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%
112.465218345224275224485224225223835223030.06
212.325084805090705087750.09
单位质量响应值RSD%判断
41918.3841296.671.06数据可信
中间条件12月-供试品溶液-2024082721批-氢氯噻嗪-含0.35%吐温20的pH6.8磷酸盐溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1355521-35552161.34055.3314.5861.3455.3314.57
2354154-35415461.10461.10
3316676-31667654.63854.64
4280896-28089648.46548.46
5250660-25066043.24843.25
6366325-36632563.20463.20
10min1457319-45731978.90474.8710.1879.0174.9610.19
2465835-46583580.37380.48
3418560-41856072.21772.31
4387819-38781966.91366.99
5383143-38314366.10666.18
6490924-49092484.70284.81
15min1486611-48661183.95881.066.4784.1981.286.49
2498125-49812585.94586.18
3455008-45500878.50578.72
4433914-43391474.86675.06
5440959-44095976.08176.26
6504355-50435587.01987.27
20min1502548-50254886.70885.205.0187.0885.555.03
2521673-52167390.00790.39
3477682-47768282.41782.76
4459818-45981879.33579.65
5481890-48189083.14383.45
6519180-51918089.57789.97
30min1519622-51962289.65488.413.5490.1788.913.57
2528787-52878791.23591.76
3503515-50351586.87587.35
4488265-48826584.24384.69
5499714-49971486.21986.67
6534730-53473092.26092.80
45min1535854-53585492.45491.742.2993.1292.382.32
2542741-54274193.64294.32
3527228-52722890.96691.59
4516907-51690789.18589.77
5520457-52045789.79890.39
6546942-54694294.36795.06
60min1544001-54400193.86093.801.5794.6894.601.61
2551715-55171595.19196.03
3541732-54173293.46894.24
4534635-53463592.24492.98
5534836-53483692.27993.02
6555169-55516995.78796.64
极限1547190-54719094.41096.692.5595.3997.642.50
2555445-55544595.83496.83
3552484-55248495.32396.26
4554947-55494795.74896.64
5586797-586797101.244102.14
6565537-56553797.57698.59
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%
115.891590051591051589051592561591131590770.09
215.921560501560991560740.03
单位质量响应值RSD%判断
10011.149803.641.49数据可信
中间条件12月-供试品溶液-2024082721批-坎地沙坦酯-含0.35%吐温20的pH6.8磷酸盐溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min173310-7331041.54438.2711.6541.5438.2711.65
271795-7179540.68540.69
366980-6698037.95737.96
463323-6332335.88435.88
554260-5426030.74830.75
675492-7549242.78042.78
10min1116144-11614465.81763.566.9865.8963.636.99
2116182-11618265.83965.91
3110884-11088462.83662.90
4106306-10630660.24260.30
5100825-10082557.13657.19
6122637-12263769.49669.57
15min1133120-13312075.43774.304.1475.6274.474.15
2135355-13535576.70476.88
3128822-12882273.00173.17
4127012-12701271.97672.14
5124028-12402870.28570.43
6138354-13835478.40378.59
20min1141265-14126580.05380.383.3780.3680.683.38
2146750-14675083.16183.47
3139349-13934978.96779.26
4135973-13597377.05477.33
5139386-13938678.98879.25
6148368-14836884.07884.40
30min1150217-15021785.12685.492.3385.5685.922.35
2153696-15369687.09787.54
3149497-14949784.71885.14
4147584-14758483.63484.04
5147770-14777083.73984.13
6156439-15643988.65289.11
45min1155201-15520187.95088.491.7788.5389.061.78
2157909-15790989.48590.07
3155680-15568088.22188.78
4153926-15392687.22787.78
5153439-15343986.95287.49
6160783-16078391.11391.72
60min1157196-15719689.08189.591.4989.8190.311.51
2159203-15920390.21890.96
3158008-15800889.54190.25
4156387-15638788.62289.32
5155624-15562488.19088.87
6162152-16215291.88992.65
极限1159011-15901190.10991.021.2990.9891.891.30
2161410-16141091.46992.36
3160848-16084891.15092.01
4160566-16056690.99091.83
5157981-15798189.52590.35
6163931-16393192.89793.81
