依折麦布辛伐他汀片项目信息
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(%)100.00对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.339478959481699482489484359481509481790.03
211.369465439464989465200.01
单位质量响应值RSD%判断
83687.4783320.420.32数据可信
加速3月-供试品溶液-依折麦布-pH7.0(内含%SDS)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121189379489560989470296.4395.471.6093.87%~97.06%
287260487217687239094.03
390449890412490431197.47
489191889216289204096.14
588380788414288397495.27
686719486708886714193.46
2024030221187995888001487998694.8497.462.5294.89%~100.03%
289019189029989024595.95
392198992216192207599.38
4937798937972937885101.09
588627588613788620695.52
690925190910590917897.99
2024030321186951586936486944093.7194.601.7292.89%~96.31%
288862488811988837295.75
385182185177985180091.81
489016089025889020995.95
588924888884988904895.82
687742487722387732494.56
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100601-201906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(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.242193678219356421928132193460219386821934770.02
211.292191544219016721908560.05
单位质量响应值RSD%判断
195149.20194052.790.40数据可信
加速3月-供试品溶液--pH7.0(内含%SDS)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
202403012116606675766820.310.302.500.29%~0.31%
26297610362000.29
36462645264570.30
46633653165820.30
56562648965260.30
66804669367480.31
202403022117175685770160.320.332.450.32%~0.34%
27010711970640.33
37240739073150.34
47313731173120.34
57087707870820.33
67426745074380.34
202403032117803787478380.360.372.670.36%~0.38%
27983784979160.36
37722793478280.36
48164824082020.38
58017814680820.37
68153828382180.38
依折麦布辛伐他汀片项目信息
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(%)100.00对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.339439089444799444929442789442339442780.03
211.369437929437819437860.01
单位质量响应值RSD%判断
83343.1683079.750.23数据可信
长期3月-供试品溶液-依折麦布-pH7.0(内含%SDS)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121191473291426891450098.9198.422.6895.65%~101.18%
290783990789190786598.19
390094090079390086697.44
489622989594389608696.92
588502788522188512495.73
6955057955256955156103.31
2024030221191542591556591549599.0298.172.6095.49%~100.85%
289359589361289360496.65
3933617933250933434100.96
4927837927926927882100.36
586976586946686961694.06
690571090569490570297.96
20240303211937609937363937486101.4098.531.8196.66%~100.40%
291647691644291645999.12
390669790669390669598.07
490094690113390104097.46
591530591523691527098.99
688864488913888889196.14
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100601-201906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(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.242186099218361121843292184004218361121843310.05
211.292182739218184221822900.03
单位质量响应值RSD%判断
194335.50193294.070.38数据可信
长期3月-供试品溶液--pH7.0(内含%SDS)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
202403012116421633663780.290.293.380.28%~0.30%
26195623262140.29
36155613761460.28
46300625262760.29
56243632262820.29
66702677167360.31
202403022115774593258530.270.273.780.26%~0.28%
25778580557920.27
36026587259490.27
46090612961100.28
55653567056620.26
66206621362100.29
202403032116873670567890.310.312.050.30%~0.32%
26712670267070.31
36553648265180.30
46582674466630.31
56990694469670.32
66772677867750.31
依折麦布辛伐他汀片项目信息
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(%)100.00对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
111.339456229455939456759457189454079456030.02
211.369473969472599473280.02
单位质量响应值RSD%判断
83460.1183391.550.06数据可信
中间条件3月-供试品溶液-依折麦布-pH7.0(内含%SDS)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
2024030121189952689959889956297.0498.111.6196.45%~99.77%
289485289500289492796.54
390158790192390175597.28
490538990529890534497.67
5931398930989931194100.46
692413192364592388899.67
2024030221191761791776591769199.0098.830.7298.09%~99.58%
292229292223692226499.49
390410390403990407197.53
491374991370691372898.57
591902191859991881099.12
692020592061492041099.29
2024030321191556691575391566098.7898.070.9997.05%~99.09%
290456890429890443397.57
392428292428092428199.71
490114790096990105897.21
590342690345490344097.46
690574690548190561497.70
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100601-201906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(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.242198056218965421891972189296218893521910280.18
211.292192837219152621921820.05
单位质量响应值RSD%判断
194931.32194170.240.28数据可信
中间条件3月-供试品溶液--pH7.0(内含%SDS)
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
202403012116793665567240.310.324.850.30%~0.34%
26693680967510.31
36528652565260.30
47112714571280.33
57371747174210.34
67262720972360.33
202403022117535723773860.340.352.360.34%~0.36%
27654749275730.35
37305738573450.34
47635763576350.35
57544740674750.34
67705784977770.36
202403032118041794079900.370.381.380.37%~0.38%
28102787079860.37
38200831082550.38
48054836282080.38
58368827083190.38
68296840983520.38
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