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%
111.834541014543674542674539894540174541480.04
211.944518184517764517970.01
单位质量响应值RSD%判断
38389.5237838.941.03数据可信
供试品溶液-2024082321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%
5min1320608-32060860.38662.7713.3960.3962.7713.40
2271278-27127851.09551.09
3318208-31820859.93459.93
4320795-32079560.42160.42
5371055-37105569.88869.89
6397627-39762774.89374.89
10min1432545-43254581.46983.886.8781.5783.986.88
2405611-40561176.39676.48
3429515-42951580.89981.00
4447093-44709384.20984.31
5463347-46334787.27187.39
6493897-49389793.02593.15
15min1460497-46049786.73489.284.2586.9789.524.26
2444787-44478783.77583.99
3480478-48047890.49890.73
4470178-47017888.55888.80
5485991-48599191.53691.80
6502020-50202094.55594.83
20min1471178-47117888.74691.553.4489.1391.943.45
2464828-46482887.55087.90
3501328-50132894.42594.81
4478853-47885390.19190.58
5495664-49566493.35893.77
6504604-50460495.04295.48
30min1484147-48414791.18993.772.6991.7294.312.70
2484609-48460991.27691.77
3514261-51426196.86197.40
4489113-48911392.12492.66
5507707-50770795.62696.20
6507167-50716795.52496.12
45min1495835-49583593.39095.792.1794.0796.492.17
2502326-50232694.61395.26
3526032-52603299.07899.78
4502573-50257394.65995.35
5516445-51644597.27298.00
6508217-50821795.72296.48
60min1497470-49747093.69896.542.3294.5397.402.31
2510352-51035296.12496.93
3530939-530939100.002100.87
4508615-50861595.79796.65
5521566-52156698.23699.13
6506412-50641295.38296.30
极限1532048-532048100.211100.050.65101.20101.070.63
2530687-53068799.954100.92
3537344-537344101.208102.24
4530452-53045299.910100.92
5527355-52735599.327100.38
6529225-52922599.679100.75
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%
116.171515801517401515151515071516321515950.07
216.221505501505481505490.01
单位质量响应值RSD%判断
9375.089281.690.71数据可信
供试品溶液-2024082321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%
5min169852-6985242.03743.4113.2242.0443.4113.23
258010-5801034.91134.91
369779-6977941.99441.99
469813-6981342.01442.01
579745-7974547.99147.99
685591-8559151.50951.51
10min1111454-11145467.07468.336.5067.1468.406.50
2102756-10275661.83961.90
3109024-10902465.61165.68
4116385-11638570.04170.11
5117925-11792570.96871.05
6123695-12369574.44174.53
15min1127718-12771876.86278.294.1077.0478.484.11
2121094-12109472.87573.04
3129972-12997278.21878.40
4132112-13211279.50679.69
5133114-13311480.10980.31
6136568-13656882.18882.40
20min1136069-13606981.88783.702.9882.2084.022.99
2132278-13227879.60679.89
3141876-14187685.38285.69
4139733-13973384.09284.41
5141285-14128585.02685.36
6143226-14322686.19486.54
30min1143774-14377486.52488.722.3986.9789.182.40
2142827-14282785.95486.37
3151182-15118290.98291.43
4146898-14689888.40488.86
5149561-14956190.00790.48
6150314-15031490.46090.95
45min1148878-14887889.59692.012.0090.1992.622.01
2150022-15002290.28490.84
3156970-15697094.46695.07
4152395-15239591.71292.32
5154528-15452892.99693.62
6154566-15456693.01993.66
60min1150803-15080390.75493.241.9191.4994.001.92
2152747-15274791.92492.63
3159073-15907395.73196.49
4154260-15426092.83593.59
5156580-15658094.23195.01
6156150-15615093.97294.77
极限1158649-15864995.47695.720.8896.3796.640.89
2157478-15747894.77195.63
3161672-16167297.29598.22
4158594-15859495.44396.36
5158885-15888595.61896.55
6159066-15906695.72796.68
