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%
110.338584485983858228586685865858760.08
210.358580186060859300.22
单位质量响应值RSD%判断
8313.268302.420.10数据可信
中间条件24月-供试品溶液-2022110111批-比索洛尔-0.005mhcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min192012-9201299.47998.461.7299.4898.461.72
288800-8880096.00696.01
392140-9214099.61799.62
492976-92976100.521100.52
590204-9020497.52497.52
690281-9028197.60797.61
10min192410-9241099.90998.961.88100.0799.121.88
289029-8902996.25496.41
392636-92636100.153100.32
493765-93765101.374101.54
590560-9056097.90998.07
690803-9080398.17198.33
15min192892-92892100.43098.841.89100.7699.171.89
288910-8891096.12596.45
392198-9219899.680100.01
493488-93488101.074101.41
590492-9049297.83598.16
690573-9057397.92398.25
20min191984-9198499.44898.541.7999.9599.041.79
288825-8882596.03396.51
392141-9214199.618100.12
493316-93316100.888101.39
590233-9023397.55598.04
690376-9037697.71098.20
30min191742-9174299.18798.351.8599.8599.001.85
288520-8852095.70396.34
392018-9201899.485100.15
493214-93214100.778101.45
590077-9007797.38798.04
690214-9021497.53598.19
45min191406-9140698.82398.141.7699.6598.961.76
288545-8854595.73096.53
391784-9178499.232100.06
492984-92984100.529101.37
589929-8992997.22798.04
689976-8997697.27798.09
极限191256-9125698.66197.901.7599.6698.891.75
288211-8821195.36996.33
391545-9154598.97499.97
492669-92669100.189101.20
589699-8969996.97897.95
689955-8995597.25598.23
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%
113.701047931042261040731040531049831044260.42
213.791044721050071047400.37
单位质量响应值RSD%判断
7622.347595.360.26数据可信
中间条件24月-供试品溶液-2022110111批-氨氯地平-0.005mhcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1113197-11319796.45496.611.5296.4596.611.52
2110746-11074694.36694.37
3115441-11544198.36698.37
4112593-11259395.93995.94
5113231-11323196.48396.48
6115092-11509298.06998.07
10min1115051-11505198.03497.191.3398.1997.351.33
2111098-11109894.66694.82
3114897-11489797.90398.07
4114407-11440797.48597.65
5113964-11396497.10897.27
6114961-11496197.95798.12
15min1113998-11399897.13797.081.3497.4697.411.34
2111252-11125294.79795.11
3115121-11512198.09498.42
4115163-11516398.12998.45
5113184-11318496.44396.77
6114897-11489797.90398.23
20min1112994-11299496.28196.571.0096.7797.051.00
2111387-11138794.91295.38
3114414-11441497.49197.98
4113471-11347196.68897.17
5113251-11325196.50096.98
6114457-11445797.52898.02
30min1112531-11253195.88796.571.4196.5397.211.41
2110967-11096794.55495.19
3115108-11510898.08298.74
4114148-11414897.26497.91
5112511-11251195.87096.51
6114713-11471397.74698.40
45min1112838-11283896.14896.201.4596.9597.011.45
2110123-11012393.83594.62
3114363-11436397.44898.26
4113044-11304496.32497.13
5112365-11236595.74596.55
6114673-11467397.71298.53
极限1112364-11236495.74495.921.4696.7196.881.45
2109924-10992493.66594.61
3113066-11306696.34397.32
4113665-11366596.85397.82
5111769-11176995.23796.20
6114619-11461997.66698.64
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%
110.338573985721857118577385818857520.06
210.358582585844858340.02
单位质量响应值RSD%判断
8301.268293.140.07数据可信
中间条件24月-供试品溶液-2022110211批-比索洛尔-0.005mhcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min189815-8981597.22897.481.7097.2397.481.70
291446-9144698.99398.99
391465-9146599.01499.01
487418-8741894.63394.63
590676-9067698.16098.16
689496-8949696.88296.88
10min190190-9019097.63498.091.6897.8098.261.68
292092-9209299.69399.86
391950-9195099.53999.70
487938-8793895.19695.35
591005-9100598.51698.68
690517-9051797.98898.15
15min190141-9014197.58197.951.7097.9198.271.70
291933-9193399.52199.85
391928-9192899.51599.85
487772-8777295.01695.33
590804-9080498.29898.63
690289-9028997.74198.07
20min189904-8990497.32497.641.6597.8198.131.65
291675-9167599.24199.74
391325-9132598.86299.36
487500-8750094.72295.20
590678-9067898.16298.65
690097-9009797.53398.02
30min189571-8957196.96497.501.6897.6198.151.68
291753-9175399.32699.99
391241-9124198.77299.43
