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%
110.021724311712921714241714841714101716080.28
210.031690981693021692000.09
单位质量响应值RSD%判断
17126.5516869.391.07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%
5min181676-8167643.10535.6114.3743.1135.6114.36
267082-6708235.40335.40
375457-7545739.82339.82
463754-6375433.64733.65
561992-6199232.71732.72
654828-5482828.93628.94
10min1163135-16313586.09682.094.2686.3482.294.28
2156531-15653182.61082.81
3160176-16017684.53484.76
4157476-15747683.10983.30
5151233-15123379.81480.00
6144737-14473776.38676.55
15min1181913-18191396.00695.452.2296.7296.102.23
2187869-18786999.14999.80
3180532-18053295.27795.97
4180863-18086395.45296.10
5177025-17702593.42694.05
6176949-17694993.38693.97
20min1186437-18643798.39499.121.3199.64100.301.30
2192714-192714101.706102.91
3187405-18740598.904100.12
4187392-18739298.898100.08
5186525-18652598.44099.58
6186434-18643498.39299.50
30min1191214-191214100.915101.370.72102.71103.100.68
2191604-191604101.121102.89
3191476-191476101.053102.82
4193339-193339102.036103.76
5190653-190653100.619102.31
6194198-194198102.490104.14
45min1191064-191064100.836101.561.19103.19103.861.14
2195522-195522103.188105.52
3189838-189838100.189102.52
4191922-191922101.288103.58
5191340-191340100.981103.23
6194920-194920102.871105.09
60min1191918-191918101.286101.390.89104.20104.250.86
2194381-194381102.586105.49
3189625-189625100.076102.96
4191127-191127100.869103.73
5192055-192055101.359104.17
6193617-193617102.183104.97
极限1189969-189969100.258100.401.45103.74103.821.39
2192821-192821101.763105.24
3187945-18794599.189102.63
4186772-18677298.570101.99
5189961-189961100.253103.63
6193934-193934102.350105.71
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%
111.171621851620611618511616671619861619500.13
211.111600161599291599720.04
单位质量响应值RSD%判断
14498.6614398.920.49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%
5min1164253-16425393.90092.312.3393.9092.312.33
2161560-16156092.36192.36
3166369-16636995.11095.11
4162341-16234192.80792.81
5157360-15736089.96089.96
6156902-15690289.69889.70
10min1177102-177102101.24699.311.70101.7799.831.70
2175154-175154100.132100.65
3173295-17329599.06999.60
4176076-176076100.659101.17
5169486-16948696.89297.39
6171210-17121097.87898.38
15min1175598-175598100.38699.872.05101.47100.942.04
2179932-179932102.864103.93
3172035-17203598.34999.43
4177073-177073101.229102.30
5170071-17007197.22698.26
6173500-17350099.187100.23
20min1172533-17253398.63499.191.54100.28100.811.53
2177599-177599101.530103.17
3172006-17200698.33399.96
4175739-175739100.467102.10
5170373-17037397.39998.98
6172801-17280198.787100.38
30min1173269-17326999.05598.541.63101.24100.711.62
2171721-17172198.170100.37
3171292-17129297.924100.10
4176866-176866101.111103.31
5168292-16829296.20998.33
6172736-17273698.750100.89
45min1172370-17237098.54198.182.11101.28100.902.09
2176892-176892101.126103.88
3168550-16855096.35799.07
4174412-17441299.708102.47
5167216-16721695.59498.25
6171009-17100997.763100.45
60min1173222-17322299.02897.621.75102.32100.891.75
2173231-17323199.033102.35
3168357-16835796.24799.50
4173780-17378099.347102.66
5166927-16692795.42998.61
6169075-16907596.65799.89
极限1170583-17058397.51996.451.57101.36100.261.56
2171915-17191598.281102.14
3166966-16696695.45199.24
4169577-16957796.944100.81
5164570-16457094.08297.80
6168698-16869896.441100.21
