依折麦布匹伐他汀钙片项目信息
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101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.421247511245771248261248681249541247950.12
210.491261431260381260900.06
单位质量响应值RSD%判断
11976.4912020.020.26数据可信
长期3月-供试品溶液-2024061321批-依折麦布-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1131432-13143294.94188.1810.2094.9488.1810.20
2131783-13178395.19495.19
3126151-12615191.12691.13
4128692-12869292.96292.96
5113890-11389082.26982.27
6100521-10052172.61272.61
10min1138007-13800799.69097.103.3199.8597.253.32
2138833-138833100.287100.45
3134994-13499497.51497.67
4136162-13616298.35898.51
5127001-12700191.74091.88
6131553-13155395.02895.15
15min1138332-13833299.92598.372.56100.2598.682.56
2140797-140797101.706102.03
3135629-13562997.97398.29
4136706-13670698.75199.07
5130457-13045794.23794.53
6135131-13513197.61397.89
20min1138076-13807699.74098.182.58100.2398.652.58
2141031-141031101.875102.37
3134744-13474497.33397.81
4135814-13581498.10698.59
5130588-13058894.33194.78
6135220-13522097.67798.12
30min1138226-13822699.84998.272.55100.5198.912.55
2141152-141152101.962102.63
3134865-13486597.42198.06
4135811-13581198.10498.75
5130843-13084394.51595.12
6135375-13537597.78998.39
45min1137266-13726699.15598.052.4899.9898.852.48
2141144-141144101.956102.79
3134508-13450897.16397.97
4135427-13542797.82798.64
5130971-13097194.60895.37
6135070-13507097.56998.34
60min1137439-13743999.28097.882.38100.2798.852.39
2140534-140534101.516102.52
3134804-13480497.37798.34
4134937-13493797.47398.45
5130951-13095194.59395.51
6134361-13436197.05797.99
极限1137176-13717699.09097.832.38100.2498.962.38
2140410-140410101.426102.60
3134225-13422596.95898.08
4134769-13476997.35198.49
5130759-13075994.45595.53
6135279-13527997.72098.81
依折麦布匹伐他汀钙片项目信息
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ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.923661803665473655343644183651273655610.24
211.013664443667173665800.06
单位质量响应值RSD%判断
33476.2833295.190.39数据可信
长期3月-供试品溶液-2024061321批-匹伐他汀钙-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min176899-7689920.73019.3537.6220.7319.3537.62
271202-7120219.19519.19
3110845-11084529.88129.88
487929-8792923.70423.70
536724-367249.9009.90
647182-4718212.71912.72
10min1254601-25460168.63558.9821.2968.6759.0121.30
2205264-20526455.33555.37
3269423-26942372.63172.68
4250507-25050767.53167.57
5153751-15375141.44841.46
6179137-17913748.29148.31
15min1327780-32778088.36283.718.2088.5183.848.22
2307890-30789083.00083.12
3334251-33425190.10790.28
4330334-33033489.05189.20
5269553-26955372.66672.75
6293294-29329479.06679.17
20min1356452-35645296.09293.303.9796.3993.574.00
2343583-34358392.62292.89
3356389-35638996.07596.40
4356615-35661596.13696.44
5321775-32177586.74486.95
6341658-34165892.10492.34
30min1374016-374016100.827100.261.51101.28100.681.54
2370110-37011099.774100.19
3375465-375465101.217101.70
4377946-377946101.886102.35
5361965-36196597.57897.93
6371906-371906100.258100.64
45min1384253-384253103.586103.430.54104.21104.020.57
2382422-382422103.093103.68
3382881-382881103.216103.87
4386675-386675104.239104.87
5380849-380849102.669103.18
6384978-384978103.782104.34
60min1387896-387896104.568104.360.54105.37105.130.55
2386222-386222104.117104.87
3384757-384757103.722104.54
4390589-390589105.294106.10
5385707-385707103.978104.66
6387604-387604104.490105.22
极限1385643-385643103.961104.210.67104.93105.140.65
2384949-384949103.774104.70
3382857-382857103.210104.20
4390142-390142105.174106.15
5388098-388098104.623105.48
6387630-387630104.497105.40
依折麦布匹伐他汀钙片项目信息
