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(%)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%
117.67 1949861951281950901948881952071950600.07
217.721953131961521957320.31
单位质量响应值RSD%判断
11039.0511045.820.05数据可信
供试品溶液-24041202-1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%
5min1103671-10367194.84395.060.6194.8495.060.61
2104580-10458095.67495.67
3103448-10344894.63894.64
4103397-10339794.59294.59
5104833-10483395.90695.91
6103508-10350894.69394.69
10min1104184-10418495.31294.960.6196.3796.020.60
2104391-10439195.50196.56
3103272-10327294.47795.53
4104217-10421795.34296.39
5103928-10392895.07896.14
6102797-10279794.04395.10
15min1102850-10285094.09193.430.5496.2095.540.53
2102620-10262093.88196.01
3101685-10168593.02695.13
4101404-10140492.76994.88
5102132-10213293.43595.56
6102077-10207793.38495.48
20min1101997-10199793.31192.630.6996.4795.780.67
2101455-10145592.81595.98
3102106-10210693.41196.55
4100533-10053391.97295.11
5100685-10068592.11195.27
6100762-10076292.18195.32
30min199444-9944490.97591.050.3995.1795.230.38
299481-9948191.00995.21
3100017-10001791.50095.67
499131-9913190.68994.85
599963-9996391.45095.63
699134-9913490.69294.85
45min197050-9705088.78590.040.9493.9995.220.89
299318-9931890.86096.07
398207-9820789.84495.03
498395-9839590.01695.19
599553-9955391.07596.27
697981-9798189.63794.80
60min196756-9675688.51688.850.5994.7195.040.57
297467-9746789.16795.39
397553-9755389.24695.43
497405-9740589.11095.28
597406-9740689.11195.32
696116-9611687.93194.09
90min195525-9552587.39088.260.9894.5795.440.92
296554-9655488.33295.54
396565-9656588.34295.52
497422-9742289.12696.29
597535-9753589.22996.43
695273-9527387.16094.30
极限196208-9620888.01587.430.4196.1695.590.38
295856-9585687.69395.88
395271-9527187.15895.32
495373-9537387.25195.40
595484-9548487.35395.55
695223-9522387.11495.22
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(%)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%
116.411871761955441940121967501951931937351.96
216.371987832007991997910.72
单位质量响应值RSD%判断
11805.9112204.702.35数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-24041202-1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%
5min120579-2057917.59217.951.3717.5917.951.37
221346-2134618.24818.25
321109-2110918.04518.05
420805-2080517.78517.79
521232-2123218.15018.15
620900-2090017.86717.87
10min137533-3753332.08533.182.2632.2833.382.25
239331-3933133.62233.83
338990-3899033.33133.53
439015-3901533.35233.55
539943-3994334.14634.35
638062-3806232.53832.74
15min148542-4854241.49742.352.0942.0542.922.08
250547-5054743.21043.79
350276-5027642.97943.55
448841-4884141.75242.32
550594-5059443.25143.83
648459-4845941.42641.99
20min157778-5777849.39248.621.9750.4149.661.94
257202-5720248.90049.96
357640-5764049.27450.32
456122-5612247.97649.01
557537-5753749.18650.25
654951-5495146.97548.00
30min164802-6480255.39654.822.4956.9656.402.46
264274-6427454.94556.54
365210-6521055.74557.34
463231-6323154.05455.62
565841-6584156.28557.89
661419-6141952.50554.05
45min166305-6630556.68159.434.1258.8661.624.02
269781-6978159.65361.86
369860-6986059.72061.94
468209-6820958.30960.47
574723-7472363.87866.11
668257-6825758.35060.48
60min168583-6858358.62960.985.2861.4463.835.13
271424-7142461.05763.93
371214-7121460.87863.76
470377-7037760.16262.98
578467-7846767.07870.02
667949-6794958.08760.86
90min170712-7071260.44963.275.9763.9166.795.79
273019-7301962.42165.97
373839-7383963.12266.68
473070-7307062.46465.95
582623-8262370.63174.32
670778-7077860.50563.92
极限179089-7908967.61068.753.2871.7472.983.28
280265-8026568.61572.86
381006-8100669.24973.51
479231-7923167.73171.91
585280-8528072.90277.38
677662-7766266.39070.48
