比索洛尔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(%)99.80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%
110.208432384295841668418784203842350.09
210.228379283999838960.18
单位质量响应值RSD%判断
8258.338209.000.43数据可信
供试品溶液-6030401批-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%
5min185360-8536093.11992.713.2893.1292.713.28
284390-8439092.06192.06
381243-8124388.62888.63
489428-8942897.55797.56
583251-8325190.81890.82
686238-8623894.07794.08
10min188680-8868096.74196.953.1196.9097.113.11
289555-8955597.69597.85
384289-8428991.95192.10
492191-92191100.571100.73
587653-8765395.62095.77
690882-9088299.14399.30
15min189556-8955697.69697.462.6298.0197.772.62
289691-8969197.84498.16
385502-8550293.27493.57
492339-92339100.732101.06
588158-8815896.17196.48
690767-9076799.01799.34
20min189551-8955197.69197.562.7098.1798.042.70
289520-8952097.65798.14
385627-8562793.41093.87
492780-92780101.213101.71
588266-8826696.28996.76
690835-9083599.09299.58
30min189489-8948997.62397.702.6098.2798.342.60
289534-8953497.67298.31
386053-8605393.87594.49
492794-92794101.229101.90
588294-8829496.32096.95
691165-9116599.452100.10
45min189618-8961897.76497.512.6998.5798.322.70
289416-8941697.54498.35
385614-8561493.39694.16
492807-92807101.243102.08
588226-8822696.24597.04
690633-9063398.87199.69
极限189518-8951897.65597.682.7798.6298.652.77
289519-8951997.65698.62
385849-8584993.65294.58
493202-93202101.674102.68
588257-8825796.27997.23
690918-9091899.182100.16
比索洛尔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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%) 99.90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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.811044301039031045231046721039111042880.35
213.891034631036621035620.14
单位质量响应值RSD%判断
7551.637455.870.91数据可信
供试品溶液-6030401批-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%
5min137277-3727732.20932.3415.3332.2132.3415.32
231005-3100526.79026.79
335642-3564230.79730.80
447155-4715540.74540.74
540220-4022034.75234.75
633245-3324528.72628.73
10min175793-7579365.49067.258.2065.5467.318.20
278422-7842267.76167.81
368551-6855159.23259.28
484521-8452173.03173.10
585322-8532273.72373.78
674394-7439464.28164.33
15min184802-8480273.27475.734.1273.4475.904.13
284801-8480173.27373.43
386819-8681975.01775.17
493623-9362380.89681.09
590375-9037578.08978.27
685445-8544573.82973.98
20min188062-8806276.09179.974.2176.3880.264.22
291582-9158279.13279.41
389126-8912677.01077.29
494944-9494482.03782.36
598649-9864985.23885.55
692960-9296080.32380.60
30min192957-9295780.32079.907.2880.7380.327.27
282659-8265971.42271.83
393891-9389181.12781.53
498816-9881685.38385.84
599812-9981286.24386.70
686671-8667174.88975.30
45min197407-9740784.16583.425.5084.7183.985.50
290938-9093878.57679.11
395366-9536682.40282.94
499141-9914185.66486.27
5105098-10509890.81191.41
691330-9133078.91479.45
极限1102876-10287688.89189.612.9489.5890.312.95
2101420-10142087.63388.29
3103544-10354489.46890.14
4101897-10189788.04588.79
5109741-10974194.82395.57
6102798-10279888.82389.49
比索洛尔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(%)99.80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%
110.208394683899840708381883885839240.12
210.228487685088849820.18
单位质量响应值RSD%判断
8227.848315.260.75数据可信
供试品溶液-6030401批-比索洛尔-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min189279-8927996.95098.372.5596.9598.372.55
291945-9194599.84599.84
388522-8852296.12896.13
489107-8910796.76396.76
594613-94613102.742102.74
690045-9004597.78297.78
10min189282-8928296.95398.952.5897.1199.112.58
292514-92514100.463100.63
389408-8940897.09097.25
489593-8959397.29197.45
595222-95222103.404103.57
690694-9069498.48698.65
15min189542-8954297.23698.942.5097.5699.272.50
292327-92327100.260100.59
389478-8947897.16697.49
489342-8934297.01897.34
595119-95119103.292103.64
690858-9085898.66598.99
20min188910-8891096.54998.662.5997.0399.162.59
292010-9201099.916100.42
389273-8927396.94397.43
489324-8932496.99997.48
595049-95049103.216103.73
690567-9056798.34998.84
30min188885-8888596.52298.282.4197.1798.942.41
291345-9134599.19399.86
389023-8902396.67297.32
488952-8895296.59597.24
