坎地氢噻片项目信息
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(%)99.70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%
112.694852584852534853724850914853264852600.03
212.714838234835344836780.05
单位质量响应值RSD%判断
38239.5638054.920.35数据可信
供试品溶液-2024082821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%
5min1364665-36466568.62274.6410.5768.6274.6410.57
2402535-40253575.74875.75
3442496-44249683.26883.27
4386025-38602572.64172.64
5339749-33974963.93363.93
6444278-44427883.60383.60
10min1482626-48262690.81992.175.1290.9392.305.13
2484910-48491091.24991.38
3520379-52037997.92398.06
4478803-47880390.10090.22
5454625-45462585.55085.66
6517535-51753597.38897.53
15min1512016-51201696.35096.083.1896.6296.363.19
2498741-49874193.85294.13
3532401-532401100.186100.49
4505024-50502495.03495.31
5489674-48967492.14692.39
6525723-52572398.92999.23
20min1522881-52288198.39497.252.6398.8297.692.64
2503168-50316894.68595.12
3533764-533764100.442100.91
4515229-51522996.95497.38
5499170-49917093.93294.34
6526612-52661299.09699.56
30min1530602-53060299.84797.952.34100.4498.552.35
2505455-50545595.11595.71
3534175-534175100.520101.16
4519730-51973097.80198.39
5506714-50671495.35295.91
6526452-52645299.06699.70
45min1534158-534158100.51697.972.32101.2798.732.33
2506032-50603295.22495.97
3532470-532470100.199101.00
4519933-51993397.84098.59
5507233-50723395.45096.17
6523979-52397998.60199.40
60min1532653-532653100.23397.842.30101.1698.772.30
2505091-50509195.04795.96
3531701-531701100.054101.02
4518523-51852397.57498.49
5507083-50708395.42196.30
6524644-52464498.72699.69
极限1539136-539136101.453100.731.09102.54101.821.10
2528182-52818299.392100.46
3543468-543468102.268103.41
4536709-536709100.996102.08
5529521-52952199.644100.68
6534779-534779100.633101.76
坎地氢噻片项目信息
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(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
116.343012933011493013093013453016793013550.07
216.283013183011603012390.04
单位质量响应值RSD%判断
18442.7818503.620.24数据可信
供试品溶液-2024082821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%
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
10min12587-25870.7860.699.470.790.699.73
22068-20680.6280.63
32444-24440.7430.74
42049-20490.6230.62
52187-21870.6650.66
62354-23540.7150.72
15min14972-49721.5111.4510.001.511.4510.07
25016-50161.5241.53
35455-54551.6581.66
44216-42161.2811.28
54277-42771.3001.30
64654-46541.4141.42
20min15591-55911.6991.826.011.701.826.12
26379-63791.9381.94
36455-64551.9621.97
45663-56631.7211.72
55876-58761.7861.79
65965-59651.8131.82
30min16951-69512.1122.125.842.122.135.87
27534-75342.2892.30
37425-74252.2562.26
46539-65391.9871.99
56645-66452.0192.03
66839-68392.0782.08
45min17036-70362.1382.355.942.152.365.92
28451-84512.5682.58
37942-79422.4132.42
47616-76162.3142.32
57751-77512.3552.37
67698-76982.3392.35
60min19013-90132.7392.525.592.752.535.54
27996-79962.4302.44
37817-78172.3752.39
47949-79492.4162.43
58639-86392.6252.64
68286-82862.5182.53
极限19284-92842.8212.734.232.842.754.25
29375-93752.8492.87
38766-87662.6642.68
48706-87062.6462.66
58487-84872.5792.60
69309-93092.8292.85
坎地氢噻片项目信息
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(%)99.70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%
112.694833154829584830284828334827354829740.05
212.714813544814854814200.02
单位质量响应值RSD%判断
38059.4237877.260.34数据可信
供试品溶液-2024083021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%
5min1289428-28942854.72060.0410.7854.7260.0410.78
2305705-30570557.79857.80
3288386-28838654.52354.52
4380370-38037071.91471.91
5313627-31362759.29659.30
6328029-32802962.01862.02
10min1433056-43305681.87585.895.5681.9785.995.56
2445183-44518384.16884.26
3426374-42637480.61280.70
4495264-49526493.63793.76
5458435-45843586.67386.77
6467348-46734888.35988.46
15min1496790-49679093.92595.042.1494.1595.282.16
2502013-50201394.91395.15
3487157-48715792.10492.33
4519238-51923898.16998.45
5503128-50312895.12395.37
6507840-50784096.01496.26
20min1513147-51314797.01897.781.0197.4098.181.02
2516764-51676497.70198.10
3511057-51105796.62297.00
4525395-52539599.33399.77
5516196-51619697.59498.00
6520617-52061798.43098.84
30min1523842-52384299.04099.660.5799.59100.230.57
