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MAD-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(%)94.94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%
114.884531194537054532224533344538564534470.08
214.884531004538164534580.12
单位质量响应值RSD%判断
30473.5930474.330.01数据可信
供试品溶液-24020201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%
5min1277717-27771752.82649.7710.7752.8349.7710.77
2288804-28880454.93554.94
3209343-20934339.82139.82
4274385-27438552.19352.19
5265366-26536650.47750.48
6254135-25413548.34148.34
10min1470533-47053389.50387.197.0889.5987.277.08
2481894-48189491.66491.76
3394010-39401074.94775.01
4476702-47670290.67790.76
5466857-46685788.80488.89
6460182-46018287.53487.61
15min1526286-526286100.10899.572.05100.3599.802.06
2534647-534647101.699101.94
3502917-50291795.66395.85
4525303-52530399.921100.16
5524978-52497899.860100.09
6526595-526595100.167100.39
20min1528196-528196100.472100.360.64100.88100.760.64
2533880-533880101.553101.97
3526252-526252100.102100.45
4524840-52484099.833100.24
5525111-52511199.885100.28
6527514-527514100.342100.74
30min1526765-526765100.200100.330.67100.77100.890.68
2534301-534301101.633102.22
3527760-527760100.389100.91
4525388-52538899.938100.51
5524601-52460199.788100.35
6525923-525923100.039100.60
45min1526367-526367100.124100.260.72100.86100.990.72
2533531-533531101.487102.24
3525893-525893100.034100.72
4523809-52380999.637100.37
5523675-52367599.612100.34
6529330-529330100.687101.41
60min1525163-52516399.89599.970.65100.80100.860.65
2532143-532143101.223102.14
3525685-52568599.994100.85
4523013-52301399.486100.39
5523281-52328199.537100.43
6523932-52393299.661100.56
极限1524322-52432299.73599.770.65100.81100.840.66
2531133-531133101.030102.12
3523551-52355199.588100.61
4522320-52232099.354100.42
5521747-52174799.245100.31
6524076-52407699.688100.75
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MAD-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(%)94.94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%
114.884527914537064538424539514533054535190.11
214.884525544518404521970.12
单位质量响应值RSD%判断
30478.4330389.580.21数据可信
供试品溶液-24020203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%
5min1469524-46952489.42984.536.6689.4384.536.66
2462256-46225688.04488.04
3473570-47357090.19990.20
4424838-42483880.91880.92
5433773-43377382.61982.62
6398921-39892175.98175.98
10min1528322-528322100.62899.640.99100.7899.780.99
2524789-52478999.955100.10
3522673-52267399.55299.70
4516439-51643998.36598.50
5528601-528601100.681100.82
6517932-51793298.64998.78
15min1528887-528887100.735100.150.73101.05100.450.73
2525915-525915100.169100.48
3524453-52445399.891100.21
4519077-51907798.86799.17
5529743-529743100.898101.20
6526692-526692100.317100.61
20min1527705-527705100.510100.110.60100.99100.580.59
2524391-52439199.879100.36
3523080-52308099.629100.11
4521506-52150699.33099.79
5529730-529730100.896101.37
6527108-527108100.397100.85
30min1528036-528036100.57399.950.61101.23100.590.61
2524613-52461399.921100.57
3522287-52228799.478100.13
4520276-52027699.09599.72
5528347-528347100.633101.27
6524962-52496299.988100.61
45min1526231-526231100.23099.820.59101.05100.630.59
2523704-52370499.748100.56
3521405-52140599.310100.12
4520086-52008699.05999.85
5528348-528348100.633101.44
6524776-52477699.952100.74
60min1525025-525025100.00099.600.62100.99100.580.62
2522947-52294799.604100.58
3519599-51959998.96699.95
4518773-51877398.80999.77
5527011-527011100.378101.36
6524359-52435999.873100.83
极限1522642-52264299.54699.340.56100.70100.480.56
2521973-52197399.419100.56
3518812-51881298.81699.96
4517804-51780498.62499.75
5525856-525856100.158101.30
6522368-52236899.494100.62
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