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D5551-23-012对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)19.2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%
112.382016581985781995751984741982651993100.71
212.421995492005612000550.36
单位质量响应值RSD%判断
16099.3516107.490.04数据可信
供试品溶液-24103001-1批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1126103-12610363.14664.693.8263.1564.703.82
2130948-13094865.57365.57
3127908-12790864.05064.05
4121741-12174160.96260.96
5133510-13351066.85666.86
6134960-13496067.58267.58
10min1148345-14834574.28476.192.4574.3876.292.45
2149790-14979075.00875.11
3152167-15216776.19876.29
4149488-14948874.85774.95
5155306-15530677.77077.87
6157823-15782379.03079.13
15min1153087-15308776.65978.452.0976.8678.662.10
2153882-15388277.05777.27
3155767-15576778.00178.21
4156033-15603378.13478.34
5160122-16012280.18280.40
6161114-16111480.67880.90
20min1155047-15504777.64079.521.9577.9679.851.95
2156549-15654978.39278.72
3158043-15804379.14179.47
4158419-15841979.32979.65
5161375-16137580.80981.15
6163392-16339281.81982.16
30min1157628-15762878.93381.091.9679.3781.541.96
2159873-15987380.05780.50
3161904-16190481.07481.52
4161314-16131480.77981.22
5164470-16447082.35982.82
6166468-16646883.35983.82
45min1161819-16181981.03183.292.0381.5983.862.03
2164440-16444082.34482.91
3165970-16597083.11083.68
4165380-16538082.81583.38
5169050-16905084.65285.23
6171270-17127085.76486.35
60min1165494-16549482.87285.182.3183.5585.872.31
2168466-16846684.36085.05
3169093-16909384.67485.37
4167811-16781184.03284.72
5173945-17394587.10487.81
6175751-17575188.00888.73
极限1208941-208941104.628103.421.37105.43104.241.36
2207980-207980104.147104.96
3206219-206219103.265104.08
4202472-202472101.389102.20
5209572-209572104.944105.78
6204038-204038102.173103.02
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D5551-23-012对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)19.2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%
112.381982271990291982901990311984241986000.21
212.421994021988371991200.21
单位质量响应值RSD%判断
16042.0016032.210.05数据可信
供试品溶液-24103001-2批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1115570-11557058.11163.675.7658.1163.675.76
2120448-12044860.56460.56
3129234-12923464.98264.98
4130273-13027365.50465.50
5128672-12867264.69964.70
6135600-13560068.18368.18
10min1138056-13805669.41874.675.1169.5174.775.11
2141779-14177971.29071.38
3152109-15210976.48476.58
4152482-15248276.67276.77
5147907-14790774.37174.47
6158712-15871279.80479.91
15min1143776-14377672.29477.094.9072.4977.304.90
2146815-14681573.82274.02
3157450-15745079.17079.38
4156539-15653978.71278.92
5151209-15120976.03276.24
6164127-16412782.52782.75
20min1146592-14659273.71078.394.7674.0178.714.76
2149207-14920775.02575.33
3160048-16004880.47680.81
4158718-15871879.80780.14
5154170-15417077.52077.84
6166618-16661883.78084.13
30min1149792-14979275.31980.244.7375.7380.684.73
2153382-15338277.12477.55
3164741-16474182.83683.29
4162546-16254681.73282.18
5156993-15699378.94079.38
6169976-16997685.46885.94
45min1154917-15491777.89682.795.0778.4283.355.06
2157239-15723979.06479.60
3170592-17059285.77886.35
4168109-16810984.52985.10
5160784-16078480.84681.40
6176288-17628888.64289.24
60min1157930-15793079.41184.765.5380.0585.445.52
2159666-15966680.28480.94
3176323-17632388.65989.36
4171591-17159186.28086.98
5164762-16476282.84683.52
6181118-18111891.07091.80
极限1202893-202893102.019102.231.55102.78103.051.56
2204035-204035102.594103.37
3205247-205247103.203104.04
4201552-201552101.345102.18
5198523-19852399.822100.63
6207679-207679104.426105.30
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