苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405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10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.379051490331903849041790488904270.09
214.359029489957901260.27
单位质量响应值RSD%判断
6292.766280.560.14数据可信
供试品溶液-2024121111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%
5min185610-8561095.54694.860.9995.5594.860.99
283778-8377893.50293.50
385146-8514695.02895.03
484787-8478794.62894.63
586154-8615496.15396.15
684476-8447694.28194.28
10min187104-8710497.21497.361.3598.1798.311.35
285031-8503194.90095.83
388008-8800898.22299.17
487175-8717597.29398.24
588291-8829198.53899.50
687793-8779397.98398.93
15min185790-8579095.74797.461.5597.6799.381.54
285831-8583195.79397.68
388988-8898899.316101.25
487025-8702597.12599.04
588549-8854998.826100.77
687756-8775697.94199.86
20min185722-8572295.67195.860.6298.5698.760.61
285284-8528495.18298.02
385317-8531795.21998.14
486430-8643096.46199.35
586211-8621196.21799.15
686402-8640296.43099.33
30min183926-8392693.66794.451.4797.5198.311.44
282999-8299992.63296.43
385397-8539795.30899.19
483726-8372693.44497.30
586077-8607796.06799.96
685642-8564295.58299.45
45min182804-8280492.41493.600.8697.1998.400.86
283231-8323192.89197.61
384154-8415493.92198.75
483900-8390093.63898.43
584551-8455194.36499.22
684560-8456094.37499.20
60min181785-8178591.27792.000.6096.9897.740.61
281884-8188491.38897.04
382974-8297492.60498.37
482678-8267892.27498.00
582761-8276192.36798.17
682506-8250692.08297.85
极限180536-8053689.88390.251.0496.5096.910.99
280060-8006089.35295.91
381387-8138790.83397.53
481313-8131390.75097.40
579901-7990189.17595.90
682013-8201391.53298.22
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405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10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.378986989859900028985089973899110.08
214.358992089997899580.07
单位质量响应值RSD%判断
6256.856268.850.14数据可信
供试品溶液-2024121111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%
5min185129-8512995.37195.310.5595.3795.310.55
284916-8491695.13295.13
385495-8549595.78195.78
485723-8572396.03696.04
584561-8456194.73494.73
684640-8464094.82394.82
10min186415-8641596.81198.091.7697.7699.041.74
290353-90353101.223102.17
387838-8783898.40599.36
487126-8712697.60898.57
586022-8602296.37197.32
687576-8757698.11299.06
15min185761-8576196.07997.601.1198.0099.541.10
287979-8797998.563100.53
387853-8785398.422100.36
486105-8610596.46498.40
587243-8724397.73999.65
687798-8779898.361100.29
20min185266-8526695.52496.270.6698.4199.180.65
285649-8564995.95398.90
386947-8694797.407100.33
485811-8581196.13599.04
585840-8584096.16799.06
686090-8609096.44799.36
30min183580-8358093.63594.981.3297.4798.851.28
284574-8457494.74998.66
385876-8587696.207100.11
483380-8338093.41197.27
585437-8543795.71699.57
685829-8582996.155100.03
45min184878-8487895.08994.200.6099.8699.020.56
283935-8393594.03398.89
384375-8437594.52699.39
483424-8342493.46098.26
583834-8383493.92098.73
684059-8405994.17299.01
60min181952-8195291.81192.160.3997.5497.920.39
282559-8255992.49198.29
382081-8208191.95697.76
482050-8205091.92197.65
582178-8217892.06497.81
682737-8273792.69198.47
极限180186-8018689.83390.460.7896.4897.150.75
281046-8104690.79697.52
380821-8082190.54497.27
480758-8075890.47497.12
579963-7996389.58396.25
681709-8170991.53998.25
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405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10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.378981789971900339010389942899730.12
214.358996490102900330.11
单位质量响应值RSD%判断
6261.176274.080.15数据可信
供试品溶液-2024121611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%
5min185273-8527395.45994.541.4595.4694.541.45
282589-8258992.45592.45
383925-8392593.95093.95
486167-8616796.46096.46
584540-8454094.63994.64
684195-8419594.25294.25
10min186486-8648696.81796.820.9597.7797.760.94
286409-8640996.73197.66
385416-8541695.61996.56
487555-8755598.01498.98
585806-8580696.05697.00
687239-8723997.66098.60
15min186978-8697897.36896.631.4699.2998.551.45
286359-8635996.67598.57
384730-8473094.85196.75
486958-8695897.34599.29
584942-8494295.08997.00
687950-8795098.456100.38
20min185813-8581396.06495.511.4498.9698.391.41
286831-8683197.203100.06
383376-8337693.33696.18
485299-8529995.48898.41
584530-8453094.62797.49
686060-8606096.34099.24
30min183781-8378193.78994.361.8997.6598.201.85
285991-8599196.263100.09
382961-8296192.87196.65
485298-8529895.48799.36
582084-8208491.88995.69
685657-8565795.88999.76
45min183313-8331393.26593.991.4398.0698.771.37
286169-8616996.462101.26
383572-8357293.55598.26
484467-8446794.55799.38
583047-8304792.96797.69
683204-8320493.14397.97
60min183437-8343793.40492.341.4599.1398.061.40
284235-8423594.297100.06
381216-8121690.91896.56
482002-8200291.79797.57
581376-8137691.09796.75
682632-8263292.50398.26
极限181351-8135191.06991.171.3297.7397.811.29
282653-8265392.52699.23
379770-7977089.29995.85
482345-8234592.18198.87
580734-8073490.37896.94
681779-8177991.54898.23
