坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.234431444337442884425044252442880.09
214.304423844209442240.05
单位质量响应值RSD%判断
3112.303092.590.45数据可信
长期3月-供试品溶液-24041101批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150376-50376102.521104.231.68102.52104.221.68
252436-52436106.714106.71
350392-50392102.554102.55
451718-51718105.253105.25
550666-50666103.112103.11
651699-51699105.214105.21
10min151279-51279104.359102.371.98105.50103.521.96
249261-49261100.252101.44
349712-49712101.170102.31
451441-51441104.689105.86
549297-49297100.326101.47
650808-50808103.401104.57
15min149452-49452100.641101.471.50102.94103.761.49
250562-50562102.900105.20
349408-49408100.551102.82
450554-50554102.884105.22
548790-4879099.294101.55
650384-50384102.538104.86
20min149312-49312100.356100.441.22103.77103.861.22
249525-49525100.790104.23
348534-4853498.773102.15
450076-50076101.911105.39
548801-4880199.316102.68
649857-49857101.465104.92
30min148575-4857598.85699.311.39103.39103.841.38
249187-49187100.102104.66
348773-4877399.259103.74
449208-49208100.144104.75
547578-4757896.827101.29
649457-49457100.651105.24
45min146089-4608993.79795.441.6699.43101.081.61
248080-4808097.849103.52
347011-4701195.673101.25
446983-4698395.616101.34
545981-4598193.57799.12
647237-4723796.133101.84
60min145676-4567692.95693.771.2399.63100.471.22
246266-4626694.157100.92
345820-4582093.24999.89
446223-4622394.070100.85
545433-4543392.46299.04
647029-4702995.710102.48
极限145196-4519691.98092.481.2399.68100.221.22
245533-4553392.665100.47
344849-4484991.27398.95
446320-4632094.267102.10
544956-4495691.49199.10
645791-4579193.190101.03
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.234405944041440574424744274441360.26
214.304402844006440170.04
单位质量响应值RSD%判断
3101.623078.110.54数据可信
加速3月-供试品溶液-24041101批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min149906-49906101.979100.601.50101.98100.601.50
248660-4866099.43399.43
349936-49936102.040102.04
449613-49613101.380101.38
549162-49162100.459100.46
648101-4810198.29198.29
10min149101-49101100.334100.110.81101.47101.230.80
248975-48975100.076101.18
348744-4874499.604100.74
449220-49220100.577101.70
549527-49527101.204102.32
648393-4839398.88799.98
15min147887-4788797.85396.731.31100.1098.961.30
247619-4761997.30699.52
347436-4743696.93299.17
447574-4757497.21499.46
547386-4738696.82999.07
646134-4613494.27196.46
20min146539-4653995.09995.411.3598.4398.721.33
246411-4641194.83798.14
346610-4661095.24498.56
446837-4683795.70899.03
547820-4782097.716101.03
645934-4593493.86297.10
30min146416-4641694.84794.770.6399.2499.130.60
246632-4663295.28999.64
345830-4583093.65098.03
446469-4646994.95699.34
546574-4657495.17099.57
646337-4633794.68698.97
45min145396-4539692.76392.732.5498.2198.152.42
243360-4336088.60394.01
345882-4588293.75699.17
445940-4594093.87599.32
546720-4672095.469100.93
644975-4497591.90397.24
60min144524-4452490.98192.301.7997.4698.751.72
245010-4501091.97498.37
345107-4510792.17398.63
446281-4628194.571101.06
545924-4592493.842100.36
644164-4416490.24696.60
极限143850-4385089.60490.481.0297.0997.951.00
244029-4402989.97097.39
344329-4432990.58398.06
444908-4490891.76699.30
544697-4469791.33598.90
643844-4384489.59296.95
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.234398843972439954404743970439940.08
214.304434544377443610.06
单位质量响应值RSD%判断
3091.643102.170.25数据可信
长期3月-供试品溶液-24041102批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min149413-49413100.74199.563.76100.7499.563.76
249824-49824101.579101.58
349589-49589101.100101.10
449183-49183100.272100.27
545126-4512692.00192.00
649854-49854101.640101.64
10min149120-49120100.14399.351.23101.26100.461.26
249116-49116100.135101.26
348577-4857799.036100.16
448979-4897999.856100.97
547582-4758297.00898.03
649025-4902599.950101.08
15min148857-4885799.60798.861.03101.84101.071.03
248807-4880799.505101.75
348124-4812498.113100.34
447841-4784197.53699.76
548216-4821698.300100.40
649104-49104100.111102.35
20min147767-4776797.38597.390.67100.72100.700.65
247886-4788697.628100.97
348032-4803297.925101.24
447142-4714296.11199.42
547882-4788297.620100.81
647908-4790897.673101.02
30min146696-4669695.20294.971.2199.6299.361.21
246539-4653994.88199.31
347088-4708896.001100.40
446136-4613694.06098.44
545767-4576793.30897.58
647255-4725596.341100.78
45min146378-4637894.55393.881.03100.0399.321.00
246008-4600893.79999.28
345780-4578093.33498.80
445324-4532492.40497.82
546107-4610794.00199.31
646686-4668695.181100.69
60min144636-4463691.00292.031.2697.5398.521.20
245468-4546892.69899.23
345037-4503791.81998.32
444434-4443490.59097.04
545280-4528092.31598.67
645983-4598393.748100.31
极限145406-4540692.57291.281.33100.1198.801.29
245221-4522192.19499.75
345063-4506391.87299.40
444021-4402189.74897.20
544064-4406489.83697.22
644873-4487391.48599.09
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.234417844186441954420844160441850.05
214.304458744573445800.03
单位质量响应值RSD%判断
3105.063117.480.29数据可信
加速3月-供试品溶液-24041102批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min149173-4917399.78998.760.6799.7998.770.67
248886-4888699.20699.21
348716-4871698.86198.86
448512-4851298.44798.45
548299-4829998.01598.02
648424-4842498.26998.27
10min148767-4876798.96599.080.97100.07100.180.96
249106-4910699.653100.75
349311-49311100.069101.17
448027-4802797.46398.56
548603-4860398.63299.72
649136-4913699.714100.81
15min148571-4857198.56797.611.67100.7899.801.64
248518-4851898.459100.67
348263-4826397.942100.15
446612-4661294.59296.77
547827-4782797.05799.24
648793-4879399.018101.22
20min147291-4729195.96996.251.2499.2799.531.21
248133-4813397.678100.98
347023-4702395.42698.72
446607-4660794.58197.81
548025-4802597.459100.72
647504-4750496.40299.70
30min147740-4774096.88196.291.86101.25100.641.81
247196-4719695.777100.17
348697-4869798.823103.18
446062-4606293.47597.75
547137-4713795.657100.00
647848-4784897.100101.47
45min146721-4672194.81394.120.85100.2699.540.85
246262-4626293.88199.33
346354-4635494.06899.52
445813-4581392.97098.29
546209-4620993.77499.18
646915-4691595.206100.66
60min145874-4587493.09492.610.7999.5999.080.79
245690-4569092.72099.22
345705-4570592.75199.25
444939-4493991.19697.55
545945-4594593.23899.69
645672-4567292.68499.19
极限145236-4523691.79990.950.7599.3398.440.74
245066-4506691.45498.98
344702-4470290.71598.25
444473-4447390.25197.61
544423-4442390.14997.64
644996-4499691.31298.85
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