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(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.091723881726021723671723901728281725150.12
216.051738881736411737640.11
单位质量响应值RSD%判断
10721.8810826.420.69数据可信
长期3月-供试品溶液-24041101批-pH6.5(内含0.35%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min167081-6708134.95335.419.1934.9535.419.19
268006-6800635.43535.43
361860-6186032.23232.23
461406-6140631.99632.00
571287-7128737.14437.14
678110-7811040.69940.70
10min1117130-11713061.03160.496.0161.4260.896.03
2115965-11596560.42460.82
3108682-10868256.62956.99
4109333-10933356.96857.32
5117609-11760961.28061.69
6127873-12787366.62867.08
15min1140495-14049573.20573.294.6774.2774.364.71
2142488-14248874.24475.31
3134013-13401369.82870.81
4133424-13342469.52170.51
5142277-14227774.13475.23
6151298-15129878.83480.03
20min1153553-15355380.00980.023.5781.8981.903.62
2156284-15628481.43283.32
3148220-14822077.23078.99
4147375-14737576.79078.55
5153810-15381080.14382.06
6162234-16223484.53286.60
30min1163585-16358585.23686.401.9288.0189.172.01
2166871-16687186.94889.74
3163413-16341385.14787.77
4163514-16351485.19987.81
5165909-16590986.44789.25
6171594-17159489.40992.42
45min1165350-16535086.15687.832.0589.8791.562.12
2171387-17138789.30193.06
3165828-16582886.40589.97
4166792-16679286.90790.47
5167940-16794087.50591.27
6174041-17404190.68494.69
60min1163960-16396085.43288.322.2390.1093.022.25
2171577-17157789.40094.15
3169781-16978188.46592.99
4166659-16665986.83891.36
5170305-17030588.73893.48
6174700-17470091.02896.04
极限1168003-16800387.53888.361.2793.1694.051.35
2169940-16994088.54794.29
3168020-16802087.54793.06
4170036-17003688.59794.09
5168016-16801687.54593.27
6173486-17348690.39596.42
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(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.091731991739751740921737441739941738010.21
216.051738341739711739020.06
单位质量响应值RSD%判断
10801.8010835.020.22数据可信
加速3月-供试品溶液-24041101批-pH6.5(内含0.35%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min165752-6575234.11934.6810.0034.1234.6810.00
254444-5444428.25128.25
367659-6765935.10935.11
468967-6896735.78835.79
574126-7412638.46538.46
670015-7001536.33136.33
10min1113039-11303958.65759.474.3759.0459.854.40
2105311-10531154.64754.96
3115990-11599060.18860.58
4119176-11917661.84162.24
5116185-11618560.28960.72
6117888-11788861.17361.58
15min1137997-13799771.60872.642.3172.6473.682.36
2134611-13461169.85170.77
3142588-14258873.99075.05
4142253-14225373.81674.90
5139730-13973072.50773.60
6142682-14268274.03975.12
20min1151259-15125978.49079.511.5380.3281.361.58
2149710-14971077.68679.38
3155421-15542180.64982.53
4155159-15515980.51382.42
5152997-15299779.39181.29
6154785-15478580.31982.23
30min1163816-16381685.00586.050.8587.7088.780.87
2165285-16528585.76888.33
3168056-16805687.20689.98
4166429-16642986.36189.16
5165585-16558585.92388.71
6165794-16579486.03288.83
45min1171098-17109888.78489.040.5192.4392.740.57
2170686-17068688.57092.08
3172672-17267289.60193.35
4171782-17178289.13992.90
5170823-17082388.64192.38
6172518-17251889.52193.28
60min1169034-16903487.71388.971.1792.3493.651.09
2173759-17375990.16594.66
3173408-17340889.98394.72
4171311-17131188.89593.64
5169313-16931387.85892.58
6171935-17193589.21993.97
极限1169109-16910987.75288.620.9993.3694.280.90
2172920-17292089.73095.23
3168840-16884087.61293.35
4171120-17112088.79694.53
5170255-17025588.34794.05
6172386-17238689.45395.19