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101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.421256711260851255641256141255281256920.18
210.491269051267441268240.09
单位质量响应值RSD%判断
12062.5712089.990.17数据可信
加速3月-供试品溶液-2024061321批-依折麦布-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1112891-11289181.02187.915.5981.0287.915.59
2116756-11675683.79483.79
3120550-12055086.51786.52
4128518-12851892.23692.24
5129780-12978093.14293.14
6126422-12642290.73290.73
10min1127775-12777591.70396.843.2591.8496.993.25
2132677-13267795.22195.36
3138195-13819599.18199.33
4137709-13770998.83298.99
5139389-139389100.038100.19
6133879-13387996.08396.23
15min1129820-12982093.17097.302.7293.4697.602.72
2134180-13418096.29996.60
3139062-13906299.803100.11
4136865-13686598.22698.54
5139592-139592100.184100.51
6133891-13389196.09296.40
20min1130451-13045193.62397.532.6094.0798.012.60
2134918-13491896.82997.29
3139257-13925799.943100.42
4137282-13728298.52699.01
5139653-139653100.227100.72
6133842-13384296.05796.53
30min1130171-13017193.42297.432.6894.0298.072.68
2134947-13494796.85097.47
3139196-13919699.899100.54
4137026-13702698.34298.99
5139723-139723100.278100.93
6133508-13350895.81796.45
45min1129331-12933192.81997.172.8693.5797.972.87
2134734-13473496.69797.48
3139238-13923899.930100.74
4137069-13706998.37399.18
5139117-13911799.843100.67
6132888-13288895.37296.16
60min1129697-12969793.08296.792.5693.9997.752.57
2133740-13374095.98496.93
3138157-13815799.154100.13
4135998-13599897.60498.58
5138762-13876299.588100.58
6132817-13281795.32196.27
极限1130169-13016993.42196.812.4594.4997.932.45
2134406-13440696.46297.56
3138562-13856299.444100.59
4135386-13538697.16598.30
5138380-13838099.314100.47
6132454-13245495.06196.17
依折麦布匹伐他汀钙片项目信息
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ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.923658943654623656513655443671543659410.20
211.013668323684833676580.32
单位质量响应值RSD%判断
33511.0833393.100.25数据可信
加速3月-供试品溶液-2024061321批-匹伐他汀钙-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1157643-15764342.41338.8618.7042.4138.8618.71
2156992-15699242.23742.24
3158034-15803442.51842.52
4145203-14520339.06639.07
590299-9029924.29424.29
6158528-15852842.65142.65
10min1308869-30886983.09978.307.3683.1778.367.37
2304935-30493582.04082.11
3306382-30638282.43082.50
4292324-29232478.64878.71
5253163-25316368.11268.15
6280532-28053275.47575.55
15min1347877-34787793.59492.142.9893.8092.332.99
2349568-34956894.04994.26
3353937-35393795.22495.43
4341676-34167691.92592.12
5326530-32653087.85088.00
6335215-33521590.18790.38
20min1366006-36600698.47197.661.8598.8498.011.87
2365703-36570398.39098.75
3372383-372383100.187100.55
4362318-36231897.47997.83
5353005-35300594.97395.27
6358612-35861296.48296.83
30min1374982-374982100.886101.501.16101.42102.011.17
2379555-379555102.116102.64
3384585-384585103.470104.00
4375637-375637101.062101.57
5372026-372026100.091100.55
6376818-376818101.380101.89
45min1384076-384076103.333103.491.05104.03104.171.06
2387406-387406104.229104.93
3391420-391420105.309106.01
4381508-381508102.642103.32
5381505-381505102.641103.27
6382001-382001102.774103.45
60min1381112-381112102.535103.480.90103.40104.330.90
2386221-386221103.910104.78
3390656-390656105.103105.98
4384214-384214103.370104.22
5383183-383183103.092103.89
6382312-382312102.858103.71
极限1381540-381540102.650103.581.11103.69104.601.11
2386843-386843104.077105.12
3392413-392413105.576106.63
4381395-381395102.611103.64
5385327-385327103.669104.64
6382371-382371102.874103.89
依折麦布匹伐他汀钙片项目信息
