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%
113.781735751738101739231741271741031739080.14
213.831746251743351744800.12
单位质量响应值RSD%判断
12620.3212616.050.03数据可信
加速6月-供试品溶液-2025102321批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1130896-13089673.37572.713.1873.3772.713.18
2125883-12588370.56570.56
3123333-12333369.13569.14
4133425-13342574.79274.79
5132713-13271374.39374.39
6132053-13205374.02374.02
5min1183627-183627102.934104.122.16102.93104.122.16
2185196-185196103.813103.81
3179377-179377100.551100.55
4190504-190504106.788106.79
5186720-186720104.667104.67
6189035-189035105.965105.97
10min1191087-191087107.115107.130.93107.12107.130.93
2189833-189833106.412106.41
3188593-188593105.717105.72
4193790-193790108.630108.63
5191626-191626107.417107.42
6191705-191705107.462107.46
15min1188452-188452105.638105.891.28105.64105.891.28
2189199-189199106.057106.06
3184328-184328103.326103.33
4190969-190969107.049107.05
5189893-189893106.446106.45
6190529-190529106.802106.80
20min1188936-188936105.910106.561.23105.91106.561.23
2189518-189518106.236106.24
3189096-189096105.999106.00
4194352-194352108.945108.95
5190960-190960107.044107.04
6187710-187710105.222105.22
30min1189113-189113106.009106.870.95106.01106.870.95
2192039-192039107.649107.65
3188757-188757105.809105.81
4193072-193072108.228108.23
5191516-191516107.356107.36
6189394-189394106.166106.17
45min1190066-190066106.543106.890.93106.54106.890.93
2191448-191448107.318107.32
3188295-188295105.550105.55
4192913-192913108.139108.14
5192132-192132107.701107.70
6189302-189302106.115106.11
60min1193590-193590108.518107.230.99108.52107.230.99
2189205-189205106.060106.06
3189455-189455106.200106.20
4193169-193169108.282108.28
5191906-191906107.574107.57
6190457-190457106.762106.76
极限1191958-191958107.604106.121.27107.60106.121.27
2186871-186871104.752104.75
3189717-189717106.347106.35
4192306-192306107.799107.80
5187854-187854105.303105.30
6187163-187163104.916104.92
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%
113.781746891745301745471744731742591745000.09
213.831749751747341748540.10
单位质量响应值RSD%判断
12663.2812643.090.12数据可信
加速6月-供试品溶液-2025102421批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1124098-12409869.37271.474.5669.3771.474.56
2121831-12183168.10468.10
3126860-12686070.91670.92
4136911-13691176.53476.53
5124566-12456669.63369.63
6132883-13288374.28374.28
5min1167443-16744393.60296.091.8593.6096.101.85
2170354-17035495.22995.23
3173747-17374797.12697.13
4169764-16976494.89994.90
5175485-17548598.09798.10
6174613-17461397.61097.61
10min1171476-17147695.85697.721.4395.8697.731.43
2173980-17398097.25697.26
3177219-17721999.06799.07
4172549-17254996.45696.46
5176761-17676198.81198.81
6176921-17692198.90098.90
15min1173633-17363397.06298.841.3197.0698.841.31
2177921-17792199.45999.46
3178432-17843299.74599.74
4174323-17432397.44897.45
5177179-17717999.04499.04
6179366-179366100.267100.27
20min1172926-17292696.66798.771.4396.6798.771.43
2178618-17861899.84999.85
3178430-17843099.74499.74
4174302-17430297.43697.44
5176865-17686598.86998.87
6178976-178976100.049100.05
30min1172483-17248396.41998.731.5896.4298.731.58
2178034-17803499.52299.52
3178903-178903100.008100.01
4174034-17403497.28697.29
5176842-17684298.85698.86
6179368-179368100.268100.27
45min1171978-17197896.13799.332.5296.1499.332.52
2180271-180271100.773100.77
3181763-181763101.607101.61
4173257-17325796.85296.85
5176419-17641998.62098.62
6182479-182479102.007102.01
60min1172700-17270096.54199.371.9496.5499.371.94
2179118-179118100.128100.13
3181258-181258101.325101.32
4174497-17449797.54597.55
5178324-17832499.68499.68
6180720-180720101.024101.02
极限1173777-17377797.14399.381.5697.1499.381.56
2178665-17866599.87599.88
3180417-180417100.854100.85
4174958-17495897.80397.80
5178649-17864999.86699.87