594474-94474102.591103.28
690368-9036898.13298.79
45min188474-8847496.07698.192.4996.8899.012.49
291827-9182799.717100.55
388925-8892596.56597.37
488836-8883696.46997.28
594243-94243102.340103.20
690228-9022897.98098.80
极限188696-8869696.31798.232.5497.2899.212.54
291558-9155899.425100.42
388805-8880596.43597.40
488632-8863296.24797.22
594438-94438102.552103.58
690611-9061198.39699.38
比索洛尔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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%) 99.90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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.811039541039321040681043311034291039430.32
213.891050001050771050380.06
单位质量响应值RSD%判断
7526.657562.130.34数据可信
供试品溶液-6030401批-氨氯地平-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min194251-9425180.99784.454.8281.0084.454.82
299257-9925785.29985.30
3105997-10599791.09191.09
497737-9773783.99383.99
592573-9257379.55579.55
699812-9981285.77685.78
10min1112860-11286096.98996.003.5497.1296.143.54
2110779-11077995.20195.34
3119181-119181102.421102.57
4108690-10869093.40593.55
5109384-10938494.00294.13
6109376-10937693.99594.14
15min1112187-11218796.41195.994.1196.7196.294.11
2111997-11199796.24796.55
3120304-120304103.386103.71
4107810-10781092.64992.94
5108514-10851493.25493.54
6109348-10934893.97194.27
20min1111115-11111595.48995.184.0195.9595.644.01
2110606-11060695.05295.51
3119276-119276102.503103.00
4107577-10757792.44992.90
5107572-10757292.44492.89
6108405-10840593.16093.62
30min1110575-11057595.02594.824.0295.6495.444.02
2109081-10908193.74194.36
3118984-118984102.252102.92
4106584-10658491.59592.20
5108090-10809092.89093.49
6108679-10867993.39694.01
45min1110088-11008894.60794.424.2595.3895.204.25
2109797-10979794.35795.13
3118712-118712102.018102.85
4106314-10631491.36392.12
5105871-10587190.98391.74
6108447-10844793.19693.96
极限1108929-10892993.61194.144.4794.5495.074.47
2109810-10981094.36895.30
3118660-118660101.973102.98
4105009-10500990.24291.15
5105622-10562290.76991.67
6109221-10922193.86294.78
比索洛尔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(%)99.80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%
110.208423984057839458400084055840590.14
210.228409184199841450.10
单位质量响应值RSD%判断
8241.088233.370.07数据可信
供试品溶液-6030401批-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%
5min190655-9065598.85299.212.2798.8599.212.27
291104-9110499.34199.34
388076-8807696.04096.04
494228-94228102.748102.75
589875-8987598.00198.00
691974-91974100.290100.29
10min191027-9102799.257100.212.8599.42100.372.85
291773-91773100.071100.24
387958-8795895.91196.07
495494-95494104.128104.30
591168-9116899.41199.57
693974-93974102.471102.64
15min190870-9087099.086100.052.5699.42100.382.56
291764-91764100.061100.39
388608-8860896.62096.94
495612-95612104.257104.60
590831-9083199.04499.37
692829-92829101.222101.56
20min191249-9124999.499100.042.6599.99100.542.65
291713-91713100.005100.50
388496-8849696.49796.98
495404-95404104.030104.55
590204-9020498.36098.85
693411-93411101.857102.36
30min191309-9130999.56599.782.77100.23100.442.77
291232-9123299.481100.15
388189-8818996.16396.80
495220-95220103.829104.52
589647-8964797.75398.41
693440-93440101.889102.56
45min191324-9132499.58199.742.47100.41100.582.47
291394-9139499.658100.49
388117-8811796.08496.89
494838-94838103.413104.28
590396-9039698.56999.39
692775-92775101.163102.01
极限190833-9083399.04699.572.72100.04100.582.72
291120-9112099.359100.36
387970-8797095.92496.89
495008-95008103.598104.64
589823-8982397.94498.93
693155-93155101.578102.59
比索洛尔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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%) 99.90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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.811037171039011035761033761041041037350.28
213.891041881033681037780.56
单位质量响应值RSD%判断
7511.597471.420.38数据可信
供试品溶液-6030401批-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%
5min191193-9119378.92280.943.7078.9280.943.70
291117-9111778.85678.86
392313-9231379.89279.89
498005-9800584.81884.82
590663-9066378.46478.46
697852-9785284.68584.69
10min1109696-10969694.93596.141.8795.0796.281.87
