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2000
标示量(mg)6.25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%
112.112411622411412410312410802410432410910.03
212.242402382400672401520.06
单位质量响应值RSD%判断
19908.4219620.261.04数据可信
中间条件36月-供试品溶液-2023021121批-坎地沙坦酯-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1131024-13102447.59050.995.1247.5950.995.12
2140375-14037550.98750.99
3137879-13787950.08050.08
4143094-14309451.97451.97
5137371-13737149.89649.90
6152533-15253355.40355.40
10min1250115-25011590.84695.473.5090.9395.563.50
2269054-26905497.72597.81
3273728-27372899.42399.51
4254156-25415692.31492.40
5267973-26797397.33397.42
6262024-26202495.17295.26
15min1274513-27451399.708100.201.4499.94100.451.44
2276303-276303100.358100.61
3282599-282599102.645102.89
4272720-27272099.05799.30
5277555-277555100.813101.06
6271540-27154098.62898.88
20min1275892-275892100.209100.451.42100.61100.861.42
2276411-276411100.398100.81
3283261-283261102.886103.31
4272987-27298799.15499.56
5278207-278207101.050101.46
6272612-27261299.01899.43
30min1274547-27454799.721100.321.26100.28100.901.26
2275821-275821100.183100.77
3282449-282449102.591103.18
4272721-27272199.05799.63
5277499-277499100.793101.37
6274155-27415599.578100.16
45min1274907-27490799.851100.461.19100.58101.201.19
2276035-276035100.261101.01
3282386-282386102.568103.33
4272836-27283699.09999.84
5277875-277875100.929101.68
6275410-275410100.034100.78
60min1274457-27445799.688100.321.18100.58101.231.19
2275502-275502100.068100.98
3281940-281940102.406103.34
4272396-27239698.93999.84
5277443-277443100.773101.69
6275420-275420100.038100.95
极限1273712-27371299.417100.151.20100.48101.231.20
2275072-27507299.911100.99
3281449-281449102.228103.33
4271692-27169298.68499.75
5276752-276752100.522101.61
6275670-275670100.129101.21
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%
115.557544174972750157503075172751260.26
215.727517674970750730.20
单位质量响应值RSD%判断
4831.254775.640.82数据可信
中间条件36月-供试品溶液-2023021121批-氢氯噻嗪-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118451-1845121.56422.173.9621.5622.173.95
218856-1885622.03822.04
318525-1852521.65121.65
419418-1941822.69422.69
518313-1831321.40321.40
620272-2027223.69323.69
10min146079-4607953.85456.222.7153.8956.262.71
248879-4887957.12657.16
349105-4910557.39157.43
446985-4698554.91354.95
548256-4825656.39856.43
649326-4932657.64957.69
15min162634-6263473.20273.781.3473.3373.921.34
263427-6342774.12974.26
364391-6439175.25675.39
461861-6186172.29972.43
563303-6330373.98474.11
663174-6317473.83373.97
20min169839-6983981.62381.991.2281.8782.241.22
269740-6974081.50781.76
371626-7162683.71283.97
469373-6937381.07881.33
570699-7069982.62882.88
669625-6962581.37381.63
30min176228-7622889.09089.371.1089.4789.761.10
275890-7589088.69589.09
377888-7788891.03091.43
475626-7562688.38688.77
577027-7702790.02490.41
676170-7617089.02289.42
45min180331-8033193.88593.661.1694.4294.201.16
279880-7988093.35893.90
381599-8159995.36795.92
478858-7885892.16492.70
580515-8051594.10094.64
679637-7963793.07493.62
60min180777-8077794.40794.651.1295.1095.341.11
280395-8039593.96094.65
382386-8238696.28796.99
480241-8024193.78094.47
581796-8179695.59896.30
680291-8029193.83994.54
极限181386-8138695.11894.691.2795.9695.541.26
280500-8050094.08394.93
382534-8253496.46097.33
479863-7986393.33894.18
581669-8166995.44996.31
680149-8014993.67394.53
