托伐普坦口崩片项目信息
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101242-202302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(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
116.472576692578372577642586012587682581280.20
216.532616272619032617650.08
单位质量响应值RSD%判断
15672.6215835.750.74数据可信
加速3月-供试品溶液-shui(内含0.22%SDS)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121125672625647425660097.6399.541.4198.07%~101.01%
2265944265963265954101.19
326225326225926225699.78
425815225822425818898.24
5265172264962265067100.85
626186726137226162099.54
20240302211263333263087263210100.1599.171.2597.88%~100.46%
225756925732825744897.95
325871525857225864498.41
425879225917025898198.54
525953425973225963398.79
6267705264161265933101.18
2024030321125914125919925917098.6199.881.7698.03%~101.72%
226262226257626259999.91
325960125990825975498.83
425772825769925771498.06
5266026265890265958101.19
6269753269807269780102.65
托伐普坦口崩片项目信息
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101242-202302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(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
116.472603572601392600272604572601742602310.07
216.532610222614522612370.12
单位质量响应值RSD%判断
15800.3015803.810.02数据可信
长期3月-供试品溶液-shui(内含0.22%SDS)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240301211266039265526265782100.82100.070.4999.55%~100.58%
226236526218926227799.49
326355826293026324499.85
4265157264691264924100.49
526345926297826321899.84
626351326331326341399.92
2024030221126003326050826027098.7398.911.0097.88%~99.94%
225950725937525944198.41
3265918265795265856100.84
425991225978725985098.57
526045626070326058098.84
625879025840325859698.09
2024030321125662325641325651897.3099.201.2197.94%~100.46%
2265137266125265631100.76
3263916264309264112100.18
426105826108926107499.03
526059826067626063798.86
626093326142326117899.07
托伐普坦口崩片项目信息
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101242-202302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(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
116.472640302641732639652634902638002638920.10
216.532619942620002619970.01
单位质量响应值RSD%判断
16022.5915849.790.77数据可信
中间条件3月-供试品溶液-shui(内含0.22%SDS)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121126264926260026262498.7899.490.8898.58%~100.40%
226252026273826262998.78
3266037265827265932100.03
426233226202026217698.61
5267772267435267604100.66
6266136265952266044100.07
20240302211266009265811265910100.0299.381.2998.05%~100.72%
226230426230426230498.66
3267694267248267471100.61
425966525946325956497.63
5267986267946267966100.79
626210426212426211498.59
2024030321126238026267726252898.7598.020.9097.10%~98.95%
226099326056226077898.09
325654525634625644696.46
426265926224926245498.72
525985125910725947997.60
626183426203126193298.52
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