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%
111.311694381700231677971690241697571692080.52
211.361708781717441713110.36
单位质量响应值RSD%判断
14960.9215080.190.57数据可信
供试品溶液-2023122321批-瑞舒伐他汀钙-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min180870-8087046.10245.5911.0946.1045.5911.09
289094-8909450.79150.79
372741-7274141.46841.47
491990-9199052.44252.44
573812-7381242.07942.08
671345-7134540.67240.67
10min1124573-12457371.01672.044.7771.2772.294.78
2131482-13148274.95575.24
3117048-11704866.72766.96
4131651-13165175.05175.34
5122403-12240369.77970.01
6131013-13101374.68874.91
15min1144695-14469582.48881.543.4483.1482.203.45
2144333-14433382.28182.98
3134962-13496276.93977.54
4146006-14600683.23583.94
5139650-13965079.61180.23
6148571-14857184.69785.34
20min1147504-14750484.08985.123.6785.2086.233.68
2155377-15537788.57789.73
3141397-14139780.60781.64
4151775-15177586.52487.69
5145415-14541582.89883.96
6154418-15441888.03089.14
30min1148123-14812384.44287.343.8586.0288.923.84
2158662-15866290.45092.10
3144840-14484082.57084.05
4155635-15563588.72490.38
5152399-15239986.87988.40
6159608-15960890.98992.59
45min1154588-15458888.12789.773.5990.1791.843.60
2160969-16096991.76593.92
3148463-14846384.63686.57
4160982-16098291.77293.92
5155831-15583188.83690.84
6164010-16401093.49995.60
60min1153630-15363087.58188.072.4990.1290.632.51
2158542-15854290.38193.04
3149894-14989485.45187.86
4159725-15972591.05693.71
5152868-15286887.14789.65
6152225-15222586.78089.41
极限1155585-15558588.69690.081.9991.7293.142.02
2158593-15859390.41093.57
3154777-15477788.23591.12
4163695-16369593.31996.48
5157507-15750789.79192.78
6157925-15792590.03093.14
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%
111.081864681867921867221877701869161869340.27
211.171882761895091888920.47
单位质量响应值RSD%判断
16871.3016910.650.17数据可信
供试品溶液-2023122321批-依折麦布-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min117072-170729.0748.418.039.078.418.04
215565-155658.2738.27
315889-158898.4458.44
417471-174719.2869.29
514624-146247.7737.77
614316-143167.6097.61
10min121202-2120211.26911.521.6111.3211.571.61
222122-2212211.75811.80
321841-2184111.60811.66
421947-2194711.66511.72
521460-2146011.40611.45
621490-2149011.42211.46
15min125653-2565313.63512.706.3913.7512.806.35
225328-2532813.46213.57
322727-2272712.07912.19
423827-2382712.66412.78
521647-2164711.50511.61
624129-2412912.82512.93
20min126242-2624213.94813.873.4214.1414.053.39
226901-2690114.29814.48
325736-2573613.67913.86
426431-2643114.04814.23
526791-2679114.23914.41
624489-2448913.01613.19
30min127792-2779214.77115.093.3315.0415.353.31
229613-2961315.73916.00
327877-2787714.81715.07
429165-2916515.50115.77
527136-2713614.42314.67
628821-2882115.31815.57
45min130986-3098616.46916.302.3716.8216.642.37
230909-3090916.42816.78
329659-2965915.76416.10
431208-3120816.58716.94
529868-2986815.87516.20
631388-3138816.68317.02
60min129933-2993315.90916.223.5616.3516.653.51
230940-3094016.44516.89
329474-2947415.66516.09
432507-3250717.27717.72
530264-3026416.08516.50
629998-2999815.94416.37
极限132349-3234917.19317.022.6317.7217.542.61
231455-3145516.71817.25
331950-3195016.98117.49
433522-3352217.81718.36
531769-3176916.88517.39
631131-3113116.54617.06
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%
