依折麦布阿托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DJ333-221017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(%)99.67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%
19.431636071636051637351635031636281636160.06
29.481635081636971636020.09
单位质量响应值RSD%判断
17350.5817257.590.38数据可信
供试品溶液-2022092201批-依折麦布-pH6.8(钾盐内含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%
5min148131-4813124.95123.4517.0524.9523.4517.04
233968-3396817.60917.61
348141-4814124.95624.96
452315-5231527.12027.12
551584-5158426.74126.74
637299-3729919.33619.34
10min1137429-13742971.24366.877.5171.3867.007.52
2114747-11474759.48459.58
3130930-13093067.87468.01
4123895-12389564.22764.38
5141350-14135073.27573.42
6125573-12557365.09665.20
15min1169178-16917887.70185.953.3888.2486.453.40
2158266-15826682.04482.47
3169021-16902187.62088.14
4160530-16053083.21883.73
5172813-17281389.58690.14
6164962-16496285.51685.98
20min1182332-18233294.52093.851.4995.5494.821.51
2178862-17886292.72193.61
3180114-18011493.37094.37
4177480-17748092.00592.97
5184685-18468595.74096.79
6182738-18273894.73195.67
30min1191400-19140099.22199.121.09100.77100.621.13
2188211-18821197.56898.97
3191372-19137299.206100.73
4189829-18982998.40799.89
5194370-194370100.761102.35
6191996-19199699.530101.00
45min1185056-18505695.93297.620.9798.0399.670.96
2188355-18835597.64299.58
3189299-18929998.132100.20
4187574-18757497.23899.27
5190091-19009198.542100.69
6189456-18945698.213100.24
60min1188265-18826597.59698.341.01100.23100.941.03
2188605-18860597.772100.26
3191496-19149699.271101.89
4188076-18807697.498100.07
5192676-19267699.882102.57
6189108-18910898.033100.60
极限1186495-18649596.67897.861.1299.85101.001.13
2186767-18676796.81999.85
3192099-19209999.583102.75
4188146-18814697.534100.64
5190003-19000398.497101.74
6189167-18916798.063101.18
依折麦布阿托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100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.553138323137073140723134573139243137980.08
210.543139713141563140640.05
单位质量响应值RSD%判断
29743.8929797.340.13数据可信
供试品溶液-2022092201批-阿托伐他汀钙-pH6.8(钾盐内含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%
5min1260658-26065872.32164.9517.2572.3264.9517.25
2207040-20704057.44457.44
3164225-16422545.56545.57
4259172-25917271.90971.91
5266158-26615873.84773.85
6247253-24725368.60268.60
10min1323962-32396289.88585.566.8190.2985.926.85
2301384-30138483.62183.94
3269401-26940174.74775.00
4313049-31304986.85787.26
5325543-32554390.32490.73
6316855-31685587.91388.29
15min1335829-33582993.17791.143.6094.0891.983.67
2325147-32514790.21491.00
3306936-30693685.16185.83
4330326-33032691.65192.53
5340948-34094894.59895.51
6331718-33171892.03792.91
20min1343739-34373995.37293.723.0096.7995.063.07
2337054-33705493.51794.80
3318287-31828788.31089.45
4340765-34076594.54795.94
5346732-34673296.20397.64
6340202-34020294.39195.77
30min1349915-34991597.08695.441.9399.0397.302.01
2337955-33795593.76795.57
3335632-33563293.12394.75
4345615-34561595.89397.81
5352454-35245497.79099.76
6342266-34226694.96396.87
45min1335179-33517992.99792.841.0495.4995.231.08
2333057-33305792.40894.73
3333315-33331592.48094.63
4333295-33329592.47494.92
5341238-34123894.67897.19
6331540-33154091.98794.42
60min1339751-33975194.26693.651.6697.2796.561.62
2333183-33318392.44395.28
3342074-34207494.91097.57
4335256-33525693.01895.98
5344830-34483095.67598.72
6330184-33018491.61194.56
极限1336167-33616793.27193.291.8896.8096.721.78
2329290-32929091.36394.72
3346063-34606396.01799.21
4333930-33393092.65196.13
5340892-34089294.58298.16
6330969-33096991.82995.28
