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DSMF-387-240606对照品来源自制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%
111.001886021888211885171885401880751885110.15
211.021891371898501894940.27
单位质量响应值RSD%判断
17137.3617195.460.24数据可信
供试品溶液-2024011221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%
5min139557-3955720.68731.5434.7120.6931.5434.71
258981-5898130.84530.85
362031-6203132.44032.44
493370-9337048.83048.83
570989-7098937.12537.13
636910-3691019.30319.30
10min1127118-12711866.47974.208.4666.5974.388.51
2145528-14552876.10776.28
3136894-13689471.59271.77
4153393-15339380.22080.49
5156851-15685182.02882.23
6131532-13153268.78768.89
15min1158262-15826282.76688.143.8383.2588.723.89
2169013-16901388.38988.98
3165833-16583386.72687.30
4174686-17468691.35692.07
5175995-17599592.04092.70
6167420-16742087.55688.05
20min1174043-17404391.01992.132.3491.9693.212.38
2172099-17209990.00391.09
3172002-17200289.95291.01
4180444-18044494.36795.59
5181328-18132894.82996.00
6177137-17713792.63793.61
30min1177571-17757192.86493.781.8294.3195.371.86
2176085-17608592.08793.67
3175713-17571391.89393.45
4182106-18210695.23696.98
5183164-18316495.78997.49
6181330-18133094.83096.32
45min1183808-18380896.12694.931.9198.0997.041.85
2177880-17788093.02695.12
3178929-17892993.57595.64
4178520-17852093.36195.64
5185775-18577597.15599.39
6184236-18423696.35098.37
60min1184692-18469296.58895.171.8299.0997.801.77
2176268-17626892.18394.80
3180059-18005994.16696.76
4182356-18235695.36798.16
5183756-18375696.09998.87
6184705-18470596.59599.15
极限1181999-18199995.18094.791.5998.2297.961.54
2176018-17601892.05295.18
3181359-18135994.84597.96
4181713-18171395.03198.36
5181616-18161694.98098.29
6184822-18482296.65699.75
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.181599571602821599621603541599501601010.13
211.141604861606501605680.08
单位质量响应值RSD%判断
14320.3014413.640.46数据可信
供试品溶液-2024011221批-阿托伐他汀钙-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%
5min1101866-10186658.69070.7514.8458.6970.7414.84
2109303-10930362.97562.97
3133919-13391977.15777.16
4148228-14822885.40185.40
5110167-11016763.47263.47
6133259-13325976.77776.78
10min1152361-15236187.78291.184.9988.1191.575.03
2148461-14846185.53585.89
3158449-15844991.29091.72
4167968-16796896.77497.25
5155215-15521589.42789.78
6167057-16705796.24996.68
15min1161112-16111292.82495.123.8293.6496.023.87
2156540-15654090.19091.02
3167382-16738296.43797.37
4174181-174181100.354101.37
5162401-16240193.56794.42
6168918-16891897.32298.28
20min1165677-16567795.45495.303.6696.7896.733.69
2154875-15487589.23190.56
3164851-16485194.97896.45
4173388-17338899.897101.47
5165514-16551495.36096.73
6168190-16819096.90298.40
30min1161427-16142793.00695.242.8894.8797.202.91
2158855-15885591.52493.35
3164175-16417594.58996.59
4171228-17122898.653100.78
5169569-16956997.69799.60
6166623-16662395.99998.04
45min1164636-16463694.85595.992.0097.2398.471.99
2162752-16275293.76996.10
3165138-16513895.14497.67
4166708-16670896.04898.72
5172264-17226499.249101.69
6168115-16811596.85999.43
60min1165234-16523495.19996.281.8398.1099.301.88
2162594-16259493.67896.53
3165950-16595095.61298.66
4170278-17027898.105101.31
5170268-17026898.099101.09
6168309-16830996.971100.08
极限1164464-16446494.75696.431.4198.1999.991.47
2165501-16550195.35398.72
3166009-16600995.64699.23
4169484-16948497.648101.40
5168654-16865497.170100.71
6170150-17015098.031101.68
