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4000
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%
19.984273242747426834276642721427300.08
29.954252442552425380.05
单位质量响应值RSD%判断
4281.564275.180.11数据可信
供试品溶液-2024010321批-比索洛尔-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min145222-4522247.47047.961.5847.4747.961.58
246204-4620448.50048.50
345990-4599048.27648.28
445211-4521147.45847.46
544799-4479947.02547.03
646692-4669249.01349.01
10min145360-4536047.61448.281.5547.6948.351.55
246683-4668349.00349.08
346291-4629148.59248.67
445500-4550047.76147.84
545247-4524747.49647.57
646860-4686049.18949.27
15min145280-4528047.53048.231.5547.6948.391.55
246615-4661548.93249.09
346199-4619948.49548.66
445576-4557647.84148.00
545154-4515447.39847.56
646846-4684649.17449.34
20min145294-4529447.54548.041.4947.7848.281.49
246403-4640348.70948.95
345881-4588148.16148.40
445227-4522747.47547.71
545067-4506747.30747.54
646707-4670749.02849.27
30min145069-4506947.30947.951.5847.6348.271.58
246189-4618948.48548.81
346083-4608348.37348.70
445107-4510747.34947.67
544972-4497247.20747.52
646663-4666348.98249.31
45min145070-4507047.31047.821.4447.7148.221.44
246063-4606348.35248.76
345778-4577848.05348.46
445087-4508747.32847.72
544855-4485547.08447.48
646493-4649348.80449.21
极限144861-4486147.09147.721.6047.5748.201.60
246090-4609048.38148.87
345663-4566347.93248.42
444918-4491847.15047.63
544742-4474246.96647.44
646475-4647548.78549.28
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%
114.105064250471502825022650297503840.34
214.145030150109502050.28
单位质量响应值RSD%判断
3573.333550.570.46数据可信
供试品溶液-2024010321批-左氨氯地平-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min154361-5436196.36095.810.9696.3695.810.96
253572-5357294.96194.96
353753-5375395.28295.28
454166-5416696.01496.01
554877-5487797.27497.27
653577-5357794.97094.97
10min154970-5497097.43997.420.9497.6097.580.95
255012-5501297.51397.67
355347-5534798.10798.27
454922-5492297.35497.51
555485-5548598.35298.51
654009-5400995.73695.89
15min155064-5506497.60696.841.1597.9397.161.15
254838-5483897.20597.53
355000-5500097.49297.81
453500-5350094.83395.16
555089-5508997.65097.98
654290-5429096.23496.55
20min154424-5442496.47196.511.3096.9696.991.30
255269-5526997.96998.45
354952-5495297.40797.89
453384-5338494.62895.11
554764-5476497.07497.56
653868-5386895.48695.96
30min154338-5433896.31996.441.0096.9797.081.00
254954-5495497.41198.06
354692-5469296.94697.59
453819-5381995.39996.04
554911-5491197.33497.99
653720-5372095.22395.86
45min154060-5406095.82695.451.3296.6396.261.32
253186-5318694.27795.09
353708-5370895.20296.01
454441-5444196.50197.30
554761-5476197.06997.88
652933-5293393.82894.62
极限153873-5387395.49595.860.9496.4696.820.93
254660-5466096.89097.86
354766-5476697.07798.04
453861-5386195.47396.43
553637-5363795.07696.05
653664-5366495.12496.08
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4000
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%
19.984323343234432514327343208432400.06
29.954368743683436850.01
单位质量响应值RSD%判断
4332.674390.450.94数据可信
供试品溶液-2024010321批-比索洛尔-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min143133-4313344.41546.503.9944.4246.503.98
244615-4461545.94145.94
345400-4540046.74946.75
447744-4774449.16349.16
546597-4659747.98247.98
643442-4344244.73344.73
10min143488-4348844.78146.903.9744.8546.983.97
245038-4503846.37746.45
345664-4566447.02147.10
448089-4808949.51849.60
547130-4713048.53148.61
643874-4387445.17845.25
15min143417-4341744.70746.884.0544.8647.034.05
244875-4487546.20946.36
345703-4570347.06147.22
448145-4814549.57649.74
547121-4712148.52248.68
643887-4388745.19145.34
20min143353-4335344.64246.814.1144.8647.044.11
244847-4484746.18046.41
345742-4574247.10247.34
448078-4807849.50749.75
547051-4705148.44948.69
643699-4369944.99845.22
30min143320-4332044.60846.694.3644.9147.004.35
244753-4475346.08346.39
345827-4582747.18947.50
448060-4806049.48849.82
546939-4693948.33448.66
643141-4314144.42344.72
45min143237-4323744.52246.643.9244.8947.033.92
244660-4466045.98746.37
345640-4564046.99747.39
447899-4789949.32349.73
546589-4658947.97448.38
643723-4372345.02345.40
极限142986-4298644.26446.604.1644.7147.064.16
244662-4466245.98946.45
345549-4554946.90347.37
447831-4783149.25349.75
546890-4689048.28448.77
643582-4358244.87745.33
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%
114.105019150279500035003549952500920.28
214.145000150007500040.01
单位质量响应值RSD%判断
3552.623536.350.33数据可信
供试品溶液-2024010321批-左氨氯地平-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min152957-5295794.33395.432.3394.3395.422.33
253716-5371695.68595.68
354501-5450197.08397.08
451439-5143991.62991.63
554949-5494997.88197.88
653859-5385995.94095.94
10min153900-5390096.01397.452.0696.1797.612.06
255890-5589099.55799.72
355303-5530398.51298.67
453026-5302694.45694.61
555703-5570399.22499.39
654424-5442496.94697.11
15min154039-5403996.26097.432.0796.5897.752.07
255609-5560999.05799.38
354945-5494597.87498.20
452839-5283994.12394.43
555969-5596999.698100.03
654762-5476297.54897.87
20min154056-5405696.29097.282.3196.7797.772.31
254822-5482297.65598.15
355733-5573399.27899.77
452549-5254993.60694.07
556032-5603299.810100.31
654484-5448497.05397.54
30min153699-5369995.65595.752.4296.2996.392.41
253503-5350395.30595.96
355246-5524698.41099.06
452462-5246293.45194.07
555292-5529298.49299.15
652312-5231293.18493.83
45min153318-5331894.97696.202.3295.7797.002.32
254760-5476097.54598.36
355080-5508098.11598.93
451855-5185592.37093.15
554996-5499697.96598.79
654018-5401896.22397.02
极限152959-5295994.33696.142.4595.2997.112.45
254888-5488897.77398.75
354842-5484297.69198.67
452074-5207492.76093.69
555499-5549998.86199.85
653581-5358195.44496.41
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