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%
110.214294543075429784284042888429450.21
210.214313943197431680.10
单位质量响应值RSD%判断
4206.174228.010.37数据可信
供试品溶液-2024010321不同溶出仪批-富马酸比索洛尔-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%
5min143615-4361592.89694.722.0092.9094.721.99
244487-4448794.75494.75
344019-4401993.75793.76
443885-4388593.47193.47
544741-4474195.29595.29
646074-4607498.13498.13
10min143510-4351092.67394.792.2492.8394.942.24
244789-4478995.39795.55
343775-4377593.23793.39
443876-4387693.45293.61
544881-4488195.59395.75
646186-4618698.37298.54
15min143357-4335792.34794.312.2092.6694.622.20
244394-4439494.55694.87
343609-4360992.88493.20
443767-4376793.22093.53
544507-4450794.79695.11
646037-4603798.05598.38
20min143001-4300191.58993.732.0892.0594.212.09
244299-4429994.35394.83
343373-4337392.38192.85
443595-4359592.85493.32
544194-4419494.13094.61
645582-4558297.08697.58
30min143081-4308191.75993.391.9692.3794.021.96
243941-4394193.59194.22
343207-4320792.02792.65
443344-4334492.31992.94
544127-4412793.98794.62
645372-4537296.63997.29
45min142626-4262690.79092.622.1691.5693.402.16
243808-4380893.30794.10
342666-4266690.87591.65
442966-4296691.51492.29
543762-4376293.20994.00
645075-4507596.00696.82
极限142303-4230390.10291.901.9791.0292.841.97
243276-4327692.17493.12
342562-4256290.65491.58
442675-4267590.89491.82
543439-4343992.52293.47
644630-4463095.05896.03
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%
1104844548742485304845348472485280.26
2104852148599485600.12
单位质量响应值RSD%判断
4852.804856.000.05数据可信
供试品溶液-2024010321不同溶出仪批-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%
5min154216-5421670.51571.171.9470.5271.171.94
253474-5347469.55069.55
354916-5491671.42671.43
456543-5654373.54273.54
554154-5415470.43570.43
655026-5502671.56971.57
10min155032-5503271.57671.051.1871.6971.171.18
255017-5501771.55771.67
354726-5472671.17871.30
455322-5532271.95472.08
553894-5389470.09670.21
653781-5378169.94970.07
15min154838-5483871.32471.161.2571.5671.391.25
254504-5450470.89071.12
354708-5470871.15571.39
455937-5593772.75473.00
554337-5433770.67370.91
653931-5393170.14470.38
20min153882-5388270.08170.471.8470.4470.821.83
254506-5450670.89271.25
354400-5440070.75471.11
455686-5568672.42772.79
553951-5395170.17170.52
652646-5264668.47368.83
30min153852-5385270.04269.771.4470.5170.241.43
253028-5302868.97069.44
353583-5358369.69270.17
454848-5484871.33771.82
553892-5389270.09470.56
652638-5263868.46368.93
45min153125-5312569.09669.201.3569.6969.791.36
252926-5292668.83769.42
353532-5353269.62670.22
454440-5444070.80771.41
552881-5288168.77969.36
652339-5233968.07468.65
极限153426-5342669.48868.601.5470.1969.301.53
252783-5278368.65169.35
353225-5322569.22669.93
453290-5329069.31170.03
552454-5245468.22368.92
651269-5126966.68267.38
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%
110.214384843612435464352243531436120.32
210.214349743213433550.47
单位质量响应值RSD%判断
4271.504246.330.42数据可信
供试品溶液-手动取样2024010321批-富马酸比索洛尔-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%
5min143460-4346091.65794.171.6691.6694.171.66
244434-4443493.71293.71
345462-4546295.88095.88
445175-4517595.27495.27
544272-4427293.37093.37
645095-4509595.10695.11
10min143325-4332591.37394.051.8591.5394.211.85
244148-4414893.10893.26
345535-4553596.03496.19
445034-4503494.97795.14
544301-4430193.43193.59
645237-4523795.40595.56
15min142992-4299290.67093.061.7190.9893.371.71
243616-4361691.98692.30
344947-4494794.79495.11
444759-4475994.39794.71
543898-4389892.58192.89
644525-4452593.90494.22
20min142531-4253189.69891.991.7690.1592.461.76
243118-4311890.93691.40
344588-4458894.03694.51
444035-4403592.87093.34
