精氨酸培哚普利片项目信息
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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.943186783186453181443186443189483186120.10
29.863175963173653174800.06
单位质量响应值RSD%判断
32053.5232198.780.32数据可信
供试品溶液-2023092022批-pH1.2盐酸溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1172204-17220445.73440.8616.9945.7340.8616.99
2116729-11672931.00131.00
3179462-17946247.66147.66
4177627-17762747.17447.17
5140816-14081637.39837.40
6136248-13624836.18536.18
10min1187260-18726049.73248.955.2349.8149.015.24
2171218-17121845.47245.52
3189956-18995650.44850.53
4187214-18721449.72049.80
5196061-19606152.07052.13
6174075-17407546.23146.29
15min1188473-18847350.05549.753.2750.2149.903.28
2178055-17805547.28847.42
3192851-19285151.21751.38
4186927-18692749.64449.81
5194537-19453751.66551.81
6183160-18316048.64448.78
20min1187925-18792549.90949.892.2550.1550.122.27
2181671-18167148.24848.45
3189959-18995950.44950.70
4186538-18653849.54149.78
5194426-19442651.63651.87
6186582-18658249.55249.77
30min1188053-18805349.94350.101.7650.2750.421.76
2184473-18447348.99249.28
3189957-18995750.44950.78
4186349-18634949.49049.82
5194101-19410151.54951.87
6188944-18894450.18050.48
极限1188313-18831350.01250.241.3150.4250.641.31
2187675-18767549.84350.21
3190034-19003450.46950.89
4186239-18623949.46149.87
5193438-19343851.37351.78
6189424-18942450.30750.69
精氨酸培哚普利片项目信息
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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.943183643182813178333179653179643180810.08
29.863173273171783172520.04
单位质量响应值RSD%判断
32000.1032175.660.39数据可信
供试品溶液-2023092022批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1171598-17159845.62745.3811.8245.6345.3911.82
2183778-18377848.86648.87
3130678-13067834.74734.75
4182698-18269848.57948.58
5180685-18068548.04448.04
6174674-17467446.44546.45
10min1185874-18587449.42350.371.2549.5050.441.25
2191543-19154350.93151.01
3189837-18983750.47750.53
4192344-19234451.14451.22
5188054-18805450.00350.08
6188979-18897950.24950.33
15min1186791-18679149.66751.042.0949.8351.202.07
2188681-18868150.17050.34
3197748-19774852.58152.72
4193201-19320151.37251.54
5194456-19445651.70551.87
6190847-19084750.74650.91
20min1186883-18688349.69250.902.3649.9351.142.33
2188241-18824150.05350.30
3199381-19938153.01553.24
4192995-19299551.31751.57
5189297-18929750.33350.58
6191802-19180251.00051.25
30min1186223-18622349.51650.892.5049.8451.222.48
2188174-18817450.03550.37
3199810-19981053.12953.45
4192603-19260351.21351.55
5189342-18934250.34550.68
6192166-19216651.09651.43
极限1186796-18679649.66851.002.7250.0751.422.70
2187278-18727849.79750.21
3201148-20114853.48553.89
4192165-19216551.09651.52
5190655-19065550.69551.11
6192867-19286751.28351.70
精氨酸培哚普利片项目信息
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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.943176643175663158603158663158443165600.31
29.863176713174243175480.06
单位质量响应值RSD%判断
31847.0832205.680.80数据可信
供试品溶液-2023092121批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1242108-24210864.50176.7217.6264.5076.7217.62
2320002-32000285.25385.25
3286064-28606476.21176.21
4213944-21394456.99857.00
5322107-32210785.81485.81
6343593-34359391.53891.54
10min1362391-36239196.54697.952.0496.6598.082.06
2370814-37081498.79098.93
3369691-36969198.49198.62
4355842-35584294.80194.90
5370060-37006098.58998.73
6377267-377267100.509100.66
15min1366673-36667397.68798.871.6997.9699.161.71
2374015-37401599.64399.95
3374230-37423099.70099.99
4360507-36050796.04496.30
5373970-37397099.63199.94
6377181-377181100.486100.81
20min1369950-36995098.56099.061.2898.9999.521.30
2371418-37141898.95199.42
3374278-37427899.713100.17
4363527-36352796.84997.26
5376088-376088100.195100.67
6375785-375785100.114100.60
30min1367768-36776897.97899.121.1998.5799.741.21
2371983-37198399.10199.74
3374142-37414299.677100.30
4366036-36603697.51798.09
5377328-377328100.525101.17
6375156-37515699.947100.60
极限1371783-37178399.04899.911.0599.81100.691.05
2371480-37148098.96799.77
3376221-376221100.230101.02
4373835-37383599.595100.33
5382097-382097101.796102.60
6374586-37458699.795100.62
精氨酸培哚普利片项目信息
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DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.943179193180233186163178083172163179160.16
29.863187953184433186190.08
单位质量响应值RSD%判断
31983.5032314.300.73数据可信
供试品溶液-2023092121批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1294865-29486578.25677.6329.5778.2677.6329.57
2359073-35907395.29795.30
3328443-32844387.16887.17
4331753-33175388.04688.05
5319705-31970584.84984.85
6121096-12109632.13932.14
10min1365880-36588097.10496.083.1297.2396.203.15
2370834-37083498.41898.58
3363319-36331996.42496.57
4361752-36175296.00896.15
5370066-37006698.21498.36
6340208-34020890.29090.34
15min1366982-36698297.39697.781.1397.6998.071.11
2373127-37312799.02799.35
3366359-36635997.23197.54
4362006-36200696.07596.38
5369963-36996398.18798.49
6372191-37219198.77898.98
20min1370353-37035398.29198.331.1798.7598.791.14
2371897-37189798.70099.19
3367307-36730797.48297.95
4364453-36445396.72597.19
5372192-37219298.77999.25
6376898-376898100.028100.40
30min1371281-37128198.53798.441.1399.1699.051.09
2372194-37219498.77999.43
3367790-36779097.61098.24
4365104-36510496.89897.53
5371747-37174798.66199.29
6377311-377311100.137100.67
极限1372960-37296098.98399.291.2199.77100.081.17
2372588-37258898.88499.70
3374610-37461099.420100.21
4367779-36777997.60798.40
5375246-37524699.589100.39
6381596-381596101.274101.98
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