氢氯噻嗪坎地沙坦酯片项目信息
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%
112.014608744606634607994605534606244607030.03
212.064583454584244583840.02
单位质量响应值RSD%判断
38359.9538008.620.66数据可信
中间条件6月-供试品溶液-2024082321批-氢氯噻嗪-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1408411-40841176.78069.4415.7776.7869.4415.77
2392248-39224873.74273.74
3374730-37473070.44870.45
4360317-36031767.73967.74
5421180-42118079.18179.18
6259297-25929748.74748.75
10min1474968-47496889.29383.997.3489.4284.107.35
2453398-45339885.23885.36
3443303-44330383.34083.46
4454060-45406085.36285.48
5470483-47048388.45088.58
6384253-38425372.23972.32
15min1487010-48701091.55787.903.9991.8388.164.00
2470312-47031288.41788.68
3464947-46494787.40987.67
4467455-46745587.88088.14
5481850-48185090.58790.87
6433856-43385681.56481.77
20min1493209-49320992.72289.422.9793.1589.822.99
2479124-47912490.07490.49
3473922-47392289.09689.50
4471945-47194588.72489.13
5484219-48421991.03291.46
6451494-45149484.88085.22
30min1498808-49880893.77591.241.7894.3691.791.80
2488909-48890991.91492.48
3482419-48241990.69491.24
4478770-47877090.00890.56
5488371-48837191.81392.39
6474611-47461189.22689.70
45min1501527-50152794.28692.581.1495.0393.281.13
2492684-49268492.62393.34
3487774-48777491.70092.40
4486521-48652191.46592.16
5490342-49034292.18392.92
6495852-49585293.21993.85
60min1501978-50197894.37193.051.2995.2793.911.26
2493201-49320192.72193.59
3489100-48910091.95092.80
4489676-48967692.05892.91
5492076-49207692.50993.40
6503829-50382994.71995.50
极限1530894-53089499.80799.321.15100.86100.331.12
2518523-51852397.48198.51
3528008-52800899.264100.27
4526217-52621798.92899.93
5529024-52902499.455100.50
6537000-537000100.955101.90
氢氯噻嗪坎地沙坦酯片项目信息
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%
116.521526001525771526151528361525201526300.08
216.491522431522781522600.02
单位质量响应值RSD%判断
9239.109233.470.05数据可信
中间条件6月-供试品溶液-2024082321批-坎地沙坦酯-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min183957-8395751.02846.7814.4651.0346.7814.46
281016-8101649.24149.24
378543-7854347.73847.74
474940-7494045.54845.55
587366-8736653.10053.10
656013-5601334.04434.04
10min1118940-11894072.29169.197.1072.3869.267.11
2112812-11281268.56668.65
3113577-11357769.03169.11
4117918-11791871.67071.75
5121071-12107173.58673.67
698682-9868259.97860.03
15min1130723-13072379.45377.983.5779.6678.183.58
2125616-12561676.34976.54
3127274-12727477.35677.55
4131905-13190580.17180.37
5133280-13328081.00781.22
6121043-12104373.56973.73
20min1137387-13738783.50382.252.0983.8482.572.11
2132686-13268680.64680.97
3134519-13451981.76082.08
4137935-13793583.83684.16
5137915-13791583.82484.17
6131506-13150679.92880.21
30min1143938-14393887.48486.460.9787.9686.920.99
2140435-14043585.35585.81
3141573-14157386.04786.51
4142929-14292986.87187.34
5143424-14342487.17287.66
6141212-14121285.82886.24
45min1147818-14781889.84389.130.8990.4789.740.88
2144524-14452487.84188.44
3145764-14576488.59489.20
4147297-14729789.52690.14
5146696-14669689.16189.79
6147815-14781589.84190.40
60min1149280-14928090.73190.170.9391.5090.920.91
2146503-14650389.04389.79
3147593-14759389.70690.46
4148723-14872390.39391.16
5147722-14772289.78490.56
6150346-15034691.37992.08
极限1157539-15753995.75194.921.2496.6795.821.22
2153289-15328993.16894.06
3155375-15537594.43695.34
4155824-15582494.70995.62
5156046-15604694.84495.77
6158948-15894896.60797.47
