左氨氯地平叶酸片项目信息
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5000
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%
117.307485474691748977482674801748140.11
217.247365573671736630.02
单位质量响应值RSD%判断
4324.514272.800.86数据可信
供试品溶液-24082901批-左氨氯地平-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%
5min139768-3976893.46091.762.9293.4691.762.92
240467-4046795.10395.10
337486-3748688.09788.10
437929-3792989.13989.14
539555-3955592.96092.96
639073-3907391.82791.83
10min143372-43372101.93099.702.29102.97100.722.30
243777-43777102.882103.94
341388-4138897.26898.25
441732-4173298.07699.07
541768-4176898.16199.19
642502-4250299.886100.91
15min139683-3968393.26197.582.8595.4399.712.80
242547-4254799.991102.19
341484-4148497.49399.55
440591-4059195.39597.47
542621-42621100.165102.29
642207-4220799.192101.32
20min141742-4174298.10097.031.84101.31100.251.84
242317-4231799.451102.76
340472-4047295.11598.26
440396-4039694.93698.08
541640-4164097.860101.10
641163-4116396.73999.97
30min142326-4232699.47296.062.52103.77100.352.47
241382-4138297.254101.67
339398-3939892.59196.79
440057-4005794.14098.33
540987-4098796.325100.65
641098-4109896.586100.89
45min137708-3770888.61990.242.0194.0295.591.94
238821-3882191.23596.73
337315-3731587.69692.92
438763-3876391.09996.34
539396-3939692.58697.98
638372-3837290.18095.56
60min138881-3888191.37688.242.3097.7694.602.18
237360-3736087.80194.31
337602-3760288.37094.57
436195-3619585.06391.32
537482-3748288.08894.51
637767-3776788.75895.14
90min138382-3838290.20387.263.9697.6194.603.76
238051-3805189.42596.91
334409-3440980.86688.05
436565-3656585.93393.13
537693-3769388.58495.99
637683-3768388.56095.93
极限137842-3784288.93486.341.5897.3494.651.50
236445-3644585.65194.13
336343-3634385.41193.49
436651-3665186.13594.29
536847-3684786.59694.98
636306-3630685.32493.68
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8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%
116.039749297496976469763897341975230.13
216.039638396561964720.14
单位质量响应值RSD%判断
6083.786018.220.77数据可信
供试品溶液-24082901批-叶酸-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%
5min111988-1198820.32721.3711.5920.3321.3611.60
213551-1355122.97822.98
312835-1283521.76421.76
413005-1300522.05222.05
510028-1002817.00417.00
614195-1419524.07024.07
10min121762-2176236.90038.486.5237.1338.726.55
223884-2388440.49940.75
323882-2388240.49540.74
422537-2253738.21538.46
520259-2025934.35234.54
623826-2382640.40040.67
15min127769-2776947.08647.117.8547.7247.777.85
229587-2958750.16950.87
328768-2876848.78049.47
427734-2773447.02747.70
523603-2360340.02240.59
629224-2922449.55350.27
20min131352-3135253.16252.226.2454.3253.416.26
232551-3255155.19556.46
330429-3042951.59752.83
431310-3131053.09054.28
527161-2716146.05547.07
631988-3198854.24055.51
30min134307-3430758.17257.974.9759.9259.745.03
235431-3543160.07861.95
333914-3391457.50659.31
435066-3506659.45961.24
530960-3096052.49754.02
635447-3544760.10561.97
45min137465-3746563.52762.613.0065.9265.023.11
237078-3707862.87165.41
337498-3749863.58366.03
437334-3733463.30565.75
534687-3468758.81760.93
637488-3748863.56666.10
60min136875-3687562.52763.292.5265.6366.392.61
236963-3696362.67665.92
337508-3750863.60066.75
438429-3842965.16268.31
535916-3591660.90163.66
638245-3824564.85068.09
90min138776-3877665.75067.072.2669.5570.882.25
238669-3866965.56969.51
340483-4048368.64572.50
439564-3956467.08670.96
539063-3906366.23769.68
640773-4077369.13673.10
极限140888-4088869.33170.211.0673.8674.771.14
241179-4117969.82574.49
342032-4203271.27175.89
441394-4139470.18974.80
541139-4113969.75773.93
641818-4181870.90875.64
左氨氯地平叶酸片项目信息