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2000
标示量(mg)6.25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%
112.112408722405932408042406522407572407360.05
212.242430422430182430300.01
单位质量响应值RSD%判断
19879.1119855.390.09数据可信
中间条件36月-供试品溶液-2023021121批-坎地沙坦酯-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1151244-15124454.64752.556.3154.6552.556.30
2154354-15435455.77155.77
3139870-13987050.53850.54
4155213-15521356.08156.08
5135301-13530148.88748.89
6136645-13664549.37249.37
10min1271096-27109697.95295.293.2798.0495.383.27
2259814-25981493.87693.97
3271441-27144198.07798.16
4268832-26883297.13497.23
5262013-26201394.67094.75
6249130-24913090.01590.10
15min1277221-277221100.165100.320.73100.42100.560.73
2275940-27594099.70299.95
3281433-281433101.687101.93
4278090-278090100.479100.73
5276197-27619799.795100.03
6276975-276975100.076100.31
20min1277312-277312100.198100.420.70100.62100.840.69
2276821-276821100.021100.44
3281320-281320101.646102.06
4278380-278380100.584101.01
5275669-27566999.604100.01
6278137-278137100.496100.90
30min1276149-27614999.778100.240.71100.37100.820.71
2276854-276854100.032100.61
3281098-281098101.566102.15
4277736-277736100.351100.94
5275610-27561099.583100.15
6277114-277114100.126100.69
45min1276185-27618599.791100.220.69100.55100.970.69
2276522-27652299.912100.66
3280795-280795101.456102.21
4277906-277906100.413101.17
5275381-27538199.500100.24
6277491-277491100.263101.00
60min1276569-27656999.929100.100.71100.85101.020.71
2276180-27618099.789100.70
3280680-280680101.415102.34
4277170-277170100.147101.07
5274822-27482299.298100.20
6276891-276891100.046100.95
极限1275394-27539499.50599.760.69100.59100.850.69
2275379-27537999.499100.58
3279598-279598101.024102.12
4276450-27645099.886100.98
5274018-27401899.008100.08
6275840-27584099.666100.73
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%
115.557564175295753497537675311753940.19
215.727611976015760670.10
单位质量响应值RSD%判断
4848.494838.870.15数据可信
中间条件36月-供试品溶液-2023021121批-氢氯噻嗪-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min120323-2032323.55422.825.6923.5522.825.68
220717-2071724.01124.01
318852-1885221.84921.85
420970-2097024.30424.30
518284-1828421.19121.19
618996-1899622.01622.02
10min150286-5028658.28156.663.4258.3256.703.43
249273-4927357.10757.15
349778-4977857.69257.73
450256-5025658.24658.29
547622-4762255.19355.23
646132-4613253.46653.50
15min164557-6455774.82174.191.6274.9674.321.62
263956-6395674.12474.26
365486-6548675.89776.03
464338-6433874.56774.70
563097-6309773.12973.26
662635-6263572.59372.72
20min171263-7126382.59382.301.0482.8582.561.04
271126-7112682.43482.69
372011-7201183.46083.72
471273-7127382.60482.87
569843-6984380.94781.20
670562-7056281.78082.03
30min176104-7610488.20389.371.0388.6089.761.03
277858-7785890.23690.63
377917-7791790.30590.70
477501-7750189.82390.22
576242-7624288.36388.75
677029-7702989.27689.66
45min180038-8003892.76393.341.3393.3193.881.32
281056-8105693.94394.49
382172-8217295.23695.78
480478-8047893.27393.82
578963-7896391.51792.05
680513-8051393.31393.85
60min182153-8215395.21494.491.1595.9195.191.15
281100-8110093.99494.70
382929-8292996.11496.82
481392-8139294.33295.04
580192-8019292.94193.63
681413-8141394.35795.04
极限181211-8121194.12294.080.7194.9894.940.71
281086-8108693.97894.84
381800-8180094.80595.67
481500-8150094.45795.32
580128-8012892.86793.71
681333-8133394.26495.11
