氟伐他汀缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.921409050141151914092831410736140758414096340.11
211.251464290146560314649460.07
单位质量响应值RSD%判断
129087.36130217.420.62数据可信
加速6月-供试品溶液-2024041521批-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%
240min1359331-35933124.57426.946.0924.5726.946.09
2383124-38312426.20126.20
3416538-41653828.48628.49
4420754-42075428.77428.77
5379469-37946925.95125.95
6404730-40473027.67927.68
480min1691331-69133147.27951.754.9547.3251.794.94
2751228-75122851.37551.41
3794887-79488754.36154.40
4791749-79174954.14654.19
5756799-75679951.75651.79
6754354-75435451.58951.63
720min11015781-101578169.46773.163.3369.5773.283.34
21076000-107600073.58573.70
31088855-108885574.46474.59
41110027-111002775.91276.04
51038090-103809070.99371.11
61089783-108978374.52874.65
960min11379088-137908894.31395.722.9794.5295.952.97
21348806-134880692.24292.47
31436448-143644898.23598.47
41460897-146089799.907100.15
51378208-137820894.25294.48
61394607-139460795.37495.60
1200min11455739-145573999.55599.160.8699.9199.530.86
21448830-144883099.08299.45
31454197-145419799.44999.83
41467678-1467678100.371100.76
51432087-143208797.93798.30
61441037-144103798.54998.92
1440min11452824-145282499.35598.980.7299.8699.500.72
21452850-145285099.35799.87
31445323-144532398.84299.37
41461341-146134199.938100.48
51433948-143394898.06498.58
61437592-143759298.31498.84
极限11452322-145232299.32198.810.7999.9799.480.79
21449763-144976399.14699.81
31443807-144380798.73999.42
41458872-145887299.769100.46
51427485-142748597.62298.28
61437036-143703698.27698.94
氟伐他汀缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.921404944140734514059371406866140614414062470.07
211.251457691146118014594360.17
单位质量响应值RSD%判断
128777.20129727.640.52数据可信
加速6月-供试品溶液-2024041521批-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%
240min1398168-39816827.31427.852.1227.3127.852.13
2392301-39230126.91126.91
3410301-41030128.14628.15
4411285-41128528.21428.21
5411026-41102628.19628.20
6413023-41302328.33328.33
480min1744244-74424451.05454.164.1551.1054.204.15
2764640-76464052.45452.49
3816832-81683256.03456.08
4776584-77658453.27353.32
5828422-82842256.82956.87
6805977-80597755.28955.33
720min11050386-105038672.05577.134.0272.1777.254.02
21088875-108887574.69674.81
31151819-115181979.01479.14
41147542-114754278.72078.84
51138497-113849778.10078.23
61168827-116882780.18080.31
960min11321204-132120490.63397.323.5190.8697.563.50
21445327-144532799.14899.38
31440191-144019198.79699.04
41412295-141229596.88297.12
51441372-144137298.87799.12
61451921-145192199.60099.85
1200min11435833-143583398.49799.170.7898.8699.560.79
21460133-1460133100.164100.54
31448801-144880199.38699.78
41434170-143417098.38398.77
51438092-143809298.65299.04
61457020-145702099.950100.35
1440min11437994-143799498.64598.940.8399.1599.480.82
21460137-1460137100.164100.69
31442474-144247498.95299.49
41429352-142935298.05298.59
51432204-143220498.24898.79
61452030-145203099.608100.15
极限11430938-143093898.16198.530.9598.8299.210.94
21459460-1459460100.117100.80
31434799-143479998.42699.12
41424231-142423197.70198.38
51424279-142427997.70498.39
61443880-144388099.04999.74
氟伐他汀缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.921403070140348314025641403061140204114028440.04
211.251464474146193214632030.13
单位质量响应值RSD%判断
128465.57130062.490.88数据可信
加速6月-供试品溶液-2024041721批-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%
240min1421713-42171328.92729.168.2228.9329.168.22
2437476-43747630.00830.01
3467613-46761332.07632.08
4361493-36149324.79624.80
5431792-43179229.61929.62
6430660-43066029.54129.54
480min1845277-84527757.98156.3510.7358.0256.3910.73
2882257-88225760.51860.56
3894356-89435661.34861.40
4657428-65742845.09645.13
5858815-85881558.91058.95
6790974-79097454.25654.30
720min11204482-120448282.62178.4111.1082.7578.5411.09
21210728-121072883.04983.19
31218055-121805583.55283.69
4905615-90561562.12062.23
51228700-122870084.28284.41
61091161-109116174.84874.97
960min11445052-144505299.12395.299.9999.3895.549.99
21439214-143921498.72298.98
31440788-144078898.83099.10
41107784-110778475.98876.19
51473820-1473820101.096101.36
61428754-142875498.00598.24
1200min11456715-145671599.92399.851.01100.33100.231.03
21447723-144772399.30699.71
31449984-144998499.46199.87
41440377-144037798.80299.11
51482746-1482746101.708102.12
61455973-145597399.872100.26
1440min11441256-144125698.86298.990.7899.4299.530.78
21435531-143553198.47099.03
31432413-143241398.25698.82
41442676-144267698.96099.42
51464164-1464164100.434101.00
61442611-144261198.95599.49
极限11439223-143922398.72398.910.8199.4299.600.82
21434663-143466398.41099.12
31435905-143590598.49599.21
41437717-143771798.61999.23
51465466-1465466100.523101.24
61439002-143900298.70899.39
氟伐他汀缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.921400605140364714026671400341140119314016910.11
