培哚普利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1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.944156441529414834151441483415150.09
29.964171441692417030.04
单位质量响应值RSD%判断
4176.564187.050.18数据可信
供试品溶液-24040702批-培哚普利-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%
5min144378-4437890.54377.6311.3290.5477.6311.32
235520-3552072.47072.47
338219-3821977.97777.98
438037-3803777.60677.61
540449-4044982.52782.53
631686-3168664.64864.65
10min144723-4472391.24786.234.3492.2587.104.37
240000-4000081.61182.42
343266-4326688.27489.14
440398-4039882.42383.29
543265-4326588.27289.19
641936-4193685.56186.28
15min144658-4465891.11486.714.2393.1388.534.26
240503-4050382.63784.35
343612-4361288.98090.83
440304-4030482.23184.01
543666-4366689.09090.99
642251-4225186.20387.87
20min144360-4436090.50686.063.5693.5488.843.61
241149-4114983.95586.59
342826-4282687.37790.21
440112-4011281.83984.53
542913-4291387.55490.44
641720-4172085.12087.75
30min143587-4358788.92986.892.9692.9790.642.99
241568-4156884.81088.37
343756-4375689.27493.08
440563-4056382.76086.36
543110-4311087.95691.82
642952-4295287.63491.21
45min142689-4268987.09786.862.1792.1291.562.16
242288-4228886.27990.78
342996-4299687.72392.52
440865-4086583.37687.90
543203-4320388.14692.98
643389-4338988.52593.07
极限143486-4348688.72390.302.6594.7295.972.48
245126-4512692.06997.53
344355-4435590.49696.27
442387-4238786.48191.93
544564-4456490.92396.74
645635-4563593.10898.64
培哚普利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8000
标示量(mg)2.5 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%
114.063968939716398223986339761397700.19
214.204044240472404570.06
单位质量响应值RSD%判断
2828.592849.080.52数据可信
供试品溶液-24040702批-左氨氯地平-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%
5min142321-4232196.64289.054.3496.6489.054.34
238333-3833387.53587.53
337779-3777986.27086.27
439135-3913589.36689.37
538301-3830187.46287.46
638102-3810287.00787.01
10min141192-4119294.06489.193.5595.1490.183.55
238832-3883288.67489.65
336969-3696984.42085.38
439294-3929489.72990.72
538505-3850587.92888.90
639562-3956290.34191.31
15min141350-4135094.42488.863.6996.5490.843.68
239080-3908089.24191.20
337162-3716284.86186.76
439322-3932289.79391.78
538655-3865588.27090.22
637915-3791586.58088.55
20min140923-4092393.44987.983.7796.6290.953.76
238861-3886188.74191.69
336480-3648083.30386.14
438654-3865488.26891.26
537875-3787586.48989.42
638388-3838887.66090.59
30min140263-4026391.94287.922.7096.1591.862.74
238448-3844887.79791.73
337164-3716484.86588.63
438674-3867488.31492.28
537841-3784186.41190.30
638612-3861288.17292.08
45min137069-3706984.64885.662.2889.8890.582.21
238061-3806186.91491.82
336179-3617982.61687.32
438353-3835387.58192.53
537164-3716484.86589.72
638244-3824487.33292.22
极限139181-3918189.47187.101.5595.6492.971.60
238199-3819987.22993.11
337842-3784286.41492.04
437536-3753685.71591.64
537744-3774486.19091.98
638347-3834787.56793.42
培哚普利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1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.944137841296413084133641338413310.08
29.964180741902418540.17
单位质量响应值RSD%判断
4158.054202.210.75数据可信
供试品溶液-24040701批-培哚普利-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%
5min144916-4491691.68068.1819.3591.6868.1819.34
225273-2527351.58651.59
331572-3157264.44364.44
434540-3454070.50170.50
532976-3297667.30967.31
631128-3112863.53763.54
10min145059-4505991.97280.318.6592.9981.078.73
235303-3530372.05872.63
341404-4140484.51185.23
438328-3832878.23379.02
538033-3803377.63178.38
637957-3795777.47678.18
15min144574-4457490.98282.806.7293.0284.456.81
237088-3708875.70277.08
342939-4293987.64589.30
439086-3908679.78081.43
539680-3968080.99382.60
640028-4002881.70383.27
20min144753-4475391.34783.895.4594.4086.465.59
238465-3846578.51380.73
342522-4252286.79389.42
439601-3960180.83183.37
540632-4063282.93685.45
640614-4061482.89985.37
30min144612-4461291.05985.593.8795.1389.094.06
240120-4012081.89184.98
342722-4272287.20290.79
440527-4052782.72186.16
541757-4175785.23288.66
641851-4185185.42488.82
45min144873-4487391.59287.123.0696.6791.573.27
241398-4139884.49988.50
343109-4310987.99292.55
441338-4133884.37788.73
542513-4251386.77591.15
642865-4286587.49491.84
极限144762-4476291.36691.331.6597.4696.751.62
244178-4417890.17495.11
343776-4377689.35394.89
444595-4459591.02596.32
545432-4543292.73398.08
645723-4572393.32798.64
培哚普利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8000
