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%
111.073731383754193753673764293757133752130.33
211.053728983753923741450.48
单位质量响应值RSD%判断
33894.5833859.280.08数据可信
供试品溶液-2024121821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%
5min1204440-20444054.09655.291.7854.1055.291.78
2213547-21354756.50656.51
3208214-20821455.09455.09
4211455-21145555.95255.95
5204992-20499254.24254.24
6211135-21113555.86755.87
10min1274399-27439972.60774.251.8472.7074.351.84
2287191-28719175.99276.09
3279362-27936273.92174.01
4282437-28243774.73474.83
5275407-27540772.87472.96
6284948-28494875.39975.49
15min1307811-30781181.44883.941.9381.6684.161.93
2323801-32380185.67985.90
3317946-31794684.13084.35
4318617-31861784.30884.53
5312606-31260682.71782.93
6322701-32270185.38885.61
20min1330034-33003487.32989.451.6187.6889.811.61
2341161-34116190.27390.64
3339932-33993289.94890.30
4339351-33935189.79490.15
5333175-33317588.16088.51
6344667-34466791.20191.56
30min1346335-34633591.64294.301.9792.1394.801.97
2360091-36009195.28295.80
3360760-36076095.45995.96
4357648-35764894.63595.14
5349232-34923292.40992.91
6364110-36411096.34596.86
45min1355577-35557794.08797.101.8494.7397.761.84
2369350-36935097.73298.40
3371101-37110198.19598.86
4368187-36818797.42498.09
5362989-36298996.04996.70
6374556-37455699.10999.78
60min1358250-35825094.79597.791.8595.6098.621.85
2371148-37114898.20899.04
3374612-37461299.12499.95
4371140-37114098.20599.03
5365296-36529696.65997.47
6377035-37703599.765100.60
极限1360022-36002295.26497.951.8796.2298.941.86
2372811-37281198.64899.65
3375619-37561999.391100.38
4372226-37222698.49399.48
5363387-36338796.15497.13
6377052-37705299.770100.77
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%
111.073755653760213748983756183754483755100.11
211.053739363751463745410.23
单位质量响应值RSD%判断
33921.4133895.110.06数据可信
供试品溶液-2024121821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%
5min1219528-21952858.03555.103.8658.0355.103.85
2216186-21618657.15157.15
3206386-20638654.56054.56
4207091-20709154.74754.75
5198199-19819952.39652.40
6203127-20312753.69953.70
10min1292215-29221577.25073.823.9577.3573.913.95
2291978-29197877.18777.28
3277376-27737673.32773.42
4278691-27869173.67573.77
5268197-26819770.90170.99
6266924-26692470.56470.65
15min1328039-32803986.72183.862.9486.9584.082.94
2328486-32848686.83987.06
3315943-31594383.52383.74
4315735-31573583.46883.68
5307393-30739381.26381.47
6307779-30777981.36581.57
20min1347245-34724591.79889.262.4592.1789.612.46
2348065-34806592.01592.38
3336390-33639088.92889.28
4335104-33510488.58888.94
5328798-32879886.92187.26
6330266-33026687.30987.65
30min1366127-36612796.78994.332.3197.3194.832.32
2366768-36676896.95997.48
3355965-35596594.10394.60
4355232-35523293.90994.41
5346479-34647991.59592.08
6350269-35026992.59793.09
45min1377552-37755299.81096.992.05100.4997.652.06
2374699-37469999.05699.74
3365449-36544996.61097.27
4363496-36349696.09496.75
5360696-36069695.35495.99
6359404-35940495.01295.65
60min1380189-380189100.50797.692.06101.3698.512.06
2376897-37689799.637100.49
3368876-36887697.51698.33
4367290-36729097.09797.91
5361533-36153395.57596.37
6362445-36244595.81696.62
极限1379258-379258100.26197.731.80101.2898.721.81
2376238-37623899.462100.48
3368775-36877597.49098.47
4366389-36638996.85997.84
5362813-36281395.91396.87
6364622-36462296.39297.35
