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%
110.912169702168032170492171362157582167430.27
211.042162342165692164020.11
单位质量响应值RSD%判断
19866.4519601.630.95数据可信
加速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%
5min187905-8790580.02484.033.0780.0284.033.07
291839-9183983.60583.61
391981-9198183.73583.73
494110-9411085.67385.67
591633-9163383.41883.42
696395-9639587.75387.75
10min192887-9288784.55988.902.8284.6989.042.82
298518-9851889.68589.82
396385-9638587.74487.88
498947-9894790.07690.22
598268-9826889.45889.60
6100933-10093391.88492.03
15min194644-9464486.15990.522.7586.4390.812.75
299611-9961190.68090.97
3100283-10028391.29291.58
4101065-10106592.00492.30
598437-9843789.61289.90
6102591-10259193.39393.69
20min195296-9529686.75291.342.9187.1791.782.91
2101019-10101991.96292.40
399521-9952190.59991.04
4102315-10231593.14293.59
5100052-10005291.08291.52
6103790-10379094.48594.94
30min196735-9673588.06292.772.9288.6293.362.92
2102640-10264093.43894.03
3101428-10142892.33592.92
4103751-10375194.44995.05
5101393-10139392.30392.89
6105502-10550296.04396.66
极限198100-9810089.30594.473.2190.0195.223.21
2104586-10458695.20995.96
3103131-10313193.88594.63
4105760-10576096.27897.04
5103082-10308293.84094.58
6107984-10798498.30399.08
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%
110.912162082162132160392163632167362163120.13
211.042167562171612169580.14
单位质量响应值RSD%判断
19826.9519651.990.63数据可信
加速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%
5min196808-9680888.10286.753.1488.1086.753.14
297762-9776288.97188.97
393466-9346685.06185.06
498323-9832389.48189.48
590420-9042082.28982.29
695151-9515186.59486.59
10min1101678-10167892.53491.502.9292.6891.642.92
2102334-10233493.13193.28
3100767-10076791.70591.85
4103412-10341294.11294.26
595067-9506786.51886.66
699976-9997690.98591.13
15min1103556-10355694.24393.433.4194.5493.733.41
2105244-10524495.78096.08
3102897-10289793.64493.94
4105860-10586096.34096.65
596082-9608287.44287.72
6102346-10234693.14293.44
20min1104822-10482295.39694.233.1795.8594.693.17
2105392-10539295.91496.38
3102670-10267093.43793.89
4106949-10694997.33197.80
597528-9752888.75889.18
6103916-10391694.57195.02
30min1106077-10607796.53895.713.1597.1596.313.15
2107921-10792198.21698.84
3105097-10509795.64696.25
4108409-10840998.66099.29
599252-9925290.32790.90
6104216-10421694.84495.45
极限1107525-10752597.85697.303.2298.6398.073.22
2110071-110071100.173100.96
3104866-10486695.43696.20
4110010-110010100.117100.91
5101101-10110192.00992.73
6107912-10791298.20898.97
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)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%
110.912170922181072164742165952179652172470.35
211.042161512163552162530.07
单位质量响应值RSD%判断
19912.6519588.131.17数据可信
加速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%
5min187246-8724679.36083.965.2179.3683.965.22
290721-9072182.52182.52
388523-8852380.52280.52
490831-9083182.62182.62
598664-9866489.74689.75
697835-9783588.99288.99
10min192202-9220283.86888.295.0984.0088.435.09
295692-9569287.04387.18
393064-9306484.65284.79
495034-9503486.44486.58
5103908-10390894.51694.67
6102484-10248493.22193.37
15min193992-9399285.49689.954.9985.7790.244.99
297357-9735788.55788.84
394863-9486386.28986.56
497070-9707088.29688.58
5105330-10533095.81096.12
6104716-10471695.25195.55
20min195449-9544986.82291.275.0487.2491.715.04
299116-9911690.15790.59
395964-9596487.29087.71
498293-9829389.40989.84
5106683-10668397.04097.51
6106536-10653696.90797.37
30min196691-9669187.95192.685.3188.5193.275.31
2100076-10007691.03091.61
397449-9744988.64189.21
499836-9983690.81291.39
5109184-10918499.31599.94
6108106-10810698.33598.96
极限197959-9795989.10593.955.2089.8194.695.20
2102239-10223992.99893.73
398463-9846389.56390.28
4101278-10127892.12492.85
5110235-110235100.271101.07
6109523-10952399.624100.41
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%