6180217-180217100.743100.74
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%
113.781736891738541738111736581736961737420.05
213.831750511748501749500.09
单位质量响应值RSD%判断
12608.2712650.040.24数据可信
加速6月-供试品溶液-2025102521批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1122881-12288168.82270.806.1868.8270.806.18
2121342-12134267.96067.96
3124346-12434669.64369.64
4138867-13886777.77677.78
5132756-13275674.35374.35
6118247-11824766.22766.23
5min1168571-16857194.41295.311.5194.4195.311.51
2168104-16810494.15094.15
3170367-17036795.41895.42
4175006-17500698.01698.02
5170395-17039595.43495.43
6168628-16862894.44494.44
10min1170954-17095495.74796.620.7995.7596.620.79
2172401-17240196.55796.56
3171962-17196296.31196.31
4171448-17144896.02396.02
5174374-17437497.66297.66
6173901-17390197.39797.40
15min1173523-17352397.18597.240.7997.1997.240.79
2171591-17159196.10396.10
3175119-17511998.07998.08
4174789-17478997.89497.89
5174196-17419697.56297.56
6172544-17254496.63796.64
20min1174138-17413897.53097.660.8897.5397.660.88
2171728-17172896.18096.18
3174855-17485597.93197.93
4176444-17644498.82198.82
5174781-17478197.89097.89
6174298-17429897.61997.62
30min1174339-17433997.64298.430.9997.6498.420.99
2173735-17373597.30497.30
3175875-17587598.50398.50
4176716-17671698.97498.97
5178526-17852699.98799.99
6175250-17525098.15398.15
45min1173579-17357997.21798.050.9497.2298.060.93
2174583-17458397.77997.78
3173683-17368397.27597.28
4178031-17803199.71099.71
5175420-17542098.24898.25
6175152-17515298.09898.10
60min1176610-17661098.91498.660.8198.9198.660.81
2178262-17826299.84099.84
3175695-17569598.40298.40
4176937-17693799.09899.10
5175237-17523798.14598.15
6174245-17424597.59097.59
极限1174916-17491697.96698.161.2897.9798.161.28
2171451-17145196.02596.02
3175858-17585898.49398.49
4178388-17838899.91099.91
5175366-17536698.21898.22
6175640-17564098.37198.37
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%
113.781751641747291749211752891758681751940.25
213.831766041767281766660.05
单位质量响应值RSD%判断
12713.6412774.110.34数据可信
中间条件6月-供试品溶液-2025102321批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1127866-12786670.97073.585.6170.9773.585.61
2130049-13004972.18172.18
3121254-12125467.30067.30
4138926-13892677.10877.11
5140266-14026677.85277.85
6137041-13704176.06276.06
5min1181162-181162100.551100.071.72100.55100.071.72
2181244-181244100.596100.60
3177778-17777898.67298.67
4183060-183060101.604101.60
5183176-183176101.669101.67
6175397-17539797.35197.35
10min1185216-185216102.801102.211.42102.80102.211.42
2183152-183152101.655101.66
3184088-184088102.175102.17
4188084-188084104.393104.39
5184289-184289102.286102.29
6180112-18011299.96899.97
15min1184363-184363102.327101.021.53102.33101.021.53
2181857-181857100.936100.94
3183897-183897102.069102.07
4183382-183382101.783101.78
5181805-181805100.908100.91
6176751-17675198.10298.10
20min1181695-181695100.847102.862.80100.85102.862.80
2184243-184243102.261102.26
3185776-185776103.112103.11
4186201-186201103.348103.35
5194516-194516107.963107.96
6179489-17948999.62299.62
30min1185052-185052102.710102.141.24102.71102.141.24
2182889-182889101.509101.51
3185285-185285102.839102.84
4184883-184883102.616102.62
5186102-186102103.293103.29
6179907-17990799.85499.85
45min1184844-184844102.594102.261.04102.59102.261.04
2183454-183454101.823101.82
3186780-186780103.669103.67
4185710-185710103.075103.07
5183226-183226101.696101.70
6181475-181475100.724100.72
60min1184517-184517102.413102.101.20102.41102.101.20
2184100-184100102.181102.18
3187704-187704104.182104.18
4183836-183836102.035102.03
5182112-182112101.078101.08
6181444-181444100.707100.71
极限1194129-194129107.748106.150.85107.75106.150.85
2190577-190577105.776105.78
3191171-191171106.106106.11
4189933-189933105.419105.42
5189774-189774105.331105.33
