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%
110.098167681690816558176581694816960.06
210.128191981934819260.02
单位质量响应值RSD%判断
8096.738095.450.02数据可信
中间条件18月-供试品溶液-2022110311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%
5min188066-8806697.70399.301.9297.7099.301.92
290314-90314100.197100.20
387362-8736296.92296.92
490580-90580100.492100.49
591916-91916101.974101.97
688821-8882198.54098.54
10min188267-8826797.92699.862.1898.09100.022.18
291213-91213101.194101.36
387476-8747697.04897.21
491458-91458101.466101.63
592365-92365102.472102.64
689257-8925799.02499.19
15min188423-8842398.09999.831.9998.42100.161.99
290924-90924100.873101.21
387805-8780597.41397.74
491441-91441101.447101.78
592212-92212102.302102.64
689080-8908098.82899.16
20min188313-8831397.97799.852.3298.47100.352.31
290925-90925100.874101.38
387651-8765197.24297.73
491275-91275101.263101.77
593057-93057103.240103.75
688790-8879098.50699.00
30min188167-8816797.81599.532.0398.47100.192.03
290623-90623100.539101.21
387408-8740896.97397.62
491133-91133101.105101.78
592030-92030102.100102.78
688908-8890898.63799.29
45min188151-8815197.79799.262.0198.61100.102.01
290682-90682100.605101.44
387068-8706896.59597.40
490789-90789100.724101.57
591600-91600101.623102.48
688554-8855498.24499.07
极限187678-8767897.27298.902.0298.2599.902.02
290187-90187100.056101.06
386869-8686996.37597.34
490329-90329100.213101.22
591503-91503101.516102.54
688321-8832197.98598.97
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%
113.941035141035981034781035171034951035200.05
213.961034301034441034370.01
单位质量响应值RSD%判断
7426.117409.530.16数据可信
中间条件18月-供试品溶液-2022110311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%
5min1116100-116100101.475100.003.34101.48100.003.34
2109080-10908095.34095.34
3111489-11148997.44597.45
4117444-117444102.650102.65
5119133-119133104.126104.13
6113198-11319898.93998.94
10min1117155-117155102.397100.603.21102.57100.773.21
2110995-11099597.01397.17
3111262-11126297.24797.41
4118252-118252103.356103.53
5119515-119515104.460104.63
6113437-11343799.14899.31
15min1117378-117378102.592100.732.99102.93101.072.99
2111044-11104497.05697.38
3111953-11195397.85198.18
4117594-117594102.781103.12
5119595-119595104.530104.88
6113931-11393199.57999.91
20min1117178-117178102.417100.553.16102.93101.063.16
2110636-11063696.70097.18
3111680-11168097.61298.10
4117861-117861103.014103.53
5119517-119517104.462104.98
6113406-11340699.12199.62
30min1115833-115833101.24299.583.28101.92100.253.28
2109617-10961795.80996.45
3110228-11022896.34396.99
4117074-117074102.327103.01
5118552-118552103.618104.31
6112315-11231598.16798.83
45min1115781-115781101.19699.443.20102.05100.273.20
2109160-10916095.40996.21
3110551-11055196.62597.44
4116409-116409101.745102.60
5118379-118379103.467104.34
6112324-11232498.17599.00
极限1116024-116024101.40999.452.98102.43100.452.98
2110093-11009396.22597.19
3110479-11047996.56297.53
4115648-115648101.080102.11
5118391-118391103.478104.52
6112057-11205797.94298.93
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%
110.098207082103820678210082111820900.03
210.128235982395823770.04
单位质量响应值RSD%判断
8135.788140.020.04数据可信
中间条件18月-供试品溶液-5543C0421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%
5min187453-8745396.52497.153.3196.5297.153.31
291020-91020100.461100.46
386336-8633695.29195.29
485712-8571294.60294.60
592244-92244101.812101.81
685370-8537094.22594.22
10min188224-8822497.37598.193.2397.5498.353.24
291771-91771101.290101.46
387117-8711796.15396.31
487208-8720896.25496.41
593267-93267102.941103.11
686166-8616695.10495.26
15min188164-8816497.30998.013.3397.6398.333.33
291740-91740101.256101.59
386917-8691795.93296.25
486885-8688595.89796.22
593156-93156102.819103.16
685925-8592594.83895.15
20min187750-8775096.85297.743.3597.3498.233.35
