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%
1 10.722190382184312210282213302207742201200.59
2 10.772211892209022210460.10
单位质量响应值RSD%判断
20533.5820524.230.04数据可信
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%
5min1198129-19812986.68787.401.1186.6987.401.11
2201161-20116188.01488.01
3197781-19778186.53586.53
4197593-19759386.45386.45
5201191-20119188.02788.03
6202741-20274188.70588.71
10min1211489-21148992.53393.090.8892.6893.240.88
2213481-21348193.40493.55
3210915-21091592.28292.43
4211023-21102392.32992.47
5214799-21479993.98194.13
6214912-21491294.03094.18
15min1217155-21715595.01295.420.6995.3195.720.69
2219240-21924095.92496.23
3216792-21679294.85395.15
4216347-21634794.65894.96
5218996-21899695.81796.12
6219973-21997396.24596.55
20min1220578-22057896.50996.700.5396.9797.160.53
2222318-22231897.27197.73
3220470-22047096.46296.92
4219234-21923495.92196.38
5221362-22136296.85297.32
6222159-22215997.20197.67
30min1224430-22443098.19598.300.6098.8198.920.60
2225411-22541198.62499.25
3224324-22432498.14898.77
4222312-22231297.26897.88
5225449-22544998.64199.27
6226098-22609898.92599.55
极限1225966-22596698.86799.350.6999.65100.130.69
2227561-22756199.565100.35
3228087-22808799.795100.58
4224724-22472498.32399.10
5226961-22696199.302100.09
6229075-229075100.227101.02
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%
1 10.722206972205862203972205792207272205970.06
2 10.772200172205682202920.18
单位质量响应值RSD%判断
20578.0820454.220.43数据可信
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%
5min1200699-20069987.86788.130.9487.8788.130.95
2199065-19906587.15287.15
3201648-20164888.28388.28
4204740-20474089.63689.64
5200626-20062687.83587.84
6200970-20097087.98687.99
10min1212277-21227792.93693.090.9793.0893.240.97
2211269-21126992.49592.64
3213337-21333793.40093.55
4216437-21643794.75794.91
5211499-21149992.59592.74
6210986-21098692.37192.52
15min1216486-21648694.77995.060.8795.0895.360.87
2216628-21662894.84195.14
3217495-21749595.22095.52
4220710-22071096.62896.94
5215747-21574794.45594.76
6215714-21571494.44194.74
20min1218698-21869895.74796.160.7796.2196.620.77
2219073-21907395.91196.37
3220052-22005296.34096.80
4222856-22285697.56898.04
5218570-21857095.69196.15
6218605-21860595.70696.16
30min1222879-22287997.57897.630.9998.2098.250.99
2221963-22196397.17797.79
3223950-22395098.04798.67
4226881-22688199.33099.96
5220764-22076496.65297.27
6221528-22152896.98697.60
极限1224143-22414398.13198.441.0798.9199.231.07
2224767-22476798.40499.18
3225077-22507798.54099.33
4229308-229308100.392101.19
5223533-22353397.86498.64
6222326-22232697.33698.11
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%
1 10.722196922197012205912199872193332198610.22
2 10.772199232201892200560.09
单位质量响应值RSD%判断
20509.4220432.310.27数据可信
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%
5min1191711-19171184.11785.052.4584.1285.052.45
2189703-18970383.23683.24
3194566-19456685.37085.37
4202914-20291489.03389.03
5191256-19125683.91883.92
6192817-19281784.60384.60
10min1205271-20527190.06790.732.3390.2190.872.33
2202259-20225988.74588.88
3207667-20766791.11891.26
4215865-21586594.71594.86
5203884-20388489.45889.60
6205700-20570090.25590.40
15min1210344-21034492.29393.192.6992.5893.482.69
2207960-20796091.24791.53
3213854-21385493.83394.13
4223290-22329097.97398.28
5209034-20903491.71892.01
6209805-20980592.05692.35
20min1213285-21328593.58394.352.6994.0394.802.69
2209531-20953191.93692.37
3216724-21672495.09295.54
4225770-22577099.06199.53
5211474-21147492.78993.23
6213371-21337193.62194.07
30min1215956-21595694.75595.692.5695.3696.302.56
2213532-21353293.69294.28
3219166-21916696.16496.77
4228805-228805100.393101.03
5215110-21511094.38494.98
6215931-21593194.74495.35
极限1218713-21871395.96596.902.6196.7297.662.61
2216617-21661795.04595.79
3221241-22124197.07497.84
4232117-232117101.846102.65
5217240-21724095.31996.07
6219120-21912096.14496.90
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%
