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%
110.032994148299515629938862995379299657029950280.04
29.992980049298023829801440.01
单位质量响应值RSD%判断
298606.98298312.710.07数据可信
中间条件24月-供试品溶液-2023010811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%
5min1351415-35141511.72710.587.3011.7310.587.30
2315612-31561210.53210.53
3333882-33388211.14211.14
4311911-31191110.40910.41
5284923-2849239.5089.51
6304866-30486610.17410.17
10min1862111-86211128.77027.404.8828.7927.424.89
2816754-81675427.25627.27
3867574-86757428.95228.97
4824348-82434827.51027.53
5763536-76353625.48025.49
6792561-79256126.44926.46
15min11326355-132635544.26242.453.9244.3242.503.92
21257610-125761041.96842.02
31333516-133351644.50144.56
41269809-126980942.37542.43
51206131-120613140.25040.30
61239034-123903441.34841.40
20min11717195-171719557.30555.393.6457.4355.523.63
21644059-164405954.86454.98
31745364-174536458.24558.37
41652791-165279155.15655.28
51592236-159223653.13553.25
61608008-160800853.66153.78
30min12251370-225137075.13173.512.4775.3473.712.47
22208077-220807773.68673.89
32271308-227130875.79776.01
42203303-220330373.52773.73
52141126-214112671.45271.64
62141173-214117371.45471.65
45min12686343-268634389.64788.461.4089.9788.771.40
22663078-266307888.87089.18
32681062-268106289.47189.80
42660294-266029488.77889.09
52622744-262274487.52487.82
62590809-259080986.45986.76
60min12858504-285850495.39294.400.7295.8594.850.73
22833905-283390594.57195.02
32842664-284266494.86395.33
42823290-282329094.21794.66
52808097-280809793.71094.14
62807124-280712493.67794.11
极限12904941-290494196.94296.790.5897.5597.370.58
22928177-292817797.71798.30
32907020-290702097.01197.62
42889814-288981496.43797.02
52885964-288596496.30896.88
62885598-288559896.29696.87
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%
110.032981138297788529791552980408298544329808060.10
29.992982646297928029809630.08
单位质量响应值RSD%判断
297189.03298394.690.29数据可信
中间条件24月-供试品溶液-2023010811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%
5min1331875-33187511.10010.635.2211.1010.635.22
2320744-32074410.72810.73
3292986-2929869.7999.80
4328101-32810110.97410.97
5301993-30199310.10110.10
6331740-33174011.09511.10
10min1827320-82732027.67127.113.9127.6927.133.91
2846000-84600028.29628.31
3764997-76499725.58625.60
4837494-83749428.01128.03
5786632-78663226.31026.33
6801078-80107826.79326.81
15min11276909-127690942.70842.173.2542.7742.223.26
21309801-130980143.80843.87
31210354-121035440.48240.53
41290130-129013043.15043.21
51212821-121282140.56440.62
61264234-126423442.28442.34
20min11659121-165912155.49154.992.6655.6155.112.66
21683948-168394856.32256.45
31590884-159088453.20953.32
41686762-168676256.41656.54
51589873-158987353.17553.29
61654041-165404155.32255.44
30min12229655-222965574.57473.051.9174.7873.261.91
22229449-222944974.56774.78
32131226-213122671.28271.48
42192663-219266373.33673.54
52143519-214351971.69371.89
62178837-217883772.87473.08
45min12662912-266291289.06588.240.9689.3888.550.96
22662525-266252589.05289.37
32613321-261332187.40687.71
42655544-265554488.81889.14
52608157-260815787.23387.54
62627142-262714287.86888.18
60min12818058-281805894.25493.580.6294.7094.030.62
22812948-281294894.08394.54
32804084-280408493.78694.22
42796995-279699593.54994.00
52777608-277760892.90193.33
62778555-277855592.93293.38
极限12882611-288261196.41395.930.8397.0196.520.84
22890946-289094696.69197.29
32854841-285484195.48496.06
42888968-288896896.62597.22
52830434-283043494.66895.24
62861490-286149095.70696.29
