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%
112.464851794848194849654842114833964845140.15
212.324837354834284835820.05
单位质量响应值RSD%判断
38885.5539251.790.67数据可信
中间条件12月-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%
5min1406120-40612074.62170.9018.5374.6270.9018.52
2401197-40119773.71773.72
3433735-43373579.69579.70
4441059-44105981.04181.04
5387097-38709771.12671.13
6246025-24602545.20545.21
10min1478681-47868187.95483.709.3888.0883.829.40
2460404-46040484.59684.72
3482581-48258188.67088.80
4481138-48113888.40588.54
5459602-45960284.44884.57
6370889-37088968.14868.22
15min1484508-48450889.02486.495.6089.3086.755.62
2475041-47504187.28587.55
3487432-48743289.56289.84
4489296-48929689.90490.19
5468570-46857086.09686.36
6419461-41946177.07377.26
20min1486070-48607089.31287.863.8389.7388.263.86
2483393-48339388.82089.23
3488582-48858289.77390.20
4494640-49464090.88691.32
5472493-47249386.81787.22
6443902-44390281.56381.88
30min1488506-48850689.75989.752.0790.3390.302.10
2497728-49772891.45492.01
3493564-49356490.68891.27
4498333-49833391.56592.15
5477959-47795987.82188.37
6474652-47465287.21487.67
45min1490933-49093390.20590.781.4590.9291.481.47
2502600-50260092.34993.06
3495896-49589691.11791.85
4501241-50124192.09992.84
5484243-48424388.97689.67
6489450-48945089.93390.53
60min1490786-49078690.17891.031.3591.0591.881.35
2504191-50419192.64193.50
3497208-49720891.35892.24
4499770-49977091.82992.72
5485339-48533989.17790.02
6495289-49528991.00591.75
极限1521031-52103195.73596.300.7396.7597.300.72
2526333-52633396.71097.73
3519045-51904595.37096.41
4529246-52924697.24598.29
5522834-52283496.06797.06
6526227-52622796.69097.59
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%
115.891535031534651533181528951529241532210.20
215.921526431527001526720.03
单位质量响应值RSD%判断
9642.619589.950.39数据可信
中间条件12月-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%
5min186874-8687450.71548.1918.1850.7248.1918.18
284921-8492149.57549.58
391211-9121153.24753.25
494683-9468355.27455.27
584642-8464249.41249.41
652984-5298430.93130.93
10min1128187-12818774.83370.1410.4874.9270.2210.49
2119309-11930969.65069.73
3126848-12684874.05174.14
4127374-12737474.35874.45
5123878-12387872.31872.40
695332-9533255.65355.70
15min1137827-13782780.46177.086.4280.6777.286.44
2130078-13007875.93776.14
3136392-13639279.62379.84
4136787-13678779.85480.07
5135445-13544579.07079.27
6115650-11565067.51467.66
20min1144897-14489784.58881.204.5084.9381.524.52
2136872-13687279.90380.23
3141333-14133382.50782.85
4142259-14225983.04883.40
5141689-14168982.71583.05
6127462-12746274.41074.67
30min1148704-14870486.81085.202.4487.2985.662.47
2144157-14415784.15684.61
3146698-14669885.63986.12
4149558-14955887.30987.80
5146790-14679085.69386.17
6139790-13979081.60781.99
45min1151706-15170688.56387.521.4489.1988.121.47
2149279-14927987.14687.74
3151137-15113788.23188.86
4152240-15224088.87589.51
5148475-14847586.67787.29
6146684-14668485.63186.15
60min1153811-15381189.79288.351.5090.5789.101.54
2151585-15158588.49289.24
3152489-15248989.02089.79
4152643-15264389.11089.89
5150092-15009287.62188.38
6147477-14747786.09486.75
极限1155434-15543490.73991.450.9491.6792.350.94
2157631-15763192.02292.91
3155855-15585590.98591.91
4159204-15920492.94093.87
5155989-15598991.06391.97
6155833-15583390.97291.78
