坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903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4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.091727711731071730041732711731211730550.11
216.051737701739411738560.07
单位质量响应值RSD%判断
10755.4410832.150.51数据可信
长期3月-供试品溶液-2024042711批-pH6.5(内含0.35%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min167206-6720634.95436.234.7734.9536.234.78
270753-7075336.79836.80
366375-6637534.52134.52
467895-6789535.31235.31
570259-7025936.54236.54
675462-7546239.24839.25
10min1116219-11621960.44561.822.4360.8362.222.44
2117284-11728460.99961.41
3116835-11683560.76661.15
4118667-11866761.71862.11
5120223-12022362.52862.93
6123957-12395764.47064.91
15min1142211-14221173.96474.551.5775.0275.641.58
2141896-14189673.80074.89
3142860-14286074.30175.36
4141393-14139373.53874.62
5144148-14414874.97176.07
6147466-14746676.69777.85
20min1154669-15466980.44381.491.0682.3283.411.08
2155820-15582081.04282.95
3156622-15662281.45983.34
4156051-15605181.16283.06
5157540-15754081.93683.87
6159441-15944182.92584.93
30min1163835-16383585.21087.211.7687.9990.041.76
2166215-16621586.44889.26
3166240-16624086.46189.25
4167732-16773287.23790.03
5170232-17023288.53791.38
6171873-17187389.39192.32
45min1167232-16723286.97787.171.2390.7090.961.25
2165192-16519285.91689.68
3166840-16684086.77390.52
4166913-16691386.81190.58
5168186-16818687.47391.30
6171290-17129089.08793.01
60min1168529-16852987.65188.431.1692.3493.191.19
2168170-16817087.46592.19
3169866-16986688.34793.06
4169220-16922088.01192.74
5170760-17076088.81293.61
6173567-17356790.27295.18
极限1166127-16612786.40288.341.4292.0694.081.42
2169446-16944688.12893.82
3170435-17043588.64394.34
4169497-16949788.15593.86
5169931-16993188.38194.17
6173665-17366590.32396.23
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903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4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.091732441733801733001733151733001733080.03
216.051731211730821731020.02
单位质量响应值RSD%判断
10771.1610785.170.10数据可信
加速3月-供试品溶液-2024042711批-pH6.5(内含0.35%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min158220-5822030.32434.808.9930.3234.808.99
273258-7325838.15638.16
364860-6486033.78233.78
462088-6208832.33832.34
571072-7107237.01737.02
671336-7133637.15537.15
10min1106661-10666155.55459.075.3155.8959.465.33
2117198-11719861.04261.47
3109223-10922356.88857.26
4108928-10892856.73557.09
5116496-11649660.67661.09
6121995-12199563.54063.95
15min1132510-13251069.01772.223.9069.9773.273.93
2139613-13961372.71773.82
3135184-13518470.41071.42
4135710-13571070.68471.67
5141460-14146073.67974.76
6147532-14753276.84177.96
20min1147841-14784177.00279.683.0678.7281.523.10
2152878-15287879.62681.54
3149204-14920477.71279.50
4151719-15171979.02280.80
5155440-15544080.96082.86
6160765-16076583.73485.71
30min1160807-16080783.75587.062.9086.3389.792.94
2167344-16734487.16089.96
3164688-16468885.77788.43
4165660-16566086.28388.94
5169249-16924988.15290.96
6175141-17514191.22194.12
45min1166287-16628786.61089.882.3890.1293.582.43
2172460-17246089.82593.59
3171018-17101889.07492.68
4173169-17316990.19493.81
5173577-17357790.40794.19
6178938-17893893.19997.12
60min1167485-16748587.23490.412.4591.7095.102.45
2171489-17148989.31994.08
3174953-17495391.12395.72
4176437-17643791.89696.51
5171610-17161089.38294.17
6179478-17947893.48098.43
极限1170367-17036788.73590.021.4494.1795.721.54
2172550-17255089.87295.63
3170222-17022288.65994.27
4172495-17249589.84395.48
5174770-17477091.02896.81
6176587-17658791.97497.97
