依折麦布阿托伐他汀片项目信息
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%
110.231747341745801748981748611746711747490.08
210.161746961756801751880.40
单位质量响应值RSD%判断
17082.0117242.910.67数据可信
供试品溶液-2023121221批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min155254-5525428.90320.1330.5528.9020.1330.55
236285-3628518.98118.98
325190-2519013.17713.18
446235-4623524.18624.19
525986-2598613.59313.59
641938-4193821.93821.94
10min1133942-13394270.06562.2311.9870.2362.3412.01
2121396-12139663.50263.61
3103549-10354954.16754.24
4135828-13582871.05271.19
5103011-10301153.88553.96
6116055-11605560.70860.83
15min1164666-16466686.13781.746.0386.6982.206.08
2155410-15541081.29581.75
3147318-14731877.06277.44
4169490-16949088.66089.19
5145535-14553576.12976.50
6155190-15519081.18081.64
20min1172988-17298890.49088.674.0791.5289.594.14
2171126-17112689.51690.43
3161928-16192884.70585.51
4178593-17859393.42294.44
5160684-16068484.05484.85
6171775-17177589.85690.77
30min1169583-16958388.70990.832.3190.2492.232.34
2172951-17295190.47191.88
3171840-17184089.89091.16
4180808-18080894.58196.12
5171240-17124089.57690.84
6175358-17535891.73093.14
45min1172541-17254190.25693.121.6992.2895.021.65
2178226-17822693.23095.14
3178681-17868193.46895.24
4181586-18158694.98897.05
5177719-17771992.96594.73
6179303-17930393.79495.71
60min1171331-17133189.62392.081.6392.1594.511.61
2177578-17757892.89195.32
3175711-17571191.91594.21
4180016-18001694.16796.76
5175950-17595092.04094.32
6175573-17557391.84294.28
极限1171486-17148689.70493.222.6192.7396.162.56
2177540-17754092.87195.82
3177621-17762192.91495.72
4185779-18577997.181100.30
5179846-17984694.07896.87
6176946-17694692.56195.51
依折麦布阿托伐他汀片项目信息
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%
110.733025663023833024843022943026103024670.05
210.713025143035743030440.25
单位质量响应值RSD%判断
28188.9128295.420.27数据可信
供试品溶液-2023121221批-阿托伐他汀-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1210996-21099661.71065.6113.0761.7165.6113.07
2237567-23756769.48269.48
3199905-19990558.46758.47
4257183-25718375.21975.22
5186756-18675654.62154.62
6253559-25355974.15974.16
10min1293567-29356785.86088.922.0186.2089.282.01
2305450-30545089.33589.72
3303499-30349988.76589.09
4310211-31021190.72891.15
5309532-30953290.52990.83
6301865-30186588.28788.70
15min1310242-31024290.73792.691.8691.5693.551.83
2310626-31062690.84991.73
3323832-32383294.71295.53
4320414-32041493.71294.63
5321724-32172494.09594.90
6314731-31473192.05092.95
20min1313674-31367491.74193.551.2193.0694.921.20
2316951-31695192.69994.09
3322420-32242094.29995.64
4320428-32042893.71695.16
5323938-32393894.74396.07
6321709-32170994.09195.50
30min1301666-30166688.22991.912.4390.0693.812.39
2310402-31040290.78492.69
3320270-32027093.67095.54
4316081-31608192.44594.41
5323026-32302694.47696.33
6314149-31414991.88093.82
45min1306582-30658289.66793.042.3091.9995.442.25
2316528-31652892.57594.98
3325241-32524195.12497.51
4315836-31583692.37394.85
5326734-32673495.56097.94
6317809-31780992.95095.40
60min1305544-30554489.36391.901.8392.1894.821.80
2315132-31513292.16795.09
3317556-31755692.87695.79
4313701-31370191.74994.74
5322404-32240494.29497.21
6310942-31094290.94293.91
极限1312547-31254791.41193.472.2394.7396.902.19
2316778-31677892.64996.08
3318173-31817393.05796.49
4327981-32798195.92599.42
5328733-32873396.14599.58
6313286-31328691.62795.10
依折麦布阿托伐他汀片项目信息