291664-91664101.172101.68
386660-8666095.64996.13
486640-8664095.62796.10
592852-92852102.483103.00
685774-8577494.67195.14
30min187914-8791497.03397.703.3697.6898.353.36
291232-91232100.695101.37
386676-8667695.66696.30
486731-8673195.72796.36
593058-93058102.710103.39
685486-8548694.35394.98
45min187600-8760096.68697.523.2497.4998.333.24
291148-91148100.602101.44
386466-8646695.43596.23
486573-8657395.55396.35
592664-92664102.276103.13
685675-8567594.56295.35
极限187300-8730096.35597.473.3597.3298.443.35
291374-91374100.852101.86
386493-8649395.46496.42
486287-8628795.23796.19
592683-92683102.297103.32
685708-8570894.59895.54
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%
113.941037941038011038371039061037771038230.05
213.961037751038381038060.05
单位质量响应值RSD%判断
7447.857435.960.12数据可信
中间条件18月-供试品溶液-5543C0421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%
5min1104900-10490091.38994.222.9891.3994.222.98
2109669-10966995.54495.54
3109183-10918395.12195.12
4103530-10353090.19690.20
5111909-11190997.49697.50
6109715-10971595.58495.58
10min1109697-10969795.56898.152.4695.7298.312.46
2114896-114896100.098100.26
3114033-11403399.34699.50
4109317-10931795.23795.39
5115984-115984101.046101.21
6112054-11205497.62297.78
15min1109806-10980695.66398.472.6095.9798.792.60
2115512-115512100.634100.96
3114189-11418999.48299.81
4109958-10995895.79696.10
5116822-116822101.776102.11
6111906-11190697.49397.81
20min1109806-10980695.66398.322.5896.1398.802.58
2115372-115372100.513101.01
3113449-11344998.83799.33
4109985-10998595.81996.29
5116918-116918101.859102.36
6111594-11159497.22197.71
30min1109036-10903694.99397.342.4495.6297.992.44
2113609-11360998.97799.64
3112785-11278598.25998.91
4109014-10901494.97395.60
5115669-115669100.771101.44
6110270-11027096.06896.71
45min1108619-10861994.62997.432.5695.4298.242.56
2113984-11398499.303100.13
3112701-11270198.18699.00
4109364-10936495.27896.07
5115944-115944101.011101.85
6110373-11037396.15796.96
极限1108405-10840594.44397.332.6395.3998.302.63
2114081-11408199.388100.38
3112529-11252998.03699.02
4108806-10880694.79295.74
5115755-115755100.846101.85
6110718-11071896.45897.42
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%
110.098370783638837018371083752837020.05
210.128352583456834900.06
单位质量响应值RSD%判断
8295.548250.000.39数据可信
中间条件18月-供试品溶液-2022110111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%
5min191659-9165999.51897.753.2799.5297.753.27
290637-9063798.40898.41
387683-8768395.20195.20
490278-9027898.01898.02
594127-94127102.197102.20
685804-8580493.16193.16
10min193386-93386101.39398.923.63101.5699.083.63
291785-9178599.65599.82
388142-8814295.69995.86
491563-9156399.41499.58
595338-95338103.512103.68
686418-8641893.82793.98
15min193144-93144101.13098.544.04101.4698.874.04
291589-9158999.44299.77
387979-8797995.52295.84
491393-9139399.22999.56
595330-95330103.503103.85
685142-8514292.44292.75
20min192943-92943100.91298.573.61101.4299.063.61
291346-9134699.17899.67
387927-8792795.46695.94
491228-9122899.05099.54
595123-95123103.279103.79
686157-8615793.54494.01
30min192896-92896100.86198.433.64101.5399.083.65
291346-9134699.17899.84
387659-8765995.17595.81
490992-9099298.79499.45
594978-94978103.121103.81
686055-8605593.43394.05
45min192612-92612100.55298.113.59101.3998.933.59
291065-9106598.87399.70
387447-8744794.94595.74
490790-9079098.57499.40
594495-94495102.597103.46
685767-8576793.12193.90
极限192439-92439100.36597.923.63101.3798.903.63
290945-9094598.74399.73
387266-8726694.74895.70
490505-9050598.26599.25
594397-94397102.490103.52
685565-8556592.90193.83
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%
113.941050241051411050731050571051001050790.05
213.961048121046801047460.09
单位质量响应值RSD%判断
7537.957503.300.33数据可信
中间条件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%
