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%
110.912181032176412182262182782184522181400.15
2 11.042162442178912170680.54
单位质量响应值RSD%判断
19994.5019661.961.19数据可信
中间条件6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%
5min1198887-19888790.10087.412.2290.1087.412.22
2188023-18802385.17985.18
3197518-19751889.48089.48
4191688-19168886.83986.84
5191191-19119186.61486.61
6190421-19042186.26586.26
10min1212273-21227396.16493.432.2396.3193.572.23
2201089-20108991.09891.24
3211491-21149195.81095.96
4204939-20493992.84292.99
5202938-20293891.93592.08
6204646-20464692.70992.85
15min1217663-21766398.60695.792.1998.9296.092.20
2207283-20728393.90494.20
3217025-21702598.31798.63
4209120-20912094.73695.04
5208323-20832394.37594.67
6209231-20923194.78695.08
20min1220350-22035099.82397.012.17100.3097.482.17
2209235-20923594.78895.24
3219471-21947199.42599.90
4212680-21268096.34996.81
5210899-21089995.54296.00
6212255-21225596.15696.61
30min1223212-223212101.12098.612.02101.7699.232.02
2212811-21281196.40897.02
3222960-222960101.006101.64
4215892-21589297.80498.42
5214503-21450397.17597.79
6216617-21661798.13298.75
极限1226125-226125102.440100.012.09103.25100.802.09
2216521-21652198.08998.86
3227035-227035102.852103.66
4218490-21849098.98199.76
5217352-21735298.46599.24
6219017-21901799.220100.00
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%
110.912172282174992177142175002176612175200.09
2 11.042164502170412167460.20
单位质量响应值RSD%判断
19937.6719632.791.09数据可信
长期6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%
5min1184725-18472583.86684.101.5083.8784.101.50
2187874-18787485.29585.30
3182037-18203782.64582.65
4182546-18254682.87682.88
5185336-18533684.14384.14
6188965-18896585.79085.79
10min1197918-19791889.85590.371.3289.9990.511.32
2201099-20109991.29991.44
3197693-19769389.75389.89
4196134-19613489.04589.18
5198268-19826890.01490.15
6203266-20326692.28392.43
15min1204153-20415392.68692.991.1492.9893.281.14
2206608-20660893.80094.09
3203646-20364692.45692.74
4202210-20221091.80492.09
5203792-20379292.52292.81
6208550-20855094.68294.98
20min1207242-20724294.08894.421.3394.5394.861.33
2210004-21000495.34295.79
3205608-20560893.34693.79
4204546-20454692.86493.30
5208512-20851294.66595.11
6211915-21191596.21096.66
30min1210705-21070595.66096.191.5896.2696.791.58
2213411-21341196.88997.50
3208385-20838594.60795.20
4208841-20884194.81495.41
5212446-21244696.45197.05
6217398-21739898.69999.31
极限1214634-21463497.44498.551.9898.2099.311.97
2217575-21757598.77999.55
3213191-21319196.78997.54
4212825-21282596.62397.38
5223108-223108101.291102.05
6221073-221073100.368101.15
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%
110.912172502176562174222171242171302173160.11
2 11.042181362181662181510.01
单位质量响应值RSD%判断
19918.9719760.050.57数据可信
长期6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%
5min1186296-18629684.34485.621.3584.3485.621.35
2193072-19307287.41187.41
3186700-18670084.52784.53
4189775-18977585.91985.92
5188375-18837585.28585.28
6190534-19053486.26286.26
10min1198248-19824889.75591.472.0489.9091.612.03
2209597-20959794.89395.04
3199476-19947690.31190.45
4201639-20163991.29091.43
5199956-19995690.52890.67
6203310-20331092.04792.19
15min1203158-20315891.97893.892.1292.2794.192.12
2215381-21538197.51297.82
3204867-20486792.75293.04
4206793-20679393.62393.92
5205094-20509492.85493.15
6208999-20899994.62294.92
20min1206648-20664893.55895.362.2994.0095.812.29
2219544-21954499.39699.86
3207854-20785494.10494.55
4209327-20932794.77195.22
5207893-20789394.12294.57
6212486-21248696.20196.66
30min1210653-21065395.37196.942.0795.9797.542.07
2222385-222385100.683101.31
3210844-21084495.45896.06
4213598-21359896.70497.31
5211825-21182595.90296.51
6215353-21535397.49998.11
极限1215732-21573297.67199.462.2598.43100.242.24
2228806-228806103.590104.39
3216699-21669998.10898.87
4218218-21821898.79699.57
5216995-21699598.24299.01
6221699-221699100.372101.15
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