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68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7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%
19.9599777100011999249976699981998920.12
210.00100101999761000380.09
单位质量响应值RSD%判断
10039.4010003.800.26数据可信
加速6月-供试品溶液-2023111921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%
5min151036-5103645.69644.5316.2145.7044.5316.21
249864-4986444.64744.65
357896-5789651.83851.84
457647-5764751.61551.62
536473-3647332.65732.66
645492-4549240.73240.73
10min176887-7688768.84270.9512.2869.1071.2012.29
277035-7703568.97569.22
388921-8892179.61779.91
486726-8672677.65277.94
562129-6212955.62855.81
683722-8372274.96275.19
15min184842-8484275.96576.387.4476.6077.027.48
285777-8577776.80277.43
390102-9010280.67581.40
489027-8902779.71280.43
573065-7306565.42065.91
689043-8904379.72680.37
20min191352-9135281.79485.727.2282.8586.787.25
296776-9677686.65087.71
399895-9989589.44390.62
4102153-10215391.46592.63
583949-8394975.16576.02
6100271-10027189.78090.87
30min199928-9992889.47290.902.9590.9992.443.00
2101213-10121390.62392.16
3103998-10399893.11794.79
4106166-10616695.05896.73
599559-9955989.14290.41
698290-9829088.00689.59
45min1106240-10624095.12494.192.0297.1396.241.94
2106690-10669095.52797.57
3101663-10166391.02693.22
4107274-10727496.05098.25
5105570-10557094.52496.29
6103738-10373892.88494.96
60min1103502-10350292.67293.415.7195.2195.985.48
2102265-10226591.56594.14
396448-9644886.35789.05
4102090-10209091.40894.14
5107641-10764196.37898.67
6114020-114020102.090104.68
极限1104781-10478193.81893.092.9096.8796.182.77
2108728-10872897.352100.43
399586-9958689.16692.34
4104172-10417293.27296.51
5104244-10424493.33796.16
6102293-10229391.59094.75
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68522100802对照品来源自制对照品使用方法直接使用
对照品含量(%)99.7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%
19.95100345100428999291000141002261001880.22
210.001016101018821017460.19
单位质量响应值RSD%判断
10069.1510174.600.74数据可信
加速6月-供试品溶液-2023111921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%
5min136002-3600231.91627.6019.3431.9227.6019.35
223049-2304920.43320.43
323825-2382521.12121.12
433527-3352729.72229.72
534914-3491430.95230.95
635457-3545731.43331.43
10min163161-6316155.99353.948.0756.1754.098.06
253336-5333647.28347.40
363884-6388456.63456.75
456092-5609249.72749.89
563074-6307455.91656.09
665503-6550358.07058.24
15min184371-8437174.79773.215.7975.2873.665.81
275421-7542166.86267.24
383476-8347674.00374.44
478216-7821669.34069.78
586288-8628876.49676.98
687692-8769277.74178.24
20min1101136-10113689.65987.113.4490.5687.973.42
297260-9726086.22386.97
3102535-10253590.89991.74
494086-9408683.40984.24
599510-9951088.21889.13
695027-9502784.24385.17
30min1107469-10746995.27392.253.1896.6893.593.11
2105800-10580093.79495.02
399437-9943788.15389.50
4107356-10735695.17396.46
5101786-10178690.23591.63
6102487-10248790.85792.25
45min1104005-10400592.20393.021.3194.1394.871.23
2106778-10677894.66196.41
3103230-10323091.51593.35
4106299-10629994.23696.05
5104802-10480292.90994.81
6104421-10442192.57194.47
60min1104471-10447192.61694.021.1495.0696.391.06
2106563-10656394.47096.74
3107993-10799395.73898.08
4106269-10626994.21096.55
5105572-10557293.59296.01
6105434-10543493.46995.89
极限1102212-10221290.61391.813.2493.5794.713.14
2104829-10482992.93395.73
397856-9785686.75189.63
4104627-10462792.75495.62
5103964-10396492.16695.10
6107899-10789995.65598.59
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