乌帕替尼缓释片项目信息
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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
114.941702721701171701011703761699891701710.09
214.951702131701371701750.04
单位质量响应值RSD%判断
11390.2911382.940.05数据可信
中间条件6月-供试品溶液-2025081321批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min127680-2768014.51013.934.1514.5113.924.15
228199-2819914.78214.78
325499-2549913.36613.37
426229-2622913.74913.75
525854-2585413.55313.55
625930-2593013.59213.59
60min148884-4888425.62524.473.5025.6524.493.50
248351-4835125.34525.37
344701-4470123.43223.45
446664-4666424.46124.48
545781-4578123.99824.02
645730-4573023.97123.99
120min176561-7656140.13339.032.6240.2039.092.62
276596-7659640.15140.22
372157-7215737.82437.89
474876-7487639.25039.31
572378-7237837.94038.00
674142-7414238.86538.93
240min1117077-11707761.37160.921.5461.5061.051.54
2118435-11843562.08362.22
3114402-11440259.96960.09
4116561-11656161.10161.23
5113763-11376359.63459.76
6117089-11708961.37761.50
360min1140876-14087673.84674.041.3774.0874.271.37
2143601-14360175.27575.51
3140496-14049673.64773.87
4142117-14211774.49774.73
5138040-13804072.36072.58
6142375-14237574.63274.86
480min1156840-15684082.21582.541.3482.5782.901.34
2159517-15951783.61883.98
3157565-15756582.59582.94
4158081-15808182.86583.22
5153677-15367780.55780.90
6159115-15911583.40783.76
600min1166074-16607487.05587.821.2387.5588.311.23
2169045-16904588.61289.11
3168352-16835288.24988.73
4168616-16861688.38888.88
5164012-16401285.97486.45
6169133-16913388.65989.15
720min1171836-17183690.07591.121.1790.7291.761.17
2175771-17577192.13892.79
3174554-17455491.50092.13
4174360-17436091.39992.04
5170828-17082889.54790.17
6175582-17558292.03992.68
960min1178997-17899793.82994.781.2394.6295.571.23
2182465-18246595.64796.45
3181597-18159795.19295.98
4181580-18158095.18395.98
5177242-17724292.90993.68
6182975-18297595.91496.71
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1182934-18293495.89396.801.1096.8497.741.10
2186484-18648497.75498.72
3185938-18593897.46898.41
4184705-18470596.82197.77
5181538-18153895.16196.09
6186339-18633997.67898.63
1440min1185593-18559397.28798.121.1098.3999.231.10
2189201-18920199.178100.30
3188048-18804898.57499.68
4187204-18720498.13199.24
5183998-18399896.45197.54
6189064-18906499.106100.22
极限1185126-18512697.04298.091.3298.3199.361.31
2188471-18847198.795100.09
3188316-18831698.71499.98
4186934-18693497.99099.27
5183564-18356496.22397.47
6190333-19033399.771101.05
乌帕替尼缓释片项目信息
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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
114.941697381700261701781700771696661699370.14
214.951702791699831701310.13
单位质量响应值RSD%判断
11374.6311380.000.04数据可信
中间条件6月-供试品溶液-2025081321批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min126261-2626113.77714.041.9713.7814.041.96
226465-2646513.88413.88
326359-2635913.82913.83
427014-2701414.17214.17
527661-2766114.51214.51
626812-2681214.06614.07
60min147666-4766625.00724.771.8025.0324.801.80
247010-4701024.66324.69
345814-4581424.03524.06
447772-4777225.06225.09
548175-4817525.27425.30
646837-4683724.57224.60
120min175576-7557639.64939.731.1039.7139.801.10
276513-7651340.14040.20
374291-7429138.97539.04
476339-7633940.04940.11
576276-7627640.01640.08
675430-7543039.57239.64
240min1115728-11572860.71461.440.8860.8461.570.88