111.311691031679211673521674641681711680020.42
211.361681431692571687000.47
单位质量响应值RSD%判断
14854.2914850.350.02数据可信
供试品溶液-2023122321批-瑞舒伐他汀钙-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min172395-7239541.73847.117.6241.7447.117.62
285777-8577749.45349.45
375305-7530543.41543.42
483943-8394348.39548.40
586761-8676150.02050.02
686053-8605349.61249.61
10min1135425-13542578.07674.115.0278.3174.385.00
2125663-12566372.44872.72
3117972-11797268.01468.26
4130524-13052475.25175.52
5134418-13441877.49677.77
6127299-12729973.39173.67
15min1150848-15084886.96883.694.2687.6384.364.26
2147399-14739984.97985.66
3133196-13319676.79177.41
4145404-14540483.82984.52
5148355-14835585.53186.24
6145766-14576684.03884.72
20min1162383-16238393.61888.403.9594.7789.543.93
2153552-15355288.52789.68
3143900-14390082.96284.01
4150902-15090286.99988.15
5153577-15357788.54189.72
6155714-15571489.77390.92
30min1160953-16095392.79488.323.7794.4689.953.75
2154537-15453789.09590.74
3144555-14455583.34084.85
4151077-15107787.10088.74
5150546-15054686.79488.47
6157438-15743890.76792.42
45min1164280-16428094.71290.243.2196.9092.363.21
2154263-15426388.93791.07
3149882-14988286.41188.38
4154090-15409088.83790.96
5156885-15688590.44892.61
6159748-15974892.09994.25
60min1158697-15869791.49389.112.2094.2091.722.22
2156456-15645690.20192.83
3148940-14894085.86888.32
4154166-15416688.88191.49
5152954-15295488.18290.84
6156118-15611890.00692.67
极限1160567-16056792.57189.932.0095.7993.052.01
2153079-15307988.25491.39
3152035-15203587.65290.58
4157267-15726790.66993.78
5155733-15573389.78492.93
6157221-15722190.64293.81
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%
111.081868791857831860371847861864871859940.43
211.171854571880761867661.00
单位质量响应值RSD%判断
16786.4616720.320.28数据可信
供试品溶液-2023122321批-依折麦布-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min114205-142057.61212.1722.977.6112.1722.97
219774-1977410.59610.60
325997-2599713.93113.93
428702-2870215.38015.38
525524-2552413.67713.68
622066-2206611.82411.82
10min125666-2566613.75314.1016.9313.8014.1716.78
234534-3453418.50618.56
321195-2119511.35811.44
424135-2413512.93313.02
526409-2640914.15214.23
625920-2592013.89013.96
15min125368-2536813.59414.758.7613.7114.908.70
225631-2563113.73513.90
330272-3027216.22216.36
427579-2757914.77914.94
530649-3064916.42416.58
625658-2565813.74913.89
20min128617-2861715.33514.604.8115.5314.834.70
227620-2762014.80115.04
324750-2475013.26313.49
427731-2773114.86015.10
527232-2723214.59314.84
627549-2754914.76314.98
30min130503-3050316.34515.643.2916.6215.953.20
229151-2915115.62115.94
327720-2772014.85415.16
429582-2958215.85216.17
529602-2960215.86316.19
628563-2856315.30615.61
45min131573-3157316.91916.463.6717.2916.863.62
229648-2964815.88716.29
329530-2953015.82416.21
431702-3170216.98817.40
531939-3193917.11517.53
629941-2994116.04416.43
60min129819-2981915.97916.191.7616.4416.681.74
231155-3115516.69517.19
330498-3049816.34316.82
429870-2987016.00616.51
530102-3010216.13116.64
629817-2981715.97816.45
极限131576-3157616.92016.861.7717.4717.441.77
231670-3167016.97117.56
331111-3111116.67117.24
432135-3213517.22017.81
531767-3176717.02317.62
630558-3055816.37516.94
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