110.912165942176002175802177572177882174640.23
211.042164182170512167340.21
单位质量响应值RSD%判断
19932.5419631.701.08数据可信
加速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%
5min195587-9558786.80786.671.9786.8186.671.97
293646-9364685.04485.04
394094-9409485.45185.45
497943-9794388.94688.95
597431-9743188.48188.48
693940-9394085.31185.31
10min1101559-10155992.23091.281.7292.3791.421.72
298604-9860489.54789.69
399083-9908389.98290.12
4102619-10261993.19393.34
5101952-10195292.58792.73
699246-9924690.13090.27
15min1103233-10323393.75193.061.9094.0593.361.90
2100496-10049691.26591.56
3101333-10133392.02592.32
4105447-10544795.76196.06
5103599-10359994.08394.38
6100725-10072591.47391.77
20min1104580-10458094.97494.261.9195.4394.721.91
2101863-10186392.50692.95
3102569-10256993.14893.59
4105977-10597796.24396.71
5106003-10600396.26696.72
6101793-10179392.44392.89
30min1105319-10531995.64595.411.7096.2696.021.70
2102640-10264093.21293.81
3104343-10434394.75995.36
4107258-10725897.40698.03
5106879-10687997.06297.68
6103931-10393194.38494.98
极限1107370-10737097.50896.692.2898.2897.462.28
2103982-10398294.43195.18
3104546-10454694.94395.70
4109464-10946499.409100.20
5108908-10890898.90499.69
6104543-10454394.94095.70
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%
110.912173822177092173062173552173672174240.08
211.042163392166072164730.09
单位质量响应值RSD%判断
19928.8719608.061.15数据可信
加速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%
5min197368-9736888.48687.402.6988.4987.402.69
294594-9459485.96585.97
394973-9497386.31086.31
497445-9744588.55688.56
599951-9995190.83390.83
692686-9268684.23184.23
10min1101737-10173792.45792.172.6992.6092.312.69
2100187-10018791.04891.19
3100085-10008590.95591.10
4102407-10240793.06593.21
5106037-10603796.36496.52
698046-9804689.10289.24
15min1104101-10410194.60594.322.7094.9194.622.70
2102300-10230092.96893.26
3102341-10234193.00593.30
4105155-10515595.56395.87
5108433-10843398.54298.85
6100415-10041591.25591.54
20min1105621-10562195.98695.592.7596.4596.052.75
2104665-10466595.11795.57
3103319-10331993.89494.34
4105935-10593596.27296.73
5110062-110062100.022100.50
6101529-10152992.26892.71
30min1107112-10711297.34196.802.8697.9697.422.86
2105340-10534095.73196.34
3104540-10454095.00495.61
4107948-10794898.10198.72
5111442-111442101.276101.92
6102742-10274293.37093.96
极限1108626-10862698.71798.002.6599.5098.782.65
2107029-10702997.26698.03
3106031-10603196.35997.12
4108749-10874998.82999.61
5112479-112479102.219103.03
6104117-10411794.61995.37
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%
110.912183592179592176312179082187962181310.21
211.042168032180642174340.42
单位质量响应值RSD%判断
19993.6819695.111.07数据可信
加速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%
5min198953-9895389.58288.332.1289.5888.332.12
299402-9940289.98889.99
395814-9581486.74086.74
499811-9981190.35890.36
594992-9499285.99686.00
696468-9646887.33287.33
10min1104765-10476594.84393.682.1094.9993.822.10
2105264-10526495.29595.44
3101597-10159791.97592.12
4105756-10575695.74095.89
5100348-10034890.84490.99
6103138-10313893.37093.52
15min1106731-10673196.62395.671.9996.9395.981.99
2107168-10716897.01997.33
3103875-10387594.03794.34
4108454-10845498.18398.49
5103043-10304393.28493.58
6104814-10481494.88895.19
20min1107779-10777997.57296.771.9098.0497.231.90
2108882-10888298.57099.04
3104473-10447394.57995.03
4109271-10927198.92299.40
5105146-10514695.18895.64
6105815-10581595.79496.25
30min1109142-10914298.80697.872.3499.4498.502.33
2109666-10966699.28099.91
3105878-10587895.85196.46
4111935-111935101.334101.97
5106022-10602295.98196.59
6106031-10603195.98996.61
极限1109931-10993199.52098.582.42100.3299.372.42
2111934-111934101.333102.13
3106341-10634196.27097.04
4111743-111743101.160101.97
5106449-10644996.36897.14
6106981-10698196.84997.63
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