氢溴酸氟硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号171336-202301对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.71787601793901787841787761789171789250.15
213.751797351792221794780.21
单位质量响应值RSD%判断
13060.2213052.950.04数据可信
中间条件6月-供试品溶液-2025102321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%
2min146086-4608624.96626.9612.1724.9726.9612.17
242776-4277623.17323.17
357827-5782731.32731.33
448978-4897826.53326.53
556437-5643730.57430.57
646476-4647625.17825.18
5min1109246-10924659.18262.304.9059.1862.304.89
2106743-10674357.82757.83
3117011-11701163.38963.39
4119750-11975064.87364.87
5117194-11719463.48863.49
6120049-12004965.03565.03
10min1127816-12781669.24374.673.6969.2474.673.69
2139111-13911175.36175.36
3141206-14120676.49676.50
4137847-13784774.67774.68
5139716-13971675.68975.69
6141283-14128376.53876.54
15min1134570-13457072.90177.794.3672.9077.794.36
2140358-14035876.03776.04
3147744-14774480.03880.04
4139943-13994375.81275.81
5150789-15078981.68881.69
6148181-14818180.27580.27
20min1138761-13876175.17278.743.2575.1778.743.25
2140418-14041876.06976.07
3150266-15026681.40481.40
4146098-14609879.14779.15
5149191-14919180.82280.82
6147402-14740279.85379.85
30min1145955-14595579.06983.062.5979.0783.062.59
2152514-15251482.62282.62
3153930-15393083.38983.39
4154175-15417583.52283.52
5157099-15709985.10685.11
6156231-15623184.63684.64
45min1147337-14733779.81881.412.7879.8281.412.78
2145355-14535578.74478.74
3156284-15628484.66584.66
4151666-15166682.16382.16
5153360-15336083.08183.08
6147693-14769380.01180.01
60min1144006-14400678.01382.963.3578.0182.963.35
2150814-15081481.70181.70
3157840-15784085.50885.51
4154250-15425083.56383.56
5157224-15722485.17485.17
6154669-15466983.79083.79
90min1148496-14849680.44682.102.4380.4582.102.43
2148180-14818080.27480.27
3149704-14970481.10081.10
4151955-15195582.31982.32
5157978-15797885.58285.58
6152991-15299182.88182.88
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1154372-15437283.62984.020.7283.6384.020.72
2155958-15595884.48884.49
3153422-15342283.11483.11
4155205-15520584.08084.08
5155054-15505483.99884.00
6156540-15654084.80384.80
极限1141426-14142676.61682.063.9276.6282.063.92
2150750-15075081.66781.67
3154477-15447783.68683.69
4152070-15207082.38282.38
5159491-15949186.40286.40
6150621-15062181.59781.60
氢溴酸氟硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号171336-202301对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.71782831784771784951786311789001785570.13
213.751800171801431800800.05
单位质量响应值RSD%判断
13033.3613096.730.35数据可信
中间条件6月-供试品溶液-2025102421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%
2min166171-6617135.82435.0218.1735.8235.0218.16
274429-7442940.29540.29
346485-4648525.16625.17
471990-7199038.97538.97
554315-5431529.40629.41
674747-7474740.46740.47
5min1105799-10579957.27860.293.8857.2860.293.88
2111943-11194360.60560.60
3109159-10915959.09759.10
4109942-10994259.52159.52
5112735-11273561.03361.03
6118644-11864464.23264.23
10min1126396-12639668.42969.885.2468.4369.885.24
2133608-13360872.33472.33
3119510-11951064.70164.70
4132836-13283671.91671.92
5124449-12444967.37567.38
6137669-13766974.53274.53
15min1137572-13757274.48075.774.7874.4875.774.78
2142900-14290077.36477.36
3132494-13249471.73171.73
4143868-14386877.88877.89
5133293-13329372.16372.16
6149612-14961280.99881.00
20min1141502-14150276.60877.475.9576.6177.475.95
2150470-15047081.46381.46
3132279-13227971.61471.61
4145019-14501978.51278.51
5135197-13519773.19473.19
