依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号RSF-703-230318-D对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.081696891696021697361698301697821697280.06
211.041698231699201698720.05
单位质量响应值RSD%判断
15318.4115386.960.32数据可信
加速6月-供试品溶液-瑞舒伐他汀钙-pH4.5(内含0.2%Tween80)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121117379417406417392997.01100.942.4598.35%～103.54%
2184784184860184822103.08
3182503182298182400101.73
4185311185470185390103.40
5181819181833181826101.41
617748217767217757799.04
20240302211185720185769185744103.60102.922.23100.52%～105.33%
2183973184008183990102.62
317693717683317688598.66
4189136189112189124105.48
5185975186038186006103.74
6185529185417185473103.45
2024030321117539617536317538097.8299.422.4996.83%～102.02%
217343517350317346996.75
317609017586917598098.15
4180372180122180247100.53
517862417868317865499.64
6185634186081185858103.66
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-D对照品来源工作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5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.071850881850491850101852911854031851680.10
211.071845271850141847700.19
单位质量响应值RSD%判断
16727.0116691.060.16数据可信
加速6月-供试品溶液-依折麦布-pH4.5(内含0.2%Tween80)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121117799317787317793395.8497.981.1796.78%～99.17%
218273118277818275498.44
318211818211518211698.09
418127018158218142697.72
518408718359318384099.02
618321018340518330898.74
20240302211185932186150186041100.21100.771.2399.47%～102.07%
2190268190292190280102.49
318510918503918507499.69
4188650188502188576101.57
5188127188289188208101.37
618442518422718432699.28
2024030321117461517487017474294.1297.341.6995.61%～99.06%
218043918051718047897.21
318192118166518179397.92
418171618162218166997.85
518266918325218296098.55
618222618303718263298.37
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号RSF-703-230318-D对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.081702631704871704771705201705991704690.08
211.041710351711111710730.04
单位质量响应值RSD%判断
15385.2915495.740.51数据可信
长期6月-供试品溶液-瑞舒伐他汀钙-pH4.5(内含0.2%Tween80)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121116909816889316899693.7298.752.5396.13%～101.37%
2180501180801180651100.18
3180666180469180568100.14
417992317982517987499.75
517966017973217969699.65
617857117868717862999.06
2024030221116896116899016897693.7199.313.4595.72%～102.90%
217542517547117544897.30
3183558183753183656101.85
417836217849717843098.95
5182137182331182234101.06
6185588185800185694102.98
2024030321117979117968417973899.68101.101.7299.28%～102.92%
217981018015817998499.81
3181315181645181480100.64
4186476186937186706103.54
5185872185724185798103.04
618015418016818016199.91
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-D对照品来源工作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5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.071854911861641861021857841858951858870.15
211.071865721868191866960.10
单位质量响应值RSD%判断
16791.9616865.040.31数据可信
长期6月-供试品溶液-依折麦布-pH4.5(内含0.2%Tween80)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121118037318015618026496.4198.341.1897.13%～99.56%
218244718231818238297.54
318597618602218599999.47
418427318419318423398.53
518456518563818510298.99
618522818550118536499.13
2024030221117696117707917702094.6797.321.7495.55%～99.10%
217976617978017977396.14
318587618584018585899.40
418403318411218407298.44
518209418211718210697.39
618303918305118304597.89
2024030321118540618567418554099.2398.791.3897.37%～100.21%
218445218515218480298.83
317986118051618018896.37
4187098187757187428100.24
518633518654818644299.71
618374118408518391398.36
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号RSF-703-230318-D对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)98.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.081705151707521706341709051708411707290.10
211.041709371713491711430.18
单位质量响应值RSD%判断
15408.7515502.080.43数据可信
中间条件6月-供试品溶液-瑞舒伐他汀钙-pH4.5(内含0.2%Tween80)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121117088717140217114494.8299.772.7196.94%～102.61%
217961117971217966299.54
3181386181369181378100.49
4184913185318185116102.56
5183333183685183509101.67
617966017975617970899.56
2024030221117129217133917131694.9298.802.7096.01%～101.60%
217968317975517971999.57
317572517566317569497.34
417888317888017888299.11
5185760186033185896102.99
617852817839917846498.88
2024030321116118916184116151589.4898.324.4793.71%～102.93%
217919017936317927699.33
3181644181654181649100.64
4181265180720180992100.28
517881117925817903499.19
6182139182509182324101.01
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-D对照品来源工作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5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.071854801859481861741865481866201861540.26
211.071857631864641861140.27
单位质量响应值RSD%判断
16816.0816812.470.02数据可信
中间条件6月-供试品溶液-依折麦布-pH4.5(内含0.2%Tween80)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121117755517792017773895.1498.372.5595.74%～101.00%
217847917877517862795.61
318498118479018488698.96
4189616189909189762101.57
518507218498318502899.04
618671018653418662299.89
2024030221117725117734017729694.9097.542.0495.46%～99.61%
2188023188173188098100.68
318219918229318224697.55
418116518126418121497.00
518434518428518431598.66
618025018002318013696.42
2024030321117548517606317577494.0896.561.8894.66%～98.47%
217778917763917771495.12
318210218224018217197.51
418202018157518179897.31
517973217977417975396.21
618506718537818522299.14
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