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%
111.001910401906621905361906071905491906790.11
211.021906781911421909100.18
单位质量响应值RSD%判断
17334.4517323.960.05数据可信
供试品溶液-2024011621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%
5min134440-3444017.84221.9625.6117.8421.9625.60
226555-2655513.75713.76
356912-5691229.48429.48
446627-4662724.15524.16
549012-4901225.39125.39
640826-4082621.15021.15
10min1103526-10352653.63260.8510.3153.7360.9710.33
2103192-10319253.45953.54
3123757-12375764.11364.28
4128237-12823766.43466.57
5130681-13068167.70067.84
6115339-11533959.75259.87
15min1147624-14762476.47880.134.3576.8780.594.39
2146273-14627375.77876.15
3153671-15367179.61080.13
4160260-16026083.02483.53
5162751-16275184.31484.83
6157492-15749281.59082.04
20min1164734-16473485.34187.332.3586.1688.232.38
2166037-16603786.01686.81
3165840-16584085.91486.88
4175410-17541090.87291.84
5169254-16925487.68388.67
6170131-17013188.13789.04
30min1176572-17657291.47492.101.0392.7793.491.03
2177766-17776692.09393.37
3175154-17515490.74092.18
4178995-17899592.72994.20
5177796-17779692.10893.58
6180392-18039293.45394.85
45min1179249-17924992.86193.781.7594.6795.681.69
2184390-18439095.52497.31
3178494-17849492.47094.41
4184665-18466595.66797.65
5177236-17723691.81893.80
6182113-18211394.34596.26
60min1179656-17965693.07294.011.1695.3996.431.13
2183309-18330994.96497.28
3183021-18302194.81597.27
4183145-18314594.87997.40
5178293-17829392.36694.86
6181364-18136493.95796.39
极限1177875-17787592.14994.231.3694.9997.181.34
2184327-18432795.49298.33
3182376-18237694.48197.47
4183356-18335694.98998.03
5180001-18000193.25196.26
6183408-18340895.01697.97
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%
111.183184633188213177293183483185753183870.13
211.143188913192473190690.08
单位质量响应值RSD%判断
28478.2628641.740.41数据可信
供试品溶液-2024011621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%
5min1238423-23842369.10264.9118.3169.1064.9218.31
2198631-19863157.56957.57
3240474-24047469.69669.70
4272843-27284379.07779.08
5155458-15545845.05645.06
6238010-23801068.98268.98
10min1301543-30154387.39588.025.5187.7888.385.56
2298262-29826286.44586.76
3312673-31267390.62191.01
4321804-32180493.26893.71
5274380-27438079.52379.77
6313475-31347590.85491.24
15min1313820-31382090.95492.443.0391.8293.293.09
2315246-31524691.36792.17
3323476-32347693.75294.64
4331232-33123296.00096.96
5304460-30446088.24188.93
6325490-32549094.33695.22
20min1317649-31764992.06393.172.6393.4494.542.70
2319664-31966492.64793.96
3324173-32417393.95495.37
4333016-33301696.51798.01
5308248-30824889.33990.52
6326116-32611694.51795.93
30min1321950-32195093.31093.461.6095.2095.351.69
2318368-31836892.27294.09
3325735-32573594.40796.34
4326783-32678394.71196.74
5314641-31464191.19292.87
6327429-32742994.89896.84
45min1321498-32149893.17993.491.8295.5895.891.90
2324045-32404593.91796.25
3322253-32225393.39895.86
4330592-33059295.81598.37
5312563-31256390.58992.77
6324430-32443094.02996.49
60min1322056-32205693.34193.491.4896.2696.411.57
2321224-32122493.10095.96
3327687-32768794.97397.95
4327581-32758194.94298.03
5314848-31484891.25293.94
6322049-32204993.33996.33
极限1317459-31745992.00893.501.0495.4596.941.10
2323409-32340993.73397.11
3323498-32349893.75997.26
4325932-32593294.46498.08
5319840-31984092.69895.89
6325579-32557994.36297.87
