富马酸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10071-202203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%
110.098735487941878238761887730876930.26
210.128200282098820500.09
单位质量响应值RSD%判断
8691.088107.714.92数据不可信!(响应值差异过大,请重新称样测定!)
长期18月-供试品溶液-2022110111批-富马酸比索洛尔-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%
5min181557-8155787.31987.764.8487.3287.764.84
274352-7435279.60579.61
385128-8512891.14391.14
483902-8390289.83089.83
582359-8235988.17888.18
684509-8450990.48090.48
10min184821-8482190.81494.162.7690.9694.302.76
286163-8616392.25192.38
391428-9142897.88898.04
489310-8931095.62095.77
586873-8687393.01193.16
689076-8907695.37095.52
15min191471-9147197.93496.571.5098.2396.871.49
289402-8940295.71996.01
391709-9170998.18998.50
490726-9072697.13697.45
588224-8822494.45794.76
689631-8963195.96496.27
20min192035-9203598.53896.721.5099.0097.181.50
289767-8976796.10996.56
391566-9156698.03698.51
490734-9073497.14597.62
588462-8846294.71295.17
689460-8946095.78196.25
30min190751-9075197.16396.271.7297.7996.901.71
290009-9000996.36996.97
392147-9214798.65899.30
490179-9017996.55197.18
587831-8783194.03794.65
688600-8860094.86095.49
45min191090-9109097.52695.541.9798.3196.321.96
289391-8939195.70796.47
391469-9146997.93298.74
487554-8755493.74094.53
587309-8730993.47894.25
688580-8858094.83995.63
极限188049-8804994.27095.401.5995.2296.341.58
289177-8917795.47896.40
391484-9148497.94898.92
489778-8977896.12197.07
587551-8755193.73794.67
688561-8856194.81895.76
富马酸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(%)99.9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%
113.941031351032131032531032961030721031940.09
213.961033161032721032940.04
单位质量响应值RSD%判断
7402.737399.280.04数据可信
长期18月-供试品溶液-2022110111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%
5min181906-8190671.75174.356.7171.7574.356.71
275241-7524165.91265.91
385187-8518774.62574.63
486543-8654375.81375.81
589400-8940078.31678.32
690935-9093579.66179.66
10min185493-8549374.89381.977.1475.0182.107.13
285576-8557674.96675.08
394618-9461882.88783.01
495775-9577583.90184.03
598362-9836286.16786.30
6101604-10160489.00789.14
15min196029-9602984.12387.325.6084.3787.585.60
290968-9096879.69079.92
399186-9918686.88987.15
4101658-10165889.05489.32
5103790-10379090.92291.20
6106404-10640493.21293.49
20min1101279-10127988.72290.894.7489.1191.304.75
296002-9600284.09984.47
3102568-10256889.85190.26
4105189-10518992.14792.56
5107935-10793594.55394.98
6109553-10955395.97096.41
30min1106688-10668893.46194.853.0993.9995.413.10
2103206-10320690.41090.92
3107870-10787094.49695.05
4108110-10811094.70695.27
5111191-11119197.40597.99
6112600-11260098.64099.24
45min1111495-11149597.67297.041.5698.3697.761.56
2110486-11048696.78897.45
3110125-11012596.47197.19
4108043-10804394.64895.37
5111274-11127497.47898.22
6113239-11323999.19999.96
极限1107504-10750494.17597.201.6595.0398.081.65
2112206-11220698.29499.11
3110735-11073597.00697.88
4111141-11114197.36198.25
5111527-11152797.70098.61
6112640-11264098.67599.60
富马酸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10071-202203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%
110.098283982828828798268682779828020.09
210.128224482308822760.06
单位质量响应值RSD%判断
8206.348130.040.67数据可信
长期18月-供试品溶液-2022110211批-富马酸比索洛尔-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%
5min181766-8176689.91490.911.9889.9190.911.97
280770-8077088.81988.82
382338-8233890.54390.54
481835-8183589.99089.99
584885-8488593.34493.34
684436-8443692.85192.85
10min187154-8715495.83997.551.2495.9997.701.24
288228-8822897.02097.17
388603-8860397.43397.58
488800-8880097.64997.80
588971-8897197.83797.99
690515-9051599.53599.69
15min188013-8801396.78498.401.4197.0998.711.40
288189-8818996.97897.29
389599-8959998.52898.84
489874-8987498.83099.14
589784-8978498.73199.05
691423-91423100.534100.85
20min187965-8796596.73198.701.1697.2099.181.16
289803-8980398.75299.22
389668-8966898.60499.08
490081-9008199.05899.54
589813-8981398.76399.25
691190-91190100.278100.77
30min187638-8763896.37298.621.5997.0099.271.59
289582-8958298.50999.15
389353-8935398.25898.90
489664-8966498.60099.24
589773-8977398.71999.37
692102-92102101.280101.94
45min187158-8715895.84498.201.4996.6499.011.49
289447-8944798.36199.16
388966-8896697.83298.64
489960-8996098.92599.73
589098-8909897.97798.79
691197-91197100.285101.11
极限187138-8713895.82297.961.2796.7798.921.27
289401-8940198.31099.27
388839-8883997.69298.66
489097-8909797.97698.95
589395-8939598.30499.28
690601-9060199.630100.62
富马酸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(%)99.9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%
113.941037701036671037001034851035541036350.12
213.961034131035081034600.07
单位质量响应值RSD%判断
7434.367411.170.23数据可信
长期18月-供试品溶液-2022110211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%
5min182968-8296872.46975.284.0972.4775.284.09
281291-8129171.00471.00
388443-8844377.25177.25
488025-8802576.88676.89
590540-9054079.08279.08
685856-8585674.99174.99
10min192466-9246680.76583.793.2280.8983.913.22
292582-9258280.86680.98
398829-9882986.32286.45
497955-9795585.55985.69
599094-9909486.55486.69
694626-9462682.65182.78
15min199956-9995687.30789.203.1687.5689.463.17
296972-9697284.70084.95
3105299-10529991.97492.25
4104704-10470491.45491.72
5104090-10409090.91891.19
6101697-10169788.82789.09
20min1104444-10444491.22793.232.2591.6393.642.26
2104091-10409190.91891.31
3109114-10911495.30695.73
4109755-10975595.86696.29
5107419-10741993.82594.25
6105588-10558892.22692.64
30min1109891-10989195.98497.692.2396.5498.262.23
2109704-10970495.82196.37
3114885-114885100.346100.93
4114769-114769100.245100.83
5112122-11212297.93398.52
6109663-10966395.78596.35
45min1110840-11084096.81398.982.5297.5399.712.51
2112300-11230098.08998.79
3116703-116703101.934102.69
4117007-117007102.200102.95
5112514-11251498.27599.02
6110561-11056196.57097.29
极限1111164-11116497.09698.942.3297.9799.842.32
2112459-11245998.22799.10
3116255-116255101.543102.46
4116703-116703101.934102.85
5112691-11269198.43099.34
6110398-11039896.42797.31
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