氢氯噻嗪坎地沙坦酯片项目信息
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%
112.014585524589904586074584704581514585540.07
212.064555944560274558100.07
单位质量响应值RSD%判断
38181.0237795.190.72数据可信
中间条件6月-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%
5min1272462-27246251.48750.8716.3451.4950.8716.34
2248512-24851246.96146.96
3325419-32541961.49461.49
4306298-30629857.88157.88
5261328-26132849.38349.38
6201161-20116138.01338.01
10min1412597-41259777.96876.845.4878.0576.925.49
2396103-39610374.85174.93
3423805-42380580.08680.19
4429664-42966481.19381.29
5409551-40955177.39377.47
6367925-36792569.52769.59
15min1461148-46114887.14386.522.6387.3686.742.63
2459031-45903186.74386.95
3460560-46056087.03287.27
4476148-47614889.97790.21
5440429-44042983.22883.44
6449897-44989785.01785.20
20min1478669-47866990.45490.353.2990.8190.703.29
2487579-48757992.13792.49
3482054-48205491.09391.47
4494540-49454093.45393.83
5448776-44877684.80585.15
6477037-47703790.14590.47
30min1497472-49747294.00794.003.8494.5294.513.84
2512451-51245196.83897.34
3506489-50648995.71196.24
4511709-51170996.69797.23
5461295-46129587.17187.66
6495233-49523393.58494.06
45min1518268-51826897.93797.124.2198.6197.784.20
2531146-531146100.370101.03
3524253-52425399.06899.76
4525824-52582499.365100.06
5471910-47191089.17789.81
6512231-51223196.79697.42
60min1527405-52740599.66398.934.50100.5099.764.49
2546020-546020103.181104.01
3534168-534168100.941101.80
4532501-532501100.626101.49
5478207-47820790.36691.15
6522894-52289498.81199.60
极限1531697-531697100.474100.842.01101.47101.832.02
2548367-548367103.625104.63
3541214-541214102.273103.30
4534223-534223100.952101.98
5517059-51705997.70898.64
6529330-529330100.027100.98
氢氯噻嗪坎地沙坦酯片项目信息
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%
116.521524241525781527441523821522051524670.14
216.491517561519861518710.11
单位质量响应值RSD%判断
9229.249209.880.15数据可信
中间条件6月-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%
5min152707-5270732.09332.2614.7632.0932.2614.76
248725-4872529.66829.67
362625-6262538.13238.13
460588-6058836.89236.89
551885-5188531.59331.59
641353-4135325.18025.18
10min1101025-10102561.51460.484.8761.5760.544.88
295018-9501857.85657.91
3103995-10399563.32263.39
4103474-10347463.00563.07
5100565-10056561.23461.29
691925-9192555.97356.01
15min1123679-12367975.30874.361.4675.4674.511.47
2120830-12083073.57373.72
3122026-12202674.30174.47
4124752-12475275.96176.13
5120063-12006373.10673.26
6121358-12135873.89474.03
20min1134784-13478482.06981.782.2982.3582.062.28
2134710-13471082.02482.29
3133398-13339881.22681.52
4137158-13715883.51583.81
5128791-12879178.42078.70
6136999-13699983.41883.68
30min1146026-14602688.91589.033.0889.3389.453.07
2149166-14916690.82791.23
3146370-14637089.12489.55
4149328-14932890.92591.36
5137520-13752083.73584.14
6148908-14890890.67091.07
45min1153887-15388793.70193.053.6394.2793.613.62
2157267-15726795.75996.32
3154391-15439194.00894.58
4155256-15525694.53595.12
5141784-14178486.33286.88
6154313-15431393.96194.51
60min1155429-15542994.64094.493.8895.3695.203.86
2161377-16137798.26298.98
3157383-15738395.83096.56
4157061-15706195.63496.38
5143663-14366387.47688.17
6156142-15614295.07495.78
极限1157901-15790196.14596.351.9497.0397.221.94
2162166-16216698.74299.62
3160293-16029397.60298.50
4158216-15821696.33797.24
5153051-15305193.19294.03
6157775-15777596.06996.93
氢氯噻嗪坎地沙坦酯片项目信息