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%
111.834518034516284518004514104513964516070.05
211.944516374520094518230.06
单位质量响应值RSD%判断
38174.7337841.120.63数据可信
供试品溶液-2024082321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%
5min1265041-26504150.05853.9210.3450.0653.9210.35
2322954-32295460.99661.00
3261428-26142849.37649.38
4313245-31324559.16259.16
5253100-25310047.80347.80
6297200-29720056.13256.13
10min1397391-39739175.05581.936.8575.1482.026.85
2446827-44682784.39284.49
3418322-41832279.00879.09
4467500-46750088.29688.40
5408717-40871777.19477.27
6463948-46394887.62687.72
15min1458979-45897986.68790.003.5886.9090.233.59
2472427-47242789.22789.47
3470300-47030088.82589.04
4497483-49748393.95994.21
5462303-46230387.31587.52
6497577-49757793.97794.22
20min1477891-47789190.25992.672.6690.6193.052.67
2488461-48846192.25592.65
3482366-48236691.10491.47
4505085-50508595.39595.80
5481703-48170390.97991.33
6508579-50857996.05596.45
30min1493023-49302393.11795.332.1393.6295.862.14
2502405-50240594.88995.43
3499498-49949894.34094.85
4516098-51609897.47598.04
5497695-49769593.99994.50
6519706-51970698.15798.71
45min1512742-51274296.84198.201.4097.5098.891.42
2517516-51751697.74398.45
3516428-51642897.53898.21
4528059-52805999.734100.46
5514882-51488297.24697.91
6530048-530048100.110100.83
60min1523478-52347898.86999.640.7499.69100.500.76
2526112-52611299.367100.23
3525846-52584699.316100.15
4531737-531737100.429101.32
5525184-52518499.191100.02
6533039-533039100.675101.56
极限1529182-52918299.946100.200.66100.93101.220.68
2529798-529798100.063101.09
3526965-52696599.528100.53
4531763-531763100.434101.49
5528538-52853899.825100.81
6536805-536805101.386102.44
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%
116.171509361510531509391509101509441509560.04
216.221509501509241509370.02
单位质量响应值RSD%判断
9335.569305.610.23数据可信
供试品溶液-2024082321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%
5min154667-5466732.92635.978.8832.9335.978.88
267031-6703140.37340.37
357554-5755434.66534.66
463821-6382138.43938.44
553685-5368532.33432.33
661575-6157537.08637.09
10min199281-9928159.79765.476.7359.8565.526.73
2112361-11236167.67567.74
3107303-10730364.62864.69
4117085-11708570.52070.58
5101277-10127760.99961.05
6114861-11486169.18069.24
15min1124740-12474075.13178.243.4975.2978.413.49
2128218-12821877.22577.41
3129698-12969878.11778.28
4135449-13544981.58181.76
5126108-12610875.95576.11
6135180-13518081.41981.60
20min1136582-13658282.26384.382.2882.5484.682.29
2138876-13887683.64583.95
3139154-13915483.81284.11
4143685-14368586.54186.86
5137890-13789083.05183.33
6144352-14435286.94387.26
30min1146589-14658988.29089.841.5088.7190.281.51
2147909-14790989.08589.53
3148445-14844589.40889.84
4151854-15185491.46191.92
5148195-14819589.25789.68
6151998-15199891.54892.01
45min1152939-15293992.11593.050.9892.6893.640.99
2153532-15353292.47293.07
3153844-15384492.66093.24
4156460-15646094.23594.85
5153883-15388392.68393.25
6156301-15630194.14094.75
60min1155361-15536193.57494.380.7494.2995.120.76
2156029-15602993.97694.73
3156513-15651394.26795.01
4158479-15847995.45196.22
5156132-15613294.03894.76
6157668-15766894.96395.73
极限1157494-15749494.85895.600.6695.7396.500.68
2158014-15801495.17196.08
3158500-15850095.46496.36
4160260-16026096.52497.45
5158361-15836195.38096.26
6159684-15968496.17797.10
