氢溴酸替格列汀片项目信息
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MAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)94.94对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.77 2250122247982250092250662252142250200.07
214.712243782234102238940.31
单位质量响应值RSD%判断
15234.9415220.530.07数据可信
高温10天-供试品溶液-G246批-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%
5min176757-7675729.21929.2714.0429.2229.2714.04
278737-7873729.97229.97
374882-7488228.50528.50
457494-5749421.88621.89
588325-8832533.62233.62
685143-8514332.41132.41
10min1184665-18466570.29561.5810.9170.3461.6210.91
2157912-15791260.11160.16
3169019-16901964.34064.39
4131464-13146450.04450.08
5168171-16817164.01764.07
6159325-15932560.64960.70
15min1220859-22085984.07383.515.5984.2483.665.60
2218149-21814983.04283.19
3233660-23366088.94689.10
4197101-19710175.02975.15
5226132-22613286.08086.24
6220398-22039883.89884.05
20min1257738-25773898.11297.473.1198.4297.763.12
2256087-25608797.48397.77
3265914-265914101.224101.53
4242066-24206692.14692.39
5260237-26023799.06399.37
6254340-25434096.81897.11
30min1267164-267164101.700101.560.58102.17102.020.59
2267528-267528101.838102.29
3266618-266618101.492101.96
4265295-265295100.988101.39
5269166-269166102.462102.93
6265064-265064100.900101.36
45min1267244-267244101.730101.550.57102.37102.180.57
2266759-266759101.546102.17
3266351-266351101.390102.03
4266327-266327101.381101.95
5269294-269294102.511103.15
6264716-264716100.768101.39
60min1266329-266329101.382101.400.61102.19102.190.61
2267193-267193101.711102.50
3265244-265244100.969101.78
4265955-265955101.240101.98
5269071-269071102.426103.24
6264478-264478100.677101.47
极限1266030-266030101.268101.180.69102.25102.140.69
2266961-266961101.623102.58
3264105-264105100.535101.51
4265495-265495101.065101.97
5268553-268553102.229103.21
6263609-263609100.347101.31
氢溴酸替格列汀片项目信息
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MAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)94.94对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.77 4509464508184519394518444513954513880.12
214.714504844505704505270.02
单位质量响应值RSD%判断
30561.1430627.260.16数据可信
高温10天-供试品溶液-G031批-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%
5min1140362-14036226.59422.9136.9226.5922.9136.92
2137668-13766826.08426.08
3137616-13761626.07426.07
430183-301835.7195.72
5145980-14598027.65927.66
6133806-13380625.35225.35
10min1306756-30675658.12154.4020.6958.1754.4420.71
2311817-31181759.08059.12
3310340-31034058.80058.84
4166853-16685331.61431.62
5324800-32480061.54061.59
6302021-30202157.22457.27
15min1433814-43381482.19478.0415.3682.3478.1715.38
2436654-43665482.73382.87
3436860-43686082.77282.91
4283916-28391653.79353.86
5452847-45284785.80185.95
6427320-42732080.96481.10
20min1507267-50726796.11292.9110.0196.3993.1710.04
2513017-51301797.20197.48
3514970-51497097.57197.85
4390610-39061074.00974.16
5512767-51276797.15497.45
6503623-50362395.42195.69
30min1535912-535912101.539100.921.49101.98101.331.55
2529913-529913100.402100.84
3534401-534401101.253101.69
4518781-51878198.29398.57
5542555-542555102.798103.25
6534154-534154101.206101.64
45min1534281-534281101.230101.420.88101.84102.000.89
2530266-530266100.469101.08
3535241-535241101.412102.02
4535363-535363101.435101.87
5544065-544065103.084103.71
6532551-532551100.902101.50
60min1532720-532720100.934101.140.86101.71101.890.87
2528869-528869100.204100.98
3533612-533612101.103101.88
4533250-533250101.035101.64
5542427-542427102.773103.57
6531959-531959100.790101.56
极限1532708-532708100.932100.761.00101.88101.681.00
2524880-52488099.449100.39
3531780-531780100.756101.70
4531842-531842100.768101.54
5540849-540849102.474103.44
6528694-528694100.171101.11
氢溴酸替格列汀片项目信息
