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%
111.062341122336332343232336842348432341190.22
211.092336042336392336220.02
单位质量响应值RSD%判断
21168.0821066.010.35数据可信
供试品溶液-770ABI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%
5min1206700-20670087.91988.033.2087.9288.043.21
2203868-20386886.71486.71
3216546-21654692.10792.11
4212710-21271090.47590.48
5198395-19839584.38784.39
6203596-20359686.59986.60
10min1217702-21770292.59993.072.9792.7593.222.97
2215976-21597691.86592.01
3228686-22868697.27197.42
4224157-22415795.34495.50
5210808-21080889.66689.81
6215474-21547491.65191.80
15min1221971-22197194.41494.843.2894.7295.143.28
2219617-21961793.41393.71
3234163-23416399.60099.92
4228952-22895297.38497.69
5214165-21416591.09491.38
6218954-21895493.13193.43
20min1225231-22523195.80196.243.3796.2696.703.37
2222399-22239994.59795.05
3236821-236821100.731101.21
4233878-23387899.47999.95
5216754-21675492.19592.64
6222560-22256094.66595.12
30min1228949-22894997.38397.513.1698.0098.143.16
2226450-22645096.32096.93
3239707-239707101.958102.61
4235258-235258100.066100.70
5219495-21949593.36193.96
6225698-22569896.00096.61
极限1229902-22990297.78898.433.2498.5799.213.24
2228413-22841397.15597.93
3243125-243125103.412104.23
4237171-237171100.880101.68
5222169-22216994.49995.25
6227683-22768396.84497.61
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%
111.062339402338292342742335062345382340170.18
211.092341992338512340250.11
单位质量响应值RSD%判断
21158.8621102.340.19数据可信
供试品溶液-770ABI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%
5min1202185-20218585.94387.431.9185.9487.441.91
2209003-20900388.84188.84
3207455-20745588.18388.18
4210692-21069289.55989.56
5201062-20106285.46685.47
6203770-20377086.61786.62
10min1214338-21433891.10992.561.8191.2592.711.81
2220454-22045493.70993.86
3221085-22108593.97794.12
4222277-22227794.48494.63
5213296-21329690.66690.81
6215076-21507691.42391.57
15min1218900-21890093.04894.471.6793.3494.761.67
2224781-22478195.54895.85
3224970-22497095.62895.93
4226867-22686796.43596.74
5219215-21921593.18293.48
6218673-21867392.95293.25
20min1221449-22144994.13295.521.7294.5895.981.72
2226679-22667996.35596.82
3228066-22806696.94497.41
4229621-22962197.60598.07
5220703-22070393.81594.26
6221825-22182594.29194.74
30min1224733-22473395.52896.951.5496.1397.571.55
2230316-23031697.90198.52
3231447-23144798.38299.01
4231962-23196298.60099.23
5224569-22456995.45896.06
6225491-22549195.85096.46
极限1226594-22659496.31998.051.9597.0898.821.95
2234168-23416899.538100.33
3233534-23353499.269100.06
4236265-236265100.430101.22
5226322-22632296.20396.97
6227059-22705996.51697.28
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%
111.062332962333462326892328842329092330250.13
211.092338482345932342200.23
单位质量响应值RSD%判断
21069.1721119.930.18数据可信
供试品溶液-771ABI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%
5min1198412-19841284.48386.542.4084.4886.542.40
2201632-20163285.85485.85
3201272-20127285.70185.70
4202950-20295086.41686.42
5202573-20257386.25586.26
6212606-21260690.52790.53
10min1209257-20925789.10191.382.5389.2491.522.53
2212452-21245290.46290.60
3213103-21310390.73990.88
4213247-21324790.80090.94
5214500-21450091.33491.48
6225090-22509095.84395.99
15min1214488-21448891.32993.402.5591.6293.702.55
2217698-21769892.69592.99
3217184-21718492.47692.77
4218371-21837192.98293.28
5218016-21801692.83193.13
6230389-23038998.09998.41
20min1216846-21684692.33394.362.5492.7794.812.54
2220541-22054193.90694.35
3219383-21938393.41393.86
4220434-22043493.86094.31
5219685-21968593.54193.99
6232739-23273999.10099.57
30min1221791-22179194.43895.882.4995.0396.492.49
2223116-22311695.00295.61
3222813-22281394.87395.48
4223073-22307394.98495.59
5223747-22374795.27195.88
6236500-236500100.701101.34
极限1222889-22288994.90696.642.5195.6697.412.51
2224022-22402295.38896.15
3226148-22614896.29397.06
4225182-22518295.88296.65
5225243-22524395.90896.67
6238331-238331101.481102.29
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%