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%
111.834522994520744521024517184519734520330.05
211.944497104492694494900.07
单位质量响应值RSD%判断
38210.7437645.731.06数据可信
供试品溶液-2024082521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%
5min1206220-20622039.03254.2616.2839.0354.2616.28
2279675-27967552.93552.93
3279139-27913952.83452.83
4290196-29019654.92654.93
5340148-34014864.38164.38
6324552-32455261.42961.43
10min1372465-37246570.49879.676.5670.5679.766.57
2429989-42998981.38581.47
3446791-44679184.56684.65
4407467-40746777.12377.21
5443362-44336283.91784.02
6425398-42539880.51680.62
15min1440328-44032883.34288.003.5583.5288.223.57
2476567-47656790.20190.43
3479084-47908490.67890.91
4449848-44984885.14485.36
5478771-47877190.61990.87
6465042-46504288.02088.26
20min1471076-47107689.16291.322.1689.4891.692.18
2492598-49259893.23693.61
3490003-49000392.74493.12
4471180-47118089.18289.54
5492506-49250693.21893.62
6477440-47744090.36790.75
30min1497094-49709494.08794.861.2494.5695.381.25
2508636-50863696.27196.80
3503273-50327395.25695.79
4494987-49498793.68894.20
5507789-50778996.11196.66
6495415-49541593.76994.30
45min1516353-51635397.73297.970.7798.3698.650.77
2523781-52378199.13899.83
3515135-51513597.50198.19
4514782-51478297.43498.10
5521303-52130398.66999.38
6514445-51444597.37198.06
60min1524783-52478399.32799.560.81100.12100.400.81
2533184-533184100.917101.77
3522102-52210298.82099.68
4525128-52512899.393100.22
5528656-528656100.060100.94
6522198-52219898.83899.69
极限1530606-530606100.430101.110.55101.38102.120.56
2536688-536688101.581102.60
3538074-538074101.843102.86
4534932-534932101.248102.24
5531473-531473100.594101.64
6533363-533363100.951101.97
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%
116.171509841508151509921507061509581508910.09
216.221503011503251503130.02
单位质量响应值RSD%判断
9331.549267.140.49数据可信
供试品溶液-2024082521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%
5min145988-4598827.76236.5814.2327.7636.5814.23
260324-6032436.41636.42
358667-5866735.41635.42
459951-5995136.19136.19
570108-7010842.32342.32
668560-6856041.38841.39
10min191375-9137555.16163.617.4655.2163.677.46
2108290-10829065.37265.43
3111280-11128067.17767.24
4100967-10096760.95261.01
5111559-11155967.34667.42
6108776-10877665.66665.73
15min1115861-11586169.94376.004.9370.0876.164.94
2129473-12947378.16078.33
3131601-13160179.44579.62
4120729-12072972.88273.04
5129954-12995478.45178.63
6127706-12770677.09377.27
20min1131042-13104279.10782.813.0879.3683.103.09
2140267-14026784.67684.98
3141295-14129585.29785.60
4132973-13297380.27380.56
5139797-13979784.39384.71
6137652-13765283.09883.40
30min1146787-14678788.61290.111.5789.0090.541.58
2151270-15127091.31991.76
3151437-15143791.41991.86
4146491-14649188.43488.85
5151244-15124491.30391.76
6148406-14840689.59090.04
45min1155958-15595894.14994.460.9094.6895.050.91
2157954-15795495.35495.95
3158066-15806695.42196.02
4154437-15443793.23093.79
5156760-15676094.63395.24
6155717-15571794.00394.60
60min1158182-15818295.49195.830.7196.1896.560.72
2159763-15976396.44697.20
3160353-16035396.80297.56
4157620-15762095.15295.87
5158776-15877695.85096.61
6157733-15773395.22095.97
极限1160542-16054296.91697.410.7097.7798.310.71
2161548-16154897.52398.44
3163506-16350698.70599.62
4161027-16102797.20998.09
5160455-16045596.86397.79
6161069-16106997.23498.14
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%