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%
110.032966176296492829639102962445296328829641490.05
29.992958747295586829573080.07
单位质量响应值RSD%判断
295528.32296026.830.12数据可信
中间条件24月-供试品溶液-2023011011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%
5min1341811-34181111.51011.294.2211.5111.294.22
2341807-34180711.51011.51
3339562-33956211.43411.43
4344178-34417811.59011.59
5337084-33708411.35111.35
6306781-30678110.33110.33
10min1857994-85799428.89228.362.2128.9128.382.21
2821486-82148627.66327.68
3860437-86043728.97428.99
4835943-83594328.15028.17
5857123-85712328.86328.88
6820959-82095927.64527.66
15min11319967-131996744.44944.052.5144.5144.112.51
21257675-125767542.35142.41
31342927-134292745.22245.28
41293147-129314743.54543.61
51340384-134038445.13645.20
61293970-129397043.57343.63
20min11706075-170607557.45057.002.4657.5857.122.46
21617259-161725954.46054.58
31733713-173371358.38158.51
41674456-167445656.38656.51
51712389-171238957.66357.79
61711653-171165357.63857.76
30min12261223-226122376.14475.342.0076.3675.552.00
22149681-214968172.38872.59
32274982-227498276.60876.82
42237912-223791275.35975.57
52252372-225237275.84676.06
62247442-224744275.68075.89
45min12672859-267285990.00689.391.0290.3389.721.02
22604226-260422687.69588.01
32674651-267465190.06690.40
42671707-267170789.96790.29
52646974-264697489.13489.46
62657641-265764189.49389.82
60min12798842-279884294.24894.150.2994.7194.600.29
22787984-278798493.88394.33
32801760-280176094.34694.81
42807135-280713594.52794.98
52788022-278802293.88494.35
62791395-279139593.99794.45
极限12846822-284682295.86495.980.2696.4796.580.26
22860616-286061696.32896.91
32854470-285447096.12196.73
42853939-285393996.10396.70
52842965-284296595.73496.34
62841992-284199295.70196.30
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%
110.032949267295870929420262945091294095129472090.25
29.992959555296288529612200.08
单位质量响应值RSD%判断
293839.38296418.420.62数据可信
中间条件24月-供试品溶液-2023011011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%
5min1340252-34025211.48311.292.6111.4811.282.60
2341785-34178511.53511.53
3323149-32314910.90610.91
4339183-33918311.44711.45
5338749-33874911.43211.43
6323372-32337210.91310.91
10min1834124-83412428.15128.390.4828.1728.410.48
2844490-84449028.50028.52
3839618-83961828.33628.35
4843913-84391328.48128.50
5844396-84439628.49728.51
6841440-84144028.39728.41
15min11282595-128259543.28643.961.2143.3544.021.20
21317366-131736644.45944.52
31314586-131458644.36544.42
41301555-130155543.92643.99
51284993-128499343.36743.43
61315010-131501044.38044.44
20min11656400-165640055.90157.071.4656.0357.191.45
21704092-170409257.51157.64
31708616-170861657.66357.79
41686263-168626356.90957.03
51669713-166971356.35056.48
61720618-172061858.06858.19
30min12205115-220511574.42075.521.2774.6375.731.26
22255832-225583276.13176.34
32250757-225075775.96076.17
42255314-225531476.11476.32
52198184-219818474.18674.40
62261267-226126776.31576.53
45min12650278-265027889.44389.550.8489.7689.880.84
22675668-267566890.30090.63
32649015-264901589.40189.73
42673013-267301390.21090.54
52614616-261461688.24088.56
62658908-265890889.73490.06
60min12789437-278943794.14094.160.3694.5994.620.36
22788345-278834594.10394.57
32786933-278693394.05594.52
42809547-280954794.81895.28
52781249-278124993.86394.32
62784327-278432793.96794.43
极限12842668-284266895.93696.240.2696.5396.840.26
22858485-285848596.47097.07
32844085-284408595.98496.58
42855940-285594096.38496.99
52849245-284924596.15896.75
62859337-285933796.49997.10
