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(%)99.70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%
112.014737914738274734934737424738794737460.04
211.794589744591454590600.03
单位质量响应值RSD%判断
39445.9638936.390.92数据可信
供试品溶液-2024052121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%
5min1314749-31474957.65370.4612.0057.6570.4612.01
2414563-41456375.93675.94
3354564-35456464.94664.95
4436580-43658079.96979.97
5417305-41730576.43876.44
6370386-37038667.84467.84
10min1449907-44990782.41088.444.9782.5188.564.98
2507877-50787793.02993.16
3483146-48314688.49988.61
4504205-50420592.35692.49
5493528-49352890.40090.53
6458450-45845083.97584.09
15min1488373-48837389.45693.342.8789.6993.612.88
2520140-52014095.27595.56
3520008-52000895.25195.51
4521668-52166895.55595.84
5513235-51323594.01094.29
6494153-49415390.51590.77
20min1503565-50356592.23995.262.4092.6295.682.41
2526771-52677196.48996.93
3533953-53395397.80598.22
4528711-52871196.84597.29
5521011-52101195.43495.87
6506307-50630792.74193.14
30min1517534-51753494.79796.681.6095.3397.261.61
2528050-52805096.72497.32
3539327-53932798.78999.37
4534982-53498297.99398.60
5527130-52713096.55597.15
6519817-51981795.21695.77
45min1528967-52896796.89297.461.3297.5998.201.33
2530150-53015097.10897.87
3542152-54215299.307100.05
4538862-53886298.70499.48
5528795-52879596.86097.61
6523474-52347495.88596.60
60min1530718-53071897.21297.651.2698.0798.561.26
2530035-53003597.08798.01
3542561-54256199.382100.29
4539748-53974898.86699.80
5530881-53088197.24298.16
6524794-52479496.12797.00
极限1535224-53522498.03898.250.9899.0699.320.99
2535623-53562398.11199.20
3543285-54328599.514100.59
4541452-54145299.179100.28
5533829-53382997.78298.86
6528913-52891396.88297.92
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(%)99.80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%
115.753019153015703018423017023019803018020.06
215.8163130313133443131880.08
单位质量响应值RSD%判断
19162.0319801.972.33数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2024052121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
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(%)99.70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%
112.014683454679984681094680464680394681070.03
211.794566114566574566340.01
单位质量响应值RSD%判断
38976.4438730.620.45数据可信
供试品溶液-2024052121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%
5min1395278-39527873.03063.879.2073.0363.869.20
2371283-37128368.59768.60
3321959-32195959.48459.48
4327959-32795960.59360.59
5344448-34444863.63963.64
6313106-31310657.84957.85
10min1483918-48391889.40787.393.3389.5387.503.33
2479636-47963688.61688.73
3457720-45772084.56784.67
4493662-49366291.20891.31
5470189-47018986.87186.98
6452902-45290283.67783.77
15min1506108-50610893.50793.042.2493.7893.292.25
2514223-51422395.00695.27
3493721-49372191.21991.46
4517843-51784395.67595.93
5500113-50011392.40092.65
6489334-48933490.40890.64
20min1511507-51150794.50594.391.8694.9394.801.86
2520202-52020296.11196.53
3503840-50384093.08893.48
4523123-52312396.65197.06
5508109-50810993.87794.28
6498519-49851992.10592.49
30min1515130-51513095.17495.971.6695.7696.531.66
2524603-52460396.92497.50
3516730-51673095.47096.02
4529265-52926597.78698.36
5525108-52510897.01897.58
6505669-50566993.42693.97
45min1519517-51951795.98596.912.0196.7397.642.01
2527266-52726697.41698.16
3522562-52256296.54797.25
4534276-53427698.71199.45
5536016-53601699.03399.76
6507548-50754893.77394.47
60min1520718-52071896.20697.152.0897.1198.042.07
2528501-52850197.64498.55
3524279-52427996.86497.73
4534782-53478298.80599.71
5538644-53864499.518100.41
6508129-50812993.88194.73
极限1532825-53282598.44399.010.8899.51100.060.88
2532509-53250998.38599.45
3532811-53281198.44199.47
4543873-543873100.484101.55
5539501-53950199.677100.73
6533901-53390198.64299.65
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(%)99.80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%
115.753064243061603062383063733063543063100.04
215.8163125513126933126220.04
单位质量响应值RSD%判断
19448.2519766.191.15数据可信
供试品溶液-2024052121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
