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%
110.881665711667691663451671091669341667460.18
211.001678961680521679740.07
单位质量响应值RSD%判断
15325.9215270.360.26数据可信
供试品溶液-23112303批-瑞舒伐他汀钙-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1107130-10713059.96463.5613.2259.9663.5613.22
2111005-11100562.13362.13
3111451-11145162.38262.38
4129991-12999172.76072.76
5130742-13074273.18073.18
691013-9101350.94250.94
10min1149533-14953383.69886.414.3084.0386.764.33
2150612-15061284.30284.65
3148565-14856583.15683.50
4162681-16268191.05791.46
5162964-16296491.21591.62
6151887-15188785.01585.30
15min1165322-16532292.53594.423.4993.3395.263.50
2165460-16546092.61393.43
3160842-16084290.02890.84
4173780-17378097.26998.18
5176483-17648398.78299.70
6170282-17028295.31296.07
20min1168305-16830594.20597.123.9795.5298.483.98
2171854-17185496.19197.52
3165758-16575892.77994.09
4176507-17650798.796100.25
5185226-185226103.676105.14
6173418-17341897.06798.35
30min1170121-17012195.22198.283.6497.06100.183.63
2173005-17300596.83698.70
3167067-16706793.51295.34
4179797-179797100.637102.64
5180949-180949101.282103.32
6182544-182544102.175104.00
45min1174804-17480497.84397.752.10100.21100.202.13
2172806-17280696.72499.12
3168642-16864294.39496.74
4176503-17650398.794101.35
5179419-179419100.426103.03
6175688-17568898.337100.73
60min1168098-16809894.08995.632.6897.0098.622.70
2171581-17158196.03998.98
3163333-16333391.42294.29
4173331-17333197.018100.13
5176477-17647798.779101.94
6172323-17232396.45499.39
极限1164422-16442292.03293.901.8295.4697.421.85
2165790-16579092.79796.27
3165002-16500292.35695.73
4171376-17137695.92499.57
5169342-16934294.78598.49
6170612-17061295.49698.97
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%
111.031811981808881809901812651813961811470.12
211.011818001817771817880.01
单位质量响应值RSD%判断
16423.1216511.170.38数据可信
供试品溶液-23112303批-依折麦布-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111403-114036.2327.0415.396.237.0415.39
210282-102825.6205.62
311934-119346.5226.52
414963-149638.1788.18
515122-151228.2658.26
613540-135407.4007.40
10min116533-165339.0369.585.369.079.625.41
216287-162878.9028.93
317394-173949.5079.54
418363-1836310.03610.08
518389-1838910.05010.10
618175-181759.9339.97
15min117572-175729.6049.974.419.6910.064.47
217170-171709.3849.46
317859-178599.7619.85
419058-1905810.41610.52
518971-1897110.36910.47
618776-1877610.26210.36
20min118502-1850210.11210.292.1610.2510.442.21
218663-1866310.20010.33
318504-1850410.11310.26
418963-1896310.36410.52
519578-1957810.70010.86
618773-1877310.26010.41
30min118124-181249.90610.483.4510.1010.693.46
218922-1892210.34210.53
318988-1898810.37810.58
419304-1930410.55110.77
519913-1991310.88311.10
619821-1982110.83311.04
45min120641-2064111.28111.281.2611.5311.541.23
220401-2040111.15011.40
321014-2101411.48511.74
420456-2045611.18011.46
520871-2087111.40711.69
620420-2042011.16011.43
60min120965-2096511.45811.651.5711.7711.981.60
221402-2140211.69712.01
321007-2100711.48111.80
421489-2148911.74512.08
521845-2184511.93912.28
621184-2118411.57811.91
极限120649-2064911.28611.601.9611.6611.991.94
221098-2109811.53111.90
321765-2176511.89612.28
421291-2129111.63712.04
520960-2096011.45611.86
621613-2161311.81312.21
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%