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%
110.032962346296061929628262960137295736829606590.08
29.992952914295275929528360.01
单位质量响应值RSD%判断
295180.36295579.180.10数据可信
中间条件24月-供试品溶液-2023011111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%
5min1279910-2799109.4389.885.259.449.885.22
2289727-2897279.7699.77
3272696-2726969.1959.20
4295673-2956739.9709.97
5309440-30944010.43410.43
6310610-31061010.47410.47
10min1703656-70365623.72724.943.6923.7424.963.68
2772257-77225726.04026.05
3711576-71157623.99424.01
4738391-73839124.89824.91
5757592-75759225.54525.56
6755058-75505825.46025.48
15min11132185-113218538.17739.372.1338.2339.422.13
21192965-119296540.22640.28
31151013-115101338.81138.86
41163032-116303239.21739.27
51197188-119718840.36840.42
61169677-116967739.44139.49
20min11488430-148843050.18951.671.9150.3051.781.91
21544922-154492252.09452.21
31520578-152057851.27351.38
41538199-153819951.86751.98
51576737-157673753.16653.28
61525603-152560351.44251.56
30min12054698-205469869.28370.411.4969.4770.601.49
22097877-209787770.73970.93
32093536-209353670.59370.78
42080991-208099170.17070.36
52140936-214093672.19172.39
62060760-206076069.48769.68
45min12548395-254839585.93086.710.8586.2287.000.85
22597462-259746287.58587.88
32589754-258975487.32587.62
42556420-255642086.20186.49
52585243-258524387.17387.48
62551629-255162986.03986.33
60min12753325-275332592.84093.180.6493.2693.610.63
22784095-278409593.87894.31
32777183-277718393.64594.07
42737973-273797392.32392.75
52772579-277257993.48993.92
62755263-275526392.90693.33
极限12846055-284605595.96796.080.4696.5296.640.46
22862185-286218596.51197.08
32865801-286580196.63397.20
42836523-283652395.64696.21
52850880-285088096.13096.70
62834587-283458795.58096.14
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%
110.032947992295449429530112952273295038529516310.09
29.992928607292516729268870.09
单位质量响应值RSD%判断
294280.26292981.680.32数据可信
中间条件24月-供试品溶液-2023011111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%
5min1284304-2843049.6449.914.379.649.914.39
2283445-2834459.6159.61
3307761-30776110.43910.44
4275396-2753969.3429.34
5299715-29971510.16610.17
6301937-30193710.24210.24
10min1731741-73174124.82124.992.6624.8425.012.66
2722680-72268024.51424.53
3751830-75183025.50225.52
4707496-70749623.99824.01
5758440-75844025.72725.74
6748438-74843825.38725.40
15min11152035-115203539.07739.421.5139.1339.481.51
21154062-115406239.14639.20
31179001-117900139.99240.05
41136205-113620538.54038.59
51173995-117399539.82239.88
61178381-117838139.97140.02
20min11513404-151340451.33551.821.2251.4551.931.22
21522120-152212051.63151.74
31545982-154598252.44052.55
41502856-150285650.97751.09
51530917-153091751.92952.04
61550845-155084552.60552.72
30min12063929-206392970.00970.600.7270.2070.790.72
22085101-208510170.72770.91
32091553-209155370.94671.14
42070651-207065170.23770.42
52073031-207303170.31870.51
62103817-210381771.36271.55
45min12557430-255743086.74986.770.3287.0487.060.33
22561125-256112586.87487.17
32558867-255886786.79887.10
42546276-254627686.37086.66
52570820-257082087.20387.50
62553490-255349086.61586.91
60min12751507-275150793.33293.410.2293.7593.830.22
22745070-274507093.11493.54
32752010-275201093.34993.78
42760683-276068393.64394.06
52752877-275287793.37893.81
62759944-275994493.61894.05
极限12851113-285111396.71196.410.2897.2796.980.27
22836664-283666496.22096.78
32838418-283841896.28096.85
42850173-285017396.67997.24
52845174-284517496.50997.08
62832091-283209196.06596.64
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