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%
111.311684371683351683411683441678231682560.15
211.361703731705121704420.06
单位质量响应值RSD%判断
14876.7515003.700.61数据可信
供试品溶液-23112303批-瑞舒伐他汀钙-pH2.0(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%
5min1125969-12596972.19967.136.4172.2067.126.41
2105584-10558460.51560.51
3115156-11515666.00166.00
4124823-12482371.54271.54
5116506-11650666.77566.77
6114669-11466965.72265.72
10min1159082-15908291.17792.121.0491.5892.491.03
2160523-16052392.00392.34
3162488-16248893.12993.50
4163000-16300093.42393.82
5159278-15927891.28991.66
6159954-15995491.67792.04
15min1164514-16451494.29095.831.0395.2096.721.02
2167084-16708495.76396.61
3169053-16905396.89297.78
4166889-16688995.65296.57
5166554-16655495.46096.34
6169108-16910896.92397.80
20min1171822-17182298.47999.401.3999.91100.821.37
2173474-17347499.426100.81
3175313-175313100.480101.90
4175311-175311100.479101.93
5169447-16944797.11898.53
6175200-175200100.415101.83
30min1169161-16916196.95499.402.7198.93101.372.67
2174655-174655100.103102.03
3177075-177075101.490103.47
4177269-177269101.601103.61
5166094-16609495.19697.14
6176328-176328101.062103.03
45min1165127-16512794.64297.591.9097.16100.111.87
2171731-17173198.427100.91
3172559-17255998.901101.45
4171488-17148898.288100.86
5167443-16744395.96998.45
6173265-17326599.306101.84
60min1164562-16456294.31896.541.4797.3699.601.43
2171075-17107598.051101.09
3168750-16875096.71899.81
4168237-16823796.42499.54
5167039-16703995.73898.75
6170939-17093997.973101.06
极限1164536-16453694.30395.841.0197.8799.441.00
2168067-16806796.32799.91
3169180-16918096.965100.60
4167018-16701895.72699.38
5166215-16621595.26598.81
6168318-16831896.471100.10
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DSMF-387-240606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(%)99.75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%
111.081853561850751852491850141848951851180.10
211.171860971875581868280.56
单位质量响应值RSD%判断
16707.4016725.870.08数据可信
供试品溶液-23112303批-依折麦布-pH2.0(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%
5min1117791-11779163.25852.5723.5663.2652.5723.55
262781-6278133.71633.72
383342-8334244.75844.76
4126006-12600667.67067.67
595131-9513151.08951.09
6102232-10223254.90354.90
10min1164870-16487088.54285.906.8988.8986.196.94
2139043-13904374.67274.86
3157972-15797284.83785.09
4169241-16924190.88991.27
5161261-16126186.60486.89
6167286-16728689.83990.14
15min1171647-17164792.18191.913.2493.0292.683.31
2160321-16032186.09986.70
3171247-17124791.96692.69
4174170-17417093.53694.42
5173824-17382493.35094.12
6175599-17559994.30495.11
20min1179307-17930796.29595.811.8797.6597.091.95
2173419-17341993.13394.21
3178184-17818495.69296.92
4182165-18216597.83099.23
5175902-17590294.46695.75
6181469-18146997.45698.78
30min1176295-17629594.67796.022.4496.5797.842.43
2177949-17794995.56697.16
3181351-18135197.39399.16
4183988-18398898.809100.75
5171864-17186492.29894.11
6181368-18136897.40299.27
45min1173471-17347193.16195.641.4995.5897.991.46
2179062-17906296.16398.29
3178562-17856295.89598.20
4181215-18121597.32099.81
5176933-17693395.02097.34
6179289-17928996.28598.70
60min1177044-17704495.08096.040.8998.0198.920.84
2180947-18094797.17699.84
3177050-17705095.08397.92
4179664-17966496.48799.52
5178581-17858195.90598.75
6179746-17974696.53199.48
极限1177607-17760795.38295.900.3498.8499.310.33
2178831-17883196.03999.24
3178947-17894796.10299.47
4179104-17910496.18699.76
5178859-17885996.05499.44
6178066-17806695.62999.11
