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%
19.481672951673551673471672851673481673260.02
29.541680361683101681730.12
单位质量响应值RSD%判断
17650.4217628.200.09数据可信
中间条件6月-供试品溶液-2023120821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%
5min139452-3945220.07928.8431.9120.0828.8431.91
236378-3637818.51518.51
382639-8263942.05942.06
448965-4896524.92124.92
568140-6814034.68034.68
664464-6446432.80932.81
10min1122291-12229162.24070.559.0762.3570.719.12
2127382-12738264.83164.93
3157243-15724380.02980.26
4137643-13764370.05370.19
5143217-14321772.89073.08
6143925-14392573.25073.43
15min1156436-15643679.61884.964.0080.0885.514.07
2162592-16259282.75183.21
3175993-17599389.57190.25
4168833-16883385.92786.45
5169153-16915386.09086.69
6168579-16857985.79886.39
20min1170906-17090686.98290.452.4287.8891.482.48
2178860-17886091.03191.95
3183044-18304493.16094.34
4179208-17920891.20892.21
5179762-17976291.49092.57
6174562-17456288.84389.91
30min1179940-17994091.58093.811.4492.9695.341.45
2187192-18719295.27196.70
3183649-18364993.46895.16
4184546-18454693.92495.44
5186935-18693595.14096.72
6183699-18369993.49395.05
45min1181241-18124192.24296.613.3794.1398.663.37
2185084-18508494.19896.16
3191059-19105997.23999.45
4191412-19141297.41999.45
5190185-19018596.79498.91
6199994-199994101.787103.87
60min1183747-18374793.51894.212.3895.9296.792.32
2188867-18886796.12498.60
3186811-18681195.07797.83
4184651-18465193.97896.55
5189244-18924496.31598.97
6177308-17730890.24192.89
极限1182268-18226892.76593.411.8195.6996.511.76
2187499-18749995.42798.44
3184495-18449593.89897.18
4183428-18342893.35596.45
5185625-18562594.47497.66
6177853-17785390.51893.66
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%
110.921525411525671525671525881526321525790.03
211.011534431536771535600.11
单位质量响应值RSD%判断
13972.4413947.320.13数据可信
中间条件6月-供试品溶液-2023120821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%
5min192433-9243354.69272.0922.1954.6972.0922.19
2132882-13288278.62678.63
3154798-15479891.59391.59
495895-9589556.74156.74
5148033-14803387.59187.59
6106951-10695163.28363.28
10min1135359-13535980.09192.538.6580.4092.948.70
2163917-16391796.98997.43
3168782-16878299.868100.38
4144611-14461185.56685.88
5167230-16723098.94999.44
6158433-15843393.74494.10
15min1148819-14881988.05696.745.5588.8097.665.63
2167013-16701398.82199.80
3171505-171505101.479102.54
4156544-15654492.62693.42
5171694-171694101.591102.63
6165449-16544997.89698.77
20min1155498-15549892.00897.784.2793.2599.244.37
2169283-169283100.164101.69
3172429-172429102.026103.65
4159594-15959494.43195.74
5172103-172103101.833103.43
6162633-16263396.22997.65
30min1158932-15893294.03997.912.8295.7999.902.92
2168132-16813299.483101.56
3165937-16593798.184100.38
4161566-16156695.59897.43
5172021-172021101.784103.95
6166214-16621498.348100.30
45min1160490-16049094.961100.824.0697.23103.364.05
2164698-16469897.451100.08
3175260-175260103.701106.44
4170118-170118100.658103.02
5172498-172498102.066104.80
6179318-179318106.102108.60
60min1164060-16406097.07498.432.8499.87101.532.89
2167571-16757199.151102.33
3171153-171153101.271104.59
4165139-16513997.712100.63
5171311-171311101.364104.66
6158913-15891394.02897.11
极限1163197-16319796.56397.782.1399.90101.422.20
2166408-16640898.463102.19
3169079-169079100.043103.92
4165370-16537097.849101.31
5168001-16800199.406103.27
6159433-15943394.33697.94
