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%
1 10.881696511703871701431700621705201701530.20
2 11.001713261717541715400.18
单位质量响应值RSD%判断
15639.0615594.550.21数据可信
供试品溶液-23112303批-瑞舒伐他汀钙-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1123065-12306567.47780.279.8067.4880.279.80
2157406-15740686.30786.31
3163302-16330289.53989.54
4138041-13804175.68975.69
5148262-14826281.29381.29
6148285-14828581.30581.31
10min1171068-17106893.79897.572.1894.1798.012.21
2176949-17694997.02297.50
3182827-182827100.245100.74
4179114-17911498.20998.63
5178671-17867197.96698.42
6179011-17901198.15398.60
15min1174479-17447995.66899.402.4996.56100.392.50
2178052-17805297.62798.65
3186575-186575102.300103.35
4184161-184161100.976101.94
5180367-18036798.89699.89
6184089-184089100.937101.93
20min1179370-17937098.350100.392.7499.78101.932.74
2178325-17832597.77799.34
3191008-191008104.731106.35
4185393-185393101.652103.18
5179071-17907198.18699.73
6185348-185348101.627103.19
30min1179900-17990098.64099.591.57100.61101.691.58
2179889-17988998.634100.74
3185495-185495101.708103.91
4184943-184943101.405103.50
5178899-17889998.091100.18
6180686-18068699.071101.19
45min1176421-17642196.73399.392.5299.25102.042.52
2179235-17923598.276100.93
3188882-188882103.565106.33
4183603-183603100.671103.33
5177718-17771897.444100.08
6181730-18173099.644102.32
60min1174100-17410095.46097.911.7998.52101.111.78
2181032-18103299.261102.46
3179044-17904498.171101.52
4178325-17832597.777100.99
5176052-17605296.53099.71
6182812-182812100.237103.46
极限1173572-17357295.17097.342.1198.76101.092.08
2172861-17286194.78198.53
3178074-17807497.639101.53
4180831-18083199.151102.91
5177775-17777597.475101.19
6182089-18208999.840103.62
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%
111.031818741809431805391808141813141810970.29
211.011809881820351815120.41
单位质量响应值RSD%判断
16418.5916486.100.30数据可信
供试品溶液-23112303批-依折麦布-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min112618-126186.9037.868.116.907.868.11
215959-159598.7308.73
314499-144997.9317.93
413929-139297.6207.62
515271-152718.3548.35
613958-139587.6367.64
10min116706-167069.1399.843.559.189.883.54
218326-1832610.02510.07
318047-180479.8729.92
418364-1836410.04610.09
518202-182029.95710.00
618279-182799.99910.04
15min117936-179369.8129.633.629.909.733.54
216844-168449.2149.32
318488-1848810.11410.21
418017-180179.8569.95
517336-173369.4839.59
617048-170489.3269.42
20min117057-170579.3319.562.279.479.712.27
217334-173349.4829.64
318125-181259.91510.07
417770-177709.7219.87
517385-173859.5109.66
617203-172039.4119.56
30min117180-171809.3989.333.209.599.543.13
217821-178219.7499.96
317075-170759.3419.55
416564-165649.0619.27
517397-173979.5179.72
616333-163338.9359.14
45min117865-178659.7739.594.1210.029.844.03
218243-182439.98010.24
318309-1830910.01610.28
417301-173019.4649.72
516819-168199.2019.46
616626-166269.0959.35
60min117433-174339.5369.563.619.849.873.53
218665-1866510.21010.53
317268-172689.4469.76
417037-170379.3209.63
516906-169069.2489.56
617561-175619.6079.91
极限115695-156958.5869.154.028.949.523.89
217129-171299.3709.74
316358-163588.9489.32
417082-170829.3449.71
516554-165549.0569.42
617587-175879.6219.98
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%
1 10.881712081714061716381726281718111717380.32