1 10.722199762202492206132206132203602203620.13
2 10.772198962200042199500.04
单位质量响应值RSD%判断
20556.1620422.470.47数据可信
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%
5min1194404-19440485.22386.160.8585.2286.160.85
2198886-19888687.18887.19
3197973-19797386.78786.79
4196728-19672886.24286.24
5195445-19544585.67985.68
6195864-19586485.86385.86
10min1208502-20850291.40392.241.0291.5592.381.02
2213649-21364993.65993.80
3212321-21232193.07793.22
4209496-20949691.83991.98
5208379-20837991.34991.49
6210132-21013292.11892.26
15min1212597-21259793.19894.570.8793.4994.870.87
2218092-21809295.60795.91
3216882-21688295.07795.38
4216226-21622694.78995.09
5215467-21546794.45694.75
6215148-21514894.31694.61
20min1215824-21582494.61395.771.0695.0696.221.06
2221752-22175297.21297.67
3220635-22063596.72297.18
4218098-21809895.61096.06
5216514-21651494.91595.37
6217953-21795395.54696.00
30min1219486-21948696.21897.400.9396.8398.020.93
2225475-22547598.84499.47
3223459-22345997.96098.58
4221812-22181297.23897.85
5221732-22173297.20397.81
6221173-22117396.95897.57
极限1221357-22135797.03898.360.9897.8199.130.98
2228166-228166100.023100.81
3224740-22474098.52199.30
4223821-22382198.11998.89
5223912-22391298.15898.93
6224203-22420398.28699.06
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%
1 10.722202862210602215802206872208472208920.22
2 10.772196552198102197320.05
单位质量响应值RSD%判断
20605.6020402.230.71数据可信
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%
5min1207454-20745490.88089.611.1890.8889.611.18
2202684-20268488.79088.79
3206531-20653190.47690.48
4205408-20540889.98489.98
5201035-20103588.06888.07
6204194-20419489.45289.45
10min1220207-22020796.46795.301.1896.6295.451.18
2215736-21573694.50894.66
3219235-21923596.04196.19
4218597-21859795.76295.91
5213308-21330893.44593.59
6218171-21817195.57595.72
15min1224345-22434598.28097.441.2598.5997.751.25
2220231-22023196.47796.78
3225146-22514698.63098.94
4223699-22369997.99798.31
5217917-21791795.46495.77
6223202-22320297.77998.09
20min1228243-22824399.98798.811.44100.4699.281.44
2223348-22334897.84398.31
3227597-22759799.704100.18
4227612-22761299.711100.18
5220003-22000396.37796.84
6226533-22653399.23899.71
30min1231151-231151101.261100.161.21101.90100.801.21
2226227-22622799.10499.73
3230627-230627101.032101.67
4230870-230870101.138101.78
5224511-22451198.35298.97
6228451-228451100.078100.72
极限1234437-234437102.701101.301.41103.51102.101.41
2228791-228791100.227101.02
3233795-233795102.419103.23
4232073-232073101.665102.47
5225934-22593498.97699.76
6232407-232407101.811102.61
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%
1 10.722202912203262207552208162207332205840.12
2 10.772190422191112190760.03
单位质量响应值RSD%判断
20576.8720341.320.82数据可信
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%
5min1209953-20995392.17789.981.6692.1889.981.66
2203834-20383489.49189.49
3202791-20279189.03389.03
4203933-20393389.53489.53
5208109-20810991.36891.37
6201013-20101388.25288.25
10min1224225-22422598.44395.811.7698.6095.961.76
2216766-21676695.16895.32
3216574-21657495.08495.23
4216583-21658395.08895.24
5221398-22139897.20297.35
6213812-21381293.87194.02
15min1228921-228921100.50598.131.60100.8298.441.60
2223161-22316197.97698.28
3222373-22237397.63097.94
4221162-22116297.09897.41
5226348-22634899.37599.69
6219087-21908796.18796.49
20min1233246-233246102.40499.491.85102.8999.961.85
2225388-22538898.95499.42
3225777-22577799.12499.59
4224371-22437198.50798.98
5229533-229533100.773101.25
6221342-22134297.17797.64
30min1235851-235851103.547100.931.77104.20101.571.77
2228461-228461100.303100.94
3229559-229559100.785101.42
4227516-22751699.888100.52
5233285-233285102.421103.07
6224678-22467898.64299.27
极限1237882-237882104.439101.761.80105.27102.571.80
2231218-231218101.513102.32
3230708-230708101.289102.09
4229248-229248100.648101.45
5235276-235276103.295104.11
6226337-22633799.370100.16
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