沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.562894632897792898782894442896592896450.07
228.562898342905272901800.17
单位质量响应值RSD%判断
10141.6310160.360.14数据可信
影响因素30天-供试品溶液-2024032721批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1148661-148661102.27780.3523.69102.2880.3523.69
284167-8416757.90657.91
393901-9390164.60364.60
4144406-14440699.35099.35
5129827-12982789.32089.32
699768-9976868.63968.64
10min1241749-241749166.321149.2810.13166.49149.4110.14
2189035-189035130.054130.15
3193317-193317133.000133.11
4237705-237705163.539163.70
5217875-217875149.896150.04
6222164-222164152.847152.96
15min1310840-310840213.855198.655.93214.30199.035.95
2262965-262965180.917181.23
3277032-277032190.595190.92
4296074-296074203.696204.13
5299439-299439206.011206.41
6286086-286086196.824197.19
20min1324042-324042222.938222.241.41223.74222.961.43
2315100-315100216.786217.40
3324656-324656223.360224.01
4328662-328662226.116226.89
5324416-324416223.195223.94
6321305-321305221.055221.75
30min1323867-323867222.817223.830.77223.99224.910.77
2322837-322837222.109223.08
3327596-327596225.383226.40
4329171-329171226.466227.62
5324561-324561223.295224.41
6324011-324011222.916223.98
45min1323094-323094222.285223.670.79223.83225.120.79
2324066-324066222.954224.30
3327711-327711225.462226.86
4328972-328972226.329227.86
5323636-323636222.658224.14
6323126-323126222.307223.74
60min1322148-322148221.635223.240.83223.55225.070.83
2323019-323019222.234223.95
3326880-326880224.890226.66
4328762-328762226.185228.09
5323233-323233222.381224.24
6322888-322888222.144223.95
极限1321718-321718221.339222.630.76223.63224.830.76
2322354-322354221.776223.86
3326034-326034224.308226.45
4327341-327341225.207227.49
5321884-321884221.453223.68
6322201-322201221.671223.85
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.565031575037355031215030125032825032610.06
228.565032605042605037600.15
单位质量响应值RSD%判断
17621.1817638.660.08数据可信
影响因素30天-供试品溶液-2024032721批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1256023-25602395.81775.3324.5895.8275.3324.58
2143911-14391153.85953.86
3160484-16048460.06260.06
4254854-25485495.38095.38
5222260-22226083.18283.18
6170087-17008763.65663.66
10min1417489-417489156.247139.7410.54156.41139.8610.55
2322102-322102120.548120.64
3332314-332314124.370124.47
4410431-410431153.605153.76
5374326-374326140.093140.23
6383571-383571143.553143.66
15min1538592-538592201.570186.576.31201.99186.936.32
2449825-449825168.349168.64
3478889-478889179.226179.53
4511737-511737191.519191.93
5517955-517955193.846194.22
6494100-494100184.919185.26
20min1562000-562000210.330209.031.75211.09209.701.77
2540497-540497202.283202.85
3562521-562521210.525211.13
4568810-568810212.879213.61
5561475-561475210.134210.83
6555787-555787208.005208.66
30min1561925-561925210.302210.730.94211.41211.740.95
2555442-555442207.876208.78
3567604-567604212.428213.38
4570267-570267213.424214.51
5562283-562283210.436211.48
6560847-560847209.899210.90
45min1559203-559203209.284210.231.04210.74211.591.05
2554060-554060207.359208.61
3567871-567871212.528213.84
4569317-569317213.069214.51
5560641-560641209.822211.22
6559223-559223209.291210.64
60min1558221-558221208.916210.011.01210.72211.741.01
2554024-554024207.345208.95
3566731-566731212.101213.77
4568968-568968212.938214.74
5559974-559974209.572211.32
6558999-558999209.207210.91
极限1557378-557378208.601209.660.88210.75211.730.88
2555535-555535207.911209.86
3565402-565402211.604213.62
4567314-567314212.319214.47
5557589-557589208.680210.77
6558037-558037208.847210.89
