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(%)99.70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%
111.784462204465094461844456454462474461610.08
211.784447344449774448560.04
单位质量响应值RSD%判断
37874.4537763.670.21数据可信
中间条件6月-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%
5min1347506-34750665.96068.379.7665.9668.379.76
2380954-38095472.30972.31
3326718-32671862.01462.01
4395250-39525075.02275.02
5395330-39533075.03775.04
6315517-31551759.88859.89
10min1466700-46670088.58489.835.7188.6989.945.71
2493267-49326793.62793.75
3455789-45578986.51386.62
4481483-48148391.39091.52
5508666-50866696.55096.67
6433577-43357782.29782.40
15min1498864-49886494.68994.892.9994.9595.163.00
2513534-51353497.47497.75
3489905-48990592.98993.24
4496934-49693494.32394.60
5520471-52047198.79099.08
6479965-47996591.10291.34
20min1504228-50422895.70796.321.8696.1296.741.87
2516102-51610297.96198.40
3500200-50020094.94395.35
4502457-50245795.37195.81
5522188-52218899.11699.57
6499613-49961394.83195.22
30min1507161-50716196.26496.951.3796.8497.531.39
2515609-51560997.86798.47
3502573-50257395.39395.95
4508949-50894996.60397.20
5522177-52217799.11499.73
6508049-50804996.43396.98
45min1508204-50820496.46297.071.2497.2097.821.26
2515243-51524397.79898.56
3503058-50305895.48596.20
4509802-50980296.76597.52
5521497-52149798.98599.77
6510740-51074096.94397.65
60min1507795-50779596.38497.041.2197.2897.951.22
2514569-51456997.67098.60
3503716-50371695.61096.49
4509528-50952896.71397.63
5521515-52151598.98899.93
6510407-51040796.88097.75
极限1522731-52273199.21999.440.81100.28100.510.83
2527602-527602100.144101.24
3520308-52030898.75999.80
4521334-52133498.954100.03
5530556-530556100.705101.82
6520758-52075898.84599.88
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(%)99.80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%
115.642946512948442952312952032948402949540.09
215.602948602951522950060.07
单位质量响应值RSD%判断
18858.9518910.640.20数据可信
中间条件6月-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%
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(%)99.70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%
111.784441054441494439964440364442914441150.03
211.784415724416384416050.02
单位质量响应值RSD%判断
37700.7637487.690.41数据可信
中间条件6月-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%
5min1381170-38117072.78371.385.3372.7871.385.33
2375474-37547471.69571.70
3382310-38231073.00073.00
4387018-38701873.89973.90
5333900-33390063.75763.76
6383153-38315373.16173.16
10min1483450-48345092.31390.884.0092.4391.004.00
2489407-48940793.45093.57
3485175-48517592.64292.76
4479154-47915491.49291.62
5437820-43782083.60083.71
6480775-48077591.80291.92
15min1513344-51334498.02197.261.4898.3097.531.49
2514701-51470198.28098.56
3515748-51574898.48098.76
4510613-51061397.49997.78
5495875-49587594.68594.93
6505795-50579596.57996.85
20min1517545-51754598.82399.300.8799.2699.740.86
2519605-51960599.21699.66
3527307-527307100.687101.13
4520439-52043999.37699.81
5521593-52159399.596100.00
6513850-51385098.11798.55
30min1522080-52208099.68999.950.80100.29100.550.79
2520873-52087399.458100.06
3529560-529560101.117101.73
4524689-524689100.187100.79
5525777-525777100.395100.96
6517699-51769998.85299.45
45min1523002-52300299.865100.130.84100.63100.890.83
2520922-52092299.468100.24
3530255-530255101.250102.03
4525699-525699100.380101.15
5527798-527798100.781101.52
6518632-51863299.03199.79
60min1530881-530881101.369100.440.94102.31101.380.94
2521269-52126999.534100.47
3531618-531618101.510102.46
4525722-525722100.384101.32
5527256-527256100.677101.58
6519484-51948499.193100.12
极限1534906-534906102.138100.800.85103.24101.900.85
2525901-525901100.419101.52
3529674-529674101.139102.25
4528926-528926100.996102.10
5526589-526589100.550101.62
6521451-52145199.569100.66
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(%)99.80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%
115.642952202955282954522950892956992953980.09
215.602946702944722945710.05
单位质量响应值RSD%判断
18887.3418882.760.02数据可信
中间条件6月-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%
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(%)99.70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%
