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%
112.694734564733384732164733684734774733710.03
212.714733624732274732940.03
单位质量响应值RSD%判断
37302.6837237.920.13数据可信
供试品溶液-2024082821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%
5min1393263-39326375.74468.147.6575.7468.157.64
2371373-37137371.52871.53
3314102-31410260.49760.50
4353818-35381868.14768.15
5339583-33958365.40565.41
6350716-35071667.54967.55
10min1478860-47886092.23088.843.4892.3688.953.48
2472865-47286591.07691.19
3439914-43991484.72984.83
4463236-46323689.22189.33
5443466-44346685.41385.52
6469109-46910990.35290.46
15min1497322-49732295.78694.631.5996.0794.901.60
2499769-49976996.25796.53
3481658-48165892.76993.01
4493892-49389295.12695.39
5481748-48174892.78793.04
6493621-49362195.07395.34
20min1501793-50179396.64796.880.8397.0997.300.83
2508105-50810597.86398.29
3501742-50174296.63797.03
4507706-50770697.78698.21
5501218-50121896.53796.94
6497399-49739995.80196.22
30min1510932-51093298.40798.370.8999.0198.950.89
2513350-51335098.87399.47
3509690-50969098.16898.73
4515450-51545099.27899.86
5512527-51252798.71599.28
6502389-50238996.76297.34
45min1514677-51467799.12999.031.0899.8999.781.07
2515644-51564499.315100.07
3515047-51504799.20099.92
4519959-519959100.146100.90
5516189-51618999.420100.15
6503610-50361096.99797.74
60min1512743-51274398.75699.091.1799.69100.001.16
2516238-51623899.429100.35
3515954-51595499.375100.26
4521358-521358100.416101.33
5516869-51686999.551100.45
6503590-50359096.99397.90
极限1521476-521476100.438100.410.54101.53101.480.53
2517455-51745599.664100.75
3522834-522834100.700101.75
4525299-525299101.175102.26
5521781-521781100.497101.56
6519078-51907899.976101.04
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%
116.343089083093093092353092923092693092030.06
216.283095563097873096720.06
单位质量响应值RSD%判断
18923.0719021.620.37数据可信
供试品溶液-2024082821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%
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
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%
112.694724354729104725294725554725824726020.04
212.714708664707664708160.02
单位质量响应值RSD%判断
37242.0837042.960.38数据可信
供试品溶液-2024083021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%
5min1356062-35606268.81567.824.0968.8267.824.10
2345762-34576266.82566.82
3333174-33317464.39264.39
4345156-34515666.70866.71
5375941-37594172.65772.66
6349374-34937467.52367.52
10min1479418-47941892.65690.701.4692.7790.811.47
2466728-46672890.20390.31
3462097-46209789.30889.42
4465241-46524189.91690.03
5476152-47615292.02592.15
6466107-46610790.08390.20
15min1511499-51149998.85696.901.5499.1397.171.54
2502848-50284897.18497.45
3494998-49499895.66795.92
4508668-50866898.30998.57
5498500-49850096.34496.62
6491824-49182495.05495.32
20min1520511-520511100.59899.041.60101.0399.461.60
2512404-51240499.03199.45
3507093-50709398.00598.42
4523987-523987101.270101.69
5507402-50740298.06498.50
6503353-50335397.28297.70
30min1528808-528808102.202100.581.75102.80101.171.75
2517021-51702199.923100.51
3515267-51526799.584100.16
4534505-534505103.303103.90
5515749-51574999.678100.28
6511162-51116298.79199.37
45min1530428-530428102.515101.231.52103.29101.991.52
2519690-519690100.439101.19
3521496-521496100.788101.53
4536431-536431103.675104.44
5519323-519323100.368101.13
6515413-51541399.613100.36
60min1531838-531838102.787101.681.48103.73102.601.48
2521788-521788100.845101.77
3523380-523380101.152102.07
4538565-538565104.087105.03
5523846-523846101.243102.17
6517105-51710599.940100.85
极限1531659-531659102.753102.331.35103.87103.421.34
2528740-528740102.188103.28
3530087-530087102.449103.53
4540809-540809104.521105.63
5526375-526375101.731102.83
6519038-519038100.313101.39
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%
116.343093353094913094233094163094233094180.02
216.283090523088013089260.06
单位质量响应值RSD%判断
18936.2318975.800.15数据可信
供试品溶液-2024083021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%
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
