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DJ333-221017对照品来源自制对照品使用方法直接使用
对照品含量(%)99.67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%
110.021704501693171689921689851692751694040.36
210.031715001716271715640.06
单位质量响应值RSD%判断
16906.5917105.080.83数据可信
供试品溶液-2024011221批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min166882-6688235.28034.934.8735.2834.934.87
266896-6689635.28835.29
364461-6446134.00334.00
461897-6189732.65132.65
571592-7159237.76537.76
665622-6562234.61634.62
10min1148331-14833178.24579.842.5578.4480.042.54
2146120-14612077.07977.27
3155969-15596982.27482.46
4149814-14981479.02779.21
5153635-15363581.04381.25
6154290-15429081.38881.58
15min1173731-17373191.64393.792.6092.2794.432.59
2170766-17076690.07990.70
3181587-18158795.78796.43
4182133-18213396.07596.70
5178115-17811593.95694.62
6180505-18050595.21795.86
20min1180374-18037495.14897.701.7696.2998.861.76
2182751-18275196.40197.53
3187753-18775399.040100.22
4184852-18485297.51098.66
5186378-18637898.31599.50
6189146-18914699.775100.95
30min1182289-18228996.15899.151.8597.83100.851.84
2187412-18741298.860100.52
3188877-18887799.633101.36
4188077-18807799.211100.91
5187902-18790299.119100.85
6193163-193163101.894103.62
45min1186298-18629898.27299.641.54100.48101.891.51
2191309-191309100.916103.13
3185205-18520597.69699.98
4187628-18762898.974101.22
5190647-190647100.567102.85
6192229-192229101.401103.69
60min1187457-18745798.88499.061.77101.63101.861.73
2188203-18820399.277102.05
3181534-18153495.75998.58
4189336-18933699.875102.67
5189013-18901399.705102.54
6191183-191183100.849103.71
极限1186210-18621098.22699.421.46101.52102.781.45
2186358-18635898.304101.63
3186820-18682098.548101.90
4187589-18758998.953102.31
5192396-192396101.489104.88
6191478-191478101.005104.42
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%
111.171587791600681598881598541600841597350.35
211.111623831620441622140.15
单位质量响应值RSD%判断
14300.3614600.721.47数据可信
供试品溶液-2024011221批-阿托伐他汀钙-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1160874-16087491.96694.161.8991.9794.161.89
2164283-16428393.91593.92
3165649-16564994.69694.70
4164057-16405793.78693.79
5170177-17017797.28597.28
6163266-16326693.33493.33
10min1175454-175454100.301102.361.33100.81102.891.33
2178575-178575102.085102.61
3177482-177482101.461101.99
4179930-179930102.860103.38
5181144-181144103.554104.09
6181780-181780103.918104.44
15min1178138-178138101.836102.310.53102.90103.400.53
2178796-178796102.212103.30
3178201-178201101.872102.96
4178859-178859102.248103.34
5179147-179147102.412103.53
6180696-180696103.298104.39
20min1176363-176363100.821101.720.82102.45103.380.81
2179032-179032102.347104.00
3177008-177008101.190102.85
4177559-177559101.505103.17
5177318-177318101.367103.05
6180285-180285103.063104.73
30min1173141-17314198.979100.031.26101.17102.261.24
2175127-175127100.114102.34
3173664-17366499.278101.50
4174807-17480799.931102.16
5173965-17396599.450101.70
6179195-179195102.440104.68
45min1174495-17449599.75399.481.42102.50102.261.39
2176120-176120100.682103.46
3169722-16972297.02499.79
4172698-17269898.726101.51
5174808-17480899.932102.73
6176258-176258100.761103.57
60min1174486-17448699.74898.821.94103.05102.151.89
2173002-17300298.899102.24
3166406-16640695.12998.44
4173866-17386699.393102.72
5173246-17324699.039102.39
6176140-176140100.693104.06
极限1173199-17319999.01298.891.28102.86102.771.26
2170574-17057497.511101.40
3170597-17059797.525101.36
4172708-17270898.731102.61
5174757-17475799.903103.81
6176087-176087100.663104.59