2118574-11857462.20762.34
3116493-11649361.11561.24
4116783-11678361.26761.40
5117965-11796561.88762.02
6117138-11713861.45361.58
360min1140878-14087873.90874.450.7174.1474.680.71
2143766-14376675.42375.66
3141678-14167874.32874.56
4142188-14218874.59574.83
5141385-14138574.17474.41
6141580-14158074.27674.51
480min1156721-15672182.21982.680.5382.5783.040.53
2158781-15878183.30083.66
3156617-15661782.16582.52
4157725-15772582.74683.10
5158058-15805882.92183.28
6157699-15769982.73383.09
600min1167356-16735687.79988.170.5988.2988.660.59
2169232-16923288.78389.28
3166747-16674787.47987.97
4168606-16860688.45588.95
5167542-16754287.89688.39
6168846-16884688.58089.07
720min1174710-17471091.65791.251.4192.3091.891.39
2169936-16993689.15289.80
3177190-17719092.95893.59
4174137-17413791.35692.00
5172693-17269390.59991.24
6174921-17492191.76892.41
960min1180681-18068194.78994.960.4195.5895.750.41
2181854-18185495.40596.20
3180074-18007494.47195.26
4181259-18125995.09395.89
5180381-18038194.63295.43
6181737-18173795.34396.14
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1185062-18506297.08896.940.6198.0497.890.61
2185766-18576697.45798.41
3182824-18282495.91496.86
4185648-18564897.39598.35
5184127-18412796.59797.55
6185238-18523897.18098.13
1440min1188016-18801698.63798.250.5099.7599.360.50
2188183-18818398.72599.84
3185735-18573597.44198.55
4187515-18751598.37599.49
5186626-18662697.90899.02
6187547-18754798.39199.51
极限1187563-18756398.40098.080.4899.6899.360.48
2187571-18757198.40499.69
3185474-18547497.30498.58
4187186-18718698.20299.48
5186298-18629897.73699.01
6187672-18767298.45799.74
乌帕替尼缓释片项目信息
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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
114.941696491696821699771694361697331696950.12
214.951694481696541695510.09
单位质量响应值RSD%判断
11358.4311341.200.11数据可信
中间条件6月-供试品溶液-1276525批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min125685-2568513.50813.172.1613.5113.172.14
225544-2554413.43313.43
324296-2429612.77712.78
424638-2463812.95712.96
524882-2488213.08513.09
625242-2524213.27513.27
60min143764-4376423.01522.352.3323.0422.372.34
243498-4349822.87522.90
341564-4156421.85821.88
441398-4139821.77121.79
542085-4208522.13222.15
642668-4266822.43922.46
120min170116-7011636.87436.031.9236.9336.091.92
269741-6974136.67636.74
367134-6713435.30535.36
466974-6697435.22135.28
568938-6893836.25436.31
668179-6817935.85535.91
240min1112188-11218858.99957.751.3659.1257.871.36
2109823-10982357.75557.88
3108037-10803756.81656.93
4108693-10869357.16157.28
5110732-11073258.23358.35
6109416-10941657.54157.66
360min1138746-13874672.96671.741.7173.1971.951.70
2135365-13536571.18871.41
3134313-13431370.63470.85
4134461-13446170.71270.92
5139834-13983473.53873.75
6135736-13573671.38371.60
480min1156182-15618282.13581.131.3982.4881.461.39
2155172-15517281.60481.94
3151632-15163279.74280.07
4151922-15192279.89580.22
5156665-15666582.38982.73
6154061-15406181.02081.35
600min1167885-16788588.29087.151.4088.7787.621.40
2163444-16344485.95486.43
3163435-16343585.95086.41
4164410-16441086.46286.93
5168808-16880888.77589.25
6166349-16634987.48287.95
720min1174564-17456491.80290.641.4892.4391.261.48
2169953-16995389.37789.99
3169686-16968689.23789.84
4170695-17069589.76890.37
5175461-17546192.27492.90