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%
112.464832514823594811254819294815874820500.17
212.324812994816434814710.06
单位质量响应值RSD%判断
38687.8039080.440.72数据可信
中间条件12月-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%
5min1278906-27890651.49060.6911.6051.4960.6911.60
2363129-36312967.03967.04
3293260-29326054.14054.14
4349929-34992964.60264.60
5316697-31669758.46758.47
6370570-37057068.41368.41
10min1421027-42102777.72881.545.0277.8181.645.03
2434498-43449880.21580.33
3415589-41558976.72476.81
4448783-44878382.85282.96
5456450-45645084.26784.36
6473725-47372587.45787.57
15min1459418-45941884.81585.843.6185.0386.073.61
2449529-44952982.99083.24
3443902-44390281.95182.17
4470446-47044686.85187.10
5482303-48230389.04089.28
6484054-48405489.36489.62
20min1468386-46838686.47187.123.3386.8387.503.33
2455956-45595684.17684.56
3452420-45242083.52383.88
4477987-47798788.24388.63
5490698-49069890.59090.98
6485900-48590089.70490.11
30min1491669-49166990.76989.253.1291.2789.783.12
2467164-46716486.24586.77
3462466-46246685.37885.87
4489249-48924990.32390.86
5500404-50040492.38292.92
6489811-48981190.42690.98
45min1506842-50684293.57190.493.3894.2291.173.37
2471658-47165887.07587.74
3469384-46938486.65587.29
4495846-49584691.54092.23
5506955-50695593.59194.28
6490406-49040690.53691.25
60min1508849-50884993.94190.883.1994.7591.703.17
2475314-47531487.75088.56
3473094-47309487.34088.12
4498037-49803791.94592.79
5508303-50830393.84094.69
6489992-48999290.46091.32
极限1536423-53642399.03296.052.45100.0097.032.43
2498650-49865092.05893.02
3519969-51996995.99496.92
4524767-52476796.88097.87
5526418-52641897.18598.19
6515559-51555995.18096.19
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%
115.891529441531251530671528261522581528440.23
215.921525611516121520860.45
单位质量响应值RSD%判断
9618.889553.140.49数据可信
中间条件12月-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%
5min158272-5827234.12640.9111.5634.1340.9111.56
276994-7699445.09045.09
363073-6307336.93736.94
476929-7692945.05245.05
567708-6770839.65239.65
676187-7618744.61744.62
10min1108917-10891763.78567.834.2663.8467.904.26
2115826-11582667.83167.91
3111571-11157165.33965.40
4117448-11744868.78168.86
5118753-11875369.54569.61
6122470-12247071.72271.80
15min1127523-12752374.68177.243.1274.8477.423.13
2127884-12788474.89275.08
3130333-13033376.32676.50
4132236-13223677.44177.63
5136117-13611779.71479.90
6137286-13728680.39880.59
20min1136605-13660579.99980.932.4480.2981.242.44
2133799-13379978.35678.67
3136760-13676080.09080.39
4137721-13772180.65380.97
5142999-14299983.74484.06
6141270-14127082.73183.06
30min1147360-14736086.29885.592.6486.7286.042.63
2140390-14039082.21682.66
3143877-14387784.25884.69
4145097-14509784.97385.43
5151042-15104288.45488.91
6149159-14915987.35187.82
45min1151813-15181388.90687.482.3489.4788.072.33
2144780-14478084.78785.37
3145763-14576385.36385.93
4149074-14907487.30287.90
5153456-15345689.86890.47
6151376-15137688.65089.26
60min1153290-15329089.77188.402.3890.4889.142.37
2145501-14550185.20985.93
3148615-14861587.03387.75
4150134-15013487.92288.66
5155389-15538991.00091.75
6152812-15281289.49190.25
极限1160744-16074494.13691.662.2795.0092.542.25
2150166-15016687.94188.81
3156981-15698191.93292.79
4156944-15694491.91092.80
5158407-15840792.76793.67
6155874-15587491.28492.19