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%
112.465072125079085070335069765068595071980.09
212.325063225062355062780.02
单位质量响应值RSD%判断
40706.1041093.990.68数据可信
中间条件12月-供试品溶液-2024082721批-氢氯噻嗪
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1328483-32848357.65453.1815.4757.6553.1815.47
2254602-25460244.68644.69
3268520-26852047.12947.13
4300493-30049352.74152.74
5382993-38299367.22167.22
6283007-28300749.67249.67
10min1448343-44834378.69177.296.0278.7977.386.03
2409771-40977171.92172.00
3411452-41145272.21672.29
4441750-44175077.53477.62
5479800-47980084.21284.32
6451016-45101679.16079.24
15min1492476-49247686.43785.763.6386.6685.983.64
2468030-46803082.14682.34
3465699-46569981.73781.94
4495120-49512086.90187.12
5507720-50772089.11289.36
6502725-50272588.23688.45
20min1518731-51873191.04588.772.6191.4289.132.62
2490299-49029986.05586.39
3488911-48891185.81186.15
4506693-50669388.93289.29
5516367-51636790.63091.03
6513632-51363290.15090.51
30min1534515-53451593.81591.901.7094.3492.411.71
2516806-51680690.70791.18
3510214-51021489.55090.03
4523355-52335591.85792.37
5529153-52915392.87493.43
6527661-52766192.61293.12
45min1550286-55028696.58394.531.3797.2695.181.38
2535442-53544293.97894.60
3527674-52767492.61593.24
4538174-53817494.45795.12
5539453-53945394.68295.39
6540332-54033294.83695.50
60min1556725-55672597.71395.691.1398.5596.511.14
2539699-53969994.72595.51
3540493-54049394.86495.65
4545011-54501195.65796.48
5543735-54373595.43496.30
6545577-54557795.75796.58
极限1560366-56036698.35296.911.1299.3697.881.10
2559552-55955298.21099.15
3549440-54944096.43597.37
4549027-54902796.36297.34
5546719-54671995.95796.98
6547644-54764496.12097.10
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%
115.891552091553081554941557851554181554430.15
215.921557451556731557090.04
单位质量响应值RSD%判断
9782.449780.720.02数据可信
中间条件12月-供试品溶液-2024082721批-坎地沙坦酯
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min169508-6950839.89136.4714.9439.8936.4714.94
254053-5405331.02231.02
356872-5687232.63932.64
464187-6418736.83836.84
579142-7914245.42045.42
657494-5749432.99633.00
10min1112448-11244864.53563.855.8964.6063.915.89
2101939-10193958.50458.56
3107022-10702261.42161.48
4113724-11372465.26765.33
5121344-12134469.64169.72
6111048-11104863.73263.79
15min1133642-13364276.69976.953.5976.8777.123.60
2127092-12709272.93973.09
3130097-13009774.66474.82
4138243-13824379.33979.51
5139564-13956480.09780.29
6135867-13586777.97578.14
20min1146551-14655184.10782.892.7084.4183.182.71
2137713-13771379.03579.31
3141667-14166781.30481.59
4147459-14745984.62884.93
5146767-14676784.23184.56
6146402-14640284.02284.31
30min1155721-15572189.37088.091.3889.8188.521.39
2150487-15048786.36686.77
3151353-15135386.86387.28
4155238-15523889.09389.54
5153965-15396588.36288.83
6154188-15418888.49088.92
45min1160418-16041892.06690.830.9392.6691.410.94
2157065-15706590.14190.69
3156587-15658789.86790.43
4159495-15949591.53692.13
5157762-15776290.54191.15
6158252-15825290.82291.40
60min1161240-16124092.53791.290.7393.2892.020.74
2158617-15861791.03291.73
3157852-15785290.59391.30
4159226-15922691.38192.13
5158656-15865691.05491.82
6158779-15877991.12591.85
极限1162283-16228393.13692.350.8094.0393.230.78
2162788-16278893.42694.27
3159835-15983591.73192.59
4160320-16032092.00992.91
5159940-15994091.79192.71
6160317-16031792.00892.89
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