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%
111.311688581686881681611679391681491683590.24
211.361703361707431705400.17
单位质量响应值RSD%判断
14885.8515012.320.60数据可信
供试品溶液-23112303批-瑞舒伐他汀钙-pH6.6(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%
5min1145153-14515383.14487.3810.1683.1487.3810.16
2166643-16664395.45495.45
3129596-12959674.23374.23
4169281-16928196.96596.97
5160646-16064692.01992.02
6143982-14398282.47482.47
10min1176981-176981101.37698.521.73101.8499.011.71
2171146-17114698.03398.56
3171941-17194198.48998.90
4171504-17150498.23898.78
5167767-16776796.09896.61
6172687-17268798.91699.37
15min1177974-177974101.94498.811.97102.9799.851.94
2170253-17025397.52298.60
3170190-17019097.48698.45
4169145-16914596.88797.97
5172545-17254598.83599.88
6174945-174945100.209101.22
20min1176967-176967101.36898.501.82102.96100.081.81
2169362-16936297.01198.63
3168260-16826096.38097.88
4172609-17260998.871100.49
5173396-17339699.322100.92
6171148-17114898.03499.60
30min1177219-177219101.51298.031.98103.67100.161.96
2169064-16906496.84199.00
3169101-16910196.86298.90
4169948-16994897.34799.52
5172989-17298999.089101.23
6168510-16851096.52398.63
45min1177983-177983101.95097.852.62104.67100.522.57
2166914-16691495.60998.30
3168299-16829996.40398.98
4167556-16755695.97798.69
5174616-174616100.021102.72
6169560-16956097.12599.77
60min1176084-176084100.86297.462.56104.15100.682.53
2167334-16733495.85099.07
3167182-16718295.76398.87
4168874-16887496.73299.98
5175215-175215100.364103.62
6166231-16623195.21898.40
极限1170293-17029397.54596.121.76101.3999.881.72
2164259-16425994.08897.85
3167260-16726095.80799.45
4164874-16487494.44198.22
5171734-17173498.370102.18
6168426-16842696.475100.19
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DSMF-387-240606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(%)99.75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%
111.081878281868351872651867171874471872180.25
211.171895381902441898910.27
单位质量响应值RSD%判断
16896.9317000.090.44数据可信
供试品溶液-23112303批-依折麦布-pH6.6(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%
5min179875-7987542.31043.9725.3142.3143.9725.32
2100488-10048853.22853.23
352433-5243327.77427.77
4112437-11243759.55859.56
577544-7754441.07541.07
675256-7525639.86339.86
10min1155138-15513882.17683.573.2682.4183.823.29
2165968-16596887.91388.21
3152441-15244180.74880.90
4156904-15690483.11283.44
5154360-15436081.76481.99
6161839-16183985.72685.95
15min1172996-17299691.63692.181.8192.3392.891.80
2176652-17665293.57294.36
3172839-17283991.55292.16
4170155-17015590.13190.92
5172644-17264491.44992.13
6178829-17882994.72595.42
20min1177132-17713293.82693.941.0395.0395.161.08
2177450-17745093.99595.30
3174148-17414892.24693.36
4179604-17960495.13696.43
5177294-17729493.91295.10
6178439-17843994.51995.74
30min1179017-17901794.82594.610.4596.5596.360.50
2179218-17921894.93196.76
3177344-17734493.93995.56
4179109-17910994.87496.70
5179098-17909894.86896.58
6177893-17789394.22995.98
45min1180408-18040895.56294.411.0897.8196.681.03
2175942-17594293.19695.55
3176908-17690893.70895.85
4176760-17676093.62995.98
5179497-17949795.07997.32
6179885-17988595.28597.56
60min1177729-17772994.14394.101.1796.9296.901.17
2177467-17746794.00496.88
3175448-17544892.93495.60
4179265-17926594.95697.83
5180628-18062895.67898.45
6175396-17539692.90795.71
极限1173406-17340691.85393.011.0195.1696.330.96
2174151-17415192.24795.64
3175836-17583693.14096.32
4174965-17496592.67996.08
5177851-17785194.20797.51
6177389-17738993.96397.28
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