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)0
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%
19.998195982026822058235082241821560.20
29.958206881936820020.12
单位质量响应值RSD%判断
8223.828241.410.16数据可信
中间条件6月-供试品溶液-2024021621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%
5min189556-8955697.70898.353.0997.7198.363.09
292179-92179100.570100.57
389557-8955797.70997.71
489002-8900297.10497.10
586263-8626394.11594.12
694331-94331102.918102.92
10min190822-9082299.08999.542.8599.2599.712.85
293467-93467101.975102.14
390129-9012998.33398.50
490234-9023498.44898.61
587761-8776195.75095.91
695021-95021103.671103.84
15min190617-9061798.86699.532.7499.1999.862.74
293033-93033101.502101.84
390725-9072598.98399.31
490010-9001098.20398.53
587891-8789195.89296.21
695064-95064103.717104.06
20min190562-9056298.80699.402.5599.3099.902.56
293397-93397101.899102.41
390600-9060098.84799.34
490059-9005998.25798.75
587855-8785595.85296.33
694186-94186102.760103.28
30min190410-9041098.64099.442.7699.30100.102.76
293296-93296101.789102.47
390463-9046398.69899.35
489890-8989098.07298.73
587919-8791995.92296.56
694886-94886103.523104.21
45min190209-9020998.42199.202.7299.24100.022.72
293156-93156101.636102.48
390316-9031698.53799.36
489667-8966797.82998.65
587701-8770195.68496.48
694475-94475103.075103.94
极限190231-9023198.44598.832.8099.4399.822.80
292773-92773101.218102.23
390088-9008898.28899.27
489185-8918597.30398.28
587090-8709095.01895.97
694141-94141102.710103.74
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)0
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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.5410013899852992329956199867997300.35
213.519977299511996420.19
单位质量响应值RSD%判断
7365.587375.430.10数据可信
中间条件6月-供试品溶液-2024021621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%
5min1106672-10667293.82090.023.6993.8290.023.68
297163-9716385.45785.46
3106824-10682493.95493.95
4101673-10167389.42489.42
5100334-10033488.24688.25
6101430-10143089.21089.21
10min1115185-115185101.30898.012.55101.4698.162.55
2107611-10761194.64694.79
3114233-114233100.470100.63
4111419-11141997.99598.14
5110087-11008796.82496.97
6110109-11010996.84396.99
15min1114610-114610100.80298.352.81101.1398.662.81
2107385-10738594.44794.75
3116177-116177102.180102.50
4111233-11123397.83298.14
5110994-11099497.62297.93
6110523-11052397.20797.52
20min1113649-11364999.95798.052.49100.4598.522.49
2108185-10818595.15195.61
3115528-115528101.609102.10
4111178-11117897.78398.26
5111367-11136797.95098.42
6108965-10896595.83796.31
30min1115317-115317101.42498.482.85102.0899.122.85
2108195-10819595.16095.78
3116247-116247102.242102.91
4110416-11041697.11397.75
5111783-11178398.31698.95
6109836-10983696.60397.23
45min1114995-114995101.14198.242.73101.9799.042.73
2107973-10797394.96595.74
3115755-115755101.809102.64
4111140-11114097.75098.55
5110168-11016896.89597.69
6110118-11011896.85197.64
极限1114623-114623100.81398.042.80101.8199.012.80
2107575-10757594.61495.55
3115736-115736101.792102.80
4110294-11029497.00697.97
5111074-11107497.69298.65
6109534-10953496.33797.29
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)0
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%
19.998171481619817608177181757817240.08
29.958222382170821960.05
单位质量响应值RSD%判断
8180.588260.900.70数据可信
中间条件6月-供试品溶液-2024021821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%
5min190629-9062999.02499.461.1999.0299.461.19
292313-92313100.864100.86
391792-91792100.295100.29
491364-9136499.82799.83
589211-8921197.47497.47
690862-9086299.27899.28
10min190880-9088099.298100.381.3599.46100.541.35
293593-93593102.262102.43
392662-92662101.245101.41
492195-92195100.735100.90
590144-9014498.49498.66
691744-91744100.242100.41
15min191287-9128799.743100.451.19100.07100.781.19
293232-93232101.868102.21
392894-92894101.499101.83
492160-92160100.697101.03
590254-9025498.61498.94
691769-91769100.269100.60
20min191060-9106099.495100.281.3699.99100.781.36
293360-93360102.008102.52
392788-92788101.383101.89
491979-91979100.499101.00
589886-8988698.21298.70
691587-91587100.071100.57
30min190762-9076299.16999.981.3099.83100.641.30
292885-92885101.489102.17
392548-92548101.121101.79
491621-91621100.108100.78
589638-8963897.94198.60
691548-91548100.028100.69
45min190797-9079799.20799.941.19100.04100.781.19
292836-92836101.435102.28
392234-92234100.777101.62
491628-91628100.115100.95
589757-8975798.07198.89
691568-91568100.050100.88
极限190156-9015698.50799.561.2799.50100.571.28
292740-92740101.330102.35
391780-91780100.281101.29
491398-9139899.864100.87
589499-8949997.78998.77
691171-9117199.616100.62
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)0