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%
110.231744611746751748391749291749001747610.12
210.161753931754361754140.02
单位质量响应值RSD%判断
17083.1917265.160.75数据可信
供试品溶液-2023121421批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147874-4787425.02622.6425.3925.0322.6425.39
232847-3284717.17117.17
357126-5712629.86229.86
435222-3522218.41218.41
553868-5386828.15928.16
632977-3297717.23917.24
10min1129156-12915667.51663.786.6567.6563.906.68
2108824-10882456.88756.98
3126020-12602065.87766.04
4116443-11644360.87060.97
5129542-12954267.71867.87
6122023-12202363.78763.88
15min1158243-15824382.72181.003.5083.2481.483.49
2146985-14698576.83677.25
3150365-15036578.60379.13
4158905-15890583.06783.51
5154290-15429080.65581.19
6160902-16090284.11184.56
20min1170807-17080789.28986.893.0290.2687.823.01
2157777-15777782.47783.32
3163295-16329585.36286.33
4169264-16926488.48289.38
5166107-16610786.83287.81
6170115-17011588.92789.84
30min1174205-17420591.06591.421.7192.5392.831.73
2170316-17031689.03290.33
3173314-17331490.59992.04
4175549-17554991.76893.16
5177055-17705592.55594.02
6178848-17884893.49294.90
45min1178252-17825293.18192.351.5095.1694.281.50
2175257-17525791.61593.41
3172493-17249390.17092.12
4175844-17584491.92293.83
5178542-17854293.33295.31
6179644-17964493.90895.84
60min1175945-17594591.97591.441.2794.4793.871.28
2172379-17237990.11192.41
3173998-17399890.95793.40
4173372-17337290.63093.04
5175188-17518891.57994.07
6178591-17859193.35895.81
极限1171595-17159589.70191.541.9192.7194.481.85
2175300-17530091.63894.44
3174913-17491391.43594.39
4171954-17195489.88892.81
5176075-17607592.04395.05
6180790-18079094.50797.48
依折麦布阿托伐他汀片项目信息
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%
110.733021303021413023403021953024123022440.05
210.713033593033073033330.02
单位质量响应值RSD%判断
28168.1328322.410.39数据可信
供试品溶液-2023121421批-阿托伐他汀-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1247807-24780772.46968.729.1872.4768.729.18
2197554-19755457.77357.77
3225393-22539365.91465.91
4248560-24856072.68972.69
5256877-25687775.12175.12
6233823-23382368.37968.38
10min1305624-30562489.37788.552.9089.7888.932.91
2297515-29751587.00587.33
3288530-28853084.37884.74
4304951-30495189.18089.58
5305977-30597789.48089.90
6314208-31420891.88792.27
15min1313052-31305291.54991.572.5992.4592.452.57
2318110-31811093.02893.83
3297275-29727586.93587.77
4317544-31754492.86393.76
5314265-31426591.90492.82
6318562-31856293.16094.05
20min1318191-31819193.05291.991.9694.4693.381.97
2314238-31423891.89693.22
3302876-30287688.57389.89
4319840-31984093.53494.95
5314338-31433891.92593.35
6317920-31792092.97394.38
30min1313568-31356891.70092.971.6793.6294.861.69
2315641-31564192.30694.14
3310813-31081390.89492.70
4321209-32120993.93595.87
5322219-32221994.23096.17
6323988-32398894.74796.67
45min1316813-31681392.64992.661.9795.0895.071.98
2315951-31595192.39794.74
3305121-30512189.23091.54
4320251-32025193.65496.11
5320790-32079093.81296.27
6322157-32215794.21296.66
60min1312037-31203791.25291.541.5194.2094.461.53
2309139-30913990.40593.26
3307030-30703089.78892.60
4316328-31632892.50795.48
5313562-31356291.69894.68
6319976-31997693.57496.55
极限1304296-30429688.98991.542.1392.4494.972.09
2313473-31347391.67295.03
3308339-30833990.17193.48
4312503-31250391.38994.88
5315705-31570592.32595.81
6323723-32372394.67098.16
依折麦布阿托伐他汀片项目信息
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%