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.562898942900802901832904212899332901020.08
228.562909122906622907870.07
单位质量响应值RSD%判断
10157.6310181.620.17数据可信
影响因素30天-供试品溶液-2024032721批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1107959-10795974.13979.2518.5474.1479.2518.54
2138259-13825994.94794.95
399854-9985468.57368.57
4141467-14146797.15097.15
587398-8739860.01960.02
6117434-11743480.64580.65
10min1216229-216229148.491148.4016.34148.61148.5316.34
2241907-241907166.125166.28
3196891-196891135.211135.33
4264541-264541181.668181.83
5162798-162798111.798111.90
6214198-214198147.096147.23
15min1285232-285232195.877194.5911.78196.25194.9711.79
2310125-310125212.972213.41
3278190-278190191.042191.38
4318376-318376218.638219.10
5223446-223446153.447153.73
6284768-284768195.559195.94
20min1340618-340618233.913218.699.00234.61219.399.01
2325477-325477223.515224.30
3323170-323170221.931222.59
4336741-336741231.250232.08
5261990-261990179.916180.46
6322708-322708221.613222.32
30min1318718-318718218.873222.324.21219.96223.394.24
2328745-328745225.759226.92
3329501-329501226.278227.31
4337619-337619231.853233.07
5298813-298813205.204206.05
6329010-329010225.941227.02
45min1318770-318770218.909223.362.41220.36224.802.44
2322262-322262221.307222.85
3329236-329236226.096227.50
4336894-336894231.355232.96
5315667-315667216.778217.96
6328662-328662225.702227.15
60min1318610-318610218.799223.942.01220.62225.752.03
2321898-321898221.057222.96
3328828-328828225.816227.60
4336610-336610231.160233.15
5322031-322031221.148222.69
6328591-328591225.653227.48
极限1317519-317519218.050225.532.14220.23227.722.11
2326204-326204224.014226.29
3327198-327198224.697226.86
4334878-334878229.971232.34
5337298-337298231.633233.55
6327367-327367224.813227.02
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.565036985034075039785038055034195036610.05
228.565053835054485054160.01
单位质量响应值RSD%判断
17635.1917696.640.25数据可信
影响因素30天-供试品溶液-2024032721批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1184296-18429668.83373.8719.0568.8373.8719.05
2238075-23807588.91988.92
3170152-17015263.55063.55
4243599-24359990.98290.98
5148710-14871055.54255.54
6201847-20184775.38875.39
10min1372562-372562139.149139.1016.70139.26139.2216.70
2417800-417800156.045156.19
3338798-338798126.538126.64
4457803-457803170.986171.14
5278362-278362103.966104.06
6369285-369285137.925138.05
15min1493174-493174184.197182.8612.01184.54183.2212.02
2536769-536769200.479200.89
3480708-480708179.541179.86
4551014-551014205.799206.24
5383873-383873143.373143.64
6492113-492113183.800184.16
20min1579601-579601216.476205.068.98217.13205.729.00
2563238-563238210.365211.11
3559238-559238208.871209.49
4583194-583194217.818218.60
5450735-450735168.346168.85
6558186-558186208.478209.14
30min1551895-551895206.128209.164.43207.14210.164.47
2570177-570177212.957214.05
3571229-571229213.349214.31
4584521-584521218.314219.46
5514041-514041191.990192.78
6568231-568231212.230213.24
45min1552424-552424206.326210.212.51207.68211.562.55
2558036-558036208.422209.87
3570056-570056212.911214.23
4583745-583745218.024219.53
5544255-544255203.275204.38
6568484-568484212.324213.69
60min1551606-551606206.020210.772.10207.72212.472.12
2557703-557703208.298210.09
3569567-569567212.729214.40
4583058-583058217.767219.64
5554771-554771207.202208.65
6569255-569255212.612214.33
极限1549649-549649205.289212.032.04207.33214.082.01
2562747-562747210.181212.32
3566549-566549211.601213.63
4579818-579818216.557218.79
5580669-580669216.875218.66
6566817-566817211.702213.77
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.562903402904382903162904852906432904440.05