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%
112.694703884702874712134714654710184708740.11
212.714693034694524693780.03
单位质量响应值RSD%判断
37105.9136929.820.34数据可信
供试品溶液-2024090121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%
5min1402642-40264278.08068.2015.7878.0868.2015.78
2338147-33814765.57365.57
3306224-30622459.38259.38
4382057-38205774.08874.09
5409026-40902679.31879.32
6272130-27213052.77152.77
10min1487799-48779994.59386.948.3094.7287.058.31
2420338-42033881.51181.62
3429529-42952983.29483.39
4475602-47560292.22892.35
5478853-47885392.85892.99
6397927-39792777.16577.25
15min1506404-50640498.20193.124.6298.4993.384.63
2461630-46163089.51889.76
3471863-47186391.50391.74
4495492-49549296.08596.36
5495340-49534096.05596.34
6450421-45042187.34587.56
20min1509050-50905098.71496.082.2399.1796.502.26
2488106-48810694.65395.05
3490647-49064795.14595.54
4501468-50146897.24497.68
5503669-50366997.67198.12
6479900-47990093.06193.42
30min1511166-51116699.12498.270.9399.7498.840.96
2503592-50359297.65698.21
3501477-50147797.24697.79
4506821-50682198.28298.88
5513395-51339599.557100.17
6504025-50402597.74098.26
45min1513169-51316999.51398.900.85100.2999.640.88
2506870-50687098.29199.01
3504474-50447497.82798.54
4510259-51025998.94999.71
5516404-516404100.140100.92
6508789-50878998.66399.34
60min1512785-51278599.43899.000.89100.3999.900.90
2506999-50699998.31699.20
3505174-50517497.96298.84
4510211-51021198.93999.87
5517901-517901100.430101.37
6509986-50998698.89699.74
极限1511431-51143199.17699.300.93100.29100.370.94
2508032-50803298.51799.56
3505770-50577098.07899.12
4514507-51450799.772100.87
5518943-518943100.633101.74
6513735-51373599.623100.63
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%
116.343078533082463089233090643087343085640.17
216.283079623081493080560.05
单位质量响应值RSD%判断
18883.9718922.360.15数据可信
供试品溶液-2024090121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%
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
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%
112.694685024685914683234682974684254684280.03
212.714685924687214686560.02
单位质量响应值RSD%判断
36913.1636873.010.08数据可信
供试品溶液-516246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%
5min1165490-16549032.20044.3719.6532.2044.3719.65
2266399-26639951.83451.83
3279185-27918554.32254.32
4221966-22196643.18943.19
5187797-18779736.54036.54
6247521-24752148.16148.16
10min1306282-30628259.59472.0912.7859.6572.1712.78
2380221-38022173.98174.07
3441335-44133585.87285.96
4346731-34673167.46567.54
5348118-34811867.73467.80
6400471-40047177.92178.00
15min1381593-38159374.24884.358.2474.4084.558.25
2433650-43365084.37784.59
3486134-48613494.58994.82
4421294-42129481.97282.16
5420688-42068881.85582.03
6457813-45781389.07889.29
20min1424042-42404282.50790.445.5282.7890.785.55
2464961-46496190.46990.82
3498293-49829396.95497.35
4460411-46041189.58489.90
5456108-45610888.74689.06
6485128-48512894.39394.75
30min1466953-46695390.85695.613.1591.2796.103.19
2496980-49698096.69997.20
3508116-50811698.86699.42
4478965-47896593.19493.66
5494977-49497796.30996.77
6502435-50243597.76098.28
45min1494836-49483696.28298.131.7396.8598.771.75
2507061-50706198.66099.32
3511250-51125099.475100.19
4491822-49182295.69596.32
5510879-51087999.403100.02
6510132-51013299.25899.94
60min1502702-50270297.81298.671.3998.5499.481.41
2507770-50777098.79899.63
3511629-51162999.549100.43
4495153-49515396.34397.13
5512786-51278699.774100.56
6512613-51261399.741100.58
极限1510812-51081299.390100.721.70100.28101.691.72
2523945-523945101.946102.94
3518464-518464100.879101.93
4503599-50359997.98798.93
5522564-522564101.677102.63
6526371-526371102.418103.43
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%
116.343072553073803073603073423072503073170.02
216.283080163080573080360.01
单位质量响应值RSD%判断
18807.6518921.130.43数据可信
供试品溶液-516246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%
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
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