盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)0
对照品批号420158-202301对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.612180002180922180032177382175322178730.11
216.652169642179232174440.32
单位质量响应值RSD%判断
13116.9813059.700.31数据可信
长期12月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
1批119406519382919394799.0999.361.8097.50%～101.23%
218853318787218820296.16
3195837195817195827100.05
4198573198652198612101.48
5195711196076195894100.09
619468819405819437399.31
1批1196000195452195726100.0098.841.7097.08%～100.59%
2197556198138197847101.08
318830018800418815296.13
419222619252119237498.29
519320519289719305198.63
619373619333719353698.88
1批119348619267119307898.6599.262.3796.79%～101.73%
2200780201233201006102.70
3198246198593198420101.38
418964318979918972196.93
519349619396119372898.98
618988218954918971696.93
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)0
对照品批号420158-202301对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.612186272188522192782192012188462189610.13
216.652204652201712203180.10
单位质量响应值RSD%判断
13182.4813232.310.27数据可信
长期12月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
1批119279319298519288997.6697.320.8796.43%～98.21%
219226719304219265497.54
319155119140019147696.95
419411819418819415398.30
518931718920818926295.83
619296919272119284597.64
1批119371319401519386498.1699.621.5198.05%～101.20%
2197732197352197542100.02
3201338201696201517102.03
4198129197979198054100.28
519379319342419360898.03
619595919595819595899.22
1批118965018977918971496.0696.871.6595.20%～98.54%
219754519709019731899.91
318853218853018853195.46
419183119213319198297.20
519046219032019039196.40
618987219008118997696.19
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)0
对照品批号420158-202301对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.612191202193452191552196602193572193270.10
216.652174842177302176070.08
单位质量响应值RSD%判断
13204.5213069.490.73数据可信
长期12月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
1批1197752197466197609100.59100.832.2698.44%～103.22%
218969118955718962496.53
3198362198465198414101.00
4201870202092201981102.82
5199315199337199326101.47
6201548201377201462102.55
1批1198295198612198454101.02100.921.9498.87%～102.97%
2203236202963203100103.39
319559019567019563099.58
419486719479919483399.18
519453719504419479099.16
6202749202614202682103.17
1批119393419348519371098.61100.661.4899.10%～102.21%
2201659201619201639102.64
3199424199345199384101.49
4199091199406199248101.43
5196993197193197093100.33
619556719512719534799.44
盐酸达泊西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)0
对照品批号420158-202301对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.612203672204752206792204612205822205130.06
216.652215062204292209680.35
单位质量响应值RSD%判断
13275.9213271.350.03数据可信
长期12月-供试品溶液-pH1.0
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
1批119217119239419228296.8796.720.9695.75%～97.70%
219275019293419284297.15
319211019222519216896.81
418874018904418889295.16
519132719135719134296.40
619444919444619444897.96
1批119076019095719085896.1599.032.2896.66%～101.40%
219230619212819221796.84
3197868200223199046100.28
4202467203438202952102.24
519601419982219791899.71
619547219735619641498.95
1批118796818950418873695.0898.091.7096.34%～99.84%
219622819541619582298.65
319364319324619344497.45
419492619566119529498.39
519768619656519712699.31
619753419810419781999.66
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