6154137-15413783.44883.45
30min1147768-14776880.00080.325.9780.0080.325.97
2156582-15658284.77284.77
3137120-13712074.23574.24
4151426-15142681.98081.98
5138947-13894775.22475.22
6158316-15831685.71085.71
45min1151720-15172082.13980.794.8082.1480.794.80
2147752-14775279.99179.99
3141229-14122976.46076.46
4157637-15763785.34385.34
5141006-14100676.33976.34
6155994-15599484.45384.45
60min1148258-14825880.26581.453.9180.2781.453.91
2150222-15022281.32881.33
3146667-14666779.40479.40
4153728-15372883.22783.23
5143601-14360177.74477.74
6160226-16022686.74486.74
90min1150868-15086881.67881.277.2781.6881.277.26
2156785-15678584.88284.88
3142070-14207076.91576.92
4156222-15622284.57784.58
5132670-13267071.82671.83
6162071-16207187.74387.74
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1153095-15309582.88482.635.2782.8882.635.27
2159186-15918686.18186.18
3146025-14602579.05679.06
4156641-15664184.80484.80
5140163-14016375.88375.88
6160641-16064186.96986.97
极限1149156-14915680.75183.025.7580.7583.025.75
2163708-16370888.63088.63
3143422-14342277.64777.65
4154033-15403383.39283.39
5145946-14594679.01379.01
6163781-16378188.66988.67
氢溴酸氟硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号171336-202301对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.71788981789551788151786171789261788420.08
213.751781501781561781530.01
单位质量响应值RSD%判断
13054.1612956.580.54数据可信
中间条件6月-供试品溶液-2025102521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%
2min156432-5643230.69230.477.5330.6930.477.53
260075-6007532.67332.67
347899-4789926.05126.05
456384-5638430.66630.67
557163-5716331.09031.09
658231-5823131.67031.67
5min1104749-10474956.97159.233.1556.9759.233.15
2104559-10455956.86756.87
3111991-11199160.90960.91
4111862-11186260.83960.84
5109350-10935059.47359.47
6110941-11094160.33860.34
10min1124625-12462567.78168.222.1667.7868.222.16
2121443-12144366.05066.05
3128078-12807869.65969.66
4128047-12804769.64269.64
5126930-12693069.03469.03
6123441-12344167.13767.14
15min1127873-12787369.54771.663.1069.5571.663.10
2127108-12710869.13169.13
3133738-13373872.73772.74
4138125-13812575.12375.12
5132845-13284572.25172.25
6130893-13089371.19071.19
20min1132458-13245872.04173.751.6772.0473.751.67
2135978-13597873.95573.96
3135658-13565873.78173.78
4138929-13892975.56075.56
5133861-13386172.80472.80
6136767-13676774.38474.38
30min1131679-13167971.61775.693.1571.6275.693.15
2137833-13783374.96474.96
3142216-14221677.34877.35
4144028-14402878.33378.33
5138137-13813775.13075.13
6141125-14112576.75576.75
45min1133756-13375672.74776.984.0972.7576.994.08
2141683-14168377.05877.06
3144970-14497078.84678.85
4149746-14974681.44381.44
5136458-13645874.21674.22
6142673-14267377.59777.60
60min1140676-14067676.51079.122.3276.5179.122.32
2143704-14370478.15778.16
3146884-14688479.88779.89
4150438-15043881.82081.82
5144187-14418778.42078.42
6147000-14700079.95079.95
90min1136559-13655974.27177.353.0474.2777.353.04
2136993-13699374.50774.51
3144935-14493578.82778.83
4145875-14587579.33879.34
5143204-14320477.88577.89
6145710-14571079.24879.25
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1138595-13859575.37980.313.3375.3880.313.33
2151684-15168482.49782.50
3150385-15038581.79181.79
4150532-15053281.87181.87
5145608-14560879.19379.19
6149214-14921481.15481.15
极限1138134-13813475.12879.893.5775.1379.893.57
2147225-14722580.07280.07
3148289-14828980.65180.65
4153121-15312183.27983.28
5144170-14417078.41178.41
6150371-15037181.78381.78
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