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MAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)94.94对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.77 4501194512364504154502344493934502790.15
214.714523834524964524400.02
单位质量响应值RSD%判断
30486.0530757.310.63数据可信
高温10天-供试品溶液-PVC批-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%
5min1176606-17660633.43232.715.3733.4332.715.37
2167670-16767031.74031.74
3185572-18557235.12935.13
4178153-17815333.72533.72
5159123-15912330.12230.12
6169647-16964732.11532.11
10min1331818-33181862.81462.434.6962.8762.484.69
2324577-32457761.44361.50
3350898-35089866.42666.48
4343160-34316064.96165.02
5309262-30926258.54458.59
6319068-31906860.40060.45
15min1445883-44588384.40784.923.8884.5785.083.88
2443427-44342783.94284.10
3470346-47034689.03889.21
4468325-46832588.65588.82
5427086-42708680.84981.00
6436408-43640882.61382.77
20min1518767-51876798.20499.182.7598.5199.492.75
2522262-52226298.86699.16
3540349-540349102.290102.61
4542270-542270102.653102.97
5508045-50804596.17496.46
6511971-51197196.91897.21
30min1543016-543016102.794103.680.96103.26104.150.97
2550466-550466104.205104.66
3552896-552896104.665105.15
4550678-550678104.245104.73
5549812-549812104.081104.52
6539454-539454102.120102.57
45min1541197-541197102.450103.551.17103.09104.191.17
2549657-549657104.052104.69
3553408-553408104.762105.42
4549142-549142103.954104.61
5551541-551541104.408105.02
6537187-537187101.691102.31
60min1540972-540972102.408103.450.98103.21104.260.99
2548680-548680103.867104.67
3550819-550819104.272105.11
4548113-548113103.759104.59
5551591-551591104.418105.21
6538698-538698101.977102.77
极限1540445-540445102.308103.141.07103.29104.121.07
2547568-547568103.656104.64
3550259-550259104.166105.18
4547310-547310103.607104.61
5548283-548283103.792104.76
6535138-535138101.303102.27
氢溴酸替格列汀片项目信息
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MAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)94.94对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.77 4506524503424516244512774518834511560.15
214.714520234520134520180.01
单位质量响应值RSD%判断
30545.4330728.620.43数据可信
高温10天-供试品溶液-PVDC批-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%
5min1174319-17431932.98232.2126.1832.9832.2126.18
2193752-19375236.65936.66
380906-8090615.30815.31
4189304-18930435.81735.82
5184106-18410634.83434.83
6198941-19894137.64137.64
10min1321431-32143160.81762.3719.0060.8762.4319.01
2363948-36394868.86168.92
3207646-20764639.28839.31
4355761-35576167.31267.37
5351106-35110666.43166.49
6378081-37808171.53571.60
15min1436999-43699982.68384.0714.5782.8484.2314.58
2480480-48048090.91091.09
3318092-31809260.18560.28
4469820-46982088.89389.06
5466038-46603888.17788.35
6494499-49449993.56293.74
20min1519178-51917898.23297.7211.6398.5398.0211.65
2554408-554408104.897105.22
3396711-39671175.06075.25
4538577-538577101.902102.22
5537373-537373101.674101.99
6552686-552686104.571104.91
30min1549730-549730104.012103.853.51104.47104.323.56
2567338-567338107.344107.85
3512140-51214096.90097.22
4552772-552772104.588105.08
5550731-550731104.202104.69
6560595-560595106.068106.58
45min1551417-551417104.331105.271.18104.96105.901.16
2566344-566344107.156107.84
3560763-560763106.100106.58
4550475-550475104.153104.82
5550872-550872104.228104.89
6558417-558417105.656106.34
60min1547678-547678103.624104.931.39104.43105.741.36
2565472-565472106.991107.85
3560995-560995106.144106.80
4549089-549089103.891104.73
5547423-547423103.576104.41
6556894-556894105.368106.23
极限1549189-549189103.910104.931.19104.89105.911.18
2563878-563878106.689107.73
3558468-558468105.665106.50
4547563-547563103.602104.61
5549874-549874104.039105.04
6558456-558456105.663106.70
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