111.062342992343962343222336722341862341750.13
211.092338862339132339000.01
单位质量响应值RSD%判断
21173.1521091.070.28数据可信
供试品溶液-771ABI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%
5min1206671-20667187.84485.832.5087.8485.832.50
2198339-19833984.30284.30
3209077-20907788.86788.87
4196162-19616283.37783.38
5202102-20210285.90285.90
6199206-19920684.67184.67
10min1217480-21748092.43890.322.5392.5890.462.53
2209045-20904588.85388.99
3220123-22012393.56293.71
4206783-20678387.89188.03
5213072-21307290.56590.71
6208424-20842488.58988.73
15min1223377-22337794.94592.422.6095.2592.712.60
2213121-21312190.58590.87
3224839-22483995.56695.87
4211261-21126189.79590.08
5217973-21797392.64892.94
6214021-21402190.96891.26
20min1225242-22524295.73793.422.5796.2093.862.57
2215906-21590691.76992.21
3227466-22746696.68397.15
4213638-21363890.80591.24
5220737-22073793.82294.27
6215686-21568691.67692.12
30min1228433-22843397.09494.552.8097.7195.152.80
2217795-21779592.57293.16
3231178-23117898.26098.88
4215580-21558091.63192.22
5222815-22281594.70695.31
6218902-21890293.04393.64
极限1229128-22912897.38995.402.3898.1796.172.38
2220030-22003093.52294.27
3231711-23171198.48799.28
4217793-21779392.57193.31
5225382-22538295.79796.56
6222703-22270394.65895.41
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)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%
111.062337232346972347392341922337312342160.22
211.092339672344252341960.14
单位质量响应值RSD%判断
21176.8521117.760.20数据可信
供试品溶液-790ACE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%
5min1202599-20259986.05186.481.0286.0586.481.02
2204018-20401886.65486.65
3200526-20052685.17185.17
4206790-20679087.83187.83
5204299-20429986.77386.77
6203395-20339586.38986.39
10min1213900-21390090.85191.211.2590.9991.351.25
2214344-21434491.04091.18
3210752-21075289.51489.66
4218996-21899693.01593.16
5215675-21567591.60591.75
6214793-21479391.23091.37
15min1219304-21930493.14693.311.3293.4493.611.32
2219549-21954993.25093.55
3215233-21523391.41791.71
4224286-22428695.26295.56
5220434-22043493.62693.92
6219372-21937293.17593.47
20min1223647-22364794.99194.731.3295.4495.181.32
2222610-22261094.55095.00
3218316-21831692.72793.17
4227531-22753196.64197.10
5222711-22271194.59395.05
6223431-22343194.89995.35
30min1225596-22559695.81996.111.2296.4396.721.22
2225415-22541595.74296.35
3222503-22250394.50595.10
4230993-23099398.11198.73
5226512-22651296.20896.82
6226736-22673696.30396.91
极限1226860-22686096.35696.951.4497.1297.721.44
2227535-22753596.64297.41
3223604-22360494.97395.73
4233536-23353699.19199.98
5229515-22951597.48398.25
6228500-22850097.05297.82
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%
111.062332922335052331852329902334622332870.10
211.092331332332742332040.05
单位质量响应值RSD%判断
21092.8621028.310.22数据可信
供试品溶液-790ACE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%
5min1203402-20340286.74888.002.5386.7587.992.53
2206784-20678488.19088.19
3203807-20380786.92186.92
4212585-21258590.66490.66
5199335-19933585.01385.01
6212047-21204790.43590.43
10min1215047-21504791.71492.882.7191.8693.022.71
2218491-21849193.18393.33
3216071-21607192.15192.30
4223729-22372995.41795.57
5208751-20875189.02989.17
6224542-22454295.76495.91
15min1220118-22011893.87795.964.2794.1796.274.26
2223760-22376095.43095.73
3221368-22136894.41094.71
4229330-22933097.80698.12
5213836-21383691.19891.49
6241667-241667103.067103.38
20min1222958-22295895.08897.142.6895.5497.602.68
2233577-23357799.617100.08
3223842-22384295.46595.92
4232785-23278599.27999.75
5220167-22016793.89894.34
6233262-23326299.48399.96
30min1226201-22620196.47197.682.7797.0898.302.77
2229165-22916597.73598.36
3227390-22739096.97897.59
4235517-235517100.444101.08
5219478-21947893.60494.20
6236518-236518100.871101.52
极限1228583-22858397.48799.403.0398.26100.193.02
2232165-23216599.01599.81
3239710-239710102.233103.01
4238407-238407101.677102.48
5221608-22160894.51295.27
6237949-237949101.482102.30
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