氨溴酸替格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.606753336740176748906753046746756748440.08
214.706736416729886733140.07
单位质量响应值RSD%判断
46222.1945803.670.65数据可信
供试品溶液-G031批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1240193-24019330.29225.3824.7030.2925.3824.69
2238828-23882830.12030.12
3221712-22171227.96127.96
4195661-19566124.67624.68
5106610-10661013.44513.45
6204239-20423925.75725.76
10min1443818-44381855.97254.838.2756.0254.888.29
2474373-47437359.82559.88
3462965-46296558.38658.43
4438450-43845055.29555.34
5374918-37491847.28247.30
6414282-41428252.24752.29
15min1631201-63120179.60376.174.1479.7576.314.15
2621125-62112578.33378.48
3623392-62339278.61978.76
4597221-59722175.31875.45
5570826-57082671.98972.09
6580235-58023573.17673.31
20min1717235-71723590.45390.592.2290.7390.852.24
2743043-74304393.70893.99
3728552-72855291.88192.16
4716514-71651490.36390.62
5698667-69866788.11288.33
6705712-70571289.00089.25
30min1800002-800002100.892101.322.90101.32101.732.90
2848924-848924107.061107.50
3792468-79246899.941100.37
4787151-78715199.27199.68
5803828-803828101.374101.74
6787945-78794599.37199.77
45min1798902-798902100.753100.311.10101.35100.891.12
2802885-802885101.255101.87
3805339-805339101.565102.16
4791331-79133199.798100.37
5781733-78173398.58899.12
6792202-79220299.908100.47
极限1796206-796206100.413100.180.67101.18100.920.65
2787587-78758799.326100.11
3800303-800303100.930101.69
4794770-794770100.232100.97
5798688-798688100.726101.43
6788490-78849099.440100.17
氨溴酸替格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.606744796747076745326742196743616744600.03
214.706789936791626790780.02
单位质量响应值RSD%判断
46195.8946195.780.01数据可信
供试品溶液-G031批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1171989-17198921.60425.1328.4421.6025.1328.45
2220280-22028027.67027.67
3250366-25036631.44931.45
497053-9705312.19112.19
5233050-23305029.27429.27
6227516-22751628.57928.58
10min1481402-48140260.47056.778.2360.5156.828.24
2461306-46130657.94657.99
3460287-46028757.81857.87
4378424-37842447.53547.56
5473185-47318559.43859.49
6457194-45719457.42957.48
15min1610868-61086876.73276.963.8976.8777.093.91
2623720-62372078.34778.49
3612085-61208576.88577.03
4567578-56757871.29571.39
5627902-62790278.87279.02
6633709-63370979.60279.74
20min1735008-73500892.32691.622.1592.5991.882.16
2737600-73760092.65292.92
3722947-72294790.81191.09
4700290-70029087.96588.18
5741273-74127393.11393.39
6738992-73899292.82693.10
30min1789802-78980299.20999.690.4899.63100.110.47
2793250-79325099.642100.07
3798839-798839100.344100.77
4795579-79557999.934100.30
5789012-78901299.11099.54
6795421-79542199.915100.35
45min1789331-78933199.150100.562.2399.73101.142.19
2792895-79289599.597100.19
3791448-79144899.416100.01
4835220-835220104.914105.45
5790501-79050199.29799.90
6803837-803837100.972101.57
极限1789366-78936699.15499.590.6899.90100.340.67
2791904-79190499.473100.23
3798022-798022100.241101.00
4793482-79348299.671100.38
5784890-78489098.59299.36
6799157-799157100.384101.15
氨溴酸替格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.603381003378513381233381853381283380770.04
214.703377103378003377550.02
单位质量响应值RSD%判断
23155.9622976.530.56数据可信
供试品溶液-G246批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1136287-13628734.28633.3320.1034.2933.3320.10
2150698-15069837.91237.91
379909-7990920.10320.10
4150967-15096737.97937.98
5141548-14154835.61035.61
6135440-13544034.07334.07
10min1257796-25779664.85564.7411.2264.9164.8011.22
2278113-27811369.96670.03
3199963-19996350.30550.34
4270647-27064768.08868.15
5269067-26906767.69067.75
6268440-26844067.53267.59
15min1343099-34309986.31586.825.4386.4886.995.45
2360727-36072790.74990.93
3308757-30875777.67577.79
4355087-35508789.33089.51
5351077-35107788.32288.49
6351987-35198788.55188.72
20min1391415-39141598.47098.852.9198.7899.162.93
2402321-402321101.213101.54
3371059-37105993.34993.60
4399369-399369100.471100.80
5394250-39425099.18399.50
6399078-399078100.397100.71
30min1402116-402116101.162101.410.70101.63101.880.72
2406281-406281102.209102.71
3401067-401067100.898101.30
4405720-405720102.068102.56
5399107-399107100.405100.89
6404386-404386101.733102.22
45min1400673-400673100.799101.120.83101.44101.760.85
2405114-405114101.916102.59
3397940-397940100.111100.68
4406097-406097102.163102.83
5398984-398984100.374101.03
6402829-402829101.341101.99
极限1399195-399195100.427100.730.89101.24101.540.92
2403468-403468101.502102.34
3395292-39529299.445100.18
4404147-404147101.673102.51
5397720-397720100.056100.88
6402610-402610101.286102.11
氨溴酸替格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.603365653365123366383366273364713365630.03
214.703381053380613380830.01
单位质量响应值RSD%判断
23052.2622998.840.17数据可信
供试品溶液-G246批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1138629-13862934.93733.0115.9734.9433.0115.96
2129419-12941932.61532.62
3150419-15041937.90837.91
4132817-13281733.47233.47
5143425-14342536.14536.15
691134-9113422.96722.97
10min1268340-26834067.62665.266.0567.6865.326.06
2256532-25653264.65064.70
3278060-27806070.07570.14
4253844-25384463.97264.03
5264689-26468966.70566.77
6232323-23232358.54958.59
15min1358313-35831390.30087.823.4290.4787.993.43
2350810-35081088.40988.57
3360839-36083990.93791.12
4343135-34313586.47586.64
5349922-34992288.18588.36
6327926-32792682.64282.78
20min1399425-399425100.66199.251.72100.9899.561.74
2398422-398422100.408100.72
3400369-400369100.899101.23
4389768-38976898.22798.53
5391746-39174698.72699.04
6383190-38319096.56996.84
30min1405346-405346102.153100.950.95102.64101.430.96
2404145-404145101.850102.33
3402082-402082101.330101.83
4398403-398403100.403100.87
5396449-39644999.911100.39
6397099-397099100.075100.51
45min1401928-401928101.292100.420.94101.95101.060.95
2400118-400118100.835101.48
3402217-402217101.364102.03
4398003-398003100.302100.94
5395738-39573899.732100.38
6392720-39272098.97199.57
极限1399715-399715100.734100.560.67101.56101.370.67
2402120-402120101.340102.15
3401797-401797101.259102.10
4397241-397241100.110100.92
5395465-39546599.663100.48
6397822-397822100.257101.02
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