富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.048307082913830528315483246830870.15
210.068285982796828280.06
单位质量响应值RSD%判断
8275.608233.400.37数据可信
加速6月-供试品溶液-2024110221批-富马酸比索洛尔-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%
5min189803-8980397.71897.971.6197.7297.971.61
288873-8887396.70696.71
388206-8820695.98195.98
489980-8998097.91197.91
592089-92089100.206100.21
691261-9126199.30599.30
10min191007-9100799.02898.841.6099.1999.001.60
289565-8956597.45997.62
388987-8898796.83096.99
490587-9058798.57198.73
592775-92775100.952101.12
692089-92089100.206100.37
15min190926-9092698.94098.771.5599.2799.101.55
289553-8955397.44697.77
388865-8886596.69897.02
490677-9067798.66999.00
592512-92512100.666101.00
692060-92060100.174100.51
20min190600-9060098.58698.501.5699.0899.001.56
289136-8913696.99397.48
388790-8879096.61697.10
490555-9055598.53799.03
592501-92501100.654101.16
691567-9156799.638100.14
30min190365-9036598.33098.411.4698.9999.061.46
289322-8932297.19597.84
388623-8862396.43497.08
490658-9065898.64999.30
592166-92166100.290100.96
691490-9149099.554100.22
45min190609-9060998.59598.371.4899.4299.191.48
289269-8926997.13797.95
388562-8856296.36897.17
490373-9037398.33999.16
592175-92175100.299101.14
691426-9142699.484100.32
极限190035-9003597.97198.031.5798.9699.021.57
288795-8879596.62197.59
388281-8828196.06297.03
490133-9013398.07799.06
591909-91909100.010101.02
691380-9138099.434100.43
富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.065052850392506355041450636505210.24
214.065039550596504960.29
单位质量响应值RSD%判断
3593.243591.470.04数据可信
加速6月-供试品溶液-2024110221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%
5min149804-4980487.53486.492.0487.5386.492.04
250114-5011488.07988.08
349024-4902486.16386.16
447731-4773183.89083.89
550194-5019488.21988.22
648410-4841085.08485.08
10min151805-5180591.05191.482.1691.2091.622.16
251446-5144690.42090.57
351664-5166490.80390.95
450788-5078889.26389.40
554014-5401494.93395.08
652568-5256892.39292.53
15min151547-5154790.59791.542.2690.8991.832.26
251934-5193491.27791.57
351518-5151890.54690.84
450913-5091389.48389.77
554282-5428295.40495.71
652301-5230191.92292.22
20min150869-5086989.40691.233.0589.8591.683.05
249895-4989587.69488.14
352178-5217891.70692.15
451587-5158790.66891.11
554556-5455695.88696.35
652357-5235792.02192.47
30min151738-5173890.93391.871.5591.5392.471.56
251547-5154790.59791.19
352025-5202591.43792.04
452107-5210791.58192.17
553808-5380894.57195.20
652389-5238992.07792.68
45min151501-5150190.51691.441.1191.2792.201.11
251979-5197991.35692.10
352007-5200791.40692.16
451413-5141390.36291.10
552993-5299393.13993.92
652275-5227591.87792.63
极限151038-5103889.70390.972.0590.6091.872.05
251533-5153390.57391.47
351415-5141590.36591.27
451424-5142490.38191.27
553887-5388794.71095.65
651249-5124990.07390.98
富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.048285182711829538281982815828300.11
210.068302183023830220.01
单位质量响应值RSD%判断
8250.008252.680.03数据可信
加速6月-供试品溶液-2024110321批-富马酸比索洛尔-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%
5min189842-8984297.79897.811.6197.8097.801.61
290875-9087598.92298.92
391196-9119699.27199.27
490908-9090898.95898.96
588651-8865196.50196.50
687624-8762495.38395.38
10min190833-9083398.87698.811.5799.0498.971.57
291517-9151799.62199.79
392360-92360100.538100.70
491652-9165299.76899.93
589783-8978397.73397.89
688470-8847096.30496.46
15min190846-9084698.89098.681.6799.2299.011.67
291392-9139299.48599.82
392045-92045100.196100.53
491938-91938100.079100.41
589475-8947597.39897.72
688232-8823296.04596.36
20min190612-9061298.63698.521.7299.1399.021.72
291660-9166099.777100.27
391871-91871100.006100.51
491605-9160599.717100.21
589271-8927197.17697.66
688042-8804295.83896.32
30min190485-9048598.49798.371.7599.1599.021.75
