叶酸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%
117.431939661939841939691937641937971938960.06
217.491944431941381942900.12
单位质量响应值RSD%判断
11124.2711108.630.10数据可信
供试品溶液-24070801批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1111283-111283101.128102.012.12101.13102.012.12
2116144-116144105.546105.55
3113995-113995103.593103.59
4110638-110638100.542100.54
5109772-10977299.75599.76
6111660-111660101.471101.47
10min1109660-10966099.654101.442.28100.78102.572.28
2115788-115788105.222106.40
3113247-113247102.913104.06
4110190-110190100.135101.25
5109115-10911599.158100.27
6111729-111729101.534102.66
15min1110082-110082100.037101.042.03102.27103.302.04
2114748-114748104.277106.62
3112800-112800102.507104.80
4110138-110138100.088102.32
5108401-10840198.509100.72
6110959-110959100.834103.09
20min1107291-10729197.50199.282.44100.84102.662.43
2113450-113450103.098106.60
3111491-111491101.317104.75
4107894-10789498.049101.39
5106678-10667896.944100.25
6108684-10868498.767102.14
30min1106795-10679597.05098.152.57101.48102.642.55
2112392-112392102.136106.78
3110087-110087100.042104.60
4106128-10612896.444100.88
5104876-10487695.30699.69
6107736-10773697.905102.38
45min1105644-10564496.00497.112.57101.51102.682.55
2111043-111043100.910106.69
3108932-10893298.992104.66
4105888-10588896.226101.73
5103246-10324693.82599.27
6106386-10638696.678102.24
60min1103974-10397494.48695.552.19101.06102.202.19
2108996-10899699.050105.95
3106724-10672496.985103.76
4103438-10343893.999100.57
5103019-10301993.619100.10
6104704-10470495.150101.79
90min1103021-10302193.62094.972.17101.24102.692.18
2107934-10793498.085106.09
3106425-10642596.714104.56
4103712-10371294.248101.86
5101801-10180192.512100.04
6104159-10415994.655102.35
极限1101188-10118891.95593.492.10100.62102.262.10
2106049-10604996.372105.46
3104550-10455095.010103.93
4101175-10117591.943100.61
5100828-10082891.627100.18
6103468-10346894.027102.77
叶酸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%
116.001942881941161942151942141940281941720.06
215.991942891944521943700.06
单位质量响应值RSD%判断
12135.7512155.720.12数据可信
供试品溶液-24070801批-叶酸-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min168062-6806257.49558.281.0657.4958.281.06
269277-6927758.52158.52
369945-6994559.08559.09
469481-6948158.69358.69
568953-6895358.24758.25
668254-6825457.65757.66
10min186597-8659773.15276.072.5273.7976.712.50
289294-8929475.43076.08
389875-8987575.92176.58
493591-9359179.06079.71
590825-9082576.72477.37
690098-9009876.11076.75
15min194556-9455679.87581.121.7181.3382.611.68
296109-9610981.18782.68
396694-9669481.68183.18
493827-9382779.26080.79
598411-9841183.13284.63
696549-9654981.55983.05
20min195430-9543080.61483.732.6682.9586.132.61
298738-9873883.40885.80
398841-9884183.49585.90
4103373-10337387.32389.73
5100345-10034584.76687.19
698015-9801582.79785.19
30min198096-9809682.86685.632.1786.1088.962.14
2101680-10168085.89389.21
3101155-10115585.45088.79
4104579-10457988.34291.72
5102568-10256886.64390.01
6100166-10016684.61487.93
45min198791-9879183.45386.122.5587.6190.402.50
2102150-10215086.29090.56
3101513-10151385.75290.04
4106193-10619389.70694.07
5103103-10310387.09591.42
699942-9994284.42588.68
60min198398-9839883.12185.442.3488.2090.672.31
2100935-10093585.26490.49
3100436-10043684.84290.08
4104422-10442288.21093.57
5103463-10346387.39992.70
699218-9921883.81489.00
90min197675-9767582.51085.852.5188.5292.032.46
2101256-10125685.53591.71
3100661-10066185.03391.21
4105199-10519988.86695.21
5103327-10332787.28593.55
6101628-10162885.84991.97
极限1109061-10906192.12893.360.9399.05100.500.91
2110401-11040193.260100.39
3110909-11090993.689100.81
4109693-10969392.66299.99
5111209-11120993.943101.18
