比拉斯汀口崩片项目信息
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D1BSF0200923对照品来源自制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500
标示量(mg)20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%
111.073768273763863765003763363767943765690.07
211.053757723762173759940.09
单位质量响应值RSD%判断
34017.0734026.610.02数据可信
供试品溶液-3L77C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%
5min1184931-18493148.72548.582.4148.7348.582.41
2188018-18801849.53949.54
3178273-17827346.97146.97
4186234-18623449.06949.07
5189086-18908649.82049.82
6179715-17971547.35147.35
10min1259354-25935468.33468.031.4468.4268.121.44
2258562-25856268.12568.21
3253274-25327466.73266.81
4257083-25708367.73667.82
5264421-26442169.66969.75
6256616-25661667.61367.69
15min1297520-29752078.39077.981.2778.5978.181.27
2295343-29534377.81678.01
3291280-29128076.74676.94
4292646-29264677.10677.30
5301654-30165479.47979.68
6297379-29737978.35378.54
20min1318843-31884384.00883.741.3384.3384.061.33
2318122-31812283.81884.14
3311538-31153882.08382.40
4314691-31469182.91483.24
5323652-32365285.27585.61
6320005-32000584.31484.64
30min1339571-33957189.46988.861.2489.9489.321.24
2339262-33926289.38889.85
3331087-33108787.23487.69
4333296-33329687.81688.28
5342057-34205790.12490.60
6338218-33821889.11389.58
45min1353673-35367393.18592.261.5993.8092.871.59
2352086-35208692.76793.38
3341715-34171590.03490.63
4345022-34502290.90691.51
5356096-35609693.82394.45
6352351-35235192.83793.45
60min1357966-35796694.31693.251.7695.0994.021.76
2358669-35866994.50195.27
3344902-34490290.87491.62
4347736-34773691.62192.38
5359860-35986094.81595.60
6354359-35435993.36694.13
极限1358713-35871394.51393.711.7095.4494.631.70
2359819-35981994.80495.73
3346538-34653891.30592.21
4349441-34944192.07092.98
5360443-36044394.96995.91
6358945-35894594.57495.50
比拉斯汀口崩片项目信息
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D1BSF0200923对照品来源自制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500
标示量(mg)20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%
111.073762783751433743463750083744723750490.21
211.053741863752103746980.20
单位质量响应值RSD%判断
33879.7733909.320.07数据可信
供试品溶液-3L77C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%
5min1179792-17979247.54948.671.4447.5548.671.44
2186280-18628049.26549.26
3182303-18230348.21348.21
4186440-18644049.30749.31
5185721-18572149.11749.12
6183613-18361348.56048.56
10min1250080-25008066.13868.041.6066.2268.121.60
2259672-25967268.67568.76
3259711-25971168.68568.77
4255991-25599167.70167.78
5261601-26160169.18569.27
6256473-25647367.82967.91
15min1290994-29099476.95878.381.2077.1578.571.20
2299852-29985279.30179.50
3296656-29665678.45678.65
4296592-29659278.43978.63
5300254-30025479.40779.60
6293790-29379077.69877.89
20min1313623-31362382.94384.241.3183.2684.561.31
2321887-32188785.12985.46
3317704-31770484.02284.35
4321160-32116084.93685.26
5323044-32304485.43585.76
6313665-31366582.95483.28
30min1335923-33592388.84189.731.2689.3090.191.26
2342930-34293090.69491.16
3335249-33524988.66289.13
4341824-34182490.40190.87
5344499-34449991.10991.58
6335193-33519388.64889.11
45min1349121-34912192.33193.371.1892.9493.991.18
2355363-35536393.98294.60
3349825-34982592.51793.13
4353494-35349493.48894.11
5360018-36001895.21395.84
6350490-35049092.69393.30
60min1352516-35251693.22994.361.1993.9995.131.19
2358254-35825494.74795.52
3353968-35396893.61394.38
4358590-35859094.83595.61
5363684-36368496.18396.97
6353644-35364493.52794.29
极限1353642-35364293.52794.941.3894.4495.861.38
2360774-36077495.41396.35
3354315-35431593.70594.63
4359855-35985595.17096.10
5367176-36717697.10698.05
6358096-35809694.70595.62
比拉斯汀口崩片项目信息
