塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.961520055151882215225691520633152063115205420.09
29.921513540150912715113340.21
单位质量响应值RSD%判断
152664.86152352.220.15数据可信
中间条件24月-供试品溶液-2023010511批-pH1.0(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1164791-16479110.7629.9120.3110.769.9120.33
2145621-1456219.5109.51
3160082-16008210.45510.45
4110734-1107347.2327.23
5199747-19974713.04513.05
6129698-1296988.4708.47
10min1423374-42337427.65025.8214.9927.6725.8414.99
2375177-37517724.50224.52
3398330-39833026.01426.03
4319560-31956020.87020.88
5493117-49311732.20432.22
6363017-36301723.70823.72
15min1685324-68532444.75741.8112.7044.8141.8612.70
2612345-61234539.99140.04
3622286-62228640.64040.69
4541010-54101035.33235.37
5776870-77687050.73650.80
6603432-60343239.40939.46
20min1922707-92270760.26056.2111.0860.3856.3311.09
2843277-84327755.07355.18
3816030-81603053.29353.41
4748253-74825348.86748.96
51017904-101790466.47766.62
6816240-81624053.30753.41
30min11228510-122851080.23176.636.0480.4576.836.06
21188184-118818477.59877.79
31122736-112273673.32473.52
41082802-108280270.71670.88
51274325-127432583.22383.47
61143798-114379874.69974.89
45min11389636-138963690.75490.851.4991.0991.171.51
21375436-137543689.82790.14
31374327-137432789.75490.06
41376999-137699989.92990.20
51426056-142605693.13393.50
61404315-140431591.71392.01
60min11427868-142786893.25193.621.2393.7294.071.23
21407529-140752991.92392.37
31420871-142087192.79493.23
41445373-144537394.39494.80
51451109-145110994.76995.28
61448154-144815494.57695.01
极限11453828-145382894.94695.451.2595.5696.041.24
21437695-143769593.89394.48
31448821-144882194.61995.20
41477532-147753296.49497.05
51464966-146496695.67496.32
61486179-148617997.05997.64
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.961519437152134115197401519739151704015194590.11
29.921515030151544015152350.02
单位质量响应值RSD%判断
152556.12152745.460.09数据可信
中间条件24月-供试品溶液-2023010511批-pH1.0(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1154239-15423910.0649.839.7810.069.839.77
2136407-1364078.9008.90
3161651-16165110.54710.55
4134912-1349128.8038.80
5172190-17219011.23511.23
6144649-1446499.4389.44
10min1395878-39587825.83025.537.5725.8425.547.56
2354428-35442823.12523.14
3425966-42596627.79327.81
4367459-36745923.97623.99
5424172-42417227.67627.69
6379362-37936224.75224.77
15min1645643-64564342.12641.516.3642.1841.566.37
2580960-58096037.90637.95
3680006-68000644.36844.43
4616348-61634840.21540.26
5682482-68248244.53044.59
6611986-61198639.93039.98
20min1878257-87825757.30455.736.4057.4255.856.40
2777123-77712350.70550.81
3900839-90083958.77758.90
4836586-83658654.58554.69
5919176-91917659.97360.10
6813226-81322653.06153.17
30min11205220-120522078.63776.354.2578.8476.554.26
21101094-110109471.84372.02
31202429-120242978.45578.67
41159459-115945975.65175.84
51227128-122712880.06680.28
61125933-112593373.46473.65
45min11372150-137215089.52990.331.2089.8590.641.20
21368351-136835189.28189.57
31406729-140672991.78592.11
41394167-139416790.96591.27
51368951-136895189.32089.66
61396057-139605791.08991.39
60min11410762-141076292.04893.230.7892.5093.680.78
21429256-142925693.25593.68
31444642-144464294.25994.73
41432884-143288493.49193.93
51425257-142525792.99493.46
61430727-143072793.35193.79
极限11441100-144110094.02794.980.7694.6295.570.75
21457953-145795395.12795.69
31468873-146887395.84096.45
41459994-145999495.26095.84
51443608-144360894.19194.80
61462881-146288195.44996.03