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DSMF-387-240606对照品来源自制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%
111.001885431885301885221885971884901885360.03
211.021891661893561892610.08
单位质量响应值RSD%判断
17139.6417174.320.15数据可信
供试品溶液-2024011222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%
5min156537-5653729.58334.1118.2329.5834.1118.24
252582-5258227.51427.51
377290-7729040.44340.44
476187-7618739.86539.87
574348-7434838.90338.90
654208-5420828.36528.36
10min1131575-13157568.84874.728.9169.0174.918.93
2136590-13659071.47271.62
3143524-14352475.10075.32
4164072-16407285.85286.07
5150001-15000178.48978.71
6131014-13101468.55468.71
15min1159489-15948983.45486.214.3084.0086.824.34
2164902-16490286.28686.84
3163389-16338985.49486.14
4175970-17597092.07892.78
5168907-16890788.38289.03
6155916-15591681.58482.12
20min1169630-16963088.76090.521.9989.7791.602.06
2172214-17221490.11291.14
3172311-17231190.16391.28
4177131-17713192.68593.90
5177150-17715092.69593.84
6169491-16949188.68789.68
30min1174554-17455491.33793.181.8592.8494.771.88
2178331-17833193.31394.84
3174455-17445591.28592.90
4181320-18132094.87796.60
5182287-18228795.38397.04
6177570-17757092.91594.40
45min1176505-17650592.35794.721.5794.3796.831.57
2180411-18041194.40196.45
3184725-18472596.65998.78
4179832-17983294.09896.35
5182923-18292395.71697.90
6181755-18175595.10597.11
60min1177456-17745692.85593.851.3395.3896.481.26
2181204-18120494.81697.39
3178672-17867293.49196.15
4175898-17589892.04094.81
5181525-18152594.98497.70
6181360-18136094.89897.43
极限1175032-17503291.58793.311.1994.6396.461.20
2179216-17921693.77696.88
3176884-17688492.55695.74
4178522-17852293.41396.70
5181146-18114694.78698.03
6179098-17909893.71496.77
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.181595791596221595691601901599301597780.18
211.141600801607141603970.28
单位质量响应值RSD%判断
14291.4114398.290.53数据可信
供试品溶液-2024011222批-阿托伐他汀钙-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%
5min1116016-11601666.94670.0720.9666.9570.0720.95
283064-8306447.93147.93
3149512-14951286.27486.27
4118407-11840768.32568.33
5150309-15030986.73486.73
6111263-11126364.20364.20
10min1144230-14423083.22688.835.2783.6089.225.32
2150060-15006086.59086.86
3159940-15994092.29192.77
4152119-15211987.77888.16
5166869-16686996.29096.77
6150384-15038486.77787.13
15min1151407-15140787.36890.823.7388.2091.703.78
2157115-15711590.66191.41
3160853-16085392.81893.81
4153157-15315788.37789.24
5167268-16726896.52097.54
6154496-15449689.15089.99
20min1153917-15391788.81691.383.6690.1492.773.70
2157768-15776891.03892.29
3161889-16188993.41694.92
4151322-15132287.31988.68
5167591-16759196.70698.26
6157658-15765890.97592.31
30min1156394-15639490.24591.582.6692.0693.482.71
2158043-15804391.19792.95
3159024-15902491.76393.79
4154130-15413088.93990.78
5166546-16654696.10398.19
6158151-15815191.25993.10
45min1156550-15655090.33592.023.0192.6594.423.06
2158377-15837791.39093.65
3165042-16504295.23597.77
4153434-15343488.53790.87
5165405-16540595.44598.07
6157991-15799191.16793.51
60min1158402-15840291.40491.232.3594.2294.152.39
2159065-15906591.78794.56
3159096-15909691.80494.87
4151959-15195987.68690.52
5163344-16334494.25697.41
6156771-15677190.46393.32
极限1155314-15531489.62290.661.7792.9594.081.85
2156933-15693390.55693.84
3157466-15746690.86494.44
4156233-15623390.15293.47
5162312-16231293.66097.34
6154417-15441789.10492.46