依折麦布阿托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DJ333-221017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(%)99.67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%
19.431628171634531635611636621635321634050.21
29.481636311642411639360.27
单位质量响应值RSD%判断
17328.2117292.830.15数据可信
供试品溶液-2022092201批-依折麦布-pH6.8(钠盐内含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%
5min146826-4682624.26522.1420.4724.2722.1420.47
249989-4998925.90425.90
348743-4874325.25925.26
426550-2655013.75813.76
539445-3944520.44020.44
644742-4474223.18523.19
10min1126898-12689865.75964.7310.1465.8964.8610.14
2139201-13920172.13472.28
3114888-11488859.53559.68
4105170-10517054.49954.58
5129298-12929867.00267.12
6134027-13402769.45369.58
15min1163956-16395684.96284.005.7585.4684.485.78
2171310-17131088.77389.32
3151129-15112978.31578.79
4149873-14987377.66478.04
5169350-16935087.75788.24
6166938-16693886.50787.02
20min1178770-17877092.63991.442.7893.6192.402.82
2180890-18089093.73794.78
3168339-16833987.23388.14
4172629-17262989.45690.27
5178440-17844092.46893.44
6179718-17971893.13094.13
30min1184743-18474395.73495.991.4797.2297.451.47
2183581-18358195.13296.69
3181310-18131093.95595.35
4185773-18577396.26897.58
5189210-18921098.04999.54
6186792-18679296.79698.31
45min1186821-18682196.81197.583.6798.8399.573.64
2187875-18787597.35799.44
3176015-17601591.21193.12
4190217-19021798.570100.41
5196201-196201101.671103.70
6192684-19268499.849101.90
60min1190255-19025598.59098.811.39101.15101.351.38
2188139-18813997.494100.12
3189428-18942898.162100.58
4190018-19001898.467100.86
5195795-195795101.461104.06
6190470-19047098.702101.31
极限1188138-18813897.49398.011.60100.60101.091.61
2187267-18726797.042100.21
3188208-18820897.529100.49
4186750-18675096.77499.71
5195022-195022101.060104.22
6189430-18943098.163101.32
依折麦布阿托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100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.553127563136983135463135843133203133810.12
210.543147143149593148360.06
单位质量响应值RSD%判断
29704.3629870.590.40数据可信
供试品溶液-2022092201批-阿托伐他汀钙-pH6.8(钠盐内含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%
5min1252867-25286770.12067.127.9570.1267.127.95
2258478-25847871.67671.68
3224714-22471462.31362.31
4211925-21192558.76758.77
5247156-24715668.53668.54
6257166-25716671.31271.31
10min1320077-32007788.75787.732.9489.1588.112.96
2320560-32056088.89189.29
3301903-30190383.71884.06
4307755-30775585.34085.67
5324765-32476590.05790.44
6323231-32323189.63290.03
15min1338928-33892893.98593.261.9494.8794.121.96
2337434-33743493.57094.46
3328233-32823391.01991.83
4330521-33052191.65392.45
5346538-34653896.09596.98
6336290-33629093.25394.15
20min1345048-34504895.68294.550.9297.0995.930.94
2342271-34227194.91296.32
3335763-33576393.10794.42
4340150-34015094.32495.63
5342281-34228194.91596.33
6340359-34035994.38295.79
30min1343415-34341595.22994.651.3397.1796.561.32
2336762-33676293.38495.32
3335702-33570293.09094.92
4344418-34441895.50797.34
5347238-34723896.28998.23
6340478-34047894.41596.35
45min1340639-34063994.45994.423.8196.9296.843.75
2340928-34092894.53997.00
3316026-31602687.63489.99
4346173-34617395.99498.36
5354118-35411898.197100.67
6345008-34500895.67198.13
60min1346094-34609495.97295.361.3798.9698.311.38
2341828-34182894.78997.77
3338508-33850893.86896.71
4343913-34391395.36798.26
5351934-35193497.591100.61
6341080-34108094.58197.57
极限1341761-34176194.77094.331.5598.2997.821.56
2338754-33875493.93697.45
3334178-33417892.66896.03
4337897-33789793.69997.13
5349674-34967496.965100.53
6338760-33876093.93897.46
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