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405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10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.379000689991900908989890119900210.10
214.359032790108902180.18
单位质量响应值RSD%判断
6264.516286.970.26数据可信
供试品溶液-2024121611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%
5min184588-8458894.57094.890.9594.5794.890.95
285588-8558895.68895.69
385308-8530895.37595.38
485783-8578395.90695.91
583881-8388193.78093.78
684090-8409094.01394.01
10min186856-8685697.10696.800.4798.0597.750.47
285831-8583195.96096.92
386812-8681297.05698.01
486891-8689197.14598.10
586700-8670096.93197.87
686418-8641896.61697.56
15min186590-8659096.80897.120.6598.7399.040.63
287132-8713297.41499.33
386397-8639796.59398.52
487087-8708797.36499.29
586250-8625096.42898.34
687753-8775398.109100.01
20min186335-8633596.52395.690.9199.4198.580.89
284375-8437594.33297.22
385745-8574595.86498.75
485668-8566895.77798.68
586401-8640196.59799.47
685031-8503195.06597.95
30min184983-8498395.01295.010.9798.8698.850.94
284880-8488094.89798.73
384012-8401293.92697.77
486251-8625196.429100.29
584247-8424794.18998.03
685496-8549695.58599.42
45min184753-8475394.75594.040.9399.5598.830.88
284573-8457394.55399.34
382844-8284492.62097.41
484041-8404193.95898.78
584836-8483694.84799.63
683616-8361693.48398.28
60min183965-8396593.87492.151.0699.6297.881.01
281295-8129590.88896.62
382033-8203391.71497.43
482373-8237392.09497.86
582477-8247792.21097.94
682382-8238292.10497.83
极限182728-8272892.49191.241.0099.1897.900.95
280868-8086890.41197.05
381268-8126890.85897.49
482375-8237592.09698.78
581699-8169991.34097.99
680734-8073490.26196.91
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405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10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.378987490096900108991790073899940.11
214.359003590163900990.11
单位质量响应值RSD%判断
6262.636278.680.19数据可信
供试品溶液-2024122311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%
5min182840-8284092.69193.683.3292.6993.683.32
280320-8032089.87189.87
387006-8700697.35297.35
485448-8544895.60995.61
580907-8090790.52890.53
685829-8582996.03596.04
10min185096-8509695.21596.661.4696.1497.601.45
286070-8607096.30597.20
387461-8746197.86198.83
484777-8477794.85895.81
587588-8758898.00398.91
687343-8734397.72998.69
15min183951-8395193.93495.141.2095.8197.041.19
285029-8502995.14097.00
386743-8674397.05899.01
484190-8419094.20196.11
585519-8551995.68897.57
684723-8472394.79896.74
20min184414-8441494.45294.221.2497.2797.071.22
284501-8450194.54997.36
386006-8600696.23399.16
483425-8342593.34596.19
583102-8310292.98495.83
683772-8377293.73496.62
30min182087-8208791.84892.911.0395.6196.700.97
284428-8442894.46898.23
382509-8250992.32096.21
483625-8362593.56997.35
582881-8288192.73796.51
682670-8267092.50196.32
45min179985-7998589.49691.061.4394.1895.791.37
283423-8342393.34398.05
381693-8169391.40796.22
480761-8076190.36595.08
581417-8141791.09995.80
681023-8102390.65895.41
60min179916-7991689.41990.261.3195.0095.901.27
282053-8205391.81097.45
381739-8173991.45997.18
479762-7976289.24794.87
579655-7965589.12794.74
680900-8090090.52096.17
极限178318-7831887.63187.950.5494.1094.490.54
278950-7895088.33894.89
378768-7876888.13594.77
477886-7788687.14893.66
578761-7876188.12794.63
678944-7894488.33194.89
苯磺酸左氨氯地平片项目信息
介质体积(ml)500取样体积(ml) 5补液体积(ml)5
对照品批号100546-202405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10000
标示量(mg)2.5供试品稀释倍数5系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.379040790487903389055790319904220.12
214.359048990572905300.07
单位质量响应值RSD%判断
6292.416308.710.19数据可信
供试品溶液-2024122311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%
5min187141-8714197.04093.503.1497.0493.503.14
283296-8329692.75992.76
382220-8222091.56091.56
480294-8029489.41689.42
584077-8407793.62893.63
686724-8672496.57696.58
10min187780-8778097.75296.281.0198.7297.221.02
286698-8669896.54797.47
385977-8597795.74496.66
486340-8634096.14897.04
585190-8519094.86895.80
686787-8678796.64697.61
15min185261-8526194.94794.720.6296.8996.610.62
284686-8468694.30696.20
384717-8471794.34196.21
485470-8547095.18097.04
584428-8442894.01995.90
685761-8576195.50497.44
20min185956-8595695.72194.640.8698.6297.480.87
285521-8552195.23698.07
384434-8443494.02696.84
484045-8404593.59396.40
584641-8464194.25697.08
685300-8530094.99097.88
30min182872-8287292.28692.510.7996.1496.300.75
282573-8257391.95395.74
382840-8284092.25196.01
484311-8431193.88997.63
582597-8259791.98095.75
683231-8323192.68696.52
45min181229-8122990.45790.670.8995.2395.390.83
280684-8068489.85094.56
381828-8182891.12495.80
482589-8258991.97196.65
580746-8074689.91994.61
681472-8147290.72795.49
60min181306-8130690.54289.720.8296.2295.340.80
280354-8035489.48295.09
380161-8016189.26794.86
481070-8107090.28095.88
579567-7956788.60694.19
680945-8094590.14095.81
极限179191-7919188.18787.670.6694.7794.190.64
279030-7903088.00894.51
378948-7894887.91794.40
478773-7877387.72294.23
577748-7774886.58093.05
678669-7866987.60694.18
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