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500
标示量(mg)20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%
114.313327083318623318043324383326183322860.13
214.413304853302023303440.07
单位质量响应值RSD%判断
23220.5522924.640.91数据可信
供试品溶液-24062002-1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%
5min1100498-10049825.27644.1033.6725.2844.1033.66
2209822-20982252.77252.77
3224022-22402256.34456.34
4201135-20113550.58850.59
5217504-21750454.70554.70
699064-9906424.91624.92
10min1238282-23828259.93080.0218.8359.9780.1018.84
2352611-35261188.68588.77
3358626-35862690.19890.29
4348350-34835087.61487.70
5366790-36679092.25292.34
6244349-24434961.45661.50
15min1327405-32740582.34693.809.1282.4994.019.15
2392064-39206498.60898.84
3384356-38435696.67096.91
4392695-39269598.76799.00
5408022-408022102.622102.87
6333166-33316683.79583.94
20min1375426-37542694.42497.913.2094.7098.283.24
2394360-39436099.18699.59
3384173-38417396.62497.03
4394126-39412699.12799.52
5409122-409122102.899103.31
6378584-37858495.21895.50
30min1388831-38883197.79597.902.9098.2398.432.90
2392339-39233998.67799.24
3385459-38545996.94797.51
4374101-37410194.09094.65
5408541-408541102.752103.34
6386237-38623797.14397.59
45min1389520-38952097.96898.362.0498.5799.052.06
2391456-39145698.45599.19
3384049-38404996.59297.32
4389661-38966198.00498.72
5406314-406314102.192102.95
6385512-38551296.96097.56
极限1388299-38829997.66198.302.1198.4299.152.13
2391084-39108498.36299.26
3382617-38261796.23297.12
4389982-38998298.08598.96
5406463-406463102.230103.16
6386529-38652997.21697.98
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500
标示量(mg)20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%
114.313309493309333310973309893302403308420.11
214.413287403293893290640.14
单位质量响应值RSD%判断
23119.6422835.810.88数据可信
供试品溶液-24062002-1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%
5min1174582-17458244.09051.717.4044.0951.717.40
2216080-21608054.57154.57
3210331-21033153.11953.12
4207043-20704352.28852.29
5207874-20787452.49852.50
6212547-21254753.67853.68
10min1310715-31071578.47186.664.8478.5486.754.85
2355555-35555589.79589.89
3348911-34891188.11788.21
4342106-34210686.39886.49
5347633-34763387.79487.88
6353968-35396889.39489.48
15min1372006-37200693.94998.432.8194.1598.662.82
2404971-404971102.275102.52
3388810-38881098.19398.43
4390127-39012798.52698.76
5386574-38657497.62997.86
6395965-395965100.000100.24
20min1381156-38115696.26098.922.0896.6299.312.08
2405418-405418102.388102.80
3390236-39023698.55398.95
4391461-39146198.86399.26
5387248-38724897.79998.20
6394564-39456499.646100.05
30min1379089-37908995.73898.592.1996.2699.152.19
2403678-403678101.948102.53
3388840-38884098.20198.76
4391904-39190498.97599.53
5384282-38428297.05097.61
6394468-39446899.622100.19
45min1380435-38043596.07898.751.9996.7699.482.00
2403597-403597101.928102.68
3388896-38889698.21598.94
4390993-39099398.74599.47
5387464-38746497.85398.57
6394776-39477699.700100.44
极限1379325-37932595.79898.001.9996.6498.891.99
2401417-401417101.377102.30
3385945-38594597.47098.36
4386927-38692797.71898.61
5383171-38317196.76997.65
6391423-39142398.85399.76
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500
标示量(mg)20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%
114.313304993289263298063289873299183296270.21
214.413289593296213292900.15
单位质量响应值RSD%判断
23034.7322851.490.57数据可信
供试品溶液-24062002-1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%
5min1164856-16485641.69646.7417.0641.7046.7417.05
2200432-20043250.69450.69
3220296-22029655.71855.72
4169648-16964842.90842.91
5213624-21362454.03154.03
6140026-14002635.41635.42
10min1300753-30075376.06881.8111.3476.1481.8911.34
2346180-34618087.55787.64
3369684-36968493.50293.59
4307235-30723577.70777.78
5346096-34609687.53687.63
6270767-27076768.48368.54
15min1375360-37536094.93796.334.6695.1396.554.68
2393386-39338699.49799.73
3402691-402691101.850102.10
4371653-37165394.00094.20
5388883-38888398.35898.59
6353285-35328589.35489.53
20min1391720-39172099.07599.392.1899.4399.772.20
2397035-397035100.420100.82
3407438-407438103.051103.47
4382240-38224096.67897.04
5388806-38880698.33898.74
6390543-39054398.77899.10
30min1395996-395996100.15799.422.21100.6899.962.20
2389309-38930998.46599.03
3404302-404302102.258102.85
4381482-38148296.48697.00
5386945-38694597.86898.43
6400490-400490101.293101.78
45min1386475-38647597.74998.932.4298.4499.642.42
2391339-39133998.97999.71
3402052-402052101.688102.45
4377267-37726795.42096.10
5388355-38835598.22498.95
6401467-401467101.540102.20
极限1393777-39377799.59699.182.53100.44100.062.52
2391520-39152099.02599.92
3402465-402465101.793102.72
4377067-37706795.36996.21
5385502-38550297.50398.39
6402579-402579101.822102.65
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500
标示量(mg)20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%
114.313274943272573276253272553267213272700.11
214.413275033273943274480.03
单位质量响应值RSD%判断
22870.0222723.660.46数据可信
供试品溶液-24062002-1批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1203081-20308151.69346.6823.5751.6946.6823.57
298585-9858525.09425.09
3202653-20265351.58451.58
4219025-21902555.75255.75
5194072-19407249.40049.40
6182912-18291246.55946.56
10min1343830-34383087.52080.6517.4687.6180.7317.47
2208340-20834053.03253.07
3340125-34012586.57786.66
4361550-36155092.03192.12
5332465-33246584.62784.71
6314750-31475080.11880.20
15min1388013-38801398.76794.7111.2299.0094.9211.24
2287903-28790373.28473.41
3386980-38698098.50498.73
4398327-398327101.392101.64
5392153-39215399.821100.04
6378968-37896896.46496.68
20min1388299-38829998.84097.605.6199.2497.965.65
2341121-34112186.83187.08
3387504-38750498.63799.03
4398668-398668101.479101.89
5398869-398869101.530101.92
6386032-38603298.26398.63
30min1386380-38638098.35199.631.5598.91100.161.54
2394610-394610100.446100.84
3385976-38597698.24898.81
4397460-397460101.171101.76
5398313-398313101.389101.95
6385621-38562198.15898.69
45min1386471-38647198.37499.652.0699.10100.342.01
2402660-402660102.495103.06
3383778-38377897.68998.41
4396388-396388100.899101.65
5396204-396204100.852101.58
6383285-38328597.56398.26
极限1386608-38660898.40999.832.2999.30100.702.23
2405005-405005103.092103.83
3383237-38323797.55198.44
4396304-396304100.877101.80
5398312-398312101.388102.28
6383756-38375697.68398.55
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