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%
110.764443844447444774446444492444640.05
210.834447244458444650.03
单位质量响应值RSD%判断
4132.344105.720.46数据可信
供试品溶液-2022081101批-培哚普利-磷酸盐缓冲液(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%
5min134673-3467371.82172.893.5671.8272.893.56
235150-3515072.80972.81
334227-3422770.89770.90
437501-3750177.67977.68
534091-3409170.61570.62
635487-3548773.50773.51
10min138499-3849979.74682.803.7080.5483.613.69
241244-4124485.43286.24
338158-3815879.04079.83
441884-4188486.75887.62
540311-4031183.49984.28
639742-3974282.32183.14
15min142876-4287688.81387.301.6990.5089.021.70
242554-4255488.14689.90
341110-4111085.15486.82
442807-4280788.67090.50
541833-4183386.65288.36
641681-4168186.33788.07
20min141088-4108885.10986.493.2687.7889.193.23
242416-4241687.86090.60
339564-3956481.95284.56
443465-4346590.03392.84
542503-4250388.04090.72
641488-4148885.93788.63
30min142334-4233487.69088.961.7891.3192.621.81
243533-4353390.17393.89
341747-4174786.47490.00
443767-4376790.65894.47
543138-4313889.35593.01
643165-4316589.41193.06
45min141707-4170786.39187.111.2290.9891.761.27
242573-4257388.18592.90
341285-4128585.51790.00
442496-4249688.02592.85
541875-4187586.73991.39
642375-4237587.77592.41
极限144211-4421191.57891.610.3497.1397.230.41
244261-4426191.68197.38
344231-4423191.61997.05
444486-4448692.14797.95
544117-4411791.38396.99
644053-4405391.25196.86
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%
113.981631571632251633021631181631601631920.05
213.981630611632191631400.07
单位质量响应值RSD%判断
11673.2511669.530.03数据可信
供试品溶液-2022081101批-氨氯地平-磷酸盐缓冲液(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%
5min159326-5932632.95134.004.8032.9534.004.80
261761-6176134.30334.30
358266-5826632.36232.36
466659-6665937.02437.02
560321-6032133.50333.50
660933-6093333.84333.84
10min189417-8941749.66451.635.4550.0352.015.44
297854-9785454.35054.73
385999-8599947.76548.13
499133-9913355.06055.47
594261-9426152.35452.73
691118-9111850.60950.98
15min1113297-11329762.92761.483.2563.8562.443.25
2112054-11205462.23763.22
3107330-10733059.61360.50
4115896-11589664.37165.39
5108415-10841560.21661.17
6107209-10720959.54660.48
20min1113271-11327162.91364.415.6464.5366.055.60
2120639-12063967.00568.68
3105880-10588058.80860.36
4123867-12386768.79870.54
5119294-11929466.25867.88
6112895-11289562.70464.30
30min1123162-12316268.40770.253.8370.7272.603.83
2131472-13147273.02275.44
3119212-11921266.21368.42
4131190-13119072.86575.37
5128593-12859371.42373.78
6125307-12530769.59871.89
45min1124925-12492569.38670.902.8772.4674.032.91
2132040-13204073.33876.57
3122264-12226467.90870.85
4130937-13093772.72576.04
5128228-12822871.22074.37
6127518-12751870.82673.90
极限1155317-15531786.26685.890.5390.1189.800.54
2154886-15488686.02790.07
3154897-15489786.03389.73
4155236-15523686.22190.34
5153143-15314385.05989.00
6154325-15432585.71589.57
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%
110.764440544318441424436944297443060.23
210.834440344383443930.04
单位质量响应值RSD%判断
4117.664099.080.32数据可信
供试品溶液-2022081101批-培哚普利-磷酸盐缓冲液(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%
5min136464-3646475.72773.067.5475.7373.067.54
238981-3898180.95480.95
335882-3588274.51874.52
433459-3345969.48669.49
531237-3123764.87164.87
635070-3507072.83272.83
10min141336-4133685.84483.375.0186.6984.185.02
243127-4312789.56490.46
340314-4031483.72284.55
437157-3715777.16677.94
539447-3944781.92182.64
639479-3947981.98882.80
15min141877-4187786.96887.272.2988.7689.012.34
243641-4364190.63192.53
342565-4256588.39790.16
441438-4143886.05687.69
541713-4171386.62788.26
640904-4090484.94786.67
20min143592-4359290.53086.794.4493.2989.504.41
243576-4357690.49693.40
342725-4272588.72991.47
438985-3898580.96283.55
541459-4145986.10088.69
640424-4042483.95086.61
30min143489-4348990.31689.482.8094.0893.152.85
244619-4461992.66296.57
343819-4381991.00194.73
441104-4110485.36388.85
542884-4288489.05992.61
642591-4259188.45192.05
45min141843-4184386.89787.292.1291.6791.962.19
243306-4330689.93694.87
342572-4257288.41193.15
440629-4062984.37688.81
541927-4192787.07291.61
641923-4192387.06491.64
极限144701-4470192.83392.300.9298.5797.940.97
244962-4496293.37599.31
344196-4419691.78497.50
444746-4474692.92698.30
544016-4401691.41096.92
644054-4405491.48997.04
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%
113.981629381630161622131629361625731627350.21
213.981629021626991628000.09
单位质量响应值RSD%判断
11640.5611645.210.03数据可信
供试品溶液-2022081101批-氨氯地平-磷酸盐缓冲液(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%
5min165229-6522936.31834.208.4636.3234.208.46
269082-6908238.46338.46
361859-6185934.44234.44
457097-5709731.79031.79
554976-5497630.60930.61
660327-6032733.58933.59
10min197344-9734454.19952.287.1454.6052.667.14
2103991-10399157.90058.33
395654-9565453.25853.64
485218-8521847.44847.80
592847-9284751.69552.04
688312-8831249.17049.54
15min1110803-11080361.69361.684.7062.7062.644.71
2118906-11890666.20467.28
3112557-11255762.66963.64
4111058-11105861.83562.72
5108300-10830060.29961.21
6103057-10305757.38058.30
20min1123636-12363668.83864.817.4070.5366.457.35
2125943-12594370.12271.93
3120023-12002366.82668.50
4105998-10599859.01760.58
5116659-11665964.95366.54
6106106-10610659.07860.63
30min1129284-12928471.98370.884.7774.4473.254.80
2135144-13514475.24577.83
3129293-12929371.98874.40
4118414-11841465.93068.15
5129825-12982572.28474.59
6121869-12186967.85470.07
45min1127599-12759971.04471.244.0074.3074.404.04
2135219-13521975.28778.71
3129180-12918071.92575.14
4119874-11987466.74369.70
5130301-13030172.54975.66
6125565-12556569.91272.88
极限1155478-15547886.56786.901.0190.6190.851.03
2157745-15774587.82992.09
3155813-15581386.75390.77
4158220-15822088.09491.79
5154845-15484586.21490.13
6154381-15438185.95689.70
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