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%
111.101893551894471895161893791894731894340.04
211.181896091891991894040.16
单位质量响应值RSD%判断
17066.1316941.320.52数据可信
中间条件12月-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%
5min162268-6226832.87623.4122.4432.8823.4122.45
243124-4312422.76922.77
336362-3636219.19819.20
439642-3964220.93020.93
548556-4855625.63725.64
636071-3607119.04519.04
10min1133400-13340070.43265.698.7870.6265.838.79
2124774-12477465.87866.00
3111460-11146058.84958.96
4133209-13320970.33270.45
5133178-13317870.31570.46
6110536-11053658.36158.47
15min1159329-15932984.12284.674.2884.7085.174.28
2155356-15535682.02582.52
3154051-15405181.33681.77
4171795-17179590.70491.21
5165169-16516987.20687.74
6156525-15652582.64283.07
20min1167252-16725288.30690.473.3889.3591.443.37
2166712-16671288.02188.97
3166499-16649987.90888.79
4181297-18129795.72196.73
5173377-17337791.54092.56
6173003-17300391.34292.23
30min1172654-17265491.15893.712.3992.6995.182.37
2173559-17355991.63693.07
3175813-17581392.82694.20
4183609-18360996.94298.48
5178815-17881594.41195.94
6180456-18045695.27796.67
45min1176043-17604392.94795.152.1594.9997.142.13
2178097-17809794.03295.98
3176317-17631793.09294.98
4184792-18479297.56699.65
5182343-18234396.27398.32
6183656-18365696.96798.89
60min1182007-18200796.09695.681.8998.6598.191.89
2179438-17943894.74097.21
3177592-17759293.76596.17
4186522-18652298.480101.10
5178279-17827994.12896.71
6183431-18343196.84899.31
极限1187741-18774199.12395.772.43102.2198.822.42
2177393-17739393.66096.65
3177071-17707193.49096.42
4185707-18570798.050101.22
5179757-17975794.90898.02
6180686-18068695.39998.40
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100590-202406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%
111.323179493178623176083178703176383177850.05
211.273180903173793177340.16
单位质量响应值RSD%判断
28072.8828192.900.31数据可信
中间条件12月-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%
5min1267830-26783078.80361.1224.1078.8061.1124.10
2149589-14958944.01344.01
3190295-19029555.99055.99
4160550-16055047.23847.24
5261888-26188877.05477.05
6216140-21614063.59463.59
10min1318565-31856593.73086.966.1394.1787.306.19
2281092-28109282.70582.95
3296402-29640287.20987.52
4269912-26991279.41579.68
5311082-31108291.52991.96
6296224-29622487.15787.51
15min1330286-33028697.17992.233.3398.1493.053.41
2307047-30704790.34191.05
3313597-31359792.26993.06
4299301-29930188.06288.77
5317703-31770393.47794.41
6312766-31276692.02492.86
20min1326380-32638096.03092.981.8897.5394.311.97
2314869-31486992.64393.85
3313029-31302992.10193.41
4308425-30842590.74791.94
5316862-31686293.22994.69
6316461-31646193.11194.46
30min1322681-32268194.94193.201.2896.9795.051.38
2314508-31450892.53794.26
3316743-31674393.19495.01
4310705-31070591.41893.11
5317112-31711293.30395.28
6318820-31882093.80595.67
45min1321283-32128394.53093.470.8697.0995.840.95
2317472-31747293.40995.64
3313366-31336692.20194.54
4316075-31607592.99895.20
5319096-31909693.88796.38
6318708-31870893.77296.16
60min1326605-32660596.09693.881.6099.1896.761.57
2318836-31883693.81096.56
3315581-31558192.85295.70
4322680-32268094.94197.66
5312185-31218591.85394.87
6318473-31847393.70396.61
极限1332294-33229497.77093.992.59101.3997.402.56
2312001-31200191.79995.07
3314983-31498392.67696.04
4327121-32712196.24899.50
5313459-31345992.22895.75
6316885-31688593.23696.66