228.562916062913042914550.08
单位质量响应值RSD%判断
10169.6110205.010.25数据可信
影响因素30天-供试品溶液-2024032721批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1113404-11340477.74385.7213.6977.7485.7213.69
2140819-14081996.53796.54
3126542-12654286.75086.75
4116082-11608279.57979.58
5104441-10444171.59871.60
6148972-148972102.126102.13
10min1231946-231946159.008153.777.95159.14153.927.94
2230724-230724158.170158.33
3231318-231318158.578158.72
4189170-189170129.684129.82
5238563-238563163.544163.66
6224150-224150153.664153.83
15min1297692-297692204.080189.226.30204.47189.626.30
2284606-284606195.109195.53
3278295-278295190.782191.19
4245362-245362168.205168.55
5278139-278139190.675191.07
6271987-271987186.458186.88
20min1310745-310745213.028204.673.54213.76205.383.54
2302304-302304207.241207.99
3300049-300049205.695206.42
4278864-278864191.172191.80
5300252-300252205.835206.54
6299097-299097205.043205.78
30min1322813-322813221.301221.981.02222.39223.041.03
2322928-322928221.380222.47
3326022-326022223.501224.57
4322628-322628221.174222.12
5319442-319442218.990220.04
6329032-329032225.564226.64
45min1322336-322336220.974222.971.19222.43224.401.19
2324147-324147222.216223.68
3330000-330000226.228227.67
4321851-321851220.642221.96
5322938-322938221.387222.80
6330247-330247226.397227.85
60min1322448-322448221.051223.001.39222.88224.801.39
2323729-323729221.929223.76
3332029-332029227.619229.44
4321551-321551220.436222.12
5322115-322115220.823222.61
6329871-329871226.140227.97
极限1321164-321164220.171222.311.05222.37224.481.05
2322901-322901221.361223.57
3328573-328573225.250227.45
4322688-322688221.215223.27
5321828-321828220.626222.78
6328573-328573225.250227.46
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.565042915042105044495044195045925043920.03
228.565056695055175055930.03
单位质量响应值RSD%判断
17660.7817702.840.17数据可信
影响因素30天-供试品溶液-2024032721批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1194684-19468472.64780.0514.0472.6580.0414.04
2241504-24150490.11990.12
3217455-21745581.14581.14
4198211-19821173.96473.96
5178133-17813366.47166.47
6257072-25707295.92895.93
10min1400357-400357149.395143.327.69149.52143.457.68
2395968-395968147.758147.91
3398586-398586148.735148.87
4324699-324699121.163121.29
5398319-398319148.635148.75
6386456-386456144.208144.37
15min1514212-514212191.881177.496.42192.25177.866.42
2488997-488997182.472182.87
3479950-479950179.096179.48
4421699-421699157.359157.68
5479891-479891179.074179.43
6469106-469106175.050175.45
20min1536900-536900200.347192.063.61201.04192.733.62
2518488-518488193.477194.18
3518062-518062193.318194.00
4480247-480247179.207179.79
5518108-518108193.335193.99
6516342-516342192.676193.37
30min1558401-558401208.370208.791.10209.39209.781.11
2557587-557587208.067209.09
3562878-562878210.041211.04
4556710-556710207.739208.63
5551772-551772205.897206.88
6569754-569754212.607213.62
45min1557882-557882208.177209.991.18209.55211.321.18
2560330-560330209.090210.46
3570909-570909213.038214.39
4557543-557543208.050209.28
5558308-558308208.336209.66
6571402-571402213.222214.59
60min1557701-557701208.109210.181.41209.83211.861.41
2559835-559835208.906210.62
3575324-575324214.685216.39
4557124-557124207.894209.47
5558301-558301208.333210.00
6571147-571147213.127214.85
极限1555167-555167207.164209.311.16209.23211.341.16
2558490-558490208.404210.47
3569057-569057212.347214.41
4556006-556006207.477209.40
5557557-557557208.055210.07
6569240-569240212.415214.49
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.562905412903662903922901862903132903600.05