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%
111.073745313761413766803767063763623760840.24
211.053780403784353782380.08
单位质量响应值RSD%判断
33973.2634229.680.54数据可信
供试品溶液-2024121921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%
5min1190771-19077150.14749.951.2250.1549.941.22
2188437-18843749.53449.53
3189150-18915049.72149.72
4194364-19436451.09251.09
5188925-18892549.66249.66
6188373-18837349.51749.52
10min1265763-26576369.86070.121.5269.9470.201.52
2271387-27138771.33871.42
3265455-26545569.77969.86
4271776-27177671.44171.53
5261416-26141668.71768.80
6264752-26475269.59469.68
15min1310022-31002281.49480.951.8081.6981.151.80
2315814-31581483.01783.22
3303897-30389779.88480.08
4310984-31098481.74781.95
5300210-30021078.91579.11
6306856-30685680.66280.86
20min1328115-32811586.25086.772.3286.5987.112.32
2343551-34355190.30890.65
3324889-32488985.40285.73
4331802-33180287.22087.56
5321291-32129184.45784.79
6330927-33092786.99087.32
30min1348539-34853991.61991.872.0892.1092.352.08
2361431-36143195.00895.50
3344022-34402290.43290.91
4351815-35181592.48092.97
5340419-34041989.48589.95
6350671-35067192.18092.66
45min1362910-36291095.39794.922.0696.0395.552.06
2372271-37227197.85798.51
3355821-35582193.53394.16
4364168-36416895.72796.37
5350642-35064292.17292.79
6360727-36072794.82395.45
60min1366155-36615596.25096.202.2197.0496.992.20
2379176-37917699.673100.48
3361342-36134294.98595.77
4368696-36869696.91897.72
5354994-35499493.31694.09
6365359-36535996.04196.83
极限1369440-36944097.11397.313.2298.0798.273.21
2392055-392055103.058104.04
3363826-36382695.63896.58
4370713-37071397.44898.41
5356503-35650393.71394.64
6368663-36866396.90997.86
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%
111.073765853770173775473774213770173771170.11
211.053782593784813783700.05
单位质量响应值RSD%判断
34066.5834241.630.37数据可信
供试品溶液-2024121921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%
5min1190944-19094450.11550.712.1950.1250.712.19
2193407-19340750.76150.76
3195518-19551851.31651.32
4191003-19100350.13050.13
5200215-20021552.54852.55
6188205-18820549.39649.40
10min1262787-26278768.97169.932.4069.0570.022.40
2272438-27243871.50471.59
3270723-27072371.05471.14
4266730-26673070.00670.09
5270523-27052371.00171.09
6255520-25552067.06467.15
15min1302071-30207179.28180.742.0279.4880.942.02
2307735-30773580.76880.97
3317421-31742183.31083.51
4307510-30751080.70980.91
5310853-31085381.58681.79
6300238-30023878.80078.99
20min1326192-32619285.61286.751.2485.9487.081.25
2331618-33161887.03687.37
3336579-33657988.33888.68
4333011-33301187.40287.74
5329704-32970486.53486.88
6325998-32599885.56185.89
30min1347984-34798491.33292.191.0591.8092.661.05
2352802-35280292.59693.08
3357926-35792693.94194.43
4349412-34941291.70692.19
5350419-35041991.97192.46
6348878-34887891.56692.03
45min1360123-36012394.51894.891.0695.1495.531.06
2361059-36105994.76395.40
3369192-36919296.89897.54
4359739-35973994.41795.05
5358730-35873094.15294.79
6360518-36051894.62195.24
60min1364910-36491095.77495.890.9996.5696.680.99
2363717-36371795.46196.26
3372371-37237197.73298.54
4365491-36549195.92696.72
5362372-36237295.10895.90
6363289-36328995.34996.13
极限1366446-36644696.17796.521.0497.1297.481.03
2364975-36497595.79196.75
3374799-37479998.36999.34
4369269-36926996.91897.87
5366200-36620096.11397.07
6364887-36488795.76896.71
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%