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%
111.101901571899491898791896931904991900350.17
211.181900871901351901110.02
单位质量响应值RSD%判断
17120.2717004.560.48数据可信
中间条件12月-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%
5min130869-3086916.24220.9527.2616.2420.9527.25
250236-5023626.43226.43
355713-5571329.31429.31
429628-2962815.58915.59
539261-3926120.65820.66
633225-3322517.48217.48
10min1107823-10782356.73264.8910.6056.8265.0110.63
2127907-12790767.30067.45
3144618-14461876.09376.26
4111899-11189958.87758.96
5125849-12584966.21766.33
6121908-12190864.14364.24
15min1154257-15425781.16486.064.3981.5786.544.44
2161579-16157985.01785.54
3174473-17447391.80192.39
4158023-15802383.14683.56
5166564-16656487.64088.12
6166478-16647887.59488.05
20min1168547-16854788.68393.213.0589.5494.163.09
2174828-17482891.98892.98
3183650-18365096.63097.73
4175266-17526692.21893.09
5179810-17981094.60995.58
6180780-18078095.12096.06
30min1178661-17866194.00597.342.9095.3598.822.93
2178840-17884094.09995.60
3191450-191450100.734102.37
4184645-18464597.15398.54
5186921-18692198.35199.85
6189505-18950599.710101.18
45min1177607-17760793.45097.122.3695.3299.142.35
2181215-18121595.34997.38
3185075-18507597.38099.57
4188474-18847499.168101.10
5186775-18677598.274100.32
6188354-18835499.105101.13
60min1177954-17795493.63397.182.5696.0299.732.57
2179731-17973194.56897.12
3188066-18806698.953101.69
4186994-18699498.389100.87
5185865-18586597.795100.38
6189535-18953599.726102.30
极限1179278-17927894.32997.481.9797.24100.572.01
2183070-18307096.32599.41
3189048-18904899.470102.75
4187489-18748998.650101.67
5184897-18489797.286100.42
6187797-18779798.812101.94
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%
111.323175853175893179463173133180583176980.10
211.273167803170803169300.07
单位质量响应值RSD%判断
28065.1928121.560.15数据可信
中间条件12月-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%
5min1236009-23600969.53861.7116.0769.5461.7116.07
2248281-24828173.15373.15
3158268-15826846.63246.63
4208776-20877661.51461.51
5183510-18351054.06954.07
6221758-22175865.33965.34
10min1297554-29755487.67189.801.7788.0690.141.77
2304365-30436589.67890.08
3303305-30330589.36689.62
4307102-30710290.48490.83
5302564-30256489.14789.45
6313713-31371392.43292.80
15min1312017-31201791.93393.971.5692.8194.821.50
2313171-31317192.27393.18
3321659-32165994.77395.53
4322539-32253995.03395.88
5322675-32267595.07395.87
6321557-32155794.74395.62
20min1316876-31687693.36495.541.8394.7596.901.78
2316561-31656193.27194.69
3327481-32748196.48997.77
4327013-32701396.35197.72
5327867-32786796.60397.93
6329775-32977597.16598.57
30min1320762-32076294.50996.022.3196.4197.922.24
2313478-31347892.36394.30
3333413-33341398.237100.05
4326701-32670196.25998.17
5329905-32990597.20399.06
6331165-33116597.57499.52
45min1312698-31269892.13394.762.2894.5697.182.23
2313795-31379592.45694.90
3319328-31932894.08796.45
4326984-32698496.34298.78
5328667-32866796.83899.24
6328182-32818296.69599.18
60min1312414-31241492.04994.612.3894.9997.572.32
2311183-31118391.68794.65
3323613-32361395.34998.24
4323003-32300395.16998.15
5326767-32676796.27899.22
6329749-32974997.157100.18
极限1312607-31260792.10695.252.1195.5698.732.04
2317627-31762793.58597.06
3327768-32776896.57399.99
4324165-32416595.51299.02
5330099-33009997.260100.73
6327436-32743696.476100.04
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%
