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%
111.012302052303202310022306072303122304890.15
211.002304042300762302400.11
单位质量响应值RSD%判断
20934.5120930.910.02数据可信
供试品溶液-777ABL批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1189353-18935381.24977.689.3281.2577.689.31
2164064-16406470.39870.40
3155879-15587966.88666.89
4187578-18757880.48880.49
5191844-19184482.31882.32
6197498-19749884.74484.74
10min1207778-20777889.15588.822.2989.2988.952.29
2202955-20295587.08687.20
3206295-20629588.51988.63
4202350-20235086.82686.96
5207150-20715088.88689.02
6215506-21550692.47192.61
15min1212572-21257291.21291.072.1491.5091.342.14
2209215-20921589.77290.03
3211101-21110190.58190.84
4206848-20684888.75689.04
5213620-21362091.66291.95
6220040-22004094.41794.71
20min1216710-21671092.98892.522.1493.4292.942.15
2214369-21436991.98392.40
3213668-21366891.68392.09
4209226-20922689.77790.20
5216459-21645992.88093.32
6223236-22323695.78896.24
30min1220548-22054894.63594.342.0295.2394.922.02
2219986-21998694.39494.96
3219912-21991294.36294.92
4212738-21273891.28491.86
5219217-21921794.06494.66
6226706-22670697.27797.89
45min1222855-22285595.62594.911.9796.3795.651.97
2220329-22032994.54195.26
3220087-22008794.43795.16
4214757-21475792.15092.88
5220973-22097394.81795.57
6228121-22812197.88498.66
60min1223456-22345695.88395.622.1196.7996.522.11
2222240-22224095.36196.24
3220512-22051294.61995.50
4216396-21639692.85393.74
5223826-22382696.04196.95
6230659-23065998.97399.91
极限1224012-22401296.12196.111.8297.1997.171.82
2222976-22297695.67796.72
3223750-22375096.00997.04
4218153-21815393.60794.64
5224196-22419696.20097.27
6230874-23087499.066100.17
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%
111.012303742306822312152298812313262306960.26
211.002302002307352304680.17
单位质量响应值RSD%判断
20953.3220951.640.01数据可信
供试品溶液-777ABL批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1192005-19200582.31075.719.8482.3175.719.84
2183655-18365578.73078.73
3175485-17548575.22875.23
4190074-19007481.48281.48
5144472-14447261.93361.93
6174019-17401974.59974.60
10min1210460-21046090.22189.332.0990.3689.462.08
2201099-20109986.20886.34
3206281-20628188.42988.55
4212281-21228191.00291.14
5212476-21247691.08591.19
6207703-20770389.03989.16
15min1215014-21501492.17391.541.8492.4691.811.84
2208007-20800789.16989.44
3210002-21000290.02590.30
4216534-21653492.82593.11
5218307-21830793.58593.84
6213312-21331291.44491.72
20min1218949-21894993.86092.872.0994.3093.302.09
2211026-21102690.46490.89
3211438-21143890.64091.06
4220902-22090294.69795.14
5221130-22113094.79595.21
6216456-21645692.79193.22
30min1223006-22300695.59994.341.8996.2094.921.89
2214878-21487892.11592.69
3214801-21480192.08292.66
4224217-22421796.11896.72
5221434-22143494.92595.49
6222038-22203895.18495.76
45min1225909-22590996.84495.731.8497.6096.471.84
2219246-21924693.98794.72
3218750-21875093.77594.50
4228552-22855297.97798.74
5226210-22621096.97397.70
6221211-22121194.83095.57
60min1228273-22827397.85796.202.0798.7897.102.06
2218821-21882193.80594.69
3218884-21888493.83294.72
4228547-22854797.97598.90
5228036-22803697.75598.64
6223869-22386995.96996.87
极限1230508-23050898.81596.562.0199.9097.622.01
2222045-22204595.18796.23
3218651-21865193.73294.77
4228470-22847097.94299.03
5228083-22808397.77698.83
6223740-22374095.91496.97
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%