211.251458606145820414584050.02
单位质量响应值RSD%判断
128359.98129636.000.70数据可信
加速6月-供试品溶液-2024041721批-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%
240min1431115-43111529.63329.535.3729.6329.535.37
2450185-45018530.94330.94
3427376-42737629.37629.38
4458908-45890831.54331.54
5414819-41481928.51328.51
6395696-39569627.19827.20
480min1854592-85459258.74056.994.5558.7857.044.55
2823911-82391156.63256.68
3817230-81723056.17256.22
4874656-87465660.11960.17
5839320-83932057.69157.73
6765091-76509152.58952.63
720min11202578-120257882.65980.003.9582.7980.133.95
21158967-115896779.66279.79
31161270-116127079.82079.95
41197257-119725782.29382.43
51185531-118553181.48781.62
61077699-107769974.07674.20
960min11457078-1457078100.15299.250.74100.4199.500.75
21449970-144997099.66499.91
31429047-142904798.22698.47
41451366-145136699.760100.02
51440553-144055399.01699.27
61435628-143562898.67898.91
1200min11465789-1465789100.751100.090.37101.16100.490.37
21457231-1457231100.163100.56
31450066-145006699.670100.07
41454762-145476299.993100.40
51453119-145311999.880100.28
61456105-1456105100.085100.46
1440min11453695-145369599.92099.040.64100.4899.580.65
21446686-144668699.43899.99
31431356-143135698.38498.93
41444851-144485199.31299.87
51430469-143046998.32398.87
61438008-143800898.84299.37
极限11447996-144799699.52898.730.55100.2499.430.55
21434769-143476998.61999.32
31426325-142632598.03898.73
41439996-143999698.97899.69
51429704-142970498.27198.97
61439266-143926698.92899.61
氟伐他汀缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.921394551139587213953531394824139366613948530.06
211.251462479145608114592800.32
单位质量响应值RSD%判断
127733.79129713.781.09数据可信
加速6月-供试品溶液-2024041821批-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%
240min1440076-44007630.31430.261.8330.3130.261.83
2441825-44182530.43530.43
3443641-44364130.56030.56
4446708-44670830.77130.77
5423829-42382929.19529.19
6439531-43953130.27730.28
480min1881072-88107260.69260.311.6260.7460.351.62
2852531-85253158.72658.77
3867915-86791559.78559.83
4879946-87994660.61460.66
5876927-87692760.40660.45
6894621-89462161.62561.67
720min11221015-122101584.10883.931.0684.2484.071.06
21201748-120174882.78182.91
31224442-122444284.34484.48
41221247-122124784.12484.26
51205720-120572083.05583.19
61236629-123662985.18485.32
960min11465464-1465464100.947100.820.76101.21101.080.76
21452473-1452473100.052100.31
31467998-1467998101.121101.38
41470634-1470634101.303101.57
51448305-144830599.765100.02
61477156-1477156101.752102.02
1200min11452739-1452739100.070100.230.84100.48100.640.84
21451230-145123099.966100.37
31457936-1457936100.428100.84
41456176-1456176100.307100.72
51437274-143727499.00599.41
61474908-1474908101.597102.02
1440min11454026-1454026100.15999.930.81100.72100.500.81
21444247-144424799.485100.04
31448264-144826499.762100.33
41449884-144988499.874100.44
51436714-143671498.96699.52
61471502-1471502101.363101.93
极限11450559-145055999.92099.940.75100.63100.650.75
21445016-144501699.538100.25
31451088-145108899.956100.67
41453233-1453233100.104100.82
51436180-143618098.93099.64
61468910-1468910101.184101.91
氟伐他汀缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.921398466139674613942271396055139864513968280.14
211.251460631145940514600180.06
单位质量响应值RSD%判断
127914.65129779.381.03数据可信
加速6月-供试品溶液-2024041821批-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%
240min1424672-42467229.22528.415.0929.2228.425.08
2431398-43139829.68829.69
3410791-41079128.27028.27
4419740-41974028.88528.89
5372364-37236425.62525.63
6418311-41831128.78728.79
480min1781161-78116153.75854.687.0553.8054.727.05
2872489-87248960.04260.09
3796452-79645254.81054.85
4817703-81770356.27256.32
5700545-70054548.21048.25
6798732-79873254.96755.01
720min11080608-108060874.36577.436.0474.4977.566.04
21226769-122676984.42384.56
31168854-116885480.43880.56
41145210-114521078.81078.94
51040989-104098971.63871.75
61088489-108848974.90775.03
960min11453120-1453120100.00099.432.79100.2499.672.80
21500197-1500197103.240103.50
31456401-1456401100.226100.47
41430510-143051098.44498.69
51377034-137703494.76494.98
61451607-145160799.896100.13
1200min11468398-1468398101.051100.451.32101.44100.841.33
21493717-1493717102.794103.21
31456433-1456433100.228100.62
41438769-143876999.01299.41
51451200-145120099.868100.23
61449811-144981199.772100.16
1440min11462527-1462527100.647100.011.46101.19100.561.47
21491159-1491159102.618103.19
31450046-145004699.789100.33
41431694-143169498.52699.07
51443307-144330799.32599.83
61441195-144119599.17999.72
极限11468618-1468618101.06799.831.48101.76100.521.49
21485995-1485995102.262102.99
31440607-144060799.13999.83
41436534-143653498.85999.55
51437709-143770998.94099.60
61434552-143455298.72299.41
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