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%
19.481694881700471699871696941693071697050.19
29.541686291697371691830.47
单位质量响应值RSD%判断
17901.3717734.070.67数据可信
中间条件6月-供试品溶液-2023120822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%
5min130061-3006115.14724.2227.5915.1524.2227.58
260379-6037930.42330.42
348410-4841024.39224.39
441781-4178121.05221.05
566072-6607233.29133.29
641748-4174821.03521.04
10min1104187-10418752.49665.1112.6352.5865.2412.65
2136873-13687368.96569.13
3133719-13371967.37667.51
4134276-13427667.65767.77
5149999-14999975.57975.76
6116271-11627158.58558.70
15min1146097-14609773.61380.766.7173.9981.256.76
2168299-16829984.80085.35
3165573-16557383.42683.94
4164135-16413582.70283.19
5170254-17025485.78586.39
6147278-14727874.20874.65
20min1162262-16226281.75886.553.4082.5487.503.48
2172708-17270887.02188.04
3175311-17531188.33389.31
4174776-17477688.06389.02
5178030-17803089.70390.78
6167551-16755184.42385.28
30min1170552-17055285.93591.115.7187.1792.535.70
2186613-18661394.02795.53
3170295-17029585.80587.27
4196336-19633698.927100.37
5185159-18515993.29594.87
6175975-17597588.66789.99
45min1181054-18105491.22694.354.6492.9496.284.54
2181579-18157991.49193.52
3178333-17833389.85591.80
4191407-19140796.44398.43
5189637-18963795.55197.65
6201509-201509101.533103.35
60min1176643-17664389.00490.801.0991.2393.251.16
2180989-18098991.19493.73
3181843-18184391.62494.06
4181813-18181391.60994.14
5179423-17942390.40593.03
6180513-18051390.95493.33
极限1175761-17576188.56089.680.8291.2892.640.90
2177936-17793689.65592.70
3176841-17684189.10492.05
4179429-17942990.40893.44
5178843-17884390.11293.24
6179149-17914990.26793.15
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%
110.921546961549381549551545961541901546750.21
211.011540301548231544260.37
单位质量响应值RSD%判断
14164.3814025.980.70数据可信
中间条件6月-供试品溶液-2023120822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%
5min1119703-11970370.15068.2121.0670.1568.2121.07
278004-7800445.71345.71
3134408-13440878.76778.77
498869-9886957.94057.94
5145719-14571985.39685.40
6121673-12167371.30471.30
10min1155459-15545991.10491.874.8891.4992.254.95
2145745-14574585.41185.66
3161787-16178794.81295.25
4154185-15418590.35790.68
5168362-16836298.66599.14
6155105-15510590.89691.29
15min1165910-16591097.22897.162.0098.1298.041.98
2169421-16942199.286100.01
3165501-16550196.98997.95
4163213-16321395.64896.47
5169496-16949699.330100.35
6161206-16120694.47295.37
20min1163338-16333895.72197.631.3297.1699.061.34
2165823-16582397.17798.46
3166240-16624097.42298.92
4168158-16815898.54699.90
5169751-16975199.479101.05
6166226-16622697.41398.84
30min1159978-15997893.75298.415.1895.72100.395.04
2172051-172051100.827102.65
3159444-15944493.43995.48
4181814-181814106.549108.45
5171153-171153100.301102.43
6163163-16316395.61897.59
45min1165563-16556397.025100.044.6199.51102.554.52
2164379-16437996.33198.71
3162174-16217495.03997.60
4175979-175979103.129105.62
5173934-173934101.931104.61
6182184-182184106.765109.26
60min1160850-16085094.26395.981.3497.2999.061.30
2164168-16416896.20799.12
3165095-16509596.75199.84
4166931-16693197.827100.89
5163764-16376495.97199.22
6161914-16191494.88797.98
极限1159812-15981293.65594.611.1297.2198.221.14
2160824-16082494.24897.70
3160273-16027393.92597.55
4164252-16425296.25799.87
5163146-16314695.60899.39
6160388-16038893.99297.61
