托伐普坦口崩片项目信息
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101242-202302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)15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%
116.582022042004162004052023012001642010980.53
216.532021252019502020380.07
单位质量响应值RSD%判断
12128.9512222.500.55数据可信
加速6月-供试品溶液-2025051121批-SHUI(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1204711-204711100.779101.361.45100.78101.361.45
2201940-20194099.41599.41
3204099-204099100.478100.48
4206952-206952101.882101.88
5210499-210499103.628103.63
6207196-207196102.002102.00
10min1207125-207125101.967103.351.31102.14103.521.31
2206816-206816101.815101.98
3209469-209469103.121103.29
4211600-211600104.170104.34
5214004-214004105.354105.53
6210531-210531103.644103.81
15min1206897-206897101.855102.991.29102.19103.331.30
2206734-206734101.775102.11
3207421-207421102.113102.45
4210701-210701103.728104.07
5213577-213577105.144105.49
6209867-209867103.317103.66
20min1206451-206451101.635102.801.36102.14103.311.36
2206621-206621101.719102.22
3206424-206424101.622102.13
4211179-211179103.963104.48
5213090-213090104.904105.43
6209151-209151102.965103.48
30min1206283-206283101.553102.631.41102.23103.321.40
2205694-205694101.263101.94
3206051-206051101.439102.12
4211322-211322104.033104.72
5212449-212449104.588105.29
6209059-209059102.919103.61
45min1205917-205917101.373102.641.45102.22103.491.45
2205594-205594101.214102.06
3206193-206193101.508102.36
4211237-211237103.992104.85
5212580-212580104.653105.53
6209379-209379103.077103.93
60min1205551-205551101.192102.191.43102.21103.221.43
2204388-204388100.620101.63
3204872-204872100.858101.88
4209750-209750103.260104.30
5211116-211116103.932104.98
6209796-209796103.282104.31
极限1203914-203914100.386101.761.44101.57102.961.44
2203806-203806100.333101.51
3204751-204751100.799101.98
4209316-209316103.046104.25
5210681-210681103.718104.94
6207806-207806102.303103.50
托伐普坦口崩片项目信息
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101242-202302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)15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%
116.582026862003992027282024871997332016070.71
216.532019232001582010400.63
单位质量响应值RSD%判断
12159.6512162.130.02数据可信
中间条件6月-供试品溶液-2025051121批-SHUI(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1191383-19138394.33195.964.3094.3395.964.30
2201272-20127299.20599.21
3179498-17949888.47388.47
4202011-20201199.57099.57
5196239-19623996.72596.72
6197683-19768397.43697.44
10min1205287-205287101.184101.910.63101.34102.070.63
2207800-207800102.423102.59
3208388-208388102.713102.86
4206752-206752101.906102.07
5205232-205232101.157101.32
6207104-207104102.080102.24
15min1205480-205480101.279102.150.72101.61102.480.71
2207166-207166102.110102.45
3209516-209516103.269103.59
4206852-206852101.956102.29
5206111-206111101.590101.92
6208308-208308102.673103.01
20min1204559-204559100.825102.021.09101.32102.521.09
2207578-207578102.313102.82
3210345-210345103.677104.17
4204300-204300100.698101.20
5207671-207671102.359102.86
6207459-207459102.255102.76
30min1203558-203558100.332101.961.13100.99102.631.12
2207205-207205102.130102.81
3210159-210159103.586104.25
4204979-204979101.032101.71
5207962-207962102.503103.17
6207340-207340102.196102.87
45min1204119-204119100.609101.811.06101.44102.641.05
2208552-208552102.794103.64
3209431-209431103.227104.06
4205302-205302101.192102.03
5207213-207213102.134102.97
6204661-204661100.876101.72
60min1203646-203646100.375101.821.34101.37102.831.33
2206073-206073101.572102.59
3209432-209432103.227104.24
4204851-204851100.969101.98
5210525-210525103.766104.78
6204942-204942101.014102.03
极限1203321-203321100.215101.141.18101.38102.321.17
2204592-204592100.842102.03
3209667-209667103.343104.52
4203070-203070100.091101.27
5204709-204709100.899102.08
6205787-205787101.431102.61
