10995096.18598.18
60min1107457-10745794.00496.202.1496.6498.862.09
2112140-11214098.101100.78
3107107-10710793.69896.34
4112058-11205898.029100.78
5109251-10925195.57398.26
6111812-11181297.814100.35
极限1107943-10794394.42996.671.4497.5899.861.40
2111978-11197897.959101.18
3111578-11157897.609100.77
4110791-11079196.920100.22
5109227-10922795.55298.77
6111529-11152997.566100.64
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