普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
116.631108961106691110251110321107741108790.15
216.661112421112691112560.02
单位质量响应值RSD%判断
6667.416678.030.12数据可信
中间条件36月-供试品溶液-2022101211批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1102276-10227691.41391.611.7291.4191.601.72
2101522-10152290.73990.74
399703-9970389.11389.11
4104376-10437693.29093.29
5102864-10286491.93991.94
6104212-10421293.14493.14
5min1108798-10879897.24296.611.4697.2496.601.46
2107720-10772096.27996.28
3105298-10529894.11494.11
4109114-10911497.52597.52
5109783-10978398.12398.12
6107813-10781396.36296.36
10min1110059-11005998.37097.581.3598.3797.581.35
2108458-10845896.93996.94
3106522-10652295.20895.21
4110221-11022198.51498.51
5110337-11033798.61898.62
6109439-10943997.81597.82
15min1110972-11097299.18697.971.5699.1997.971.56
2108504-10850496.98096.98
3106695-10669595.36395.36
4110455-11045598.72398.72
5111051-11105199.25699.26
6109978-10997898.29798.30
30min1110763-11076398.99998.091.4699.0098.091.46
2108988-10898897.41297.41
3106875-10687595.52495.52
4110250-11025098.54098.54
5111276-11127699.45799.46
6110302-11030298.58798.59
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
116.631113591111791112761113441111191112550.10
216.661110481112331111400.12
单位质量响应值RSD%判断
6690.026671.070.21数据可信
中间条件36月-供试品溶液-2022101411批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1102605-10260591.60089.112.7391.6089.112.73
2100432-10043289.66089.66
398937-9893788.32588.33
497527-9752787.06787.07
5103076-10307692.02092.02
696337-9633786.00486.00
5min1109355-10935597.62695.422.1197.6395.422.11
2107437-10743795.91495.91
3105077-10507793.80793.81
4106830-10683095.37295.37
5109022-10902297.32997.33
6103570-10357092.46192.46
10min1110559-11055998.70196.622.2498.7096.622.24
2107966-10796696.38696.39
3105949-10594994.58594.59
4108980-10898097.29197.29
5110939-11093999.04099.04
6104952-10495293.69593.70
15min1110804-11080498.92097.041.9598.9297.041.95
2108852-10885297.17797.18
3106629-10662995.19295.19
4109014-10901497.32297.32
5111016-11101699.10999.11
6105864-10586494.50994.51
30min1111681-11168199.70297.431.9899.7097.431.97
2109164-10916497.45597.46
3107268-10726895.76395.76
4109203-10920397.49097.49
5111290-11129099.35399.35
6106219-10621994.82694.83
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
116.631112751108201109151114871113191111630.26
216.661110421111561110990.08
单位质量响应值RSD%判断
6684.496668.610.17数据可信
中间条件36月-供试品溶液-2022101511批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1104732-10473293.55590.552.4293.5590.552.41
2100962-10096290.18790.19
397262-9726286.88286.88
4100982-10098290.20590.20
5101858-10185890.98790.99
6102425-10242591.49491.49
5min1112137-112137100.16997.941.72100.1797.941.72
2108991-10899197.35997.36
3106646-10664695.26495.26
4109510-10951097.82397.82
5111050-11105099.19899.20
6109490-10949097.80597.80
10min1113709-113709101.57499.221.61101.5799.221.61
2110689-11068998.87698.88
3108262-10826296.70896.71
4110972-11097299.12999.13
5111981-111981100.030100.03
6110839-11083999.01099.01
15min1113490-113490101.37899.451.61101.3899.451.61
2110904-11090499.06899.07
3108265-10826596.71196.71
4111491-11149199.59299.59
5112597-112597100.580100.58
6111244-11124499.37299.37
30min1114730-114730102.486100.191.60102.49100.191.60
2112118-112118100.152100.15
3109498-10949897.81297.81
4111737-11173799.81299.81
5113445-113445101.338101.34
6111452-11145299.55899.56
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
116.631115781114361116431116521115351115690.08
216.661120551121431120990.06
单位质量响应值RSD%判断
6708.906728.630.21数据可信
中间条件36月-供试品溶液-EP4189批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min154081-5408148.00650.513.6948.0150.503.69
255597-5559749.35249.35
357044-5704450.63650.64
456137-5613749.83149.83
559814-5981453.09553.09
658708-5870852.11352.11
5min1100863-10086389.53387.961.4789.5387.961.47
298689-9868987.60387.60
397583-9758386.62186.62
497614-9761486.64986.65
5100761-10076189.44289.44
699057-9905787.92987.93
10min1111525-11152598.99798.141.0799.0098.141.07
2110538-11053898.12198.12
3109527-10952797.22397.22
4109825-10982597.48897.49
5112399-11239999.77399.77
6109553-10955397.24697.25
15min1113046-113046100.34799.391.06100.3599.401.06
2112211-11221199.60699.61
3110823-11082398.37498.37
4111246-11124698.74998.75
5113623-113623100.859100.86
6110890-11089098.43398.43
30min1113206-113206100.48999.341.16100.4999.341.16
2112185-11218599.58399.58
3110953-11095398.48998.49
4111114-11111498.63298.63
5113577-113577100.818100.82
6110426-11042698.02198.02
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