坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.971723571722231730761727611729421726720.22
215.951724531725931725230.06
单位质量响应值RSD%判断
10812.2710816.490.03数据可信
影响因素30天-供试品溶液-2024042711批-pH6.5(内含0.35%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min159939-5993931.11435.3811.1331.1135.3811.14
269653-6965336.15736.16
374916-7491638.88938.89
473329-7332938.06538.07
573655-7365538.23438.23
657426-5742629.81029.81
10min1120820-12082062.71864.292.7363.0664.682.77
2120663-12066362.63663.04
3129139-12913967.03667.47
4124786-12478664.77665.20
5125944-12594465.37865.80
6121728-12172863.18963.52
15min1147741-14774176.69276.621.3877.7377.731.38
2143989-14398974.74575.84
3150050-15005077.89179.07
4147924-14792476.78777.93
5147203-14720376.41377.56
6148711-14871177.19678.23
20min1160815-16081583.47983.181.7085.3785.131.67
2155983-15598380.97182.90
3163307-16330784.77386.82
4158537-15853782.29784.29
5160021-16002183.06785.07
6162712-16271284.46486.35
30min1172777-17277789.68989.061.1792.5191.941.13
2169144-16914487.80390.63
3172429-17242989.50892.49
4172154-17215489.36592.28
5169034-16903487.74690.67
6173827-17382790.23493.06
45min1175041-17504190.86490.971.3194.6894.841.26
2173621-17362190.12793.93
3174633-17463390.65294.63
4178077-17807792.44096.34
5172317-17231789.45093.35
6177795-17779592.29396.13
60min1171291-17129188.91790.050.7693.7594.930.76
2174399-17439990.53195.34
3175105-17510590.89795.88
4173712-17371290.17495.10
5173305-17330589.96394.85
6173002-17300289.80594.66
极限1173519-17351990.07490.181.3695.8996.061.26
2175331-17533191.01496.83
3171369-17136988.95894.95
4177250-17725092.01197.94
5171062-17106288.79894.69
6173771-17377190.20596.06
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.971741631740461735801737531738241738730.14
215.951725241722731723980.11
单位质量响应值RSD%判断
10887.4810808.650.52数据可信
影响因素30天-供试品溶液-2024042711批-pH6.5(内含0.35%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min160440-6044031.27730.405.8531.2830.405.85
253062-5306227.45927.46
363146-6314632.67832.68
459978-5997831.03831.04
557065-5706529.53129.53
658822-5882230.44030.44
10min1119053-11905361.60962.282.4861.9662.622.49
2118029-11802961.07961.38
3125021-12502164.69865.06
4121882-12188263.07363.42
5121287-12128762.76563.09
6116847-11684760.46860.81
15min1144737-14473774.90176.001.4575.9377.031.45
2147181-14718176.16677.15
3148888-14888877.04978.13
4149803-14980377.52278.57
5145163-14516375.12176.15
6145389-14538975.23876.25
20min1157067-15706781.28182.161.0283.1584.031.02
2159835-15983582.71484.54
3160506-16050683.06185.00
4158138-15813881.83683.74
5160168-16016882.88684.75
6156847-15684781.16883.01
30min1165482-16548285.63687.911.8688.4090.691.83
2172997-17299789.52592.27
3173839-17383989.96192.82
4170234-17023488.09590.91
5168179-16817987.03289.81
6168482-16848287.18989.94
45min1171107-17110788.54789.810.9492.2793.580.95
2174786-17478690.45194.19
3175779-17577990.96594.83
4173353-17335389.70993.50
5173636-17363689.85693.60
6172663-17266389.35293.07
60min1166981-16698186.41288.151.3391.1192.911.26
2170008-17000887.97892.73
3170192-17019288.07492.94
4169132-16913287.52592.32
5172961-17296189.50794.25
6172710-17271089.37794.09
极限1169227-16922787.57488.381.0993.2494.121.05
2173502-17350289.78695.51
3170704-17070488.33994.19
4171135-17113588.56294.33
5171793-17179388.90294.64
6168293-16829387.09192.79
