坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903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)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%
1 15.901686191688351689541689911692361689270.14
2 15.931703511703041703280.02
单位质量响应值RSD%判断
10624.3410692.280.46数据可信
高温30天-供试品溶液-2025033121批-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%
5min171170-7117037.48638.624.8937.4938.624.89
270821-7082137.30237.30
373760-7376038.85038.85
474808-7480839.40239.40
579534-7953441.89141.89
669802-6980236.76536.77
10min1128971-12897167.93066.773.3668.3567.203.36
2125544-12554466.12566.54
3124818-12481865.74366.17
4128081-12808167.46167.90
5132832-13283269.96470.43
6120312-12031263.36963.78
15min1152973-15297380.57280.402.6381.7481.572.65
2154114-15411481.17382.32
3150615-15061579.33080.49
4154379-15437981.31382.50
5157819-15781983.12484.37
6145982-14598276.89078.00
20min1166848-16684887.88087.322.0789.9589.392.09
2165084-16508486.95189.00
3162328-16232885.49987.54
4169765-16976589.41691.51
5169164-16916489.10091.27
6161537-16153785.08387.05
30min1171513-17151390.33792.312.1093.3895.352.08
2176281-17628192.84895.87
3172264-17226490.73393.73
4181627-18162795.66498.75
5176163-17616392.78695.94
6173742-17374291.51194.42
45min1181382-18138295.53596.231.3499.58100.301.35
2181744-18174495.72699.77
3182546-18254696.148100.15
4187528-18752898.772102.92
5182299-18229996.018100.21
6180763-18076395.20999.14
60min1177026-17702693.24195.961.8198.35101.091.78
2182669-18266996.213101.33
3180152-18015294.88799.96
4186400-18640098.178103.42
5184465-18446597.159102.41
6182393-18239396.068101.05
极限1180766-18076695.21196.982.43101.35103.182.37
2183674-18367496.742102.92
3178471-17847194.002100.13
4191171-191171100.691107.03
5186675-18667598.323104.66
6183982-18398296.905102.96
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903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)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%
1 15.901708961712011712951715261717721713380.20
2 15.931704251703651703950.03
单位质量响应值RSD%判断
10775.9710696.480.53数据可信
高温30天-供试品溶液-2025033121批-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%
5min165405-6540534.19934.822.2034.2034.822.19
268061-6806135.58835.59
365475-6547534.23634.24
468679-6867935.91135.91
565379-6537934.18634.19
666561-6656134.80434.80
10min1118746-11874662.09163.393.1862.4763.783.17
2118870-11887062.15562.55
3117549-11754961.46561.85
4127230-12723066.52766.93
5124696-12469665.20265.58
6120254-12025462.87963.27
15min1142831-14283174.68476.673.5175.7577.763.50
2146210-14621076.45177.54
3139579-13957972.98474.05
4153584-15358480.30781.45
5151057-15105778.98680.09
6146545-14654576.62677.71
20min1156847-15684782.01384.163.2783.9186.113.26
2160237-16023783.78685.72
3154049-15404980.55082.42
4169057-16905788.39890.43
5163132-16313285.29987.28
6162443-16244384.93986.88
30min1167611-16761187.64189.322.7290.4592.202.72
2171206-17120689.52192.39
3163380-16338085.42988.20
4175691-17569191.86694.88
5174767-17476791.38394.31
6172305-17230590.09692.98
45min1173668-17366890.80992.772.2494.5996.642.25
2180073-18007394.15898.02
3171472-17147289.66093.38
4181501-18150194.90498.94
5178259-17825993.20997.15
6179522-17952293.87097.75
60min1176975-17697592.53893.431.4997.3398.331.55
2180772-18077294.52399.43
3174262-17426291.11995.83
4181327-18132794.81399.90
5179932-17993294.08499.06
6178853-17885393.52098.44
极限1177327-17732792.72293.861.9598.5499.801.97
2182304-18230495.324101.28
3173324-17332490.62996.36
4181732-18173295.025101.17
5180918-18091894.600100.63
