坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.904475204471044470154474814456034469450.18
212.024447934445084446500.05
单位质量响应值RSD%判断
37558.4036992.511.08数据可信
供试品溶液-2024052221批-氢氯噻嗪-pH6.8(内含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1299285-29928557.63964.8712.1657.6464.8712.16
2295639-29563956.93756.94
3366064-36606470.50070.50
4304535-30453558.65058.65
5381850-38185073.54073.54
6373642-37364271.95971.96
10min1422272-42227281.32586.524.6581.4286.634.66
2423973-42397381.65281.75
3460021-46002188.59588.71
4455399-45539987.70487.80
5463070-46307089.18289.30
6470828-47082890.67690.80
15min1464905-46490589.53592.202.4189.7792.452.41
2463719-46371989.30789.54
3483874-48387493.18893.45
4491106-49110694.58194.83
5484227-48422793.25693.53
6484555-48455593.32093.59
20min1477963-47796392.05093.971.5992.4394.371.60
2480273-48027392.49592.87
3489838-48983894.33794.76
4499258-49925896.15196.55
5490953-49095394.55294.98
6489255-48925594.22594.65
30min1485491-48549193.50094.921.1794.0395.481.17
2494754-49475495.28495.82
3494234-49423495.18495.76
4502349-50234996.74697.31
5490907-49090794.54395.13
6489404-48940494.25394.84
45min1490852-49085294.53295.711.0195.2296.431.01
2500969-50096996.48197.17
3498015-49801595.91296.65
4504146-50414697.09397.82
5494246-49424695.18695.93
6493495-49349595.04195.78
60min1492271-49227194.80695.660.8295.6596.540.81
2498706-49870696.04596.90
3497786-49778695.86896.76
4503289-50328996.92897.81
5493664-49366495.07495.97
6494640-49464095.26296.16
极限1516115-51611599.398100.260.96100.40101.300.95
2527152-527152101.523102.54
3525766-525766101.256102.31
4515289-51528999.239100.29
5521006-521006100.340101.40
6518307-51830799.820100.88
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.921654121654071653651655941652891654130.07
215.961648621645891647260.12
单位质量响应值RSD%判断
10390.2610321.180.48数据可信
供试品溶液-2024052221批-坎地沙坦酯-pH6.8(内含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min170303-7030338.11142.0411.2238.1142.0411.22
268776-6877637.28337.28
383711-8371145.38045.38
469938-6993837.91337.91
585838-8583846.53346.53
686711-8671147.00647.01
10min1111195-11119560.27964.246.0060.3464.306.01
2109627-10962759.42959.49
3123960-12396067.19867.27
4116327-11632763.06163.12
5123608-12360867.00867.09
6126248-12624868.43968.52
15min1132190-13219071.66075.083.5771.8275.253.58
2132354-13235471.74971.91
3142541-14254177.27177.46
4139561-13956175.65675.82
5141868-14186876.90677.10
6142444-14244477.21977.41
20min1145736-14573679.00381.292.3079.2981.602.31
2145338-14533878.78779.07
3151897-15189782.34382.66
4152038-15203882.41982.71
5152125-15212582.46782.78
6152640-15264082.74683.07
30min1155823-15582384.47186.561.5384.8987.001.54
2157732-15773285.50685.92
3160465-16046586.98887.44
4162515-16251588.09988.53
5160746-16074687.14087.59
6160761-16076187.14887.61
45min1161156-16115687.36289.131.1687.9289.711.17
2163665-16366588.72289.28
3164692-16469289.27989.88
4166832-16683290.43991.02
5164996-16499689.44490.04
6165149-16514989.52790.13
60min1162450-16245088.06489.671.0888.7790.401.09
2164642-16464289.25289.95
3165533-16553389.73590.48
4167724-16772490.92391.65
5165691-16569189.82190.57
6166407-16640790.20990.96
极限1169719-16971992.00493.401.0692.8594.281.06
2173451-17345194.02794.88
3174697-17469794.70395.60
4171139-17113992.77493.65
5173239-17323993.91294.81
6171520-17152092.98193.88
