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%
111.904433154432144432364433454430634432350.03
212.024441334442084441700.02
单位质量响应值RSD%判断
37246.6436952.580.57数据可信
供试品溶液-2024052221批-8mg12.5mg-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%
5min1281265-28126554.42355.198.5854.4255.188.58
2243902-24390247.19347.19
3309668-30966859.91959.92
4304837-30483758.98458.98
5297688-29768857.60157.60
6273884-27388452.99552.99
10min1430764-43076483.35084.494.5783.4484.584.57
2412668-41266879.84879.93
3472973-47297391.51791.62
4438089-43808984.76784.87
5436220-43622084.40584.50
6429168-42916883.04183.13
15min1475890-47589092.08193.512.8292.3193.752.82
2469463-46946390.83891.05
3506829-50682998.06898.32
4484548-48454893.75794.00
5489070-48907094.63294.87
6473916-47391691.69991.93
20min1496976-49697696.16196.431.8196.5496.821.82
2491492-49149295.10095.46
3512861-51286199.23599.65
4496922-49692296.15196.55
5504122-50412297.54497.94
6487916-48791694.40894.79
30min1508835-50883598.45698.171.2299.0098.721.23
2504983-50498397.71198.23
3514193-51419399.493100.07
4502934-50293497.31497.87
5514226-51422699.499100.06
6499036-49903696.56097.10
45min1515669-51566999.77899.270.99100.4999.981.00
2511699-51169999.01099.69
3518408-518408100.308101.06
4509381-50938198.56299.28
5517434-517434100.120100.84
6505530-50553097.81698.51
60min1516391-51639199.91899.340.87100.79100.220.88
2510985-51098598.87299.72
3516287-51628799.898100.81
4509582-50958298.60199.48
5519203-519203100.462101.35
6508116-50811698.31799.18
极限1517249-517249100.08499.290.80101.12100.340.80
2510702-51070298.81799.83
3512931-51293199.249100.33
4510932-51093298.86299.91
5518781-518781100.380101.44
6508349-50834998.36299.39
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%
115.921548101548161550351549311548311548850.07
215.961554511554131554320.02
单位质量响应值RSD%判断
9728.969738.850.08数据可信
供试品溶液-2024052221批-8mg12.5mg-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%
5min1-0.0000.15244.950.000.15244.95
2-0.0000.00
3-0.0000.00
41593-15930.9190.92
5-0.0000.00
6-0.0000.00
10min14052-40522.3371.9629.112.341.9629.15
23127-31271.8031.80
31529-15290.8820.88
43668-36682.1152.12
53875-38752.2352.23
64184-41842.4132.41
15min15615-56153.2382.8916.643.242.9016.62
25106-51062.9452.95
33532-35322.0372.04
45760-57603.3223.33
54616-46162.6622.67
65460-54603.1493.15
20min15757-57573.3203.3410.873.333.3510.95
25669-56693.2693.28
34987-49872.8762.88
46789-67893.9153.93
55383-53833.1043.11
66190-61903.5703.58
30min17070-70704.0773.8711.944.093.8911.99
26736-67363.8853.90
35435-54353.1343.14
47877-78774.5434.56
56771-67713.9053.92
66408-64083.6963.71
45min17344-73444.2354.286.914.264.306.92
27786-77864.4904.51
36794-67943.9183.93
46915-69153.9884.01
57584-75844.3744.39
68128-81284.6884.71
60min18534-85344.9224.519.694.954.549.66
28340-83404.8104.84
36688-66883.8573.88
48517-85174.9124.94
57425-74254.2824.31
67420-74204.2794.31
极限18182-81824.7194.724.084.764.764.07
28100-81004.6714.71
38074-80744.6564.68
47939-79394.5794.62
57985-79854.6054.64
68847-88475.1025.14
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%
111.904424124424564427584425524427584425870.04
212.024396554376604386580.33
单位质量响应值RSD%判断
