地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DRm0341024-D对照品来源自制对照品对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.442125364212600421271842127436212767921267330.05
210.232167585216900821682960.05
单位质量响应值RSD%判断
203710.06211954.642.81数据不可信!(响应值差异过大,请重新称样测定!)
加速6月-供试品溶液-含0.5%吐温20的pH6.8
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121120452532046080204566698.4799.232.3296.81%~101.64%
2208287720832942083086100.27
3209483821002662097552100.96
4211422921169452115587101.83
520459152042736204432698.40
619814501984296198287395.44
2024030221119830731983319198319695.4697.891.5296.33%~99.45%
220265472027834202719097.58
320568282053469205514898.92
420279832026114202704897.57
520341142035808203496197.95
620628242086167207449699.86
2024030321119901671997372199377095.9798.292.0496.18%~100.39%
220632722065778206452599.38
3209666720985512097609100.97
420722962070234207126599.70
520195722017633201860297.16
620051172006224200567096.54
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DRm0341024-D对照品来源自制对照品对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.442229981222694922241192221014222065722245440.18
210.232140085214041621402500.02
单位质量响应值RSD%判断
213078.93209213.101.30数据可信
长期6月-供试品溶液
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121120754062076942207617498.3495.242.9092.35%~98.13%
219807011979910198030693.80
320499532058372205416297.29
420464162052719204956897.08
519243031925847192507591.18
619970871961988197953893.76
2024030221119029571905748190435290.2093.752.1291.66%~95.83%
219584121959800195910692.79
320208402023558202219995.78
419963281998142199723594.60
519899931995021199250794.37
619942542006280200026794.74
2024030321119223841930975192668091.2693.171.8991.33%~95.01%
219327911931564193217891.52
320211082023392202225095.78
419941831995540199486294.49
519754791932229195385492.54
619724991972813197265693.43
地拉罗司颗粒项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DRm0341024-D对照品来源自制对照品对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数100
标示量(mg)360供试品稀释倍数4系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.442245416225310022511312240184223698922453640.31
210.232244192224771022459510.12
单位质量响应值RSD%判断
215073.18219545.551.46数据可信
中间条件6月-供试品溶液
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121120361452036087203611693.7193.541.1992.37%~94.70%
220385282039111203882093.83
320434812044636204405894.07
420672112066045206662895.11
520045532006032200529292.29
620035882003405200349692.21
2024030221120082612008085200817392.4293.571.0792.52%~94.62%
220153512014884201511892.74
320668422068297206757095.15
420386162040606203961193.87
520256552023181202441893.17
620423332045049204369194.06
2024030321120036352001722200267892.1794.531.5792.98%~96.08%
220358552035078203546693.68
320843772084718208454895.94
420869712090086208852896.12
520516732052349205201194.44
620590482061769206040894.82
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