110.881679751679361677981680261676931678860.09
211.001677361680251678800.13
单位质量响应值RSD%判断
15430.7015261.820.78数据可信
供试品溶液-23112303批-瑞舒伐他汀钙-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1172846-17284696.44692.8711.4996.4592.8711.49
2170030-17003094.87594.87
3174298-17429897.25697.26
4179357-179357100.079100.08
5174152-17415297.17597.17
6127921-12792171.37871.38
10min1182371-182371101.761102.351.17102.30102.861.17
2180906-180906100.943101.47
3183109-183109102.173102.71
4183432-183432102.353102.91
5187326-187326104.526105.07
6183391-183391102.330102.73
15min1188229-188229105.029102.031.86106.13103.121.84
2182365-182365101.757102.85
3178317-17831799.499100.61
4181003-181003100.997102.12
5184879-184879103.160104.28
6182360-182360101.755102.72
20min1180216-180216100.558100.810.42102.24102.460.39
2180944-180944100.965102.62
3180629-180629100.789102.45
4179455-179455100.134101.82
5181486-181486101.267102.96
6181284-181284101.154102.68
30min1180958-180958100.972100.310.94103.22102.520.93
2179361-179361100.081102.30
3177734-17773499.173101.39
4178097-17809799.376101.62
5182092-182092101.605103.86
6180344-180344100.630102.72
45min1181885-181885101.490101.130.56104.29103.890.54
2181244-181244101.132103.90
3180705-180705100.831103.60
4182494-182494101.829104.62
5179581-179581100.204103.02
6181482-181482101.265103.92
60min1178886-17888699.816100.351.34103.18103.681.29
2176906-17690698.711102.04
3183189-183189102.217105.55
4177875-17787599.252102.61
5181785-181785101.434104.81
6180378-180378100.649103.86
极限1179147-17914799.96299.631.87103.88103.521.81
2175512-17551297.934101.81
3176299-17629998.373102.27
4184784-184784103.107107.02
5177077-17707798.807102.75
6178492-17849299.596103.37
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%
111.031814261814461816941822391820411817690.20
211.011809071813931811500.19
单位质量响应值RSD%判断
16479.5116453.220.12数据可信
供试品溶液-23112303批-依折麦布-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18245-82454.5065.9315.734.515.9315.71
210559-105595.7715.77
39638-96385.2685.27
411866-118666.4866.49
511989-119896.5536.55
612823-128237.0097.01
10min112813-128137.0037.886.357.037.916.36
213938-139387.6187.65
314499-144997.9257.95
414975-149758.1858.22
515270-152708.3468.38
614993-149938.1958.23
15min114786-147868.0828.191.588.158.271.62
214972-149728.1838.26
314856-148568.1208.19
414768-147688.0728.15
515368-153688.4008.48
615158-151588.2858.37
20min113465-134657.3607.934.017.478.064.00
214701-147018.0358.15
314948-149488.1708.29
415033-150338.2178.34
514255-142557.7917.92
614682-146828.0258.16
30min114420-144207.8827.892.038.038.061.98
214605-146057.9838.15
314647-146478.0068.17
414055-140557.6827.85
514773-147738.0748.25
614125-141257.7207.90
45min113465-134657.3607.873.477.558.083.50
214595-145957.9778.19
314489-144897.9198.13
414865-148658.1258.34
514290-142907.8108.03
614710-147108.0408.26
60min113536-135367.3987.863.467.638.123.43
214472-144727.9108.16
315075-150758.2408.49
414395-143957.8688.13
514310-143107.8218.08
614525-145257.9398.20
极限113714-137147.4967.843.057.778.143.05
213875-138757.5847.88
314520-145207.9368.23
414766-147668.0718.37
514609-146097.9858.29
614582-145827.9708.28
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%
110.881675051676561676571676261680241676940.12
211.001693941698201696070.18
单位质量响应值RSD%判断