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%
110.021709621709351709301705971703991707650.15
210.031690051696691693370.28
单位质量响应值RSD%判断
17042.4216883.050.67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%
5min168540-6854036.24635.7835.4636.2535.7835.46
238137-3813720.16820.17
354840-5484029.00129.00
471291-7129137.70137.70
563001-6300133.31733.32
6110146-11014658.24958.25
10min1152856-15285680.83675.2818.6181.0475.4818.64
293385-9338549.38549.50
3138464-13846473.22573.39
4149604-14960479.11679.33
5147293-14729377.89478.08
6172483-17248391.21591.54
15min1168633-16863389.17991.124.0289.8391.744.14
2164109-16410986.78787.17
3170882-17088290.36890.94
4174166-17416692.10592.75
5171360-17136090.62191.24
6184652-18465297.65198.48
20min1185694-18569498.20296.191.8599.3597.321.92
2181121-18112195.78396.65
3179999-17999995.19096.26
4182358-18235896.43797.60
5176840-17684093.51994.64
6185374-18537498.03299.41
30min1183878-18387897.24197.901.8698.9399.561.89
2186547-18654798.653100.05
3182811-18281196.67798.28
4180499-18049995.45497.15
5186801-18680198.787100.43
6190223-190223100.597102.51
45min1189628-189628100.28299.911.14102.51102.101.08
2188948-18894899.922101.87
3192628-192628101.869104.00
4186287-18628798.515100.74
5187950-18795099.395101.58
6188061-18806199.453101.93
60min1180280-18028095.33897.672.2598.13100.432.20
2186474-18647498.614101.12
3188205-18820599.530102.23
4187310-18731099.056101.83
5178589-17858994.44497.19
6187330-18733099.067102.10
极限1183237-18323796.90298.490.93100.22101.790.94
2186856-18685698.816101.87
3187143-18714398.968102.22
4185252-18525297.968101.29
5186890-18689098.834102.10
6188054-18805499.450103.03
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%
111.171619811616481610501611561606671613000.33
211.111597541599361598450.09
单位质量响应值RSD%判断
14440.4714387.490.26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%
5min1162863-16286393.33086.814.0693.3386.814.06
2145609-14560983.44283.44
3152944-15294487.64687.65
4149444-14944485.64085.64
5147226-14722684.36984.37
6150782-15078286.40786.41
10min1171555-17155598.31196.194.2598.8396.684.23
2154299-15429988.42288.89
3173525-17352599.44099.93
4166139-16613995.20795.68
5169554-16955497.16497.63
6172084-17208498.61499.09
15min1163288-16328893.57396.742.4294.6497.762.40
2166348-16634895.32796.28
3174293-17429399.880100.92
4168318-16831896.45697.46
5167883-16788396.20797.22
6172747-17274798.994100.02
20min1172559-17255998.88697.491.47100.4799.041.45
2171953-17195398.539100.02
3171237-17123798.12999.72
4169314-16931497.02798.57
5165679-16567994.94396.49
6169978-16997897.40798.98
30min1166086-16608695.17796.031.8297.3198.121.77
2169317-16931797.02899.06
3166706-16670695.53297.67
4162659-16265993.21395.29
5169632-16963297.20999.28
6171002-17100297.994100.11
45min1169356-16935697.05197.051.3799.7199.671.36
2170071-17007197.460100.03
3173200-17320099.253101.92
4166099-16609995.18497.78
5168538-16853896.58299.19
6168818-16881896.74299.41
60min1161354-16135492.46594.592.2295.6797.762.15
2166228-16622895.25898.37
3168890-16889096.784100.01
4166944-16694495.66898.79
5159709-15970991.52294.67
6167209-16720995.82099.02
极限1163480-16348093.68395.341.0997.4099.031.06
2166555-16655595.44599.09
3167685-16768596.09399.85
4164948-16494894.52598.18
5167562-16756296.02399.68
6167990-16799096.268100.00
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