6111870-11187094.501101.58
叶酸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%
117.431941581942781942771941961941481942110.04
217.491941611937261939440.16
单位质量响应值RSD%判断
11142.3411088.850.35数据可信
供试品溶液-24070802批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1112744-112744102.465103.371.67102.46103.371.67
2115617-115617105.076105.08
3114237-114237103.821103.82
4114695-114695104.238104.24
5114768-114768104.304104.30
6110406-110406100.340100.34
10min1112460-112460102.206101.501.37103.34102.651.37
2113458-113458103.113104.28
3112121-112121101.898103.05
4111717-111717101.531102.69
5111425-111425101.266102.42
6108920-10892098.989100.10
15min1110402-110402100.336100.501.33102.61102.781.33
2112345-112345102.102104.42
3111597-111597101.422103.71
4110211-110211100.163102.45
5110893-110893100.782103.07
6108064-10806498.211100.43
20min1110409-110409100.34299.471.12103.73102.871.12
2110737-110737100.641104.09
3109426-10942699.449102.86
4108532-10853298.637102.04
5110057-110057100.023103.43
6107553-10755397.747101.05
30min1108727-10872798.81498.511.31103.32103.011.30
2109329-10932999.361103.93
3108720-10872098.807103.33
4107852-10785298.019102.51
5109872-10987299.854104.37
6105859-10585996.207100.60
45min1107533-10753397.72997.481.59103.33103.071.57
2108537-10853798.641104.31
3107823-10782397.992103.61
4108604-10860498.702104.29
5107060-10706097.299102.92
6104004-10400494.52199.98
60min1105439-10543995.82696.031.23102.51102.711.23
2106212-10621296.528103.29
3106689-10668996.962103.67
4105249-10524995.653102.33
5106997-10699797.242103.95
6103413-10341393.984100.50
90min1103886-10388694.41494.881.60102.17102.621.56
2105232-10523295.637103.48
3105423-10542395.811103.59
4104402-10440294.883102.63
5106046-10604696.377104.16
6101386-10138692.14299.70
极限1105042-10504295.46594.611.75104.27103.411.68
2103831-10383194.364103.27
3104031-10403194.546103.39
4103642-10364294.192102.99
5106802-10680297.064105.92
6101258-10125892.026100.61
叶酸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%
116.001944791940641942201943651943391942930.09
215.991935481938521937000.12
单位质量响应值RSD%判断
12143.3112113.820.18数据可信
供试品溶液-24070802批-叶酸-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min127804-2780423.52021.2911.2923.5221.2911.29
225035-2503521.17821.18
328661-2866124.24524.25
424228-2422820.49520.50
524531-2453120.75220.75
620713-2071317.52217.52
10min149045-4904541.48935.7311.9341.7535.9611.91
241076-4107634.74834.98
343727-4372736.99037.26
443323-4332336.64936.88
542686-4268636.11036.34
633550-3355028.38128.58
15min160575-6057551.24341.5915.8051.9742.2215.70
248606-4860641.11841.74
350579-5057942.78743.47
441831-4183135.38636.02
553854-5385445.55746.19
639516-3951633.42833.94
20min169090-6909058.44645.6017.9859.7446.7017.83
252079-5207944.05645.13
353736-5373645.45746.61
444909-4490937.99039.02
560346-6034651.04952.19
643274-4327436.60737.49
30min179113-7911366.92550.4420.0068.8752.0419.81
256149-5614947.49949.07
358635-5863549.60251.26
449321-4932141.72343.17
567291-6729156.92458.63
647254-4725439.97441.26
45min188264-8826474.66654.5921.5577.3556.7521.31
259972-5997250.73352.83
363014-6301453.30655.52
454061-5406145.73247.65
571989-7198960.89863.24
649863-4986342.18143.91
60min192978-9297878.65456.7922.3982.1759.5622.12
261425-6142551.96254.62
365340-6534055.27458.08
455287-5528746.76949.19
575376-7537663.76366.78
652398-5239844.32546.53
90min199358-9935884.05159.9822.6388.4463.3822.35
263633-6363353.83057.07
368254-6825457.73961.16
458436-5843649.43352.37
578916-7891666.75870.48
656844-5684448.08650.78
极限1101731-10173186.05874.738.8791.3878.809.33
285300-8530072.15975.99
390605-9060576.64680.71
484989-8498971.89575.39
589144-8914475.41079.87
678273-7827366.21469.44