228.562909352909212909280.01
单位质量响应值RSD%判断
10166.6710186.550.14数据可信
影响因素30天-供试品溶液-2024032721批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1111443-11144376.47972.2915.0576.4872.2915.05
2119127-11912781.75281.75
387650-8765060.15160.15
488822-8882260.95560.95
5125552-12555286.16186.16
699446-9944668.24668.25
10min1191077-191077131.128135.796.44131.26135.916.45
2212363-212363145.736145.87
3187243-187243128.497128.60
4184410-184410126.553126.65
5214022-214022146.874147.02
6198118-198118135.960136.07
15min1242817-242817166.635180.645.28166.98180.995.28
2275171-275171188.838189.22
3261939-261939179.758180.07
4253862-253862174.215174.53
5280961-280961192.812193.20
6264608-264608181.590181.93
20min1277257-277257190.270207.385.07190.89208.025.06
2306069-306069210.042210.74
3315883-315883216.777217.39
4294386-294386202.025202.63
5318975-318975218.899219.61
6300526-300526206.239206.88
30min1305201-305201209.447219.112.34210.39220.102.34
2322375-322375221.233222.28
3327357-327357224.652225.63
4319345-319345219.153220.09
5320788-320788220.144221.22
6320617-320617220.026221.01
45min1317435-317435217.843221.371.18219.13222.721.18
2323956-323956222.318223.73
3328885-328885225.700227.05
4321935-321935220.931222.24
5320680-320680220.069221.51
6322527-322527221.337222.69
60min1320485-320485219.936221.690.95221.59223.420.94
2324192-324192222.480224.26
3328350-328350225.333227.06
4322105-322105221.047222.72
5319983-319983219.591221.40
6323147-323147221.762223.48
极限1320875-320875220.203222.201.06222.22224.291.05
2323152-323152221.766223.92
3328442-328442225.396227.50
4327182-327182224.531226.57
5319748-319748219.430221.60
6323293-323293221.863223.95
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.565039705038875038735034715037655037930.04
228.565041065048025044540.10
单位质量响应值RSD%判断
17639.8117662.960.10数据可信
影响因素30天-供试品溶液-2024032721批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1191237-19123771.48467.4215.5871.4867.4215.58
2205223-20522376.71276.71
3148916-14891655.66555.66
4151375-15137556.58456.58
5215875-21587580.69480.69
6169554-16955463.37963.38
10min1326913-326913122.200127.146.59122.32127.266.59
2365091-365091136.470136.60
3321690-321690120.247120.34
4317288-317288118.602118.70
5369218-369218138.013138.15
6340614-340614127.321127.43
15min1417490-417490156.057169.645.42156.38169.975.43
2474952-474952177.536177.89
3451404-451404168.734169.03
4437871-437871163.675163.97
5485331-485331181.416181.78
6455988-455988170.448170.77
20min1477285-477285178.408195.005.22178.99195.615.21
2528465-528465197.539198.19
3546245-546245204.186204.76
4508292-508292189.999190.56
5551428-551428206.123206.79
6518377-518377193.769194.37
30min1526531-526531196.816206.152.40197.70207.082.40
2557067-557067208.231209.21
3565671-565671211.447212.36
4551226-551226206.047206.93
5554741-554741207.361208.37
6553813-553813207.014207.94
45min1548633-548633205.078208.611.26206.29209.881.26
2560855-560855209.647210.97
3569786-569786212.985214.25
4556047-556047207.849209.07
5555925-555925207.804209.16
6557196-557196208.279209.55
60min1554414-554414207.239208.960.97208.79210.580.97
2560980-560980209.693211.37
3568841-568841212.632214.25
4557018-557018208.212209.78
5554571-554571207.298209.00
6558233-558233208.667210.28
极限1555700-555700207.720209.661.06209.62211.641.04
2560120-560120209.372211.40
3568520-568520212.512214.49
4567243-567243212.035213.95
5554075-554075207.112209.16
6559758-559758209.237211.20
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.562906492904812905222904712904652905180.03
228.562913382913982913680.02
