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%
110.078628586196862618529985049858180.70
210.088512385210851660.08
单位质量响应值RSD%判断
8522.148449.010.61数据可信
加速3月-供试品溶液-2023101321批-富马酸比索洛尔-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min193523-9352398.99697.731.9699.0097.731.96
291159-9115996.49496.49
394225-9422599.73999.74
490297-9029795.58195.58
590697-9069796.00596.00
694074-9407499.57999.58
10min193990-9399099.49098.391.7999.6698.551.79
291908-9190897.28797.45
394721-94721100.264100.43
491244-9124496.58496.74
591245-9124596.58596.74
694582-94582100.117100.28
15min193969-9396999.46898.271.9599.8098.591.95
291341-9134196.68697.01
394531-94531100.063100.40
491052-9105296.38196.70
591230-9123096.56996.89
694875-94875100.427100.76
20min193668-9366899.15098.111.9399.6598.601.93
291421-9142196.77197.26
394288-9428899.806100.31
490889-9088996.20896.69
590997-9099796.32296.80
694847-94847100.398100.90
30min193483-9348398.95498.051.7499.6298.701.74
291617-9161796.97997.62
393918-9391899.414100.08
490936-9093696.25896.90
591094-9109496.42597.07
694703-94703100.245100.91
45min193272-9327298.73097.841.7999.5698.661.79
291326-9132696.67197.48
393617-9361799.09699.93
490658-9065895.96396.77
591007-9100796.33397.14
694694-94694100.236101.07
极限192910-9291098.34797.681.8199.3498.661.81
291237-9123796.57697.54
393979-9397999.479100.48
490585-9058595.88696.85
590675-9067595.98196.95
694281-9428199.798100.80
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%
114.705323253473538485333353612535000.46
214.695358753854537200.36
单位质量响应值RSD%判断
3639.463656.910.34数据可信
加速3月-供试品溶液-2023101321批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141837-4183772.40670.501.8672.4170.501.86
241107-4110771.14371.14
339764-3976468.81968.82
440019-4001969.26069.26
540967-4096770.90170.90
640711-4071170.45870.46
10min149509-4950985.68485.150.9685.8085.270.95
248483-4848383.90984.03
349028-4902884.85284.97
449191-4919185.13485.25
549874-4987486.31686.43
649113-4911384.99985.12
15min151382-5138288.92688.271.6389.1988.531.62
249535-4953585.72985.99
350628-5062887.62187.88
451095-5109588.42988.69
551807-5180789.66189.92
651576-5157689.26289.52
20min151470-5147089.07889.581.4889.4989.981.48
251485-5148589.10489.51
350979-5097988.22888.63
452996-5299691.71992.12
552370-5237090.63691.05
651247-5124788.69289.10
30min151807-5180789.66189.221.6790.2289.771.66
251541-5154189.20189.75
350257-5025786.97987.53
452913-5291391.57592.13
551273-5127388.73789.30
651504-5150489.13789.69
45min152135-5213590.22990.741.3290.9491.451.31
252456-5245690.78491.48
352178-5217890.30391.00
452944-5294491.62992.34
553427-5342792.46593.18
651452-5145289.04789.75
极限152735-5273591.26790.780.5892.1391.640.58
252540-5254090.93091.78
352516-5251690.88891.73
452144-5214490.24591.11
552758-5275891.30792.17
652026-5202690.04090.89
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%
110.078595285819857778624585021857630.53
210.088597985991859850.01
单位质量响应值RSD%判断
8516.688530.260.12数据可信
加速3月-供试品溶液-2023101322批-富马酸比索洛尔-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min196230-96230101.407100.041.10101.41100.041.10
295604-95604100.747100.75
395744-95744100.895100.89
494009-9400999.06699.07
593864-9386498.91498.91
694132-9413299.19699.20
10min197112-97112102.336100.631.25102.51100.801.25
296351-96351101.534101.70
396112-96112101.283101.45
494133-9413399.19799.36
594480-9448099.56399.73
694796-9479699.896100.06
15min196582-96582101.778100.500.94102.12100.830.94
296024-96024101.190101.53
395730-95730100.880101.22
494237-9423799.30799.64
594726-9472699.822100.15
694902-94902100.007100.34
20min196500-96500101.691100.351.10102.20100.851.10
296212-96212101.388101.89
395692-95692100.840101.35
493999-9399999.05699.55
594422-9442299.502100.00
694518-9451899.603100.10
30min197019-97019102.238100.761.15102.92101.431.15
