培哚普利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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
110.444355443694440744379243786437800.44
210.434340943451434300.07
单位质量响应值RSD%判断
4193.494163.950.50数据可信
供试品溶液-2022081201批-培哚普利-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%
5min143215-4321588.23683.674.3688.2483.674.36
239657-3965780.97280.97
341196-4119684.11484.11
442516-4251686.80986.81
540894-4089483.49783.50
638381-3838178.36678.37
10min145953-4595393.82792.913.1194.8193.843.09
243685-4368589.19690.10
345013-4501391.90892.84
445594-4559493.09494.06
547917-4791797.83798.76
644871-4487191.61892.49
15min145834-4583493.58492.971.5695.6194.931.54
245070-4507092.02493.91
344322-4432290.49792.45
445775-4577593.46395.46
545970-4597093.86295.88
646230-4623094.39296.28
20min145806-4580693.52792.661.1096.5995.651.13
244544-4454490.95093.86
345482-4548292.86595.83
445665-4566593.23996.28
545751-4575193.41496.47
645035-4503591.95294.89
30min145887-4588793.69291.051.5597.7995.071.53
244296-4429690.44494.37
344689-4468991.24695.24
444460-4446090.77894.85
544339-4433990.53194.63
643873-4387389.58093.54
45min145780-4578093.47491.621.3798.6296.651.32
245426-4542692.75197.68
344533-4453390.92795.93
444834-4483491.54296.62
544178-4417890.20395.30
644479-4447990.81795.77
极限145646-4564693.20091.202.0899.3897.261.94
245824-4582493.56399.52
344326-4432690.50596.52
444119-4411990.08296.18
543417-4341788.64994.75
644677-4467791.22197.19
培哚普利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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.981626371625511626411625691626391626070.03
213.991628471630421629440.09
单位质量响应值RSD%判断
11631.4011647.180.10数据可信
供试品溶液-2022081201批-氨氯地平-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%
5min1138802-13880277.30673.814.4577.3173.804.45
2128037-12803771.31071.31
3136500-13650076.02476.02
4137702-13770276.69376.69
5129347-12934772.04072.04
6124721-12472169.46369.46
10min1151938-15193884.62284.142.6185.4884.962.60
2143192-14319279.75180.54
3153411-15341185.44286.29
4151739-15173984.51185.36
5153520-15352085.50386.30
6152691-15269185.04185.81
15min1150355-15035583.74084.782.1985.5486.532.15
2147281-14728182.02883.71
3151131-15113184.17385.97
4153608-15360885.55287.34
5154203-15420385.88487.63
6156734-15673487.29389.01
20min1151503-15150384.38084.702.3487.1187.402.33
2145185-14518580.86183.45
3154760-15476086.19488.92
4153257-15325785.35788.10
5154059-15405985.80388.51
6153749-15374985.63188.32
30min1148378-14837882.63982.322.1986.3185.962.18
2141933-14193379.05082.54
3151810-15181084.55188.24
4148516-14851682.71686.41
5148691-14869182.81486.47
6147483-14748382.14185.78
45min1149245-14924583.12282.742.1487.7187.292.06
2146510-14651081.59985.97
3151950-15195084.62989.26
4143350-14335079.83984.45
5149135-14913583.06187.64
6151146-15114684.18188.73
极限1159343-15934388.74688.531.7294.2694.001.59
2161238-16123889.80295.07
3160181-16018189.21394.78
4159621-15962188.90194.40
5153555-15355585.52391.02
6159748-15974888.97294.46
培哚普利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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
110.444323443604435634326843580434500.42
210.434363443424435290.35
单位质量响应值RSD%判断
4161.884173.440.20数据可信
供试品溶液-2022081201批-培哚普利-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%
5min141479-4147984.91685.664.1484.9285.664.14
244137-4413790.35790.36
339667-3966781.20681.21
443543-4354389.14189.14
540443-4044382.79582.79
641799-4179985.57185.57
10min145115-4511592.35993.481.1293.3094.441.14
246284-4628494.75295.76
345780-4578093.72194.62
445889-4588993.94494.93
544972-4497292.06792.99
645944-4594494.05695.01
15min145258-4525892.65293.690.6694.6295.680.68
245961-4596194.09196.15
345888-4588893.94295.89
446072-4607294.31896.35
545572-4557293.29595.24
645850-4585093.86495.86
20min145355-4535592.85193.660.5395.8596.700.54
245736-4573693.63196.73
345805-4580593.77296.76
446034-4603494.24197.32
545639-4563993.43296.41
645944-4594494.05697.10
30min145309-4530992.75692.120.8296.7996.200.78
244996-4499692.11696.26
344590-4459091.28495.31
445199-4519992.53196.66
545378-4537892.89896.92
644531-4453191.16495.25
45min145733-4573393.62492.420.9298.6997.520.87
244812-4481291.73996.91
344857-4485791.83196.87
445546-4554693.24298.40
545167-4516792.46697.52
644760-4476091.63296.73
极限145670-4567093.49592.191.2799.6098.321.16
244386-4438690.86797.05
344890-4489091.89997.96
444904-4490491.92798.12
545778-4577893.71799.79
644579-4457991.26297.38
培哚普利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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.981623391627051623821625151626381625160.10
213.991624861624571624720.02
单位质量响应值RSD%判断
11624.8911613.440.07数据可信
供试品溶液-2022081201批-氨氯地平-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%
5min1132454-13245473.89874.704.6273.9074.704.62
2142815-14281579.67979.68
3126693-12669370.68470.68
4138409-13840977.22177.22
5127905-12790571.36071.36
6135073-13507375.35975.36
10min1147743-14774382.42884.422.2483.2585.252.24
2154808-15480886.37087.26
3152336-15233684.99185.78
4151560-15156084.55885.42
5146825-14682581.91682.71
6154622-15462286.26687.10
15min1147331-14733182.19884.952.0183.9486.722.00
2153766-15376685.78887.63
3154393-15439386.13887.87
4151724-15172484.64986.45
5150577-15057784.00985.71
6155807-15580786.92788.72
20min1147883-14788382.50684.921.7585.1687.631.74
2153582-15358285.68688.48
3154010-15401085.92588.61
4152247-15224784.94187.68
5150452-15045283.94086.58
6155078-15507886.52089.28
30min1147366-14736682.21883.341.0385.7886.991.07
2151411-15141184.47588.22
3149602-14960283.46587.11
4149010-14901083.13586.82
5148144-14814482.65286.22
6150700-15070084.07887.80
45min1148477-14847782.83882.742.2587.3287.322.13
2145412-14541281.12885.82
3151589-15158984.57489.14
4144040-14404080.36284.97
5147762-14776282.43986.93
6152513-15251385.08989.75
极限1160937-16093789.78989.380.4395.1994.880.43
2160418-16041889.50095.09
3159275-15927588.86294.37
4160779-16077989.70195.20
5159469-15946988.97094.37
6160371-16037189.47395.08
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