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%
110.871665841664281660291664751661151663260.15
210.931663621668311665960.20
单位质量响应值RSD%判断
15301.3815242.090.28数据可信
供试品溶液-2023122321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%
5min1121265-12126567.99367.8110.6067.9967.8110.60
2100340-10034056.26056.26
3113944-11394463.88863.89
4122563-12256368.72168.72
5136681-13668176.63676.64
6130796-13079673.33773.34
10min1169907-16990795.26692.184.2795.6492.564.29
2154690-15469086.73487.05
3156403-15640387.69488.05
4167673-16767394.01494.40
5166973-16697393.62194.05
6170751-17075195.73996.15
15min1179380-179380100.57897.783.66101.4898.673.69
2165275-16527592.66993.46
3167411-16741193.86794.71
4178045-17804599.829100.73
5176458-17645898.93999.89
6179807-179807100.817101.76
20min1183000-183000102.60799.372.78104.07100.802.81
2170856-17085695.79897.11
3172427-17242796.67998.04
4177242-17724299.379100.84
5177673-17767399.620101.12
6182118-182118102.113103.61
30min1180476-180476101.19298.502.09103.23100.492.11
2173877-17387797.49299.33
3169614-16961495.10297.00
4176149-17614998.766100.78
5177268-17726899.393101.44
6176706-17670699.078101.14
45min1183291-183291102.77099.012.61105.37101.542.63
2172345-17234596.63399.02
3171339-17133996.06998.50
4175379-17537998.334100.89
5180309-180309101.098103.70
6176827-17682799.146101.76
60min1182106-182106102.10699.702.83105.27102.782.82
2177170-17717099.338102.26
3168793-16879394.64297.60
4177750-17775099.664102.77
5178167-17816799.897103.06
6182856-182856102.527105.69
极限1172677-17267796.81998.552.26100.56102.192.26
2172653-17265396.806100.28
3171411-17141196.10999.60
4177963-17796399.783103.44
5180229-180229101.054104.77
6179693-179693100.753104.49
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%
110.941875961874481870751866031860121869470.35
210.991874001880961877480.27
单位质量响应值RSD%判断
17088.3917083.530.03数据可信
供试品溶液-2023122321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%
5min112501-125016.5687.0014.046.577.0014.05
211580-115806.0846.08
313162-131626.9166.92
411687-116876.1416.14
516382-163828.6088.61
614626-146267.6857.68
10min117307-173079.0949.234.259.139.274.24
217802-178029.3549.39
318154-181549.5399.58
416875-168758.8678.90
516701-167018.7758.82
618610-186109.7789.82
15min117577-175779.2369.413.909.329.503.82
218263-182639.5969.68
317856-178569.3829.47
419085-1908510.02810.11
517554-175549.2239.32
617085-170858.9779.07
20min117944-179449.4289.396.699.579.546.55
218204-182049.5659.70
318065-180659.4929.64
418554-185549.7499.89
515545-155458.1688.32
618927-189279.94510.09
30min119373-1937310.1799.425.3910.379.615.26
218450-184509.6949.89
318057-180579.4889.68
417344-173449.1139.31
516546-165468.6948.89
617754-177549.3299.53
45min117739-177399.3219.444.879.579.694.77
218574-185749.75910.01
317523-175239.2079.46
417162-171629.0179.26
517372-173729.1289.37
619448-1944810.21910.47
60min119664-1966410.3329.307.7610.639.607.54
218945-189459.95410.25
317232-172329.0549.35
417241-172419.0599.35
515854-158548.3308.62
617278-172789.0789.39
极限115721-157218.2609.005.358.629.355.18
217647-176479.2729.63
318056-180569.4879.84
417398-173989.1419.49
516262-162628.5458.88
617639-176399.2689.63
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%
110.871676461675571665231674371667181671760.31
210.931677441677931677680.03
单位质量响应值RSD%判断
15379.5815349.310.14数据可信
供试品溶液-2023122321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%
5min1117154-11715465.29167.776.6065.2967.776.60
2129820-12982072.35072.35
3132216-13221673.68573.69
4122511-12251168.27768.28
5112643-11264362.77762.78
6115273-11527364.24364.24
10min1159783-15978389.04990.561.6789.4190.941.68
2162960-16296090.81991.22
3167071-16707193.11093.52
4163193-16319390.94991.33
5159783-15978389.04989.40
6162199-16219990.39590.75
15min1167552-16755293.37995.091.7794.2495.971.77
2168546-16854693.93294.84
3175133-17513397.60498.53
4171304-17130495.47096.35
5168298-16829893.79494.64
6172915-17291596.36797.23
20min1174184-17418497.07597.391.2798.4598.801.27
2171095-17109595.35396.78
3177468-17746898.905100.37
4175658-17565897.89699.31
5173913-17391396.92498.29
6176174-17617498.18499.58
30min1173117-17311796.48097.661.5098.4099.611.50
2173794-17379496.85798.82
3180205-180205100.430102.45
4173913-17391396.92498.88
5174440-17444097.21799.12
6175959-17595998.064100.00
45min1172836-17283696.32397.871.0298.77100.361.01
2174069-17406997.01199.51
3175948-17594898.058100.63
4176781-17678198.522101.02
5176509-17650998.370100.81
6177497-17749798.921101.41
60min1175984-17598498.07898.181.25101.06101.221.24
2172259-17225996.00299.04
3178700-17870099.591102.71
4177409-17740998.872101.92
5177008-17700898.648101.64
6175647-17564797.890100.92
极限1170366-17036694.94796.891.8598.48100.481.81
2170939-17093995.26698.83
3174799-17479997.417101.09
4175332-17533297.714101.31
5172701-17270196.24899.79
6179016-17901699.768103.35
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%
110.941896481889321892271875631887141888170.42
210.991890811884081887440.26
单位质量响应值RSD%判断
17259.3217174.160.35数据可信
供试品溶液-2023122321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%
5min112341-123416.4356.826.006.446.825.96
214256-142567.4347.43
312963-129636.7596.76
412854-128546.7036.70
512303-123036.4156.42
613770-137707.1807.18
10min117870-178709.3189.082.359.359.112.34
217642-176429.1999.24
317662-176629.2109.25
416750-167508.7348.77
517366-173669.0559.09
617154-171548.9458.98
15min116526-165268.6179.024.138.709.114.11
218586-185869.6929.78
317570-175709.1629.25
417122-171228.9289.01
516998-169988.8638.95
616987-169878.8588.95
20min118861-188619.8359.303.909.979.443.85
218485-184859.6399.79
317799-177999.2819.42
417322-173229.0329.17
517149-171498.9429.08
617393-173939.0699.21
30min117034-170348.8828.953.729.079.143.67
217755-177559.2589.46
317723-177239.2429.43
416150-161508.4218.61
517548-175489.1509.34
616740-167408.7298.92
45min117422-174229.0859.444.649.329.684.57
218100-181009.4389.69
319401-1940110.11710.36
417378-173789.0629.29
518818-188189.81310.05
617522-175229.1379.37
60min116738-167388.7289.395.139.029.685.03
219483-1948310.15910.46
318271-182719.5279.83
417394-173949.0709.35
518135-181359.4569.75
617981-179819.3769.66
极限116180-161808.4379.134.628.789.474.41
217276-172769.0089.37
317193-171938.9659.32
417811-178119.2879.62
518143-181439.4619.80
618434-184349.6129.95
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