2524936-52493699.24699.80
3530219-530219100.245100.79
4529927-529927100.190100.80
5524648-52464899.19299.76
6529243-529243100.061100.64
45min1530709-530709100.338100.760.52101.05101.500.52
2530583-530583100.314101.04
3536692-536692101.469102.18
4532805-532805100.734101.51
5531017-531017100.396101.13
6535994-535994101.337102.08
60min1534068-534068100.973101.180.71101.85102.080.69
2531496-531496100.487101.38
3541490-541490102.376103.25
4532185-532185100.617101.56
5534186-534186100.995101.89
6537680-537680101.656102.57
极限1534637-534637101.081101.110.88102.13102.180.86
2531102-531102100.412101.47
3542559-542559102.578103.62
4530838-530838100.362101.47
5531709-531709100.527101.59
6537901-537901101.698102.78
坎地氢噻片项目信息
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(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
116.343018073018963016293014643017003016990.06
216.283011763012363012060.02
单位质量响应值RSD%判断
18463.8318501.600.15数据可信
供试品溶液-2024083021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%
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
10min13413-34131.0371.058.681.041.058.86
23559-35591.0811.08
33613-36131.0971.10
43904-39041.1861.19
53042-30420.9240.92
63249-32490.9870.99
15min15693-56931.7291.705.131.731.705.12
25831-58311.7711.77
35650-56501.7161.72
45653-56531.7171.72
55034-50341.5291.53
65757-57571.7491.75
20min16306-63061.9152.054.531.922.064.48
27019-70192.1322.14
37035-70352.1372.14
46718-67182.0402.05
56498-64981.9741.98
66979-69792.1202.12
30min18028-80282.4382.455.462.452.465.49
28337-83372.5322.54
38585-85852.6082.62
48404-84042.5532.56
57637-76372.3202.33
67494-74942.2762.28
45min18530-85302.5912.713.032.602.723.12
28987-89872.7302.74
39000-90002.7342.75
49262-92622.8132.83
58659-86592.6302.64
69043-90432.7472.76
60min18815-88152.6772.845.382.692.865.41
29512-95122.8892.91
39696-96962.9452.96
49641-96412.9282.95
58600-86002.6122.63
69774-97742.9692.99
极限18745-87452.6562.786.802.682.806.71
210074-100743.0603.08
39482-94822.8802.90
48977-89772.7272.75
58292-82922.5192.54
69357-93572.8422.86
坎地氢噻片项目信息
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(%)99.70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%
112.694812104819574819134821414823164819070.09
212.714817204817124817160.01
单位质量响应值RSD%判断
37975.3337900.550.14数据可信
供试品溶液-2024090121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%
5min1298726-29872656.52358.743.6556.5258.743.64
2317178-31717860.01560.01
3329638-32963862.37262.37
4305139-30513957.73757.74
5302843-30284357.30257.30
6309160-30916058.49858.50
10min1439197-43919783.10286.592.7483.2086.692.73
2462300-46230087.47487.57
3468764-46876488.69788.80
4445549-44554984.30484.40
5469540-46954088.84488.94
6460498-46049887.13387.23
15min1496217-49621793.89195.381.2394.1295.621.24
2503536-50353695.27695.52
3510946-51094696.67896.93
4497846-49784694.20094.44
5510497-51049796.59396.84
6505367-50536795.62395.87
20min1508969-50896996.30497.771.0496.6998.171.04
2520529-52052998.49298.90
3520727-52072798.52998.94
4511420-51142096.76897.16
5521586-52158698.69299.10
6516909-51690997.80798.21
30min1521738-52173898.72099.530.6699.27100.100.67
2528668-528668100.032100.60
3528512-528512100.002100.58
4521669-52166998.70799.26
5528915-528915100.078100.65
6526719-52671999.663100.23
45min1528714-528714100.040100.770.64100.75101.500.65
2534619-534619101.158101.89
3533721-533721100.988101.73
4527965-52796599.899100.62
5536015-536015101.422102.16
6534508-534508101.137101.87
60min1530785-530785100.432100.810.54101.31101.700.55
2535742-535742101.370102.27
3532749-532749100.804101.72
4528379-52837999.977100.86
5535795-535795101.380102.29
6533177-533177100.885101.78
极限1530831-530831100.441100.600.61101.49101.660.61
2534810-534810101.194102.27
3531575-531575100.582101.66
4526188-52618899.562100.62
5535024-535024101.234102.31
6531546-531546100.576101.64
坎地氢噻片项目信息
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(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
116.343013143014373015393014593017073014910.05
216.283018293017463017880.02
单位质量响应值RSD%判断
18451.1018537.350.33数据可信
供试品溶液-2024090121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%
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