37192.1836494.011.34数据可信
供试品溶液-2024052221批-8mg12.5mg-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%
5min1307715-30771559.96059.054.9559.9659.044.95
2299568-29956858.37258.37
3322556-32255662.85162.85
4277145-27714554.00354.00
5302127-30212758.87158.87
6309026-30902660.21560.22
10min1448570-44857087.40686.792.3987.5186.892.39
2448813-44881387.45387.55
3440583-44058385.85085.95
4426864-42686483.17683.27
5449554-44955487.59887.70
6457967-45796789.23789.34
15min1487242-48724294.94195.042.3895.1995.282.38
2491306-49130695.73395.98
3485995-48599594.69894.95
4466691-46669190.93791.17
5494713-49471396.39796.64
6500475-50047597.52097.77
20min1501449-50144997.71097.221.7198.1197.621.71
2503110-50311098.03398.44
3498058-49805897.04997.45
4482589-48258994.03594.41
5501853-50185397.78898.19
6506657-50665798.72499.14
30min1510221-51022199.41999.220.6399.9999.790.64
2508886-50888699.15999.72
3512633-51263399.889100.46
4503840-50384098.17698.71
5507843-50784398.95699.52
6511911-51191199.748100.32
45min1515681-515681100.48399.820.72101.22100.550.72
2512276-51227699.819100.55
3515123-515123100.374101.11
4510312-51031299.437100.14
5505941-50594198.58599.32
6514265-514265100.207100.95
60min1514050-514050100.16599.830.39101.06100.720.39
2511104-51110499.591100.49
3513280-513280100.015100.92
4512454-51245499.854100.72
5509019-50901999.185100.08
6513960-513960100.147101.06
极限1513117-51311799.98399.580.68101.05100.640.67
2507041-50704198.79999.86
3514810-514810100.313101.38
4511528-51152899.674100.71
5506558-50655898.70599.77
6513185-51318599.996101.07
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%
115.921548391550231550991550481546351549290.13
215.961539201540221539710.05
单位质量响应值RSD%判断
9731.729647.310.62数据可信
供试品溶液-2024052221批-8mg12.5mg-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min13672-36722.1272.199.702.132.199.71
23305-33051.9151.91
33961-39612.2952.29
44403-44032.5512.55
53669-36692.1262.13
63714-37142.1522.15
15min15652-56523.2752.9110.223.282.9110.19
25039-50392.9192.92
34911-49112.8452.85
44629-46292.6822.69
54328-43282.5082.51
65539-55393.2093.21
20min16241-62413.6163.435.343.623.445.32
25626-56263.2603.27
35862-58623.3963.40
45712-57123.3093.32
55732-57323.3213.33
66399-63993.7073.72
30min16478-64783.7533.667.273.773.677.27
26690-66903.8763.89
36407-64073.7123.73
45601-56013.2453.26
55919-59193.4293.44
66771-67713.9233.94
45min17291-72914.2244.134.374.254.154.35
26839-68393.9623.98
37430-74304.3054.33
47249-72494.2004.22
57286-72864.2214.24
66637-66373.8453.87
60min18273-82734.7934.657.534.824.687.51
27724-77244.4754.50
38409-84094.8724.90
48041-80414.6594.69
58733-87335.0605.09
67012-70124.0634.09
极限18833-88335.1184.758.125.154.788.05
28214-82144.7594.79
38383-83834.8574.89
46947-69474.0254.06
58652-86525.0135.05
68152-81524.7234.76
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%
111.904495604492614488134488574487234490430.08
212.024442564447224444890.08
单位质量响应值RSD%判断
37734.7136979.121.44数据可信
供试品溶液-2024052221批-8mg12.5mg-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%
5min1300367-30036757.72464.9611.8157.7264.9611.81
2299058-29905857.47257.47
3368940-36894070.90270.90
4306164-30616458.83858.84