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(%)99.70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%
112.014653504649154649664650904656024651850.07
211.794546914546294546600.01
单位质量响应值RSD%判断
38733.1438563.190.32数据可信
供试品溶液-2024052121批-氢氯噻嗪-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1287015-28701553.31060.846.8053.3160.846.80
2348895-34889564.80364.80
3343484-34348463.79863.80
4335264-33526462.27162.27
5320104-32010459.45559.46
6330473-33047361.38161.38
10min1412107-41210776.54482.765.5276.6382.865.53
2473944-47394488.02988.14
3472514-47251487.76487.87
4426339-42633979.18779.29
5444539-44453982.56882.67
6444007-44400782.46982.57
15min1455617-45561784.62590.135.0884.8490.375.08
2511224-51122494.95495.21
3508476-50847694.44394.70
4456463-45646384.78385.02
5495750-49575092.08092.32
6483901-48390189.87990.12
20min1476693-47669388.54093.864.4488.9094.264.44
2529385-52938598.32798.74
3520229-52022996.62697.04
4483985-48398589.89490.27
5524519-52451997.42397.81
6497354-49735492.37892.77
30min1496348-49634892.19196.543.2692.7097.093.27
2539653-539653100.234100.81
3530259-53025998.48999.06
4508199-50819994.39294.92
5533021-53302199.00299.55
6511271-51127194.96295.51
45min1527949-52794998.06098.771.7998.7299.481.81
2543901-543901101.023101.77
3537211-53721199.781100.52
4517681-51768196.15396.84
5537478-53747899.830100.55
6526300-52630097.75498.46
60min1529584-52958498.36499.011.7599.1999.881.77
2544769-544769101.184102.10
3539678-539678100.239101.14
4518470-51847096.30097.14
5536639-53663999.674100.56
6529156-52915698.28499.15
极限1532233-53223398.85699.211.1499.84100.241.16
2542600-542600100.781101.86
3536217-53621799.596100.66
4525498-52549897.60598.61
5538030-53803099.933100.98
6530226-53022698.48399.51
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(%)99.80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%
115.753050583047913050773051423054803051100.09
215.8163119683120763120220.03
单位质量响应值RSD%判断
19372.0619728.251.29数据可信
供试品溶液-2024052121批-坎地沙坦酯-pH4.5
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(%)99.70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%
112.014647824645304643754645374644274645300.04
211.794529614533154531380.06
单位质量响应值RSD%判断
38678.6038434.100.45数据可信
供试品溶液-2024052121批-氢氯噻嗪-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1335178-33517862.40462.588.1762.4062.588.17
2373707-37370769.57769.58
3332589-33258961.92261.92
4332780-33278061.95761.96
5351994-35199465.53565.53
6290546-29054654.09454.09
10min1466836-46683686.91685.052.4987.0285.162.50
2455248-45524884.75984.87
3440899-44089982.08782.19
4465041-46504186.58286.69
5466971-46697186.94187.05
6445910-44591083.02083.11
15min1497537-49753792.63291.011.7492.8891.261.74
2481272-48127289.60489.86
3481330-48133089.61589.85
4500547-50054793.19393.44
5489088-48908891.05991.31
6483169-48316989.95790.19
20min1506312-50631294.26694.001.6294.6794.401.61
2504917-50491794.00694.41
3501161-50116193.30793.70
4517651-51765196.37796.78
5492657-49265791.72492.13
6506743-50674394.34694.72
30min1511383-51138395.21096.222.0195.7796.771.99
2513512-51351295.60696.17
3511895-51189595.30595.85
4527848-52784898.27598.84
5504870-50487093.99794.56
6531231-53123198.90599.44
45min1513716-51371695.64496.942.6896.3697.652.66
2521713-52171397.13397.86
3517880-51788096.42097.12
4535373-53537399.676100.40
5499201-49920192.94293.66
6536094-53609499.811100.51
60min1512354-51235495.39197.302.2496.2798.182.22
2523276-52327697.42498.31
3518558-51855896.54697.41
4536057-53605799.804100.70
5508897-50889794.74795.62
6536446-53644699.876100.74
极限1537063-53706399.99198.721.11101.0399.761.10
2522661-52266197.31098.36
3532390-53239099.121100.15
4531776-53177699.007100.07
5523497-52349797.46598.49
6534102-53410299.440100.47
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(%)99.80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%
115.753057773052733057053054933057253055950.07
215.8163108733119263114000.24
单位质量响应值RSD%判断
19402.8619688.921.04数据可信
供试品溶液-2024052121批-坎地沙坦酯-pH4.5
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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