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DSMF-387-240606对照品来源自制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%
111.001890811889981892301894281894811892440.12
211.021882591881191881890.06
单位质量响应值RSD%判断
17204.0017077.040.53数据可信
供试品溶液-2024011223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%
5min160391-6039131.63133.1423.7631.6333.1423.76
265438-6543834.27434.27
377863-7786340.78240.78
437915-3791519.85919.86
578912-7891241.33141.33
659167-5916730.99030.99
10min1130440-13044068.32074.216.9268.5074.396.91
2140226-14022673.44673.64
3139124-13912472.86873.09
4147278-14727877.13977.25
5158047-15804782.78083.01
6134957-13495770.68670.86
15min1158222-15822282.87186.703.5983.4387.293.60
2163409-16340985.58886.19
3163131-16313185.44286.07
4168648-16864888.33288.87
5175578-17557891.96292.65
6164168-16416885.98686.55
20min1167914-16791487.94890.741.7988.9691.811.80
2174866-17486691.58992.66
3172348-17234890.27091.38
4176950-17695092.68093.71
5174705-17470591.50592.70
6172654-17265490.43091.47
30min1175733-17573392.04394.924.4093.5596.504.33
2196733-196733103.042104.62
3174828-17482891.56993.18
4180963-18096394.78296.33
5179091-17909193.80295.51
6179969-17996994.26295.81
45min1179210-17921093.86494.490.7895.8896.600.77
2179463-17946393.99796.15
3178951-17895193.72895.84
4181653-18165395.14497.21
5180801-18080194.69796.93
6182328-18232895.49797.57
60min1178371-17837193.42594.040.5595.9696.670.56
2179176-17917693.84696.52
3180842-18084294.71997.36
4180597-18059794.59197.19
5179428-17942893.97896.73
6178835-17883593.66896.27
极限1180743-18074394.66793.920.4697.7297.080.38
2179347-17934793.93697.13
3179283-17928393.90297.07
4179388-17938893.95797.08
5178239-17823993.35696.63
6178916-17891693.71096.83
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.181619531623331621731617491624201621260.17
211.141591681593941592810.11
单位质量响应值RSD%判断
14501.4314298.111.00数据可信
供试品溶液-2024011223批-阿托伐他汀钙-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%
5min1134813-13481377.49873.2410.3677.5073.2410.36
2104345-10434559.98459.98
3132158-13215875.97275.97
4119579-11957968.74168.74
5133343-13334376.65376.65
6140215-14021580.60480.60
10min1157963-15796390.80691.102.5191.2491.502.50
2157253-15725390.39890.73
3154895-15489589.04389.46
4161938-16193893.09193.47
5154353-15435388.73189.16
6164405-16440594.50994.96
15min1162522-16252293.42793.501.3894.3694.421.39
2162313-16231393.30794.14
3161213-16121392.67593.59
4163483-16348393.97994.88
5159911-15991191.92692.84
6166480-16648095.70296.68
20min1161160-16116092.64493.212.2194.1094.642.17
2165362-16536295.06096.41
3164105-16410594.33795.77
4162531-16253193.43294.85
5155468-15546889.37290.80
6164202-16420294.39395.90
30min1159917-15991791.93094.184.7293.9096.144.60
2178567-178567102.651104.53
3160359-16035992.18494.14
4161660-16166092.93294.87
5157046-15704690.27992.21
6165480-16548095.12797.16
45min1160558-16055892.29892.871.4594.7895.341.45
2162052-16205293.15795.61
3163107-16310793.76396.23
4161017-16101792.56295.02
5157864-15786490.74993.18
6164681-16468194.66897.23
60min1158408-15840891.06291.971.7694.0594.961.72
2160535-16053592.28595.25
3164340-16434094.47297.46
4159683-15968391.79594.77
5155949-15594989.64892.58
6161016-16101692.56195.64
极限1160252-16025292.12291.851.7295.6295.361.71
2160849-16084992.46595.95
3162897-16289793.64397.16
4157930-15793090.78794.27
5155280-15528089.26492.69
6161514-16151492.84896.45
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