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%
114.373419133424293440583431663420343427200.27
214.443431443451853441640.42
单位质量响应值RSD%判断
23849.6923834.070.05数据可信
供试品溶液-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%
5min1182806-18280644.49247.3417.1944.4947.3417.19
2215255-21525552.39052.39
3168963-16896341.12341.12
4146710-14671035.70735.71
5224531-22453154.64854.65
6228878-22887855.70655.71
10min1323766-32376678.80081.589.2878.8781.669.28
2364958-36495888.82588.91
3308562-30856275.09975.17
4292647-29264771.22671.29
5362642-36264288.26288.35
6358470-35847087.24687.34
15min1388502-38850294.55694.142.8894.7694.362.90
2395876-39587696.35096.59
3383717-38371793.39193.58
4366094-36609489.10289.28
5390897-39089795.13995.38
6395737-39573796.31796.55
20min1389429-38942994.78196.331.0495.1496.701.05
2396517-39651796.50696.90
3393730-39373095.82896.18
4399121-39912197.14097.47
5394932-39493296.12196.52
6401012-40101297.60098.00
30min1398649-39864997.02596.280.8097.5596.820.78
2391691-39169195.33295.89
3394381-39438195.98796.50
4398685-39868597.03497.52
5392458-39245895.51996.08
6397661-39766196.78597.35
45min1395348-39534896.22296.030.5596.9096.720.54
2396002-39600296.38197.10
3392022-39202295.41296.08
4396135-39613596.41397.06
5391644-39164495.32096.04
6396241-39624196.43997.16
极限1395251-39525196.19895.880.7797.0496.730.78
2395950-39595096.36897.24
3388624-38862494.58595.41
4395686-39568696.30497.12
5391964-39196495.39896.27
6396174-39617496.42397.31
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%
114.373433523432683443113442553448383440050.20
214.443442353440203441280.05
单位质量响应值RSD%判断
23939.1123831.580.32数据可信
供试品溶液-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%
5min1195104-19510447.39942.7523.4947.4042.7523.50
2195512-19551247.49847.50
3198278-19827848.17048.17
497446-9744623.67423.67
5162637-16263739.51239.51
6206796-20679650.24050.24
10min1339016-33901682.36277.3913.0782.4477.4613.08
2340948-34094882.83182.91
3343213-34321383.38183.46
4239407-23940758.16258.20
5304333-30433373.93674.00
6344288-34428883.64383.73
15min1397196-39719696.49693.027.1796.7193.227.19
2397370-39737096.53996.76
3401648-40164897.57897.80
4330174-33017480.21480.35
5375356-37535691.19091.38
6395624-39562496.11496.34
20min1399682-39968297.10095.891.9397.4896.251.96
2398110-39811096.71897.10
3404091-40409198.17198.55
4383069-38306993.06493.33
5389369-38936994.59594.94
6393966-39396695.71296.09
30min1395871-39587196.17496.171.2496.7196.691.25
2397526-39752696.57697.12
3403519-40351998.03298.58
4395714-39571496.13696.56
5388383-38838394.35594.85
6394220-39422095.77396.32
45min1398233-39823396.74896.431.2897.4597.111.28
2395332-39533296.04396.74
3403331-40333197.98798.70
4397850-39785096.65597.24
5388100-38810094.28694.94
6398741-39874196.87297.57
极限1399162-39916296.97496.181.3697.8397.021.37
2396205-39620596.25597.12
3402260-40226097.72698.60
4396946-39694696.43597.18
5386383-38638393.86994.68
6394452-39445295.83096.69
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%
114.373444213441333439993444243439603441870.07
214.443435683452353444020.35
单位质量响应值RSD%判断
23951.7723850.550.30数据可信
供试品溶液-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%
5min1189023-18902345.89246.826.2545.8946.826.26
2186423-18642345.26045.26
3204455-20445549.63849.64
4210010-21001050.98750.99
5177703-17770343.14343.14
6189450-18945045.99546.00
10min1330420-33042080.22081.885.1680.3081.965.16
2328721-32872179.80879.88
3356628-35662886.58386.67
4360253-36025387.46387.55
5315981-31598176.71576.79
6331572-33157280.50080.58
15min1392535-39253595.30196.122.5595.5196.342.56
2392105-39210595.19695.40
3399646-39964697.02797.25
4412755-412755100.210100.44
5382280-38228092.81193.01
6396191-39619196.18896.40
20min1394469-39446995.77096.791.9896.1497.161.98
2398243-39824396.68697.05
3399956-39995697.10297.49
4411750-41175099.966100.36
5387842-38784294.16194.52
6399665-39966597.03297.40
30min1394491-39449195.77696.592.0496.3097.122.05
2397246-39724696.44496.97
3396034-39603496.15096.70
4410687-41068799.708100.27
5386441-38644193.82194.33
6402080-40208097.61898.15
45min1394327-39432795.73696.461.9596.4297.151.96
2395830-39583096.10196.79
3396640-39664096.29797.01
4410040-41004099.551100.28
5386514-38651493.83994.51
6400402-40040297.21197.91
极限1391667-39166795.09096.311.8895.9497.171.89
2396202-39620296.19197.04
3398078-39807896.64697.52
4408291-40829199.126100.02
5386385-38638593.80894.63
6399590-39959097.01497.87
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