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.961514146151560015160581514232151331515146700.08
29.921515838151627415160560.03
单位质量响应值RSD%判断
152075.30152828.230.35数据可信
中间条件24月-供试品溶液-2023010611批-pH1.0(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1137473-1374738.9819.6517.718.989.6417.72
2175569-17556911.47011.47
3105950-1059506.9226.92
4137961-1379619.0139.01
5156269-15626910.20910.21
6172661-17266111.28011.28
10min1341187-34118722.29124.6814.4722.3024.7014.48
2433681-43368128.33328.35
3299224-29922419.54919.56
4362846-36284623.70623.72
5389118-38911825.42225.44
6440644-44064428.78828.81
15min1550724-55072435.98039.8012.5136.0339.8512.52
2681446-68144644.52144.58
3506562-50656233.09533.13
4594385-59438538.83338.88
5615089-61508940.18540.24
6707194-70719446.20346.26
20min1751185-75118549.07753.5711.0949.1853.6811.09
2892959-89295958.33958.47
3698996-69899645.66745.76
4807414-80741452.75052.86
5821126-82112653.64653.76
6948132-94813261.94462.07
30min11073749-107374970.15174.537.4670.3374.727.47
21216687-121668779.48979.70
31019039-101903966.57666.73
41147463-114746374.96775.15
51141800-114180074.59774.79
61245858-124585881.39581.62
45min11374836-137483689.82291.202.7990.1091.502.81
21443465-144346594.30594.64
31331184-133118486.97087.23
41401259-140125991.54891.85
51406010-140601091.85892.16
61418847-141884792.69793.04
60min11462490-146249095.54895.090.8495.9695.530.85
21473896-147389696.29396.77
31447602-144760294.57694.96
41441031-144103194.14694.58
51460023-146002395.38795.83
61447795-144779594.58895.07
极限11487730-148773097.19796.650.5797.7597.230.58
21489401-148940197.30697.93
31472733-147273396.21796.75
41468440-146844095.93796.51
51476269-147626996.44897.04
61481250-148125096.77497.40
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.961512468152275815118311514618151502615153400.29
29.921514846151716915160080.11
单位质量响应值RSD%判断
152142.57152823.390.32数据可信
中间条件24月-供试品溶液-2023010611批-pH1.0(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1155604-15560410.1649.6211.3610.169.6211.37
2122670-1226708.0138.01
3160699-16069910.49710.50
4136519-1365198.9178.92
5167024-16702410.91010.91
6141138-1411389.2199.22
10min1380426-38042624.84924.518.4424.8624.528.43
2336620-33662021.98822.00
3415101-41510127.11427.13
4347173-34717322.67722.69
5406903-40690326.57926.59
6364877-36487723.83323.85
15min1612994-61299440.04039.576.6240.0939.626.62
2549936-54993635.92135.97
3653411-65341142.68042.74
4572178-57217837.37437.42
5643829-64382942.05442.11
6602510-60251039.35539.40
20min1805562-80556252.61953.165.3352.7353.275.34
2763571-76357149.87649.97
3870012-87001256.82856.95
4772595-77259550.46550.57
5857965-85796556.04156.16
6813346-81334653.12753.24
30min11117302-111730272.98173.353.6673.1773.543.67
21069556-106955669.86270.04
31167982-116798276.29276.50
41096452-109645271.61971.80
51174713-117471376.73176.93
61111404-111140472.59672.78
45min11405501-140550191.80690.221.8892.1190.521.89
21351308-135130888.26688.54
31396333-139633391.20791.53
41374722-137472289.79690.08
51408128-140812891.97892.30
61351606-135160688.28688.58
60min11448924-144892494.64294.480.9595.0894.910.96
21440565-144056594.09694.51
31470416-147041696.04696.50
41435118-143511893.74194.16
51450301-145030194.73295.19
61432999-143299993.60294.03
极限11473389-147338996.24095.700.5196.8296.280.52
21457347-145734795.19395.74
31466327-146632795.77996.38
41456327-145632795.12695.69
51472967-147296796.21396.81
61464573-146457395.66596.23
