盐酸奥洛他定口崩片项目信息
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101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.782230782232312232362233062234262232550.06
210.712249912248272249090.06
单位质量响应值RSD%判断
20710.1120999.910.99数据可信
长期12月-供试品溶液-2025041521批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1195967-19596784.40583.481.1484.4083.481.14
2194042-19404283.57683.58
3192365-19236582.85382.85
4196345-19634584.56784.57
5190525-19052582.06182.06
6193722-19372283.43883.44
10min1208768-20876889.91889.581.0990.0689.721.09
2208130-20813089.64389.78
3207974-20797489.57689.71
4211116-21111690.92991.07
5204133-20413387.92288.06
6207734-20773489.47389.61
15min1213702-21370292.04391.741.1792.3392.031.17
2212710-21271091.61691.90
3213056-21305691.76592.05
4216842-21684293.39693.69
5209118-20911890.06990.35
6212585-21258591.56291.85
20min1216339-21633993.17992.861.1693.6293.301.16
2215346-21534692.75193.19
3215280-21528092.72393.16
4219403-21940394.49994.95
5211599-21159991.13891.57
6215670-21567092.89193.33
30min1219679-21967994.61894.241.3095.2294.841.30
2218740-21874094.21394.81
3219195-21919594.40995.00
4222934-22293496.02096.63
5214171-21417192.24592.83
6218065-21806593.92294.52
极限1222337-22233795.76295.231.2496.5295.981.24
2221912-22191295.57996.33
3221394-22139495.35696.11
4224459-22445996.67697.44
5216342-21634293.18093.92
6220132-22013294.81395.56
盐酸奥洛他定口崩片项目信息
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101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.782249542249602248882248812245102248390.09
210.712239322236872238100.08
单位质量响应值RSD%判断
20857.0520897.290.14数据可信
长期12月-供试品溶液-2025041621批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1197265-19726584.87083.151.7384.8783.151.73
2193924-19392483.43283.43
3195988-19598884.32084.32
4189111-18911181.36181.36
5193849-19384983.40083.40
6189499-18949981.52881.53
10min1212298-21229891.33788.811.9391.4888.951.93
2206320-20632088.76588.90
3210146-21014690.41190.55
4202893-20289387.29187.43
5202963-20296387.32187.46
6203960-20396087.75087.89
15min1216913-21691393.32390.762.0193.6291.052.01
2211443-21144390.96991.26
3214885-21488592.45092.74
4206552-20655288.86589.15
5207167-20716789.13089.41
6208779-20877989.82390.11
20min1219406-21940694.39591.882.0594.8492.322.05
2213657-21365791.92292.36
3217819-21781993.71394.16
4208240-20824089.59190.02
5209939-20993990.32290.76
6212348-21234891.35991.79
30min1222828-22282895.86893.102.1396.4793.692.12
2216693-21669393.22893.82
3220474-22047494.85595.46
4210948-21094890.75691.33
5212425-21242591.39291.98
6215039-21503992.51693.10
极限1225666-22566697.08994.052.2897.8594.792.27
2218841-21884194.15294.90
3222880-22288095.89096.65
4212728-21272891.52292.25
5214320-21432092.20792.94
6217142-21714293.42194.16
盐酸奥洛他定口崩片项目信息
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101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.782248842249382246572248242247562248120.05
210.712240932240682240800.01
单位质量响应值RSD%判断
20854.5520922.500.24数据可信
长期12月-供试品溶液-2025041821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1201637-20163786.70485.321.3686.7085.321.36
2196474-19647484.48384.48
3201509-20150986.64886.65
4196561-19656184.52184.52
5195459-19545984.04784.05
6198875-19887585.51685.52
10min1214420-21442092.20091.051.4692.3491.191.46
2210656-21065690.58290.72
3215531-21553192.67892.82
4211440-21144090.91991.06
5206758-20675888.90689.05
6211665-21166591.01691.16
15min1219344-21934494.31793.231.4394.6293.531.44
2215673-21567392.73993.03
3220970-22097095.01795.32
4216278-21627892.99993.29
5212059-21205991.18591.47
6216598-21659893.13793.43
20min1222033-22203395.47494.291.6195.9394.741.61
2218650-21865094.01994.47
3223272-22327296.00796.46
4218547-21854793.97594.42
5213171-21317191.66392.10
6219961-21996194.58395.03
30min1225487-22548796.95995.631.3697.5796.241.36
2220779-22077994.93595.54
3225442-22544296.94097.56
4221900-22190095.41796.02
5217627-21762793.57994.17
6223207-22320795.97996.59
极限1227909-22790998.00096.651.2498.7897.421.24
2222828-22282895.81696.58
3227413-22741397.78798.57
4223983-22398396.31297.08
5220700-22070094.90195.65
6225730-22573097.06397.83
盐酸奥洛他定口崩片项目信息