15413.0515418.820.03数据可信
供试品溶液-23112302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%
5min1143851-14385179.90277.694.1079.9077.694.10
2145522-14552280.83080.83
3137916-13791676.60576.61
4130632-13063272.55972.56
5137084-13708476.14376.14
6144228-14422880.11180.11
10min1171024-17102494.99596.541.2995.4496.971.29
2172580-17258095.85996.31
3173799-17379996.53696.96
4172505-17250595.81896.22
5176429-17642997.99798.42
6176506-17650698.04098.49
15min1178590-17859099.19899.090.89100.17100.060.88
2175865-17586597.68498.67
3177941-17794198.83799.80
4178142-17814298.94999.88
5179229-17922999.553100.52
6180628-180628100.330101.32
20min1176159-17615997.84798.160.8699.3799.680.85
2174590-17459096.97698.50
3178614-17861499.211100.72
4175817-17581797.65799.14
5178163-17816398.960100.48
6177016-17701698.32399.87
30min1173367-17336796.29696.401.8998.3698.471.86
2168218-16821893.43695.50
3173412-17341296.32198.38
4174486-17448696.91898.95
5173402-17340296.31698.39
6178454-17845499.122101.22
45min1176840-17684098.22696.371.40100.8398.971.38
2169688-16968894.25396.84
3172606-17260695.87498.47
4172829-17282995.99898.56
5174098-17409896.70399.31
6174904-17490497.15099.79
60min1167732-16773293.16793.861.2696.3197.001.25
2167284-16728492.91896.02
3169511-16951194.15597.28
4166687-16668792.58695.69
5170498-17049894.70397.85
6172177-17217795.63698.82
极限1170335-17033594.61294.331.5998.2897.991.57
2166186-16618692.30895.93
3169934-16993494.39098.04
4167930-16793093.27796.89
5170440-17044094.67198.34
6174163-17416396.739100.45
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%
111.031810111811871814011815571818811814070.19
211.011826481833201829840.26
单位质量响应值RSD%判断
16446.6916619.800.75数据可信
供试品溶液-23112302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%
5min1116172-11617263.24149.6117.2263.2449.6117.22
291332-9133249.71949.72
376401-7640141.59141.59
474110-7411040.34340.34
5100536-10053654.72954.73
688215-8821548.02248.02
10min1165900-16590090.31184.045.5490.6684.315.57
2150750-15075082.06482.34
3147055-14705580.05380.28
4148298-14829880.72980.95
5164658-16465889.63589.94
6149602-14960281.43981.71
15min1179359-17935997.63894.242.7398.4994.982.78
2169557-16955792.30293.03
3168581-16858191.77192.45
4173226-17322694.29994.97
5178336-17833697.08197.88
6169631-16963192.34293.06
20min1179179-17917997.54096.191.4798.9497.461.52
2174079-17407994.76496.01
3176230-17623095.93597.12
4175907-17590795.75996.96
5180455-18045598.23599.58
6174328-17432894.89996.13
30min1176775-17677596.23196.221.4798.1798.021.44
2172139-17213993.70895.48
3177630-17763096.69798.42
4177054-17705496.38398.11
5176765-17676596.22698.11
6180154-18015498.07199.83
45min1180392-18039298.20096.471.33100.6798.801.35
2173805-17380594.61596.91
3178807-17880797.33899.59
4175420-17542095.49497.76
5177459-17745996.60499.03
6177362-17736296.55198.86
60min1170941-17094193.05693.801.4596.0796.671.41
2171203-17120393.19896.02
3175217-17521795.38398.18
4168596-16859691.77994.57
5173813-17381394.61997.58
6174112-17411294.78297.62
极限1173086-17308694.22394.191.4597.7697.581.42
2169986-16998692.53695.87
3174914-17491495.21898.54
4170268-17026892.68995.99
5173604-17360494.50597.99
6176246-17624695.94499.31
点击查看处理图标(人工保存)
 
原始图谱下载图谱(姜进硙 于 2024-11-20 11:39:27 完成)
生成报告数据部分(等待生成报告)
Current page cost:71 ms