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101245-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.421256111260531259361255871261261258630.20
210.491271611265251268430.36
单位质量响应值RSD%判断
12078.9812091.800.08数据可信
中间条件3月-供试品溶液-2024061321批-依折麦布-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1117121-11712183.99381.5914.5883.9981.5914.58
296287-9628769.05269.05
3132228-13222894.82794.83
4116566-11656683.59583.59
591728-9172865.78265.78
6128728-12872892.31792.32
10min1136861-13686198.14997.092.6798.2997.232.68
2135456-13545697.14297.26
3139622-139622100.129100.29
4135387-13538797.09297.23
5128740-12874092.32692.44
6136251-13625197.71297.87
15min1139638-139638100.14198.282.12100.4498.582.13
2137181-13718198.37998.66
3140302-140302100.617100.94
4137250-13725098.42898.73
5132292-13229294.87395.14
6135588-13558897.23797.55
20min1138220-13822099.12498.172.0599.5998.632.06
2137040-13704098.27898.72
3141173-141173101.242101.73
4136959-13695998.22098.68
5132924-13292495.32695.75
6135057-13505796.85697.33
30min1139979-139979100.38698.512.20101.0299.142.20
2137893-13789398.89099.49
3141167-141167101.237101.90
4136824-13682498.12398.75
5132939-13293995.33795.92
6135400-13540097.10297.74
45min1138675-13867599.45097.922.19100.2598.702.20
2135981-13598197.51898.29
3141039-141039101.146101.98
4136295-13629597.74498.54
5132599-13259995.09395.83
6134617-13461796.54097.34
60min1139246-13924699.86098.082.22100.8399.032.23
2137161-13716198.36599.30
3140846-140846101.007102.01
4136191-13619197.66998.62
5132530-13253095.04395.94
6134612-13461296.53797.50
极限1137679-13767998.73697.301.9499.8798.421.95
2136266-13626697.72398.82
3139172-13917299.807100.97
4135273-13527397.01198.13
5131921-13192194.60795.66
6133747-13374795.91697.04
依折麦布匹伐他汀钙片项目信息
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ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.923651823657103672173655163655033658260.22
211.013644843653113648980.17
单位质量响应值RSD%判断
33500.5533142.420.76数据可信
中间条件3月-供试品溶液-2024061321批-匹伐他汀钙-pH4.5(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1149508-14950840.38330.5735.3340.3830.5735.32
258480-5848015.79615.80
3133728-13372836.12036.12
491368-9136824.67924.68
586997-8699723.49823.50
6158958-15895842.93542.94
10min1307220-30722082.98172.2311.9283.0572.2811.93
2249527-24952767.39867.42
3275352-27535274.37474.43
4237451-23745164.13664.18
5234258-23425863.27463.31
6300693-30069381.21881.29
15min1353886-35388695.58690.463.9795.7990.643.99
2330461-33046189.25989.40
3335660-33566090.66390.85
4322404-32240487.08387.23
5320527-32052786.57686.72
6346567-34656793.60993.82
20min1366099-36609998.88597.031.5299.2597.351.56
2355953-35595396.14496.43
3361914-36191497.75498.09
4356227-35622796.21896.51
5351697-35169794.99595.28
6363473-36347398.17598.54
30min1383800-383800103.666102.630.79104.20103.110.82
2375530-375530101.432101.88
3380885-380885102.878103.38
4379734-379734102.568103.02
5377773-377773102.038102.49
6382028-382028103.187103.71
45min1385299-385299104.071104.120.69104.77104.780.67
2382999-382999103.449104.07
3388099-388099104.827105.50
4386748-386748104.462105.09
5387971-387971104.792105.41
6381755-381755103.113103.81
60min1386655-386655104.437104.570.70105.31105.400.68
2385032-385032103.999104.79
3390740-390740105.540106.38
4388374-388374104.901105.70
5388712-388712104.993105.78
6383354-383354103.545104.42
极限1384513-384513103.858104.050.68104.91105.050.66
2385865-385865104.224105.19
3388383-388383104.904105.92
4384927-384927103.970104.94
5386843-386843104.488105.45
6380706-380706102.830103.87
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