6173808-17380891.40592.02
960min1181583-18158395.49394.331.4996.2795.091.49
2176611-17661192.87993.64
3176636-17663692.89293.65
4177667-17766793.43494.19
5182379-18237995.91296.69
6181306-18130695.34896.12
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1185163-18516397.37696.311.3998.3197.231.39
2180715-18071595.03795.96
3179937-17993794.62895.54
4182286-18228695.86396.78
5186268-18626897.95798.89
6184414-18441496.98297.91
1440min1188304-18830499.02897.681.39100.1398.771.39
2183036-18303696.25897.34
3182506-18250695.97997.05
4185117-18511797.35298.42
5188061-18806198.900100.00
6187466-18746698.58799.68
极限1187821-18782198.77497.651.46100.0498.901.45
2183119-18311996.30197.54
3182161-18216195.79797.02
4184790-18479097.18098.41
5188472-18847299.116100.38
6187732-18773298.72799.98
乌帕替尼缓释片项目信息
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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
114.941710731709371702731705541706341706940.19
214.951700151701161700660.05
单位质量响应值RSD%判断
11425.3011375.650.31数据可信
中间条件6月-供试品溶液-1276525批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
30min125057-2505713.11912.962.8913.1212.962.88
225533-2553313.36813.37
325344-2534413.26913.27
424700-2470012.93212.93
523618-2361812.36512.37
624294-2429412.71912.72
60min143768-4376822.91522.203.1522.9422.223.15
243380-4338022.71222.73
343276-4327622.65822.68
442150-4215022.06822.09
540259-4025921.07821.10
641584-4158421.77221.79
120min170958-7095837.15135.843.0637.2135.903.06
269377-6937736.32336.38
369819-6981936.55436.61
468132-6813235.67135.73
565028-6502834.04634.10
667445-6744535.31135.37
240min1111655-11165558.45857.601.9458.5857.721.94
2110470-11047057.83857.96
3112086-11208658.68458.80
4110392-11039257.79757.91
5106157-10615755.58055.69
6109389-10938957.27257.39
360min1138204-13820472.35871.601.3372.5871.811.34
2135867-13586771.13471.35
3138576-13857672.55372.77
4137162-13716271.81272.03
5133590-13359069.94270.15
6137103-13710371.78271.99
480min1157183-15718382.29581.141.4582.6381.471.45
2151865-15186579.51079.85
3156862-15686282.12782.47
4155924-15592481.63581.97
5152532-15253279.86080.18
6155472-15547281.39981.73
600min1168144-16814488.03387.251.3188.5187.721.31
2162856-16285685.26585.73
3168178-16817888.05188.53
4167085-16708587.47987.95
5165318-16531886.55487.01
6168250-16825088.08988.56
720min1175091-17509191.67190.871.6792.2991.481.66
2169125-16912588.54789.16
3176879-17687992.60793.23
4174526-17452691.37591.99
5171035-17103589.54790.15
6174678-17467891.45492.07
960min1182351-18235195.47294.611.5396.2595.381.53
2175408-17540891.83792.59
3181864-18186495.21795.99
4181219-18121994.87995.65
5180326-18032694.41195.16
6183059-18305995.84296.61
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
1200min1186182-18618297.47796.591.6098.4197.511.60
2178768-17876893.59694.51
3185912-18591297.33698.27
4184871-18487196.79197.72
5184308-18430896.49697.40
6186885-18688597.84598.77
1440min1189522-18952299.22698.121.95100.3299.201.95
2181083-18108394.80895.87
3188300-18830098.58699.68
4187605-18760598.22299.31
5186118-18611897.44498.51
6191854-191854100.447101.54
极限1189554-18955499.24397.941.72100.5199.191.72
2181035-18103594.78396.01
3188322-18832298.59899.86
4187193-18719398.00799.26
5186533-18653397.66198.89
6189773-18977399.357100.61
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