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%
110.011698041699121698711698301697651698360.04
210.101700711705051702880.19
单位质量响应值RSD%判断
16966.6316860.200.45数据可信
供试品溶液-X013993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%
5min148550-4855025.77030.1121.2125.7730.1121.21
252920-5292028.09028.09
353018-5301828.14228.14
442990-4299022.81922.82
569689-6968936.99136.99
673214-7321438.86238.86
10min1113886-11388660.45066.566.8460.5966.736.86
2132912-13291270.54970.71
3120361-12036163.88764.04
4119275-11927563.31163.44
5133210-13321070.70770.91
6132761-13276170.46970.69
15min1143703-14370376.27780.703.8076.7681.243.80
2160658-16065885.27785.82
3149653-14965379.43579.95
4152779-15277981.09581.57
5155508-15550882.54383.14
6149927-14992779.58180.19
20min1159084-15908484.44187.422.8985.3488.402.87
2171573-17157391.07092.09
3165269-16526987.72488.68
4168271-16827189.31890.25
5163760-16376086.92387.98
6160173-16017385.01986.07
30min1174115-17411592.42092.862.9293.7994.332.86
2179830-17983095.45396.98
3176407-17640793.63695.08
4179113-17911395.07396.50
5174491-17449192.61994.16
6165691-16569187.94889.47
45min1179886-17988695.48396.051.6097.3798.041.56
2183234-18323497.26099.32
3181661-18166196.42598.39
4184751-18475198.065100.02
5179512-17951295.28497.34
6176697-17669793.79095.80
60min1183458-18345897.37995.542.0199.7998.061.93
2181647-18164796.41899.02
3180023-18002395.55698.05
4183436-18343697.36799.87
5176621-17662193.75096.33
6174792-17479292.77995.31
极限1184789-18478998.08598.100.82101.04101.150.76
2183538-18353897.421100.56
3185940-18594098.696101.72
4186654-18665499.075102.11
5182643-18264396.946100.05
6185312-18531298.363101.41
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%
111.183127443124543124493124723121713124580.07
211.153116823117073116940.01
单位质量响应值RSD%判断
27947.9427954.620.02数据可信
供试品溶液-X013993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%
5min193938-9393827.76053.7639.6327.7653.7639.63
2136403-13640340.30940.31
3281584-28158483.21283.21
4130683-13068338.61938.62
5223440-22344066.03066.03
6225386-22538666.60566.60
10min1226058-22605866.80386.6515.9666.9686.9516.03
2254951-25495175.34275.57
3334247-33424798.77599.24
4279214-27921482.51282.73
5334087-33408798.72799.09
6330823-33082397.76398.13
15min1306246-30624690.50095.564.6091.0396.344.75
2311960-31196092.18992.83
3337339-33733999.688100.70
4312489-31248992.34593.02
5340820-340820100.717101.63
6331293-33129397.90298.81
20min1333025-33302598.41497.892.7899.4499.202.90
2318873-31887394.23295.39
3341543-341543100.931102.50
4321093-32109394.88896.07
5337597-33759799.765101.24
6335386-33538699.111100.57
30min1340534-340534100.63398.022.86102.2199.882.90
2321236-32123694.93096.61
3339699-339699100.386102.51
4320893-32089394.82896.54
5339885-339885100.441102.47
6327990-32799096.92698.93
45min1336396-33639699.41098.202.49101.54100.602.58
2321446-32144694.99297.20
3337083-33708399.613102.30
4321975-32197595.14897.39
5338749-338749100.105102.69
6338174-33817499.935102.48
60min1337672-33767299.78796.312.69102.4799.252.69
2315236-31523693.15795.89
3328219-32821996.993100.23
4315819-31581993.32996.10
5328130-32813096.967100.11
6330284-33028497.604100.70
极限1337803-33780399.82699.210.53103.07102.690.35
2335355-33535599.102102.35
3334384-33438498.815102.59
4337988-33798899.880103.17
5334950-33495098.982102.66
6333867-33386798.662102.31