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%
112.464793424798684794914795114799524796330.06
212.324812984809514811240.06
单位质量响应值RSD%判断
38493.8239052.271.02数据可信
中间条件12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%
5min1299028-29902855.36556.9710.9955.3656.9710.99
2267568-26756849.54049.54
3335579-33557962.13262.13
4283101-28310152.41652.42
5302028-30202855.92055.92
6358771-35877166.42666.43
10min1426365-42636578.94178.053.6479.0378.143.64
2401938-40193874.41874.50
3432747-43274780.12280.23
4423478-42347878.40678.49
5404602-40460274.91175.00
6440210-44021081.50481.61
15min1475968-47596888.12584.902.8388.3585.132.83
2444028-44402882.21182.42
3470273-47027387.07087.31
4457710-45771084.74484.96
5444861-44486182.36582.58
6458526-45852684.89585.14
20min1492578-49257891.20088.342.2491.5788.712.24
2466283-46628386.33286.68
3484870-48487089.77390.16
4479125-47912588.70989.07
5465186-46518686.12986.48
6474877-47487787.92388.31
30min1505634-50563493.61791.751.4294.1492.261.42
2488401-48840190.42790.91
3500101-50010192.59393.12
4498824-49882492.35792.86
5488877-48887790.51591.01
6491464-49146490.99491.53
45min1526520-52652097.48494.611.9898.1695.281.97
2499074-49907492.40393.04
3515595-51559595.46296.15
4514694-51469495.29595.96
5508062-50806294.06794.72
6501962-50196292.93893.62
60min1530247-53024798.17495.982.0999.0296.802.09
2501554-50155492.86293.65
3523664-52366496.95697.80
4526117-52611797.41098.23
5518895-51889596.07396.88
6509874-50987494.40295.24
极限1534208-53420898.90897.341.1299.9198.321.12
2521483-52148396.55297.50
3527227-52722797.61598.62
4527937-52793797.74798.73
5526415-52641597.46598.43
6517130-51713095.74696.74
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%
115.891513431513461522941514321515131515860.27
215.921530741523721527230.33
单位质量响应值RSD%判断
9539.719593.150.40数据可信
中间条件12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%
5min163099-6309937.02837.8710.1437.0337.8710.14
256945-5694533.41733.42
368508-6850840.20240.20
459751-5975135.06335.06
563625-6362537.33737.34
675248-7524844.15744.16
10min1109371-10937164.18163.513.8164.2463.573.81
2101439-10143959.52759.58
3111258-11125865.28965.36
4107004-10700462.79262.85
5107008-10700862.79562.86
6113234-11323466.44866.52
15min1130655-13065576.67174.362.8476.8474.532.85
2120815-12081570.89771.05
3130101-13010176.34676.52
4125664-12566473.74273.91
5125612-12561273.71273.88
6127496-12749674.81775.00
20min1141898-14189883.26980.622.3483.5780.922.34
2132208-13220877.58377.86
3139069-13906981.60981.91
4136739-13673980.24180.53
5136547-13654780.12980.42
6137850-13785080.89381.20
30min1151614-15161488.97086.491.8489.4186.921.84
2143556-14355684.24284.64
3148050-14805086.87987.32
4148161-14816186.94487.36
5147257-14725786.41486.84
6145685-14568585.49185.94
45min1158102-15810292.77890.181.7293.3690.751.71
2150911-15091188.55889.10
3153939-15393990.33590.92
4154436-15443690.62691.19
5153605-15360590.13990.71
6151067-15106788.64989.24
60min1158801-15880193.18891.021.7893.9391.741.78
2150648-15064888.40489.09
3154884-15488490.88991.62
4156652-15665291.92792.64
5155734-15573491.38892.11
6153889-15388990.30591.04
极限1160622-16062294.25792.271.2595.1593.141.25
2155576-15557691.29592.13
3155675-15567591.35492.24
4158411-15841192.95993.83
5156960-15696092.10892.98
6156156-15615691.63692.52
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%
