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%
1 10.722238792236782247472240762248602242480.24
2 10.772247762242992245380.16
单位质量响应值RSD%判断
20918.6620848.470.24数据可信
供试品溶液-2025041521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%
5min1233583-233583100.464100.980.67100.46100.980.67
2233373-233373100.374100.37
3233752-233752100.537100.54
4237050-237050101.955101.96
5236346-236346101.652101.65
6234524-234524100.869100.87
10min1233775-233775100.547101.070.78100.71101.230.78
2234602-234602100.902101.07
3233595-233595100.469100.64
4237184-237184102.013102.18
5237373-237373102.094102.26
6233372-233372100.373100.54
15min1233591-233591100.468100.830.86100.80101.170.86
2233680-233680100.506100.84
3232822-232822100.137100.47
4238066-238066102.392102.73
5235419-235419101.254101.59
6233040-233040100.231100.57
20min1232969-232969100.200100.530.75100.70101.030.75
2232656-232656100.065100.57
3232930-232930100.183100.69
4236400-236400101.676102.19
5235394-235394101.243101.75
6232008-23200899.787100.29
30min1232314-23231499.918100.370.86100.59101.040.86
2231767-23176799.683100.35
3232372-23237299.943100.61
4236466-236466101.704102.38
5235307-235307101.206101.88
6231915-23191599.747100.42
极限1231560-23156099.59499.930.78100.43100.770.78
2230662-23066299.208100.04
3231489-23148999.563100.40
4235335-235335101.218102.07
5233716-233716100.521101.37
6231266-23126699.468100.30
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%
1 10.722239672244562247092240262243822243080.14
2 10.772251922245062248490.22
单位质量响应值RSD%判断
20924.2520877.340.16数据可信
供试品溶液-2025041521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%
5min1231179-23117999.348100.390.7599.35100.390.75
2235603-235603101.249101.25
3233179-233179100.207100.21
4232169-23216999.77399.77
5234478-234478100.766100.77
6235049-235049101.011101.01
10min1232966-232966100.116100.940.53100.28101.100.53
2236348-236348101.569101.74
3235180-235180101.067101.23
4234328-234328100.701100.87
5236003-236003101.421101.59
6234422-234422100.742100.91
15min1231476-23147699.476100.700.9599.81101.040.95
2236006-236006101.422101.76
3234572-234572100.806101.14
4232049-23204999.722100.06
5237197-237197101.934102.27
6234690-234690100.857101.19
20min1230399-23039999.013100.440.9599.51100.940.95
2236355-236355101.572102.08
3233787-233787100.469100.97
4232677-23267799.992100.49
5235960-235960101.403101.91
6233149-233149100.195100.70
30min1230598-23059899.098100.230.9799.76100.910.97
2235509-235509101.209101.89
3232171-23217199.774100.45
4231885-23188599.651100.32
5236434-236434101.606102.28
6232860-232860100.070100.74
极限1230021-23002198.850100.130.7899.68100.960.78
2234857-234857100.929101.77
3232898-232898100.087100.92
4232128-23212899.756100.59
5234772-234772100.892101.74
6233267-233267100.245101.08
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)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%
1 10.722234192232832239882232042232492234290.15
2 10.772228152235162231660.23
单位质量响应值RSD%判断
20842.2620721.080.42数据可信
供试品溶液-2025041621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%
5min1237170-237170102.50899.551.77102.5199.561.77
2227836-22783698.47398.47
3231083-23108399.87799.88
4231917-231917100.237100.24
5228476-22847698.75098.75
6225527-22552797.47597.48
10min1238896-238896103.254100.301.74103.42100.471.74
2228944-22894498.95299.12
3232948-232948100.683100.85
4233878-233878101.085101.25
5229316-22931699.11399.28
6228420-22842098.72698.89
15min1238102-238102102.910100.041.75103.25100.371.75
2228419-22841998.72599.05
3232839-232839100.636100.97
4233194-233194100.789101.12
5228743-22874398.86599.20
6227439-22743998.30298.63
20min1238235-238235102.968100.261.63103.48100.761.63
2230159-23015999.47799.97
3232823-232823100.629101.13
4233677-233677100.998101.50
5228800-22880098.89099.38
6228119-22811998.59699.09
30min1237985-237985102.860100.231.57103.55100.901.58
2230108-23010899.455100.11
3232513-232513100.495101.16
4233631-233631100.978101.65
5229180-22918099.05499.71
6228009-22800998.54899.20
极限1237724-237724102.747100.181.56103.60101.021.56
2229708-22970899.282100.11
3232940-232940100.679101.52
4233206-233206100.794101.63
5229498-22949899.192100.02
6227660-22766098.39799.22
