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%
110.912159972164402160902160802162002161610.08
211.042167252165862166560.05
单位质量响应值RSD%判断
19813.1119624.640.68数据可信
中间条件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%
5min189431-8943181.47483.315.9581.4783.315.95
288752-8875280.85580.86
390570-9057082.51282.51
492088-9208883.89583.89
586061-8606178.40478.40
6101766-10176692.71192.71
10min194687-9468786.26287.714.6086.4087.854.61
293829-9382985.48185.62
395705-9570587.19087.33
497408-9740888.74188.88
591623-9162383.47183.60
6104413-10441395.12395.28
15min196295-9629587.72789.554.4088.0189.834.40
296085-9608587.53687.81
397606-9760688.92289.20
499339-9933990.50090.79
594083-9408385.71285.98
6106365-10636596.90197.21
20min197234-9723488.58390.614.1689.0191.054.17
296967-9696788.33988.76
398510-9851089.74590.18
4100488-10048891.54791.99
596246-9624687.68388.10
6107335-10733597.78598.26
30min198279-9827989.53591.764.2190.1192.344.21
298589-9858989.81790.39
3100356-10035691.42792.01
4101900-10190092.83493.42
596649-9664988.05088.61
6108531-10853198.87599.51
极限199649-9964990.78393.254.4991.5193.994.49
2100280-10028091.35892.08
3100819-10081991.84992.58
4103476-10347694.26995.02
598777-9877789.98890.69
6111161-111161101.271102.07
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%
110.912160192161782161362162002158752160820.07
211.042157002152862154930.14
单位质量响应值RSD%判断
19805.8719519.291.04数据可信
中间条件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%
5min193647-9364785.56283.693.2585.5683.693.25
294025-9402585.90785.91
394233-9423386.09786.10
488818-8881881.15081.15
587186-8718679.65979.66
691666-9166683.75283.75
10min197511-9751189.09288.323.1689.2388.463.16
299975-9997591.34391.49
399647-9964791.04491.19
494149-9414986.02086.16
592248-9224884.28484.42
696495-9649588.16488.30
15min1100058-10005891.41990.313.1091.7190.593.10
2102045-10204593.23593.53
3101776-10177692.98993.28
496628-9662888.28588.56
594244-9424486.10786.38
698285-9828589.79990.09
20min1100732-10073292.03591.203.1092.4891.643.10
2103355-10335594.43294.88
3102455-10245593.60994.06
497333-9733388.92989.36
595219-9521986.99887.41
699814-9981491.19691.63
30min1102028-10202893.21992.802.8593.8293.392.85
2104700-10470095.66096.27
3104414-10441495.39996.01
4100169-10016991.52192.09
596946-9694688.57689.14
6101149-10114992.41693.00
极限1103657-10365794.70793.982.6895.4694.722.68
2105671-10567196.54897.32
3105591-10559196.47497.24
4100751-10075192.05292.78
598695-9869590.17490.88
6102802-10280293.92694.67
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%
110.912154222157582154782159162156202156390.10
211.042145702142032143860.13
单位质量响应值RSD%判断
19765.2619419.021.25数据可信
中间条件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%
5min192377-9237784.70783.431.4984.7183.431.49
289696-8969682.24982.25
390047-9004782.57082.57
491002-9100283.44683.45
592868-9286885.15785.16
689914-8991482.44882.45
10min196000-9600088.02988.471.4488.1788.611.44
295063-9506387.17087.31
396146-9614688.16388.30
497035-9703588.97889.12
598972-9897290.75490.90
695641-9564187.70087.84
15min198255-9825590.09790.421.5490.3890.701.54
296849-9684988.80889.09
397774-9777489.65689.94
499023-9902390.80191.09
5101307-10130792.89593.19
698429-9842990.25690.54
20min199485-9948591.22592.251.5391.6692.691.53
2102130-10213093.65094.08
399021-9902190.79991.23
4101055-10105592.66493.10
5102582-10258294.06594.51
699358-9935891.10891.54
30min1100679-10067992.32093.341.7692.9193.941.76
299884-9988491.59192.18
3100477-10047792.13492.72
4102864-10286494.32394.92
5104635-10463595.94796.55
6102229-10222993.74194.33
极限1103833-10383395.21294.941.3195.9695.681.31
2102111-10211193.63394.37
3102153-10215393.67194.41
4104240-10424095.58596.34
5105650-10565096.87897.64
6103222-10322294.65195.39
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%
110.912151622148082149162149882149332149610.07
211.042158832155772157300.11
单位质量响应值RSD%判断
19703.1219540.760.59数据可信
中间条件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%
5min187070-8707079.71483.374.4079.7183.374.40
294568-9456886.57986.58
385181-8518177.98577.99
492443-9244384.63484.63
594741-9474186.73786.74
692399-9239984.59384.59
10min191582-9158283.84588.524.2783.9888.664.27
2100765-10076592.25392.40
391514-9151483.78383.91
498234-9823489.93590.08
5100042-10004291.59191.74
698020-9802089.73989.88
15min193693-9369385.77891.445.1786.0591.725.17
2102779-10277994.09694.39
393301-9330185.41985.69
4101152-10115292.60792.90
5102625-10262593.95594.25
6105707-10570796.77797.07
20min194752-9475286.74791.964.5887.1692.404.58
2104068-10406895.27695.73
394536-9453686.55086.96
4103657-10365794.90095.35
5104115-10411595.32095.77
6101570-10157092.99093.44
30min197190-9719088.98093.604.3189.5494.194.31
2106102-10610297.13997.75
396274-9627488.14188.70
4105079-10507996.20296.81
5105689-10568996.76197.37
6103097-10309794.38894.99
极限197026-9702688.82994.554.4589.5495.304.44
2107691-10769198.59399.37
398189-9818989.89490.60
4105207-10520796.31997.08
5107285-10728598.22299.00
6104255-10425595.44896.21
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