达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
112.312003122004392000612001182001752002210.08
2 12.272002872002182002520.03
单位质量响应值RSD%判断
16264.9116320.460.25数据可信
供试品溶液-WC2484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%
5min190667-9066744.74256.9917.9344.7456.9917.93
2125418-12541861.89161.89
3140715-14071569.43969.44
4117338-11733857.90357.90
590502-9050244.66044.66
6128279-12827963.30263.30
10min1167533-16753382.67385.527.4582.7485.607.45
2179302-17930288.48188.57
3171425-17142584.59484.70
4182288-18228889.95490.04
5151566-15156674.79474.86
6187649-18764992.60092.69
15min1179159-17915988.41090.566.9688.6090.786.96
2193874-19387495.67295.90
3178948-17894888.30688.54
4190405-19040593.96094.18
5162274-16227480.07880.26
6196493-19649396.96497.20
20min1183570-18357090.58793.245.2990.9193.595.30
2198743-19874398.07598.44
3183625-18362590.61490.98
4193621-19362195.54795.91
5174485-17448586.10486.40
6199614-19961498.50498.88
30min1192355-19235594.92296.742.2895.3897.222.30
2200371-20037198.87899.39
3193784-19378495.62796.13
4196958-19695897.19497.70
5190837-19083794.17394.60
6201881-20188199.623100.15
45min1198086-19808697.75098.111.6498.3598.741.67
2201579-20157999.474100.14
3196861-19686197.14697.79
4198961-19896198.18298.83
5194167-19416795.81696.39
6203225-203225100.286100.96
60min1198668-19866898.03898.491.1598.7999.271.17
2201249-20124999.311100.12
3198014-19801497.71598.50
4199253-19925398.32699.13
5197037-19703797.23397.95
6203228-203228100.288101.11
极限1198663-19866398.03598.870.7798.9399.800.79
2200968-20096899.173100.14
3201030-20103099.203100.14
4198870-19887098.13799.08
5199859-19985998.62599.48
6202715-202715100.035101.01
达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
112.312001912001691999782000282001432001020.05
2 12.271998881999951999420.04
单位质量响应值RSD%判断
16255.2416295.190.18数据可信
供试品溶液-WC2484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%
5min1107376-10737653.04448.6016.8153.0448.6016.81
290671-9067144.79244.79
3119144-11914458.85858.86
4104036-10403651.39451.39
598332-9833248.57648.58
670750-7075034.95134.95
10min1168110-16811083.04777.558.4383.1377.638.44
2140342-14034269.32969.40
3174608-17460886.25786.35
4155106-15510676.62376.70
5159218-15921878.65478.73
6144537-14453771.40271.45
15min1174165-17416586.03883.666.1886.2483.856.18
2164550-16455081.28881.46
3186618-18661892.19092.41
4163994-16399481.01481.21
5170524-17052484.23984.43
6156247-15624777.18777.35
20min1177162-17716287.51988.184.6187.8588.504.62
2181057-18105789.44389.74
3192295-19229594.99495.35
4168550-16855083.26483.58
5179709-17970988.77789.09
6172262-17226285.09885.37
30min1181941-18194189.87992.854.3290.3493.304.32
2189490-18949093.60994.04
3198637-19863798.12798.63
4176152-17615287.02087.46
5194061-19406195.86796.32
6187442-18744292.59793.00
45min1194814-19481496.23995.763.5896.8496.353.58
2191894-19189494.79695.36
3201144-20114499.366100.01
4181126-18112689.47790.05
5196688-19668897.16597.76
6197438-19743897.53598.08
60min1197690-19769097.66096.553.0998.4097.283.09
2193634-19363495.65696.37
3201270-20127099.428100.22
4184200-18420090.99591.70
5197480-19748097.55698.30
6198428-19842898.02498.71
极限1200482-20048299.03999.551.3099.93100.421.30
2204504-204504101.026101.88
3201208-20120899.397100.34
4198309-19830997.96598.81
5204795-204795101.169102.06
6199753-19975398.67999.51
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