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)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%
116.411949861951281950901948881952071950600.07
216.371953131961521957320.31
单位质量响应值RSD%判断
11886.6511956.750.42数据可信
供试品溶液-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%
5min1103671-10367143.92444.020.6143.9244.020.61
2104580-10458044.30944.31
3103448-10344843.83043.83
4103397-10339743.80843.81
5104833-10483344.41644.42
6103508-10350843.85543.86
10min1104184-10418444.14243.980.6144.6344.470.61
2104391-10439144.22944.72
3103272-10327243.75544.24
4104217-10421744.15544.64
5103928-10392844.03344.53
6102797-10279743.55444.04
15min1102850-10285043.57643.270.5444.5544.250.53
2102620-10262043.47944.46
3101685-10168543.08344.06
4101404-10140442.96443.94
5102132-10213243.27244.25
6102077-10207743.24944.22
20min1101997-10199743.21542.900.6944.6844.360.67
2101455-10145542.98544.45
3102106-10210643.26144.71
4100533-10053342.59544.05
5100685-10068542.65944.12
6100762-10076242.69244.14
30min199444-9944442.13342.170.3944.0844.100.38
299481-9948142.14944.09
3100017-10001742.37644.31
499131-9913142.00143.93
599963-9996342.35344.29
699134-9913442.00243.93
45min197050-9705041.11941.700.9443.5344.100.89
299318-9931842.08044.49
398207-9820741.60944.01
498395-9839541.68944.08
599553-9955342.17944.59
697981-9798141.51343.91
60min196756-9675640.99441.150.5943.8644.020.57
297467-9746741.29644.18
397553-9755341.33244.20
497405-9740541.26944.13
597406-9740641.27044.15
696116-9611640.72343.58
90min195525-9552540.47340.880.9843.8044.200.91
296554-9655440.90944.25
396565-9656540.91344.24
497422-9742241.27744.59
597535-9753541.32444.66
695273-9527340.36643.67
极限196208-9620840.76240.490.4144.5444.270.39
295856-9585640.61344.41
395271-9527140.36544.14
495373-9537340.40844.18
595484-9548440.45544.25
695223-9522340.34544.10
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%
117.67 1992701991741991131990711989501991160.06
217.722000702011272005980.38
单位质量响应值RSD%判断
11268.5911320.430.33数据可信
供试品溶液-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%
5min120629-2062918.74019.151.5418.7419.151.55
221516-2151619.54519.55
321155-2115519.21719.22
420879-2087918.96718.97
521346-2134619.39119.39
620964-2096419.04419.04
10min138081-3808134.59335.501.9634.8035.721.95
239509-3950935.89036.11
339304-3930435.70435.92
439340-3934035.73735.95
540024-4002436.35836.57
638226-3822634.72534.94
15min148714-4871444.25245.312.2544.8445.922.24
250788-5078846.13646.75
350680-5068046.03846.65
449143-4914344.64245.25
551166-5116646.48047.10
648773-4877344.30644.90
20min157888-5788852.58651.851.9453.6752.961.91
257448-5744852.18653.31
357727-5772752.44053.56
456524-5652451.34752.45
557796-5779652.50353.64
655070-5507050.02651.12
30min164885-6488558.94258.482.6660.6160.172.63
264549-6454958.63760.35
365472-6547259.47561.18
463404-6340457.59759.27
566415-6641560.33262.05
661541-6154155.90557.55
45min166652-6665260.54763.554.1062.8765.894.01
270256-7025663.82166.18
370340-7034063.89866.26
468688-6868862.39764.71
575128-7512868.24770.64
668704-6870462.41164.68
60min169515-6951563.14865.335.3966.1468.375.25
271888-7188865.30468.37
371868-7186865.28668.36
470761-7076164.28067.29
579276-7927672.01575.16
668195-6819561.94964.91
90min171227-7122764.70367.575.8768.4071.345.70
273590-7359066.85070.64
374514-7451467.68971.49
473298-7329866.58570.31
582810-8281075.22579.17
670866-7086664.37568.02
极限179194-7919471.94173.243.3276.3677.763.32
280503-8050373.13077.67
381217-8121773.77878.33
479538-7953872.25376.71
585529-8552977.69582.48
677786-7778670.66275.03