111.101889561890271892021892331892091891250.07
211.181912441911611912020.04
单位质量响应值RSD%判断
17038.2917102.150.27数据可信
中间条件12月-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%
5min142661-4266122.43625.5422.1522.4425.5422.14
253693-5369328.23828.24
358991-5899131.02431.02
442979-4297922.60322.60
532965-3296517.33717.34
660136-6013631.62731.63
10min1118939-11893962.55267.536.2362.6867.686.23
2121212-12121263.74863.90
3126990-12699066.78666.96
4132954-13295469.92370.05
5129548-12954868.13268.23
6140827-14082774.06374.24
15min1153594-15359480.77884.625.3881.2585.135.36
2151000-15100079.41479.92
3154846-15484681.43681.98
4170182-17018289.50290.02
5166787-16678787.71688.19
6168940-16894088.84989.44
20min1173349-17334991.16791.572.6592.0992.562.64
2169291-16929189.03389.99
3168602-16860288.67189.67
4179337-17933794.31795.33
5179013-17901394.14695.11
6175067-17506792.07193.15
30min1174508-17450891.77795.202.2993.2096.692.31
2180242-18024294.79296.24
3178391-17839193.81995.31
4185304-18530497.45598.99
5182875-18287596.17797.66
6184741-18474197.15998.75
45min1179224-17922494.25796.491.7996.1998.521.79
2182261-18226195.85497.83
3182448-18244895.95397.96
4188312-18831299.037101.11
5186307-18630797.982100.00
6182312-18231295.88198.01
60min1181777-18177795.60096.430.6798.0698.990.70
2182172-18217295.80798.31
3184367-18436796.96299.50
4184814-18481497.19799.82
5183953-18395396.74499.31
6183106-18310696.29998.96
极限1182236-18223695.84196.430.7998.8399.530.81
2183344-18334496.42499.46
3181640-18164095.52898.61
4185507-18550797.561100.73
5184507-18450797.036100.14
6182922-18292296.20299.40
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100590-202406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%
111.323141763139403142243142603141263141450.04
211.273175623173753174680.05
单位质量响应值RSD%判断
27751.3328169.301.06数据可信
中间条件12月-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%
5min1165302-16530248.93967.7020.2348.9467.7020.23
2181728-18172853.80253.80
3271792-27179280.46680.47
4254208-25420875.26075.26
5226138-22613866.95066.95
6272924-27292480.80180.80
10min1278629-27862982.49090.545.1882.7690.925.23
2301723-30172389.32789.63
3313701-31370192.87493.32
4304955-30495590.28490.70
5309669-30966991.68092.05
6326301-32630196.60497.05
15min1298834-29883488.47295.023.6689.2095.903.71
2325592-32559296.39497.19
3323488-32348895.77196.73
4319945-31994594.72295.64
5324327-32432796.02096.90
6333535-33353598.74699.73
20min1317066-31706693.87096.171.6295.0997.581.64
2330698-33069897.90699.24
3324475-32447596.06397.56
4320516-32051694.89196.34
5329111-32911197.43698.85
6327128-32712896.84998.38
30min1311242-31124292.14696.122.4793.8998.062.51
2330731-33073197.91699.79
3324832-32483296.16998.20
4322417-32241795.45497.43
5324288-32428896.00897.96
6334565-33456599.051101.12
45min1316590-31659093.72995.931.1595.9898.401.22
2326734-32673496.73299.15
3324597-32459796.10098.66
4324984-32498496.21498.72
5325741-32574196.43898.93
6325423-32542396.34498.97
60min1321058-32105895.05295.580.9397.8398.590.97
2324932-32493296.19999.15
3326264-32626496.59399.69
4319341-31934194.54397.58
5320182-32018294.79297.82
6325366-32536696.32799.48
极限1324679-32467996.12495.620.6699.4399.160.59
2325890-32589096.48299.97
3320789-32078994.97298.61
4321225-32122595.10198.66
5321393-32139395.15198.70
6323906-32390695.89599.59
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