111.784418744420784423104425764423374422350.07
211.784410064411034410540.02
单位质量响应值RSD%判断
37541.1737440.920.19数据可信
中间条件6月-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%
5min1438455-43845583.95173.189.7083.9573.189.70
2340580-34058065.21165.21
3405982-40598277.73377.73
4358720-35872068.68468.68
5394019-39401975.44375.44
6355607-35560768.08868.09
10min1506925-50692597.06193.562.2897.2093.682.29
2473081-47308190.58190.69
3488225-48822593.48093.61
4487791-48779193.39793.51
5483265-48326592.53192.66
6492424-49242494.28494.40
15min1522970-522970100.13397.741.72100.4398.021.72
2501439-50143996.01196.27
3510764-51076497.79698.08
4512489-51248998.12698.40
5499768-49976895.69195.97
6515431-51543198.69098.96
20min1523306-523306100.19798.861.18100.6799.301.18
2509001-50900197.45897.88
3515255-51525598.65699.10
4519436-51943699.45699.89
5509646-50964697.58298.02
6521413-52141399.835100.27
30min1525556-525556100.62899.831.10101.26100.441.10
2515569-51556998.71699.30
3520117-52011799.587100.20
4523536-523536100.241100.84
5514527-51452798.51799.12
6528987-528987101.285101.89
45min1527340-527340100.970100.491.04101.77101.261.04
2519810-51981099.528100.27
3524365-524365100.400101.18
4527305-527305100.963101.73
5517743-51774399.13299.90
6532569-532569101.971102.74
60min1527973-527973101.091100.421.05102.06101.361.06
2519568-51956899.482100.39
3524319-524319100.391101.34
4526043-526043100.721101.66
5517003-51700398.99199.92
6532003-532003101.863102.80
极限1527360-527360100.974100.571.16102.11101.671.15
2522670-522670100.076101.15
3525197-525197100.560101.67
4525761-525761100.667101.77
5515966-51596698.79299.89
6534476-534476102.336103.45
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(%)99.80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%
115.642949432949902959252957462953362953880.15
215.602958582952322955450.15
单位质量响应值RSD%判断
18886.7018945.190.22数据可信
中间条件6月-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%
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(%)99.70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%
111.784410324409454406584404924404714407200.06
211.784390814388504389660.04
单位质量响应值RSD%判断
37412.5637263.670.29数据可信
中间条件6月-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%
5min1258177-25817749.63664.6119.4649.6464.6119.45
2372742-37274271.66171.66
3378472-37847272.76372.76
4249608-24960847.98847.99
5401533-40153377.19777.20
6355914-35591468.42668.43
10min1402915-40291577.46285.4410.3577.5585.5410.36
2476657-47665791.64091.76
3479112-47911292.11292.23
4373873-37387371.87971.96
5484499-48449993.14793.28
6449304-44930486.38186.49
15min1468231-46823190.02093.924.7990.2394.164.81
2508241-50824197.71297.98
3511320-51132098.30498.58
4454234-45423487.32987.53
5503438-50343896.78897.07
6485501-48550193.34093.60
20min1496504-49650495.45597.652.1895.8298.062.21
2516457-51645799.29199.73
3521474-521474100.256100.69
4494637-49463795.09695.44
5513785-51378598.77899.22
6504688-50468897.02997.44
30min1518179-51817999.62299.920.73100.14100.490.73
2521707-521707100.301100.90
3525619-525619101.053101.66
4520610-520610100.090100.59
5514911-51491198.99499.60
6517458-51745899.484100.06
45min1522380-522380100.430100.990.87101.12101.730.85
2525417-525417101.014101.78
3530037-530037101.902102.68
4531250-531250102.135102.81
5519779-51977999.930100.70
6522972-522972100.544101.28
60min1521771-521771100.313100.910.90101.17101.820.88
2523628-523628100.670101.61
3528180-528180101.545102.49
4532680-532680102.410103.25
5519821-51982199.938100.88
6523285-523285100.604101.51
极限1521346-521346100.231101.271.23101.25102.351.22
2523569-523569100.659101.76
3531328-531328102.150103.26
4531530-531530102.189103.20
5518483-51848399.681100.79
6534392-534392102.739103.82
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(%)99.80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%
115.642955762952332953972953112950152953060.08
215.602940352938762939560.04
单位质量响应值RSD%判断
18881.4618843.330.15数据可信
中间条件6月-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%
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-
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