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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.549830599156986429846699180987500.41
213.519918799560993740.27
单位质量响应值RSD%判断
7293.217355.590.61数据可信
中间条件6月-供试品溶液-2024021821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%
5min1103435-10343591.54890.152.8191.5590.152.81
2103117-10311791.26691.27
397624-9762486.40486.40
4105077-10507793.00193.00
5102780-10278090.96890.97
699086-9908687.69887.70
10min1113821-113821100.74099.101.76100.8999.251.76
2112615-11261599.67399.82
3109930-10993097.29697.44
4114459-114459101.305101.46
5109914-10991497.28297.43
6111066-11106698.30298.45
15min1114737-114737101.55199.981.65101.87100.291.65
2112787-11278799.825100.14
3112455-11245599.53199.84
4115343-115343102.087102.41
5110189-11018997.52597.84
6112240-11224099.34199.65
20min1114554-114554101.38999.551.89101.88100.041.89
2112852-11285299.882100.37
3110906-11090698.16098.63
4115310-115310102.058102.55
5110016-11001697.37297.85
6111236-11123698.45298.93
30min1113586-113586100.53299.282.14101.1999.922.14
2113152-113152100.148100.80
3112152-11215299.26399.90
4115107-115107101.878102.54
5108296-10829695.85096.49
6110714-11071497.99098.63
45min1114147-114147101.02899.321.58101.85100.131.58
2112478-11247899.551100.37
3111415-11141598.61099.41
4114154-114154101.035101.87
5109602-10960297.00697.80
6111480-11148098.66899.47
极限1113826-113826100.74499.301.74101.74100.281.74
2112704-11270499.751100.74
3112064-11206499.185100.15
4114290-114290101.155102.16
5108879-10887996.36697.33
6111423-11142398.61899.58
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)0
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%
19.998195682017820138201381961819920.04
29.958199581908819520.08
单位质量响应值RSD%判断
8207.418236.380.25数据可信
中间条件6月-供试品溶液-2024022021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%
5min189573-8957397.85499.511.0697.8599.511.06
290347-9034798.70098.70
392172-92172100.694100.69
491195-9119599.62699.63
591475-9147599.93299.93
691777-91777100.262100.26
10min190319-9031998.669100.441.1198.83100.601.11
291470-9147099.927100.09
393036-93036101.637101.81
491557-91557100.022100.19
592782-92782101.360101.53
692466-92466101.015101.18
15min190277-9027798.623100.521.1998.95100.861.19
291405-9140599.856100.19
393341-93341101.971102.31
491809-91809100.297100.63
592667-92667101.234101.57
692590-92590101.150101.49
20min190182-9018298.520100.381.2299.01100.881.22
291006-9100699.42099.92
393164-93164101.777102.28
491825-91825100.314100.81
592643-92643101.208101.71
692492-92492101.043101.55
30min190333-9033398.684100.401.1399.34101.071.13
291125-9112599.550100.21
393141-93141101.752102.43
491792-91792100.278100.95
592511-92511101.064101.74
692511-92511101.064101.74
45min190053-9005398.37999.971.0499.20100.801.04
290903-9090399.307100.14
392487-92487101.038101.88
491208-9120899.640100.47
592194-92194100.718101.56
692189-92189100.712101.55
极限189817-8981798.12199.701.1999.11100.701.19
290418-9041898.77799.77
392701-92701101.271102.29
490841-9084199.239100.24
591920-91920100.418101.43
691868-91868100.361101.37
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)0
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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.549925798958993799909798652990690.29
213.519904499027990360.02
单位质量响应值RSD%判断
7316.777330.570.14数据可信
中间条件6月-供试品溶液-2024022021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%
5min1106536-10653694.30092.711.3894.3092.711.37
2103827-10382791.90291.90
3105602-10560293.47393.47
4104155-10415592.19292.19
5102656-10265690.86690.87
6105643-10564393.51093.51
10min1112746-11274699.79798.600.8099.9598.760.80
2110659-11065997.94998.10
3111093-11109398.33498.49
4110719-11071998.00398.16
5110891-11089198.15598.31
6112255-11225599.36299.52
15min1112103-11210399.22899.131.2299.5599.441.21
2112575-11257599.64599.96
3112541-11254199.61599.93
4110919-11091998.18098.50
5109970-10997097.34097.65
6113815-113815100.743101.06
20min1112904-11290499.93799.221.10100.4399.701.10
2111696-11169698.86799.35
3112244-11224499.35299.84
4110861-11086198.12898.61
5110857-11085798.12598.60
6114005-114005100.911101.40
30min1111845-11184598.99998.250.9599.6598.900.95
2110439-11043997.75598.40
3110909-11090998.17198.82
4110120-11012097.47298.12
5110033-11003397.39598.04
6112674-11267499.733100.39
45min1111729-11172998.89797.422.1499.7298.232.12
2110675-11067597.96498.77
3106887-10688794.61195.43
4110311-11031197.64198.45
5107728-10772895.35596.16
6113025-113025100.044100.87
极限1111270-11127098.49097.081.4299.4898.051.42
2109554-10955496.97197.94
3108674-10867496.19297.16
4108199-10819995.77296.74
5108471-10847196.01396.97
6111877-11187799.028100.02
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