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(%)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%
117.67 1949321946871943611947061941831945740.16
217.721954351955021954680.03
单位质量响应值RSD%判断
11011.5411030.930.13数据可信
供试品溶液-24041801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%
5min1107029-10702998.10399.071.1098.1099.071.11
2107352-10735298.39998.40
3109836-109836100.676100.68
4109307-109307100.191100.19
5107209-10720998.26898.27
6107791-10779198.80198.80
10min1105332-10533296.54797.541.0897.6498.641.08
2104752-10475296.01697.11
3107523-10752398.55699.67
4106463-10646397.58498.70
5106928-10692898.01099.10
6107485-10748598.52199.62
15min1104934-10493496.18396.601.5798.3598.791.55
2104915-10491596.16598.33
3106377-10637797.50599.72
4106581-10658197.69299.89
5102527-10252793.97696.16
6107006-10700698.082100.27
20min1102725-10272594.15895.221.4597.3998.481.41
2103447-10344794.82098.05
3102459-10245993.91497.21
4103989-10398995.31698.60
5104032-10403295.35698.58
6106664-10666497.768101.05
30min1103149-10314994.54794.880.3898.8299.190.39
2103029-10302994.43798.72
3104071-10407195.39299.73
4103724-10372495.07499.42
5103645-10364595.00199.29
6103433-10343394.80799.18
45min1100534-10053492.15093.041.2597.4898.411.21
2100836-10083692.42697.76
3101071-10107192.64298.04
4100824-10082492.41597.81
5101865-10186593.37098.71
6103919-10391995.252100.67
60min1100453-10045392.07592.290.8098.4398.700.78
299447-9944791.15397.51
3101848-10184893.35499.78
4100503-10050392.12198.55
5100768-10076892.36498.74
6101127-10112792.69399.17
90min198682-9868290.45291.630.8897.8399.060.85
299109-9910990.84398.21
3100534-10053492.15099.62
4100898-10089892.48399.93
5100381-10038192.00999.41
6100196-10019691.84099.35
极限198561-9856190.34191.141.0998.7299.581.05
297909-9790989.74498.12
3100866-10086692.454100.94
4100168-10016891.814100.29
599290-9929091.00999.44
699774-9977491.45399.98
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(%)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%
116.411934021943871958441945711902681936941.09
216.371992171989981991080.08
单位质量响应值RSD%判断
11803.4112162.982.13数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-24041801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%
5min118778-1877816.08115.815.3016.0815.815.30
219578-1957816.76616.77
319304-1930416.53216.53
417982-1798215.40015.40
516904-1690414.47614.48
618198-1819815.58515.58
10min134189-3418929.27929.003.6629.4629.173.67
234934-3493429.91730.10
334930-3493029.91430.10
433519-3351928.70528.88
531599-3159927.06127.22
633981-3398129.10129.27
15min144680-4468038.26437.664.6538.7738.164.64
245127-4512738.64639.17
344991-4499138.53039.05
444348-4434837.97938.47
539849-3984934.12634.59
644883-4488338.43738.93
20min151818-5181844.37743.073.7245.3143.993.71
251299-5129943.93244.88
349218-4921842.15043.09
450229-5022943.01643.93
547148-4714840.37741.22
652050-5205044.57545.50
30min161891-6189153.00350.143.8554.4351.543.83
258619-5861950.20151.64
358259-5825949.89351.31
458875-5887550.42051.81
554828-5482846.95448.24
658820-5882050.37351.79
45min168599-6859958.74855.654.9260.7657.614.87
267780-6778058.04660.04
364367-6436755.12357.09
464182-6418254.96556.92
559605-5960551.04552.86
665390-6539055.99957.98
60min173386-7338662.84757.425.3965.5159.995.28
265486-6548656.08258.72
366484-6648456.93659.52
467830-6783058.08960.65
562415-6241553.45255.83
666712-6671257.13259.73
90min177408-7740866.29260.086.2869.6563.296.12
268057-6805758.28361.55
368338-6833858.52461.74
473084-7308462.58965.79
564985-6498555.65358.62
669064-6906459.14662.38
极限179700-7970068.25464.194.4072.3568.074.37
274054-7405463.41967.33
374307-7430763.63667.50
477062-7706265.99569.90
569861-6986159.82863.42
674762-7476264.02667.92
