氢溴酸伏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%
114.181804011801501799851800561799961801180.10
214.231807241808291807760.05
单位质量响应值RSD%判断
12702.2612703.870.01数据可信
供试品溶液-2025102521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%
2min197665-9766554.38163.229.6854.3863.229.68
2104537-10453758.20758.21
3114012-11401263.48363.48
4120971-12097167.35867.36
5127973-12797371.25771.26
6116026-11602664.60564.60
5min1179751-179751100.08898.750.90100.0998.760.90
2176984-17698498.54798.55
3175403-17540397.66797.67
4176832-17683298.46298.46
5176446-17644698.24798.25
6178706-17870699.50699.51
10min1188017-188017104.690101.891.48104.69101.891.48
2183131-183131101.970101.97
3181150-181150100.867100.87
4181452-181452101.035101.03
5180756-180756100.647100.65
6183419-183419102.130102.13
15min1184773-184773102.884101.320.79102.88101.320.78
2181460-181460101.039101.04
3181300-181300100.950100.95
4181633-181633101.135101.14
5180798-180798100.671100.67
6181818-181818101.238101.24
20min1185539-185539103.310101.390.99103.31101.390.99
2182101-182101101.396101.40
3180326-180326100.408100.41
4181351-181351100.978100.98
5181823-181823101.241101.24
6181380-181380100.995100.99
30min1184205-184205102.568101.060.76102.57101.060.76
2181630-181630101.134101.13
3180725-180725100.630100.63
4180772-180772100.656100.66
5180858-180858100.704100.70
6180843-180843100.696100.70
45min1184295-184295102.618101.330.67102.62101.330.68
2182228-182228101.467101.47
3181679-181679101.161101.16
4181228-181228100.910100.91
5180897-180897100.726100.73
6181557-181557101.093101.09
60min1182843-182843101.809100.760.72101.81100.760.72
2180726-180726100.630100.63
3180265-180265100.374100.37
4179846-179846100.140100.14
5179826-179826100.129100.13
6182295-182295101.504101.50
极限1182565-182565101.654100.680.57101.65100.680.57
2180692-180692100.612100.61
3180661-180661100.594100.59
4179958-179958100.203100.20
5179727-179727100.074100.07
6181285-181285100.942100.94
氢溴酸伏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%
114.181800171799881801761801241802901801190.07
214.231816651816101816380.03
单位质量响应值RSD%判断
12702.3312764.440.35数据可信
供试品溶液-2025102521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%
2min1121499-12149967.49169.472.7167.4969.482.71
2121779-12177967.64767.65
3123378-12337868.53568.54
4129139-12913971.73571.74
5125845-12584569.90669.91
6128750-12875071.51971.52
5min1174594-17459496.98597.631.4796.9997.631.47
2173831-17383196.56196.56
3175599-17559997.54397.54
4176874-17687498.25298.25
5173324-17332496.28096.28
6180316-180316100.164100.16
10min1181514-181514100.829101.341.42100.83101.341.42
2180354-180354100.185100.18
3182378-182378101.309101.31
4183359-183359101.854101.85
5179966-17996699.96999.97
6187036-187036103.897103.90
15min1182955-182955101.630101.841.04101.63101.841.04
2183039-183039101.676101.68
3183309-183309101.826101.83
4184155-184155102.296102.30
5180322-180322100.167100.17
6186193-186193103.428103.43
20min1182994-182994101.651101.911.29101.65101.921.29
2181752-181752100.961100.96
3182966-182966101.636101.64
4184500-184500102.488102.49
5181000-181000100.544100.54
6187599-187599104.209104.21
30min1182657-182657101.464101.641.01101.46101.641.01
2181658-181658100.909100.91
3184327-184327102.392102.39
4183721-183721102.055102.06
5180267-180267100.136100.14
6185256-185256102.908102.91
45min1182881-182881101.588101.450.73101.59101.460.73
2181472-181472100.806100.81
3182300-182300101.266101.27
4184107-184107102.270102.27
5180957-180957100.520100.52
6184105-184105102.268102.27
60min1183275-183275101.807101.670.77101.81101.680.77
2182021-182021101.111101.11
3183514-183514101.940101.94
4182738-182738101.509101.51
5181292-181292100.706100.71
6185370-185370102.971102.97
极限1181881-181881101.033101.351.13101.03101.351.13
2182056-182056101.130101.13
3183870-183870102.138102.14
4183962-183962102.189102.19
5178804-17880499.32499.32
6184178-184178102.309102.31
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