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.904457804455484458444457204456374457060.03
212.024463184458994461080.07
单位质量响应值RSD%判断
37454.2937113.810.65数据可信
供试品溶液-2024052221批-氢氯噻嗪-pH6.8(内含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1343690-34369066.17362.4112.0266.1762.4012.02
2338080-33808065.09365.09
3252637-25263748.64248.64
4306417-30641758.99759.00
5347849-34784966.97466.97
6356100-35610068.56268.56
10min1478152-47815292.06281.708.0092.1781.808.00
2430257-43025782.84082.95
3374058-37405872.02072.10
4408183-40818378.59078.69
5429980-42998082.78782.90
6425391-42539181.90382.02
15min1493493-49349395.01688.153.9695.2888.403.96
2458461-45846188.27188.52
3444976-44497685.67485.88
4453751-45375187.36487.59
5449304-44930486.50886.76
6447162-44716286.09586.35
20min1496432-49643295.58190.523.0396.0090.913.02
2467824-46782490.07390.47
3469678-46967890.43090.77
4471459-47145990.77391.15
5456541-45654187.90188.29
6458962-45896288.36788.76
30min1497538-49753895.79492.162.7996.3892.702.78
2475268-47526891.50792.05
3484687-48468793.32093.81
4486329-48632993.63694.16
5464228-46422889.38189.92
6464023-46402389.34189.88
45min1498378-49837895.95693.062.9996.7093.752.98
2479167-47916792.25792.95
3496474-49647495.58996.24
4492275-49227594.78195.46
5466405-46640589.80090.49
6467185-46718589.95090.64
60min1497654-49765495.81793.192.7296.7294.042.71
2480155-48015592.44793.30
3494462-49446295.20296.01
4493946-49394695.10395.94
5468305-46830590.16691.00
6469511-46951190.39891.24
极限1515816-51581699.314100.160.75100.37101.160.74
2525111-525111101.103102.11
3522128-522128100.529101.50
4523228-523228100.741101.74
5519153-51915399.956100.95
6515900-51590099.330100.32
坎地沙坦酯氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.921650151650471651411649811650151650400.04
215.961651891650291651090.07
单位质量响应值RSD%判断
10366.8310345.180.15数据可信
供试品溶液-2024052221批-坎地沙坦酯-pH6.8(内含0.35%吐温20)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min176791-7679141.62740.408.5141.6340.408.51
278286-7828642.43742.44
363545-6354534.44634.45
470702-7070238.32638.33
576946-7694641.71141.71
680891-8089143.84943.85
10min1123852-12385267.13762.106.2467.2162.176.24
2117182-11718263.52263.59
3102151-10215155.37455.43
4112536-11253661.00361.07
5115519-11551962.62062.69
6116150-11615062.96263.04
15min1143177-14317777.61372.583.9077.7972.753.90
2135180-13518073.27873.45
3127394-12739469.05769.21
4132956-13295672.07272.24
5131976-13197671.54171.72
6132691-13269171.92972.11
20min1153398-15339883.15478.712.9183.4679.002.91
2144808-14480878.49778.80
3142667-14266777.33777.60
4145187-14518778.70378.99
5141880-14188076.91077.20
6143214-14321477.63377.93
30min1162814-16281488.25884.292.8388.7184.722.82
2154516-15451683.76084.19
3156413-15641384.78885.18
4157020-15702085.11785.53
5151410-15141082.07682.50
6150808-15080881.75082.18
45min1166777-16677790.40686.972.9391.0087.542.91
2159726-15972686.58487.15
3163783-16378388.78389.32
4162029-16202987.83288.39
5155108-15510884.08184.64
6155236-15523684.15084.71
60min1167429-16742990.75987.522.8891.5188.232.87
2160816-16081687.17587.89
3164452-16445289.14689.83
4163801-16380188.79389.50
5156342-15634284.74985.45
6155889-15588984.50485.21
极限1171654-17165493.05093.120.9793.9593.970.96
2173383-17338393.98794.85
3172338-17233893.42194.25
4173518-17351894.06094.91
5170456-17045692.40093.24
6169315-16931591.78292.63
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