2109281-10928194.57694.71
3109588-10958894.84294.98
4114622-11462299.19999.34
5112314-11231497.20197.33
6111059-11105996.11596.26
15min1108618-10861894.00395.442.5394.2995.742.53
2109325-10932594.61494.90
3109932-10993295.14095.43
4114960-11496099.49199.80
5111859-11185996.80797.10
6107009-10700992.61092.91
20min1110106-11010695.29094.981.1895.7495.431.19
2107983-10798393.45393.90
3109496-10949694.76295.21
4111962-11196296.89797.37
5109485-10948594.75395.21
6109426-10942694.70295.16
30min1109340-10934094.62795.571.4995.2396.181.49
2109480-10948094.74995.35
3109161-10916194.47295.08
4113510-11351098.23698.87
5110159-11015995.33695.95
6110903-11090395.98096.59
45min1107097-10709792.68694.772.6593.4595.542.64
2108215-10821593.65494.41
3109439-10943994.71395.48
4115121-11512199.630100.43
5107777-10777793.27594.05
6109396-10939694.67695.45
极限1109002-10900294.33595.502.4995.2596.432.49
2108543-10854393.93894.85
3109264-10926494.56295.48
4115815-115815100.231101.19
5110358-11035895.50896.43
6109106-10910694.42595.36
比索洛尔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(%)99.80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%
110.208404484032840268394384059840210.06
210.228411883890840040.20
单位质量响应值RSD%判断
8237.358219.570.16数据可信
供试品溶液-6030401批-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%
5min190267-9026798.53496.801.6998.5396.801.69
288959-8895997.10697.11
387570-8757095.59095.59
486337-8633794.24494.24
588877-8887797.01697.02
690038-9003898.28498.28
10min191582-9158299.96999.771.41100.1399.941.41
291258-9125899.61599.78
390311-9031198.58298.74
489653-8965397.86398.02
592687-92687101.175101.34
692926-92926101.436101.60
15min191712-91712100.111100.191.14100.44100.521.15
291605-9160599.994100.32
390790-9079099.10499.43
490586-9058698.88299.20
592972-92972101.486101.82
693044-93044101.565101.90
20min191609-9160999.998100.371.38100.50100.861.38
291962-91962100.384100.88
390769-9076999.08199.57
490489-9048998.77699.26
593359-93359101.909102.41
693486-93486102.047102.55
30min191246-9124699.602100.281.28100.27100.941.28
291505-9150599.885100.55
390962-9096299.29299.95
490797-9079799.11299.76
593132-93132101.661102.33
693533-93533102.099102.77
45min191418-9141899.790100.061.42100.62100.891.42
291215-9121599.568100.40
390769-9076999.08199.90
490162-9016298.41999.23
592871-92871101.376102.21
693579-93579102.149102.99
极限191171-9117199.52099.871.52100.52100.871.52
291287-9128799.647100.64
390327-9032798.59999.58
489901-8990198.13499.11
592946-92946101.458102.47
693341-93341101.889102.90
比索洛尔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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%) 99.90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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.811042301038091039741034621038231038600.27
213.891033421025991029700.52
单位质量响应值RSD%判断
7520.647413.251.02数据可信
供试品溶液-6030401批-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%
5min144040-4404038.24139.136.5338.2439.136.52
245633-4563339.62439.62
340774-4077435.40535.41
444186-4418638.36838.37
549719-4971943.17243.17
646050-4605039.98639.99
10min180246-8024669.68065.956.2069.7466.026.20
274691-7469164.85664.92
367990-6799059.03859.10
474899-7489965.03765.10
580964-8096470.30370.38
676938-7693866.80766.87
15min191255-9125579.23973.606.4779.4273.776.47
282787-8278771.88672.06
375840-7584065.85466.01
484702-8470273.54973.72
589702-8970277.89178.08
684266-8426673.17073.35
20min193531-9353181.21577.005.9681.5377.305.97
285761-8576174.46974.76
380197-8019769.63769.90
487807-8780776.24576.54
594294-9429481.87882.20
690485-9048578.57178.87
30min197109-9710984.32280.495.4384.7780.925.43
290233-9023378.35278.77
384275-8427573.17873.56
492550-9255080.36480.79
597987-9798785.08585.54
694013-9401381.63482.06
45min1101485-10148588.12283.105.4288.7183.665.42
293556-9355681.23781.79
387379-8737975.87476.38
496296-9629683.61684.17
5100784-10078487.51388.11
694698-9469882.22982.80
极限1107299-10729993.17190.844.2593.9191.544.26
2100819-10081987.54488.23
397783-9778384.90885.54
4105986-10598692.03092.73
5109743-10974395.29396.04
6106057-10605792.09292.80
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