5min1112354-11235496.85997.531.4496.8697.531.45
2114613-11461398.80798.81
3114485-11448598.69698.70
4114579-11457998.77798.78
5111798-11179896.38096.38
6110951-11095195.65095.65
10min1115958-11595899.966100.111.82100.13100.271.82
2116886-116886100.766100.93
3115936-11593699.947100.11
4119703-119703103.195103.36
5114781-11478198.95199.11
6113484-11348497.83397.99
15min1116050-116050100.04599.762.14100.37100.092.14
2115995-11599599.998100.33
3115733-11573399.772100.10
4119672-119672103.168103.50
5114922-11492299.07399.40
6111961-11196196.52096.84
20min1116044-116044100.04099.851.74100.54100.351.74
2116059-116059100.053100.55
3115920-11592099.933100.43
4119188-119188102.751103.26
5114642-11464298.83299.32
6113100-11310097.50297.99
30min1115560-11556099.62399.421.80100.28100.081.80
2115591-11559199.650100.32
3115030-11503099.16699.83
4118976-118976102.568103.25
5113901-11390198.19398.85
6112890-11289097.32197.97
45min1115246-11524699.35299.121.96100.1899.951.96
2114968-11496899.11399.94
3114736-11473698.91399.74
4118989-118989102.579103.43
5113652-11365297.97898.80
6112283-11228396.79897.61
极限1114060-11406098.33097.703.8099.3298.703.78
2114816-11481698.98299.98
3114315-11431598.55099.54
4118077-118077101.793102.81
5113557-11355797.89698.88
6105184-10518490.67891.65
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%
110.098249082551825028252182509825150.03
210.128316783161831640.01
单位质量响应值RSD%判断
8177.908217.790.35数据可信
中间条件18月-供试品溶液-2022110211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%
5min189788-8978898.37797.321.5098.3897.321.50
289719-8971998.30298.30
388659-8865997.14097.14
486280-8628094.53494.53
588917-8891797.42397.42
689593-8959398.16498.16
10min191563-91563100.32298.511.99100.4998.681.99
290843-9084399.53399.70
390055-9005598.67098.83
486590-8659094.87395.03
589485-8948598.04598.21
690946-9094699.64699.81
15min191442-91442100.18998.192.16100.5298.522.16
290807-9080799.49499.82
389638-8963898.21398.54
486138-8613894.37894.69
588914-8891497.42097.75
690777-9077799.46199.79
20min191434-91434100.18198.181.97100.6898.671.97
291011-9101199.717100.21
389877-8987798.47598.96
486493-8649394.76795.24
589006-8900697.52098.01
689829-8982998.42298.92
30min190834-9083499.52398.121.82100.1998.781.82
290608-9060899.27699.94
389675-8967598.25398.91
486482-8648294.75595.39
589241-8924197.77898.43
690481-9048199.13699.80
45min191195-9119599.91997.941.96100.7598.761.96
290622-9062299.291100.12
389376-8937697.92698.74
486310-8631094.56695.36
588697-8869797.18298.00
690141-9014198.76499.59
极限190709-9070999.38697.611.98100.3898.591.97
290243-9024398.87699.87
388911-8891197.41698.40
485832-8583294.04394.99
588861-8886197.36198.34
689962-8996298.56899.56
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%
113.941042891042821043101042871042471042830.03
213.961051701050771051240.07
单位质量响应值RSD%判断
7480.857530.370.47数据可信
中间条件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%
5min1108764-10876493.95294.562.7593.9594.562.75
2109678-10967894.74294.74
3106112-10611291.66191.66
4114688-11468899.07099.07
5110372-11037295.34195.34
6107194-10719492.59692.60
10min1114608-11460899.00097.072.4599.1697.232.45
2113141-11314197.73397.89
3109687-10968794.75094.90
4115899-115899100.116100.28
5112088-11208896.82496.98
6108837-10883794.01594.17
15min1114750-11475099.12396.802.2299.4497.122.22
2112796-11279697.43597.76
3109925-10992594.95595.27
4114890-11489099.24499.58
5110970-11097095.85896.18
6109028-10902894.18094.49
20min1115098-11509899.42496.842.7799.9197.322.76
2113428-11342897.98198.46
3110509-11050995.46095.93
4115119-11511999.44299.94
5111378-11137896.21096.69
6107097-10709792.51292.98
30min1114037-11403798.50796.252.3499.1696.892.34
2112647-11264797.30797.95
3109779-10977994.82995.46
4114266-11426698.70599.37
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