缬沙坦左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.301293271299091293671286971286751291950.41
215.351293741288941291340.27
单位质量响应值RSD%判断
8444.128412.640.27数据可信
长期12月-供试品溶液-2024081921批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min175164-7516455.84353.533.5155.8453.533.51
272937-7293754.18954.19
371190-7119052.89152.89
468209-6820950.67650.68
574063-7406355.02555.03
670705-7070552.53152.53
10min1107943-10794380.19778.401.6480.2978.491.64
2105888-10588878.67078.76
3103670-10367077.02277.11
4103779-10377977.10377.19
5106978-10697879.48079.57
6104921-10492177.95278.04
15min1117582-11758287.35886.111.7587.5886.331.75
2117024-11702486.94487.17
3115385-11538585.72685.94
4116157-11615786.29986.51
5117158-11715887.04387.27
6112092-11209283.27983.50
20min1121634-12163490.36989.780.8890.7490.140.88
2120997-12099789.89590.26
3118850-11885088.30088.66
4121423-12142390.21290.57
5121605-12160590.34790.72
6120536-12053689.55389.91
30min1126147-12614793.72291.481.4694.2492.001.46
2123173-12317391.51292.03
3120928-12092889.84490.35
4123724-12372491.92192.43
5123013-12301391.39391.91
6121816-12181690.50491.01
45min1125821-12582193.47991.781.7394.1692.441.72
2124818-12481892.73493.40
3123468-12346891.73192.39
4125162-12516292.99093.65
5120974-12097489.87890.55
6120958-12095889.86690.52
60min1123898-12389892.05191.981.8992.8992.801.88
2125787-12578793.45494.28
3123989-12398992.11892.93
4119255-11925588.60189.42
5125126-12512692.96393.78
6124747-12474792.68193.49
极限1129854-12985496.47695.501.0897.4696.471.07
2129358-12935896.10797.09
3126624-12662494.07695.04
4127019-12701994.36995.33
5129530-12953096.23597.21
6128854-12885495.73396.69
缬沙坦左氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.104674959467660046771634676158467239146754540.05
216.114682477468393446832060.03
单位质量响应值RSD%判断
290400.87290701.800.08数据可信
长期12月-供试品溶液-2024081921批-缬沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14652219-465221989.25586.922.7789.2686.922.78
24597682-459768288.20988.21
34459946-445994685.56685.57
44331598-433159883.10483.10
54647003-464700389.15589.16
64495376-449537686.24686.25
10min15182877-518287799.43697.891.4899.5898.041.48
25141931-514193198.65198.80
34998352-499835295.89696.04
45029361-502936196.49196.63
55165496-516549699.10399.25
65096977-509697797.78897.93
15min15245706-5245706100.64299.331.20100.9699.641.20
25213337-5213337100.021100.33
35084049-508404997.54097.84
45135784-513578498.53398.83
55226797-5226797100.279100.59
65159741-515974198.99299.30
20min15250774-5250774100.73999.511.11101.2299.981.11
25212865-5212865100.011100.49
35091057-509105797.67598.14
45173900-517390099.26499.73
55227831-5227831100.299100.78
65162803-516280399.05199.52
30min15249984-5249984100.72499.570.94101.37100.210.94
25220585-5220585100.160100.80
35132153-513215398.46399.09
45153136-515313698.86699.49
55227642-5227642100.295100.94
65155401-515540198.90999.55
45min15246445-5246445100.65699.451.13101.47100.261.13
25213639-5213639100.026100.84
35096438-509643897.77898.57
45153933-515393398.88199.67
55237216-5237216100.479101.29
65154993-515499398.90199.70
60min15239303-5239303100.51999.451.04101.50100.421.04
25211311-521131199.982100.96
35111522-511152298.06799.02
45151091-515109198.82699.78
55238780-5238780100.509101.49
65149300-514930098.79299.76
极限15259716-5259716100.910100.010.86102.06101.140.86
25222566-5222566100.198101.34
35217359-5217359100.098101.22
45152025-515202598.84499.97
55256919-5256919100.857102.01
65167360-516736099.138100.27
