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对照品来源自制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%
110.561825221824291825321820151820011823000.15
210.481826271825651825960.03
单位质量响应值RSD%判断
17263.2617423.280.66数据可信
供试品溶液-2024011621批-依折麦布-pH6.8(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%
5min136394-3639418.82423.1929.6718.8223.1929.67
249135-4913525.41425.41
366530-6653034.41134.41
444961-4496123.25523.26
545200-4520023.37923.38
626831-2683113.87813.88
10min1126290-12629065.32161.7214.8265.4361.8614.85
2125619-12561964.97465.12
3146310-14631075.67675.87
4102922-10292253.23553.36
5117342-11734260.69360.82
697540-9754050.45150.53
15min1164803-16480385.24181.567.3185.7182.037.36
2162428-16242884.01384.52
3171072-17107288.48489.10
4141695-14169573.28973.71
5160574-16057483.05483.52
6145543-14554375.27975.64
20min1180580-18058093.40289.534.3694.3490.454.42
2173285-17328589.62990.60
3181545-18154593.90195.00
4161914-16191483.74784.58
5173702-17370289.84490.77
6167494-16749486.63387.41
30min1184019-18401995.18094.021.7096.6495.451.64
2179171-17917192.67394.14
3179806-17980693.00194.63
4186715-18671596.57597.87
5181972-18197294.12295.55
6179018-17901892.59493.85
45min1190731-19073198.65295.941.84100.6497.881.88
2182872-18287294.58796.57
3187188-18718896.82098.96
4186371-18637196.39798.23
5184641-18464195.50297.45
6181074-18107493.65795.43
60min1191132-19113298.86096.011.68101.4098.491.68
2182751-18275194.52597.03
3186574-18657496.50299.18
4185844-18584496.12498.49
5182808-18280894.55497.04
6184650-18465095.50797.80
极限1188826-18882697.66796.871.23100.7599.881.18
2186278-18627896.34999.38
3187342-18734296.899100.11
4190702-19070298.637101.54
5184036-18403695.18998.20
6186579-18657996.50599.33
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%
110.943108463103543112683107633107693108000.11
211.053113563117843115700.10
单位质量响应值RSD%判断
28409.5128196.380.54数据可信
供试品溶液-2024011621批-阿托伐他汀钙-pH6.8(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%
5min1239635-23963569.93763.5825.5369.9463.5825.52
2230623-23062367.30767.31
3292771-29277185.44485.44
4124780-12478036.41736.42
5224044-22404465.38665.39
6195314-19531457.00257.00
10min1324066-32406694.57890.953.9694.9791.304.02
2300049-30004987.56887.94
3328424-32842495.84996.32
4302459-30245988.27288.47
5313219-31321991.41291.78
6301525-30152587.99988.32
15min1325804-32580495.08595.592.2796.0096.452.23
2319806-31980693.33494.19
3331718-33171896.81197.82
4338489-33848998.78799.48
5330209-33020996.37097.24
6319284-31928493.18293.99
20min1335179-33517997.82197.152.1199.2698.542.08
2323444-32344494.39695.77
3336632-33663298.24599.79
4342609-34260999.989101.23
5333086-33308697.21098.62
6326361-32636195.24796.57
30min1328813-32881395.96397.332.5597.9599.262.54
2322956-32295694.25496.16
3346961-346961101.259103.35
4338648-33864898.833100.63
5334312-33431297.56899.51
6329222-32922296.08297.93
45min1337231-33723198.42097.782.33100.94100.252.27
2326211-32621195.20497.63
3335852-33585298.017100.67
4347877-347877101.527103.87
5335469-33546997.905100.39
6327606-32760695.61198.00
60min1337053-33705398.36897.541.77101.43100.551.71
2326414-32641495.26398.22
3334262-33426297.553100.75
4343819-343819100.342103.25
5331068-33106896.62199.65
6332642-33264297.080100.00
极限1332596-33259697.06798.071.28100.68101.631.16
2337151-33715198.396101.88
3333368-33336897.292101.03
4343590-343590100.276103.74
5332401-33240197.010100.58
6337188-33718898.407101.86
