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%
114.793418423410923416443411823419223415360.12
214.843421313416253418780.11
单位质量响应值RSD%判断
23092.3623037.600.17数据可信
供试品溶液-H328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%
5min1140821-14082135.42838.834.8435.4338.824.84
2152038-15203838.25038.25
3160709-16070940.43240.43
4155352-15535239.08439.08
5161140-16114040.54040.54
6155906-15590639.22339.22
10min1342193-34219386.09089.442.0686.1589.502.06
2353331-35333188.89288.96
3360882-36088290.79290.86
4355131-35513189.34589.41
5360704-36070490.74790.81
6360798-36079890.77190.84
15min1403271-403271101.456102.471.18101.66102.681.17
2410723-410723103.331103.54
3400782-400782100.830101.05
4409966-409966103.141103.35
5413159-413159103.944104.16
6405868-405868102.110102.33
20min1403770-403770101.582102.531.28101.95102.921.28
2411599-411599103.552103.94
3400258-400258100.698101.09
4409500-409500103.023103.41
5414190-414190104.203104.60
6405983-405983102.139102.53
30min1402724-402724101.319102.261.23101.86102.821.23
2409972-409972103.142103.70
3399281-399281100.453101.01
4408825-408825102.854103.41
5412693-412693103.827104.39
6405268-405268101.959102.52
45min1404973-404973101.885102.051.27102.59102.771.27
2409001-409001102.898103.63
3397325-39732599.960100.68
4407004-407004102.396103.12
5412180-412180103.698104.44
6403272-403272101.457102.18
极限1401025-401025100.891101.721.33101.77102.621.32
2408001-408001102.646103.55
3396885-39688599.850100.74
4407493-407493102.519103.42
5411030-411030103.408104.32
6401528-401528101.018101.91
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%
114.793396043396023400273399953401613398780.08
214.843397963396753397360.03
单位质量响应值RSD%判断
22980.2622893.260.27数据可信
供试品溶液-H328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%
5min1163229-16322941.29540.316.6141.3040.316.61
2151699-15169938.37838.38
3156910-15691039.69739.70
4154803-15480339.16439.16
5178792-17879245.23345.23
6150620-15062038.10538.11
10min1351145-35114588.83688.393.7588.9188.463.76
2352240-35224089.11389.18
3339101-33910185.78985.86
4349745-34974588.48288.55
5371100-37110093.88593.96
6332973-33297384.23984.30
15min1400949-400949101.436102.341.07101.65102.561.08
2401014-401014101.453101.67
3408466-408466103.338103.55
4408204-408204103.272103.48
5408686-408686103.394103.63
6399855-399855101.160101.36
20min1400291-400291101.270102.201.06101.66102.581.06
2401327-401327101.532101.91
3408341-408341103.306103.69
4408436-408436103.330103.72
5406372-406372102.808103.21
6398958-398958100.933101.31
30min1399927-399927101.178102.141.11101.73102.701.11
2400734-400734101.382101.93
3408428-408428103.328103.88
4407460-407460103.084103.64
5407326-407326103.050103.63
6398589-398589100.839101.38
45min1398538-398538100.826101.821.06101.55102.541.06
2399510-399510101.072101.79
3407070-407070102.985103.71
4405789-405789102.661103.39
5406036-406036102.723103.47
6397841-397841100.650101.36
极限1398313-398313100.769101.630.94101.66102.520.94
2399393-399393101.043101.93
3405268-405268102.529103.43
4404961-404961102.451103.35
5405048-405048102.473103.39
6397293-397293100.511101.39
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