2 11.001721171719841720500.06
单位质量响应值RSD%判断
15784.7415640.910.65数据可信
供试品溶液-23112301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%
5min1156390-15639085.22781.876.0785.2381.876.07
2134923-13492373.52873.53
3146483-14648379.82879.83
4156718-15671885.40685.41
5159164-15916486.73986.74
6147694-14769480.48880.49
10min1181894-18189499.12695.382.8099.6095.842.80
2169344-16934492.28792.70
3172341-17234193.92094.36
4172434-17243493.97194.44
5174064-17406494.85995.34
6180085-18008598.14098.59
15min1176085-17608595.96096.351.2096.9897.331.21
2173481-17348194.54195.46
3175612-17561295.70296.67
4178983-17898397.53998.54
5178277-17827797.15598.16
6178335-17833597.18698.18
20min1175762-17576295.78495.110.9397.3496.630.93
2172678-17267894.10395.55
3175869-17586995.84297.34
4175971-17597195.89897.44
5174408-17440895.04696.59
6172511-17251194.01295.54
30min1171884-17188493.67195.181.4395.7697.221.42
2171273-17127393.33895.31
3176116-17611695.97798.01
4175768-17576895.78797.86
5175299-17529995.53297.61
6177531-17753196.74898.80
45min1173221-17322194.39994.360.4297.0196.940.41
2173036-17303694.29996.79
3173804-17380494.71797.28
4172444-17244493.97696.58
5172292-17229293.89396.50
6174110-17411094.88497.48
60min1171136-17113693.26393.580.7996.4096.690.80
2169322-16932292.27595.29
3172229-17222993.85996.95
4172013-17201393.74196.87
5173120-17312094.34497.47
6172540-17254094.02897.15
极限1172476-17247693.99393.980.8097.6597.600.81
2170029-17002992.66096.18
3173397-17339794.49598.11
4172399-17239993.95197.60
5174040-17404094.84698.50
6172358-17235893.92997.57
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%
111.031833101827561817351821601817511823420.38
211.011824831831681828260.27
单位质量响应值RSD%判断
16531.4616605.450.32数据可信
供试品溶液-23112301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%
5min1114005-11400561.92860.9118.1261.9360.9118.12
285911-8591146.66746.67
3121849-12184966.18966.19
4122228-12222866.39566.39
5138527-13852775.24875.25
690255-9025549.02749.03
10min1172431-17243193.66589.575.3294.0189.915.35
2148909-14890980.88881.15
3170038-17003892.36592.73
4164308-16430889.25389.62
5171138-17113892.96393.38
6162558-16255888.30288.57
15min1176280-17628095.75695.332.8396.6296.162.88
2166364-16636490.37091.08
3177763-17776396.56297.44
4178740-17874097.09297.96
5179975-17997597.76398.70
6173834-17383494.42795.19
20min1179501-17950197.50695.711.9998.9097.072.02
2173337-17333794.15795.37
3180353-18035397.96899.39
4177203-17720396.25797.66
5175302-17530295.22596.70
6171435-17143593.12494.41
30min1177707-17770796.53196.590.7198.4798.490.77
2175982-17598295.59497.33
3179913-17991397.72999.69
4177536-17753696.43898.38
5177698-17769896.52698.53
6178094-17809496.74198.55
45min1177641-17764196.49595.821.0698.9798.261.01
2178841-17884197.14799.41
3177570-17757096.45798.96
4174763-17476394.93297.41
5175329-17532995.23997.78
6174249-17424994.65397.00
60min1174445-17444594.75995.000.9597.7797.970.94
2176421-17642195.83398.64
3176761-17676196.01799.06
4175121-17512195.12698.13
5174459-17445994.76797.84
6172178-17217893.52896.40
极限1176490-17649095.87095.391.0499.4198.881.07
2175146-17514695.14098.48
3178431-17843196.924100.50
4173969-17396994.50198.03
5176111-17611195.66499.26
6173451-17345194.21997.61
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%
1 10.881704211697581703191703551697671701240.20
