恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101566-202301对照品来源中检所对照品使用方法直接使用
对照品含量(%) 100对照品水分(%)0对照品稀释倍数400
标示量(mg)25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%
1 9.851343852134417613441551343930134317213438570.04
2 9.861345855134579213458240.01
单位质量响应值RSD%判断
136432.18136493.310.04数据可信
加速6月-供试品溶液-304468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%
5min1697698-69769846.01555.8713.7246.0155.8613.72
2876918-87691857.83557.83
3914464-91446460.31160.31
4952856-95285662.84362.84
5703886-70388646.42346.42
6936586-93658661.77061.77
10min11096705-109670572.33079.337.8972.4179.437.89
21252348-125234882.59582.69
31243884-124388482.03782.14
41292984-129298485.27585.38
51069164-106916470.51470.59
61262395-126239583.25883.36
15min11217340-121734080.28685.834.9880.4886.065.00
21319021-131902186.99287.23
31322349-132234987.21287.45
41382081-138208191.15191.40
51228910-122891081.04981.24
61338953-133895388.30788.55
20min11258853-125885383.02487.465.0883.3687.835.09
21347904-134790488.89789.28
31342676-134267688.55288.93
41410996-141099693.05893.46
51232489-123248981.28581.62
61363405-136340589.91990.31
30min11285182-128518284.76088.874.7385.2389.394.74
21368600-136860090.26290.79
31357972-135797289.56190.09
41433011-143301194.51095.06
51260934-126093483.16183.63
61379675-137967590.99291.53
45min11298883-129888385.66489.764.5586.2790.424.57
21397757-139775792.18592.86
31367598-136759890.19690.88
41437123-143712394.78195.49
51275408-127540884.11684.72
61389091-138909191.61392.30
60min11305063-130506386.07290.204.7786.8391.014.78
21380527-138052791.04991.88
31380544-138054491.05091.88
41465255-146525596.63797.51
51284432-128443284.71185.46
61390105-139010591.68092.52
极限11527846-1527846100.765101.391.10101.66102.361.14
21540686-1540686101.611102.59
31536997-1536997101.368102.35
41565377-1565377103.240104.27
51514363-151436399.875100.76
61539153-1539153101.510102.51
恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101566-202301对照品来源中检所对照品使用方法直接使用
对照品含量(%) 100对照品水分(%)0对照品稀释倍数400
标示量(mg)25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%
1 9.851343763134441713447851344791134436013444230.04
2 9.861353220135300013531100.02
单位质量响应值RSD%判断
136489.64137232.250.39数据可信
加速6月-供试品溶液-304468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%
5min1982649-98264964.62060.475.0264.6260.475.02
2959543-95954363.10063.10
3879946-87994657.86657.87
4861998-86199856.68656.69
5925413-92541360.85660.86
6907750-90775059.69459.69
10min11289122-128912284.77483.001.9684.8883.101.96
21247274-124727482.02282.13
31296546-129654685.26285.36
41238257-123825781.42981.52
51257329-125732982.68382.78
61244388-124438881.83281.93
15min11366588-136658889.86888.632.3090.1288.872.30
21318004-131800486.67386.91
31400637-140063792.10792.35
41327242-132724287.28087.51
51344622-134462288.42388.66
61329842-132984287.45187.69
20min11392941-139294191.60190.913.1192.0091.303.10
21344575-134457588.42088.81
31463440-146344096.23796.63
41361488-136148889.53289.91
51374448-137444890.38590.77
61357543-135754389.27389.65
30min11411429-141142992.81791.881.9993.3792.421.99
21367806-136780689.94890.48
31445171-144517195.03595.59
41384321-138432191.03491.56
51395286-139528691.75592.29
61379084-137908490.68991.22
45min11414941-141494193.04792.361.8993.7593.061.89
21379732-137973290.73291.42
31452192-145219295.49796.21
41395363-139536391.76092.44
51400640-140064092.10792.80
61384211-138421191.02791.71
60min11420119-142011993.38892.561.8494.2593.411.84
21385068-138506891.08391.92
31453456-145345695.58096.45
41398641-139864191.97692.81
51401973-140197392.19593.04
61386170-138617091.15591.99
极限11529448-1529448100.578100.720.78101.59101.720.79
21531523-1531523100.714101.70
31546814-1546814101.720102.75
41531782-1531782100.731101.71
51538954-1538954101.203102.20
61511102-151110299.371100.36
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