比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203对照品来源中检院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)5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%
19.998249682509824978249282522825030.02
29.958238582355823700.03
单位质量响应值RSD%判断
8258.568278.390.17数据可信
加速6月-供试品溶液-比索洛尔-0.005molhcl
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121189386893498936897.0899.022.6496.27%～101.76%
288698885728863596.28
3948619482894844103.03
4924979251592506100.49
589472893818942697.14
6921099212292116100.07
20240302211946649455194608102.77101.523.2298.09%～104.95%
288125881198812295.73
3955999557995589103.84
4965839652696554104.89
5923239232592324100.29
6935259351193518101.59
20240303211922399222992234100.1998.852.4796.29%～101.40%
2937849377193778101.87
389359893658936297.07
491169911329115099.02
591923919629194299.88
687501874948749895.05
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.541003341004381003481003241004301003750.06
213.519993299936999340.01
单位质量响应值RSD%判断
7413.227397.040.16数据可信
加速6月-供试品溶液-氨氯地平-0.005molhcl
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121111350911351211351099.3797.842.9194.86%～100.83%
211014210997411005896.35
311143411141811142697.54
4115662115228115445101.06
511393711366111379999.62
610649210628310638893.13
2024030221111200311159811180097.8799.842.9996.71%～102.97%
2120579120418120498105.49
311184911165311175197.83
4114969114991114980100.65
511349111329811339499.27
611178111192911185597.92
2024030321111145011145011145097.5699.122.5696.46%～101.77%
210989611010911000296.30
3116346116241116294101.80
4117169116963117066102.48
511135511104611120097.35
611334411329111331899.20
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203对照品来源中检院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)5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%
19.998233882256822528221482229822580.06
29.958196081919819400.04
单位质量响应值RSD%判断
8234.038235.180.01数据可信
长期6月-供试品溶液-比索洛尔-0.005molhcl
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211930549309093072101.52101.882.3999.33%～104.43%
289972899288995098.11
3958909585995874104.58
4951239516595144103.78
5945649448694525103.10
6919069181791862100.20
20240302211952869521395250103.90100.022.5297.38%～102.67%
2925149250292508100.90
391369913499135999.65
490153901359014498.33
5924449247292458100.85
688522884508848696.52
2024030321190588905959059298.81100.001.7698.16%～101.84%
2919539200291978100.33
390070901219009698.27
490396903759038698.59
5941359412494130102.67
6928469292192884101.31
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.5410001410001410024799959999261000320.13
213.519975899860998090.08
单位质量响应值RSD%判断
7387.897387.790.01数据可信
长期6月-供试品溶液-氨氯地平-0.005molhcl
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121110930710937810934295.9499.352.5296.73%～101.98%
2115329115273115301101.17
3115357115388115372101.23
4115420115475115448101.30
510990310989010989696.43
6114085113953114019100.05
2024030221111029311003511016496.6699.682.6396.94%～102.43%
2114227114165114196100.20
3116358116489116424102.16
411300711302211301499.16
511046111049511047896.94
6117476117264117370102.99
2024030321111040111047611043896.9097.310.9596.34%～98.27%
211157811171511164697.96
311192411173311182898.12
411179911157911168998.00
511072511066011069297.13
610907810912310910095.73
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203对照品来源中检院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)5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%
19.998213682213821518207281976821100.11
29.958213882110821240.03
单位质量响应值RSD%判断
8219.228253.670.30数据可信
中间条件6月-供试品溶液-比索洛尔-0.005molhcl
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121189640896138962697.7498.751.8396.86%～100.65%
291463913969143099.71
3935249352893526101.99
489349893518935097.44
590176900749012598.28
689288892648927697.36
2024030221190792908339081299.03100.181.9598.13%～102.22%
2921369211992128100.47
3919719193291952100.28
488957889878897297.03
5934899351393501101.97
6937939376893780102.27
20240303211918349179691815100.1398.911.2697.60%～100.22%
291203912009120299.46
389430894148942297.52
4920509207492062100.40
589660896718966697.78
690030900269002898.18
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.549993299776998579968899528997560.16
213.519974399677997100.05
单位质量响应值RSD%判断
7367.507380.460.13数据可信
中间条件6月-供试品溶液-氨氯地平-0.005molhcl
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121111247811225111236498.7899.301.3997.85%～100.75%
2114944114844114894101.00
311225811240111233098.75
411190511200811195698.42
511114511135211124897.80
6115021114838114930101.04
2024030221111276111289011282699.1997.920.8597.06%～98.79%
210999010990210994696.65
311108811089811099397.57
411170011152711161498.12
511143111162411152898.05
611154411135111144897.97
2024030321110968010956010962096.3797.492.1695.28%～99.70%
211066011054111060097.23
311015311032411023896.91
410767810760010763994.63
5114128114418114273100.46
611301211303311302299.36
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