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DJ333-221017对照品来源自制对照品使用方法直接使用
对照品含量(%)99.67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%
110.021724311712921714241714841714101715000.29
210.031690981693021692000.09
单位质量响应值RSD%判断
17115.7716869.391.03数据可信
供试品溶液-2024011222批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min181676-8167643.11935.6214.3743.1235.6214.37
267082-6708235.41435.41
375457-7545739.83539.84
463754-6375433.65733.66
561992-6199232.72732.73
654828-5482828.94528.94
10min1163135-16313586.12382.124.2686.3682.314.28
2156531-15653182.63682.83
3160176-16017684.56184.78
4157476-15747683.13583.32
5151233-15123379.83980.02
6144737-14473776.41076.57
15min1181913-18191396.03695.482.2296.7596.132.23
2187869-18786999.18099.84
3180532-18053295.30796.00
4180863-18086395.48296.13
5177025-17702593.45694.08
6176949-17694993.41594.00
20min1186437-18643798.42499.151.3199.68100.341.30
2192714-192714101.738102.94
3187405-18740598.935100.16
4187392-18739298.929100.11
5186525-18652598.47199.62
6186434-18643498.42399.53
30min1191214-191214100.946101.400.72102.74103.140.68
2191604-191604101.152102.92
3191476-191476101.085102.85
4193339-193339102.068103.80
5190653-190653100.650102.34
6194198-194198102.522104.17
45min1191064-191064100.867101.591.19103.23103.891.14
2195522-195522103.221105.55
3189838-189838100.220102.55
4191922-191922101.320103.62
5191340-191340101.013103.26
6194920-194920102.903105.12
60min1191918-191918101.318101.420.89104.24104.290.86
2194381-194381102.618105.53
3189625-189625100.107103.00
4191127-191127100.900103.76
5192055-192055101.390104.20
6193617-193617102.215105.01
极限1189969-189969100.289100.431.45103.77103.861.39
2192821-192821101.795105.27
3187945-18794599.220102.67
4186772-18677298.601102.02
5189961-189961100.285103.66
6193934-193934102.382105.74
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%
111.171621851620611618511616671619861619550.12
211.111600161599291599720.04
单位质量响应值RSD%判断
14499.1014398.920.50数据可信
供试品溶液-2024011222批-阿托伐他汀钙-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1164253-16425393.89992.302.3393.9092.312.33
2161560-16156092.35992.36
3166369-16636995.10995.11
4162341-16234192.80692.81
5157360-15736089.95889.96
6156902-15690289.69789.70
10min1177102-177102101.24499.311.70101.7799.821.70
2175154-175154100.131100.64
3173295-17329599.06899.60
4176076-176076100.658101.17
5169486-16948696.89097.39
6171210-17121097.87698.37
15min1175598-175598100.38599.872.05101.47100.942.04
2179932-179932102.862103.93
3172035-17203598.34899.43
4177073-177073101.228102.30
5170071-17007197.22598.26
6173500-17350099.185100.23
20min1172533-17253398.63299.191.53100.27100.811.53
2177599-177599101.528103.17
3172006-17200698.33199.96
4175739-175739100.465102.10
5170373-17037397.39898.98
6172801-17280198.786100.38
30min1173269-17326999.05398.531.63101.24100.701.62
2171721-17172198.168100.37
3171292-17129297.923100.09
4176866-176866101.109103.30
5168292-16829296.20898.33
6172736-17273698.748100.89
45min1172370-17237098.53998.182.11101.28100.902.08
2176892-176892101.124103.87
3168550-16855096.35599.07
4174412-17441299.707102.46
5167216-16721695.59398.25
6171009-17100997.761100.45
60min1173222-17322299.02697.621.75102.31100.881.74
2173231-17323199.031102.34
3168357-16835796.24599.50
4173780-17378099.345102.66
5166927-16692795.42898.61
6169075-16907596.65599.89
极限1170583-17058397.51896.451.57101.36100.261.56
2171915-17191598.279102.14
3166966-16696695.45099.24
4169577-16957796.942100.81
5164570-16457094.08097.80
6168698-16869896.440100.21