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%
111.001904021903141902561901521902201902690.05
211.021913131921121917120.30
单位质量响应值RSD%判断
17297.1817396.730.41数据可信
供试品溶液-2024011821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%
5min159934-5993431.01823.4825.5131.0223.4825.51
253394-5339427.63327.63
331920-3192016.52016.52
431630-3163016.36916.37
550195-5019525.97725.98
645196-4519623.39023.39
10min1137924-13792471.38063.899.4771.5564.029.50
2133952-13395269.32469.48
3112257-11225758.09658.19
4108641-10864156.22556.32
5121017-12101762.63062.77
6126955-12695565.70365.83
15min1164941-16494185.36282.083.6685.9382.563.70
2164214-16421484.98685.52
3151657-15165778.48778.90
4158755-15875582.16182.56
5151834-15183478.57979.07
6160212-16021282.91583.41
20min1173644-17364489.86688.142.9490.9189.082.97
2176216-17621691.19792.21
3163280-16328084.50285.35
4171430-17143088.72089.58
5165262-16526285.52886.46
6171985-17198589.00789.96
30min1178512-17851292.38591.451.8693.9392.881.91
2181875-18187594.12695.64
3172629-17262989.34190.66
4174139-17413990.12291.47
5176944-17694491.57492.98
6176109-17610991.14292.59
45min1179174-17917492.72892.301.1494.7894.241.17
2181260-18126093.80895.85
3177243-17724391.72993.54
4178838-17883892.55494.41
5178336-17833692.29494.21
6175209-17520990.67692.63
60min1178019-17801992.13092.060.7194.7094.510.78
2180009-18000993.16095.72
3176296-17629691.23893.56
4177114-17711491.66294.03
5178251-17825192.25094.68
6177612-17761291.92094.38
极限1176347-17634791.26591.051.6594.3594.021.62
2178653-17865392.45895.54
3179059-17905992.66895.50
4171906-17190688.96791.84
5176529-17652991.35994.30
6173151-17315189.61192.58
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%
111.183180463180643174543180023178133178760.09
211.143196433205703201060.21
单位质量响应值RSD%判断
28432.5628734.830.75数据可信
供试品溶液-2024011821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%
5min1225928-22592865.42760.1010.2965.4360.1010.29
2182171-18217152.75552.76
3230044-23004466.61966.62
4222407-22240764.40864.41
5185033-18503353.58453.58
6199618-19961857.80857.81
10min1305474-30547488.46386.172.3188.8386.512.31
2301170-30117087.21787.51
3302845-30284587.70288.07
4288158-28815883.44983.81
5296698-29669885.92286.22
6291035-29103584.28284.60
15min1318789-31878992.31990.581.8593.1791.401.85
2315833-31583391.46392.24
3315159-31515991.26892.13
4305859-30585988.57589.40
5315961-31596191.50092.28
6305162-30516288.37389.16
20min1317844-31784492.04591.591.4793.4192.901.45
2323259-32325993.61494.90
3316555-31655591.67293.04
4310550-31055089.93391.25
5317627-31762791.98393.27
6311718-31171890.27191.55
30min1316125-31612591.54891.451.8893.4393.281.85
2323911-32391193.80295.61
3317647-31764791.98893.86
4307118-30711888.93990.75
5318848-31884892.33694.13
6311149-31114990.10791.89
45min1314278-31427891.01391.071.3693.4093.401.35
2319663-31966392.57294.90
3317720-31772092.01094.39
4311942-31194290.33692.64
5315592-31559291.39393.70
6307739-30773989.11991.40
60min1311574-31157490.23090.720.8393.1293.560.81
2317078-31707891.82494.66
3314442-31444291.06093.96
4309882-30988289.74092.55
5314486-31448691.07393.89
6312111-31211190.38593.16
极限1308692-30869289.39589.591.8692.7992.931.83
2314988-31498891.21894.57
3316508-31650891.65995.06
4301556-30155687.32990.64
5309589-30958989.65592.98
6304771-30477188.26091.54
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%