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.961519833152032115201631519357152020515199760.03
29.921513343151156415124540.09
单位质量响应值RSD%判断
152608.03152465.120.07数据可信
中间条件24月-供试品溶液-2023010711批-pH1.0(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1179023-17902311.6899.9919.9411.699.9919.91
2132709-1327098.6658.67
3108058-1080587.0567.06
4188251-18825112.29212.29
5167003-16700310.90510.90
6142915-1429159.3329.33
10min1455120-45512029.71725.5716.3729.7325.5916.37
2348125-34812522.73122.74
3292656-29265619.10919.12
4458309-45830929.92629.94
5410295-41029526.79126.81
6385439-38543925.16825.18
15min1735095-73509547.99941.1514.2748.0641.2014.27
2567937-56793737.08437.13
3493620-49362032.23132.27
4710891-71089146.41846.48
5648709-64870942.35842.41
6625302-62530240.83040.88
20min1989028-98902864.57955.1812.8464.7155.2912.85
2770531-77053150.31250.42
3685433-68543344.75644.84
4928354-92835460.61860.75
5856538-85653855.92856.05
6840312-84031254.86954.98
30min11288072-128807284.10676.018.6384.3476.218.65
21086061-108606170.91571.09
31015144-101514466.28566.44
41244900-124490081.28781.51
51178963-117896376.98177.19
61171658-117165876.50476.70
45min11408482-140848291.96891.043.5692.3391.353.58
21361777-136177788.91889.20
31309121-130912185.48085.73
41437748-143774893.87994.22
51417448-141744892.55392.87
61431048-143104893.44193.75
60min11432641-143264193.54594.481.2194.0494.931.23
21436144-143614493.77494.19
31429580-142958093.34693.73
41461190-146119095.41095.90
51449093-144909394.62095.08
61473389-147338996.20696.66
极限11466118-146611895.73196.281.0896.3796.871.09
21465162-146516295.66996.23
31459633-145963395.30895.83
41482370-148237096.79397.42
51470690-147069096.03096.63
61502910-150291098.13498.73
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.961527840150932315085661508469150805715124510.57
29.921517826151635015170880.07
单位质量响应值RSD%判断
151852.51152932.260.51数据可信
中间条件24月-供试品溶液-2023010711批-pH1.0(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1154710-15471010.1129.948.4010.119.948.39
2142424-1424249.3099.31
3156341-15634110.21810.22
4158457-15845710.35610.36
5168215-16821510.99410.99
6132162-1321628.6388.64
10min1402697-40269726.32025.574.9426.3325.594.94
2375760-37576024.55924.57
3398602-39860226.05226.07
4414709-41470927.10527.12
5394412-39441225.77825.79
6361584-36158423.63323.65
15min1653592-65359242.71841.136.4042.7741.196.40
2610123-61012339.87739.93
3635421-63542141.53041.58
4681144-68114444.51844.57
5633078-63307841.37741.43
6562879-56287936.78936.84
20min1882779-88277957.69755.275.3257.8255.385.32
2801969-80196952.41552.53
3848818-84881855.47755.59
4902809-90280959.00659.13
5850611-85061155.59555.71
6786490-78649051.40451.51
30min11187046-118704677.58375.544.0377.7975.744.04
21122004-112200473.33273.52
31173316-117331676.68676.89
41216059-121605979.48079.69
51149686-114968675.14275.34
61086872-108687271.03671.22
45min11379159-137915990.14090.742.0990.4691.052.10
21371500-137150089.63989.94
31420463-142046392.83993.15
41417681-141768192.65792.99
51396095-139609591.24791.56
61345070-134507087.91288.20
60min11426196-142619693.21494.200.7193.6794.650.71
21440057-144005794.12094.55
31455480-145548095.12895.58
41449154-144915494.71495.18
51440467-144046794.14794.60
61436585-143658593.89394.31
极限11460808-146080895.47696.541.9496.0797.121.95
21467380-146738095.90696.48
31476594-147659496.50897.10
41533966-1533966100.258100.87
51466003-146600395.81696.41
61457426-145742695.25595.82
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