对乙酰氨基酚维生素C泡腾片项目信息
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100425-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)200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 11.133616653363010936266823622723362770536247740.15
2 11.133617135360296536100500.28
单位质量响应值RSD%判断
325676.01324353.100.29数据可信
供试品溶液-A9460批-维生素C-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%
5min12906616-290661680.48876.803.1880.4976.803.18
22646896-264689673.29673.30
32728772-272877275.56375.56
42790337-279033777.26877.27
52748359-274835976.10576.11
62818693-281869378.05378.05
10min13005586-300558683.22883.699.2583.3683.819.23
23370637-337063793.33793.46
33190074-319007488.33788.46
42965147-296514782.10882.24
53064408-306440884.85784.98
62536985-253698570.25270.38
15min12859521-285952179.18480.295.2579.4680.565.24
22750354-275035476.16176.44
32949962-294996281.68881.96
43112629-311262986.19286.46
53005531-300553183.22783.49
62718647-271864775.28375.53
20min12648675-264867573.34578.796.7373.7579.196.69
22924156-292415680.97381.38
32769625-276962576.69477.10
42639884-263988473.10273.51
53117446-311744686.32686.73
62972016-297201682.29982.67
30min12952320-295232081.75377.206.1682.2877.736.13
22687416-268741674.41874.96
32719327-271932775.30175.84
42816331-281633177.98878.52
53004090-300409083.18783.74
62547397-254739770.54071.05
45min12845090-284509078.78473.516.8879.4574.176.84
22607922-260792272.21672.88
32690859-269085974.51375.18
42816114-281611477.98278.64
52628869-262886972.79673.49
62338159-233815964.74665.37
60min12866386-286638679.37474.326.6580.1775.106.60
22867750-286775079.41180.20
32593766-259376671.82472.61
42429684-242968467.28168.07
52770482-277048276.71877.53
62575180-257518071.31072.05
90min12602346-260234672.06271.734.3772.9972.644.35
22705265-270526574.91275.83
32613699-261369972.37673.28
42627815-262781572.76773.67
52620514-262051472.56573.50
62371926-237192665.68166.54
120min12374277-237427765.74765.183.2766.7966.203.24
22487419-248741968.88069.92
32336063-233606364.68865.72
42364283-236428365.47066.49
52280754-228075463.15764.22
62279682-227968263.12764.09
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12329519-232951964.50765.053.2065.6666.183.19
22448836-244883667.81168.97
32358686-235868665.31566.45
42341293-234129364.83365.97
52392606-239260666.25467.42
62223442-222344261.57062.64
对乙酰氨基酚维生素C泡腾片项目信息
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100018-202312对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)330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%
118.067650837766117076594077653242766381176576930.08
218.027787899776631977771090.20
单位质量响应值RSD%判断
424014.01431582.081.26数据可信
供试品溶液-A9460批-对乙酰氨基酚-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%
5min17581480-758148096.67495.251.0096.6795.241.00
27431657-743165794.76394.76
37441790-744179094.89294.89
47422467-742246794.64694.65
57396807-739680794.31994.32
67542969-754296996.18396.18
10min17809129-780912999.57698.100.9499.7498.260.94
27706132-770613298.26398.42
37731628-773162898.58898.75
47671176-767117697.81797.98
57631697-763169797.31497.47
67611026-761102697.05097.21
15min17781936-778193699.23097.800.8599.5698.120.85
27642590-764259097.45397.77
37688085-768808598.03398.36
47684441-768444197.98698.31
57617128-761712897.12897.45
67603326-760332696.95297.27
20min17765084-776508499.01597.680.7499.5198.170.74
27641893-764189397.44497.93
37676907-767690797.89098.38
47643686-764368697.46797.95
57629249-762924997.28397.76
67605738-760573896.98397.47
30min17779483-777948399.19897.881.0899.8698.531.08
27602610-760261096.94397.59
37652099-765209997.57498.22
47665892-766589297.75098.40
57772516-777251699.11099.75
67586223-758622396.73497.38
45min17750942-775094298.83498.031.5799.6698.841.56
27780453-778045399.211100.02
37839993-783999399.970100.78
47637343-763734397.38698.20
57572045-757204596.55397.36
67544961-754496196.20897.01
60min17745208-774520898.76197.551.0199.7598.521.01
27618456-761845697.14598.12
37645742-764574297.49398.47
47740380-774038098.70099.67
57571909-757190996.55297.52
67577708-757770896.62597.59
90min17735629-773562998.63997.690.9899.7998.830.97
27611148-761114897.05298.19
37632328-763232897.32298.46
47629474-762947497.28698.42
57586558-758655896.73897.87
67771988-777198899.103100.23
120min17883728-7883728100.52897.371.61101.8498.671.59
27581830-758183096.67897.98
37582344-758234496.68597.99
47611906-761190697.06298.36
57594081-759408196.83498.13
67563362-756336296.44397.74
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限17718122-771812298.41696.751.2399.9098.211.22
27633410-763341097.33698.79
37578586-757858696.63798.10
47605823-760582396.98498.44
57548548-754854896.25497.71
67438914-743891494.85696.31
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