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903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4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.091751931752931752831752451754941753020.07
216.051734551735741735140.05
单位质量响应值RSD%判断
10895.0910810.840.55数据可信
长期3月-供试品溶液-24041103批-pH6.5(内含0.35%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min182416-8241642.63142.675.7742.6342.675.77
287939-8793945.48845.49
378654-7865440.68540.68
475672-7567239.14239.14
583144-8314443.00743.01
687142-8714245.07545.08
10min1130272-13027267.38567.612.4167.8668.092.44
2133642-13364269.12869.63
3129606-12960667.04067.49
4125177-12517764.74965.18
5132506-13250668.54069.02
6133098-13309868.84769.35
15min1152603-15260378.93678.801.6980.1680.021.71
2155565-15556580.46881.74
3151969-15196978.60879.80
4147896-14789676.50177.66
5153937-15393779.62680.87
6152018-15201878.63379.90
20min1160111-16011182.81983.252.1484.9285.362.15
2166940-16694086.35288.52
3158637-15863782.05784.13
4156974-15697481.19783.20
5162059-16205983.82785.95
6160982-16098283.27085.41
30min1166285-16628586.01386.991.6089.0390.011.59
2172394-17239489.17392.30
3169453-16945387.65290.63
4166448-16644886.09789.00
5169234-16923487.53890.59
6165199-16519985.45188.52
45min1169359-16935987.60388.100.9291.5892.090.92
2172278-17227889.11393.23
3171552-17155288.73792.69
4169873-16987387.86991.73
5170827-17082788.36292.39
6167990-16799086.89590.91
60min1167946-16794686.87288.211.4591.8293.181.42
2173924-17392489.96495.07
3170490-17049088.18893.13
4170137-17013788.00692.85
5172757-17275789.36194.37
6167914-16791486.85691.84
极限1168979-16897987.40787.581.3593.3293.541.34
2172763-17276389.36495.47
3170884-17088488.39294.31
4166494-16649486.12191.94
5169340-16934087.59393.60
6167482-16748286.63292.58
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903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4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.091741341741971740681742151739421741110.07
216.051736021734011735020.09
单位质量响应值RSD%判断
10821.0710810.090.08数据可信
加速3月-供试品溶液-24041103批-pH6.5(内含0.35%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min179853-7985341.44740.922.3541.4540.922.35
279006-7900641.00841.01
380570-8057041.81941.82
476144-7614439.52239.52
580414-8041441.73841.74
677042-7704239.98839.99
10min1126825-12682565.82864.971.5666.2965.421.56
2123790-12379064.25264.71
3127373-12737366.11266.58
4122553-12255363.61064.05
5126354-12635465.58366.05
6124097-12409764.41264.86
15min1144259-14425974.87775.931.2076.0777.111.19
2147064-14706476.33377.50
3148486-14848677.07178.27
4144504-14450475.00476.15
5147746-14774676.68777.88
6145665-14566575.60676.77
20min1158326-15832682.17882.460.9184.2084.480.90
2158983-15898382.51984.54
3158405-15840582.21984.27
4158451-15845182.24384.22
5161602-16160283.87885.92
6157396-15739681.69583.70
30min1168546-16854687.48387.871.0190.4290.810.99
2170577-17057788.53791.47
3171904-17190489.22692.19
4168935-16893587.68590.58
5168720-16872087.57390.55
6167089-16708986.72689.63
45min1171020-17102088.76789.700.6392.6893.610.59
2172713-17271389.64593.56
3172217-17221789.38893.35
4173404-17340490.00493.87
5173796-17379690.20894.16
6173760-17376090.18994.06
60min1171136-17113688.82789.800.7993.7294.700.78
2174459-17445990.55295.47
3174207-17420790.42195.37
4171719-17171989.13094.00
5173746-17374690.18295.13
6172737-17273789.65894.53
极限1170248-17024888.36688.890.9994.2594.790.92
2172181-17218189.36995.29
3169605-16960588.03293.99
4173925-17392590.27596.13
5171780-17178089.16195.12
6169761-16976188.11393.98
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