111.012303452300992299822299222297002300100.11
211.002296462298382297420.06
单位质量响应值RSD%判断
20891.0120885.640.02数据可信
供试品溶液-777ABL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%
5min1201428-20142886.61487.426.4086.6187.426.40
2198580-19858085.39085.39
3182583-18258378.51178.51
4209174-20917489.94589.95
5206077-20607788.61388.61
6221971-22197195.44895.45
10min1226596-22659697.43797.773.0197.5897.923.01
2230375-23037599.06199.20
3214507-21450792.23892.37
4232193-23219399.84399.99
5233275-233275100.308100.46
6227329-22732997.75297.91
15min1226952-22695297.59099.182.1397.9099.492.13
2236168-236168101.552101.86
3225172-22517296.82497.11
4236142-236142101.541101.86
5232374-23237499.921100.24
6227051-22705197.63297.95
20min1226463-22646397.37999.271.8697.8599.741.85
2236298-236298101.608102.09
3228131-22813198.09798.54
4235181-235181101.128101.61
5232080-23208099.795100.28
6227002-22700297.61198.10
30min1226137-22613797.23999.202.0997.8799.842.09
2237518-237518102.133102.78
3227481-22748197.81798.43
4234436-234436100.808101.46
5232494-23249499.973100.62
6226088-22608897.21897.87
45min1225768-22576897.08098.881.7997.8799.681.79
2235622-235622101.318102.13
3227246-22724697.71698.49
4233420-233420100.371101.19
5231394-23139499.500100.31
6226307-22630797.31298.12
60min1224911-22491196.71298.761.9097.6799.731.89
2234709-234709100.925101.91
3226726-22672697.49298.43
4234338-234338100.766101.75
5231301-23130199.460100.44
6226016-22601697.18798.16
极限1224332-22433296.46398.501.8897.5899.631.87
2234232-234232100.720101.87
3226318-22631897.31798.41
4233449-233449100.383101.54
5230655-23065599.182100.33
6225393-22539396.91998.05
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%
111.012300672299492301272298302298702299690.06
211.002307072298142302600.28
单位质量响应值RSD%判断
20887.2820932.730.16数据可信
供试品溶液-777ABL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%
5min1231311-23131199.36188.666.2299.3688.666.22
2202994-20299487.19787.20
3206581-20658188.73888.74
4199169-19916985.55485.55
5195027-19502783.77583.77
6203292-20329287.32587.33
10min1240026-240026103.10599.802.22103.2799.952.22
2226508-22650897.29897.44
3229596-22959698.62498.77
4234856-234856100.884101.03
5234926-234926100.914101.05
6228074-22807497.97098.12
15min1240641-240641103.369100.122.56103.71100.442.56
2225568-22556896.89497.20
3229297-22929798.49698.81
4237166-237166101.876102.19
5236951-236951101.784102.09
6228866-22886698.31198.62
20min1240629-240629103.364100.032.55103.87100.512.55
2225418-22541896.83097.30
3229597-22959798.62599.10
4236872-236872101.750102.23
5236399-236399101.547102.02
6228307-22830798.07198.54
30min1240131-240131103.15099.862.49103.83100.512.49
2225538-22553896.88197.51
3229614-22961498.63299.27
4236144-236144101.437102.09
5236043-236043101.394102.04
6227349-22734997.65998.30
45min1240881-240881103.47299.632.70104.33100.452.70
2224943-22494396.62697.42
3227502-22750297.72598.53
4235675-235675101.236102.05
5235368-235368101.104101.92
6227306-22730697.64198.44
60min1239894-239894103.04899.412.73104.07100.392.73
2223470-22347095.99396.95
3227852-22785297.87598.84
4235961-235961101.358102.35
5234481-234481100.723101.71
6226848-22684897.44498.41
极限1240093-240093103.13399.192.78104.33100.342.78
2223323-22332395.93097.04
3226801-22680197.42498.55
4234335-234335100.660101.82
5234629-234629100.786101.94
6226283-22628397.20198.33
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