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%
19.998258782492825468247682435825070.08
29.958247982409824440.07
单位质量响应值RSD%判断
8258.968285.830.23数据可信
加速6月-供试品溶液-2024021621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%
5min192338-92338100.25998.801.94100.2698.801.94
290600-9060098.37298.37
388932-8893296.56196.56
489628-8962897.31797.32
593705-93705101.743101.74
690783-9078398.57198.57
10min193286-93286101.28899.901.70101.46100.061.70
291683-9168399.54899.71
390304-9030498.05198.21
490490-9049098.25298.41
594285-94285102.373102.54
691993-9199399.884100.05
15min193455-93455101.47299.601.92101.8199.931.92
290703-9070398.48498.81
390429-9042998.18698.51
489835-8983597.54197.87
594207-94207102.288102.63
691760-9176099.63199.96
20min193142-93142101.13299.691.75101.64100.191.75
291253-9125399.08199.57
390137-9013797.86998.36
490376-9037698.12998.62
594230-94230102.313102.82
691756-9175699.627100.12
30min192973-92973100.94899.261.84101.6299.931.84
290300-9030098.04698.71
390062-9006297.78898.44
490046-9004697.77098.42
594002-94002102.066102.75
691146-9114698.96599.63
45min192680-92680100.63099.211.74101.47100.041.74
291005-9100598.81299.63
389848-8984897.55598.37
489844-8984497.55198.37
593810-93810101.857102.71
691061-9106198.87299.70
极限192532-92532100.47099.051.67101.48100.051.67
290776-9077698.56399.55
389693-8969397.38798.36
489727-8972797.42498.40
593474-93474101.492102.51
691171-9117198.99299.98
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%
113.541010631008571009701012471013201010910.19
213.51100428997441000860.49
单位质量响应值RSD%判断
7466.107408.290.55数据可信
加速6月-供试品溶液-2024021621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%
5min1113288-11328898.74796.603.6598.7596.603.65
2110625-11062596.42696.43
3109853-10985395.75395.75
4115762-115762100.904100.90
5103790-10379090.46890.47
6111659-11165997.32797.33
10min1115093-115093100.32098.623.42100.4998.793.42
2112195-11219597.79497.96
3113077-11307798.56398.72
4117777-117777102.660102.83
5106289-10628992.64692.80
6114444-11444499.75599.92
15min1116008-116008101.11898.503.27101.4598.823.27
2111548-11154897.23097.55
3112992-11299298.48998.81
4116043-116043101.149101.49
5106400-10640092.74393.05
6115002-115002100.241100.57
20min1115322-115322100.52098.443.49101.0298.933.49
2111413-11141397.11397.60
3112837-11283798.35498.84
4117467-117467102.390102.90
5106125-10612592.50492.96
6114454-11445499.763100.26
30min1114908-114908100.15998.163.52100.8398.823.52
2110652-11065296.44997.10
3112809-11280998.33098.98
4117030-117030102.009102.69
5105805-10580592.22592.84
6114494-11449499.798100.46
45min1115060-115060100.29297.883.56101.1398.693.56
2111510-11151097.19798.01
3111791-11179197.44298.26
4116981-116981101.966102.81
5105321-10532191.80392.57
6113067-11306798.55599.38
极限1115133-115133100.35597.583.65101.3698.563.65
2110930-11093096.69297.66
3111279-11127996.99697.97
4116261-116261101.339102.36
5104785-10478591.33692.26
6113301-11330198.75899.75
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%
19.998273882795827618263782525826910.14
29.958245582587825210.12
单位质量响应值RSD%判断
8277.388293.570.14数据可信
加速6月-供试品溶液-2024021821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%
5min191938-9193899.66799.723.0599.6799.723.05
293410-93410101.263101.26
390961-9096198.60898.61
486974-8697494.28694.29
594415-94415102.352102.35
694248-94248102.171102.17
10min193030-93030100.851100.442.95101.02100.602.95
293121-93121100.949101.12
391717-9171799.42799.59
487776-8777695.15595.31
595170-95170103.171103.34
695074-95074103.067103.24
15min192612-92612100.398100.403.03100.73100.733.03
293970-93970101.870102.21
391755-9175599.46999.80
487507-8750794.86395.18
595004-95004102.991103.33
694815-94815102.786103.13
20min192545-92545100.325100.282.88100.83100.782.88
293431-93431101.285101.79
391844-9184499.565100.06
487638-8763895.00595.48
594981-94981102.966103.48
694575-94575102.526103.04
30min192654-92654100.443100.202.96101.11100.872.96
293615-93615101.485102.16
391446-9144699.13499.80
487467-8746794.82095.45
594704-94704102.665103.35
694684-94684102.644103.33
45min192390-92390100.157100.012.89100.99100.842.89
293652-93652101.525102.37
391433-9143399.12099.95
487356-8735694.70095.49
594315-94315102.244103.10
694372-94372102.306103.16
极限192305-92305100.06599.612.90101.07100.612.90
292478-92478100.252101.27
391274-9127498.94799.94
486963-8696394.27495.22
594333-94333102.263103.29
693942-93942101.839102.87
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%
