培哚普利叔丁胺片项目信息
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101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8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%
110.234379734384644379144385864383344382540.07
210.204367574374744371160.12
单位质量响应值RSD%判断
42840.0842854.510.03数据可信
供试品溶液-2023041311批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1352768-35276892.43891.068.5592.4491.068.55
2361223-36122394.65394.65
3363570-36357095.26895.27
4363900-36390095.35595.35
5287548-28754875.34875.35
6356164-35616493.32893.33
10min1383813-383813100.57399.171.01100.7399.321.01
2378364-37836499.14599.30
3372216-37221697.53497.69
4377909-37790999.02599.18
5378018-37801899.05499.18
6380528-38052899.71299.87
15min1384602-384602100.77999.061.20101.1099.381.20
2375562-37556298.41098.73
3371360-37136097.30997.63
4377006-37700698.78999.11
5379333-37933399.39999.69
6380481-38048199.699100.02
20min1383952-383952100.60999.021.21101.1099.501.20
2377095-37709598.81299.30
3370831-37083197.17197.65
4375271-37527198.33498.82
5380115-38011599.604100.06
6380015-38001599.577100.07
30min1383604-383604100.51898.811.28101.1899.461.28
2376490-37649098.65499.31
3369364-36936496.78697.43
4375084-37508498.28598.94
5377849-37784999.01099.63
6380034-38003499.582100.24
极限1383513-383513100.49498.581.34101.3299.391.34
2375623-37562398.42699.24
3368367-36836796.52597.33
4374390-37439098.10398.92
5376349-37634998.61799.40
6379073-37907399.330100.15
培哚普利叔丁胺片项目信息
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101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8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%
110.234387564382444384104381744386734384510.06
210.204382764385934384340.06
单位质量响应值RSD%判断
42859.3442983.730.21数据可信
供试品溶液-2023041311批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1371080-37108097.06894.742.8797.0794.742.87
2372187-37218797.35897.36
3350593-35059391.70991.71
4355081-35508192.88392.88
5352727-35272792.26792.27
6371306-37130697.12797.13
10min1380909-38090999.639100.051.0999.80100.201.09
2382046-38204699.937100.10
3377666-37766698.79198.94
4383551-383551100.330100.49
5389960-389960102.007102.16
6380686-38068699.58199.74
15min1379080-37908099.16199.991.2499.49100.311.24
2380007-38000799.40399.73
3378540-37854099.01999.34
4384084-384084100.470100.79
5391037-391037102.288102.61
6380676-38067699.57899.91
20min1379295-37929599.21799.851.0699.71100.341.06
2381426-38142699.774100.27
3377696-37769698.79999.28
4382116-38211699.955100.44
5389285-389285101.830102.32
6380415-38041599.510100.00
30min1377408-37740898.72399.381.1499.38100.041.13
2379461-37946199.26099.92
3376730-37673098.54699.19
4380228-38022899.461100.12
5388285-388285101.569102.23
6377469-37746998.73999.40
极限1377540-37754098.75899.381.2399.58100.201.23
2377477-37747798.74199.57
3377290-37729098.69299.50
4380503-38050399.533100.35
5389119-389119101.787102.62
6377646-37764698.78699.61
培哚普利叔丁胺片项目信息
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101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8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%
110.234360364371344364994365104364914365340.09
210.204330924340494335700.16
单位质量响应值RSD%判断
42671.9542506.860.28数据可信
供试品溶液-2023041311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%
5min1351738-35173892.72691.389.9692.7391.389.96
2348463-34846391.86391.86
3367402-36740296.85696.86
4374252-37425298.66198.66
5358863-35886394.60594.60
6278984-27898473.54773.55
10min1371117-37111797.83599.151.0197.9999.311.01
2376233-37623399.18499.34
3374763-37476398.79698.96
4382581-382581100.857101.02
5377142-37714299.42399.58
6374895-37489598.83198.95
15min1372064-37206498.08599.200.8998.4099.520.89
2375612-37561299.02099.34
3375166-37516698.90299.23
4381876-381876100.671101.00
5377963-37796399.64099.96
6375089-37508998.88299.17
20min1370592-37059297.69799.040.9198.1899.530.91
2375167-37516798.90399.39
3374410-37441098.70399.19
4380961-380961100.430100.93
5377286-37728699.46199.95
6375818-37581899.07499.53
30min1370464-37046497.66399.071.0198.3199.721.01
2376415-37641599.23299.88
3372870-37287098.29798.95
4381482-381482100.567101.24
5376807-37680799.33599.99
6376881-37688199.35499.97
极限1370874-37087497.77198.550.6898.5899.360.68
2373163-37316398.37499.19
3371110-37111097.83398.65
4376911-37691199.362100.20
5375851-37585199.08399.90
6375088-37508898.88299.66
培哚普利叔丁胺片项目信息
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101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8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%
110.234375024366894372004372214373404371900.07
210.204368314367064367680.03
单位质量响应值RSD%判断
42736.0742820.390.14数据可信
供试品溶液-2023041311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%
5min1359551-35955194.36795.202.7394.3795.202.73
2371644-37164497.54197.54
3366891-36689196.29496.29
4344986-34498690.54590.54
5370836-37083697.32997.33
6362326-36232695.09695.10
10min1381030-381030100.00598.461.86100.1698.621.86
2380959-38095999.986100.15
3377705-37770599.13299.29
4362224-36222495.06995.22
5374927-37492798.40398.56
6374059-37405998.17598.33
15min1381613-381613100.15898.491.91100.4898.821.91
2382829-382829100.477100.81
3377305-37730599.02799.35
4363228-36322895.33295.64
5372816-37281697.84998.17
6373870-37387098.12598.45
20min1380211-38021199.79098.221.77100.2898.701.77
2379934-37993499.717100.21
3375529-37552998.56199.05
4362124-36212495.04395.51
5373393-37339398.00098.49
6374110-37411098.18898.67
30min1379615-37961599.63397.941.74100.2998.591.74
2378503-37850399.341100.00
3374697-37469798.34299.00
4361525-36152594.88595.51
5371612-37161297.53398.19
6373108-37310897.92598.57
极限1377419-37741999.05797.681.6499.8898.501.64
2378695-37869599.392100.22
3374620-37462098.32299.14
4362244-36224495.07495.86
5370745-37074597.30598.12
6369362-36936296.94297.75
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