依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号RSF-703-230318-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(%)98.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.081720401720951713391718841709721716660.29
211.041732011740711736360.36
单位质量响应值RSD%判断
15493.3215727.901.07数据可信
加速6月-供试品溶液-2023122321批-瑞舒伐他汀钙-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1156499-15649985.84885.026.3685.8585.026.36
2152996-15299683.92683.93
3137075-13707575.19375.19
4159717-15971787.61387.61
5166379-16637991.26891.27
6157264-15726486.26886.27
10min1174010-17401095.45497.591.3895.9398.061.38
2179988-17998898.73399.20
3177122-17712297.16197.58
4179604-17960498.52299.01
5180132-18013298.81299.32
6176561-17656196.85397.33
15min1179784-17978498.62198.440.8699.6399.460.88
2179380-17938098.39999.41
3176675-17667596.91697.87
4181352-18135299.481100.52
5179992-17999298.73599.79
6179550-17955098.49399.51
20min1176502-17650296.82197.610.9798.3899.170.98
2176847-17684797.01098.57
3176212-17621296.66298.16
4179428-17942898.426100.01
5178183-17818397.74399.35
6180442-18044298.982100.55
30min1175064-17506496.03297.120.6998.1299.220.70
2177598-17759897.42299.52
3176062-17606296.57998.61
4177638-17763897.44499.58
5177758-17775897.51099.66
6178160-17816097.73099.84
45min1172490-17249094.62095.860.6697.2598.500.65
2174896-17489695.94098.58
3175254-17525496.13698.71
4175475-17547596.25798.93
5174844-17484495.91198.60
6175497-17549796.26998.93
60min1172229-17222994.47795.421.0097.6398.591.00
2173471-17347195.15898.33
3172197-17219794.45997.56
4173781-17378195.32898.54
5176337-17633796.73099.95
6175650-17565096.35399.55
极限1170226-17022693.37894.571.2497.0698.281.19
2170279-17027993.40797.11
3174271-17427195.59799.23
4174765-17476595.86899.61
5170964-17096493.78397.54
6173890-17389095.38899.12
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
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对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.071856031870021850941857441862161859320.39
211.071864091885931875010.83
单位质量响应值RSD%判断
16796.0316937.760.60数据可信
加速6月-供试品溶液-2023122321批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1121303-12130364.72763.8313.1364.7363.8413.13
2104570-10457055.79855.80
3104030-10403055.51055.51
4122273-12227365.24565.24
5147043-14704378.46278.46
6118565-11856563.26663.27
10min1167484-16748489.36990.902.4089.7391.262.44
2165849-16584988.49788.81
3169739-16973990.57390.88
4170334-17033490.89091.25
5177709-17770994.82595.26
6171040-17104091.26791.62
15min1179521-17952195.79295.501.2396.6596.361.28
2176648-17664894.25995.06
3176657-17665794.26495.08
4179440-17944095.74996.62
5182570-18257097.41998.38
6179043-17904395.53796.40
20min1181073-18107396.62096.341.1398.0197.731.14
2177463-17746394.69496.02
3179684-17968495.87997.21
4180992-18099296.57797.98
5180331-18033196.22497.73
6183713-18371398.02999.42
30min1180034-18003496.06696.260.5997.9998.190.61
2178481-17848195.23797.09
3180653-18065396.39698.26
4181215-18121596.69698.63
5180684-18068496.41398.45
6181361-18136196.77498.71
45min1179542-17954295.80395.290.7698.2697.750.74
2177093-17709394.49796.88
3178197-17819795.08697.49
4179888-17988895.98898.46
5176979-17697994.43697.01
6179798-17979895.94098.41
60min1176710-17671094.29294.521.0897.2897.501.11
2174623-17462393.17996.08
3175656-17565693.73096.66
4177225-17722594.56797.57
5179121-17912195.57998.68
6179451-17945195.75598.76
极限1175464-17546493.62794.131.3697.1497.651.31
2173006-17300692.31695.74
3178802-17880295.40998.86
4178312-17831295.14798.68
5174598-17459893.16596.80
6178266-17826695.12398.66