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对照品来源自制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%
110.561809131827011828811830811832971825750.53
210.481829111832391830750.13
单位质量响应值RSD%判断
17289.3017468.990.74数据可信
供试品溶液-2024011821批-依折麦布-pH6.8(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%
5min143109-4310922.25121.9815.0722.2521.9815.06
237799-3779919.51119.51
353537-5353727.63427.63
442421-4242121.89621.90
534775-3477517.95017.95
643843-4384322.63022.63
10min1124633-12463364.33162.9012.6564.4663.0212.64
2118382-11838261.10561.21
3128405-12840566.27866.43
4140993-14099372.77672.90
594425-9442548.73948.84
6124301-12430164.16064.29
15min1166110-16611085.74083.717.9286.2284.187.94
2160094-16009482.63583.08
3166400-16640085.89086.41
4176553-17655391.13191.66
5138344-13834471.40971.78
6165544-16554485.44885.93
20min1179824-17982492.81991.535.5493.7892.465.58
2174174-17417489.90390.81
3180542-18054293.19094.19
4189765-18976597.95098.98
5160133-16013382.65583.42
6179501-17950192.65293.61
30min1162261-16226183.75492.515.7185.2393.955.67
2175310-17531090.48991.90
3185960-18596095.98697.50
4190304-19030498.22999.81
5175928-17592890.80892.03
6185558-18555895.77997.25
45min1182889-18288994.40195.561.9496.3497.522.00
2180072-18007292.94794.86
3187556-18755696.81098.86
4190007-19000798.075100.20
5183732-18373294.83696.57
6186529-18652996.28098.28
60min1182761-18276194.33595.482.1396.8097.972.16
2180988-18098893.42095.85
3188908-18890897.508100.10
4190497-19049798.328101.00
5184937-18493795.45897.72
6181726-18172693.80196.34
极限1182788-18278894.34995.741.3697.3498.761.42
2182291-18229194.09397.04
3187706-18770696.888100.02
4188256-18825697.172100.38
5185151-18515195.56998.36
6186746-18674696.39299.45
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%
110.943121023121233139243127543130133127830.25
211.053111243124953118100.32
单位质量响应值RSD%判断
28590.7728218.100.93数据可信
供试品溶液-2024011821批-阿托伐他汀钙-pH6.8(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%
5min1193387-19338756.23953.4816.8156.2453.4816.81
2204446-20444659.45559.46
3170649-17064949.62749.63
4192316-19231655.92855.93
5128301-12830137.31137.31
6214372-21437262.34262.34
10min1307683-30768389.47887.114.9589.7987.414.97
2283293-28329382.38582.72
3307244-30724489.35089.63
4312458-31245890.86791.18
5278082-27808280.87081.08
6308547-30854789.72990.08
15min1325809-32580994.74993.551.8795.5694.331.87
2312080-31208090.75791.54
3329648-32964895.86696.64
4321775-32177593.57694.39
5318914-31891492.74493.40
6321817-32181793.58894.43
20min1329907-32990795.94195.831.7797.2897.131.75
2319449-31944992.90094.19
3336674-33667497.90999.21
4333274-33327496.92098.26
5329953-32995395.95497.13
6327847-32784795.34296.71
30min1286444-28644483.30192.755.3985.1794.585.27
2313234-31323491.09292.90
3330349-33034996.07097.92
4325500-32550094.65996.53
5331339-33133996.35798.06
6326725-32672595.01696.91
45min1319613-31961392.94794.541.4595.2896.901.39
2321471-32147193.48895.80
3327659-32765995.28797.67
4323737-32373794.14796.55
5332781-33278196.77799.02
6325379-32537994.62497.05
60min1319554-31955492.93094.421.7595.7897.291.67
2322920-32292093.90996.74
3329130-32913095.71598.63
4325669-32566994.70997.63
5332764-33276496.77299.55
6317932-31793292.45995.41
极限1319432-31943292.89594.921.3296.2698.321.28
2326074-32607494.82698.18
3326246-32624694.87698.32
4331718-33171896.46899.92
5329950-32995095.95399.27
6324901-32490194.48597.95
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对照品来源自制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%
