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%
110.078370283633837888360683380836220.19
210.068394483888839160.05
单位质量响应值RSD%判断
8304.078341.550.32数据可信
加速3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%
5min190197-9019797.34197.640.5297.3497.640.52
290765-9076597.95497.95
390386-9038697.54597.55
491262-9126298.49198.49
589967-8996797.09397.09
690270-9027097.42097.42
10min191219-9121998.44498.951.0898.6199.111.08
292171-9217199.47299.63
391357-9135798.59398.76
491759-9175999.02799.19
593270-93270100.658100.82
690346-9034697.50297.66
15min191166-9116698.38798.751.0898.7199.071.09
291909-9190999.18999.52
390664-9066497.84598.17
491520-9152098.76999.10
593213-93213100.596100.93
690520-9052097.69098.01
20min191295-9129598.52698.721.1099.0299.211.10
291784-9178499.05499.55
390783-9078397.97498.46
491587-9158798.84199.34
593155-93155100.534101.03
690223-9022397.36997.86
30min190944-9094498.14898.371.0598.8099.031.05
291659-9165998.91999.58
390695-9069597.87998.53
491326-9132698.56099.22
592559-9255999.890100.56
689739-8973996.84797.50
45min190611-9061197.78898.311.3898.6199.131.37
291070-9107098.28399.11
390151-9015197.29298.11
491421-9142198.66299.49
593376-93376100.772101.60
689914-8991497.03697.85
极限190495-9049597.66397.751.2098.6498.741.20
291113-9111398.33099.32
389873-8987396.99297.97
490819-9081998.01399.00
592176-9217699.477100.48
688999-8899996.04897.02
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%
113.851032221032331028071029051023141028960.37
213.971030061026901028480.22
单位质量响应值RSD%判断
7429.317362.060.65数据可信
加速3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%
5min1109123-10912395.65196.762.1895.6596.762.18
2106602-10660293.44193.44
3112392-11239298.51798.52
4110433-11043396.79996.80
5113364-11336499.36999.37
6110419-11041996.78796.79
10min1112098-11209898.25999.771.8098.4299.941.80
2110527-11052796.88297.04
3115762-115762101.470101.63
4115151-115151100.935101.10
5114793-114793100.621100.79
6114634-114634100.482100.64
15min1112085-11208598.247100.222.3098.57100.552.30
2110644-11064496.98497.30
3114996-114996100.799101.13
4114820-114820100.645100.97
5118034-118034103.462103.80
6115454-115454101.200101.53
20min1112482-11248298.595100.011.8899.08100.501.88
2110534-11053496.88897.37
3115089-115089100.881101.38
4115244-115244101.016101.51
5116234-116234101.884102.39
6114986-114986100.790101.29
30min1112445-11244598.563100.011.5899.21100.671.58
2111475-11147597.71398.35
3115070-115070100.864101.53
4115239-115239101.012101.68
5116148-116148101.809102.48
6114226-114226100.124100.79
45min1112252-11225298.39499.601.6499.21100.431.64
2110807-11080797.12797.93
3114852-114852100.673101.51
4113532-11353299.516100.35
5115920-115920101.609102.45
6114413-114413100.288101.12
极限1111960-11196098.13899.451.8299.12100.441.83
2110291-11029196.67597.64
3115114-115114100.902101.91
4114218-114218100.117101.12
5115842-115842101.541102.56
6113290-11329099.304100.30
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%
110.078358283488834408357783481835140.08
210.068323883300832690.06
单位质量响应值RSD%判断
8293.358277.240.14数据可信
加速3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%
5min192889-92889100.70099.952.35100.7099.952.36
294142-94142102.058102.06
388286-8828695.71095.71
494114-94114102.028102.03
591947-9194799.67999.68
691786-9178699.50499.50
10min192983-92983100.802100.492.32100.97100.662.32
294775-94775102.745102.91
388858-8885896.33096.49
494633-94633102.591102.76
592547-92547100.329100.50
692376-92376100.144100.31
15min193031-93031100.854100.452.38101.19100.792.38
294859-94859102.836103.18
388790-8879096.25696.58
494668-94668102.629102.97
592374-92374100.142100.48
692235-9223599.991100.32
20min193095-93095100.923100.312.28101.43100.812.28
294721-94721102.686103.20
388680-8868096.13796.62
494015-94015101.921102.43
592353-92353100.119100.62
692292-92292100.053100.55
30min192495-92495100.27399.982.46100.95100.652.46
294506-94506102.453103.14
388236-8823695.65696.30
494281-94281102.209102.89
592060-9206099.801100.47
691767-9176799.484100.15
45min192539-92539100.32199.782.33101.16100.612.33
293991-93991101.895102.75
388151-8815195.56496.36
493921-93921101.819102.67
591553-9155399.252100.09
692078-9207899.821100.65
极限192443-92443100.21799.712.22101.22100.712.22
294053-94053101.962102.99
388388-8838895.82196.78
493739-93739101.622102.64
591727-9172799.440100.44
691519-9151999.215100.21
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)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%