110.231754611753141755041755211755651754730.06
210.161756771768001762380.46
单位质量响应值RSD%判断
17152.7917346.260.80数据可信
供试品溶液-2023121621批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min129726-2972615.47123.8620.5015.4723.8620.50
250054-5005426.05126.05
355889-5588929.08829.09
446635-4663524.27224.27
551965-5196527.04627.05
640849-4084921.26021.26
10min1110870-11087057.70462.036.3357.7962.166.32
2129670-12967067.48967.63
3115556-11555660.14360.30
4118025-11802561.42861.56
5113908-11390859.28559.44
6127108-12710866.15566.27
15min1149937-14993778.03778.505.2978.4478.975.27
2161324-16132483.96484.48
3144127-14412775.01375.51
4150627-15062778.39678.87
5140554-14055473.15473.63
6158342-15834282.41282.90
20min1168017-16801787.44787.273.2288.2988.183.21
2171778-17177889.40590.39
3164391-16439185.56086.47
4170697-17069788.84289.75
5158532-15853282.51083.40
6172647-17264789.85790.80
30min1172960-17296090.02090.801.2891.3592.201.30
2176326-17632691.77293.25
3176330-17633091.77493.16
4176615-17661591.92293.33
5171440-17144089.22990.57
6173134-17313490.11091.55
45min1178196-17819692.74592.650.9794.5794.560.95
2175849-17584991.52393.52
3178934-17893493.12995.03
4180550-18055093.97095.89
5176335-17633591.77693.62
6178224-17822492.75994.70
60min1177317-17731792.28791.901.0994.6394.321.06
2175349-17534991.26393.76
3178306-17830692.80295.22
4179076-17907693.20395.64
5174609-17460990.87893.23
6174755-17475590.95493.41
极限1175404-17540491.29292.161.3194.1595.091.27
2176654-17665491.94294.95
3180876-18087694.14097.07
4178022-17802292.65495.61
5177266-17726692.26195.12
6174180-17418090.65593.62
依折麦布阿托伐他汀片项目信息
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%
110.733029903030093027363030253027753029070.05
210.713039463054923047190.36
单位质量响应值RSD%判断
28229.9228451.820.56数据可信
供试品溶液-2023121621批-阿托伐他汀-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1194409-19440956.66255.0820.6956.6655.0820.69
2162219-16221947.28047.28
3195951-19595157.11157.11
4210946-21094661.48261.48
5128927-12892737.57737.58
6241510-24151070.39070.39
10min1290755-29075584.74284.495.5785.0684.805.62
2265214-26521477.29877.56
3295372-29537286.08886.41
4302591-30259188.19288.53
5277090-27709080.76080.97
6308261-30826189.84590.24
15min1303908-30390888.57689.543.2789.3690.313.32
2291306-29130684.90385.60
3313568-31356891.39192.19
4316964-31696492.38193.21
5301678-30167887.92688.58
6315779-31577992.03692.93
20min1313204-31320491.28592.682.7792.5693.962.83
2303906-30390688.57589.74
3321726-32172693.76995.07
4326298-32629895.10296.45
5315978-31597892.09493.24
6326910-32691095.28096.68
30min1306600-30660089.36192.052.0191.1593.842.02
2311217-31121790.70692.36
3323362-32336294.24696.07
4321799-32179993.79095.66
5315401-31540191.92693.58
6316546-31654692.25994.19
45min1311351-31135190.74592.651.8393.0394.941.89
2311927-31192790.91393.07
3322223-32222393.91496.26
4324831-32483194.67497.07
5315107-31510791.84094.01
6321785-32178593.78696.23
60min1309161-30916190.10791.611.5892.8994.421.63
2311717-31171790.85293.52
3319397-31939793.09095.96
4321128-32112893.59596.51
5310113-31011390.38493.06
6314408-31440891.63694.60
极限1306261-30626189.26291.861.9292.5595.181.88
2316941-31694192.37495.54
3323760-32376094.36297.75
4318481-31848192.82396.26
5314114-31411491.55194.73
6311519-31151990.79494.27
点击查看处理图标(人工保存)
 
原始图谱下载图谱(谢鑫慧 于 2025-01-16 15:01:24 完成)
生成报告数据部分(等待生成报告)
Current page cost:82 ms