296537-96537101.730102.41
396146-96146101.318101.99
494396-9439699.474100.14
594846-9484699.948100.61
694741-9474199.838100.50
45min196712-96712101.915100.511.12102.76101.351.12
296283-96283101.463102.31
395856-95856101.013101.85
494003-9400399.06099.89
594792-9479299.892100.72
694626-9462699.717100.55
极限196435-96435101.623100.171.10102.64101.171.10
296073-96073101.241102.25
395063-95063100.177101.19
493699-9369998.74099.73
594293-9429399.366100.36
694755-9475599.853100.85
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%
114.705331253383533575355053069533340.33
214.695340553082532440.43
单位质量响应值RSD%判断
3628.163624.510.08数据可信
加速3月-供试品溶液-2023101322批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145327-4532778.91980.082.9578.9280.082.95
245635-4563579.45579.45
345072-4507278.47578.47
448718-4871884.82384.82
545478-4547879.18279.18
645723-4572379.60879.61
10min151871-5187190.31288.860.9090.4488.990.89
251052-5105288.88689.02
350750-5075088.36188.49
450622-5062288.13888.28
550771-5077188.39788.53
651150-5115089.05789.19
15min151048-5104888.87991.331.7689.1691.621.76
253038-5303892.34492.62
351579-5157989.80490.08
453355-5335592.89693.18
552822-5282291.96892.25
652907-5290792.11692.40
20min153783-5378393.64193.270.7894.0793.710.79
253749-5374993.58294.02
353406-5340692.98593.41
454203-5420394.37394.82
553142-5314292.52592.96
653141-5314192.52492.96
30min153735-5373593.55891.483.1594.1492.073.13
253871-5387193.79594.39
351923-5192390.40390.99
453136-5313692.51593.12
553095-5309592.44493.03
649479-4947986.14886.74
45min154501-5450194.89193.710.9095.6394.450.89
253635-5363593.38494.13
354113-5411394.21694.95
453865-5386593.78494.54
553728-5372893.54694.29
653076-5307692.41093.14
极限153798-5379893.66893.470.7694.5794.370.74
253806-5380693.68194.58
354144-5414494.27095.16
453036-5303692.34193.25
553383-5338392.94593.84
653944-5394493.92294.81
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%
110.078594485377858248574485799857380.26
210.088537585977856760.50
单位质量响应值RSD%判断
8514.208499.600.13数据可信
加速3月-供试品溶液-2023101323批-富马酸比索洛尔-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min192444-9244497.60797.861.4497.6197.861.44
294912-94912100.213100.21
392648-9264897.82297.82
490903-9090395.98095.98
592031-9203197.17197.17
693135-9313598.33798.34
10min193333-9333398.54699.111.1198.7199.281.11
295512-95512100.846101.01
393396-9339698.61298.78
492513-9251397.68097.84
594411-9441199.68499.85
694063-9406399.31699.48
15min193044-9304498.24098.941.1398.5799.271.13
295622-95622100.962101.30
393256-9325698.46498.79
492799-9279997.98298.30
594201-9420199.46299.79
693321-9332198.53398.86
20min192665-9266597.84098.711.2698.3399.201.25
295609-95609100.949101.45
393153-9315398.35698.85
492559-9255997.72898.21
594054-9405499.30799.80
692892-9289298.08098.57
30min192815-9281597.99998.610.9698.6599.270.96
294985-94985100.290100.96
392976-9297698.16998.82
492512-9251297.67998.33
593770-9377099.00799.67
693302-9330298.51399.17
45min192549-9254997.71898.431.2398.5399.251.23
295434-95434100.764101.60
392935-9293598.12598.94
492483-9248397.64898.46
593430-9343098.64899.47
692499-9249997.66598.49
极限192363-9236397.52198.391.1898.5099.381.18
295213-95213100.531101.54
392705-9270597.88398.87
492334-9233497.49198.47
593590-9359098.81799.81
692932-9293298.12299.11
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%
114.705320353333533635325053222532740.14
214.695365853289534740.49
单位质量响应值RSD%判断
3624.083640.160.32数据可信
加速3月-供试品溶液-2023101323批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min143453-4345375.53676.522.1875.5476.522.18
245583-4558379.23879.24
343769-4376976.08576.08
442765-4276574.34074.34
544425-4442577.22577.23
644117-4411776.69076.69
10min149762-4976286.50386.202.4786.6386.332.46
250338-5033887.50487.64
350392-5039287.59887.72