543287-4328791.29391.76
644155-4415593.12393.60
30min141799-4179988.15491.061.9688.7691.681.95
242780-4278090.22390.84
344110-4411093.02893.66
443690-4369092.14392.77
542941-4294190.56391.18
643729-4372992.22592.85
45min141311-4131187.12589.891.8687.8890.671.86
242124-4212488.84089.61
343504-4350491.75092.54
443069-4306990.83391.62
542697-4269790.04890.82
643029-4302990.74891.53
极限140885-4088586.22788.811.8387.1289.731.83
241652-4165287.84488.76
342873-4287390.41991.36
442541-4254189.71990.65
541928-4192888.42689.35
642775-4277590.21391.15
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%
1104867048519484204855348673485670.23
2104811848702484100.86
单位质量响应值RSD%判断
4856.704841.000.23数据可信
供试品溶液-手动取样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%
5min154277-5427770.67568.463.8870.6868.463.89
253023-5302369.04369.04
354865-5486571.44171.44
451086-5108666.52066.52
549384-4938464.30464.30
652805-5280568.75968.76
10min155010-5501071.63070.711.2471.7570.831.24
253742-5374269.97970.09
355306-5530672.01572.13
454004-5400470.32070.43
553909-5390970.19670.30
653871-5387170.14770.26
15min154338-5433870.75569.521.6970.9969.761.69
253175-5317569.24169.47
354456-5445670.90971.15
452420-5242068.25768.49
553575-5357569.76169.99
652396-5239668.22668.46
20min153028-5302869.04968.661.9169.4069.011.91
252174-5217467.93768.28
354167-5416770.53270.89
451713-5171367.33767.68
553528-5352869.70070.04
651766-5176667.40667.75
30min151538-5153867.10967.871.7567.5868.331.74
252854-5285468.82369.28
353558-5355869.73970.21
452011-5201167.72568.18
551558-5155867.13567.59
651198-5119866.66667.12
45min151611-5161167.20466.881.8767.7967.451.86
251679-5167967.29367.87
352372-5237268.19568.79
449967-4996765.06365.63
552111-5211167.85568.42
650419-5041965.65266.22
极限151243-5124366.72565.991.7567.4266.671.74
251176-5117666.63867.32
350677-5067765.98866.69
450127-5012765.27265.95
551619-5161967.21467.90
649217-4921764.08764.76
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%
110.214413643901438354394043934439490.26
210.214367143719436950.08
单位质量响应值RSD%判断
4304.514279.630.41数据可信
供试品溶液-2024010321批-富马酸比索洛尔-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%
5min145700-4570095.63793.372.3395.6493.382.34
244472-4447293.06793.07
344163-4416392.42192.42
442870-4287089.71589.71
544991-4499194.15394.15
645518-4551895.25695.26
10min146181-4618196.64493.992.4696.8094.142.46
244786-4478693.72493.88
344500-4450093.12693.28
443078-4307890.15090.30
545070-4507094.31994.48
645851-4585195.95396.11
15min146162-4616296.60493.892.2296.9294.202.21
244765-4476593.68093.99
344562-4456293.25693.56
443215-4321590.43790.74
544985-4498594.14194.45
645495-4549595.20895.53
20min145840-4584095.93093.592.1396.4194.062.13
244579-4457993.29193.76
344269-4426992.64293.11
443176-4317690.35590.81
544965-4496594.09994.57
645489-4548995.19695.67
30min145769-4576995.78293.472.4396.4294.092.43
244814-4481493.78394.41
344200-4420092.49893.12
442771-4277189.50890.11
544863-4486393.88694.51
645556-4555695.33695.97
45min145646-4564695.52493.102.2396.3393.882.23
244514-4451493.15593.93
343983-4398392.04492.82
442871-4287189.71790.47
544615-4461593.36794.15
645303-4530394.80695.60
极限145457-4545795.12992.832.3096.0993.762.30
244648-4464893.43694.37
343732-4373291.51992.45
442658-4265889.27190.17
544541-4454193.21294.15
645109-4510994.40095.35
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%
1104840148251483684865448721484790.42
2104892248987489540.10
单位质量响应值RSD%判断
4847.904895.400.69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%
5min154075-5407570.08468.142.4170.0868.142.40
253708-5370869.60969.61
352494-5249468.03568.04
450559-5055965.52765.53
552637-5263768.22168.22