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%
19.481676691681021681891681391679221680040.13
29.541671601678071674840.28
单位质量响应值RSD%判断
17721.9417555.970.67数据可信
中间条件6月-供试品溶液-2023120823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%
5min141689-4168921.21825.2722.6821.2225.2722.69
248537-4853724.70424.70
345423-4542323.11923.12
441289-4128921.01521.01
571593-7159336.43936.44
649418-4941825.15225.15
10min1134495-13449568.45469.236.2268.5769.376.23
2140159-14015971.33771.47
3120927-12092761.54861.68
4137078-13707869.76969.89
5146397-14639774.51274.71
6137056-13705669.75769.90
15min1164708-16470883.83183.442.6184.3383.962.64
2162599-16259982.75883.29
3157936-15793680.38580.86
4162983-16298382.95383.46
5171108-17110887.08987.71
6164276-16427683.61284.14
20min1171582-17158287.33088.451.9088.2989.431.94
2175489-17548989.31990.31
3168642-16864285.83486.75
4173168-17316888.13789.10
5177422-17742290.30291.40
6176337-17633789.75090.74
30min1175308-17530889.22691.731.8190.6893.211.83
2179429-17942991.32492.81
3180387-18038791.81293.21
4179723-17972391.47492.93
5185437-18543794.38295.98
6181046-18104692.14793.64
45min1178852-17885291.03093.061.5692.9895.051.59
2184635-18463593.97495.97
3181209-18120992.23094.13
4181567-18156792.41294.38
5186801-18680195.07697.20
6183998-18399893.64995.65
60min1176569-17656989.86891.861.8492.3294.371.87
2180160-18016091.69694.21
3177790-17779090.49092.91
4179570-17957091.39693.87
5184932-18493294.12596.78
6183870-18387093.58496.11
极限1177129-17712990.15390.411.5293.1093.431.55
2178502-17850290.85293.88
3174306-17430688.71791.64
4175019-17501989.07992.06
5181256-18125692.25495.43
6179621-17962191.42294.46
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%
110.921526651530931531301530531527141529310.15
211.011526621531061528840.21
单位质量响应值RSD%判断
14004.6713885.920.61数据可信
中间条件6月-供试品溶液-2023120823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%
5min1131153-13115377.68567.2123.4877.6967.2123.48
2136817-13681781.04081.04
388373-8837352.34652.35
4127786-12778675.69175.69
571895-7189542.58542.59
6124753-12475373.89473.89
10min1154802-15480291.69389.404.9392.1289.785.00
2158473-15847393.86894.32
3146588-14658886.82887.12
4153735-15373591.06191.48
5137984-13798481.73181.97
6154012-15401291.22591.64
15min1164504-16450497.44094.971.8098.3895.841.75
2157164-15716493.09294.06
3162590-16259096.30697.08
4157419-15741993.24394.17
5160504-16050495.07195.76
6159847-15984794.68195.60
20min1163643-16364396.93095.981.1098.4197.371.09
2160864-16086495.28496.77
3163471-16347196.82898.14
4159423-15942394.43095.87
5161272-16127295.52596.74
6163518-16351896.85698.30
30min1160096-16009694.82996.121.7496.8598.051.60
2159644-15964494.56196.58
3165518-16551898.04099.89
4160361-16036194.98696.95
5165985-16598598.317100.07
6162072-16207295.99997.98
45min1161651-16165195.75096.391.4098.3098.851.30
2163047-16304796.57799.12
3162751-16275196.40298.79
4159634-15963494.55597.05
5166601-16660198.682100.98
6162666-16266696.35198.87
60min1159260-15926094.33494.941.7297.4197.941.60
2158087-15808793.63996.72
3159443-15944394.44297.37
4157941-15794193.55296.57
5165147-16514797.821100.66
6161778-16177895.82598.88
极限1159748-15974894.62393.522.0698.2397.051.96
2157245-15724593.14096.74
3156018-15601892.41395.86
4153323-15332390.81794.36
5162822-16282296.44499.83
6158176-15817693.69297.27