5382200-38220073.45073.45
6371269-37126971.34971.35
10min1424722-42472281.62286.844.5481.7286.954.54
2427469-42746982.15082.25
3463956-46395689.16289.28
4457798-45779887.97888.08
5465937-46593789.54289.66
6471469-47146990.60590.72
15min1472374-47237490.77992.592.0991.0192.842.09
2467250-46725089.79590.03
3487504-48750493.68793.95
4494040-49404094.94395.19
5485520-48552093.30693.58
6484160-48416093.04493.31
20min1478847-47884792.02393.901.5792.4194.311.57
2483590-48359092.93593.32
3492088-49208894.56894.99
4500636-50063696.21196.61
5490981-49098194.35594.78
6485510-48551093.30493.73
30min1487374-48737493.66294.981.3294.2095.541.31
2497913-49791395.68796.22
3496811-49681195.47696.06
4504153-50415396.88797.45
5489339-48933994.04094.62
6489749-48974994.11894.70
45min1492079-49207994.56695.841.2095.2696.561.19
2504885-50488597.02797.72
3500304-50030496.14796.89
4506090-50609097.25997.98
5495319-49531995.18995.93
6493521-49352194.84395.58
60min1492253-49225394.60095.700.8995.4596.580.89
2503980-50398096.85397.71
3500166-50016696.12097.02
4500904-50090496.26297.15
5494821-49482195.09395.99
6495595-49559595.24296.14
极限1515685-51568599.103100.191.29100.11101.231.28
2529657-529657101.788102.81
3527134-527134101.303102.36
4512523-51252398.49599.54
5523877-523877100.677101.74
6519121-51912199.763100.82
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%
115.921554971551191549501549581548201550690.17
215.961534891537931536410.14
单位质量响应值RSD%判断
9740.529626.630.84数据可信
供试品溶液-2024052221批-8mg12.5mg-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%
5min160186-6018634.89239.0812.5834.8939.0812.58
258889-5888934.14034.14
373998-7399842.90042.90
460029-6002934.80134.80
575719-7571943.89743.90
675617-7561743.83843.84
10min1100729-10072958.39762.876.5258.4562.946.53
299763-9976357.83657.89
3114296-11429666.26266.33
4106634-10663461.82061.88
5114087-11408766.14166.21
6115200-11520066.78666.86
15min1122881-12288171.23974.433.5271.3974.603.53
2122471-12247171.00171.15
3132499-13249976.81577.00
4129829-12982975.26775.43
5131703-13170376.35376.54
6130923-13092375.90176.09
20min1134599-13459978.03280.672.4178.3180.962.42
2135231-13523178.39978.67
3141894-14189482.26182.57
4141962-14196282.30182.59
5141089-14108981.79582.11
6140107-14010781.22581.54
30min1145314-14531484.24486.441.6484.6586.871.65
2147569-14756985.55285.95
3150584-15058487.29987.75
4152360-15236088.32988.75
5149443-14944386.63887.08
6149357-14935786.58887.03
45min1150236-15023687.09889.241.4187.6489.811.41
2153799-15379989.16389.71
3154546-15454689.59690.19
4156966-15696690.99991.57
5154186-15418689.38889.98
6153848-15384889.19289.78
60min1151724-15172487.96089.721.0688.6590.441.07
2154332-15433289.47290.17
3155780-15578090.31291.05
4156312-15631290.62091.34
5154921-15492189.81490.55
6155504-15550490.15290.89
极限1158388-15838891.82493.681.3492.6694.551.34
2163102-16310294.55795.40
3164281-16428195.24096.13
4160383-16038392.98093.85
5162736-16273694.34495.23
6160651-16065193.13694.03
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%
111.904414874422634431154439274439524429490.25
212.024434094431864432980.04
单位质量响应值RSD%判断
37222.6136880.030.66数据可信
供试品溶液-2024052221批-8mg12.5mg-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%