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)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%
116.411949321946871943611947061941831945740.16
216.371954351955021954680.03
单位质量响应值RSD%判断
11857.0411940.620.50数据可信
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%
5min1107029-10702945.43445.881.1045.4345.881.11
2107352-10735245.57145.57
3109836-10983646.62646.63
4109307-10930746.40146.40
5107209-10720945.51145.51
6107791-10779145.75845.76
10min1105332-10533244.71445.171.0845.2245.681.08
2104752-10475244.46844.97
3107523-10752345.64446.16
4106463-10646345.19445.71
5106928-10692845.39145.90
6107485-10748545.62846.14
15min1104934-10493444.54544.741.5745.5545.751.55
2104915-10491544.53745.54
3106377-10637745.15746.18
4106581-10658145.24446.26
5102527-10252743.52344.53
6107006-10700645.42446.44
20min1102725-10272543.60744.101.4545.1045.611.42
2103447-10344743.91445.41
3102459-10245943.49445.02
4103989-10398944.14445.66
5104032-10403244.16245.66
6106664-10666445.27946.80
30min1103149-10314943.78743.940.3845.7745.940.38
2103029-10302943.73645.72
3104071-10407144.17946.19
4103724-10372444.03146.04
5103645-10364543.99845.98
6103433-10343343.90845.93
45min1100534-10053442.67743.091.2545.1445.581.21
2100836-10083642.80545.27
3101071-10107142.90545.41
4100824-10082442.80045.30
5101865-10186543.24245.72
6103919-10391944.11446.63
60min1100453-10045342.64342.740.8045.5845.710.78
299447-9944742.21645.16
3101848-10184843.23546.21
4100503-10050342.66445.64
5100768-10076842.77645.73
6101127-10112742.92945.93
90min198682-9868241.89142.440.8845.3145.880.85
299109-9910942.07245.49
3100534-10053442.67746.14
4100898-10089842.83246.28
5100381-10038142.61246.04
6100196-10019642.53446.01
极限198561-9856141.84042.211.0945.7246.121.05
297909-9790941.56345.44
3100866-10086642.81846.75
4100168-10016842.52246.45
599290-9929042.14946.05
699774-9977442.35446.31
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%
117.67 1992011986551989401987121984611987940.15
217.721993171990741991960.09
单位质量响应值RSD%判断
11250.3711241.310.06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%
5min118880-1888017.22516.965.8917.2216.965.88
220013-2001318.25918.26
319411-1941117.70917.71
418006-1800616.42816.43
516932-1693215.44815.45
618271-1827116.66916.67
10min134258-3425831.25531.043.6631.4531.233.67
235337-3533732.23932.44
335001-3500131.93332.13
433604-3360430.65830.84
531831-3183129.04129.21
634101-3410131.11231.30
15min144772-4477240.84740.264.6041.3940.804.59
245348-4534841.37341.93
345190-4519041.22941.78
444445-4444540.54941.07
540045-4004536.53537.03
644981-4498141.03841.57
20min151947-5194747.39346.063.5848.3947.043.58
251493-5149346.97948.00
349525-4952545.18446.19
450323-5032345.91246.89
547436-4743643.27844.18
652185-5218547.61048.60
30min161972-6197256.53953.523.7858.0655.013.76
258646-5864653.50555.05
358435-5843553.31254.82
458950-5895053.78255.27
555000-5500050.17951.56
658946-5894653.77955.29
45min168661-6866162.64259.324.9564.7961.414.90
267846-6784661.89864.04
364452-6445258.80260.91
464182-6418258.55660.64
559610-5961054.38456.32
665390-6539059.65861.77
60min173386-7338666.95361.245.3469.8063.985.23
265486-6548659.74562.57
366484-6648460.65663.41
467886-6788661.93564.67
562525-6252557.04459.59
666955-6695561.08663.86
90min177719-7771970.90664.086.4074.4967.506.22
268208-6820862.22965.72
368338-6833862.34765.78
473084-7308466.67770.10
564985-6498559.28862.47
669064-6906463.01066.46
极限179700-7970072.71368.394.4077.0972.524.37
274054-7405467.56271.74
374307-7430767.79371.92
477062-7706270.30774.47
569861-6986163.73767.57
674762-7476268.20872.36
