非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.253960275396261339523053955065395517139570860.11
210.354020689402255440216220.04
单位质量响应值RSD%判断
386057.17388562.510.46数据可信
供试品溶液-2024011411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%
5min1400375-4003759.3049.854.089.309.854.08
2447187-44718710.39110.39
3440682-44068210.24010.24
4417674-4176749.7069.71
5422232-4222329.8129.81
6415226-4152269.6499.65
10min1661358-66135815.36815.661.3815.3915.681.38
2679232-67923215.78415.81
3679998-67999815.80115.82
4676528-67652815.72115.74
5682538-68253815.86015.88
6662712-66271215.40015.42
15min1747175-74717517.36217.440.4017.4217.500.41
2752321-75232117.48217.54
3747675-74767517.37417.43
4753102-75310217.50017.56
5754425-75442517.53117.59
6749645-74964517.42017.48
20min1772386-77238617.94817.990.9418.0418.080.94
2774425-77442517.99618.09
3780674-78067418.14118.24
4769794-76979417.88817.98
5783434-78343418.20518.30
6763600-76360017.74417.84
30min1787111-78711118.29018.460.6018.4218.600.61
2793143-79314318.43118.57
3797471-79747118.53118.67
4799645-79964518.58218.72
5798003-79800318.54418.68
6792048-79204818.40518.54
45min1788372-78837218.32018.460.6718.4918.640.69
2792701-79270118.42018.60
3794795-79479518.46918.65
4799329-79932918.57418.75
5802099-80209918.63918.82
6790096-79009618.36018.53
60min1790317-79031718.36518.411.3018.5818.631.31
2793771-79377118.44518.66
3798726-79872618.56018.78
4785754-78575418.25918.48
5807209-80720918.75718.98
6777583-77758318.06918.28
极限1797174-79717418.52418.820.9618.7819.070.96
2809877-80987718.81919.08
3814783-81478318.93319.19
4809123-80912318.80219.06
5820158-82015819.05819.32
6807102-80710218.75519.01
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.254030302402758440297874030749402731940291480.04
210.354068931407078240698560.04
单位质量响应值RSD%判断
393087.61393222.800.03数据可信
供试品溶液-2024011411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%
5min1303161-3031616.9408.1512.486.948.1512.47
2336197-3361977.6967.70
3311985-3119857.1427.14
4388846-3888468.9018.90
5392780-3927808.9918.99
6404234-4042349.2549.25
10min1648405-64840514.84315.051.4714.8615.071.47
2665945-66594515.24515.26
3670074-67007415.33915.36
4647572-64757214.82414.84
5651199-65119914.90714.93
6660714-66071415.12515.15
15min1733735-73373516.79616.881.2116.8416.931.22
2744642-74464217.04617.10
3734301-73430116.80916.86
4722737-72273716.54516.60
5746703-74670317.09317.15
6741903-74190316.98317.04
20min1757775-75777517.34717.202.0717.4317.292.06
2761825-76182517.43917.53
3750856-75085617.18817.28
4722653-72265316.54316.63
5766169-76616917.53917.63
6748980-74898017.14517.24
30min1779790-77979017.85117.650.8817.9817.780.88
2772066-77206617.67417.80
3771862-77186217.66917.79
4760602-76060217.41117.54
5766913-76691317.55617.69
6776105-77610517.76617.90
45min1759136-75913617.37817.691.4417.5417.851.44
2775226-77522617.74617.91
3778168-77816817.81417.98
4772063-77206317.67417.84
5789333-78933318.06918.24
6761919-76191917.44217.61
60min1785965-78596517.99217.612.6118.1917.822.57
2784092-78409217.94918.16
3780958-78095817.87718.08
4740942-74094216.96117.17
5777873-77787317.80718.02
6747106-74710617.10317.31
极限1778405-77840517.81917.781.4618.0618.021.42
2792189-79218918.13518.38
3780898-78089817.87618.12
4777326-77732617.79418.04
5757760-75776017.34617.60
6772710-77271017.68917.93
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