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%
110.011694231694571694721695081694901694700.02
210.101701031705811703420.20
单位质量响应值RSD%判断
16930.0716865.540.28数据可信
供试品溶液-X013993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%
5min154064-5406428.72328.2014.5728.7228.2014.57
265307-6530734.69734.70
342492-4249222.57522.58
448657-4865725.85125.85
551246-5124627.22627.23
656742-5674230.14630.15
10min1125956-12595666.91866.878.8967.0867.028.90
2140675-14067574.73874.93
3106156-10615656.39956.52
4129928-12992869.02969.17
5126572-12657267.24667.40
6125876-12587666.87667.04
15min1157317-15731783.58081.405.5684.1181.935.58
2161984-16198486.05986.67
3137209-13720972.89773.34
4153348-15334881.47182.00
5156662-15666283.23283.76
6152779-15277981.16981.71
20min1168918-16891889.74388.283.9590.7489.263.99
2174054-17405492.47293.56
3154528-15452882.09882.94
4165739-16573988.05489.03
5168928-16892889.74990.74
6164790-16479087.55088.54
30min1185380-18538098.48994.633.3699.9896.103.38
2182244-18224496.82398.42
3168572-16857289.56090.86
4177950-17795094.54296.01
5180114-18011495.69297.18
6174484-17448492.70194.18
45min1181075-18107596.20296.482.0298.2498.482.07
2185053-18505398.316100.45
3176624-17662493.83795.63
4182248-18224896.82598.82
5186087-18608798.865100.88
6178521-17852194.84596.84
60min1184029-18402997.77297.191.94100.3599.722.01
2187930-18793099.844102.53
3177721-17772194.42096.74
4182594-18259497.00999.54
5184815-18481598.189100.76
6180496-18049695.89598.41
极限1186166-18616698.90798.241.00102.03101.311.03
2183758-18375897.628100.87
3182809-18280997.12399.97
4185223-18522398.406101.48
5187765-18776599.757102.87
6183691-18369197.592100.64
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%
111.183110183110443110943111473111163110840.02
211.153121893123523122700.04
单位质量响应值RSD%判断
27825.0428006.280.46数据可信
供试品溶液-X013993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%
5min1251270-25127074.34949.7733.9774.3549.7733.97
2207885-20788561.51261.51
3100932-10093229.86529.87
4121268-12126835.88335.88
5140646-14064641.61641.62
6187256-18725655.40855.41
10min1320914-32091494.95787.9414.4795.3788.2214.49
2326237-32623796.53296.87
3263468-26346877.95978.12
4311824-31182492.26792.47
5225977-22597766.86567.10
6334773-33477399.05799.37
15min1335054-33505499.14195.666.52100.0896.436.59
2335525-33552599.280100.16
3317192-31719293.85594.45
4326241-32624196.53397.24
5284047-28404784.04884.65
6341777-341777101.130101.99
20min1335679-33567999.32698.922.57100.82100.222.66
2340493-340493100.750102.18
3338749-338749100.234101.35
4330281-33028197.72898.98
5318898-31889894.36095.43
6341744-341744101.120102.54
30min1346838-346838102.627100.062.07104.67101.902.16
2338960-338960100.296102.29
3342092-342092101.223102.90
4334340-33434098.929100.72
5326578-32657896.63398.23
6340115-340115100.638102.62
45min1329028-32902897.35898.941.5199.97101.341.46
2336249-33624999.494102.04
3342673-342673101.395103.63
4331781-33178198.172100.51
5330427-33042797.77299.90
6336153-33615399.466102.01
60min1331311-33131198.03398.401.28101.19101.351.34
2336798-33679899.657102.76
3336649-33664999.613102.42
4328975-32897597.342100.23
5326631-32663196.64899.32
6334851-33485199.081102.17
极限1334663-33466399.02598.770.99102.72102.271.00
2329944-32994497.629101.28
3337589-33758999.891103.25
4332378-33237898.349101.78
5330812-33081297.885101.10
6337369-33736999.826103.47