113.851031301031521027761033711030821031020.21
213.971027731028411028070.05
单位质量响应值RSD%判断
7444.197359.130.82数据可信
加速3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%
5min1116396-116396101.945100.182.87101.95100.182.87
2119192-119192104.394104.39
3112705-11270598.71298.71
4112526-11252698.55698.56
5109994-10999496.33896.34
6115462-115462101.127101.13
10min1119025-119025104.248101.903.17104.42102.073.17
2121066-121066106.035106.21
3114542-114542100.321100.49
4116010-116010101.607101.77
5110467-11046796.75296.91
6116946-116946102.427102.60
15min1117907-117907103.269101.053.23103.61101.393.23
2120654-120654105.675106.03
3113594-11359499.49199.82
4114440-114440100.232100.57
5109844-10984496.20796.53
6115835-115835101.454101.79
20min1117936-117936103.294101.083.22103.81101.583.22
2119973-119973105.078105.60
3114273-114273100.086100.58
4114358-114358100.160100.66
5109273-10927395.70796.19
6116618-116618102.140102.65
30min1117808-117808103.182100.753.37103.87101.433.37
2120548-120548105.582106.28
3113343-11334399.27199.94
4114188-114188100.011100.68
5109263-10926395.69896.34
6115068-115068100.782101.46
45min1117375-117375102.803100.483.07103.66101.323.07
2119509-119509104.672105.55
3112811-11281198.80599.64
4113678-11367899.565100.40
5109554-10955495.95396.75
6115432-115432101.101101.95
极限1116679-116679102.193100.793.08103.22101.803.08
2119884-119884105.000106.05
3113910-11391099.768100.76
4114718-114718100.476101.48
5109218-10921895.65896.62
6116063-116063101.654102.67
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%
110.078338283362833198349583329833770.09
210.068355583618835860.06
单位质量响应值RSD%判断
8279.748308.750.25数据可信
加速3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%
5min190347-9034797.839100.082.4097.84100.082.40
291089-9108998.64298.64
394874-94874102.741102.74
492170-9217099.81399.81
595422-95422103.335103.33
690586-9058698.09898.10
10min191216-9121698.780100.702.5298.94100.862.53
291650-9165099.25099.41
395499-95499103.418103.59
492373-92373100.033100.20
596336-96336104.324104.50
690839-9083998.37298.54
15min191137-9113798.694100.482.4699.02100.822.47
291155-9115598.71499.04
395467-95467103.383103.73
492615-92615100.295100.63
595735-95735103.674104.02
690611-9061198.12598.45
20min190576-9057698.087100.382.3998.58100.882.39
291409-9140998.98999.48
395147-95147103.037103.55
492306-9230699.960100.46
595724-95724103.662104.18
690977-9097798.52199.01
30min190146-9014697.621100.242.4098.28100.912.40
291395-9139598.97499.63
394752-94752102.609103.30
492555-92555100.230100.90
595667-95667103.600104.29
690869-9086998.40499.06
45min190382-9038297.877100.062.3398.70100.902.33
291603-9160399.199100.02
394465-94465102.298103.16
492095-9209599.732100.57
595524-95524103.445104.31
690332-9033297.82398.64
极限190117-9011797.59099.712.4298.57100.712.42
290526-9052698.03399.02
394329-94329102.151103.18
492178-9217899.822100.82
595180-95180103.073104.11
690112-9011297.58498.57
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%
113.851023561020801024181027551025681024350.25
213.971023251024731023990.11
单位质量响应值RSD%判断
7396.037329.920.64数据可信
加速3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%
5min1111596-11159698.25398.721.4798.2598.721.47
2113952-113952100.328100.33
3109802-10980296.67496.67
4111917-11191798.53698.54
5111367-11136798.05298.05
6114094-114094100.453100.45
10min1112902-11290299.40399.791.6999.5799.961.69
2114746-114746101.027101.19
3110845-11084597.59297.75
4112970-11297099.46399.63
5112302-11230298.87599.04
6116293-116293102.389102.56
15min1112092-11209298.69099.741.7699.02100.081.76
2115484-115484101.676102.01
3111100-11110097.81798.14
4112407-11240798.96799.30
5112622-11262299.15799.48
6116034-116034102.161102.50
20min1111149-11114997.86099.452.1198.3599.952.11
2115572-115572101.754102.26
3110438-11043897.23497.72
4112669-11266999.19899.69
5111745-11174598.38598.88
6116161-116161102.273102.78
30min1111283-11128397.97899.382.1398.63100.042.13
2115708-115708101.874102.55
3109757-10975796.63497.28
4113136-11313699.609100.27
5111791-11179198.42599.08
6115582-115582101.763102.44
45min1110823-11082397.57398.812.2098.3999.632.20
2115006-115006101.256102.10
3108814-10881495.80496.61
4112372-11237298.93799.76
5111247-11124797.94698.77
6115075-115075101.316102.16
极限1111319-11131998.00998.882.0098.9999.872.00
2114555-114555100.859101.87
3109320-10932096.24997.22
4112260-11226098.83899.83
5111121-11112197.83598.82
6115251-115251101.471102.49
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