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DJ333-221017对照品来源自制对照品使用方法直接使用
对照品含量(%)99.67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%
110.021709351709301705971703991707150.16
210.031690051696691693370.28
单位质量响应值RSD%判断
17037.4316883.050.65数据可信
供试品溶液-2024011223批-依折麦布-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min168540-6854036.25235.7935.4636.2535.7935.46
238137-3813720.17120.17
354840-5484029.00629.01
471291-7129137.70737.71
563001-6300133.32233.32
6110146-11014658.25858.26
10min1152856-15285680.84775.2918.6181.0575.4918.65
293385-9338549.39349.50
3138464-13846473.23573.40
4149604-14960479.12779.34
5147293-14729377.90578.09
6172483-17248391.22891.55
15min1168633-16863389.19291.134.0289.8491.754.14
2164109-16410986.79987.19
3170882-17088290.38290.95
4174166-17416692.11992.77
5171360-17136090.63491.25
6184652-18465297.66598.50
20min1185694-18569498.21696.211.8599.3697.331.92
2181121-18112195.79796.67
3179999-17999995.20496.27
4182358-18235896.45197.61
5176840-17684093.53394.65
6185374-18537498.04799.42
30min1183878-18387897.25597.921.8698.9599.571.89
2186547-18654798.667100.07
3182811-18281196.69198.29
4180499-18049995.46897.16
5186801-18680198.801100.44
6190223-190223100.611102.53
45min1189628-189628100.29799.921.14102.53102.121.08
2188948-18894899.937101.89
3192628-192628101.883104.02
4186287-18628798.530100.76
5187950-18795099.409101.60
6188061-18806199.468101.94
60min1180280-18028095.35297.692.2598.14100.452.20
2186474-18647498.628101.13
3188205-18820599.544102.25
4187310-18731099.071101.85
5178589-17858994.45897.20
6187330-18733099.081102.11
极限1183237-18323796.91698.500.93100.24101.800.94
2186856-18685698.831101.88
3187143-18714398.982102.24
4185252-18525297.982101.31
5186890-18689098.849102.12
6188054-18805499.464103.04
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%
111.171616481610501611561606671611300.26
211.111597541599361598450.09
单位质量响应值RSD%判断
14425.2514387.490.19数据可信
供试品溶液-2024011223批-阿托伐他汀钙-pH4.5(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1162863-16286393.37986.854.0693.3886.854.06
2145609-14560983.48683.49
3152944-15294487.69287.69
4149444-14944485.68585.69
5147226-14722684.41384.41
6150782-15078286.45286.45
10min1171555-17155598.36396.244.2598.8896.724.24
2154299-15429988.46988.93
3173525-17352599.49299.98
4166139-16613995.25795.73
5169554-16955497.21597.68
6172084-17208498.66699.15
15min1163288-16328893.62396.792.4294.6997.812.40
2166348-16634895.37796.33
3174293-17429399.932100.97
4168318-16831896.50797.51
5167883-16788396.25797.27
6172747-17274799.046100.07
20min1172559-17255998.93897.541.47100.5299.101.45
2171953-17195398.591100.08
3171237-17123798.18099.78
4169314-16931497.07898.62
5165679-16567994.99396.54
6169978-16997897.45899.04
30min1166086-16608695.22796.081.8297.3698.171.77
2169317-16931797.07999.11
3166706-16670695.58297.72
4162659-16265993.26295.34
5169632-16963297.26099.33
6171002-17100298.045100.17
45min1169356-16935697.10297.101.3799.7799.731.36
2170071-17007197.512100.08
3173200-17320099.306101.98
4166099-16609995.23497.83
5168538-16853896.63399.24
6168818-16881896.79399.46
60min1161354-16135492.51494.642.2295.7297.812.15
2166228-16622895.30898.42
3168890-16889096.835100.06
4166944-16694495.71998.85
5159709-15970991.57194.72
6167209-16720995.87199.07
极限1163480-16348093.73395.391.0997.4599.081.06
2166555-16655595.49699.14
3167685-16768596.14499.90
4164948-16494894.57498.23
5167562-16756296.07399.73
6167990-16799096.319100.05
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