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%
110.011702251703401703081703591704621703390.06
210.101713681716031714860.10
单位质量响应值RSD%判断
17016.8816978.810.16数据可信
供试品溶液-X027066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%
5min162465-6246532.99132.2015.7432.9932.2015.75
244653-4465323.58423.58
355293-5529329.20329.20
464148-6414833.88033.88
569564-6956436.74136.74
669658-6965836.79036.79
10min1124719-12471965.87165.917.8366.0566.097.84
2112192-11219259.25559.39
3114187-11418760.30960.47
4129080-12908068.17468.36
5132498-13249869.98070.18
6136078-13607871.87072.07
15min1150653-15065379.56879.034.8380.1279.584.86
2143229-14322975.64776.11
3139102-13910273.46873.96
4152783-15278380.69381.26
5153217-15321780.92281.52
6158844-15884483.89484.50
20min1159279-15927984.12484.122.7785.1285.102.82
2156412-15641282.61083.49
3152398-15239880.49081.40
4161962-16196285.54186.56
5160529-16052984.78485.83
6165002-16500287.14788.22
30min1167093-16709388.25189.371.6489.7190.821.70
2167050-16705088.22889.57
3166684-16668488.03589.39
4170441-17044190.01991.51
5170292-17029289.94191.45
6173704-17370491.74393.30
45min1173198-17319891.47692.640.7093.4294.590.73
2175641-17564192.76694.60
3174914-17491492.38294.22
4176464-17646493.20095.19
5176421-17642193.17895.19
6175772-17577292.83594.90
60min1174856-17485692.35193.271.3994.8195.731.43
2176615-17661593.28095.63
3173035-17303591.38993.74
4176596-17659693.27095.78
5178890-17889094.48297.01
6179579-17957994.84697.43
极限1179315-17931594.70694.860.9497.6897.840.97
2178687-17868794.37597.24
3179047-17904794.56597.43
4177832-17783293.92396.95
5180029-18002995.08398.14
6182678-18267896.48299.59
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%
111.183120473120563119363120513120653120310.02
211.153134913136223135560.03
单位质量响应值RSD%判断
27909.7528121.610.54数据可信
供试品溶液-X027066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%
5min1152801-15280145.05245.8229.1745.0545.8229.17
298712-9871229.10429.10
3158123-15812346.62146.62
4129523-12952338.18838.19
5158090-15809046.61146.61
6235195-23519569.34569.34
10min1280433-28043382.68385.528.0682.9385.778.09
2293985-29398586.67886.84
3291683-29168386.00086.26
4273219-27321980.55680.77
5267940-26794078.99979.26
6333014-33301498.18698.57
15min1314968-31496892.86594.743.7693.5795.473.81
2325236-32523695.89296.54
3316039-31603993.18193.92
4319530-31953094.21094.87
5308814-30881491.05091.75
6343306-343306101.220102.15
20min1317562-31756293.63095.792.8694.8697.052.90
2327982-32798296.70297.88
3323586-32358695.40696.66
4330674-33067497.49698.68
5311909-31190991.96393.17
6337664-33766499.557101.05
30min1316597-31659793.34596.862.6095.0998.652.63
2329108-32910897.03498.75
3333881-33388198.441100.23
4333005-33300598.18399.91
5320013-32001394.35296.07
6338465-33846599.793101.84
45min1317825-31782593.70797.062.2695.9799.392.24
2334141-33414198.518100.77
3335200-33520098.830101.16
4334486-33448698.620100.89
5322041-32204194.95097.19
6331558-33155897.756100.36
60min1316583-31658393.34196.151.9096.1399.021.93
2329947-32994797.281100.08
3324905-32490595.79598.68
4330249-33024997.370100.19
5321936-32193694.91997.69
6333088-33308898.207101.35
极限1332373-33237397.99798.080.52101.30101.480.61
2331308-33130897.683101.02
3332451-33245198.020101.43
4330588-33058897.470100.83
5334004-33400498.477101.77
6335233-33523398.840102.53