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%
19.481667951679811686761692231694711684290.64
29.541688871694521691700.24
单位质量响应值RSD%判断
17766.7717732.700.14数据可信
长期6月-供试品溶液-2023120823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%
5min131229-3122915.79533.2027.8315.8033.2027.82
269700-6970035.25335.25
371951-7195136.39236.39
481022-8102240.98040.98
578736-7873639.82339.82
661242-6124230.97530.98
10min1115533-11553358.43568.307.9058.5268.487.95
2145128-14512873.40373.60
3138340-13834069.97070.17
4139851-13985170.73470.96
5140770-14077071.19971.42
6130596-13059666.05366.23
15min1154504-15450478.14580.652.8478.5681.222.89
2165025-16502583.46784.07
3162422-16242282.15082.74
4162115-16211581.99582.62
5158701-15870180.26880.88
6153988-15398877.88478.42
20min1167361-16736184.64886.451.1985.4987.461.26
2171080-17108086.52987.60
3173434-17343487.72088.77
4172053-17205387.02188.10
5170579-17057986.27687.34
6171040-17104086.50987.48
30min1173206-17320687.60589.601.2888.9291.091.36
2178049-17804990.05491.60
3178704-17870490.38591.92
4178533-17853390.29991.86
5178727-17872790.39791.94
6175676-17567688.85490.31
45min1178653-17865390.36091.800.8692.1693.790.95
2181524-18152491.81293.86
3182296-18229692.20294.24
4182494-18249492.30294.36
5182989-18298992.55394.60
6181023-18102391.55893.50
60min1176543-17654389.29291.001.8591.6093.501.84
2177886-17788689.97292.53
3179262-17926290.66893.22
4184836-18483693.48796.06
5177807-17780789.93292.49
6183181-18318192.65095.10
极限1180210-18021091.14790.511.1893.9593.521.09
2175798-17579888.91691.97
3180924-18092491.50894.56
4177237-17723789.64392.74
5178634-17863490.35093.41
6180904-18090491.49894.47
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%
110.921520611529501535031539071542461533330.57
211.011536861541171539020.20
单位质量响应值RSD%判断
14041.4813978.380.32数据可信
长期6月-供试品溶液-2023120823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%
5min1114802-11480267.68670.1015.9467.6970.1015.94
2136601-13660180.53880.54
3107893-10789363.61263.61
4131797-13179777.70677.71
588157-8815751.97651.98
6134145-13414579.09079.09
10min1155809-15580991.86392.445.0792.2492.835.10
2162605-16260595.86996.32
3160637-16063794.70995.06
4159931-15993194.29394.72
5141247-14124783.27783.57
6160508-16050894.63395.07
15min1166066-16606697.91095.831.8198.8096.731.84
2163253-16325396.25197.23
3164698-16469897.10397.98
4162216-16221695.64096.60
5157656-15765692.95293.70
6161325-16132595.11596.08
20min1164474-16447496.97196.851.0698.4098.291.03
2161956-16195695.48797.00
3165803-16580397.75599.17
4162836-16283696.00697.49
5164042-16404296.71797.98
6166530-16653098.18499.68
30min1161053-16105394.95496.090.9796.9298.060.89
2162741-16274195.95097.99
3164486-16448696.97898.94
4162296-16229695.68797.71
5165213-16521397.40799.21
6162081-16208195.56097.60
45min1162020-16202095.52596.641.3898.0299.151.28
2160766-16076694.78597.36
3165475-16547597.562100.06
4164252-16425296.84099.39
5166954-16695498.434100.78
6164038-16403896.71499.28
60min1159253-15925393.89395.751.7196.9298.791.69
2159923-15992394.28897.39
3162220-16222095.64298.69
4165621-16562197.648100.74
5161608-16160895.28298.17
6165747-16574797.722100.83
极限1162377-16237795.73595.081.6099.2898.651.52
2157677-15767792.96496.59
3163879-16387996.621100.19
4158405-15840593.39397.03
5162075-16207595.55798.98
6163132-16313296.18099.83
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