113.54100402100019100630100127997231001800.35
213.511001211002911002060.12
单位质量响应值RSD%判断
7398.827417.170.18数据可信
加速6月-供试品溶液-2024021821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%
5min1113322-11332299.16596.943.7199.1696.943.71
2109172-10917295.53395.53
3109174-10917495.53595.53
4117327-117327102.669102.67
5105345-10534592.18492.18
6110322-11032296.54096.54
10min1116149-116149101.63998.293.89101.8098.453.89
2109332-10933295.67395.83
3111048-11104897.17597.33
4118784-118784103.944104.12
5107062-10706293.68793.84
6111566-11156697.62897.79
15min1115443-115443101.02198.213.69101.3698.533.69
2110195-11019596.42896.75
3111693-11169397.73998.06
4118148-118148103.388103.73
5106289-10628993.01093.32
6111594-11159497.65397.98
20min1114738-114738100.40497.843.80100.9198.333.80
2109858-10985896.13496.61
3109847-10984796.12496.61
4118410-118410103.617104.13
5106331-10633193.04793.51
6111683-11168397.73198.22
30min1115140-115140100.75697.473.86101.4398.123.86
2109912-10991296.18196.82
3109776-10977696.06296.71
4117131-117131102.498103.19
5105033-10503391.91192.53
6111292-11129297.38898.04
45min1114797-114797100.45697.203.72101.2998.013.72
2109454-10945495.78096.58
3109556-10955695.86996.67
4116852-116852102.254103.11
5105376-10537692.21192.98
6110417-11041796.62397.43
极限1115189-115189100.79997.063.84101.8098.043.84
2107627-10762794.18195.14
3109586-10958695.89696.86
4116771-116771102.183103.21
5105890-10589092.66193.59
6110440-11044096.64397.62
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%
19.998259282647825438265682522825920.08
29.958220682208822070.01
单位质量响应值RSD%判断
8267.478262.010.05数据可信
加速6月-供试品溶液-2024022021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%
5min189777-8977797.56898.111.9697.5798.111.96
289431-8943197.19297.19
393526-93526101.643101.64
488777-8877796.48296.48
589144-8914496.88096.88
690986-9098698.88298.88
10min190850-9085098.73499.131.9598.9099.291.95
290051-9005197.86698.03
394501-94501102.702102.87
489790-8979097.58297.74
590241-9024198.07398.23
691842-9184299.81399.98
15min190854-9085498.73999.092.0199.0799.422.01
290156-9015697.98098.31
394659-94659102.874103.21
489928-8992897.73298.06
589881-8988197.68198.01
691610-9161099.56099.89
20min190742-9074298.61798.802.0299.1199.292.02
289706-8970697.49197.98
394278-94278102.460102.97
489416-8941697.17697.66
589773-8977397.56498.05
691544-9154499.48999.99
30min190992-9099298.88998.862.0799.5499.522.07
289651-8965197.43198.08
394491-94491102.691103.37
489418-8941897.17897.83
589971-8997197.77998.43
691291-9129199.21499.88
45min190281-9028198.11698.442.1098.9499.272.10
289460-8946097.22498.04
393925-93925102.076102.93
488925-8892596.64297.45
589293-8929397.04297.86
691619-9161999.570100.40
极限190725-9072598.59998.211.9999.5899.201.99
289018-8901896.74497.72
393570-93570101.691102.71
488967-8896796.68897.66
589073-8907396.80397.78
690866-9086698.75299.75
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%
113.541002751001481005901000471005391003200.24
213.519977999844998120.05
单位质量响应值RSD%判断
7409.167388.010.21数据可信
加速6月-供试品溶液-2024022021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%
5min1112141-11214198.25697.801.8898.2697.801.88
2114727-114727100.522100.52
3110575-11057596.88496.88
4109695-10969596.11396.11
5113157-11315799.14699.15
6109435-10943595.88595.89
10min1113201-11320199.18599.002.4199.3599.162.41
2116892-116892102.419102.59
3110835-11083597.11297.27
4110529-11052996.84497.00
5115558-115558101.250101.42
6110911-11091197.17997.34
15min1114059-11405999.93799.422.32100.2799.742.32
2117311-117311102.786103.12
3112363-11236398.45198.77
4110685-11068596.98097.30
5115474-115474101.177101.51
6110911-11091197.17997.50
20min1113209-11320999.19298.832.4099.6999.322.39
2116354-116354101.948102.46
3111150-11115097.38897.88
4109684-10968496.10396.59
5115512-115512101.210101.71
6110860-11086097.13497.62
30min1112939-11293998.95598.312.5599.6298.962.55
2116250-116250101.856102.54
3110540-11054096.85397.50
4109544-10954495.98196.62
5114583-114583100.396101.07
6109335-10933595.79896.44
45min1112875-11287598.89997.591.7699.7398.421.76
2111603-11160397.78598.63
3110590-11059096.89797.71
4109901-10990196.29497.10
5114301-114301100.149100.99
6109034-10903495.53496.34
极限1111294-11129497.51497.382.4098.5098.372.40
2115303-115303101.027102.04
3109952-10995296.33897.31
4109322-10932295.78696.75
5113015-11301599.022100.03
6107993-10799394.62295.59
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