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%
1 12.312012992006262008012002142007222007320.20
2 12.272000031989751994890.37
单位质量响应值RSD%判断
16306.4216258.270.21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%
5min147047-4704723.23123.5023.8323.2323.5023.84
242190-4219020.83320.83
355069-5506927.19227.19
429434-2943414.53414.53
549208-4920824.29824.30
662589-6258930.90630.91
10min1117246-11724657.89566.1310.7357.9366.1610.73
2142251-14225170.24270.27
3137354-13735467.82467.86
4115222-11522256.89556.92
5140983-14098369.61669.65
6150444-15044474.28774.33
15min1137537-13753767.91475.619.0868.0475.759.08
2158823-15882378.42578.56
3153120-15312075.60975.75
4135697-13569767.00567.11
5164298-16429881.12881.27
6169283-16928383.59083.75
20min1149696-14969673.91880.208.1774.1480.458.18
2166520-16652082.22582.48
3159689-15968978.85279.11
4145639-14563971.91572.12
5173724-17372485.78386.05
6179252-17925288.51288.80
30min1163898-16389880.93185.337.1581.2785.707.16
2174674-17467486.25286.63
3167628-16762882.77383.15
4156938-15693877.49477.81
5184953-18495391.32791.72
6188702-18870293.17993.59
45min1178097-17809787.94290.036.0088.4090.526.01
2183199-18319990.46190.97
3175263-17526386.54387.04
4167701-16770182.80983.24
5193822-19382295.70796.24
6195843-19584396.70597.26
60min1187807-18780792.73793.154.6293.3293.784.64
2189240-18924093.44494.09
3181786-18178689.76490.39
4176530-17653087.16887.72
5198253-19825397.89598.57
6198235-19823597.88698.59
极限1201726-20172699.61099.381.52100.34100.151.48
2200087-20008798.80099.58
3197800-19780097.67198.43
4206322-206322101.879102.57
5202691-202691100.086100.90
6198961-19896198.24499.09
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%
1 12.312009561994401992582001012000011999510.34
2 12.271994942008862001900.50
单位质量响应值RSD%判断
16242.9716315.400.32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%
5min184448-8444841.70839.689.9341.7139.689.93
273694-7369436.39636.40
381266-8126640.13640.14
474088-7408836.59136.59
574633-7463336.86036.86
693924-9392446.38846.39
10min1181216-18121689.50081.177.3589.5681.237.35
2157657-15765777.86477.92
3170357-17035784.13784.20
4145773-14577371.99572.05
5162716-16271680.36380.42
6168363-16836383.15283.22
15min1196319-19631996.95990.056.1297.1690.236.12
2176094-17609486.97087.14
3186516-18651692.11792.30
4163817-16381780.90781.07
5184113-18411390.93191.11
6187104-18710492.40892.60
20min1199994-19999498.77493.735.0899.1294.045.09
2183045-18304590.40390.70
3191834-19183494.74495.07
4173778-17377885.82686.11
5194980-19498096.29896.61
6195036-19503696.32596.66
30min1203695-203695100.60297.213.38101.0997.663.39
2190117-19011793.89694.33
3199113-19911398.33998.81
4187114-18711492.41392.83
5201493-20149399.51499.97
6199407-19940798.48498.96
45min1203771-203771100.63999.041.72101.2899.641.74
2199649-19964998.60499.18
3202161-20216199.844100.46
4194109-19410995.86796.42
5202494-202494100.009100.61
6200996-20099699.26999.89
60min1203376-203376100.44499.291.25101.24100.041.27
2199036-19903698.30199.03
3202944-202944100.231100.99
4197145-19714597.36798.06
5202731-202731100.126100.88
6200997-20099799.269100.04
极限1203192-203192100.35399.001.44101.3099.901.46
2198758-19875898.16499.04
3203051-203051100.284101.20
4195742-19574296.67497.52
5201836-20183699.684100.59
6200120-20012098.83699.76
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%
