依折麦布匹伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.851310191307261306061307081304631307040.16
210.881301561303171302360.09
单位质量响应值RSD%判断
12046.4511970.220.45数据可信
供试品溶液-24021802批-匹伐他汀钙-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%
5min1123811-12381189.36194.153.6889.3694.153.68
2125988-12598890.93390.93
3133024-13302496.01196.01
4135885-13588598.07698.08
5129737-12973793.63893.64
6134206-13420696.86496.86
10min1135985-13598598.14899.192.1798.3099.342.17
2136536-13653698.54698.70
3138336-13833699.845100.00
4141130-141130101.861102.02
5132799-13279995.84896.00
6139786-139786100.891101.05
15min1136562-13656298.56499.312.1198.8899.632.11
2136404-13640498.45098.77
3138399-13839999.890100.22
4141268-141268101.961102.29
5133085-13308596.05596.37
6139818-139818100.914101.24
20min1135282-13528297.64198.942.2598.1299.442.25
2136330-13633098.39798.88
3138403-13840399.893100.39
4140801-140801101.624102.13
5132320-13232095.50395.98
6139399-139399100.612101.11
30min1134573-13457397.12998.682.2097.7799.332.20
2135992-13599298.15398.80
3137841-13784199.488100.15
4140302-140302101.264101.94
5132335-13233595.51496.15
6139266-139266100.516101.18
45min1135052-13505297.47598.472.1798.2899.282.17
2135373-13537397.70698.51
3137424-13742499.187100.01
4140059-140059101.088101.93
5131877-13187795.18395.98
6138784-138784100.168101.00
60min1134263-13426396.90598.242.1597.8799.222.15
2134955-13495597.40598.37
3137167-13716799.00199.99
4139834-139834100.926101.94
5131968-13196895.24996.20
6138519-13851999.977100.98
极限1134411-13441197.01298.132.2298.1499.282.22
2134983-13498397.42598.56
3136929-13692998.82999.98
4139807-139807100.907102.08
5131368-13136894.81695.93
6138261-13826199.791100.96
依折麦布匹伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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(%)100.0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%
1113821333818083818133824203820493820450.07
210.933752363764423758390.23
单位质量响应值RSD%判断
34731.3634386.000.71数据可信
供试品溶液-24021802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%
5min138611-3861110.05610.355.1810.0610.355.16
240347-4034710.50810.51
339555-3955510.30110.30
436462-364629.4969.50
542439-4243911.05311.05
640928-4092810.65910.66
10min136371-363719.4729.261.839.499.271.82
235435-354359.2289.25
334965-349659.1069.12
435352-353529.2079.22
534832-348329.0719.09
636274-362749.4479.46
15min135154-351549.1559.011.769.199.041.76
234043-340438.8668.90
334847-348479.0759.11
434205-342058.9088.94
533912-339128.8328.87
635334-353349.2029.24
20min134854-348549.0778.891.649.128.931.62
233679-336798.7718.82
334087-340878.8778.92
433383-333838.6948.74
534083-340838.8768.92
634651-346519.0249.07
30min134070-340708.8738.406.628.948.466.59
234503-345038.9869.05
329779-297797.7557.82
430733-307338.0048.06
530500-305007.9438.01
633951-339518.8428.91
45min133673-336738.7708.485.228.858.565.17
233894-338948.8278.90
329236-292367.6147.69
433058-330588.6098.68
532710-327108.5198.60
632854-328548.5568.63
60min133652-336528.7648.532.608.868.622.59
233266-332668.6648.76
332968-329688.5868.67
432999-329998.5948.68
532483-324838.4608.55
631216-312168.1308.22
极限133008-330088.5968.490.788.708.590.76
232738-327388.5268.63
332620-326208.4958.60
432380-323808.4338.54
532380-323808.4338.54
632396-323968.4378.54
依折麦布匹伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.851298071298531295791297571297891297570.09
210.881317971313211315590.26
单位质量响应值RSD%判断
11959.1712091.820.78数据可信
供试品溶液-24021802批-匹伐他汀钙-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%
5min1128767-12876792.80895.241.3592.8195.241.35
2132034-13203495.16295.16
3132770-13277095.69395.69
4132116-13211695.22195.22
5133389-13338996.13996.14
6133736-13373696.38996.39
10min1137284-13728498.94699.820.8399.1099.980.83
2137423-13742399.04699.20
3138643-13864399.926100.09
4138189-13818999.59899.76
5140345-140345101.152101.31
6139091-139091100.249100.41
15min1137291-13729198.95199.830.7499.27100.160.74
2137606-13760699.17899.50
3138770-138770100.017100.34
4138197-13819799.60499.93
5139988-139988100.895101.22
6139245-139245100.360100.69
20min1136893-13689398.66499.600.8899.15100.090.88
2137055-13705598.78199.27
3138555-13855599.862100.35
4137760-13776099.28999.78
5140088-140088100.967101.46
6138815-138815100.050100.54
30min1136973-13697398.72299.300.6499.3799.950.63
2136794-13679498.59399.25
3137966-13796699.438100.10
4137409-13740999.03699.69
5138995-138995100.179100.84
6138485-13848599.812100.47
45min1136259-13625998.20798.990.7699.0299.820.76
2136238-13623898.19299.01
3137914-13791499.400100.23
4136952-13695298.70799.53
5138788-138788100.030100.86
6137928-13792899.410100.24
60min1136319-13631998.25198.930.7799.2399.920.77
2136058-13605898.06399.04
3137719-13771999.260100.25
4136693-13669398.52099.51
5138369-13836999.728100.73
6138439-13843999.779100.77
极限1135749-13574997.84098.650.8198.9899.800.81
2135618-13561897.74598.89
3137467-13746799.078100.23
4136351-13635198.27499.42
5137837-13783799.345100.51
6138190-13819099.599100.76
依折麦布匹伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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(%)100.0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%
1113768963769773766093771893773553770050.08
210.933785603774753780180.21
单位质量响应值RSD%判断
34273.1834585.360.65数据可信
供试品溶液-24021802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%
5min136590-365909.5659.571.259.579.561.25
237344-373449.7629.76
336348-363489.5029.50
436815-368159.6249.62
536447-364479.5289.53
636001-360019.4119.41
10min136180-361809.4589.132.389.479.142.35
235408-354089.2569.27
334900-349009.1239.14
433784-337848.8328.85
534829-348299.1059.12
634361-343618.9829.00
15min132428-324288.4778.772.108.518.802.10
234600-346009.0459.08
333455-334558.7458.78
433379-333798.7268.76
533691-336918.8078.84
633782-337828.8318.86
20min133905-339058.8638.664.328.918.704.33
234313-343138.9709.02
333660-336608.7998.84
430483-304837.9698.01
533881-338818.8578.90
632506-325068.4978.54
30min133351-333518.7188.453.608.788.523.58
230750-307508.0388.10
333439-334398.7418.80
431116-311168.1348.19
533051-330518.6408.70
632357-323578.4588.52
45min132493-324938.4948.432.078.578.502.07
232378-323788.4648.54
333160-331608.6688.74
431589-315898.2588.33
532452-324528.4838.56
631332-313328.1918.26
60min132973-329738.6198.461.848.718.541.83
232499-324998.4968.58
333061-330618.6438.73
431782-317828.3088.39
532103-321038.3928.48
631679-316798.2818.37
极限132874-328748.5948.322.658.708.422.62
232550-325508.5098.61
332098-320988.3918.49
430600-306007.9998.10
531492-314928.2328.34
631356-313568.1978.30
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