112.464805594797124803634805194799234802150.08
212.324789714799464794580.15
单位质量响应值RSD%判断
38540.5338917.050.69数据可信
中间条件12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%
5min1311844-31184457.80257.7511.9257.8057.7511.92
2363027-36302767.28967.29
3314824-31482458.35458.35
4264584-26458449.04249.04
5275955-27595551.15051.15
6339133-33913362.86062.86
10min1439282-43928281.42380.274.7181.5280.374.71
2449502-44950283.31783.43
3436518-43651880.91181.01
4408559-40855975.72875.81
5408263-40826375.67475.76
6456246-45624684.56784.67
15min1479747-47974788.92388.211.8689.1688.441.87
2480391-48039189.04389.29
3475298-47529888.09988.33
4463973-46397386.00086.21
5467863-46786386.72186.93
6487964-48796490.44790.69
20min1493901-49390191.54791.001.1091.9391.381.11
2494659-49465991.68792.09
3484329-48432989.77390.15
4487789-48778990.41490.77
5486912-48691290.25290.61
6498193-49819392.34392.74
30min1506259-50625993.83893.230.7894.3793.760.79
2503944-50394493.40893.96
3496819-49681992.08892.62
4500434-50043492.75893.26
5502960-50296093.22693.73
6507541-50754194.07594.63
45min1513874-51387495.24995.200.9595.9495.890.94
2513951-51395195.26395.97
3504708-50470893.55094.23
4513773-51377395.23095.89
5519267-51926796.24996.91
6516199-51619995.68096.39
60min1519807-51980796.34996.351.2797.2097.191.25
2520239-52023996.42997.30
3508564-50856494.26595.10
4520352-52035296.45097.27
5529171-52917198.08498.91
6520637-52063796.50397.37
极限1519304-51930496.25696.601.4097.2697.611.38
2522401-52240196.83097.86
3508701-50870194.29095.29
4523170-52317096.97297.95
5531085-53108598.43999.42
6522439-52243996.83797.86
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%
115.891525761519891528771529551529571526710.27
215.921522421524981523700.12
单位质量响应值RSD%判断
9607.999570.980.28数据可信
中间条件12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%
5min163347-6334737.08436.9711.6837.0836.9711.69
274609-7460943.67743.68
363898-6389837.40637.41
453285-5328531.19431.19
557455-5745533.63533.63
666360-6636038.84838.85
10min1107970-10797063.20763.684.2363.2763.744.23
2113461-11346166.42166.49
3109241-10924163.95164.01
4102412-10241259.95360.00
5105345-10534561.67061.73
6114286-11428666.90466.97
15min1130573-13057376.43976.302.6376.6176.472.63
2132799-13279977.74277.93
3129092-12909275.57275.74
4124655-12465572.97473.13
5130266-13026676.25976.42
6134626-13462678.81178.99
20min1141450-14145082.80682.782.0383.1083.072.04
2142952-14295283.68584.00
3136890-13689080.13780.43
4139153-13915381.46181.73
5144140-14414084.38184.67
6143819-14381984.19384.50
30min1149476-14947687.50588.302.1787.9488.742.16
2151059-15105988.43188.88
3146046-14604685.49785.93
4150708-15070888.22688.64
5156107-15610791.38691.81
6151648-15164888.77689.22
45min1154490-15449090.44091.482.6591.0292.062.64
2156176-15617691.42792.03
3150623-15062388.17688.75
4156192-15619291.43691.99
5163370-16337095.63896.22
6156744-15674491.75992.36
60min1155456-15545691.00591.581.6291.7392.311.62
2155949-15594991.29492.05
3152742-15274289.41790.13
4156898-15689891.84992.56
5160511-16051193.96594.70
6157088-15708891.96192.71
极限1156489-15648991.61092.171.9892.4993.051.97
2157409-15740992.14993.05
3153230-15323089.70290.57
4157989-15798992.48893.35
5162810-16281095.31096.21
6156708-15670891.73892.64
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