111.073776083780413775493778203776393777310.06
211.053781263779013780140.05
单位质量响应值RSD%判断
34122.0434209.410.19数据可信
供试品溶液-2024122021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%
5min1183665-18366548.18850.062.7548.1950.062.75
2187269-18726949.13449.13
3190071-19007149.86949.87
4195845-19584551.38451.38
5190208-19020849.90549.90
6197710-19771051.87351.87
10min1255516-25551667.03969.502.0867.1269.582.08
2264558-26455869.41269.49
3262875-26287568.97069.05
4269486-26948670.70570.79
5266016-26601669.79469.88
6270943-27094371.08771.17
15min1299587-29958778.60280.411.5578.7980.611.56
2305751-30575180.21980.42
3306687-30668780.46580.66
4309626-30962681.23681.44
5303855-30385579.72279.92
6313394-31339482.22582.43
20min1324781-32478185.21286.131.4485.5486.461.44
2325644-32564485.43985.77
3328509-32850986.19086.52
4329024-32902486.32686.66
5324651-32465185.17885.51
6337068-33706888.43688.78
30min1350795-35079592.03891.341.1392.5091.821.13
2343986-34398690.25190.72
3346941-34694191.02691.50
4349635-34963591.73392.22
5343827-34382790.20990.68
6353675-35367592.79393.28
45min1362509-36250995.11194.201.3195.7394.831.31
2352958-35295892.60593.23
3358551-35855194.07394.70
4361388-36138894.81795.45
5354169-35416992.92393.55
6364676-36467695.68096.32
60min1366056-36605696.04295.251.1496.8296.031.14
2357812-35781293.87994.66
3361663-36166394.88995.67
4365414-36541495.87396.67
5359130-35913094.22495.00
6368086-36808696.57497.38
极限1369084-36908496.83695.991.3797.7796.941.36
2358594-35859494.08495.02
3364786-36478695.70896.65
4368761-36876196.75197.70
5362044-36204494.98995.93
6371963-37196397.59198.56
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%
111.073782663785483783463781323780993782780.05
211.053802703806203804450.07
单位质量响应值RSD%判断
34171.4534429.410.54数据可信
供试品溶液-2024122021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%
5min1190090-19009049.67849.431.7449.6849.421.74
2185548-18554848.49148.49
3191024-19102449.92249.92
4188439-18843949.24749.25
5185618-18561848.51048.51
6194018-19401850.70550.70
10min1265755-26575569.45368.301.1369.5468.381.13
2256706-25670667.08867.17
3261657-26165768.38268.47
4262091-26209168.49568.58
5260200-26020068.00168.08
6261571-26157168.35968.44
15min1305386-30538679.81079.461.1180.0179.661.12
2300491-30049178.53178.72
3309016-30901680.75980.96
4301318-30131878.74778.94
5301761-30176178.86379.06
6306311-30631180.05280.25
20min1329114-32911486.01185.681.4086.3486.001.40
2325613-32561385.09685.42
3333115-33311587.05787.39
4322859-32285984.37684.70
5323407-32340784.52084.85
6332906-33290687.00287.33
30min1349507-34950791.34191.791.6991.8292.261.69
2348831-34883191.16491.63
3358787-35878793.76694.24
4346488-34648890.55291.02
5345248-34524890.22890.69
6358413-35841393.66894.15
45min1363127-36312794.90094.861.7495.5395.491.73
2361387-36138794.44595.06
3370195-37019596.74797.38
4359027-35902793.82994.45
5354150-35415092.55493.17
6369993-36999396.69597.33
60min1366059-36605995.66695.981.7696.4596.761.76
2363418-36341894.97695.75
3373357-37335797.57498.37
4366003-36600395.65296.43
5358660-35866093.73394.50
6376107-37610798.29299.09
极限1368919-36891996.41496.671.7697.3697.611.75
2364382-36438295.22896.16
3376432-37643298.37799.33
4369539-36953996.57697.51
5361792-36179294.55195.48
6378254-37825498.85399.81
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