5min1339400-33940065.75762.2712.1865.7662.2712.18
2335599-33559965.02165.02
3249698-24969848.37848.38
4303924-30392458.88458.88
5344891-34489166.82166.82
6355022-35502268.78468.78
10min1467499-46749990.57681.457.4190.6981.557.42
2427503-42750382.82782.94
3372301-37230172.13272.21
4405744-40574478.61178.71
5427526-42752682.83282.94
6421747-42174781.71281.83
15min1485441-48544194.05287.933.5694.3188.163.56
2453486-45348687.86188.11
3442660-44266085.76485.96
4451870-45187087.54887.78
5446412-44641286.49186.74
6443057-44305785.84186.09
20min1488414-48841494.62889.982.9195.0590.372.90
2463802-46380289.86090.25
3464020-46402089.90290.25
4466969-46696990.47390.85
5450777-45077787.33687.73
6452625-45262587.69488.09
30min1492574-49257495.43492.112.4596.0192.642.44
2469870-46987091.03691.58
3480811-48081193.15593.65
4481450-48145093.27993.80
5461000-46100089.31789.86
6466763-46676390.43490.97
45min1490819-49081995.09492.872.5295.8393.562.51
2474747-47474791.98092.67
3490783-49078395.08795.74
4488177-48817794.58295.26
5465816-46581690.25090.94
6465750-46575090.23790.93
60min1488429-48842994.63192.582.5995.5293.422.57
2473413-47341391.72292.57
3489358-48935894.81195.62
4488169-48816994.58195.42
5463741-46374189.84890.69
6463855-46385589.87090.71
极限1509730-50973098.758100.091.1399.81101.091.11
2523339-523339101.395102.40
3518452-518452100.448101.41
4522193-522193101.173102.17
5515857-51585799.945100.93
6510100-51010098.83099.82
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%
115.921539171543131544331546671548671544390.24
215.961543901545141544520.06
单位质量响应值RSD%判断
9700.949677.440.18数据可信
供试品溶液-2024052221批-8mg12.5mg-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%
5min165933-6593338.20036.989.9938.2036.9810.00
267500-6750039.10839.11
352734-5273430.55330.55
460103-6010334.82334.82
566375-6637538.45738.46
670303-7030340.73240.73
10min1111607-11160764.66360.156.2864.7360.216.28
2106574-10657461.74761.81
392109-9210953.36653.42
4102182-10218259.20359.26
5104832-10483260.73860.80
6105554-10555461.15661.22
15min1131517-13151776.19971.393.7776.3771.553.78
2124116-12411671.91172.08
3117470-11747068.06068.20
4122828-12282871.16571.32
5121534-12153470.41570.58
6121791-12179170.56470.73
20min1141915-14191582.22377.733.0082.5278.013.00
2133982-13398277.62777.91
3132612-13261276.83377.09
4134054-13405477.66977.94
5130596-13059675.66575.95
6131784-13178476.35376.64
30min1151518-15151887.78784.022.6388.2284.432.62
2143570-14357083.18283.60
3145907-14590784.53684.92
4146204-14620484.70885.11
5140946-14094681.66282.07
6141990-14199082.26782.68
45min1154963-15496389.78386.882.8290.3687.432.80
2149273-14927386.48687.04
3153076-15307688.69089.21
4152272-15227288.22488.77
5145433-14543384.26184.81
6144671-14467183.82084.37
60min1155398-15539890.03587.223.0090.7787.912.98
2150016-15001686.91787.62
3154010-15401089.23189.90
4153370-15337088.86089.55
5145781-14578184.46385.15
6144623-14462383.79284.48
极限1160839-16083993.18793.431.3694.0794.271.35
2163634-16363494.80795.65
3162159-16215993.95294.77
4163227-16322794.57195.41
5159675-15967592.51393.34
6157974-15797491.52892.36
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