6181361-18136194.831100.79
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903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)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%
1 15.904284542829427744277242797428030.08
2 15.934307943052430660.05
单位质量响应值RSD%判断
2692.012703.450.30数据可信
-供试品溶液-2025033121批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150797-50797105.705105.901.40105.70105.901.40
251417-51417106.995106.99
350328-50328104.729104.73
451932-51932108.067108.07
550878-50878105.873105.87
649981-49981104.007104.01
10min150421-50421104.922104.892.17106.10106.072.16
251626-51626107.430108.62
350634-50634105.365106.53
451220-51220106.585107.79
550037-50037104.123105.30
648502-48502100.929102.08
15min149351-49351102.696103.421.57105.04105.761.56
250360-50360104.795107.18
349132-49132102.240104.57
450912-50912105.944108.33
548895-48895101.747104.08
649536-49536103.081105.36
20min148923-48923101.805102.922.18105.29106.412.16
250513-50513105.114108.66
348932-48932101.824105.29
451116-51116106.368109.93
548729-48729101.401104.87
648533-48533100.993104.42
30min147570-4757098.990100.902.17103.60105.542.15
249200-49200102.381107.10
348360-48360100.633105.24
450238-50238104.541109.29
548012-4801299.909104.50
647558-4755898.965103.51
45min144739-4473993.09898.073.0598.81103.822.95
247932-4793299.743105.60
347296-4729698.419104.14
449073-49073102.117108.02
546765-4676597.314103.01
646959-4695997.718103.36
60min146651-4665197.07798.293.03103.82105.132.95
248065-48065100.020106.98
346569-4656996.907103.72
449753-49753103.532110.57
546474-4647496.709103.49
645880-4588095.473102.20
极限146783-4678397.35297.933.00105.18105.872.91
247518-4751898.881106.95
346173-4617396.082103.97
449668-49668103.355111.55
545720-4572095.140103.00
646516-4651696.796104.59
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903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)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%
1 15.904312943170431804317443185431680.06
2 15.934337943392433860.03
单位质量响应值RSD%判断
2714.972723.540.23数据可信
-供试品溶液-2025033121批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min148309-4830999.73199.222.7199.7399.222.71
249755-49755102.717102.72
346198-4619895.37395.37
447410-4741097.87697.88
547504-4750498.07098.07
649201-49201101.573101.57
10min148364-4836499.84598.261.60100.9599.361.58
246830-4683096.67897.82
348009-4800999.112100.17
446498-4649895.99397.08
547706-4770698.48799.58
648158-4815899.420100.55
15min147329-4732997.70896.401.9599.9398.601.91
245486-4548693.90496.12
347197-4719797.43699.60
445576-4557694.08996.24
547417-4741797.890100.07
647180-4718097.40199.63
20min146535-4653596.06995.462.0899.3798.722.04
245303-4530393.52696.78
347059-4705997.151100.39
445583-4558394.10497.30
545381-4538193.68796.96
647582-4758298.231101.55
30min146630-4663096.26595.281.18100.6499.601.17
245990-4599094.94499.24
346485-4648595.966100.29
445679-4567994.30298.55
545405-4540593.73698.05
646713-4671396.437100.84
45min145924-4592494.80893.062.38100.2598.442.31
244637-4463792.15197.50
345342-4534293.60699.00
444134-4413491.11296.41
543829-4382990.48395.84
646595-4659596.193101.67
60min144603-4460392.08191.392.5098.5797.802.43
243731-4373190.28096.66
345146-4514693.20299.63
442737-4273788.22894.53
543635-4363590.08296.44
645753-4575394.455101.00
极限144984-4498492.86790.771.89100.3898.201.84
242923-4292388.61295.99
343779-4377990.38097.84
443779-4377990.38097.67
543408-4340889.61496.97
644930-4493092.756100.35
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