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)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%
116.411947431944861945941953321946071947520.18
216.371953301958451955880.19
单位质量响应值RSD%判断
11867.8911947.950.48数据可信
供试品溶液-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%
5min1101363-10136342.99643.521.2243.0043.521.22
2103569-10356943.93243.93
3102369-10236943.42343.42
4101474-10147443.04343.04
5102251-10225143.37343.37
6104558-10455844.35144.35
10min1100959-10095942.82543.180.7543.3043.660.74
2102412-10241243.44143.93
3100841-10084142.77543.26
4102378-10237843.42743.90
5102511-10251143.48343.96
6101637-10163743.11243.61
15min1100572-10057242.66142.990.6243.6143.960.63
2101834-10183443.19644.17
3101160-10116042.91043.87
4100712-10071242.72043.68
5101996-10199643.26544.23
6101860-10186043.20744.18
20min1100693-10069342.71242.460.6544.1443.900.61
298885-9888541.94543.40
3100195-10019542.50143.94
4100437-10043742.60344.04
599941-9994142.39343.84
6100397-10039742.58644.04
30min198172-9817241.64342.391.5743.5444.301.51
2101219-10121942.93544.85
3102350-10235043.41545.32
499065-9906542.02143.93
598994-9899441.99143.91
699857-9985742.35744.28
45min197112-9711241.19341.500.4143.5643.880.41
298077-9807741.60244.00
398067-9806741.59843.99
497754-9775441.46543.84
598220-9822041.66344.05
697781-9778141.47743.87
60min198039-9803941.58641.300.5944.4144.140.54
297697-9769741.44144.30
396409-9640940.89543.75
497039-9703941.16244.00
597405-9740541.31744.16
697558-9755841.38244.24
90min194599-9459940.12740.530.7043.4143.830.66
294865-9486540.24043.56
396349-9634940.86944.18
495824-9582440.64743.94
595840-9584040.65343.96
695793-9579340.63343.95
极限194132-9413239.92940.481.2543.6644.241.16
295648-9564840.57244.34
394040-9404039.89043.65
495855-9585540.66044.41
595748-9574840.61444.37
697190-9719041.22644.99
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%
117.67 2000371991411995001995051987391993840.25
217.721995431994671995050.03
单位质量响应值RSD%判断
11283.7611258.750.16数据可信
供试品溶液-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%
5min116988-1698815.46416.212.7515.4616.212.77
218116-1811616.49116.49
318033-1803316.41516.42
418231-1823116.59516.60
518051-1805116.43116.43
617438-1743815.87315.87
10min132413-3241329.50530.923.9029.6831.103.89
234623-3462331.51731.70
332410-3241029.50229.68
435418-3541832.24032.42
535138-3513831.98532.17
633821-3382130.78730.96
15min144604-4460440.60242.172.0541.1042.692.05
246024-4602441.89542.43
346376-4637642.21542.73
447268-4726843.02743.57
546866-4686642.66143.20
646813-4681342.61343.13
20min152174-5217447.49349.242.8448.4450.242.83
252446-5244647.74148.74
354491-5449149.60250.58
455934-5593450.91651.94
555453-5545350.47851.49
654080-5408049.22850.22
30min160077-6007754.68758.033.7956.1759.573.74
262208-6220856.62758.16
365997-6599760.07661.61
466396-6639660.43962.03
564660-6466058.85960.43
663147-6314757.48259.02
45min166659-6665960.67863.413.5862.7665.603.55
267370-6737061.32663.48
371785-7178565.34567.54
472713-7271366.18968.45
570952-7095264.58666.81
668504-6850462.35864.54
60min169951-6995163.67566.193.2566.4469.083.23
270693-7069364.35167.19
374293-7429367.62870.55
476088-7608869.26172.25
573677-7367767.06770.01
671572-7157265.15168.02
90min171037-7103764.66468.154.1368.1371.784.06
272290-7229065.80469.36
377563-7756370.60474.28
479132-7913272.03275.80
575196-7519668.45072.14
674015-7401567.37470.97
极限174991-7499168.26372.013.3272.4576.403.31
277445-7744570.49774.78
379845-7984572.68177.14
482472-8247275.07379.64
580808-8080873.55878.01
679114-7911472.01676.36
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