6191939-191939106.532106.53
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%
113.781769361777531776781773621779491775360.23
213.831777761777091777420.03
单位质量响应值RSD%判断
12883.6012851.920.18数据可信
中间条件6月-供试品溶液-2025102421批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1136470-13647075.01672.734.0675.0272.734.06
2135442-13544274.45174.45
3122101-12210167.11767.12
4133798-13379873.54773.55
5135212-13521274.32474.32
6130870-13087071.93771.94
5min1174764-17476496.06594.231.3896.0794.241.38
2169759-16975993.31493.31
3168292-16829292.50892.51
4173303-17330395.26295.26
5170736-17073693.85193.85
6171744-17174494.40594.41
10min1174001-17400195.64695.610.3695.6595.610.36
2174459-17445995.89895.90
3174611-17461195.98195.98
4173087-17308795.14495.14
5174133-17413395.71995.72
6173313-17331395.26895.27
15min1174445-17444595.89095.680.4595.8995.680.45
2175159-17515996.28396.28
3172892-17289295.03695.04
4173863-17386395.57095.57
5174316-17431695.81995.82
6173654-17365495.45595.46
20min1174795-17479596.08295.750.2696.0895.740.26
2174575-17457595.96195.96
3173782-17378295.52695.53
4174285-17428595.80295.80
5173919-17391995.60195.60
6173737-17373795.50195.50
30min1175355-17535596.39096.281.1096.3996.281.10
2178145-17814597.92497.92
3175456-17545696.44696.45
4175035-17503596.21496.21
5174870-17487096.12496.12
6172091-17209194.59694.60
45min1176186-17618696.84796.041.0196.8596.031.01
2176727-17672797.14497.14
3175720-17572096.59196.59
4173762-17376295.51595.51
5173578-17357895.41395.41
6172286-17228694.70394.70
60min1182901-182901100.53897.691.56100.5497.691.56
2176764-17676497.16597.16
3175914-17591496.69896.70
4176066-17606696.78196.78
5175941-17594196.71296.71
6178755-17875598.25998.26
极限1177181-17718197.39496.950.9697.3996.950.96
2176810-17681097.19097.19
3178829-17882998.30098.30
4175603-17560396.52796.53
5176037-17603796.76596.77
6173775-17377595.52295.52
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%
113.781767861760501757881761711760881761770.21
213.831762911761371762140.07
单位质量响应值RSD%判断
12784.9812741.430.25数据可信
中间条件6月-供试品溶液-2025102521批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min1128200-12820071.04768.139.2571.0568.139.25
2128391-12839171.15371.15
3100359-10035955.61855.62
4129038-12903871.51271.51
5129310-12931071.66271.66
6122283-12228367.76867.77
5min1169318-16931893.83494.271.4893.8394.271.48
2168629-16862993.45393.45
3167657-16765792.91492.91
4170099-17009994.26794.27
5170101-17010194.26894.27
6174859-17485996.90596.91
10min1171250-17125094.90595.151.0794.9195.151.06
2170287-17028794.37194.37
3173662-17366296.24296.24
4171255-17125594.90894.91
5169591-16959193.98693.99
6174132-17413296.50296.50
15min1173817-17381796.32896.171.5796.3396.181.57
2173040-17304095.89795.90
3175153-17515397.06897.07
4168813-16881393.55493.55
5173481-17348196.14196.14
6176945-17694598.06198.06
20min1173322-17332296.05397.311.9696.0597.311.97
2178557-17855798.95598.95
3177668-17766898.46298.46
4171335-17133594.95294.95
5173060-17306095.90895.91
6179642-17964299.55699.56
30min1171687-17168795.14796.570.9495.1596.570.93
2174811-17481196.87996.88
3175795-17579597.42497.42
4173963-17396396.40996.41
5173308-17330896.04696.05
6175954-17595497.51297.51
45min1174381-17438196.64097.330.7896.6497.330.79
2175126-17512697.05397.05
3177443-17744398.33798.34
4175290-17529097.14497.14
5174309-17430996.60096.60
6177175-17717598.18998.19
60min1174646-17464696.78797.551.2296.7997.551.22
2176885-17688598.02898.03
3177770-17777098.51898.52
4175158-17515897.07197.07
5172983-17298395.86595.87
6178689-17868999.02899.03
极限1172711-17271195.71597.341.4095.7197.341.40
2173980-17398096.41896.42
3178363-17836398.84798.85
4174103-17410396.48696.49
5176085-17608597.58597.58
6178610-17861098.98498.98
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