坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号61123040205对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.5对照品水分(%)0.14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%
116.263862838171381623847038750384360.70
216.273869138748387200.11
单位质量响应值RSD%判断
2363.842379.840.48数据可信
供试品溶液-24101001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%
5min15522-552213.14310.7522.9713.1410.7522.96
23119-31197.4247.42
33970-39709.4499.45
45930-593014.11414.11
54214-421410.03010.03
64347-434710.34610.35
10min115036-1503635.78831.9315.3935.9332.0515.41
29869-986923.48923.57
312640-1264030.08530.19
415686-1568637.33537.49
513293-1329331.63931.75
613979-1397933.27233.39
15min122342-2234253.17749.5610.1453.7250.0310.20
216805-1680539.99840.34
320648-2064849.14549.58
422667-2266753.95054.52
521116-2111650.25950.72
621349-2134950.81351.30
20min127686-2768665.89662.696.4967.0363.716.59
223289-2328955.43156.22
326231-2623162.43363.42
428193-2819367.10368.27
526260-2626062.50263.52
626363-2636362.74763.80
30min131722-3172275.50274.913.6777.3776.633.80
229173-2917369.43570.84
331881-3188175.88177.56
432370-3237077.04578.96
532010-3201076.18877.90
631677-3167775.39577.14
45min134853-3485382.95582.471.2885.6685.021.46
233843-3384380.55182.73
334767-3476782.75085.27
434954-3495483.19585.97
534452-3445282.00084.56
635025-3502583.36485.95
60min134923-3492383.12183.401.5586.7586.881.67
234225-3422581.46084.53
334756-3475682.72486.17
435258-3525883.91887.62
535263-3526383.93087.40
635825-3582585.26888.78
极限134865-3486582.98383.740.8587.5388.140.98
234767-3476782.75086.73
335308-3530884.03788.40
435372-3537284.19088.82
535274-3527483.95788.36
635519-3551984.54089.00
坎地沙坦酯片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号61123040205对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.5对照品水分(%)0.14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%
116.263860338289387023846238590385290.42
216.273862538819387220.36
单位质量响应值RSD%判断
2369.562379.960.31数据可信
供试品溶液-24101001批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18509-850920.22722.1214.4120.2322.1214.42
29184-918421.83221.83
311802-1180228.05628.06
49565-956522.73822.74
58817-881720.96020.96
67965-796518.93418.93
10min119804-1980447.07849.036.1047.3049.286.12
219121-1912145.45445.70
322808-2280854.21954.53
421000-2100049.92150.17
520622-2062249.02249.26
620402-2040248.49948.71
15min127783-2778366.04566.813.5966.7967.603.58
226285-2628562.48463.23
328590-2859067.96468.88
428363-2836367.42468.23
528369-2836967.43868.22
629237-2923769.50270.25
20min132107-3210776.32475.663.1977.8177.193.14
230485-3048572.46873.91
331508-3150874.90076.57
432446-3244677.13078.69
531097-3109773.92375.45
633320-3332079.20880.73
30min134212-3421281.32881.372.0783.6683.742.02
233642-3364279.97382.22
333327-3332779.22481.73
434844-3484482.83185.24
534140-3414081.15783.51
635205-3520583.68986.09
45min135055-3505583.33282.850.9386.5786.120.90
234959-3495983.10486.24
334790-3479082.70286.08
435302-3530283.91987.25
534410-3441081.79985.05
634591-3459182.22985.56
60min134675-3467582.42981.581.1286.5985.781.03
234388-3438881.74785.81
333659-3365980.01484.31
434354-3435481.66685.93
534150-3415081.18185.34
634689-3468982.46286.71
极限134343-3434381.64080.991.3486.7186.101.29
234006-3400680.83885.81
333763-3376380.26185.45
434700-3470082.48887.66
533400-3340079.39884.46
634211-3421181.32686.49
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