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(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.091747211752341747491745601750251748580.16
216.051743211736491739850.28
单位质量响应值RSD%判断
10867.5010840.190.18数据可信
长期3月-供试品溶液-24041102批-pH6.5(内含0.35%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min172060-7206037.27038.223.0837.2738.223.09
275304-7530438.94838.95
371564-7156437.01437.01
475580-7558039.09139.09
571987-7198737.23337.23
676832-7683239.73939.74
10min1121596-12159662.89164.041.6563.3164.461.64
2122749-12274963.48863.92
3123361-12336163.80464.22
4122667-12266763.44563.88
5125481-12548164.90165.31
6127045-12704565.70966.15
15min1144436-14443674.70475.502.0575.8276.642.04
2142222-14222273.55974.70
3144596-14459674.78775.91
4145527-14552775.26976.41
5148969-14896977.04978.18
6150107-15010777.63778.81
20min1153434-15343479.35881.662.2781.3083.642.25
2154572-15457279.94781.90
3157294-15729481.35583.31
4158353-15835381.90283.88
5162690-16269084.14686.14
6160948-16094883.24585.28
30min1165785-16578585.74686.341.3188.5789.221.32
2165078-16507885.38188.22
3166291-16629186.00888.86
4165246-16524685.46888.35
5170458-17045888.16391.09
6168779-16877987.29590.25
45min1174128-17412890.06188.412.0793.8492.261.99
2173098-17309889.52993.32
3168165-16816586.97790.79
4165334-16533485.51389.35
5173867-17386789.92693.83
6171056-17105688.47392.40
60min1173976-17397689.98387.991.2994.7692.811.24
2168705-16870587.25792.04
3168974-16897487.39692.17
4167826-16782686.80291.59
5170559-17055988.21693.12
6170650-17065088.26393.17
极限1168207-16820786.99987.931.8292.7893.741.70
2167891-16789186.83692.59
3175952-17595291.00596.75
4167931-16793186.85692.61
5170436-17043688.15294.04
6169650-16965087.74593.64
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(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.091727941737051733111733411736581733620.22
216.051735841737201736520.06
单位质量响应值RSD%判断
10774.5210819.440.30数据可信
加速3月-供试品溶液-24041102批-pH6.5(内含0.35%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min166935-6693534.80236.453.4634.8036.453.46
267831-6783135.26835.27
370092-7009236.44436.44
472040-7204037.45637.46
573297-7329738.11038.11
670442-7044236.62636.63
10min1117134-11713460.90362.162.7761.2962.562.77
2117825-11782561.26261.65
3115395-11539559.99860.40
4120537-12053762.67263.09
5122496-12249663.69064.11
6123905-12390564.42364.83
15min1141576-14157673.61174.561.3174.6775.661.31
2142992-14299274.34775.42
3142698-14269874.19475.27
4142582-14258274.13475.25
5143645-14364574.68775.82
6146960-14696076.41077.53
20min1156229-15622981.23080.972.7383.1182.902.69
2155578-15557880.89182.79
3147477-14747776.67978.58
4157720-15772082.00583.94
5158444-15844482.38184.34
6158950-15895082.64484.62
30min1164144-16414485.34587.431.5788.1390.251.55
2169794-16979488.28391.08
3168194-16819487.45190.20
4166154-16615486.39089.24
5169165-16916587.95690.83
6171463-17146389.15092.04
45min1168703-16870387.71589.001.2191.4592.791.17
2173513-17351390.21693.99
3172116-17211689.49093.21
4168952-16895287.84591.65
5170676-17067688.74192.59
6173032-17303289.96693.85
60min1169208-16920887.97889.721.3192.6894.501.26
2172352-17235289.61394.39
3175445-17544591.22195.93
4170973-17097388.89693.68
5174242-17424290.59595.43
6173170-17317090.03894.92
极限1169902-16990288.33988.521.2394.0294.301.13
2171941-17194189.39995.18
3171458-17145889.14894.88
4169299-16929988.02593.80
5172181-17218189.52495.37
6166686-16668686.66792.55
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