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%
19.951002981003551005171003781000571003210.17
210.00999121001281000200.16
单位质量响应值RSD%判断
10082.5110002.000.57数据可信
加速6月-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%
5min167325-6732560.15754.598.4460.1654.598.44
254853-5485349.01349.01
359745-5974553.38453.38
463012-6301256.30456.30
565781-6578158.77858.78
655859-5585949.91249.91
10min181842-8184273.12970.997.5773.4671.307.57
275234-7523467.22467.50
376690-7669068.52568.82
477804-7780469.52169.83
590555-9055580.91481.24
674592-7459266.65166.93
15min187072-8707277.80279.794.8378.5480.484.84
285352-8535276.26576.91
388253-8825378.85779.53
491087-9108781.39082.09
597167-9716786.82287.60
686831-8683177.58778.23
20min190904-9090481.22685.282.9782.4086.422.94
296898-9689886.58287.65
395872-9587285.66586.78
498581-9858188.08689.24
597090-9709086.75488.01
693310-9331083.37684.45
30min197088-9708886.75290.763.8788.3892.383.77
2105771-10577194.51096.06
3105984-10598494.70196.29
4103244-10324492.25393.89
599121-9912188.56890.31
698262-9826287.80189.34
45min1100501-10050189.80292.053.0291.9194.172.97
2104987-10498793.81095.89
3107737-10773796.26798.38
4103627-10362792.59594.75
5102086-10208691.21893.45
699191-9919188.63190.66
60min1102058-10205891.19391.992.9193.8094.622.81
2106168-10616894.86597.46
3104230-10423093.13495.79
4105806-10580694.54297.21
598534-9853488.04490.78
6100916-10091690.17292.69
极限1105426-10542694.20295.011.1797.3198.151.18
2104757-10475793.60496.73
3106646-10664695.29298.46
4108219-10821996.69899.89
5107013-10701395.62098.85
6105888-10588894.61597.64
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%
19.9510017999925100318999591000551000870.17
210.009997699771998740.15
单位质量响应值RSD%判断
10058.999987.400.51数据可信
加速6月-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%
5min142877-4287738.38548.1312.8638.3848.1312.87
257882-5788251.81851.82
353394-5339447.80047.80
463287-6328756.65756.66
554782-5478249.04349.04
650364-5036445.08845.09
10min166961-6696159.94673.4610.1960.1673.7210.20
289283-8928379.92980.22
385795-8579576.80777.07
488847-8884779.53979.85
579032-7903270.75271.02
682402-8240273.76974.02
15min180289-8028971.87884.537.9072.4285.207.92
296942-9694286.78687.52
397765-9776587.52388.21
4101252-10125290.64491.40
597667-9766787.43588.10
692608-9260882.90683.57
20min194685-9468584.76591.813.9785.7192.964.02
2104308-10430893.38094.59
3104115-10411593.20794.39
4105324-10532494.29095.55
5101746-10174691.08792.24
6105159-10515994.14295.26
30min1103448-10344892.61095.911.9494.0397.562.03
2109148-10914897.71399.45
3108460-10846097.09798.79
4108364-10836497.01198.80
5106889-10688995.69197.35
6106466-10646695.31296.96
45min1106494-10649495.33795.380.3997.2797.570.40
2106411-10641195.26397.54
3106917-10691795.71697.95
4106164-10616495.04297.36
5107146-10714695.92198.11
6106115-10611594.99897.17
60min1106895-10689595.69696.461.5298.1699.181.49
2109341-10934197.886100.69
3106167-10616795.04497.81
4105880-10588094.78797.64
5108665-10866597.281100.00
6109554-10955498.077100.78
极限1106411-10641195.26396.151.3598.2699.401.36
2108073-10807396.751100.10
3106395-10639595.24898.54
4107765-10776596.47599.85
5109807-10980798.303101.57
6105951-10595194.85198.10
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