富马酸伏诺拉生片项目信息
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430030-202302对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.7485
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.992456172444182450722455722439082449170.31
214.992452472451122451800.04
单位质量响应值RSD%判断
16338.6916356.240.08数据可信
供试品溶液-12561861批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1208004-20800485.45888.116.4785.4688.116.47
2235277-23527796.66396.66
3226732-22673293.15293.15
4199417-19941781.93081.93
5213152-21315287.57387.57
6204139-20413983.87083.87
10min1242642-24264299.68999.742.2299.8399.892.22
2246786-246786101.391101.55
3249426-249426102.476102.63
4236153-23615397.02397.16
5244874-244874100.606100.75
6236793-23679397.28597.43
15min1245710-245710100.949100.950.97101.26101.260.98
2248761-248761102.202102.53
3248043-248043101.908102.23
4242632-24263299.68499.98
5245285-245285100.774101.09
6243816-243816100.171100.47
20min1243503-243503100.042100.730.60100.52101.210.61
2246102-246102101.110101.61
3247005-247005101.481101.98
4243460-243460100.025100.49
5246044-246044101.086101.57
6244967-244967100.644101.11
30min1244224-244224100.338100.760.56100.98101.410.57
2246638-246638101.330102.00
3246790-246790101.393102.06
4243695-243695100.121100.75
5245929-245929101.039101.69
6244295-244295100.368101.00
45min1242898-24289899.794100.550.90100.60101.370.90
2245108-245108100.702101.54
3248691-248691102.174103.01
4242979-24297999.827100.62
5245203-245203100.741101.56
6243587-243587100.077100.88
60min1242281-24228199.540100.280.61100.52101.260.62
2245598-245598100.903101.91
3246045-246045101.087102.09
4243331-24333199.972100.94
5244015-244015100.253101.24
6243147-24314799.896100.87
极限1241366-24136699.164100.090.83100.31101.240.83
2245112-245112100.703101.88
3246344-246344101.209102.38
4241953-24195399.405100.54
5244572-244572100.481101.63
6242341-24234199.565100.70
富马酸伏诺拉生片项目信息
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430030-202302对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.7485
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.992449522439102443722449882439962444440.21
214.992444552446772445660.07
单位质量响应值RSD%判断
16307.1416315.280.04数据可信
供试品溶液-12561861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%
5min1209450-20945086.24369.9715.5186.2469.9715.51
2140724-14072457.94457.94
3151826-15182662.51662.52
4192190-19219079.13679.14
5170726-17072670.29870.30
6154634-15463463.67263.67
10min1244403-244403100.63591.667.18100.7891.787.19
2203253-20325383.69183.79
3220735-22073590.89090.99
4233697-23369796.22796.36
5227543-22754393.69393.81
6206009-20600984.82684.93
15min1246574-246574101.52997.113.45101.8497.383.47
2225998-22599893.05793.29
3233954-23395496.33396.59
4241907-24190799.60799.90
5238923-23892398.37998.65
6227630-22763093.72993.98
20min1248243-248243102.21698.942.04102.7099.372.06
2234451-23445196.53796.93
3239458-23945898.59999.02
4241991-24199199.642100.10
5241399-24139999.39899.84
6236133-23613397.23097.63
30min1247014-247014101.710100.221.21102.36100.811.23
2240388-24038898.98299.53
3246093-246093101.331101.91
4244363-244363100.619101.24
5242523-24252399.861100.46
6239962-23996298.80799.37
45min1247269-247269101.815100.691.03102.64101.451.05
2244016-244016100.476101.19
3247158-247158101.770102.52
4244687-244687100.752101.54
5243520-243520100.272101.04
6240559-24055999.05299.78
60min1248207-248207102.202100.810.87103.19101.740.90
2244002-244002100.470101.35
3245710-245710101.173102.09
4245094-245094100.920101.88
5244192-244192100.548101.48
6241778-24177899.554100.45
极限1247036-247036101.719100.931.05102.88102.031.05
2246702-246702101.582102.63
3246871-246871101.651102.74
4244177-244177100.542101.67
5245560-245560101.112102.22
6240374-24037498.976100.04
富马酸伏诺拉生片项目信息
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430030-202302对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.7485
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.992438062423262433222424722424992428850.27
214.992424042433062428550.27
单位质量响应值RSD%判断
16203.1416201.130.01数据可信
供试品溶液-12561861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%
5min1146446-14644660.70671.9514.7060.7171.9514.70
2198342-19834282.21982.22
3160414-16041466.49766.50
4193818-19381880.34480.34
5196758-19675881.56281.56
6145612-14561260.36160.36
10min1207930-20793086.19392.145.5086.2992.265.52
2226850-22685094.03694.17
3222069-22206992.05592.17
4228840-22884094.86195.00
5239335-23933599.21299.35
6208633-20863386.48586.59
15min1229633-22963395.19097.872.5695.4398.142.57
2235815-23581597.75398.05
3233370-23337096.73997.00
4240925-24092599.871100.16
5245411-245411101.731102.03
6231412-23141295.92796.17
20min1239018-23901899.080100.171.5399.48100.601.55
2242154-242154100.380100.84
3238160-23816098.72599.15
4245937-245937101.949102.41
5246106-246106102.019102.49
6238484-23848498.85999.26
30min1243468-243468100.925101.021.22101.49101.621.23
2242029-242029100.329100.95
3240350-24035099.633100.22
4247799-247799102.720103.35
5246737-246737102.280102.92
6241824-241824100.244100.81
45min1245311-245311101.689101.681.25102.43102.451.25
2242978-242978100.722101.51
3240842-24084299.837100.59
4249145-249145103.278104.08
5247791-247791102.717103.53
6245596-245596101.807102.54
60min1245724-245724101.860101.701.08102.77102.641.08
2244137-244137101.202102.16
3240853-24085399.841100.76
4247998-247998102.803103.77
5247710-247710102.684103.67
6245631-245631101.822102.73
极限1246969-246969102.376102.300.54103.45103.420.54
2245744-245744101.869103.00
3244706-244706101.438102.53
4248169-248169102.874104.02
5247277-247277102.504103.66
6247877-247877102.753103.83
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