他达拉非片项目信息
介质体积(ml)900取样体积(ml) 0补液体积(ml) 0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数2500
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%
1 12.401264131262411260001260961266171262730.20
2 12.391267801270901269350.18
单位质量响应值RSD%判断
10183.3110244.960.43数据可信
供试品溶液-2025091521批-shui(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147660-4766033.57328.3630.4233.5728.3630.43
218730-1873013.19413.19
352552-5255237.01937.02
440514-4051428.53928.54
547368-4736833.36733.37
634768-3476824.49124.49
10min185840-8584060.46772.6318.9160.4772.6318.91
274087-7408752.18852.19
3125583-12558388.46388.46
4110697-11069777.97777.98
5116950-11695082.38282.38
6105463-10546374.29074.29
15min1102707-10270772.34986.9711.9072.3586.9711.90
2106582-10658275.07875.08
3135311-13531195.31695.32
4131862-13186292.88692.89
5132324-13232493.21293.21
6131995-13199592.98092.98
20min1118598-11859883.54391.055.5383.5491.055.53
2122001-12200185.94085.94
3136030-13603095.82295.82
4132673-13267393.45793.46
5132211-13221193.13293.13
6134045-13404594.42494.42
30min1131895-13189592.90993.452.3192.9193.452.31
2126952-12695289.42789.43
3135597-13559795.51795.52
4133921-13392194.33694.34
5133135-13313593.78393.78
6134439-13443994.70194.70
45min1133072-13307293.73894.071.5593.7494.071.55
2130095-13009591.64191.64
3136295-13629596.00996.01
4133494-13349494.03694.04
5133436-13343693.99593.99
6134833-13483394.97994.98
极限1134220-13422094.54794.721.2594.5594.721.25
2131732-13173292.79492.79
3136838-13683896.39196.39
4134801-13480194.95694.96
5134017-13401794.40494.40
6135150-13515095.20295.20
他达拉非片项目信息
介质体积(ml)900取样体积(ml) 0补液体积(ml) 0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数2500
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%
1 12.401275981273981267021269981268841271160.30
2 12.391262631266841264740.24
单位质量响应值RSD%判断
10251.2910207.750.31数据可信
供试品溶液-2025091522批-shui(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min140294-4029428.34134.1427.9128.3434.1527.90
259160-5916041.61141.61
347212-4721233.20733.21
426097-2609718.35518.36
560135-6013542.29642.30
658372-5837241.05641.06
10min1104351-10435173.39677.6312.3273.4077.6312.32
2119333-11933383.93483.93
3101891-10189171.66671.67
490228-9022863.46263.46
5123289-12328986.71686.72
6123136-12313686.60886.61
15min1127750-12775089.85490.881.6989.8590.881.69
2129782-12978291.28391.28
3128905-12890590.66690.67
4127355-12735589.57689.58
5128150-12815090.13590.14
6133289-13328993.75093.75
20min1129999-12999991.43692.331.6191.4492.331.61
2131545-13154592.52392.52
3132216-13221692.99592.99
4132593-13259393.26093.26
5127714-12771489.82889.83
6133565-13356593.94493.94
30min1131437-13143792.44792.791.5492.4592.791.54
2131584-13158492.55092.55
3132139-13213992.94192.94
4134323-13432394.47794.48
5128495-12849590.37890.38
6133566-13356693.94493.94
45min1133631-13363193.99092.792.5593.9992.802.55
2133028-13302893.56693.57
3127524-12752489.69589.69
4135774-13577495.49795.50
5128018-12801890.04290.04
6133615-13361593.97993.98
极限1133103-13310393.61993.611.6693.6293.611.65
2134063-13406394.29494.29
3131842-13184292.73292.73
4135566-13556695.35195.35
5129431-12943191.03691.04
6134541-13454194.63094.63
他达拉非片项目信息
介质体积(ml)900取样体积(ml) 0补液体积(ml) 0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数2500
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%
1 12.401267701261271267541261581267021265020.27
2 12.391264041264141264090.01
单位质量响应值RSD%判断
10201.7710202.500.01数据可信
供试品溶液-2025091621批-shui(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min127218-2721819.19524.9723.4019.2024.9723.40
229639-2963920.90320.90
346242-4624232.61232.61
438228-3822826.96026.96
543235-4323530.49130.49
627912-2791219.68519.68
10min171569-7156950.47367.8616.5650.4767.8616.57
293934-9393466.24666.25
3107323-10732375.68975.69
4103273-10327372.83272.83
5115531-11553181.47781.48
685708-8570860.44560.44
15min1100000-10000070.52483.858.6270.5283.848.62
2114035-11403580.42280.42
3123665-12366587.21487.21
4125037-12503788.18188.18
5124383-12438387.72087.72
6126212-12621289.01089.01
20min1119482-11948284.26489.002.9584.2689.002.96
2128191-12819190.40590.41
3126644-12664489.31489.31
4126978-12697889.55089.55
5125361-12536188.41088.41
6130521-13052192.04992.05
30min1125978-12597888.84590.612.2888.8490.612.28
2132471-13247193.42493.42
3127027-12702789.58589.58
4128743-12874390.79590.79
5125308-12530888.37288.37
6131360-13136092.64092.64
45min1128053-12805390.30890.892.3190.3190.892.31
2133259-13325993.98093.98
3127105-12710589.64089.64
4128398-12839890.55190.55
5125067-12506788.20288.20
6131363-13136392.64292.64
极限1128427-12842790.57291.051.9290.5791.051.92
2132777-13277793.64093.64
3128224-12822490.42990.43
4128511-12851190.63190.63
5125661-12566188.62188.62
6131023-13102392.40392.40
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