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5000
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%
117.307342073447736757247673280732600.63
217.247340073209733040.19
单位质量响应值RSD%判断
4234.684251.970.29数据可信
供试品溶液-24082901批-左氨氯地平-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%
5min137351-3735188.92291.312.1388.9291.312.13
238117-3811790.74590.75
338926-3892692.67192.67
439118-3911893.12893.13
539126-3912693.14893.15
637492-3749289.25789.26
10min137853-3785390.11797.613.8391.1098.633.81
241806-4180699.528100.54
341209-4120998.10799.14
442043-42043100.092101.13
541636-4163699.123100.16
641467-4146798.72199.71
15min140039-4003995.32198.931.8797.31101.031.88
242095-42095100.216102.33
341770-4177099.442101.56
442128-42128100.294102.44
541590-4159099.014101.15
641707-4170799.292101.38
20min140004-4000495.23897.551.6398.29100.741.63
241625-4162599.097102.32
340300-4030095.94299.17
441238-4123898.176101.44
541514-4151498.833102.07
641160-4116097.990101.18
30min139292-3929293.54396.781.6597.65101.061.67
241034-4103497.690102.02
340901-4090197.373101.66
440942-4094297.471101.82
540803-4080397.140101.47
640942-4094297.471101.75
45min136123-3612385.99889.472.3891.1494.822.33
237454-3745489.16794.58
338733-3873392.21297.58
437579-3757989.46594.90
538247-3824791.05596.47
637340-3734088.89694.26
60min135164-3516483.71588.242.8289.8294.592.75
237215-3721588.59895.00
336754-3675487.50093.90
437642-3764289.61596.04
538175-3817590.88397.31
637428-3742889.10595.46
90min135140-3514083.65887.152.3690.6994.482.32
236303-3630386.42793.82
337116-3711688.36295.73
437438-3743889.12996.55
537277-3727788.74696.18
636357-3635786.55593.90
极限133946-3394680.81585.273.7288.7893.573.54
235911-3591185.49493.84
337235-3723588.64697.00
436320-3632086.46794.88
536991-3699188.06596.49
634505-3450582.14690.45
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8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%
116.039580495950957739613195905959130.15
216.039653996672966060.10
单位质量响应值RSD%判断
5983.346026.580.51数据可信
供试品溶液-24082901批-叶酸-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%
5min114582-1458224.91523.3311.6824.9123.3311.68
216140-1614027.57727.58
311683-1168319.96219.96
412337-1233721.07921.08
513730-1373023.45923.46
613465-1346523.00623.01
10min124348-2434841.60139.349.4941.8839.609.51
226070-2607044.54344.85
319799-1979933.82934.05
421608-2160836.92037.15
523595-2359540.31540.58
622714-2271438.80939.06
15min129871-2987151.03848.786.9551.7849.486.99
231728-3172854.21155.01
326431-2643145.16045.76
427015-2701546.15846.80
528676-2867648.99649.70
627589-2758947.13947.83
20min133243-3324356.79954.265.9758.1155.506.04
234532-3453259.00260.41
329746-2974650.82451.92
429917-2991751.11652.27
532059-3205954.77656.03
631042-3104253.03954.25
30min136429-3642962.24359.744.4064.1861.584.50
237233-3723363.61765.68
333335-3333556.95758.62
433849-3384957.83559.56
534705-3470559.29761.16
634222-3422258.47260.27
45min137921-3792164.79263.524.1667.4266.024.19
239358-3935867.24770.01
335895-3589561.33163.63
437908-3790864.77067.14
536883-3688363.01965.54
635085-3508559.94762.40
60min138976-3897666.59566.565.9869.9469.775.88
241796-4179671.41374.93
336504-3650462.37165.35
441190-4119070.37873.47
539128-3912866.85470.08
636137-3613761.74464.86
90min140093-4009368.50369.435.9872.5973.385.87
243525-4352574.36778.67
338090-3809065.08168.75
443213-4321373.83477.70
541003-4100370.05874.02
637883-3788364.72768.53
极限141444-4144470.81271.414.7975.6676.144.75
244604-4460476.21181.34
340571-4057169.32073.71
443731-4373174.71979.41
541141-4114170.29475.04
639287-3928767.12671.65
左氨氯地平叶酸片项目信息
