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%
112.014566194566644562114561724559184563170.07
212.064548764546394547580.04
单位质量响应值RSD%判断
37994.7537707.960.54数据可信
中间条件6月-供试品溶液-2024082321批-氢氯噻嗪-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1279994-27999453.10165.8710.5953.1065.8710.59
2348545-34854566.10166.10
3359693-35969368.21668.22
4360281-36028168.32768.33
5390807-39080774.11674.12
6344619-34461965.35765.36
10min1424749-42474980.55487.884.9580.6488.004.96
2457929-45792986.84686.96
3453067-45306785.92486.04
4479874-47987491.00891.12
5483707-48370791.73591.86
6481104-48110491.24191.35
15min1476618-47661890.39193.962.6090.6194.222.61
2489674-48967492.86793.12
3487430-48743092.44192.70
4504174-50417495.61795.88
5509819-50981996.68796.96
6504909-50490995.75696.02
20min1508962-50896296.52596.771.0296.9097.181.03
2507927-50792796.32896.74
3504896-50489695.75396.16
4511649-51164997.03497.46
5519876-51987698.59499.03
6508135-50813596.36896.79
30min1527251-52725199.99398.891.18100.5399.461.17
2522274-52227499.04999.62
3526877-52687799.922100.49
4515351-51535197.73698.32
5524330-52433099.439100.04
6512516-51251697.19997.78
45min1531539-531539100.80699.411.28101.51100.151.27
2524251-52425199.424100.16
3530394-530394100.589101.33
4516916-51691698.03398.78
5526417-52641799.835100.60
6515554-51555497.77598.52
60min1531208-531208100.74499.451.13101.61100.351.11
2523706-52370699.321100.22
3529849-529849100.486101.39
4517756-51775698.19299.11
5526349-52634999.822100.76
6517357-51735798.11799.02
极限1531564-531564100.811100.041.19101.85101.111.18
2524486-52448699.469100.54
3530265-530265100.565101.64
4525591-52559199.678100.75
5535386-535386101.536102.64
6517762-51776298.19399.26
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%
116.521533051534081536181535801534831534790.09
216.491534631533811534220.04
单位质量响应值RSD%判断
9290.509303.940.11数据可信
中间条件6月-供试品溶液-2024082321批-坎地沙坦酯-pH1.2
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
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
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%
112.014543614544804542574543114546064544030.04
212.064527994535304531640.12
单位质量响应值RSD%判断
37835.3937575.790.49数据可信
中间条件6月-供试品溶液-2024082321批-氢氯噻嗪-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1349562-34956266.55064.4712.4166.5564.4712.41
2361540-36154068.83168.83
3262109-26210949.90149.90
4326614-32661462.18262.18
5384511-38451173.20473.20
6347544-34754466.16666.17
10min1449742-44974285.62386.737.4485.7386.847.44
2473091-47309190.06890.18
3390918-39091874.42474.51
4466668-46666888.84588.95
5486967-48696792.71092.83
6465939-46593988.70788.82
15min1492205-49220593.70793.974.9093.9694.224.91
2508400-50840096.79097.06
3446874-44687485.07785.28
4500032-50003295.19795.45
5514563-51456397.96498.24
6499410-49941095.07995.34
20min1518749-51874998.76197.323.1099.1797.733.12
2516615-51661598.35498.78
3480763-48076391.52991.88
4510394-51039497.17097.58
5526277-526277100.194100.63
6514330-51433097.91998.34
30min1529227-529227100.75699.381.72101.3399.961.74
2524658-52465899.886100.48
3508810-50881096.86997.37
4515564-51556498.15498.73
5533123-533123101.497102.10
6520781-52078199.14899.73
45min1532101-532101101.30399.951.38102.05100.681.40
2526504-526504100.237100.99
3518697-51869798.75199.41
4516427-51642798.31999.05
5534284-534284101.718102.49
6521912-52191299.363100.11
60min1530197-530197100.94099.821.38101.85100.721.39
2526269-526269100.192101.12
3518747-51874798.76099.59
4515337-51533798.11199.01
5534276-534276101.717102.66
6521079-52107999.204100.11
极限1531452-531452101.179100.330.96102.26101.400.99
2525474-525474100.041101.13
3519277-51927798.86199.85
4528226-528226100.565101.63
5533080-533080101.489102.60
6524355-52435599.828100.90
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%
116.521538581537861535581536151533751536380.13
216.491533271535741534500.12
单位质量响应值RSD%判断
9300.129305.640.05数据可信
中间条件6月-供试品溶液-2024082321批-坎地沙坦酯-pH1.2
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
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
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%