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(%)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%
117.67 1947431944861945941953321946071947520.18
217.721953301958451955880.19
单位质量响应值RSD%判断
11021.6211037.700.11数据可信
供试品溶液-24041801-1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%
5min1101363-10136392.83993.971.2292.8493.971.22
2103569-10356994.85994.86
3102369-10236993.76093.76
4101474-10147492.94092.94
5102251-10225193.65293.65
6104558-10455895.76595.76
10min1100959-10095992.46993.230.7593.5094.270.74
2102412-10241293.79994.85
3100841-10084192.36093.40
4102378-10237893.76894.80
5102511-10251193.89094.93
6101637-10163793.08994.15
15min1100572-10057292.11492.830.6294.1794.910.62
2101834-10183493.27095.37
3101160-10116092.65394.72
4100712-10071292.24294.32
5101996-10199693.41895.50
6101860-10186093.29495.39
20min1100693-10069392.22591.670.6595.3194.790.61
298885-9888590.56993.70
3100195-10019591.76994.87
4100437-10043791.99095.09
599941-9994191.53694.66
6100397-10039791.95495.09
30min198172-9817289.91691.541.5794.0295.671.51
2101219-10121992.70796.85
3102350-10235093.74397.86
499065-9906590.73494.86
598994-9899490.66994.81
699857-9985791.45995.62
45min197112-9711288.94589.610.4194.0594.760.41
298077-9807789.82995.00
398067-9806789.82094.98
497754-9775489.53394.66
598220-9822089.96095.11
697781-9778189.55894.73
60min198039-9803989.79489.170.5995.8995.310.54
297697-9769789.48195.65
396409-9640988.30194.46
497039-9703988.87895.00
597405-9740589.21395.36
697558-9755889.35495.52
90min194599-9459986.64387.510.7093.7494.640.66
294865-9486586.88794.05
396349-9634988.24695.38
495824-9582487.76594.88
595840-9584087.78094.92
695793-9579387.73794.90
极限194132-9413286.21687.411.2594.2795.521.16
295648-9564887.60495.73
394040-9404086.13194.25
495855-9585587.79495.88
595748-9574887.69695.81
697190-9719089.01697.15
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(%)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%
116.412000371991331995001995051987391993830.25
216.371995431994671995050.03
单位质量响应值RSD%判断
12150.0912187.230.22数据可信
供试品溶液-24041801-1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%
5min116988-1698814.32315.022.7514.3215.012.75
218116-1811615.27515.27
318033-1803315.20515.20
418231-1823115.37115.37
518051-1805115.22015.22
617438-1743814.70314.70
10min132413-3241327.32928.643.9027.4928.813.88
234623-3462329.19229.36
332410-3241027.32727.50
435418-3541829.86330.03
535138-3513829.62729.80
633821-3382128.51628.68
15min144604-4460437.60839.062.0538.0739.542.05
246024-4602438.80539.30
346376-4637639.10239.57
447268-4726839.85440.36
546866-4686639.51540.01
646813-4681339.47039.95
20min152174-5217443.99145.612.8444.8746.532.82
252446-5244644.22045.15
354491-5449145.94446.85
455934-5593447.16148.11
555453-5545346.75547.69
654080-5408045.59846.52
30min160077-6007750.65453.753.7952.0255.183.74
262208-6220852.45153.87
365997-6599755.64557.06
466396-6639655.98257.45
564660-6466054.51855.98
663147-6314753.24254.67
45min166659-6665956.20458.743.5858.1460.763.55
267370-6737056.80358.80
371785-7178560.52662.56
472713-7271361.30863.40
570952-7095259.82361.89
668504-6850457.75959.78
60min169951-6995158.97961.313.2561.5463.983.23
270693-7069359.60562.24
374293-7429362.64065.35
476088-7608864.15466.93
573677-7367762.12164.85
671572-7157260.34663.00
90min171037-7103759.89563.134.1363.1166.494.06
272290-7229060.95164.24
377563-7756365.39768.80
479132-7913266.72070.21
575196-7519663.40266.82
674015-7401562.40665.74
极限174991-7499163.22966.703.3267.1170.763.31
277445-7744565.29869.27
379845-7984567.32171.45
482472-8247269.53673.76
580808-8080868.13372.26
679114-7911466.70570.73
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