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2000
标示量(mg)6.25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%
112.112420332417252415462414242409262415310.17
212.242405122403822404470.04
单位质量响应值RSD%判断
19944.7619644.361.08数据可信
中间条件36月-供试品溶液-2023021221批-坎地沙坦酯-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1129561-12956146.98744.896.6546.9944.896.65
2129954-12995447.13047.13
3113738-11373841.24941.25
4130616-13061647.37047.37
5125772-12577245.61345.61
6113063-11306341.00441.00
10min1258779-25877993.85092.222.5593.9392.302.55
2255769-25576992.75992.84
3253953-25395392.10092.17
4257306-25730693.31693.40
5241582-24158287.61487.69
6258357-25835793.69793.77
15min1270592-27059298.13599.640.8398.3799.870.83
2273648-27364899.24399.48
3276288-276288100.200100.42
4275410-27541099.882100.12
5276205-276205100.170100.39
6276336-276336100.218100.44
20min1271082-27108298.31299.710.8698.71100.100.85
2273658-27365899.24699.64
3276028-276028100.106100.50
4274741-27474199.639100.04
5277779-277779100.741101.13
6276268-276268100.193100.58
30min1271066-27106698.30699.790.8198.87100.340.80
2274785-27478599.655100.22
3276142-276142100.147100.70
4275081-27508199.763100.33
5277465-277465100.627101.18
6276326-276326100.214100.77
45min1270705-27070598.17599.680.8498.90100.410.84
2274031-27403199.382100.11
3276029-276029100.106100.83
4275207-27520799.808100.54
5277291-277291100.564101.29
6275935-275935100.072100.80
60min1270421-27042198.07299.560.8498.96100.460.83
2273857-27385799.319100.21
3276448-276448100.258101.15
4274399-27439999.515100.41
5276554-276554100.297101.19
6275535-27553599.927100.82
极限1270201-27020197.99399.370.7699.05100.420.75
2273373-27337399.143100.20
3275678-27567899.979101.04
4274216-27421699.449100.51
5275849-275849100.041101.10
6274612-27461299.592100.65
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%
115.557584575647755297552675363755820.24
215.727536075121752400.23
单位质量响应值RSD%判断
4860.584786.261.09数据可信
中间条件36月-供试品溶液-2023021221批-氢氯噻嗪-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117267-1726720.09719.117.7720.1019.117.78
216876-1687619.64219.64
314956-1495617.40817.41
416951-1695119.73019.73
517773-1777320.68620.69
614704-1470417.11417.11
10min147073-4707354.78953.152.0454.8253.182.04
245905-4590553.43053.46
344473-4447351.76351.79
446216-4621653.79253.82
545245-4524552.66252.70
645051-4505152.43652.46
15min161548-6154871.63772.450.7471.7672.570.74
262341-6234172.56072.68
362809-6280973.10573.22
462547-6254772.80072.92
562367-6236772.59072.71
661886-6188672.03072.15
20min168727-6872779.99381.151.0280.2481.391.02
269608-6960881.01881.26
370402-7040281.94282.18
470465-7046582.01682.26
570048-7004881.53081.77
669087-6908780.41280.65
30min174825-7482587.09088.620.9887.4789.000.98
276169-7616988.65589.03
376799-7679989.38889.76
476595-7659589.15189.53
576663-7666389.23089.61
675778-7577888.20088.57
45min177471-7747190.17092.451.5390.6992.981.53
278889-7888991.82192.35
380914-8091494.17894.70
479617-7961792.66893.20
580421-8042193.60494.13
679280-7928092.27692.79
60min178284-7828491.11693.331.3391.7994.011.33
279637-7963792.69193.37
380586-8058693.79694.48
480723-8072393.95594.64
581223-8122394.53795.22
680649-8064993.86994.54
极限178547-7854791.42392.970.9292.2593.810.92
279552-7955292.59293.43
380057-8005793.18094.02
480319-8031993.48594.33
580550-8055093.75494.60
680236-8023693.38894.22
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