450205-5020587.27387.40
549659-4965986.32486.45
647176-4717682.00782.14
15min152194-5219490.73089.581.4291.0089.851.42
252263-5226390.85091.13
350529-5052987.83688.11
450761-5076188.23988.51
551816-5181690.07390.35
651619-5161989.73190.00
20min151547-5154789.60691.031.8090.0391.451.79
253533-5353393.05893.49
350972-5097288.60689.03
452881-5288191.92592.34
552764-5276491.72192.14
652489-5248991.24391.66
30min154307-5430794.40392.531.7994.9793.101.78
254161-5416194.15094.73
351822-5182290.08490.65
453233-5323392.53793.11
552534-5253491.32191.90
653313-5331392.67693.24
45min153336-5333692.71692.741.4993.4493.471.49
254876-5487695.39396.13
353207-5320792.49193.21
453239-5323992.54793.27
552831-5283191.83892.57
652624-5262491.47892.20
极限153974-5397493.82592.901.6794.7193.791.66
254774-5477495.21596.12
352355-5235591.01091.88
453627-5362793.22194.10
552631-5263191.49092.37
653306-5330692.66393.54
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%
110.078604486047856488543786159858670.36
210.088459684864847300.23
单位质量响应值RSD%判断
8527.018405.751.02数据可信
加速3月-供试品溶液-2024010421批-富马酸比索洛尔-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min194342-94342100.09399.211.34100.0999.211.34
293315-9331599.00399.00
395282-95282101.090101.09
493255-9325598.93998.94
591548-9154897.12897.13
693337-9333799.02699.03
10min194840-94840100.62199.881.45100.79100.051.45
293720-9372099.43399.60
396216-96216102.081102.25
493872-9387299.59499.76
592100-9210097.71497.88
694111-9411199.848100.01
15min194453-94453100.21099.471.42100.5599.811.41
293442-9344299.13899.47
395906-95906101.752102.09
493695-9369599.40699.74
592023-9202397.63297.96
693030-9303098.70199.03
20min194495-94495100.25599.561.41100.76100.061.41
293376-9337699.06899.56
395894-95894101.739102.25
493760-9376099.47599.97
591885-9188597.48697.97
693655-9365599.36499.86
30min194255-94255100.00099.361.29100.67100.021.29
293419-9341999.11399.77
395483-95483101.303101.98
493468-9346899.16599.83
591802-9180297.39898.05
693467-9346799.16499.83
45min193750-9375099.46599.111.32100.3099.941.33
293227-9322798.91099.74
395310-95310101.120101.97
493235-9323598.91899.75
591465-9146597.04097.85
693523-9352399.224100.05
极限194015-9401599.74698.951.39100.7599.941.40
292985-9298598.65399.64
395123-95123100.921101.94
492849-9284998.50999.50
591235-9123596.79697.77
693380-9338099.072100.06
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%
114.705349453354537195339253102534120.42
214.695309353108531000.02
单位质量响应值RSD%判断
3633.473614.700.37数据可信
加速3月-供试品溶液-2024010421批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min144392-4439277.33976.381.0577.3476.381.05
243818-4381876.33976.34
343144-4314475.16575.16
443520-4352075.82075.82
543966-4396676.59776.60
644222-4422277.04377.04
10min148722-4872284.88386.852.1185.0186.972.11
250617-5061788.18488.31
351237-5123789.26489.39
448816-4881685.04785.17
550429-5042987.85787.98
649280-4928085.85585.98
15min152028-5202890.64388.852.8390.9189.122.82
250362-5036287.74088.01
352746-5274691.89392.17
448613-4861384.69384.96
550875-5087588.63488.91
651381-5138189.51589.79
20min154280-5428094.56692.201.8794.9992.621.87
252469-5246991.41191.83
353169-5316992.63093.06
451302-5130289.37889.79
553042-5304292.40992.83
653270-5327092.80693.23
30min151728-5172890.12091.861.4490.7092.431.43
253300-5330092.85993.43
352942-5294292.23592.82
451847-5184790.32790.89
553030-5303092.38892.96
653509-5350993.22393.80
45min153501-5350193.20992.581.3193.9493.301.30
253784-5378493.70294.43
352064-5206490.70591.44
452724-5272491.85592.56
553831-5383193.78494.51
652922-5292292.20092.93
极限153541-5354193.27892.021.4294.1692.911.41
252448-5244891.37492.26
351965-5196590.53391.42
452192-5219290.92891.79
552968-5296892.28093.17
653815-5381593.75694.64
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