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%
110.141026921028351028201026141025771027080.12
210.121025361029811027580.31
单位质量响应值RSD%判断
10128.9910153.950.18数据可信
长期24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%
5min165481-6548157.93745.2719.5457.9445.2719.54
239450-3945034.90534.90
357825-5782551.16351.16
455053-5505348.71048.71
542209-4220937.34637.35
646985-4698541.57241.57
10min197970-9797086.68274.2213.8287.0074.4713.84
267395-6739559.63059.82
393702-9370282.90683.19
488521-8852178.32278.59
575563-7556366.85767.06
680154-8015470.91971.15
15min1103878-10387891.91082.339.9692.7183.0010.00
279470-7947070.31470.84
399365-9936587.91788.66
498219-9821986.90387.61
585331-8533175.50076.08
692066-9206681.45982.08
20min1106500-10650094.22986.927.1695.5488.047.23
287642-8764277.54478.46
3101008-10100889.37090.60
4103230-10323091.33692.52
592421-9242181.77382.77
698627-9862787.26488.34
30min1109549-10954996.92792.026.0298.7693.636.10
297935-9793586.65188.00
3109686-10968697.04898.78
4108567-10856796.05897.75
595425-9542584.43185.88
6102881-10288191.02792.59
45min1108446-10844695.95194.264.1598.3396.384.20
2106142-10614293.91395.74
3110974-11097498.188100.46
4107042-10704294.70996.94
598163-9816386.85388.77
6108448-10844895.95398.02
60min1109915-10991597.25194.974.30100.1697.614.35
2106996-10699694.66897.02
3110898-11089898.121100.94
4108923-10892396.37399.13
598303-9830386.97789.38
6108964-10896496.41099.01
极限1111037-11103798.24498.450.57101.69101.620.47
2111403-11140398.568101.44
3111630-11163098.768102.13
4110270-11027097.565100.86
5112126-11212699.207102.09
6111164-11116498.356101.49
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%
110.141027041027171025811028291025661026790.11
210.121022401023041022720.05
单位质量响应值RSD%判断
10126.1310105.930.15数据可信
长期24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%
5min163403-6340356.23950.8819.4656.2450.8819.46
276039-7603967.44767.45
350535-5053544.82544.82
444820-4482039.75639.76
557786-5778651.25751.26
651609-5160945.77845.78
10min188424-8842478.43377.0613.3178.7577.3413.33
2106580-10658094.53794.91
378327-7832769.47769.73
473786-7378665.44965.67
591123-9112380.82781.11
682991-8299173.61473.87
15min192037-9203781.63884.116.9682.3984.827.01
2104285-10428592.50293.40
389130-8913079.05979.69
488218-8821878.25078.83
5101396-10139689.93990.67
693880-9388083.27283.94
20min198016-9801686.94189.703.7188.1490.883.78
2105283-10528393.38794.80
396604-9660485.68986.76
499209-9920987.99989.02
5105363-10536393.45894.69
6102276-10227690.72091.85
30min199012-9901287.82592.743.5189.5194.423.46
2105411-10541193.50095.43
3101091-10109189.66991.22
4107521-10752195.37296.88
5106276-10627694.26896.02
6108016-10801695.81197.44
45min198722-9872287.56792.954.4189.7495.144.25
2102152-10215290.61093.06
3102135-10213590.59592.64
4111054-11105498.506100.54
5106020-10602094.04196.32
6108632-10863296.35898.52
60min199875-9987588.59093.333.8091.2596.033.74
2106241-10624194.23797.19
3100634-10063489.26391.81
4109307-10930796.95699.54
5107007-10700794.91697.71
6108228-10822895.99998.70
极限1110303-11030397.84098.391.23100.99101.621.14
2110122-11012297.679101.16
3112029-11202999.371102.42
4112472-11247299.764102.89
5111690-11169099.070102.40
6108923-10892396.61699.85
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%
110.141022061021561023861019391024531022280.20
210.121019981027551023760.53
单位质量响应值RSD%判断
10081.6610116.210.25数据可信
长期24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%
5min132879-3287929.21340.3225.0929.2140.3225.09
239465-3946535.06535.07
342925-4292538.13938.14
462688-6268855.69955.70
538656-3865634.34634.35
655675-5567549.46849.47
10min162370-6237055.41770.6316.1355.5870.8516.15
269265-6926561.54361.74
378822-7882270.03470.25
497826-9782686.92087.23
579819-7981970.92071.11
688831-8883178.92779.20
15min177133-7713368.53482.3210.6369.0082.9310.69
286482-8648276.84077.38
395746-9574685.07285.67
4104378-10437892.74193.53
591874-9187481.63182.22
6100265-10026589.08789.80
20min188984-8898479.06388.887.1379.9189.957.22
294795-9479584.22785.19
3101374-10137490.07291.15
4107210-10721095.25796.56
5100684-10068489.45990.50
6107140-10714095.19596.40
30min1104991-10499193.28696.562.8294.5898.132.92
2105181-10518193.45594.89
3112801-112801100.225101.80
4110477-11047798.160100.00
5109040-10904096.88398.42
6109548-10954897.33599.07
45min1114480-114480101.717100.771.81103.53102.881.75
2111400-11140098.980100.93
3111773-11177399.312101.44
4111924-11192499.446101.83
5116561-116561103.566105.64
6114361-114361101.611103.89
60min1120489-120489107.056100.843.11109.43103.502.93
2112101-11210199.603102.10
3112152-11215299.648102.33
4113224-113224100.601103.54
5110619-11061998.286100.94
6112365-11236599.838102.68
极限1112508-11250899.96599.001.04102.93102.231.03
2111198-11119898.801101.85
3110886-11088698.524101.76
4113127-113127100.515104.01
5110727-11072798.382101.58
6110107-11010797.831101.23
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