291383-9138399.475100.14
391750-9175099.874100.54
491550-9155099.657100.32
589302-8930297.21097.86
687735-8773595.50496.14
45min190297-9029798.29398.081.7999.1198.901.79
291230-9123099.308100.14
391654-9165499.770100.60
490915-9091598.96699.80
589192-8919297.09097.90
687313-8731395.04595.84
极限189709-8970997.65397.881.7498.6498.871.75
291133-9113399.203100.20
391403-9140399.497100.50
491017-9101799.077100.07
588814-8881496.67997.65
687452-8745295.19696.15
富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.065073150320505315073550524505680.35
214.065009250168501300.11
单位质量响应值RSD%判断
3596.593565.430.62数据可信
加速6月-供试品溶液-2024110321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%
5min147330-4733083.45184.851.4283.4584.851.42
249316-4931686.95286.95
347891-4789184.44084.44
448062-4806284.74184.74
548396-4839685.33085.33
647758-4775884.20584.21
10min150452-5045288.95590.741.4689.0990.881.46
252715-5271592.94593.09
351729-5172991.20791.35
451500-5150090.80390.94
551279-5127990.41390.56
651111-5111190.11790.26
15min151212-5121290.29592.151.1090.5892.441.10
252844-5284493.17393.47
352149-5214991.94792.24
452288-5228892.19292.49
552433-5243392.44892.74
652656-5265692.84193.13
20min151529-5152990.85492.121.5291.2992.561.52
252940-5294093.34293.80
352649-5264992.82993.27
451184-5118490.24690.69
552027-5202791.73292.18
653142-5314293.69894.14
30min150916-5091689.77391.781.2490.3692.381.24
252812-5281293.11693.73
351831-5183191.38791.99
452165-5216591.97692.57
552362-5236292.32392.92
652245-5224592.11792.72
45min151180-5118090.23991.581.2490.9892.331.23
252328-5232892.26393.03
352301-5230192.21592.97
451121-5112190.13590.88
552645-5264592.82293.58
652066-5206691.80192.56
极限149643-4964387.52990.992.1788.4291.892.16
252643-5264392.81893.74
352040-5204091.75592.66
451082-5108290.06690.97
551679-5167991.11992.03
652534-5253492.62693.53
富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.048285582843828738283182896828600.04
210.068300783135830710.11
单位质量响应值RSD%判断
8252.998257.550.04数据可信
加速6月-供试品溶液-2024110421批-富马酸比索洛尔-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%
5min190449-9044998.41199.350.8498.4199.360.84
292232-92232100.351100.35
391333-9133399.37399.37
491621-9162199.68799.69
590374-9037498.33098.33
691887-9188799.97699.98
10min191854-9185499.940100.300.64100.10100.460.64
292944-92944101.126101.29
392500-92500100.643100.81
492038-92038100.140100.31
591291-9129199.32899.49
692474-92474100.615100.78
15min191645-9164599.713100.270.67100.04100.610.67
293113-93113101.310101.65
392205-92205100.322100.66
492153-92153100.265100.60
591382-9138299.42799.76
692466-92466100.606100.94
20min191720-9172099.794100.140.62100.29100.640.62
292924-92924101.104101.61
392167-92167100.281100.78
492187-92187100.302100.80
591222-9122299.25299.75
691985-91985100.083100.58
30min191518-9151899.575100.210.63100.24100.880.63
292944-92944101.126101.80
392247-92247100.368101.04
492141-92141100.252100.92
591372-9137299.416100.08
692366-92366100.497101.17
45min191309-9130999.34799.950.78100.18100.780.77
293067-93067101.260102.10
391941-91941100.035100.87
491699-9169999.771100.61
591044-9104499.05999.89
692119-92119100.228101.06
极限191191-9119199.21999.500.55100.21100.500.55
292116-92116100.225101.24
391417-9141799.465100.47
490976-9097698.98599.99
591005-9100599.016100.01
692005-92005100.104101.11
富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.065000450381499995020249801500770.45
214.065050850261503840.35
单位质量响应值RSD%判断
3561.663583.500.44数据可信
加速6月-供试品溶液-2024110421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%
5min151152-5115290.40188.661.9390.4088.661.93
250089-5008988.52388.52
349294-4929487.11887.12
451303-5130390.66890.67
548888-4888886.40086.40
650269-5026988.84188.84
10min152044-5204491.97891.781.1192.1391.931.11
251351-5135190.75390.90