111.834482954482124482554482534485484483130.04
211.944477664478684478170.02
单位质量响应值RSD%判断
37896.2837505.610.74数据可信
供试品溶液-2024082521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%
5min1262220-26222049.92950.464.9749.9350.464.96
2255977-25597748.74048.74
3280207-28020753.35453.35
4258888-25888849.29549.29
5282255-28225553.74453.74
6250549-25054947.70747.71
10min1393155-39315574.86076.794.6874.9476.884.67
2398742-39874275.92476.01
3424833-42483380.89280.98
4427006-42700681.30681.39
5379107-37910772.18572.27
6397044-39704475.60175.68
15min1449487-44948785.58686.892.9085.7987.102.90
2459526-45952687.49887.71
3461892-46189287.94888.17
4476078-47607890.64990.87
5436569-43656983.12783.34
6454386-45438686.51986.72
20min1478713-47871391.15190.862.2991.5091.222.28
2480955-48095591.57891.93
3477559-47755990.93191.30
4492883-49288393.84994.22
5459428-45942887.47987.83
6473498-47349890.15890.51
30min1497082-49708294.64994.361.6195.1594.871.61
2498670-49867094.95195.46
3493864-49386494.03694.56
4506585-50658596.45896.98
5482126-48212691.80192.30
6494988-49498894.25094.75
45min1513418-51341897.75997.700.9298.4298.370.93
2515628-51562898.18098.84
3510019-51001997.11297.79
4520510-52051099.11099.80
5506842-50684296.50797.15
6512299-51229997.54698.20
60min1522995-52299599.58399.780.56100.41100.610.56
2525746-525746100.107100.93
3520288-52028899.06799.91
4528330-528330100.599101.45
5521901-52190199.375100.18
6524950-52495099.955100.77
极限1526272-526272100.207100.650.26101.20101.650.26
2529367-529367100.796101.79
3529074-529074100.740101.75
4529953-529953100.908101.93
5527860-527860100.509101.48
6529069-529069100.739101.73
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%
116.171504081502691502601505761503931503810.09
216.221504271506421505340.11
单位质量响应值RSD%判断
9300.009280.760.15数据可信
供试品溶液-2024082521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%
5min153158-5315832.12132.734.5032.1232.744.51
251984-5198431.41231.41
357536-5753634.76634.77
452653-5265331.81631.82
557015-5701534.45234.45
652694-5269431.84131.84
10min194306-9430656.98560.253.2757.0460.303.26
298527-9852759.53559.59
3103294-10329462.41662.47
4102774-10277462.10262.15
599522-9952260.13760.19
699810-9981060.31160.36
15min1118218-11821871.43474.262.2671.5874.412.26
2123957-12395774.90275.05
3123867-12386774.84775.01
4126477-12647776.42476.58
5121637-12163773.50073.66
6123170-12317074.42674.58
20min1132987-13298780.35881.761.6780.6382.041.66
2136341-13634182.38582.66
3134964-13496481.55381.84
4138805-13880583.87484.16
5132851-13285180.27680.56
6135929-13592982.13682.41
30min1146466-14646688.50389.281.3288.9089.701.32
2148814-14881489.92290.34
3146369-14636988.44488.87
4149841-14984190.54290.97
5145315-14531587.80788.22
6149745-14974590.48490.90
45min1154928-15492893.61693.730.7894.1694.290.78
2155926-15592694.21994.78
3153969-15396993.03693.61
4156501-15650194.56695.14
5153481-15348192.74293.30
6155903-15590394.20594.77
60min1157397-15739795.10895.350.4995.8196.070.49
2158635-15863595.85696.58
3156848-15684894.77695.50
4158411-15841195.72196.45
5157136-15713694.95095.67
6158381-15838195.70296.42
极限1158855-15885595.98996.510.4096.8597.390.40
2160533-16053397.00397.88
3159260-15926096.23497.12
4160123-16012396.75597.65
5159460-15946096.35497.23
6160091-16009196.73697.62
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