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.971746271747861746031746731746581746690.05
215.951738751739311739030.03
单位质量响应值RSD%判断
10937.3210903.010.23数据可信
影响因素30天-供试品溶液-2024042711批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118311-183119.41313.5124.709.4113.5024.71
233528-3352817.23617.24
332870-3287016.89816.90
421228-2122810.91310.91
529382-2938215.10415.10
622311-2231111.46911.47
10min157664-5766429.64432.2010.1229.7532.3510.18
270615-7061536.30136.49
368410-6841035.16835.36
455742-5574228.65528.78
565526-6552633.68533.85
657839-5783929.73329.86
15min186568-8656844.50245.336.4744.9445.836.55
296527-9652749.62250.22
393186-9318647.90448.48
481393-8139341.84242.28
587501-8750144.98245.52
683840-8384043.10043.56
20min1107498-10749855.26255.274.3056.1956.284.39
2113328-11332858.25959.41
3111720-11172057.43258.54
4101760-10176052.31253.22
5107877-10787755.45756.50
6102861-10286152.87853.81
30min1133980-13398068.87668.152.7370.4269.782.82
2137310-13731070.58772.38
3135200-13520069.50371.25
4128542-12854266.08067.57
5131927-13192767.82069.48
6128436-12843666.02667.55
45min1154635-15463579.49479.211.5681.8081.601.66
2157245-15724580.83583.41
3155654-15565480.01882.54
4153173-15317378.74280.96
5153584-15358478.95381.37
6150228-15022877.22879.49
60min1160952-16095282.74182.700.9885.9385.961.01
2161723-16172383.13786.61
3162676-16267683.62787.04
4161154-16115482.84585.94
5158019-15801981.23384.52
6160660-16066082.59185.71
极限1165169-16516984.90985.600.9189.0289.780.90
2168705-16870586.72791.13
3165059-16505984.85289.19
4166818-16681885.75789.77
5165538-16553885.09989.29
6167788-16778886.25590.29
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.971723771729721730351729981730251728810.17
215.951717321717121717220.01
单位质量响应值RSD%判断
10825.3610766.270.39数据可信
影响因素30天-供试品溶液-2024042711批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min125177-2517713.09213.9621.0713.0913.9621.07
234932-3493218.16518.16
326173-2617313.61013.61
422590-2259011.74711.75
532078-3207816.68016.68
620083-2008310.44310.44
10min162143-6214332.31432.957.4032.4633.107.47
270375-7037536.59536.80
363024-6302432.77232.92
458478-5847830.40830.54
567252-6725234.97135.16
658887-5888730.62130.74
15min186885-8688545.18046.133.7145.6846.653.80
293510-9351048.62549.23
388805-8880546.17846.69
486005-8600544.72245.19
591724-9172447.69648.27
685350-8535044.38244.84
20min1106885-10688555.58056.282.8056.5957.312.87
2112337-11233758.41559.56
3109106-10910656.73557.76
4104096-10409654.13055.09
5110594-11059457.50958.61
6106347-10634755.30056.25
30min1131762-13176268.51669.311.3170.1470.961.39
2136598-13659871.03172.83
3133539-13353969.44071.10
4132088-13208868.68570.25
5133032-13303269.17670.92
6132671-13267168.98970.55
45min1151278-15127878.66479.841.0081.0582.271.02
2154816-15481680.50483.09
3155477-15547780.84883.28
4152954-15295479.53681.87
5152703-15270379.40581.92
6153961-15396180.05982.39
60min1162098-16209884.29084.531.0287.5587.840.97
2161352-16135283.90387.38
3165788-16578886.20989.54
4162043-16204384.26287.48
5161403-16140383.92987.32
6162646-16264684.57587.80
极限1164635-16463585.61086.041.2789.8190.301.15
2165085-16508585.84490.26
3166461-16646186.55990.85
4168364-16836487.54991.70
5162138-16213884.31188.64
6166148-16614886.39690.56
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