112.014552544552814545564551974549604550500.07
212.064539044532824535930.10
单位质量响应值RSD%判断
37889.2637611.360.53数据可信
中间条件6月-供试品溶液-2024082521批-氢氯噻嗪-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1384401-38440173.09762.3414.5273.1062.3414.52
2378264-37826471.93071.93
3307736-30773658.51858.52
4283027-28302753.82053.82
5273045-27304551.92251.92
6340543-34054364.75764.76
10min1489261-48926193.03785.317.7193.1685.417.71
2473049-47304989.95490.07
3435399-43539982.79482.89
4412006-41200678.34678.44
5408701-40870177.71777.80
6473288-47328889.99990.11
15min1514797-51479797.89292.794.3298.1793.034.33
2497646-49764694.63194.90
3478995-47899591.08491.32
4461389-46138987.73687.96
5469951-46995189.36589.58
6504911-50491196.01396.27
20min1520984-52098499.06996.262.4799.5196.662.49
2508600-50860096.71497.14
3499465-49946594.97795.36
4485505-48550592.32292.69
5507747-50774796.55296.92
6515122-51512297.95498.37
30min1525267-52526799.88399.130.92100.4999.690.94
2520792-52079299.03299.62
3520155-52015598.91199.46
4512570-51257097.46997.99
5524995-52499599.832100.36
6523905-52390599.624100.21
45min1525152-52515299.86199.690.30100.63100.420.30
2523046-52304699.461100.21
3524998-52499899.832100.54
4522640-52264099.384100.07
5526646-526646100.146100.84
6523149-52314999.481100.23
60min1524049-52404999.65299.680.41100.59100.570.39
2521275-52127599.124100.04
3525561-52556199.939100.82
4522872-52287299.428100.28
5527383-527383100.286101.14
6523954-52395499.634100.55
极限1524953-52495399.82499.930.40100.93100.990.37
2522470-52247099.351100.44
3527340-527340100.278101.32
4527687-527687100.344101.36
5526723-526723100.160101.19
6523879-52387999.619100.70
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%
116.521543581543481543831543361542821543410.03
216.491539891538631539260.06
单位质量响应值RSD%判断
9342.689334.510.07数据可信
中间条件6月-供试品溶液-2024082521批-坎地沙坦酯-pH1.2
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
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
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%
112.014518594519274516624518214515104517560.04
212.064509244508174508700.02
单位质量响应值RSD%判断
37614.9937385.570.44数据可信
中间条件6月-供试品溶液-2024082521批-氢氯噻嗪-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1320274-32027461.30865.395.7561.3165.395.75
2365332-36533269.93369.93
3330674-33067463.29963.30
4365832-36583270.02970.03
5327523-32752362.69662.70
6339798-33979865.04665.05
10min1459566-45956687.97291.193.1788.0791.303.17
2490977-49097793.98594.10
3472471-47247190.44290.55
4489671-48967193.73593.85
5458276-45827687.72587.83
6487267-48726793.27593.38
15min1498407-49840795.40797.341.5095.6697.601.51
2515974-51597498.77099.04
3507365-50736597.12297.38
4516100-51610098.79499.07
5500843-50084395.87496.12
6512322-51232298.07198.33
20min1507127-50712797.07699.241.3497.4899.661.35
2524837-524837100.467100.90
3515042-51504298.59299.01
4523473-523473100.205100.64
5516254-51625498.82499.23
6523835-523835100.275100.70
30min1517647-51764799.090100.430.7799.66101.020.78
2529427-529427101.345101.95
3523033-523033100.121100.70
4526989-526989100.879101.48
5525488-525488100.591101.17
6525340-525340100.563101.16
45min1518938-51893899.337100.600.94100.07101.360.95
2533085-533085102.045102.82
3524280-524280100.360101.11
4529159-529159101.294102.07
5524461-524461100.395101.14
6523437-523437100.199100.96
60min1520682-52068299.671100.580.73100.57101.510.74
2530692-530692101.587102.53
3522449-522449100.009100.93
4529100-529100101.283102.22
5524903-524903100.479101.39
6524880-524880100.475101.40
极限1519803-51980399.503100.620.94100.57101.710.94
2531752-531752101.790102.90
3527630-527630101.001102.08
4528714-528714101.209102.32
5526140-526140100.716101.79
6519762-51976299.495100.59
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%
116.521531371532971532351533321530591532120.08
216.491532451532961532700.03
单位质量响应值RSD%判断
9274.339294.720.16数据可信
中间条件6月-供试品溶液-2024082521批-坎地沙坦酯-pH1.2
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
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
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