单位质量响应值RSD%判断
10172.2010201.960.21数据可信
影响因素30天-供试品溶液-2024032721批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1119734-11973482.08479.7310.4082.0879.7310.40
2112773-11277377.31277.31
3111195-11119576.23076.23
4134790-13479092.40692.41
5120820-12082082.82982.83
698458-9845867.49867.50
10min1200021-200021137.125147.725.64137.26147.865.64
2210916-210916144.594144.72
3230287-230287157.874158.00
4229860-229860157.581157.74
5213126-213126146.109146.25
6208681-208681143.062143.17
15min1253325-253325173.668188.376.03174.03188.746.02
2268632-268632184.162184.53
3292501-292501200.525200.92
4289946-289946198.774199.19
5259588-259588177.962178.34
6284606-284606195.113195.46
20min1287880-287880197.357208.705.01198.01209.405.00
2288793-288793197.983198.66
3326013-326013223.500224.22
4308711-308711211.638212.39
5299322-299322205.201205.88
6315875-315875216.549217.23
30min1323604-323604221.848222.290.87222.83223.330.88
2322976-322976221.418222.42
3327707-327707224.661225.76
4327204-327204224.316225.42
5323750-323750221.948222.97
6320237-320237219.540220.58
45min1326481-326481223.820224.781.72225.17226.191.71
2332401-332401227.879229.25
3326929-326929224.128225.60
4326914-326914224.117225.59
5335466-335466229.980231.37
6319110-319110218.767220.17
60min1325437-325437223.105223.571.94224.83225.361.92
2337784-337784231.569233.32
3325915-325915223.432225.28
4325860-325860223.395225.24
5322622-322622221.175222.95
6319081-319081218.747220.51
极限1325654-325654223.253222.681.31225.35224.841.30
2331016-331016226.929229.07
3325592-325592223.211225.43
4325301-325301223.011225.23
5323527-323527221.795223.94
6317824-317824217.886220.02
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.565040885039675041565037755043785040730.05
228.565057035054335055680.04
单位质量响应值RSD%判断
17649.6117701.960.21数据可信
影响因素30天-供试品溶液-2024032721批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1204917-20491776.49274.3210.6376.4974.3210.64
2192482-19248271.85071.85
3190684-19068471.17971.18
4232063-23206386.62586.63
5206209-20620976.97476.97
6168215-16821562.79262.79
10min1343749-343749128.316138.425.84128.44138.545.84
2360957-360957134.739134.86
3397009-397009148.197148.32
4396843-396843148.135148.28
5366760-366760136.905137.03
6359529-359529134.206134.31
15min1436155-436155162.809176.466.35163.15176.826.34
2455103-455103169.882170.23
3505132-505132188.557188.92
4500657-500657186.887187.28
5447325-447325166.979167.34
6492023-492023183.664183.99
20min1495584-495584184.993196.195.22185.61196.845.22
2496960-496960185.507186.13
3564286-564286210.638211.32
4533012-533012198.964199.67
5517441-517441193.152193.79
6546173-546173203.877204.51
30min1559317-559317208.784209.161.02209.70210.141.03
2554097-554097206.835207.77
3567266-567266211.751212.78
4566684-566684211.533212.57
5560035-560035209.052210.01
6554596-554596207.021208.00
45min1565290-565290211.013211.291.44212.28212.611.43
2568825-568825212.333213.61
3566029-566029211.289212.67
4566254-566254211.373212.76
5577528-577528215.581216.89
6552220-552220206.134207.45
60min1563114-563114210.201210.761.88211.82212.441.86
2584165-584165218.059219.69
3564786-564786210.825212.56
4564304-564304210.645212.38
5558558-558558208.500210.16
6552782-552782206.344208.01
极限1563546-563546210.362209.861.25212.33211.891.24
2571983-571983213.512215.51
3563870-563870210.483212.57
4563113-563113210.200212.29
5560399-560399209.187211.20
6550305-550305205.419207.43
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.562916362918202918552918192916872917630.04
228.562918522915982917250.07
单位质量响应值RSD%判断
10215.7910214.460.01数据可信
