阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ301-191212对照品来源中检院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)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.121008561006981007751007681006111007420.10
210.161002521002011002260.04
单位质量响应值RSD%判断
9954.749864.760.65数据可信
供试品溶液-2023111721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%
5min155262-5526250.06443.0611.4450.0643.0611.44
240509-4050936.69936.70
347533-4753343.06243.06
442779-4277938.75538.76
547557-4755743.08443.08
651547-5154746.69946.70
10min186089-8608977.99277.377.0578.2777.617.04
281697-8169774.01374.22
378722-7872271.31871.56
481826-8182674.13074.35
595294-9529486.33186.57
688777-8877780.42780.69
15min195487-9548786.50688.062.7387.2288.732.75
293523-9352384.72785.34
396872-9687287.76188.40
496972-9697287.85188.48
5100827-10082791.34492.06
699531-9953190.17090.88
20min196820-9682087.71490.042.7888.9191.202.78
295731-9573186.72787.81
3101165-10116591.65092.77
498535-9853589.26790.38
5102017-10201792.42293.65
6102068-10206892.46893.68
30min1102281-10228192.66192.042.1694.3493.702.17
297169-9716988.03089.60
3102259-10225992.64194.27
4102509-10250992.86794.48
5102354-10235492.72794.47
6103007-10300793.31995.04
45min1104265-10426594.45894.861.3296.6597.031.33
2102430-10243092.79694.85
3104418-10441894.59796.74
4106352-10635296.34998.48
5105776-10577695.82798.08
6105026-10502695.14897.39
60min1103718-10371893.96393.890.9596.6896.590.98
2102074-10207492.47395.05
3103323-10332393.60596.28
4104683-10468394.83797.50
5104676-10467694.83197.62
6103355-10335593.63496.40
极限1107471-10747197.36397.781.42100.60101.001.33
2110351-11035199.972103.06
3106237-10623796.24599.44
4108325-10832598.136101.33
5106511-10651196.49399.81
6108664-10866498.444101.73
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ301-191212对照品来源中检院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)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.121003631004001003391002791003441003450.05
210.16100107999841000460.09
单位质量响应值RSD%判断
9915.519847.050.49数据可信
供试品溶液-2023111721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%
5min136269-3626932.95238.7915.9632.9538.7915.96
243724-4372439.72539.73
349844-4984445.28645.29
450951-5095146.29146.29
534522-3452231.36531.36
640844-4084437.10937.11
10min176588-7658869.58471.798.0269.7772.018.01
289650-8965081.45181.67
381978-8197874.48174.73
477787-7778770.67370.93
577390-7739070.31270.49
670729-7072964.26164.47
15min1100281-10028191.11086.437.5591.6887.047.51
2102221-10222192.87393.55
394894-9489486.21686.88
488777-8877780.65881.31
5100188-10018891.02691.59
684411-8441176.69177.25
20min1106979-10697997.19590.328.5398.2791.428.47
2104947-10494795.34996.54
3101522-10152292.23893.38
492059-9205983.64084.74
5105030-10503095.42596.50
685956-8595678.09579.08
30min1108088-10808898.20395.632.6699.8297.232.65
2106570-10657096.82498.54
3104840-10484095.25296.91
4100261-10026191.09292.65
5107186-10718697.38498.98
6104622-10462295.05496.48
45min1106640-10664096.88797.381.5199.0599.511.38
2106283-10628396.56398.82
3105169-10516995.55197.74
4108426-10842698.510100.58
5106914-10691497.13699.28
6109687-10968799.656101.61
60min1106351-10635196.62597.480.8699.32100.150.77
2106579-10657996.83299.63
3106484-10648496.74699.46
4107933-10793398.062100.68
5108339-10833998.431101.11
6108084-10808498.199100.70
极限1107747-10774797.89397.670.91101.13100.880.81
2106998-10699897.213100.54
3106874-10687497.100100.35
4108414-10841498.499101.66
5106223-10622396.50999.74
6108756-10875698.810101.86