111.001910271912541909601911081910541910810.06
211.021903331907111905220.15
单位质量响应值RSD%判断
17371.0017288.750.34数据可信
供试品溶液-2024012021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%
5min160144-6014431.15725.9017.6131.1625.9017.62
245855-4585523.75523.75
340079-4007920.76220.76
460394-6039431.28631.29
551212-5121226.53026.53
642293-4229321.90921.91
10min1141043-14104373.06666.1411.2073.2466.2911.21
2136964-13696470.95371.08
3114147-11414759.13359.25
4133109-13310968.95669.13
5135223-13522370.05170.20
6105592-10559254.70154.82
15min1166191-16619186.09382.485.9486.6782.995.96
2170478-17047888.31488.84
3149896-14989677.65278.10
4162759-16275984.31684.87
5159787-15978782.77683.31
6146153-14615375.71376.14
20min1175497-17549790.91488.113.3991.9789.083.45
2175535-17553590.93491.95
3163365-16336584.62985.50
4174422-17442290.35791.38
5167738-16773886.89587.89
6163959-16395984.93785.78
30min1179027-17902792.74392.401.3894.3193.861.43
2179443-17944392.95894.48
3179116-17911692.78994.13
4181355-18135593.94995.48
5177083-17708391.73693.22
6174219-17421990.25291.57
45min1182890-18289094.74493.841.2696.8295.821.29
2182330-18233094.45496.49
3180785-18078593.65495.51
4183547-18354795.08597.13
5177374-17737491.88793.88
6179984-17998493.23995.06
60min1181320-18132093.93193.251.1996.5395.741.17
2178690-17869092.56895.13
3180194-18019493.34895.73
4182666-18266694.62897.21
5176581-17658191.47693.98
6180537-18053793.52595.86
极限1181347-18134793.94593.101.0997.0796.111.13
2179825-17982593.15696.23
3181289-18128993.91596.81
4180928-18092893.72896.83
5178489-17848992.46495.47
6176424-17642491.39594.25
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%
111.183191173194633189893191583190583191570.06
211.143178753181883180320.07
单位质量响应值RSD%判断
28547.1428548.650.01数据可信
供试品溶液-2024012021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%
5min1265069-26506976.85663.8419.6176.8663.8419.61
2251212-25121272.83872.84
3169994-16999449.28949.29
4193372-19337256.06856.07
5260090-26009075.41375.41
6181377-18137752.59052.59
10min1310681-31068190.08187.415.9890.5187.766.02
2314837-31483791.28691.69
3270123-27012378.32278.60
4303920-30392088.12188.43
5317798-31779892.14592.56
6291407-29140784.49384.79
15min1317558-31755892.07592.182.6793.0093.022.73
2331937-33193796.24597.16
3306498-30649888.86989.58
4318321-31832192.29793.10
5320506-32050692.93093.86
6312791-31279190.69391.45
20min1319143-31914392.53592.391.5293.9793.741.59
2323900-32390093.91495.36
3310287-31028789.96791.17
4322541-32254193.52094.83
5319336-31933692.59194.04
6316722-31672291.83393.10
30min1314998-31499891.33393.081.2393.2994.951.19
2321578-32157893.24195.21
3324000-32400093.94395.65
4323607-32360793.82995.66
5324545-32454594.10196.06
6317414-31741492.03493.81
45min1318560-31856092.36693.350.6394.8395.730.60
2323592-32359293.82596.31
3321537-32153793.22995.45
4324270-32427094.02196.38
5321569-32156993.23895.72
6322193-32219393.41995.71
60min1316076-31607691.64692.700.8594.6295.600.76
2317510-31751092.06195.07
3319971-31997192.77595.52
4322596-32259693.53696.41
5319259-31925992.56995.57
6322853-32285393.61196.42
极限1316094-31609491.65192.611.0595.1396.031.01
2319449-31944992.62496.14
3323500-32350093.79897.06
4319349-31934992.59595.99
5322709-32270993.56997.09
6315317-31531791.42694.75
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