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%
110.011715271711731711191712141710521712170.11
210.101713121714521713820.06
单位质量响应值RSD%判断
17104.6016968.510.57数据可信
供试品溶液-X027066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%
5min162159-6215932.75635.826.8732.7635.826.87
266812-6681235.20735.21
371704-7170437.78537.79
472863-7286338.39638.40
563010-6301033.20433.20
671312-7131237.57937.58
10min1119549-11954962.99868.244.2163.1868.444.20
2130746-13074668.89869.09
3127985-12798567.44367.65
4130436-13043668.73568.95
5133164-13316470.17370.36
6135061-13506171.17271.38
15min1147820-14782077.89680.331.8678.4380.911.87
2153459-15345980.86781.45
3150860-15086079.49880.08
4152286-15228680.24980.84
5154429-15442981.37881.95
6155765-15576582.08282.69
20min1159210-15921083.89885.761.2184.8686.781.23
2164124-16412486.48787.51
3162105-16210585.42386.45
4163683-16368386.25587.30
5162726-16272685.75186.78
6164590-16459086.73387.79
30min1170054-17005489.61290.971.2191.0492.471.21
2175966-17596692.72894.24
3171234-17123490.23491.73
4173459-17345991.40792.93
5171815-17181590.54092.04
6173251-17325191.29792.84
45min1178119-17811993.86293.580.3995.7995.580.38
2178656-17865694.14596.17
3176972-17697293.25895.26
4177596-17759693.58795.61
5177002-17700293.27495.28
6177103-17710393.32795.38
60min1180818-18081895.28494.371.3997.7396.891.35
2181428-18142895.60698.15
3175026-17502692.23294.75
4177851-17785193.72196.27
5178333-17833393.97596.50
6181006-18100695.38497.95
极限1179276-17927694.47294.900.9797.4597.940.97
2182696-18269696.27499.35
3177512-17751293.54296.57
4180604-18060495.17298.24
5179548-17954894.61597.66
6180850-18085095.30198.40
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%
111.183126783126883126183126843123773126090.05
211.153120803121193121000.01
单位质量响应值RSD%判断
27961.4527991.030.08数据可信
供试品溶液-X027066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%
5min1193648-19364857.17545.2119.5357.1745.2119.53
2120663-12066335.62635.63
3180610-18061053.32553.33
4158151-15815146.69446.69
5123654-12365436.50936.51
6141983-14198341.92141.92
10min1269594-26959479.59873.9010.4979.9274.1510.51
2229039-22903967.62467.82
3292573-29257386.38286.68
4241745-24174571.37571.63
5223163-22316365.88966.09
6245606-24560672.51572.75
15min1307766-30776690.86890.904.0591.6391.564.09
2308034-30803490.94791.52
3331875-33187597.98698.76
4297854-29785487.94288.60
5301338-30133888.97089.54
6300281-30028188.65889.29
20min1322053-32205395.08694.733.4596.3595.903.49
2323272-32327295.44696.53
3341048-341048100.695102.02
4310588-31058891.70192.85
5314297-31429792.79693.86
6313875-31387592.67293.80
30min1327968-32796896.83396.542.9998.6398.233.02
2332304-33230498.11399.72
3343144-343144101.313103.19
4316167-31616793.34995.00
5321306-32130694.86696.44
6320932-32093294.75596.40
45min1334881-33488198.87496.653.10101.2098.883.14
2326977-32697796.54098.69
3342930-342930101.250103.69
4314967-31496792.99495.17
5323960-32396095.64997.76
6320300-32030094.56996.74
60min1334440-33444098.74496.841.73101.6299.601.82
2327458-32745896.68299.37
3335488-33548899.053102.06
4324644-32464495.85198.54
5322938-32293895.34897.98
6322983-32298395.36198.06
极限1332189-33218998.07998.440.98101.51101.751.04
2336203-33620399.264102.49
3338055-33805599.811103.37
4328957-32895797.125100.35
5332190-33219098.079101.25
6332887-33288798.285101.51
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