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%
1 10.722234612242382238232243382238052239330.16
2 10.772229582230742230160.04
单位质量响应值RSD%判断
20889.2720707.150.62数据可信
供试品溶液-2025041621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%
5min1227286-22728698.159100.862.0298.16100.862.02
2229931-22993199.30199.30
3235648-235648101.770101.77
4239188-239188103.299103.30
5231460-23146099.96199.96
6237802-237802102.700102.70
10min1229215-22921598.992101.722.0999.16101.892.09
2231522-23152299.988100.15
3237399-237399102.526102.70
4241695-241695104.381104.55
5233487-233487100.837101.00
6239909-239909103.610103.78
15min1229522-22952299.124101.442.0399.45101.782.03
2230569-23056999.57699.91
3236952-236952102.333102.67
4242036-242036104.529104.87
5232835-232835100.555100.89
6237382-237382102.519102.86
20min1230405-23040599.506101.451.99100.00101.951.99
2231005-23100599.765100.26
3236669-236669102.211102.72
4241550-241550104.319104.84
5231291-23129199.888100.39
6238470-238470102.989103.50
30min1228538-22853898.699101.422.1999.36102.102.19
2230477-23047799.537100.20
3236359-236359102.077102.76
4241387-241387104.248104.94
5232634-232634100.468101.14
6239683-239683103.512104.20
极限1228513-22851398.688101.242.1499.51102.082.13
2230567-23056799.576100.41
3234701-234701101.361102.21
4241696-241696104.382105.25
5232362-232362100.351101.19
6238629-238629103.057103.92
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%
1 10.722238512219422226042231492217282226550.40
2 10.772222612223372222990.03
单位质量响应值RSD%判断
20770.0620640.580.45数据可信
供试品溶液-2025041821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%
5min1235938-235938102.351102.731.27102.35102.731.27
2237846-237846103.179103.18
3242062-242062105.008105.01
4233814-233814101.430101.43
5236913-236913102.774102.77
6234259-234259101.623101.62
10min1238023-238023103.256104.011.12103.43104.181.12
2240362-240362104.270104.44
3244246-244246105.955106.13
4237244-237244102.918103.09
5241051-241051104.569104.74
6237668-237668103.102103.27
15min1239099-239099103.723104.020.99104.07104.370.99
2239676-239676103.973104.32
3244111-244111105.897106.25
4237352-237352102.965103.31
5240285-240285104.237104.58
6238192-238192103.329103.67
20min1237063-237063102.839103.731.29103.35104.251.28
2238331-238331103.389103.91
3244904-244904106.241106.77
4237455-237455103.009103.52
5240065-240065104.142104.66
6236912-236912102.774103.29
30min1237620-237620103.081103.340.89103.77104.040.89
2237079-237079102.846103.54
3242512-242512105.203105.91
4237483-237483103.022103.71
5237548-237548103.050103.74
6237111-237111102.860103.54
极限1236762-236762102.709103.051.00103.57103.910.99
2235849-235849102.313103.18
3242212-242212105.073105.95
4236954-236954102.792103.65
5237370-237370102.973103.84
6236117-236117102.429103.29
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%
1 10.722223672228492234512232492224412228710.22
2 10.772220522227922224220.24
单位质量响应值RSD%判断
20790.2120652.000.48数据可信
供试品溶液-2025041821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%
5min1236002-236002102.301102.460.68102.30102.460.68
2236897-236897102.689102.69
3238776-238776103.504103.50
4233802-233802101.348101.35
5236327-236327102.442102.44
6236426-236426102.485102.48
10min1236394-236394102.471103.060.81102.64103.240.81
2238817-238817103.521103.69
3240742-240742104.356104.53
4235331-235331102.010102.18
5237097-237097102.776102.95
6238193-238193103.251103.42
15min1236606-236606102.563102.890.89102.90103.240.89
2237581-237581102.986103.33
3240575-240575104.283104.63
4234457-234457101.631101.97
5236313-236313102.436102.78
6238668-238668103.457103.80
20min1236962-236962102.717102.620.68103.23103.130.68
2237516-237516102.957103.47
3239328-239328103.743104.26
4234706-234706101.739102.25
5235913-235913102.263102.78
6235969-235969102.287102.80
30min1236240-236240102.404102.600.61103.09103.280.62
2236907-236907102.693103.38
3238710-238710103.475104.17
4234270-234270101.550102.23
5236902-236902102.691103.37
6237112-237112102.782103.47
极限1234979-234979101.858102.270.71102.71103.120.71
2237495-237495102.948103.81
3237724-237724103.048103.91
4233343-233343101.149102.00
5235488-235488102.078102.93
6236517-236517102.524103.38
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