351921-5192191.76091.91
452588-5258892.93993.09
551193-5119390.47490.62
652499-5249992.78292.93
15min153393-5339394.36292.151.8194.6792.451.81
252275-5227592.38692.68
350949-5094990.04390.34
452689-5268993.11893.42
551122-5112290.34890.64
652424-5242492.64992.95
20min152568-5256892.90491.961.1093.3792.421.10
252094-5209492.06692.52
352195-5219592.24592.69
452564-5256492.89793.36
551072-5107290.26090.71
651709-5170991.38691.84
30min152530-5253092.83792.001.5293.4592.601.52
251770-5177091.49492.10
351896-5189691.71692.32
453121-5312193.88194.50
550787-5078789.75690.35
652225-5222592.29892.91
45min152918-5291893.52291.492.0594.2992.252.05
250677-5067789.56290.32
352063-5206392.01192.77
453007-5300793.68094.45
550636-5063689.48990.23
651306-5130690.67491.44
极限151713-5171391.39391.141.2492.3292.061.23
250904-5090489.96390.87
351115-5111590.33691.24
452333-5233392.48993.42
551079-5107990.27291.17
652292-5229292.41693.33
富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.048317883185829368301583108830840.13
210.068270682555826300.13
单位质量响应值RSD%判断
8275.308213.720.53数据可信
加速6月-供试品溶液-2024110221批-富马酸比索洛尔-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min187907-8790795.77293.902.7395.7793.902.73
289003-8900396.96696.97
383173-8317390.61490.61
485706-8570693.37493.37
583828-8382891.32891.33
687498-8749895.32695.33
10min190651-9065198.76197.831.2798.9297.991.27
290231-9023198.30498.47
387912-8791295.77795.93
489452-8945297.45597.61
589430-8943097.43197.58
691109-9110999.26099.42
15min191320-9132099.49098.571.4799.8198.881.47
291652-9165299.852100.18
388420-8842096.33196.64
490056-9005698.11398.43
589635-8963597.65497.97
691747-9174799.955100.28
20min191329-9132999.50098.691.5599.9999.171.55
291712-9171299.917100.41
388338-8833896.24196.71
490393-9039398.48098.96
589700-8970097.72598.20
692019-92019100.252100.74
30min191427-9142799.60798.731.50100.2699.381.50
291582-9158299.776100.43
388686-8868696.62197.25
490358-9035898.44299.09
589471-8947197.47698.12
692202-92202100.451101.11
45min190966-9096699.10598.571.4899.9399.381.48
291469-9146999.653100.48
388447-8844796.36097.15
490301-9030198.38099.19
589559-8955997.57298.37
692127-92127100.369101.19
极限190906-9090699.03998.511.53100.0399.491.53
290801-9080198.92599.92
388579-8857996.50497.46
490063-9006398.12199.09
589550-8955097.56298.53
692634-92634100.922101.91
富马酸比索洛尔左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.065018349975502584998350019500840.26
214.065000949980499940.05
单位质量响应值RSD%判断
3562.163555.760.13数据可信
加速6月-供试品溶液-2024110221批-左氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130626-3062654.33249.396.1954.3349.396.19
226650-2665047.27947.28
327621-2762149.00149.00
426139-2613946.37246.37
529147-2914751.70851.71
626846-2684647.62647.63
10min142475-4247575.35373.013.4775.4473.093.47
241366-4136673.38673.46
340126-4012671.18671.27
440641-4064172.09972.18
543040-4304076.35576.44
639285-3928569.69469.77
15min147497-4749784.26281.482.6184.4881.682.61
246846-4684683.10783.31
346608-4660882.68582.89
444744-4474479.37879.58
544968-4496879.77679.99
644893-4489379.64379.84
20min147288-4728883.89281.264.4584.2581.604.44
245181-4518180.15480.49
347950-4795085.06685.40
442665-4266575.69076.02
547236-4723683.79984.15
644519-4451978.97979.31
30min149708-4970888.18582.185.4788.6882.655.46
243699-4369977.52578.00
347641-4764184.51885.00
444829-4482979.52979.99
548212-4821285.53186.02
643834-4383477.76478.22
45min149535-4953587.87884.324.1688.5284.934.15
247231-4723183.79184.39
349843-4984388.42489.05
444539-4453979.01579.60
547542-4754284.34284.97
646489-4648982.47483.06
极限149697-4969788.16584.194.6488.9684.944.62
246377-4637782.27583.02
350762-5076290.05590.82
445686-4568681.05081.77
546452-4645282.40983.18
645748-4574881.16081.89
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