110.561788371815341816801815011815511810210.68
210.481820081822971821520.12
单位质量响应值RSD%判断
17142.1417380.920.98数据可信
供试品溶液-2024012021批-依折麦布-pH6.8(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%
5min161108-6110831.75829.0511.8031.7629.0511.81
266672-6667234.64934.65
352597-5259727.33427.33
452259-5225927.15927.16
553463-5346327.78427.78
649265-4926525.60325.60
10min1135600-13560070.47166.805.8470.6566.965.84
2134144-13414469.71469.91
3136056-13605670.70870.86
4119738-11973862.22762.38
5122413-12241363.61763.77
6123243-12324364.04964.19
15min1164299-16429985.38583.782.6985.9584.312.72
2166388-16638886.47187.05
3163616-16361685.03085.58
4154995-15499580.55081.05
5160247-16024783.28083.79
6157702-15770281.95782.46
20min1177288-17728892.13691.201.7893.1892.201.80
2179624-17962493.35094.41
3174244-17424490.55491.57
4170347-17034788.52889.47
5175932-17593291.43192.40
6175483-17548391.19892.15
30min1180875-18087594.00095.831.9695.5597.331.93
2187107-18710797.23998.82
3181576-18157694.36495.88
4181539-18153994.34595.78
5189620-18962098.545100.02
6185659-18565996.48697.95
45min1185196-18519696.24597.551.8398.3299.591.79
2189146-18914698.298100.42
3183018-18301895.11497.16
4188082-18808297.74599.71
5193021-193021100.312102.34
6187798-18779897.59899.59
60min1183386-18338695.30597.931.8897.92100.501.85
2192095-19209599.831102.50
3187247-18724797.31199.88
4189361-18936198.410100.91
5192413-19241399.996102.58
6186074-18607496.70299.24
极限1191848-19184899.70297.711.29102.84100.831.25
2185770-18577096.54499.76
3186794-18679497.076100.19
4187936-18793697.669100.72
5189844-18984498.661101.80
6185876-18587696.59999.67
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%
110.943105083108463109543100183101283104910.14
211.053090133096963093540.16
单位质量响应值RSD%判断
28381.2627995.840.97数据可信
供试品溶液-2024012021批-阿托伐他汀钙-pH6.8(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%
5min1281205-28120582.40477.907.3182.4077.907.31
2246785-24678572.31872.32
3275565-27556580.75280.75
4244044-24404471.51571.51
5290949-29094985.26085.26
6256441-25644175.14875.15
10min1326103-32610395.56196.441.5996.0296.881.61
2327380-32738095.93696.34
3334534-33453498.03298.48
4323794-32379494.88595.28
5336727-33672798.67599.15
6326110-32611095.56395.98
15min1332043-33204397.30299.701.4498.29100.661.43
2343430-343430100.639101.57
3341676-341676100.125101.12
4342051-342051100.235101.16
5345282-345282101.182102.20
6336826-33682698.70499.65
20min1337913-33791399.022100.801.04100.55102.321.02
2345551-345551101.260102.75
3342406-342406100.339101.89
4347935-347935101.959103.44
5346445-346445101.522103.11
6343562-343562100.678102.17
30min1332199-33219997.348100.661.8999.43102.741.86
2344131-344131100.844102.90
3341107-34110799.958102.07
4346772-346772101.618103.67
5351267-351267102.935105.08
6345535-345535101.256103.31
45min1334782-33478298.105100.561.89100.72103.201.85
2342934-342934100.494103.11
3336771-33677198.688101.35
4349888-349888102.531105.14
5350322-350322102.659105.38
6344222-344222100.871103.49
60min1330593-33059396.877100.492.06100.04103.682.02
2346876-346876101.649104.82
3342388-342388100.334103.54
4350683-350683102.764105.95
5346638-346638101.579104.87
6340262-34026299.711102.89
极限1336960-33696098.743100.301.55102.45104.061.49
2350996-350996102.856106.60
3339363-33936399.447103.22
4346268-346268101.471105.22
5340261-34026199.710103.56
6339768-33976899.566103.30
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