标示量(mg)2.5 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%
114.064012640103400744008040106400980.06
214.204054540465405050.14
单位质量响应值RSD%判断
2851.922852.460.02数据可信
供试品溶液-24040701批-左氨氯地平-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%
5min140248-4024891.47689.802.4691.4889.802.46
239363-3936389.46589.46
338829-3882988.25188.25
438058-3805886.49986.50
540703-4070392.51092.51
639865-3986590.60690.61
10min140210-4021091.39090.491.5992.4191.491.60
239921-3992190.73391.73
339295-3929589.31090.29
438945-3894588.51589.48
540712-4071292.53193.56
639809-3980990.47991.49
15min139693-3969390.21590.491.8192.2592.491.81
239374-3937489.49091.49
339832-3983290.53192.50
438767-3876788.11090.05
540727-4072792.56594.62
640483-4048392.01094.02
20min139854-3985490.58189.802.0093.6292.811.99
239258-3925889.22692.22
338878-3887888.36391.34
438453-3845387.39790.32
540548-4054892.15895.24
640073-4007391.07994.11
30min139363-3936389.46589.041.5593.5193.051.56
239151-3915188.98392.97
338825-3882588.24292.20
438226-3822686.88190.78
539992-3999290.89495.00
639503-3950389.78393.83
45min138970-3897088.57287.581.4793.6192.571.48
238461-3846187.41592.39
338449-3844987.38892.33
437491-3749185.21090.07
538806-3880688.19993.32
639012-3901288.66793.71
极限138466-3846687.42686.301.5993.4592.271.60
237893-3789386.12492.07
337815-3781585.94791.86
436882-3688283.82689.63
538495-3849587.49293.59
638264-3826486.96793.00
培哚普利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1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.944168741625416254158141513416060.16
29.964117941169411740.02
单位质量响应值RSD%判断
4185.714133.940.89数据可信
供试品溶液-24040701批-培哚普利-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%
5min141579-4157985.28479.3810.0385.2879.3810.03
232745-3274567.16467.16
341733-4173385.60085.60
442251-4225186.66286.66
535629-3562973.08073.08
638260-3826078.47678.48
10min143512-4351289.24987.735.4290.2088.625.46
240159-4015982.37183.12
343801-4380189.84190.79
446498-4649895.37396.34
541794-4179485.72586.54
640875-4087583.84084.71
15min143208-4320888.62588.184.8990.5690.034.92
241266-4126684.64286.30
343768-4376889.77491.72
446610-4661095.60397.63
542280-4228086.72288.49
640802-4080283.69085.49
20min142987-4298788.17287.934.5691.1090.774.60
240969-4096984.03386.63
343433-4343389.08792.03
446199-4619994.76097.84
542786-4278687.76090.49
640854-4085483.79786.53
30min142020-4202086.18887.204.6590.0991.024.68
240277-4027782.61386.15
343161-4316188.52992.47
445960-4596094.27098.41
542553-4255387.28290.98
641116-4111684.33488.00
45min142804-4280487.79687.813.8092.6692.603.86
241617-4161785.36289.82
342746-4274687.67792.60
445745-4574593.82999.01
542924-4292488.04392.72
641028-4102884.15488.76
极限143189-4318988.58689.862.2094.4295.612.25
243465-4346589.15294.55
343015-4301588.22994.12
445363-4536393.04599.27
544641-4464191.56497.22
643174-4317488.55594.09
培哚普利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8000
标示量(mg)2.5 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%
114.064051040251401264021640205402620.37
214.203986239884398730.04
单位质量响应值RSD%判断
2863.582807.961.39数据可信
供试品溶液-24040701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%
5min130975-3097570.81571.492.3570.8171.492.35
230225-3022569.10069.10
331580-3158072.19872.20
431143-3114371.19971.20
531242-3124271.42571.43
632452-3245274.19274.19
10min136002-3600282.30882.651.8883.0983.441.88
235836-3583681.92882.70
335760-3576081.75482.56
435344-3534480.80381.59
536999-3699984.58785.38
636962-3696284.50285.33
15min136685-3668583.86984.901.3385.5786.611.33
237291-3729185.25586.93
336660-3666083.81285.52
436786-3678684.10085.79
537665-3766586.11087.84
637728-3772886.25488.02
20min136803-3680384.13984.961.6986.7787.621.68
236631-3663183.74686.37
336885-3688584.32686.97
436770-3677084.06486.69
538154-3815487.22889.92
637738-3773886.27789.00
30min136237-3623782.84584.552.0786.4188.152.04
236551-3655183.56387.12
336517-3651783.48587.06
436716-3671683.94087.50
537802-3780286.42390.08
638082-3808287.06390.74
45min136207-3620782.77684.151.4787.2688.691.45
236910-3691084.38488.87
336487-3648783.41787.92
436645-3664583.77888.27
537782-3778286.37791.00
636811-3681184.15788.80
极限137041-3704184.68385.681.8390.0991.151.78
237968-3796886.80292.22
337428-3742885.56891.00
436348-3634883.09988.52
538028-3802886.94092.52
638050-3805086.99092.57
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