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D1BSF0200923对照品来源自制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500
标示量(mg)20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%
111.073729573743483743923739183740793739390.16
211.053755803752813754300.06
单位质量响应值RSD%判断
33779.4933975.570.41数据可信
供试品溶液-3066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%
5min1172958-17295845.76544.098.2545.7744.098.26
2161732-16173242.79542.79
3187824-18782449.69949.70
4159963-15996342.32742.33
5147250-14725038.96338.96
6170023-17002344.98844.99
10min1244296-24429664.64162.166.9164.7262.246.91
2233198-23319861.70561.78
3255823-25582367.69167.77
4224046-22404659.28359.35
5210073-21007355.58655.65
6242138-24213864.07064.15
15min1293160-29316077.57175.794.5877.7575.974.58
2288650-28865076.37776.55
3302815-30281580.12680.32
4283859-28385975.11075.28
5263342-26334269.68169.84
6286791-28679175.88676.07
20min1321904-32190485.17784.953.7985.4985.263.79
2323823-32382385.68485.99
3336799-33679989.11889.45
4322607-32260785.36385.66
5299215-29921579.17379.45
6321939-32193985.18685.49
30min1349721-34972192.53792.923.0892.9993.363.09
2354212-35421293.72594.17
3364003-36400396.31696.79
4358441-35844194.84495.28
5332623-33262388.01388.42
6347922-34792292.06192.51
45min1360504-36050495.39096.262.4996.0096.862.50
2365145-36514596.61897.22
3376350-37635099.583100.22
4370339-37033997.99398.59
5350331-35033192.69893.25
6360062-36006295.27395.88
60min1364300-36430096.39597.412.6397.1698.172.64
2369199-36919997.69198.45
3381333-381333100.902101.71
4375567-37556799.376100.13
5353638-35363893.57394.28
6364826-36482696.53497.30
极限1365212-36521296.63697.672.6297.5798.602.63
2368391-36839197.47798.40
3382791-382791101.287102.26
4376265-37626599.561100.48
5354599-35459993.82894.69
6367537-36753797.25198.17
比拉斯汀口崩片项目信息
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D1BSF0200923对照品来源自制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500
标示量(mg)20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%
111.073747063741183743703742793738823742710.09
211.053758163759423758790.03
单位质量响应值RSD%判断
33809.4934016.200.44数据可信
供试品溶液-3066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%
5min1161781-16178142.76343.413.3442.7643.413.34
2170609-17060945.09745.10
3170350-17035045.02845.03
4160549-16054942.43742.44
5157046-15704641.51241.51
6165008-16500843.61643.62
10min1226773-22677359.94260.364.2060.0160.434.20
2242630-24263064.13464.21
3232084-23208461.34661.42
4215467-21546756.95457.02
5220776-22077658.35758.43
6232353-23235361.41761.49
15min1274314-27431472.50973.683.1372.6873.853.13
2291860-29186077.14777.33
3276821-27682173.17173.35
4266350-26635070.40470.57
5278805-27880573.69673.86
6284275-28427575.14275.32
20min1308708-30870881.60082.762.6681.8983.062.66
2323458-32345885.49985.81
3305591-30559180.77681.08
4303838-30383880.31380.60
5315348-31534883.35583.64
6321615-32161585.01285.31
30min1346176-34617691.50491.552.3991.9391.982.39
2354614-35461493.73494.19
3334548-33454888.43088.86
4339100-33910089.63390.05
5348696-34869692.17092.60
6354983-35498393.83294.27
45min1360357-36035795.25294.922.5195.8395.512.50
2366724-36672496.93597.54
3345374-34537491.29291.87
4352362-35236293.13993.71
5360302-36030295.23895.82
6369495-36949597.66898.27
60min1364233-36423396.27795.972.4897.0296.722.48
2370567-37056797.95198.72
3349460-34946092.37293.11
4356447-35644794.21994.94
5363819-36381996.16796.91
6373918-37391898.83799.60
极限1363922-36392296.19496.052.5497.0996.952.54
2371194-37119498.11799.05
3350003-35000392.51593.40
4355734-35573494.03094.91
5364823-36482396.43397.33
6374538-37453899.00199.93
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