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%
112.121988361987411990411984681991591988490.14
2 12.202000321999581999950.03
单位质量响应值RSD%判断
16406.6816393.030.06数据可信
长期6月-供试品溶液-2025080321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%
5min1176782-17678286.66784.681.5686.6784.681.56
2173529-17352985.07285.07
3169878-16987883.28283.28
4169579-16957983.13683.14
5172842-17284284.73584.74
6173768-17376885.18985.19
10min1190837-19083793.55891.851.1693.6991.981.16
2188143-18814392.23792.36
3184714-18471490.55690.68
4185910-18591091.14291.27
5186388-18638891.37691.50
6188168-18816892.24992.38
15min1196263-19626396.21894.721.2796.4994.991.27
2193718-19371894.97095.24
3191408-19140893.83794.10
4189763-18976393.03193.29
5192717-19271794.47994.74
6195416-19541695.80296.07
20min1198610-19861097.36896.341.1797.7896.751.17
2197552-19755296.85097.26
3195166-19516695.68096.08
4193097-19309794.66595.07
5195600-19560095.89396.30
6199063-19906397.59098.00
30min1201691-20169198.87997.861.3899.4498.411.38
2201224-20122498.65099.20
3198101-19810197.11997.66
4195656-19565695.92096.46
5198155-19815597.14597.69
6202890-20289099.466100.02
45min1203237-20323799.63798.551.65100.3599.251.65
2203196-20319699.616100.32
3199089-19908997.60398.29
4196629-19662996.39797.08
5198828-19882897.47598.17
6205179-205179100.589101.29
极限1202252-20225299.15498.681.79100.0199.521.78
2200797-20079798.44099.29
3204684-204684100.346101.18
4195786-19578695.98496.82
5198924-19892497.52298.36
6205255-205255100.626101.48
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%
112.121995911999291994551994921996981996330.10
2 12.202008492009002008740.02
单位质量响应值RSD%判断
16471.3716465.080.03数据可信
长期6月-供试品溶液-2025080421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%
5min1177147-17714786.48586.370.7886.4986.370.78
2178286-17828687.04287.04
3178624-17862487.20787.21
4176232-17623286.03986.04
5175100-17510085.48685.49
6176091-17609185.97085.97
10min1190940-19094093.21993.050.7993.3593.180.79
2191918-19191893.69793.83
3192525-19252593.99394.12
4190147-19014792.83292.96
5188570-18857092.06292.19
6189509-18950992.52192.65
15min1197968-19796896.65195.860.8696.9296.130.85
2197155-19715596.25496.52
3198195-19819596.76197.03
4195402-19540295.39895.67
5194035-19403594.73095.00
6195334-19533495.36595.63
20min1201882-20188298.56197.351.1398.9897.771.13
2200492-20049297.88398.30
3201568-20156898.40898.83
4198079-19807996.70597.12
5196236-19623695.80596.21
6198189-19818996.75897.17
30min1205352-205352100.25598.661.42100.8299.221.42
2202082-20208298.65999.22
3205639-205639100.396100.96
4199828-19982897.55998.12
5198749-19874997.03297.58
6200806-20080698.03698.59
45min1207234-207234101.17499.131.68101.8999.841.67
2202258-20225898.74599.46
3207223-207223101.169101.88
4200458-20045897.86698.57
5199361-19936197.33198.03
6201750-20175098.49799.20
极限1207535-207535101.32199.191.73102.19100.051.73
2202816-20281699.01799.88
3207345-207345101.229102.10
4200534-20053497.90398.75
5199265-19926597.28498.13
6201518-20151898.38499.23
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%
112.122013852012792016042023682015732016420.22
2 12.202018912021112020010.08
单位质量响应值RSD%判断
16637.1316557.460.34数据可信
长期6月-供试品溶液-2025080521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%
5min1169276-16927682.00185.161.8982.0085.161.90
2177998-17799886.22686.23
3177122-17712285.80185.80
4177534-17753486.00186.00
5177495-17749585.98285.98
6175399-17539984.96784.97
10min1185059-18505989.64691.551.2489.7791.671.24
2190774-19077492.41592.54
3190112-19011292.09492.22
4191288-19128892.66492.79
5189166-18916691.63691.76
6187513-18751390.83590.96
15min1192287-19228793.14794.360.8793.4094.620.87
2196467-19646795.17295.44
3196126-19612695.00795.27
4195460-19546094.68594.95
5195239-19523994.57894.84
6193121-19312193.55293.82
20min1196012-19601294.95296.021.1095.3596.431.10
2202108-20210897.90598.32
3198263-19826396.04296.45
4198859-19885996.33196.74
5197515-19751595.68096.09
6196553-19655395.21495.62
30min1198864-19886496.33497.120.6796.8797.670.68
2201254-20125497.49198.05
3201817-20181797.76498.32
4201630-20163097.67398.23
5200511-20051197.13197.68
6198873-19887396.33896.88
45min1200672-20067297.20997.440.8897.8998.140.88
2202211-20221197.95598.66
3202115-20211597.90898.61
4203015-20301598.34499.05
5200868-20086897.30498.00
6198059-19805995.94496.63
极限1200950-20095097.34497.340.9298.1798.180.92
2201395-20139597.56098.41
3202850-20285098.26499.11
4202260-20226097.97998.83
5200535-20053597.14397.99
6197608-19760895.72596.56
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%
112.122011862012692015982016792016632014790.12
2 12.202022382021732022060.03
单位质量响应值RSD%判断
16623.6816574.260.22数据可信
长期6月-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%
5min1124714-12471460.40875.8510.7260.4175.8510.72
2164656-16465679.75479.75
3159354-15935477.18677.19
4172489-17248983.54883.55
5154076-15407674.63074.63
6164322-16432279.59279.59
10min1198069-19806995.93894.760.9896.0394.870.97
2194254-19425494.09194.21
3193055-19305593.51093.63
4195172-19517294.53594.66
5197497-19749795.66195.77
6195715-19571594.79894.92
15min1201719-20171997.70695.991.0197.9496.251.00
2196129-19612994.99995.26
3197280-19728095.55695.81
4197141-19714195.48995.76
5199202-19920296.48796.74
6197611-19761195.71795.98
20min1202305-20230597.99096.201.0598.3796.601.04
2196551-19655195.20395.61
3198048-19804895.92896.33
4197293-19729395.56395.97
5199660-19966096.70997.11
6197843-19784395.82996.23
30min1203033-20303398.34396.631.1498.8797.171.12
2196807-19680795.32795.87
3200490-20049097.11197.65
4198287-19828796.04496.60
5200383-20038397.05997.60
6197926-19792695.86996.42
45min1202658-20265898.16196.261.2698.8496.951.24
2196196-19619695.03195.72
3197630-19763095.72696.41
4198840-19884096.31297.01
5200488-20048897.11097.80
6196552-19655295.20495.90
极限1202339-20233998.00795.951.4798.8396.791.45
2195132-19513294.51695.35
3196922-19692295.38396.22
4198547-19854796.17097.01
5200441-20044197.08797.92
6195220-19522094.55895.39
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