10min13033-30330.9211.029.840.921.029.77
23894-38941.1821.18
33464-34641.0511.05
42991-29910.9080.91
53334-33341.0121.01
63449-34491.0471.05
15min15377-53771.6321.6611.061.631.6611.11
25750-57501.7451.75
35925-59251.7981.80
45349-53491.6241.63
56040-60401.8331.84
64375-43751.3281.33
20min15728-57281.7392.028.401.742.028.38
26271-62711.9041.91
37108-71082.1582.16
46840-68402.0762.08
57213-72132.1892.19
66722-67222.0402.04
30min18184-81842.4842.307.542.492.317.51
27759-77592.3552.36
38002-80022.4292.44
47817-78172.3732.38
56803-68032.0652.07
66949-69492.1092.12
45min18615-86152.6152.616.272.632.626.31
29275-92752.8152.83
38893-88932.6992.71
47935-79352.4092.42
58888-88882.6982.71
67980-79802.4222.43
60min19032-90322.7422.798.912.762.808.94
210092-100923.0633.08
310010-100103.0383.06
48385-83852.5452.56
58128-81282.4672.48
69433-94332.8632.88
极限19208-92082.7952.873.472.822.903.41
29013-90132.7362.76
39633-96332.9242.95
49365-93652.8432.86
59749-97492.9592.98
69853-98532.9913.01
坎地氢噻片项目信息
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(%)99.70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%
112.694824154825404824144822144826514824470.04
212.714793124787714790420.08
单位质量响应值RSD%判断
38017.8937690.170.62数据可信
供试品溶液-516246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%
5min1230981-23098143.80343.279.5443.8043.279.54
2230884-23088443.78443.78
3268228-26822850.86650.87
4217232-21723241.19541.20
5207535-20753539.35639.36
6214065-21406540.59540.59
10min1396164-39616475.12778.354.6175.2078.424.61
2428485-42848581.25781.33
3437947-43794783.05183.14
4388704-38870473.71373.78
5419655-41965579.58279.65
6407862-40786277.34677.41
15min1460610-46061087.34988.642.8587.5588.842.85
2477224-47722490.49990.71
3480247-48024791.07391.30
4447009-44700984.77084.96
5478315-47831590.70690.90
6461164-46116487.45487.65
20min1488988-48898892.73093.292.1393.0793.642.14
2495165-49516593.90294.26
3499453-49945394.71595.09
4474753-47475390.03190.36
5504801-50480195.72996.08
6488616-48861692.66093.00
30min1510933-51093396.89297.301.7297.3997.801.72
2513911-51391197.45797.97
3515532-51553297.76498.30
4499625-49962594.74895.23
5526873-52687399.915100.42
6511546-51154697.00897.50
45min1518023-51802398.23699.310.7298.9099.980.72
2522041-52204198.99899.68
3525541-52554199.662100.36
4523515-52351599.27899.92
5529363-529363100.387101.06
6523736-52373699.32099.98
60min1518651-51865198.35699.671.1199.18100.511.11
2524515-52451599.468100.31
3525558-52555899.665100.53
4525218-52521899.601100.41
5536269-536269101.697102.54
6523344-52334499.246100.07
极限1518969-51896998.41699.300.5699.40100.300.57
2524421-52442199.450100.46
3524541-52454199.473100.50
4524371-52437199.440100.41
5527627-527627100.058101.07
6521873-52187398.96799.96
坎地氢噻片项目信息
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(%)99.80对照品水分(%)0对照品稀释倍数1000
标示量(mg)16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%
116.343020463021983021333020303021613021140.03
216.283009923010863010390.03
单位质量响应值RSD%判断
18489.2318491.340.01数据可信
供试品溶液-516246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%
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
10min12388-23880.7250.8410.860.730.8410.61
22830-28300.8590.86
33172-31720.9630.96
43004-30040.9120.91
52474-24740.7510.75
62819-28190.8560.86
15min13952-39521.2001.2711.741.201.2711.77
25086-50861.5441.55
33742-37421.1361.14
43909-39091.1871.19
54002-40021.2151.22
64355-43551.3221.32
20min15469-54691.6601.5011.061.661.5011.12
25181-51811.5731.58
35579-55791.6941.70
44450-44501.3511.35
54344-43441.3191.32
64558-45581.3841.39
30min16419-64191.9491.837.891.951.837.78
25270-52701.6001.61
35720-57201.7371.74
45870-58701.7821.79
56396-63961.9421.95
66407-64071.9451.95
45min17418-74182.2522.265.002.262.274.96
27795-77952.3672.38
37988-79882.4252.43
47017-70172.1302.14
57235-72352.1972.21
67230-72302.1952.20
60min18912-89122.7062.556.622.722.566.65
28595-85952.6092.62
38922-89222.7092.72
48502-85022.5812.59
57776-77762.3612.37
67646-76462.3212.33
极限18373-83732.5422.627.602.562.647.52
29308-93082.8262.84
39027-90272.7412.76
49015-90152.7372.75
58529-85292.5892.61
67491-74912.2742.29
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