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号RSF-703-230318-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(%)98.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.081734881744831741691742471740191740810.22
211.041753751757361755560.15
单位质量响应值RSD%判断
15711.2815901.810.86数据可信
长期6月-供试品溶液-2023122321批-瑞舒伐他汀钙-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1151382-15138282.01075.4020.2282.0175.4020.22
2150037-15003781.28181.28
3156708-15670884.89584.90
4158976-15897686.12486.12
584809-8480945.94545.94
6133226-13322672.17472.17
10min1170458-17045892.34491.439.1592.8091.849.19
2174605-17460594.59195.04
3178200-17820096.53897.01
4173504-17350493.99494.47
5137836-13783674.67274.93
6177987-17798796.42396.82
15min1172078-17207893.22294.926.4494.1995.846.50
2184033-18403399.698100.68
3181667-18166798.41799.42
4175847-17584795.26496.26
5154247-15424783.56284.23
6183362-18336299.335100.27
20min1167574-16757490.78294.733.6192.2796.183.66
2176481-17648195.60797.14
3181138-18113898.13099.68
4175897-17589795.29196.82
5166927-16692790.43191.57
6181121-18112198.12199.61
30min1169440-16944091.79395.082.4493.7897.062.39
2173872-17387294.19496.26
3177245-17724596.02198.12
4173611-17361194.05296.11
5176688-17668895.71997.36
6182151-18215198.679100.71
45min1165861-16586189.85494.093.1992.3596.603.12
2173819-17381994.16596.75
3177421-17742196.11698.75
4168779-16877991.43594.02
5175414-17541495.02997.20
6180837-18083797.967100.55
60min1165798-16579889.82093.312.8492.8296.342.73
2172741-17274193.58196.69
3167750-16775090.87794.04
4172794-17279493.61096.70
5175247-17524794.93997.64
6179145-17914597.050100.18
极限1163622-16362288.64192.162.5492.1495.722.48
2167239-16723990.60094.23
3172087-17208793.22796.90
4170148-17014892.17695.79
5171455-17145592.88496.11
6176199-17619995.45499.12
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
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对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.071889011895031894571896491905451896110.32
211.071886911883541885220.13
单位质量响应值RSD%判断
17128.3617029.990.41数据可信
长期6月-供试品溶液-2023122321批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1132706-13270669.93157.2420.7969.9357.2420.79
2119355-11935562.89662.90
3115647-11564760.94260.94
4122987-12298764.80964.81
577227-7722740.69640.70
683854-8385444.18844.19
10min1171748-17174890.50587.164.9190.8987.484.96
2168805-16880588.95489.30
3171017-17101790.11990.46
4170203-17020389.69090.05
5158364-15836483.45283.68
6152235-15223580.22280.47
15min1178539-17853994.08393.682.4994.9794.482.55
2183009-18300996.43997.28
3180794-18079495.27296.11
4179518-17951894.59995.46
5172573-17257390.93991.63
6172247-17224790.76891.46
20min1175184-17518492.31594.171.5893.7395.501.59
2181310-18131095.54396.92
3182304-18230496.06797.44
4179352-17935294.51295.90
5177922-17792293.75894.95
6176186-17618692.84394.04
30min1178132-17813293.86995.000.9595.8096.840.85
2180754-18075495.25097.16
3180586-18058695.16297.06
4178299-17829993.95795.87
5181646-18164695.72197.44
6182213-18221396.01997.73
45min1176073-17607392.78493.851.5195.2396.221.44
2179922-17992294.81297.25
3180307-18030795.01597.45
4173778-17377891.57494.01
5178116-17811693.86096.11
6180343-18034395.03497.28
60min1174630-17463092.02392.981.5594.9995.881.46
2179006-17900694.32997.30
3171825-17182590.54593.50
4176921-17692193.23196.17
5177824-17782493.70696.48
6178448-17844894.03596.81
极限1173374-17337491.36191.770.9194.8495.180.82
2172740-17274091.02794.52
3173865-17386591.62095.08
4174166-17416691.77995.24
5173487-17348791.42194.71
6177218-17721893.38796.68