托伐普坦口崩片项目信息
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101242-202302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)15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%
116.584024854005874045854014984011814020670.39
216.534058074011464034760.82
单位质量响应值RSD%判断
24250.1224408.710.47数据可信
加速6月-供试品溶液-2025050821批-SHUI(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1401973-40197399.03598.151.7699.0398.151.76
2396415-39641597.66597.67
3408281-408281100.589100.59
4400962-40096298.78598.79
5394842-39484297.27897.28
6387837-38783795.55295.55
10min1409943-409943100.998101.470.87101.16101.640.87
2414858-414858102.209102.37
3408707-408707100.694100.86
4412255-412255101.568101.73
5408272-408272100.586100.75
6417178-417178102.781102.94
15min1406978-406978100.268101.081.23100.60101.411.22
2414344-414344102.082102.42
3407964-407964100.511100.85
4404170-40417099.57699.91
5410458-410458101.125101.45
6417752-417752102.922103.25
20min1405506-40550699.905101.081.46100.41101.581.45
2418495-418495103.105103.61
3406528-406528100.157100.66
4405501-40550199.904100.40
5408434-408434100.626101.12
6417152-417152102.774103.28
30min1405830-40583099.985100.581.00100.65101.251.00
2414065-414065102.014102.69
3402699-40269999.21399.88
4407452-407452100.384101.05
5407838-407838100.479101.15
6411699-411699101.431102.10
45min1408129-408129100.551100.781.06101.38101.621.06
2413353-413353101.838102.68
3402357-40235799.12999.96
4411689-411689101.428102.26
5406154-406154100.065100.90
6412762-412762101.693102.54
60min1406059-406059100.041100.201.15101.04101.201.14
2412485-412485101.624102.64
3401442-40144298.90499.90
4404450-40445099.645100.65
5403485-40348599.407100.41
6412237-412237101.563102.58
极限1404863-40486399.74799.791.31100.91100.961.30
2407355-407355100.360101.54
3400695-40069598.72099.88
4402920-40292099.268100.44
5400081-40008198.56899.73
6414335-414335102.080103.26
托伐普坦口崩片项目信息
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101242-202302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)15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%
116.584088114062594090444056714018844063340.72
216.534079704062204070950.31
单位质量响应值RSD%判断
24507.4824627.650.35数据可信
中间条件6月-供试品溶液-2025050821批-SHUI(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1332097-33209781.02685.736.4781.0385.736.47
2341955-34195583.43183.43
3389739-38973995.08995.09
4328544-32854480.15980.16
5353508-35350886.24986.25
6362457-36245788.43388.43
10min1395387-39538796.46799.821.9796.6099.961.97
2411340-411340100.359100.50
3410788-410788100.225100.38
4405465-40546598.92699.06
5412689-412689100.689100.83
6419097-419097102.252102.40
15min1405180-40518098.857100.751.4099.15101.061.41
2415741-415741101.433101.74
3410005-410005100.034100.36
4409100-40910099.813100.11
5416964-416964101.732102.04
6420635-420635102.627102.95
20min1408072-40807299.562101.081.15100.02101.561.15
2415793-415793101.446101.92
3410820-410820100.233100.72
4412297-412297100.593101.06
5418384-418384102.078102.56
6420500-420500102.594103.08
30min1407683-40768399.467100.951.07100.09101.601.07
2413694-413694100.934101.58
3410441-410441100.140100.80
4413483-413483100.882101.51
5418261-418261102.048102.70
6419065-419065102.244102.90
45min1406470-40647099.171100.380.8999.96101.200.89
2413653-413653100.924101.74
3409028-40902899.795100.62
4412509-412509100.645101.45
5416770-416770101.684102.51
6410189-410189100.079100.91
60min1405799-40579999.008100.330.9599.97101.310.95
2413189-413189100.811101.79
3407150-40715099.337100.33
4411724-411724100.453101.42
5415580-415580101.394102.38
6413792-413792100.958101.95
极限1404453-40445398.679100.180.9999.80101.320.99
2410954-410954100.265101.41
3408079-40807999.564100.72
4410306-410306100.107101.24
5414277-414277101.076102.24
6415507-415507101.376102.54
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