1 12.311996711999462000541995201999381998260.12
2 12.272009022020432014720.41
单位质量响应值RSD%判断
16232.8216419.890.82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%
5min1126159-12615962.13062.0018.9262.1362.0018.91
2165109-16510981.31181.31
3134397-13439766.18766.19
4125361-12536161.73761.74
595220-9522046.89346.89
6109093-10909353.72553.73
10min1186741-18674191.96594.461.5292.0694.561.52
2194661-19466195.86595.99
3190472-19047293.80293.90
4193460-19346095.27495.37
5193810-19381095.44695.52
6191751-19175194.43294.51
15min1191823-19182394.46797.171.7494.7097.411.73
2200334-20033498.65998.92
3195563-19556396.30996.55
4197306-19730697.16897.40
5201303-20130399.13699.35
6197563-19756397.29497.52
20min1193267-19326795.17897.451.5795.5597.831.56
2197887-19788797.45497.87
3196423-19642396.73397.12
4198237-19823797.62698.01
5202766-20276699.856100.22
6198644-19864497.82798.19
30min1193845-19384595.46398.081.5395.9898.611.52
2199075-19907598.03998.60
3199267-19926798.13398.66
4199827-19982798.40998.94
5203297-203297100.118100.63
6199701-19970198.34798.86
45min1193153-19315395.12297.781.6695.7898.461.65
2198868-19886897.93798.64
3197197-19719797.11497.79
4199274-19927498.13798.81
5203107-203107100.024100.69
6199752-19975298.37299.03
60min1192080-19208094.59497.681.7995.4098.501.78
2198737-19873797.87298.73
3198005-19800597.51298.33
4198914-19891497.95998.78
5202999-20299999.971100.78
6199342-19934298.17098.98
极限1192455-19245594.77998.122.1795.7299.082.16
2198608-19860897.80998.81
3197277-19727797.15398.12
4204813-204813100.865101.83
5202707-20270799.827100.79
6199525-19952598.26099.22
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%
1 12.312011102004162002262007992004632006030.18
2 12.272006042012712009380.24
单位质量响应值RSD%判断
16295.9416376.370.35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%
5min1146436-14643672.07074.1510.4772.0774.1510.46
2134420-13442066.15766.16
3164141-16414180.78480.78
4161169-16116979.32179.32
5130704-13070464.32864.33
6167100-16710082.24082.24
10min1201307-20130799.07698.101.3299.1898.211.32
2197975-19797597.43697.54
3203188-203188100.002100.12
4197757-19775797.32997.45
5196020-19602096.47496.57
6199666-19966698.26898.39
15min1203240-203240100.02799.251.18100.2899.511.18
2200237-20023798.54998.79
3205364-205364101.073101.34
4200002-20000298.43498.70
5199071-19907197.97598.22
6202056-20205699.44499.72
20min1205111-205111100.94899.601.46101.35100.011.46
2200863-20086398.85799.25
3206678-206678101.719102.14
4200292-20029298.57698.99
5199146-19914698.01298.40
6202142-20214299.48799.91
30min1204144-204144100.47299.561.34101.03100.121.35
2201225-20122599.03599.58
3206424-206424101.594102.17
4200271-20027198.56699.13
5199003-19900397.94298.48
6202735-20273599.779100.35
45min1203809-203809100.30799.471.34101.02100.181.35
2200910-20091098.88099.57
3206313-206313101.540102.27
4199942-19994298.40499.11
5199043-19904397.96298.64
6202612-20261299.718100.44
60min1203408-203408100.11099.361.17100.97100.221.17
2200914-20091498.88299.72
3205597-205597101.187102.07
4200091-20009198.47799.33
5199198-19919898.03898.87
6202109-20210999.471100.34
极限1203247-203247100.03199.231.22101.04100.231.23
2200674-20067498.76499.75
3205642-205642101.209102.24
4199692-19969298.28199.28
5199076-19907697.97898.95
6201351-20135199.098100.12
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