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号RSF-703-230318-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(%)98.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.081766301759081760981764181758611761830.19
211.041751741751261751500.02
单位质量响应值RSD%判断
15900.9915865.040.17数据可信
中间条件6月-供试品溶液-2023122321批-瑞舒伐他汀钙-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1133771-13377172.11873.6713.7872.1273.6713.78
2138274-13827474.54674.55
3153862-15386282.94982.95
4108781-10878158.64558.65
5160143-16014386.33686.34
6125043-12504367.41367.41
10min1170679-17067992.01692.473.8892.4292.883.90
2181340-18134097.76398.18
3175487-17548794.60895.07
4164873-16487388.88689.21
5173073-17307393.30693.79
6163678-16367888.24188.62
15min1175238-17523894.47393.622.4695.3994.542.49
2176811-17681195.32196.28
3175190-17519094.44895.43
4171499-17149992.45893.28
5177201-17720195.53296.53
6166004-16600489.49590.36
20min1177377-17737795.62793.962.3497.0695.402.36
2177813-17781395.86297.35
3173803-17380393.70095.21
4172132-17213292.79994.13
5177177-17717795.51997.05
6167392-16739290.24491.61
30min1174657-17465794.16093.272.8496.1395.242.86
2179519-17951996.78198.80
3174345-17434593.99296.02
4169701-16970191.48893.34
5174585-17458594.12196.18
6165239-16523989.08390.95
45min1174212-17421293.92093.271.8096.4195.751.86
2174207-17420793.91896.47
3173731-17373193.66196.21
4169849-16984991.56893.93
5177214-17721495.53998.12
6168839-16883991.02493.38
60min1173509-17350993.54192.852.9396.5595.852.94
2178745-17874596.36499.44
3175298-17529894.50697.58
4168102-16810290.62693.49
5172922-17292293.22596.34
6164738-16473888.81391.68
极限1176572-17657295.19391.723.0098.7395.242.99
2172923-17292393.22596.84
3172736-17273693.12596.72
4165642-16564289.30092.67
5170085-17008591.69595.33
6162802-16280287.76991.13
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
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对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.071897351905811900171904601900121901610.19
211.071889581893011891300.13
单位质量响应值RSD%判断
17178.0517084.910.39数据可信
中间条件6月-供试品溶液-2023122321批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min185355-8535544.84150.0129.7344.8450.0129.73
283061-8306143.63643.64
3126463-12646366.43866.44
458633-5863330.80330.80
5131961-13196169.32669.33
685632-8563244.98744.99
10min1149689-14968978.63982.067.0078.8982.347.06
2156357-15635782.14382.38
3168194-16819488.36188.73
4138361-13836172.68872.86
5165274-16527486.82787.21
6159317-15931783.69883.95
15min1167530-16753088.01289.482.7188.7090.212.78
2166207-16620787.31788.02
3175467-17546792.18293.04
4165106-16510686.73987.31
5172388-17238890.56491.43
6175193-17519392.03892.75
20min1174748-17474891.80492.091.4392.9893.321.48
2173682-17368291.24492.43
3174242-17424291.53892.91
4172413-17241390.57891.63
5178027-17802793.52794.90
6178647-17864793.85395.08
30min1175394-17539492.14493.261.2893.8395.001.33
2180187-18018794.66296.35
3177401-17740193.19895.08
4174331-17433191.58593.15
5178676-17867693.86895.76
6179095-17909594.08895.84
45min1178252-17825293.64594.451.3895.8496.711.41
2178094-17809493.56295.78
3179009-17900994.04396.44
4177982-17798293.50395.57
5181234-18123495.21297.62
6184185-18418596.76299.03
60min1175779-17577992.34693.401.3195.0696.181.28
2181143-18114395.16497.90
3178716-17871693.88996.81
4176303-17630392.62195.21
5175380-17538092.13695.08
6179392-17939294.24497.05
极限1177595-17759593.30092.301.0896.5395.601.08
2176595-17659592.77596.04
3176502-17650292.72696.17
4172779-17277990.77093.87
5173937-17393791.37894.83
6176732-17673292.84796.18
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