2 11.001714031725191719610.46
单位质量响应值RSD%判断
15636.4015632.820.02数据可信
供试品溶液-23112303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%
5min1134987-13498773.93068.9510.8073.9368.9510.80
2124298-12429868.07668.08
3134324-13432473.56773.57
4140534-14053476.96876.97
5117191-11719164.18364.18
6104046-10404656.98456.98
10min1171570-17157093.96592.703.2694.3893.093.26
2158888-15888887.02087.40
3170034-17003493.12493.53
4175070-17507095.88296.31
5171320-17132093.82994.19
6168700-16870092.39492.71
15min1174545-17454595.59596.151.5296.5397.051.55
2172568-17256894.51295.37
3176854-17685496.85997.79
4179734-17973498.43799.40
5176446-17644696.63697.51
6173221-17322194.87095.70
20min1174147-17414795.37796.221.6196.8497.661.63
2173395-17339594.96596.35
3180439-18043998.823100.29
4177827-17782797.39298.90
5173601-17360195.07896.49
6174765-17476595.71597.07
30min1171475-17147593.91394.941.1495.9196.901.15
2171132-17113293.72695.64
3176223-17622396.51498.53
4174146-17414695.37697.42
5174510-17451095.57697.52
6172579-17257994.51896.41
45min1170388-17038893.31894.831.4195.8397.331.39
2171209-17120993.76896.20
3175501-17550196.11898.67
4173236-17323694.87897.46
5176544-17654496.69099.16
6172061-17206194.23496.65
60min1164353-16435390.01393.072.3393.0596.092.30
2167582-16758291.78194.74
3175471-17547196.10299.19
4172083-17208394.24697.35
5171790-17179094.08697.10
6168297-16829792.17395.11
极限1167702-16770291.84793.482.1095.3897.022.07
2167926-16792691.97095.44
3177193-17719397.045100.66
4170461-17046193.35896.99
5171907-17190794.15097.68
6168882-16888292.49395.94
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%
111.031819101814111814471804541804741811390.36
211.011824201832151828180.31
单位质量响应值RSD%判断
16422.3916604.720.79数据可信
供试品溶液-23112303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%
5min188780-8878048.38754.0116.6948.3954.0216.68
2129468-12946870.56370.56
383132-8313245.30945.31
490743-9074349.45749.46
599926-9992654.46254.46
6102584-10258455.91155.91
10min1157431-15743185.80488.443.9086.0788.743.94
2171860-17186093.66894.06
3154125-15412584.00284.25
4161672-16167288.11588.39
5162051-16205188.32288.62
6166450-16645090.71991.03
15min1171494-17149493.46894.552.3194.2195.342.35
2179955-17995598.08098.99
3168217-16821791.68292.40
4175661-17566195.73996.50
5173099-17309994.34395.14
6172409-17240993.96794.78
20min1175036-17503695.39995.570.8596.6696.890.86
2176233-17623396.05197.51
3175047-17504795.40596.63
4177151-17715196.55197.85
5172796-17279694.17895.50
6175887-17588795.86397.20
30min1175535-17553595.67195.350.5897.4797.200.53
2173243-17324394.42196.41
3174575-17457595.14796.91
4176051-17605195.95297.78
5174681-17468195.20597.05
6175616-17561695.71597.58
45min1173430-17343094.52394.880.8596.8597.260.82
2173266-17326694.43496.95
3172986-17298694.28196.57
4175923-17592395.88298.25
5175984-17598495.91598.28
6172881-17288194.22496.63
60min1167309-16730991.18792.991.1294.0495.891.08
2170074-17007492.69495.73
3171744-17174493.60496.41
4172733-17273394.14497.04
5171531-17153193.48896.39
6170267-17026792.79995.72
极限1171565-17156593.50793.540.6296.8696.960.55
2170802-17080293.09196.65
3173599-17359994.61697.95
4171082-17108293.24496.67
5171876-17187693.67697.10
6170776-17077693.07796.52
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