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5000
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%
117.307397073888737427371873878738390.15
217.247220572209722070.01
单位质量响应值RSD%判断
4268.154188.341.34数据可信
供试品溶液-24091402批-左氨氯地平-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%
5min137218-3721888.92988.071.5788.9388.071.57
236439-3643987.06787.07
337382-3738289.32189.32
437413-3741389.39589.39
535990-3599085.99585.99
636720-3672087.73987.74
10min140228-4022896.12191.515.3897.1192.495.31
238378-3837891.70092.67
336942-3694288.26989.26
434885-3488583.35484.35
539383-3938394.10295.06
639966-3996695.49596.47
15min140164-4016495.96891.473.6598.0293.463.61
238970-3897093.11595.10
337937-3793790.64792.62
435987-3598785.98787.91
538719-3871992.51594.52
637912-3791290.58792.62
20min134746-3474683.02288.143.1586.1491.163.01
237892-3789290.53993.56
336650-3665087.57290.55
436997-3699788.40191.28
537893-3789390.54293.57
637159-3715988.78891.83
30min138026-3802690.85988.361.7694.9092.341.72
236685-3668587.65591.68
336298-3629886.73090.68
436798-3679887.92591.78
537489-3748989.57693.61
636574-3657487.39091.42
45min137751-3775190.20288.662.2595.2693.632.14
236708-3670887.71092.71
335736-3573685.38890.30
437900-3790090.55895.39
537670-3767090.00995.04
636866-3686688.08893.09
60min136616-3661687.49086.731.8093.5592.691.75
236453-3645387.10193.08
335023-3502383.68489.55
436247-3624786.60992.45
536749-3674987.80893.84
636699-3669987.68993.67
90min134259-3425981.85885.192.6788.8992.122.45
235610-3561085.08792.03
334992-3499283.61090.41
436723-3672387.74694.55
536652-3665287.57694.58
635690-3569085.27892.23
极限135786-3578685.50783.362.9693.4591.232.76
235877-3587785.72593.61
333093-3309379.07286.80
435271-3527184.27792.05
534495-3449582.42290.40
634807-3480783.16891.07
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8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%
116.039639296895965419659896887966630.23
216.039593196153960420.17
单位质量响应值RSD%判断
6030.135991.390.46数据可信
供试品溶液-24091402批-叶酸-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%
5min18254-825414.08914.056.2214.0914.046.21
28260-826014.09914.10
37683-768313.11513.11
47613-761312.99513.00
58880-888015.15815.16
68679-867914.81514.81
10min119387-1938733.09332.088.4433.2532.238.42
219090-1909032.58632.74
317414-1741429.72529.87
416779-1677928.64128.79
521273-2127336.31236.48
618802-1880232.09432.26
15min126392-2639245.05042.279.1545.5742.789.12
225580-2558043.66444.18
323981-2398140.93541.41
420529-2052935.04235.50
526535-2653545.29445.87
625571-2557143.64944.17
20min129319-2931950.04649.125.6651.0750.105.68
228465-2846548.58949.59
326915-2691545.94346.87
426939-2693945.98446.84
530504-3050452.06953.14
630513-3051352.08453.09
30min134182-3418258.34755.667.1459.9357.197.13
233040-3304056.39857.94
330679-3067952.36853.81
429381-2938150.15251.51
535812-3581261.13062.78
632560-3256055.57857.16
45min137378-3737863.80362.826.7466.0364.976.72
237203-3720363.50465.67
333288-3328856.82158.84
434522-3452258.92860.85
539909-3990968.12370.46
638530-3853065.76967.97
60min139054-3905466.66366.337.6069.6069.177.54
239323-3932367.12370.00
334335-3433558.60861.26
436974-3697463.11365.69
542918-4291873.25976.35
640538-4053869.19772.13
90min142012-4201271.71369.487.8675.3973.067.80
241160-4116070.25873.88
335622-3562260.80564.11
438413-3841365.56968.85
544617-4461776.15980.06
642396-4239672.36876.07
极限141871-4187171.47271.695.2775.9576.055.35
242601-4260172.71877.12
338640-3864065.95769.94
440774-4077469.59973.60
545251-4525177.24181.99
642871-4287173.17977.69
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