影响因素30天-供试品溶液-2024032721批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1119298-11929881.56178.6219.2681.5678.6219.26
2137379-13737993.92293.92
3124475-12447585.10085.10
4123962-12396284.74984.75
573170-7317050.02450.02
6111676-11167676.35076.35
10min1203527-203527139.145138.5013.87139.28138.6313.88
2214525-214525146.664146.82
3237083-237083162.087162.23
4202132-202132138.192138.33
5151622-151622103.659103.74
6206633-206633141.269141.40
15min1264172-264172180.607173.558.56180.97173.928.58
2259650-259650177.515177.92
3281417-281417192.397192.81
4249848-249848170.814171.19
5215889-215889147.597147.85
6252159-252159172.394172.76
20min1311449-311449212.928195.576.58213.60196.236.59
2286510-286510195.878196.58
3301236-301236205.946206.68
4279436-279436191.042191.70
5257468-257468176.023176.53
6280278-280278191.618192.27
30min1322375-322375220.398213.383.49221.42214.363.52
2318920-318920218.036219.06
3322000-322000220.142221.22
4304350-304350208.075209.05
5295500-295500202.025202.82
6309517-309517211.608212.58
45min1324520-324520221.865220.791.40223.26222.121.43
2327518-327518223.914225.30
3327272-327272223.746225.19
4318198-318198217.543218.86
5316884-316884216.644217.78
6323281-323281221.018222.34
60min1323794-323794221.368221.660.79223.13223.360.80
2328407-328407224.522226.28
3324373-324373221.764223.58
4320907-320907219.395221.08
5322646-322646220.584222.08
6325168-325168222.308224.00
极限1325833-325833222.762222.801.00224.89224.871.00
2328190-328190224.374226.51
3323682-323682221.292223.48
4321979-321979220.128222.18
5324706-324706221.992223.85
6330960-330960226.268228.33
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920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(%)99.85对照品水分(%)5.54对照品稀释倍数125
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.565061665058705061895057275052305058360.08
228.565061755060395061070.02
单位质量响应值RSD%判断
17711.3417720.830.04数据可信
影响因素30天-供试品溶液-2024032721批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1204400-20440076.12573.3119.8776.1373.3119.87
2235796-23579687.81887.82
3213377-21337779.46979.47
4213789-21378979.62279.62
5122872-12287245.76245.76
6190743-19074371.03971.04
10min1349386-349386130.123129.6714.15130.25129.7914.15
2368494-368494137.239137.39
3408791-408791152.247152.38
4347919-347919129.577129.71
5258827-25882796.39696.47
6355594-355594132.435132.55
15min1455386-455386169.601162.788.67169.94163.128.69
2446792-446792166.400166.78
3485133-485133180.680181.07
4430281-430281160.251160.60
5370907-370907138.138138.37
6433882-433882161.592161.93
20min1537597-537597200.219183.506.71200.85184.116.72
2492907-492907183.575184.23
3519562-519562193.502194.19
4481083-481083179.171179.79
5442978-442978164.980165.45
6482041-482041179.528180.14
30min1556119-556119207.117200.523.61208.08201.433.63
2550381-550381204.980205.94
3556702-556702207.334208.34
4524719-524719195.423196.34
5508720-508720189.464190.21
6533747-533747198.785199.69
45min1560528-560528208.759207.841.55210.06209.091.59
2565878-565878210.752212.05
3567993-567993211.539212.89
4549285-549285204.572205.81
5546609-546609203.575204.63
6558073-558073207.845209.08
60min1560099-560099208.599208.710.83210.25210.300.85
2567921-567921211.513213.16
3560849-560849208.879210.59
4554276-554276206.431208.01
5557155-557155207.503208.90
6562003-562003209.308210.89
极限1562419-562419209.463209.920.93211.46211.860.93
2567607-567607211.396213.40
3560384-560384208.706210.76
4557144-557144207.499209.42
5562597-562597209.530211.27
6571772-571772212.947214.88
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