叶酸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%
117.431952601953851952901953531954841953540.05
217.491941991939531940760.09
单位质量响应值RSD%判断
11207.9211096.400.71数据可信
供试品溶液-24070804批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1115169-115169104.327103.182.15104.33103.182.15
2113651-113651102.952102.95
3114690-114690103.893103.89
4116473-116473105.509105.51
5109343-10934399.05099.05
6114090-114090103.350103.35
10min1111871-111871101.340101.841.77102.50102.991.77
2112054-112054101.506102.65
3113012-113012102.373103.53
4114839-114839104.028105.20
5109049-10904998.78399.88
6113712-113712103.008104.16
15min1111173-111173100.708101.171.53102.99103.451.53
2112103-112103101.550103.82
3112194-112194101.632103.92
4114176-114176103.428105.76
5108941-10894198.686100.88
6111541-111541101.041103.33
20min1109907-10990799.56199.771.61102.96103.171.62
2110658-110658100.241103.64
3111219-111219100.749104.17
4111961-111961101.421104.90
5106848-10684896.790100.08
6110206-11020699.832103.25
30min1107947-10794797.78598.842.01102.30103.351.99
2108951-10895198.695103.21
3109656-10965699.333103.87
4111838-111838101.310105.91
5105599-10559995.658100.03
6110662-110662100.245104.77
45min1107137-10713797.05197.651.50102.65103.261.51
2107290-10729097.190102.80
3107971-10797197.807103.45
4109783-10978399.448105.18
5105316-10531695.402100.83
6109291-10929199.003104.64
60min1107365-10736597.25897.001.61103.93103.691.62
2107194-10719497.103103.79
3107551-10755197.426104.16
4109140-10914098.866105.70
5103885-10388594.106100.60
6107324-10732497.221103.96
90min1104633-10463394.78395.721.43102.54103.491.45
2105517-10551795.584103.35
3106226-10622696.226104.04
4108058-10805897.886105.82
5103620-10362093.866101.40
6105940-10594095.967103.79
极限1102522-10252292.87194.381.85101.68103.221.82
2104682-10468294.828103.66
3104668-10466894.815103.70
4106790-10679096.737105.76
5101417-10141791.870100.45
6105081-10508195.189104.07
叶酸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%
116.001941541943371942051941951945031942790.08
215.991940751937481939120.12
单位质量响应值RSD%判断
12142.4412127.080.09数据可信
供试品溶液-24070804批-叶酸-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123576-2357619.93420.146.6519.9320.146.65
221422-2142218.11218.11
324927-2492721.07621.08
422958-2295819.41119.41
525986-2598621.97121.97
624050-2405020.33420.33
10min133243-3324328.10728.745.1328.3328.965.14
231833-3183326.91527.12
335446-3544629.97030.20
432698-3269827.64627.86
536465-3646530.83131.08
634240-3424028.95029.18
15min139028-3902832.99834.854.6733.5335.404.63
242869-4286936.24636.75
342669-4266936.07736.64
439158-3915833.10833.63
543204-4320436.52937.12
640404-4040434.16234.71
20min143184-4318436.51237.884.9637.4138.814.95
242525-4252535.95536.86
347575-4757540.22541.19
443239-4323936.55937.45
547397-4739740.07441.07
644895-4489537.95938.89
30min147667-4766740.30343.386.0541.6144.735.99
248150-4815040.71142.01
355161-5516146.63948.05
450234-5023442.47343.77
553991-5399145.65047.09
652618-5261844.48945.84
45min153397-5339745.14748.976.8046.9050.806.73
254414-5441446.00747.76
362941-6294153.21755.15
455857-5585747.22749.00
561577-6157752.06454.01
659313-5931350.14951.99
60min157651-5765148.74453.047.0551.0055.426.97
259453-5945350.26852.53
368454-6845457.87860.40
460132-6013250.84253.14
567352-6735256.94659.47
663352-6335253.56455.96
90min161367-6136751.88657.878.5754.6860.848.42
265026-6502654.98057.80
375086-7508663.48666.65
465000-6500054.95857.82
575806-7580664.09467.25
668415-6841557.84560.84
极限166940-6694056.59861.467.1959.9765.067.13
268840-6884058.20561.64
379038-7903866.82770.70
469195-6919558.50561.97
578646-7864666.49670.36
673448-7344862.10165.74
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