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%
112.311991801993071992941991391991051992050.05
212.291994621994461994540.01
单位质量响应值RSD%判断
16182.3716228.970.21数据可信
供试品溶液-WK2927批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1149082-14908273.96360.5427.2273.9660.5427.23
2140145-14014569.52969.53
3121825-12182560.44060.44
4129977-12997764.48564.48
556890-5689028.22428.22
6134300-13430066.62966.63
10min1176611-17661187.62182.0911.1587.7382.1811.16
2175035-17503586.83986.94
3160014-16001479.38779.48
4171707-17170785.18885.28
5130377-13037764.68364.73
6179011-17901188.81288.91
15min1184716-18471691.64286.599.7991.8886.809.81
2182989-18298990.78591.02
3169744-16974484.21484.42
4179049-17904988.83089.05
5142221-14222170.55970.70
6188510-18851093.52493.76
20min1188957-18895793.74688.799.1594.1389.139.17
2187691-18769193.11893.49
3174610-17461086.62886.96
4182439-18243990.51290.87
5148001-14800173.42773.67
6192109-19210995.31095.68
30min1192447-19244795.47890.908.4896.0091.388.51
2192541-19254195.52496.03
3179580-17958089.09489.56
4186867-18686792.70993.20
5153503-15350376.15676.51
6194373-19437396.43396.95
45min1194682-19468296.58692.747.8897.2593.357.90
2197672-19767298.07098.72
3183431-18343191.00491.60
4190463-19046394.49395.13
5158803-15880378.78679.26
6196500-19650097.48898.15
极限1196955-19695597.71498.990.9598.5299.740.88
2200500-20050099.473100.27
3199561-19956199.00799.74
4199987-19998799.21899.99
5202263-202263100.347100.94
6197907-19790798.18698.99
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%
112.312001542003432001212001981999922001620.07
212.292005172005992005580.03
单位质量响应值RSD%判断
16260.1116318.800.26数据可信
供试品溶液-WK2927批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min186496-8649642.69248.6116.1842.6948.6016.18
292836-9283645.82145.82
398143-9814348.44148.44
4128015-12801563.18563.18
583904-8390441.41341.41
6101470-10147050.08350.08
10min1133474-13347465.87976.399.4365.9476.469.43
2154566-15456676.29076.36
3168714-16871483.27383.35
4167875-16787582.85882.95
5141316-14131669.75069.81
6162671-16267180.29080.37
15min1142271-14227170.22181.419.3470.3881.609.35
2164103-16410380.99781.18
3180602-18060289.14089.34
4176272-17627287.00387.22
5151105-15110574.58174.75
6175257-17525786.50286.70
20min1147127-14712772.61883.489.0772.8983.799.07
2167661-16766182.75383.06
3185256-18525691.43791.77
4180467-18046789.07489.42
5155086-15508676.54676.82
6179245-17924588.47088.80
30min1154494-15449476.25485.918.1276.6386.348.13
2172142-17214284.96585.39
3189669-18966993.61594.08
4185072-18507291.34691.83
5160700-16070079.31779.71
6182270-18227089.96390.42
45min1162154-16215480.03588.416.8980.5388.976.91
2178973-17897388.33688.89
3193046-19304695.28295.89
4188299-18829992.93993.56
5166711-16671182.28482.80
6185545-18554591.58092.17
极限1194466-19446695.98397.801.4096.5998.501.44
2200108-20010898.76899.46
3202067-20206799.735100.49
4198984-19898498.21398.97
5196425-19642596.95097.59
6196863-19686397.16697.90
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