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)2.5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%
110.912133652147812150782151282134542143610.42
211.042151512132822142160.62
单位质量响应值RSD%判断
19648.1219403.620.89数据可信
长期6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%
5min187840-8784080.81781.432.4380.8281.432.43
290802-9080283.54283.54
389414-8941482.26582.27
485815-8581578.95478.95
590717-9071783.46483.46
686426-8642679.51679.52
10min193550-9355086.07086.802.1486.2186.942.14
296034-9603488.35688.49
395290-9529087.67187.81
491319-9131984.01884.15
596674-9667488.94589.08
693187-9318785.73685.87
15min196201-9620188.50989.361.8688.7989.641.86
298234-9823490.38090.67
397968-9796890.13590.42
494621-9462187.05687.33
599613-9961391.64991.94
696130-9613088.44488.72
20min197848-9784890.02590.581.7590.4591.011.75
299852-9985291.86892.31
399629-9962991.66392.10
496086-9608688.40488.82
5100301-10030192.28292.72
697017-9701789.26089.68
30min198913-9891391.00592.011.7591.5892.591.75
2100543-10054392.50493.09
3100990-10099092.91593.50
498019-9801990.18290.75
5102746-10274694.53195.12
698836-9883690.93491.51
极限1100755-10075592.69993.941.7993.4394.671.79
2103653-10365395.36696.11
3102832-10283294.61095.35
499990-9999091.99592.71
5104513-10451396.15796.91
6100870-10087092.80593.53
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)2.5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%
110.912134332134052149482133292146152139460.37
211.042151012135902143460.50
单位质量响应值RSD%判断
19610.0819415.400.71数据可信
长期6月-供试品溶液-b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%
5min189682-8968282.56681.161.8382.5781.161.83
290245-9024583.08483.08
387980-8798080.99981.00
488258-8825881.25581.25
586193-8619379.35479.35
686603-8660379.73179.73
10min196216-9621688.58186.921.8088.7287.061.80
295933-9593388.32188.46
395364-9536487.79787.93
493819-9381986.37586.51
591943-9194384.64884.78
693196-9319685.80185.93
15min198475-9847590.66189.061.6390.9589.341.64
297916-9791690.14790.43
397629-9762989.88290.16
496686-9668689.01489.29
594603-9460387.09687.37
695104-9510487.55887.83
20min199352-9935291.46989.902.0991.9090.322.09
299603-9960391.70092.14
398439-9843990.62891.06
497958-9795890.18590.61
594274-9427486.79487.21
696247-9624788.61089.03
30min1101704-10170493.63491.602.1694.2292.182.16
2101533-10153393.47794.07
3100353-10035392.39092.97
499518-9951891.62192.20
596544-9654488.88389.45
697349-9734989.62590.19
极限1103745-10374595.51393.231.7796.2693.961.77
2102192-10219294.08394.83
3101659-10165993.59394.33
4101523-10152393.46794.20
598762-9876290.92591.64
699705-9970591.79492.51
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)2.5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%
110.912148602137432153282152282137082145730.37
211.042148622147302147960.05
单位质量响应值RSD%判断
19667.5519456.160.77数据可信
长期6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%
5min193274-9327485.65884.651.6185.6684.651.60
289983-8998382.63582.64
393117-9311785.51385.51
490775-9077583.36383.36
593592-9359285.95085.95
692313-9231384.77584.78
10min199157-9915791.06090.101.4891.2090.241.48
296731-9673188.83288.97
398213-9821390.19390.34
496018-9601888.17888.32
599725-9972591.58291.73
698831-9883190.76190.90
15min1100640-10064092.42292.301.1692.7292.591.16
299723-9972391.58091.87
3101216-10121692.95193.24
498586-9858690.53690.82
5101133-10113392.87593.17
6101761-10176193.45293.74
20min1102901-10290194.49994.101.9094.9594.541.90
2101101-10110192.84693.28
3102944-10294494.53894.99
499393-9939391.27791.71
5104885-10488596.32196.77
6103570-10357095.11395.56
30min1105010-10501096.43595.901.8597.0496.501.85
2103076-10307694.65995.25
3104745-10474596.19296.80
4101399-10139993.11993.71
5106922-10692298.19198.80
6105413-10541396.80597.41
极限1107520-10752098.74097.801.9099.5198.561.90
2104653-10465396.10896.86
3107253-10725398.49599.26
4103536-10353695.08295.83
5109039-109039100.135100.91
6106972-10697298.23799.01
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)2.5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%
110.912134182138332144902144332143782141100.22
211.042134452135152134800.03
单位质量响应值RSD%判断
19625.1119336.961.05数据可信
长期6月-供试品溶液-b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%
5min190921-9092183.84583.301.6983.8583.301.69
288713-8871381.80981.81
392516-9251685.31685.32
489069-8906982.13782.14
589321-8932182.37082.37
691419-9141984.30584.30
10min197521-9752189.93288.901.7090.0789.041.70
294309-9430986.97087.11
398103-9810390.46890.61
495155-9515587.75087.89
595420-9542087.99488.13
697907-9790790.28890.43
15min1100618-10061892.78891.631.7593.0891.921.75
296973-9697389.42689.71
3101130-10113093.26093.55
498319-9831990.66890.95
598263-9826390.61690.90
6100890-10089093.03993.33
20min1102131-10213194.18392.811.8494.6393.251.84
297660-9766090.06090.49
3102131-10213194.18394.63
499640-9964091.88692.32
5100087-10008792.29892.73
6102206-10220694.25294.70
30min1103713-10371395.64294.072.0296.2494.662.01
298452-9845290.79091.37
3103860-10386095.77796.38
4101082-10108293.21693.80
5101843-10184393.91794.51
6103116-10311695.09195.69
极限1105617-10561797.39895.941.6998.1696.691.69
2101778-10177893.85794.59
3105491-10549197.28198.05
4102494-10249494.51895.26
5103182-10318295.15295.90
6105645-10564597.42398.19
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