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%
112.014553934554414554174558504556024555410.05
212.064535434535504535460.01
单位质量响应值RSD%判断
37930.1437607.460.61数据可信
中间条件6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%
5min1319836-31983660.79061.379.8260.7961.379.82
2273175-27317551.92151.92
3318690-31869060.57260.57
4352924-35292467.07967.08
5361419-36141968.69368.69
6311289-31128959.16559.17
10min1406232-40623277.21180.704.8177.3180.804.82
2395132-39513275.10175.19
3427150-42715081.18681.29
4444676-44467684.51784.63
5445855-44585584.74184.86
6428515-42851581.44681.54
15min1449757-44975785.48387.402.0185.7187.642.02
2447378-44737885.03185.24
3464464-46446488.27888.51
4470377-47037789.40289.65
5461648-46164887.74388.00
6465539-46553988.48388.72
20min1470547-47054789.43590.371.3989.8190.751.40
2468083-46808388.96689.32
3479946-47994691.22191.60
4484543-48454392.09592.50
5470633-47063389.45189.85
6479098-47909891.06091.44
30min1498718-49871894.78994.021.4595.3194.551.44
2490683-49068393.26293.76
3497825-49782594.61995.15
4502980-50298095.59996.15
5482701-48270191.74592.30
6495090-49509094.09994.63
45min1520172-52017298.86797.392.1199.5598.082.09
2513725-51372597.64198.30
3517370-51737098.33499.03
4518662-51866298.58099.29
5491122-49112293.34594.05
6513378-51337897.57598.27
60min1531078-531078100.93999.112.57101.7899.962.55
2527022-527022100.168100.99
3524879-52487999.761100.62
4526517-526517100.073100.95
5494530-49453093.99394.85
6524582-52458299.705100.56
极限1536128-536128101.899100.581.29102.91101.601.28
2534181-534181101.529102.52
3529280-529280100.598101.62
4532349-532349101.181102.23
5517519-51751998.36299.38
6525542-52554299.887100.91
氢氯噻嗪坎地沙坦酯片项目信息
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%
116.521521951521551523311523971521531522460.08
216.491518301517101517700.06
单位质量响应值RSD%判断
9215.869203.760.10数据可信
中间条件6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%
5min166382-6638240.46340.168.5040.4640.168.50
257021-5702134.75734.76
364939-6493939.58339.58
471014-7101443.28643.29
572545-7254544.21944.22
663407-6340738.64938.65
10min1104500-10450063.69765.794.4163.7665.864.41
2101364-10136461.78561.84
3107090-10709065.27665.34
4113736-11373669.32769.40
5112776-11277668.74268.82
6108123-10812365.90565.97
15min1124144-12414475.67177.001.9275.8477.181.93
2124456-12445675.86176.02
3124991-12499176.18776.36
4129995-12999579.23779.42
5125703-12570376.62176.81
6128659-12865978.42378.60
20min1134892-13489282.22282.861.5382.5283.171.53
2135677-13567782.70182.99
3135295-13529582.46882.77
4138848-13884884.63384.95
5133119-13311981.14181.46
6137833-13783384.01584.32
30min1145418-14541888.63888.661.6889.0789.101.67
2145875-14587588.91789.34
3145489-14548988.68189.12
4147774-14777490.07490.54
5140888-14088885.87786.33
6147269-14726989.76690.21
45min1153067-15306793.30192.471.9993.8993.061.98
2152523-15252392.96993.54
3152281-15228192.82193.41
4153677-15367793.67294.28
5145621-14562188.76289.36
6153035-15303593.28193.88
60min1156109-15610995.15593.702.0095.8994.451.98
2154828-15482894.37495.10
3153584-15358493.61694.36
4155032-15503294.49895.27
5147690-14769090.02390.77
6155105-15510594.54395.29
极限1158866-15886696.83595.461.2097.7396.361.19
2157616-15761696.07396.96
3156266-15626695.25096.15
4157315-15731595.89096.81
5153348-15334893.47294.36
6156219-15621995.22296.13
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