缬沙坦左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.301284781289971282641276811285111283860.38
215.351300811300371300590.03
单位质量响应值RSD%判断
8391.248472.900.69数据可信
长期12月-供试品溶液-2024081921批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min168993-6899351.23752.424.1151.2452.424.11
273420-7342054.52554.52
365593-6559348.71248.71
470742-7074252.53652.54
572229-7222953.64053.64
672529-7252953.86353.86
10min1104062-10406277.28178.022.4777.3778.112.47
2109475-10947581.30181.39
3102424-10242476.06576.15
4103481-10348176.85076.94
5104169-10416977.36177.45
6106714-10671479.25179.34
15min1115118-11511885.49286.651.9585.7186.871.95
2120756-12075689.67989.91
3115961-11596186.11886.33
4114383-11438384.94685.16
5117508-11750887.26787.49
6116348-11634886.40586.63
20min1119036-11903688.40189.302.6988.7689.672.69
2125377-12537793.11193.49
3119192-11919288.51788.87
4118649-11864988.11488.47
5116463-11646386.49186.85
6122794-12279491.19291.56
30min1121451-12145190.19591.501.9290.7092.011.93
2126515-12651593.95694.49
3120199-12019989.26589.76
4122615-12261591.05991.56
5123115-12311591.43191.94
6125330-12533093.07693.59
45min1118102-11810287.70891.394.1288.3692.054.10
2128900-12890095.72796.41
3123514-12351491.72792.37
4115869-11586986.04986.71
5125388-12538893.11993.78
6126553-12655393.98494.66
60min1122628-12262891.06992.941.4791.8793.751.47
2127571-12757194.74095.59
3124972-12497292.81093.61
4123511-12351191.72592.52
5126176-12617693.70494.52
6125986-12598693.56394.39
极限1123129-12312991.44194.992.0692.3995.962.05
2130462-13046296.88797.89
3129225-12922595.96896.92
4128166-12816695.18296.13
5126975-12697594.29795.27
6129456-12945696.14097.13
缬沙坦左氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.104659363465905846575214659977465792946587700.03
216.114728281471418347212320.22
单位质量响应值RSD%判断
289364.60293062.200.90数据可信
长期12月-供试品溶液-2024081921批-缬沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14492899-449289986.00685.282.9486.0185.282.94
24649836-464983689.01089.01
34261992-426199281.58681.59
44378800-437880083.82283.82
54438046-443804684.95684.96
64509244-450924486.31986.32
10min15052325-505232596.71597.271.9496.8697.411.94
25256640-5256640100.626100.77
34987745-498774595.47995.61
44995972-499597295.63695.78
55088440-508844097.40697.55
65106401-510640197.75097.89
15min15104364-510436497.71198.901.6298.0299.201.62
25316755-5316755101.777102.09
35116072-511607297.93598.23
45093800-509380097.50997.81
55190143-519014399.35399.66
65177840-517784099.11899.42
20min15107386-510738697.76999.161.5298.2499.621.52
25317272-5317272101.787102.27
35147205-514720598.53198.99
45110042-511004297.82098.28
55204622-520462299.630100.10
65192546-519254699.39999.87
30min15107812-510781297.77799.261.4698.4199.891.46
25315699-5315699101.757102.41
35170936-517093698.98599.61
45116953-511695397.95298.58
55206710-520671099.670100.31
65192407-519240799.396100.03
45min15101011-510101197.64799.291.5398.44100.091.53
25312951-5312951101.704102.53
35172974-517297499.02499.81
45110830-511083097.83598.62
55229647-5229647100.109100.91
65193879-519387999.425100.23
60min15094555-509455597.52399.081.4698.48100.051.46
25302448-5302448101.503102.50
35168618-516861898.94199.89
45105584-510558497.73498.69
55197940-519794099.502100.47
65186830-518683099.290100.26
极限15091820-509182097.47199.191.3498.59100.321.34
25287952-5287952101.225102.39
35169471-516947198.957100.07
45126714-512671498.13999.25
55210076-521007699.735100.87
65202701-520270199.594100.73
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