氢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%
114.59 3305253316653318363322703323573317310.23
214.513328063327743327900.01
单位质量响应值RSD%判断
22736.8722935.220.62数据可信
供试品溶液-H322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%
5min1145074-14507436.86533.9611.1336.8633.9611.13
2139590-13959035.47135.47
3140450-14045035.69035.69
4115571-11557129.36829.37
5114013-11401328.97228.97
6147131-14713137.38737.39
10min1265602-26560267.49267.353.5767.5567.413.57
2277839-27783970.60270.66
3263051-26305166.84466.90
4251406-25140663.88563.93
5259526-25952665.94866.00
6272870-27287069.33969.40
15min1355279-35527990.28089.631.8890.4589.801.89
2358536-35853691.10891.28
3353727-35372789.88690.06
4340067-34006786.41486.57
5351870-35187089.41489.57
6356866-35686690.68390.86
20min1398369-398369101.230101.050.90101.55101.370.90
2397659-397659101.049101.38
3395501-395501100.501100.82
4394270-394270100.188100.49
5404304-404304102.738103.04
6395881-395881100.597100.93
30min1395280-395280100.445100.952.19100.94101.442.17
2399540-399540101.527102.02
3398058-398058101.151101.64
4404255-404255102.725103.19
5405165-405165102.957103.44
6381300-38130096.89297.39
45min1396818-396818100.835101.541.25101.50102.191.24
2393747-393747100.055100.72
3396081-396081100.648101.31
4400316-400316101.724102.36
5406867-406867103.389104.04
6403616-403616102.563103.22
极限1397398-397398100.983101.440.69101.81102.270.68
2398654-398654101.302102.14
3395293-395293100.448101.27
4402889-402889102.378103.19
5401240-401240101.959102.78
6399822-399822101.599102.43
氢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%
114.59 3325843327053318113323313329843324830.14
214.513301273303813302540.06
单位质量响应值RSD%判断
22788.4222760.440.09数据可信
供试品溶液-H322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%
5min199413-9941325.33029.1418.4325.3329.1418.43
2107842-10784227.47727.48
3125183-12518331.89631.90
492590-9259023.59123.59
5151008-15100838.47638.48
6110069-11006928.04528.04
10min1260668-26066866.41667.345.1566.4667.395.16
2246594-24659462.83062.88
3268600-26860068.43768.49
4255657-25565765.14065.18
5286515-28651573.00273.07
6267676-26767668.20268.25
15min1359221-35922191.52790.431.5991.6890.591.59
2344277-34427787.71987.87
3357967-35796791.20791.37
4355021-35502190.45790.60
5358916-35891691.44991.64
6354126-35412690.22990.39
20min1407864-407864103.921101.891.49104.23102.201.50
2393197-393197100.184100.48
3397662-397662101.321101.64
4395986-395986100.894101.19
5406553-406553103.587103.93
6398168-398168101.450101.76
30min1406364-406364103.539102.151.03104.02102.641.02
2403881-403881102.906103.37
3397695-397695101.330101.82
4400676-400676102.089102.56
5394989-394989100.640101.15
6401958-401958102.416102.90
45min1404939-404939103.176103.012.14103.83103.662.12
2404634-404634103.098103.73
3420246-420246107.076107.73
4398413-398413101.513102.15
5395572-395572100.789101.47
6401969-401969102.419103.07
极限1403729-403729102.867101.831.25103.69102.651.24
2402234-402234102.486103.29
3403687-403687102.857103.69
4393351-393351100.223101.03
5393246-393246100.196101.04
6401600-401600102.325103.15
氢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%
114.59 6678436708776691886689306673686688410.21
214.516686246699866693050.15
单位质量响应值RSD%判断
45842.4346127.150.44数据可信
供试品溶液-H042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%
5min1235050-23505029.66120.8841.3929.6620.8841.38
297642-9764212.32112.32
3248981-24898131.41931.42
495452-9545212.04512.05
5189357-18935723.89523.89
6126178-12617815.92215.92
10min1448504-44850456.59750.4517.1256.6550.4817.13
2305143-30514338.50638.53
3491320-49132062.00062.05
4341247-34124743.06243.08
5396887-39688750.08350.12
6415671-41567152.45352.48
15min1628371-62837179.29474.017.8879.4474.137.90
2515773-51577365.08565.17
3638818-63881880.61280.77
4560190-56019070.69070.78
5572550-57255072.25072.37
6603276-60327676.12776.24
20min1731992-73199292.37089.684.0092.6589.924.02
2665609-66560983.99384.19
3739294-73929493.29193.58
4698301-69830188.11988.33
5698051-69805188.08788.33
6730853-73085392.22692.47
30min1790344-79034499.733100.400.85100.16100.800.84
2799622-799622100.904101.24
3799750-799750100.920101.37
4800254-800254100.984101.34
5784296-78429698.97099.36
6799730-799730100.918101.31
45min1792079-79207999.952100.520.61100.55101.080.60
2801295-801295101.115101.62
3801370-801370101.125101.74
4797520-797520100.639101.16
5789685-78968599.650100.21
6797472-797472100.633101.20
极限1790161-79016199.710100.260.73100.47100.990.72
2799508-799508100.890101.56
3795848-795848100.428101.21
4798665-798665100.783101.48
5784903-78490399.04799.77
6798096-798096100.712101.44
氢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%
114.59 6629066631946619706614846616326622370.12
214.516678066688866683460.12
单位质量响应值RSD%判断
45389.7946061.061.04数据可信
供试品溶液-H042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%
5min1163918-16391820.80323.6022.9620.8023.6022.96
2230103-23010329.20329.20
3123200-12320015.63515.64
4220700-22070028.00928.01
5216535-21653527.48127.48
6161488-16148820.49520.49
10min1414128-41412852.55854.938.5852.5954.978.59
2473991-47399160.15560.20
3370385-37038547.00647.03
4462139-46213958.65158.70
5434442-43444255.13655.18
6442051-44205156.10156.14
15min1596393-59639375.68975.793.1575.8175.923.16
2621209-62120978.83878.99
3567122-56712271.97472.08
4612644-61264477.75177.90
5593005-59300575.25975.40
6592678-59267875.21875.35
20min1717723-71772391.08790.821.6791.3491.081.69
2732037-73203792.90493.18
3696301-69630188.36888.59
4721134-72113491.52091.79
5709907-70990790.09590.36
6716686-71668690.95691.21
30min1794709-794709100.858101.060.47101.26101.470.45
2793266-793266100.674101.11
3801601-801601101.732102.10
4793328-793328100.682101.11
5794580-794580100.841101.25
6800482-800482101.590101.99
45min1794388-794388100.817100.850.60101.39101.430.59
2786942-78694299.872100.47
3797534-797534101.216101.76
4792153-792153100.533101.13
5796472-796472101.081101.66
6800572-800572101.602102.18
极限1794482-794482100.829100.710.67101.57101.460.65
2784774-78477499.597100.37
3798398-798398101.326102.04
4793656-793656100.724101.49
5791022-791022100.390101.14
6799029-799029101.406102.15
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