651971-5197167.35767.36
10min154130-5413070.15669.981.1670.2770.101.16
254584-5458470.74470.86
354548-5454870.69770.81
454154-5415470.18770.30
552938-5293868.61168.72
653636-5363669.51569.63
15min152912-5291268.57769.482.0468.8169.702.04
254248-5424870.30970.54
355447-5544771.86372.09
453635-5363569.51469.74
552821-5282168.45968.69
652572-5257268.13668.36
20min153098-5309868.81869.571.0269.1769.921.02
253161-5316168.90069.25
354608-5460870.77571.13
453806-5380669.73670.08
553674-5367469.56569.91
653741-5374169.65269.99
30min153320-5332069.10669.161.0469.5769.621.03
252562-5256268.12368.59
353928-5392869.89470.36
454019-5401970.01270.47
553007-5300768.70069.16
653321-5332169.10769.56
45min153204-5320468.95668.480.7469.5369.050.73
252507-5250768.05268.63
353414-5341469.22869.81
452690-5269068.28968.86
552461-5246167.99368.57
652731-5273168.34368.92
极限153319-5331969.10568.361.3369.8069.051.32
251912-5191267.28167.97
351788-5178867.12067.82
453205-5320568.95769.65
553206-5320668.95869.64
653048-5304868.75369.44
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%
110.214347543402432394344943379433890.22
210.214382243656437390.27
单位质量响应值RSD%判断
4249.664283.940.57数据可信
供试品溶液-2024010321批-富马酸比索洛尔-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%
5min144680-4468094.05794.422.4394.0694.422.43
246768-4676898.45398.45
345452-4545295.68295.68
443935-4393592.48992.49
544211-4421193.07093.07
644073-4407392.77992.78
10min145085-4508594.91095.562.6195.0795.712.61
247448-4744899.884100.05
346081-4608197.00697.17
444610-4461093.91094.06
544890-4489094.49994.65
644238-4423893.12793.28
15min144969-4496994.66595.352.6494.9895.662.64
247311-4731199.59699.93
346127-4612797.10397.42
444506-4450693.69194.00
544681-4468194.05994.37
644169-4416992.98193.29
20min144829-4482994.37195.122.3994.8495.592.39
247024-4702498.99199.49
345817-4581796.45196.93
444578-4457893.84294.31
544853-4485394.42194.89
643999-4399992.62393.09
30min144616-4461693.92294.772.5494.5595.412.53
246958-4695898.85299.51
345806-4580696.42797.07
444265-4426593.18393.81
544534-4453493.75094.38
643946-4394692.51293.13
45min144687-4468794.07294.622.5794.8695.422.56
246655-4665598.21599.04
346055-4605596.95297.76
444270-4427093.19493.97
544327-4432793.31494.10
643695-4369591.98392.76
极限144741-4474194.18594.552.4795.1395.502.47
246739-4673998.39199.38
345740-4574096.28897.25
444160-4416092.96293.90
544224-4422493.09794.04
643882-4388292.37793.30
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%
1104866948555484154869548438485540.27
2104869748227484620.69
单位质量响应值RSD%判断
4855.404846.200.14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%
5min152395-5239568.19769.642.6068.2069.642.59
255454-5545472.17972.18
352799-5279968.72368.72
454664-5466471.15171.15
553806-5380670.03470.03
651879-5187967.52667.53
10min154554-5455471.00871.751.9171.1271.861.91
256939-5693974.11274.23
354761-5476171.27771.39
455730-5573072.53872.66
554029-5402970.32470.44
654715-5471571.21771.33
15min153678-5367869.86770.731.3370.1070.971.32
254088-5408870.40170.64
354182-5418270.52370.76
455687-5568772.48272.72
553892-5389270.14670.38
654538-5453870.98771.22
20min154397-5439770.80370.922.4171.1571.272.41
256510-5651073.55373.91
352802-5280268.72769.08
455446-5544672.16972.53
553856-5385670.09970.45
653892-5389270.14670.50
30min154149-5414970.48070.851.5570.9571.321.55
255993-5599372.88173.36
354000-5400070.28670.75
454725-5472571.23071.71
554109-5410970.42870.90
653638-5363869.81570.28
45min154344-5434470.73470.122.8371.3270.712.82
255535-5553572.28472.89
353808-5380870.03770.62
454719-5471971.22271.82
553772-5377269.99070.57
651069-5106966.47167.05
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