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%
111.501707441710511704111716951719661711730.38
211.551686531706251696390.83
单位质量响应值RSD%判断
14884.6114687.360.95数据可信
供试品溶液-CLB01071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%
5min179421-7942145.99646.915.7146.0046.915.71
284314-8431448.83048.83
382228-8222847.62147.62
477759-7775945.03345.03
574787-7478743.31243.31
687535-8753550.69550.69
10min1124130-12413071.88969.493.3672.1469.753.36
2123037-12303771.25671.53
3117065-11706567.79768.06
4113664-11366465.82766.08
5119614-11961469.27369.51
6122427-12242770.90271.18
15min1133149-13314977.11276.673.3877.7777.323.37
2137388-13738879.56780.23
3130479-13047975.56676.21
4124590-12459072.15572.77
5135362-13536278.39379.02
6133324-13332477.21377.89
20min1142761-14276182.67882.131.6983.7683.201.70
2145372-14537284.19185.30
3142730-14273082.66183.72
4138348-13834880.12381.14
5140582-14058281.41782.48
6141100-14110081.71782.82
30min1149298-14929886.46487.652.7888.0189.182.76
2156898-15689890.86692.44
3151849-15184987.94289.46
4144943-14494383.94285.40
5154657-15465789.56891.08
6150425-15042587.11788.68
45min1154792-15479289.64689.292.6791.6791.302.65
2158088-15808891.55593.64
3152693-15269388.43190.44
4148099-14809985.77087.70
5159223-15922392.21294.22
6152124-15212488.10190.14
60min1153524-15352488.91289.091.8391.4391.601.80
2157333-15733391.11893.71
3154012-15401289.19491.69
4153675-15367588.99991.40
5155499-15549990.05692.58
6148931-14893186.25288.78
极限1152280-15228088.19190.472.1991.2193.482.15
2156711-15671190.75793.85
3159383-15938392.30595.30
4153093-15309388.66291.56
5160834-16083493.14596.17
6154970-15497089.74992.76
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%
111.081859991862751858481871111853461861160.35
211.171851791855461853620.15
单位质量响应值RSD%判断
16797.4716594.630.86数据可信
供试品溶液-CLB01071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%
5min17800-78004.1945.8921.324.195.8921.35
211448-114486.1566.16
310731-107315.7705.77
411809-118096.3506.35
59295-92954.9985.00
614630-146307.8677.87
10min120185-2018510.85411.092.0910.8811.122.13
220565-2056511.05811.09
320464-2046411.00411.04
420890-2089011.23311.27
520298-2029810.91510.94
621351-2135111.48111.52
15min122021-2202111.84112.443.9611.9212.543.96
224589-2458913.22213.32
323774-2377412.78412.88
422554-2255412.12812.23
522890-2289012.30812.40
622989-2298912.36212.47
20min125431-2543113.67513.244.6413.8213.404.59
224923-2492313.40213.57
325594-2559413.76213.93
425151-2515113.52413.69
522552-2255212.12712.28
624112-2411212.96613.14
30min126057-2605714.01114.763.8814.2414.993.88
228513-2851315.33215.58
327882-2788214.99315.23
426751-2675114.38514.62
526782-2678214.40114.63
628664-2866415.41315.66
45min129474-2947415.84916.022.7716.1516.342.75
230818-3081816.57216.90
329774-2977416.01016.33
428417-2841715.28015.60
529921-2992116.08916.39
630360-3036016.32516.66
60min130403-3040316.34816.352.9916.7416.762.94
231422-3142216.89617.32
330584-3058416.44616.86
431250-3125016.80417.21
529017-2901715.60316.00
629767-2976716.00616.43
极限130147-3014716.21116.672.6516.6917.172.66
231253-3125316.80517.32
331887-3188717.14617.65
431386-3138616.87717.38
529818-2981816.03416.51
631497-3149716.93717.45
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%
111.501712351702481697701699011692451700800.44
211.551689671699521694600.42
单位质量响应值RSD%判断
14789.5714671.860.57数据可信
供试品溶液-CLB01071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%
5min178689-7868945.74245.727.9245.7445.727.92
272341-7234142.05242.05
370258-7025840.84140.84
481343-8134347.28447.28
586154-8615450.08150.08
683116-8311648.31548.31
10min1115894-11589467.36967.874.1267.6268.124.13
2112479-11247965.38465.62
3111121-11112164.59464.82
4118594-11859468.93869.20
5117954-11795468.56668.84
6124499-12449972.37172.64
15min1130111-13011175.63375.662.9776.2676.292.98
2127425-12742574.07274.67
3126274-12627473.40373.99
4131519-13151976.45177.10
5128548-12854874.72475.38
6137061-13706179.67380.34
20min1141008-14100881.96781.753.3883.0282.803.38
2136336-13633679.25280.26
3138374-13837480.43681.43
4143107-14310783.18784.26
5136291-13629179.22580.30
6148641-14864186.40487.52
30min1148222-14822286.16186.831.5887.6688.341.60
2148297-14829786.20487.65
3149267-14926786.76888.21
4150345-15034587.39588.93
5146659-14665985.25286.77
6153478-15347889.21690.81
45min1151902-15190288.30087.883.2090.2889.873.16
2147171-14717185.55087.48
3153801-15380189.40491.33
4153440-15344089.19491.21
5143790-14379083.58485.57
6156969-15696991.24593.33
60min1153576-15357689.27389.801.6091.7592.281.59
2152160-15216088.45090.85
3157758-15775891.70494.12
4154420-15442089.76492.28
5151924-15192488.31390.77
6157099-15709991.32193.92
极限1156012-15601290.68989.712.4493.6692.692.44
2149624-14962486.97689.87
3154683-15468389.91792.85
4156228-15622890.81593.83
5150158-15015887.28690.23
6159308-15930892.60595.71
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%
111.081881661877151869981879391883641878360.29
211.171849731858971854350.36
单位质量响应值RSD%判断
16952.7116601.161.49数据可信
供试品溶液-CLB01071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%
5min111936-119366.3885.8810.156.395.8810.15
29568-95685.1205.12
310727-107275.7415.74
412648-126486.7696.77
510515-105155.6275.63
610499-104995.6195.62
10min120643-2064311.04711.165.6411.0811.205.66
219722-1972210.55510.58
319246-1924610.30010.33
421690-2169011.60811.65
522021-2202111.78511.82
621827-2182711.68111.71
15min122254-2225411.91012.594.6412.0112.684.59
224225-2422512.96413.05
322683-2268312.13912.23
423409-2340912.52812.63
523278-2327812.45812.55
625276-2527613.52713.62
20min124263-2426312.98513.454.5213.1513.624.48
224700-2470013.21913.38
324270-2427012.98913.15
426782-2678214.33314.50
524430-2443013.07413.24
626370-2637014.11214.28
30min127278-2727814.59815.123.6614.8315.363.64
227640-2764014.79215.02
327989-2798914.97915.21
427866-2786614.91315.16
528634-2863415.32415.56
630165-3016516.14316.39
45min130026-3002616.06915.933.9116.3916.263.84
228304-2830415.14715.46
331290-3129016.74517.06
429295-2929515.67816.01
528859-2885915.44415.77
630851-3085116.51016.85
60min130164-3016416.14316.432.5116.5516.842.47
229983-2998316.04616.44
331925-3192517.08517.49
431077-3107716.63117.05
530060-3006016.08716.50
631023-3102316.60317.03
极限130988-3098816.58416.721.8317.0817.221.84
230587-3058716.36916.86
331413-3141316.81117.31
431263-3126316.73117.24
530950-3095016.56317.06
632250-3225017.25917.78
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