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ301-191212对照品来源中检院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)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.121004931003991003931004001003651004100.05
210.169967199628996500.04
单位质量响应值RSD%判断
9921.949808.070.82数据可信
供试品溶液-2023111821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%
5min150614-5061446.06241.8120.6146.0641.8120.61
245678-4567841.57041.57
333092-3309230.11630.12
447648-4764843.36343.36
560169-6016954.75854.76
638474-3847435.01435.01
10min178904-7890471.80875.197.0072.0675.427.01
281537-8153774.20474.43
385988-8598878.25578.42
479492-7949272.34372.58
592676-9267684.34184.65
677146-7714670.20870.40
15min192158-9215883.87088.397.4184.5289.047.40
2101217-10121792.11492.76
3101900-10190092.73693.34
488330-8833080.38681.03
5106831-10683197.22398.00
692337-9233784.03384.62
20min1103951-10395194.60293.104.5795.7294.244.58
2105319-10531995.84797.00
3105664-10566496.16197.28
496049-9604987.41188.50
5106176-10617696.62797.94
696640-9664087.94989.00
30min1106644-10664497.05397.171.3598.7098.831.36
2107463-10746397.79899.49
3109081-10908199.271100.92
4104791-10479195.36796.94
5106610-10661097.02298.87
6106058-10605896.52098.06
45min1108485-10848598.72898.451.79100.91100.651.78
2106904-10690497.29099.52
3111451-111451101.428103.63
4105690-10569096.18598.29
5108391-10839198.643101.03
6108159-10815998.432100.51
60min1108191-10819198.46198.011.37101.19100.751.38
2109606-10960699.749102.52
3108653-10865398.881101.65
4107266-10726697.619100.26
5107081-10708197.451100.39
6105352-10535295.87798.50
极限1104996-10499695.55397.261.0298.83100.551.03
2107641-10764197.960101.29
3106648-10664897.057100.37
4106478-10647896.902100.08
5107922-10792298.216101.69
6107568-10756897.894101.05
阿齐沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ301-191212对照品来源中检院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)20供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.1299982100041999939998099911999810.05
210.169928099378993290.07
单位质量响应值RSD%判断
9879.559776.480.75数据可信
供试品溶液-2023111821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%
5min149057-4905744.81347.5523.2044.8147.5523.20
269299-6929963.30463.30
335828-3582832.72832.73
442466-4246638.79238.79
557401-5740152.43552.43
658259-5825953.21953.22
10min177363-7736370.67079.326.6870.9279.596.69
288135-8813580.51080.86
386290-8629078.82579.01
484653-8465377.32977.54
594732-9473286.53686.83
689839-8983982.06782.36
15min189893-8989382.11687.394.3882.7688.094.38
294143-9414385.99886.80
395391-9539187.13887.76
495638-9563887.36488.01
5102847-10284793.94994.72
696061-9606187.75088.50
20min196525-9652588.17491.592.9989.2792.782.99
297572-9757289.13190.41
3102155-10215593.31794.42
4100294-10029491.61792.75
5104747-10474795.68596.98
6100264-10026491.59092.83
30min1101347-10134792.57995.261.9094.1796.961.91
2103389-10338994.44496.22
3103868-10386894.88296.50
4106578-10657897.35799.00
5106447-10644797.23899.06
6104048-10404895.04696.79
45min1107250-10725097.97197.331.12100.0799.561.09
2104399-10439995.36797.66
3106308-10630897.11199.26
4107010-10701097.75299.93
5107834-10783498.505100.87
6106475-10647597.26399.54
60min1105911-10591196.74896.620.7899.3999.380.72
2105480-10548096.35499.18
3105813-10581396.65999.35
4107199-10719997.925100.65
5105498-10549896.37199.28
6104699-10469995.64198.46
极限1106151-10615196.96797.201.34100.15100.501.34
2108380-10838099.004102.37
3104334-10433495.30898.53
4105913-10591396.750100.02
5106056-10605696.881100.33
6107594-10759498.286101.63
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