替普瑞酮颗粒项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1110.05483735433055493395523615532815493320.72
2111.25668875674995671930.08
单位质量响应值RSD%判断
4993.935100.661.50数据可信
供试品溶液-2025112021批-pH4.0(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1394380-39438069.20668.671.7469.2168.671.74
2394617-39461769.24769.25
3399804-39980470.15870.16
4380278-38027866.73166.73
5387252-38725267.95567.95
6391648-39164868.72668.73
10min1455138-45513879.86877.102.2079.9877.222.20
2441282-44128277.43677.55
3442151-44215177.58977.71
4425953-42595374.74674.86
5435156-43515676.36176.47
6436601-43660176.61576.73
15min1468867-46886782.27780.482.0582.5380.732.05
2462940-46294081.23781.48
3466532-46653281.86782.11
4443949-44394977.90478.14
5457009-45700980.19680.44
6452641-45264179.42979.67
20min1480935-48093584.39482.691.7584.7883.071.75
2475215-47521583.39183.77
3477553-47755383.80184.18
4458515-45851580.46080.83
5468039-46803982.13282.51
6467141-46714181.97482.35
30min1495382-49538286.93084.792.0587.4685.302.05
2489569-48956985.91086.43
3489658-48965885.92586.45
4469553-46955382.39782.90
5479179-47917984.08684.60
6475733-47573383.48283.99
45min1499018-49901887.56886.321.5488.2486.971.54
2496008-49600887.04087.70
3497575-49757587.31487.98
4478560-47856083.97884.61
5489928-48992885.97386.62
6490289-49028986.03686.69
60min1512948-51294890.01288.031.9190.8388.831.91
2506471-50647188.87689.68
3505694-50569488.73989.55
4485068-48506885.12085.90
5497729-49772987.34288.14
6502096-50209688.10888.90
90min1521333-52133391.48489.251.9992.4590.191.99
2514197-51419790.23191.19
3514040-51404090.20491.16
4492773-49277386.47287.39
5506121-50612188.81489.75
6503063-50306388.27889.22
120min1520747-52074791.38189.591.8492.5090.691.84
2515841-51584190.52091.63
3515263-51526390.41891.53
4493862-49386286.66387.73
5508707-50870789.26890.36
6508880-50888089.29890.39
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1523032-52303291.78290.281.5293.0591.531.53
2517812-51781290.86692.12
3519396-51939691.14492.40
4500597-50059787.84589.05
5512662-51266289.96291.20
6513498-51349890.10991.35
替普瑞酮颗粒项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1110.05587775593265589985580175580035586240.11
2111.25702925709165706040.08
单位质量响应值RSD%判断
5078.405131.330.74数据可信
供试品溶液-2025112021批-pH4.0(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1394691-39469168.47368.401.3168.4768.401.31
2398626-39862669.15669.16
3395471-39547168.60968.61
4384325-38432566.67566.68
5394687-39468768.47368.47
6397804-39780469.01469.01
10min1438446-43844676.06476.051.0276.1876.161.02
2442793-44279376.81876.93
3437607-43760775.91976.03
4430337-43033774.65874.77
5442261-44226176.72676.84
6438816-43881676.12976.24
15min1459736-45973679.75879.651.3080.0079.891.30
2465822-46582280.81481.06
3462850-46285080.29880.54
4448732-44873277.84978.08
5460865-46086579.95480.20
6456660-45666079.22479.47
20min1465581-46558180.77281.090.6281.1581.470.62
2469571-46957181.46481.84
3470248-47024881.58281.96
4462779-46277980.28680.65
5467032-46703281.02481.40
6469433-46943381.44081.81
30min1482044-48204483.62883.460.6184.1483.970.61
2482223-48222383.65984.17
3485146-48514684.16684.68
4476341-47634182.63983.14
5480567-48056783.37283.88
6480199-48019983.30883.82
45min1492247-49224785.39885.210.7786.0585.860.77
2491832-49183285.32685.98
3494574-49457485.80286.45
4483855-48385583.94284.58
5492886-49288685.50986.16
6491472-49147285.26485.91
60min1498316-49831686.45186.280.6287.2487.070.62
2497680-49768086.34187.14
3500018-50001886.74687.54
4491682-49168285.30086.08
5496488-49648886.13486.93
6499681-49968186.68887.48
90min1507063-50706387.96887.720.7588.9088.660.75
2504747-50474787.56788.51
3510077-51007788.49189.43
4498949-49894986.56187.48
5505661-50566187.72588.66
6507443-50744388.03488.97
120min1510345-51034588.53888.490.7889.6289.570.78
2509720-50972088.42989.51
3515024-51502489.35090.44
4502991-50299187.26288.33
5511395-51139588.72089.80
6511018-51101888.65589.74
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1513457-51345789.07889.080.4190.3190.310.42
2512992-51299288.99790.23
3515970-51597089.51490.75
4509737-50973788.43289.64
5514151-51415189.19890.43
6514455-51445589.25190.48
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