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对照品来源中检院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1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.769364494556945439459794483943650.43
210.809565295588956200.05
单位质量响应值RSD%判断
8769.988853.700.68数据可信
供试品溶液-2024041021批-瑞舒伐他汀钙-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min194362-9436291.50688.502.9391.5188.502.93
288272-8827285.60085.60
393619-9361990.78690.79
491003-9100388.24988.25
592273-9227389.48089.48
688021-8802185.35785.36
10min196795-9679593.86696.111.9994.3796.601.97
299336-9933696.33096.81
3100103-10010397.07397.58
496648-9664893.72394.21
5100343-10034397.30697.80
6101420-10142098.35198.82
15min197232-9723294.28997.022.0895.3298.042.05
2102686-10268699.578100.59
3101106-10110698.04699.09
498844-9884495.85296.86
598789-9878995.79996.84
6101609-10160998.53499.55
20min198335-9833595.35996.741.7596.9198.301.74
2101864-10186498.781100.35
3100506-10050697.46499.05
498585-9858595.60197.14
5101478-10147898.40799.98
697793-9779394.83396.40
30min197572-9757294.61996.932.1596.7099.042.12
2102813-10281399.701101.81
398413-9841395.43597.56
499198-9919896.19698.27
5102394-10239499.295101.41
699368-9936896.36198.46
45min198474-9847495.49497.101.6398.1099.741.61
2103233-103233100.109102.78
3100275-10027597.24099.90
499568-9956896.55599.16
599825-9982596.80499.47
699422-9942296.41399.04
60min196849-9684993.91896.102.3597.0699.282.31
2103049-10304999.930103.15
398652-9865295.66698.87
497240-9724094.29797.44
5100535-10053597.492100.70
698251-9825195.27798.44
极限197809-9780994.84996.551.7798.51100.261.73
2102062-10206298.973102.75
398261-9826195.28799.02
498163-9816395.19298.86
5100067-10006797.038100.79
6101025-10102597.967101.66
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对照品来源中检院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1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.778316383121831418317983150831510.03
210.828319183085831380.10
单位质量响应值RSD%判断
7720.617683.730.34数据可信
供试品溶液-2024041021批-依折麦布-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14676-46765.4644.3721.695.464.3721.63
24391-43915.1315.13
34332-43325.0625.06
43192-31923.7303.73
52873-28733.3573.36
62975-29753.4763.48
10min17239-72398.4598.793.498.498.813.53
27802-78029.1179.15
37888-78889.2179.25
47360-73608.6008.62
57388-73888.6338.65
67440-74408.6948.71
15min18147-81479.5208.885.519.608.955.53
27587-75878.8658.94
37787-77879.0999.18
47270-72708.4958.56
56979-69798.1558.22
67815-78159.1329.20
20min17665-76658.9578.922.799.099.052.82
27662-76628.9539.08
37975-79759.3199.45
47344-73448.5828.70
57488-74888.7508.86
67692-76928.9889.11
30min17347-73478.5858.722.748.778.892.64
27763-77639.0719.25
37176-71768.3858.57
47407-74078.6558.82
57602-76028.8839.04
67472-74728.7318.90
45min17687-76878.9828.683.689.218.903.68
27529-75298.7989.03
37697-76978.9949.22
47390-73908.6358.85
56979-69798.1558.36
67290-72908.5188.74
60min17100-71008.2968.392.988.578.662.96
27489-74898.7519.03
37274-72748.5008.78
47175-71758.3848.64
57206-72068.4208.68
66838-68387.9908.25
极限17581-75818.8588.762.479.189.082.41
27335-73358.5718.90
37520-75208.7879.11
47453-74538.7099.01
57291-72918.5208.82
67802-78029.1179.43
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对照品来源中检院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1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.769643596538963939642696484964550.06
210.809722096765969920.34
单位质量响应值RSD%判断
8964.228980.740.14数据可信
供试品溶液-2024041021批-瑞舒伐他汀钙
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min193415-9341588.96487.692.9488.9687.692.94
290107-9010785.81485.81
392408-9240888.00588.01
487886-8788683.69883.70
595566-9556691.01391.01
693090-9309088.65588.65
10min199426-9942694.68995.081.3895.1895.561.38
2101558-10155896.71997.20
3100054-10005495.28795.78
498310-9831093.62694.09
5101225-10122596.40296.91
698426-9842693.73694.23
15min198796-9879694.08995.161.6395.1196.181.62
2102805-10280597.90798.92
399555-9955594.81195.83
498877-9887794.16695.15
5100835-10083596.03197.07
698674-9867493.97294.99
20min199682-9968294.93295.591.8296.4897.141.81
2102795-10279597.89799.46
3101015-10101596.20297.75
498159-9815993.48294.99
5101853-10185397.00098.57
698739-9873994.03495.57
30min198720-9872094.01695.642.2396.0997.722.21
2104112-10411299.151101.25
3100829-10082996.02598.10
498802-9880294.09496.12
5101706-10170696.86098.97
698403-9840393.71495.77
45min197941-9794193.27494.721.7395.8797.321.72
2101712-10171296.86699.52
3100475-10047595.68898.30
498417-9841793.72896.28
5100664-10066495.86898.52
697532-9753292.88595.46
60min198452-9845293.76194.102.3796.8797.242.33
2102517-10251797.632100.82
3100045-10004595.27898.42
497544-9754492.89695.97
598707-9870794.00497.19
695605-9560591.05094.14
极限196032-9603291.45693.462.5895.0997.122.54
2101720-10172096.873100.61
399080-9908094.35998.03
495595-9559591.04094.63
5100104-10010495.33499.04
696292-9629291.70495.30
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对照品来源中检院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1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.778308583095830888314183144831110.04
210.828292982995829620.06
单位质量响应值RSD%判断
7716.907667.470.46数据可信
供试品溶液-2024041021批-依折麦布
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14781-47815.5944.9414.845.594.9414.84
23269-32693.8253.82
33928-39284.5964.60
43916-39164.5824.58
54901-49015.7345.73
64538-45385.3105.31
10min17452-74528.7198.822.788.758.852.77
27254-72548.4878.51
37402-74028.6618.69
47828-78289.1599.18
57619-76198.9148.95
67686-76868.9939.02
15min17691-76918.9999.103.229.089.183.19
27878-78789.2189.29
37330-73308.5768.65
48030-80309.3959.47
57787-77879.1119.19
67951-79519.3039.38
20min17852-78529.1879.090.839.329.220.86
27775-77759.0979.22
37677-76778.9829.10
47771-77719.0929.22
57729-77299.0439.18
67829-78299.1609.29
30min17478-74788.7498.992.068.939.161.99
27797-77979.1239.29
37723-77239.0369.21
47771-77719.0929.27
57486-74868.7598.94
67830-78309.1619.34
45min17493-74938.7678.801.029.009.030.99
27588-75888.8789.10
37496-74968.7718.99
47595-75958.8869.12
57391-73918.6488.88
67555-75558.8409.07
60min17351-73518.6018.571.918.888.851.89
27261-72618.4968.77
37085-70858.2908.56
47486-74868.7599.04
57414-74148.6758.95
67361-73618.6138.89
极限17285-72858.5248.621.208.858.941.17
27401-74018.6598.98
37295-72958.5358.85
47298-72988.5398.87
57402-74028.6618.99
67507-75078.7839.11
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