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101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.782247992249572246852244752242322246300.13
210.712246092244172245130.07
单位质量响应值RSD%判断
20837.6620962.930.43数据可信
中间条件12月-供试品溶液-2025041521批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1202227-20222786.90986.021.6586.9186.021.65
2205470-20547088.30288.30
3198441-19844185.28285.28
4197173-19717384.73784.74
5200616-20061686.21686.22
6197033-19703384.67784.68
10min1212225-21222591.20690.501.3591.3590.641.35
2215040-21504092.41592.56
3209721-20972190.12990.27
4209027-20902789.83189.97
5210715-21071590.55790.70
6206772-20677288.86289.00
15min1215612-21561292.66191.841.3092.9692.141.30
2217338-21733893.40393.70
3213617-21361791.80492.10
4212556-21255691.34891.64
5213895-21389591.92392.22
6209198-20919889.90590.19
20min1217808-21780893.60592.611.3094.0693.061.30
2219307-21930794.24994.71
3213947-21394791.94692.39
4214650-21465092.24892.69
5215782-21578292.73493.18
6211526-21152690.90591.34
30min1220362-22036294.70293.761.2295.3194.361.22
2221787-22178795.31595.93
3216983-21698393.25093.85
4216778-21677893.16293.76
5218621-21862193.95494.56
6214500-21450092.18392.77
极限1221095-22109595.01794.241.3195.7895.001.31
2223319-22331995.97396.75
3217573-21757393.50494.26
4218636-21863693.96194.71
5219961-21996194.53095.29
6215084-21508492.43493.18
盐酸奥洛他定口崩片项目信息
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101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.782256972254702255872255922257172256130.05
210.712248742252772250760.13
单位质量响应值RSD%判断
20928.8521015.500.30数据可信
中间条件12月-供试品溶液-2025041621批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1198836-19883685.15884.021.0885.1684.021.08
2195024-19502483.52683.53
3193313-19331382.79382.79
4196906-19690684.33284.33
5198056-19805684.82484.82
6194973-19497383.50483.50
10min1212025-21202590.80789.041.6390.9589.181.63
2205951-20595188.20588.34
3203578-20357887.18987.33
4208655-20865589.36489.50
5211441-21144190.55790.70
6205749-20574988.11988.26
15min1215466-21546692.28190.801.4692.5791.091.46
2209959-20995989.92290.21
3208066-20806689.11189.39
4212746-21274691.11691.41
5215512-21551292.30092.59
6210331-21033190.08190.37
20min1217848-21784893.30191.721.6193.7592.161.61
2211456-21145690.56391.00
3210315-21031590.07490.51
4215808-21580892.42792.87
5217897-21789793.32293.77
6211622-21162290.63491.07
30min1221143-22114394.71292.921.7295.3193.511.72
2214292-21429291.77892.36
3213333-21333391.36791.95
4217663-21766393.22193.82
5221536-22153694.88095.48
6213746-21374691.54492.13
极限1222389-22238995.24693.551.6496.0194.301.64
2215536-21553692.31193.05
3214592-21459291.90692.64
4219835-21983594.15294.90
5222454-22245495.27396.03
6215818-21581892.43193.17
盐酸奥洛他定口崩片项目信息
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101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.782247642244732247252247372250422247480.09
210.712245202253472249340.26
单位质量响应值RSD%判断
20848.6121002.240.52数据可信
中间条件12月-供试品溶液-2025041821批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1207312-20731288.98887.411.4588.9987.411.45
2200454-20045486.04486.04
3200645-20064586.12686.13
4206694-20669488.72288.72
5202515-20251586.92886.93
6204151-20415187.63187.63
10min1217518-21751893.36892.331.5293.5292.481.52
2210638-21063890.41590.56
3211574-21157490.81790.96
4218238-21823893.67793.83
5217261-21726193.25893.40
6215365-21536592.44492.59
15min1221759-22175995.18994.171.4295.4994.471.42
2215400-21540092.45992.75
3216251-21625192.82593.12
4223458-22345895.91896.22
5219681-21968194.29794.60
6219829-21982994.36094.66
20min1225569-22556996.82495.341.7997.2995.801.79
2217228-21722893.24493.69
3218338-21833893.72094.17
4227454-22745497.63398.10
5222011-22201195.29795.75
6222115-22211595.34295.80
30min1227990-22799097.86396.351.5898.4996.971.58
2220065-22006594.46295.07
3220762-22076294.76195.37
4228575-22857598.11598.74
5224898-22489896.53697.15
6224502-22450296.36696.98
极限1230122-23012298.77997.201.6899.5797.981.67
2221338-22133895.00895.77
3222641-22264195.56796.33
4230426-23042698.90999.70
5227715-22771597.74598.52
6226459-22645997.20697.98
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