487456-8745694.67495.31
590424-9042497.88798.54
689949-8994997.37398.02
45min189471-8947196.85597.281.6297.6798.091.62
291363-9136398.90499.73
391039-9103998.55399.38
487301-8730194.50695.30
590248-9024897.69798.51
689749-8974997.15697.97
极限189250-8925096.61697.051.6697.5998.021.66
291136-9113698.65899.65
390801-9080198.29599.29
486957-8695794.13495.08
589900-8990097.32098.30
689844-8984497.25998.23
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%
113.701040231039021044431046481044501042930.31
213.791042781042731042760.01
单位质量响应值RSD%判断
7612.637561.710.48数据可信
中间条件24月-供试品溶液-2022110211批-氨氯地平-0.005mhcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1110229-11022994.19496.771.7694.1996.771.76
2113184-11318496.71996.72
3115159-11515998.40798.41
4115360-11536098.57998.58
5113777-11377797.22697.23
6111739-11173995.48595.48
10min1110209-11020994.17797.241.7894.3397.401.78
2113215-11321596.74696.91
3115666-11566698.84099.00
4115647-11564798.82498.99
5114371-11437197.73497.90
6113649-11364997.11797.28
15min1110973-11097394.83096.811.2495.1497.131.24
2113282-11328296.80397.13
3114128-11412897.52697.85
4115187-11518798.43198.76
5113172-11317296.70997.03
6112974-11297496.54096.86
20min1110458-11045894.39096.741.5994.8697.231.59
2113150-11315096.69097.17
3114540-11454097.87898.37
4115685-11568598.85799.35
5112962-11296296.53097.02
6112467-11246796.10796.59
30min1110109-11010994.09296.401.5594.7297.041.55
2112123-11212395.81396.46
3114786-11478698.08898.74
4114653-11465397.97598.63
5112514-11251496.14796.79
6112664-11266496.27596.92
45min1109699-10969993.74196.241.5394.5397.041.53
2112516-11251696.14996.95
3114408-11440897.76598.58
4114327-11432797.69698.52
5112183-11218395.86496.67
6112600-11260096.22097.02
极限1108929-10892993.08395.691.6094.0396.661.59
2111972-11197295.68496.65
3113901-11390197.33298.31
4113513-11351397.00197.98
5112276-11227695.94396.91
6111311-11131195.11996.08
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%
110.338653886542864808655286758865740.13
210.358632686455863900.11
单位质量响应值RSD%判断
8380.838346.860.29数据可信
中间条件24月-供试品溶液-2022110311批-比索洛尔-0.005mhcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min189353-8935395.95798.632.2295.9698.622.22
291652-9165298.42698.43
395103-95103102.132102.13
491227-9122797.97097.97
593167-93167100.053100.05
690524-9052497.21597.21
10min190022-9002296.67699.542.1196.8499.712.11
292053-9205398.85799.02
395702-95702102.776102.95
492119-9211998.92899.09
594056-94056101.008101.17
692204-9220499.01999.18
15min189925-8992596.57299.182.1596.8999.512.15
292086-9208698.89299.22
395477-95477102.534102.88
491895-9189598.68799.02
593713-93713100.640100.97
691009-9100997.73698.06
20min189492-8949296.10798.812.2196.5999.302.21
291888-9188898.68099.17
395439-95439102.493103.01
491619-9161998.39198.88
592843-9284399.705100.21
690762-9076297.47097.96
30min189697-8969796.32798.952.3296.9799.612.32
291589-9158998.35999.02
395222-95222102.260102.94
491535-9153598.30198.96
594194-94194101.156101.83
690602-9060297.29997.95
45min189174-8917495.76598.522.2496.5799.352.24
291511-9151198.27599.10
395032-95032102.056102.91
491275-9127598.02198.84
593023-9302399.899100.74
690438-9043897.12297.94
极限190301-9030196.97598.602.1297.9499.582.12
291107-9110797.84198.83
394709-94709101.709102.73
491051-9105197.78198.76
593730-93730100.658101.66
689962-8996296.61197.59
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(%)99.9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%
113.701044431041361035931037121043731040510.37
213.791032461036741034600.30
单位质量响应值RSD%判断
7594.967502.540.87数据可信
中间条件24月-供试品溶液-2022110311批-氨氯地平-0.005mhcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1113695-11369597.65394.671.8397.6594.661.83
2110776-11077695.14695.15
3108986-10898693.60993.61
4109884-10988494.38094.38
5110237-11023794.68394.68
6107721-10772192.52292.52
10min1114679-11467998.49896.661.2198.6696.821.21
2113661-11366197.62497.78
3111439-11143995.71595.87
4111711-11171195.94996.11
5112363-11236396.50996.67
6111357-11135795.64595.80
15min1115083-11508398.84596.772.4699.1797.092.46
2116595-116595100.144100.47
3110928-11092895.27795.59
4111041-11104195.37495.69
5113041-11304197.09197.41
6109312-10931293.88994.20
20min1114314-11431498.18596.101.5998.6896.581.59
2113099-11309997.14197.63
3111438-11143895.71596.19
4111818-11181896.04196.52
5111570-11157095.82896.31
6109059-10905993.67194.14
30min1114004-11400497.91995.912.0098.5796.551.99
2113874-11387497.80798.46
3110390-11039094.81495.45
4110139-11013994.59995.24
5112884-11288496.95797.60
6108679-10867993.34593.97
45min1112779-11277996.86695.221.6797.6896.011.67
2112749-11274996.84197.65
3109783-10978394.29395.08
4109908-10990894.40095.19
5111720-11172095.95796.76
6108203-10820392.93693.72
极限1111725-11172595.96194.611.9096.9495.571.90
2113241-11324197.26398.24
3109578-10957894.11795.07
4108734-10873493.39294.34
5110205-11020594.65695.62
6107435-10743592.27693.21
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%
110.338650186660866338660986589865980.07
210.358740087635875180.19
单位质量响应值RSD%判断
8383.168455.850.62数据可信
中间条件24月-供试品溶液-5543C0421批-比索洛尔-0.005mhcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min192723-9272398.92097.592.5698.9297.592.56
289085-8908595.03895.04
391119-9111997.20897.21
488510-8851094.42594.43
592963-9296399.17699.18
694449-94449100.761100.76
10min193258-9325899.49098.562.5499.6698.722.54
289653-8965395.64495.80
393915-93915100.191100.35
489571-8957195.55795.71
592547-9254798.73298.90
695360-95360101.733101.90
15min193233-9323399.46498.232.7599.7998.562.75
289595-8959595.58395.90
391732-9173297.86298.19
489217-8921795.17995.50
592638-9263898.82999.16
696061-96061102.481102.82
20min192872-9287299.07998.002.2599.5798.492.25
290165-9016596.19196.67
391619-9161997.74298.23
489134-8913495.09195.57
592459-9245998.63899.13
694933-94933101.277101.79
30min192729-9272998.92697.862.0399.5998.512.03
289740-8974095.73796.37
390492-9049296.53997.19
490509-9050996.55897.19
592168-9216898.32798.99
694737-94737101.068101.75
45min192597-9259798.78597.492.4399.6198.312.43
289159-8915995.11795.91
391045-9104597.12997.95
488767-8876794.69995.49
592115-9211598.27199.09
694642-94642100.967101.81
极限192431-9243198.60897.282.4899.6098.262.48
288672-8867294.59895.55
391206-9120697.30198.28
488570-8857094.48995.44
591853-9185397.99198.98
694397-94397100.705101.72
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%
113.701043321038841041821045641041331042190.25
213.791055911052651054280.22
单位质量响应值RSD%判断
7607.237645.250.36数据可信
中间条件24月-供试品溶液-5543C0421批-氨氯地平-0.005mhcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1113671-11367196.63794.853.2296.6494.853.21
2110999-11099994.36694.37
3114290-11429097.16497.16
4111150-11115094.49494.49
5104929-10492989.20589.21
6114351-11435197.21697.22
10min1114757-11475797.56196.711.9897.7296.871.99
2112011-11201195.22695.38
3115602-11560298.27998.44
4111817-11181795.06195.22
5111562-11156294.84494.99
6116810-11681099.30699.47
15min1114803-11480397.60096.682.0397.9297.002.03
2111768-11176895.02095.34
3115858-11585898.49798.82
4112465-11246595.61295.93
5110943-11094394.31894.62
6116505-11650599.04799.37
20min1114261-11426197.13996.232.2597.6396.712.25
2110310-11031093.78094.25
3116613-11661399.13999.63
4110363-11036393.82594.30
5112727-11272795.83596.30
6114885-11488597.67098.16
30min1114289-11428997.16395.083.1997.8195.723.18
2105790-10579089.93790.57
3112857-11285795.94596.60
4111632-11163294.90495.54
5110437-11043793.88894.51
6116061-11606198.66999.32
45min1115367-11536798.07996.171.9598.8996.971.95
2111011-11101194.37695.16
3115535-11553598.22299.04
4110999-11099994.36695.16
5111438-11143894.73995.52
6114347-11434797.21298.03
极限1114117-11411797.01795.642.1797.9996.602.17
2110593-11059394.02194.96
3114264-11426497.14298.12
4109808-10980893.35394.30
5110628-11062894.05094.99
6115585-11558598.26599.25
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