非布司他片项目信息
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430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.772069578205659620600972060503205792920609410.25
210.652101577210032021009480.05
单位质量响应值RSD%判断
191359.42197272.112.16数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-250601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%
5min1201394-2013949.3218.6520.599.328.6520.60
2112527-1125275.2085.21
3216857-21685710.03610.04
4211434-2114349.7859.79
5180901-1809018.3728.37
6198041-1980419.1659.17
10min1418012-41801219.34618.9210.1719.3618.9310.17
2327765-32776515.16915.18
3434436-43443620.10620.12
4441081-44108120.41420.43
5406232-40623218.80118.81
6425207-42520719.67919.69
15min1521208-52120824.12224.134.9124.1724.184.93
2476817-47681722.06722.10
3538278-53827824.91224.96
4547852-54785225.35525.41
5510015-51001523.60423.65
6534600-53460024.74224.79
20min1637589-63758929.50828.093.0029.6028.183.00
2594021-59402127.49227.56
3599270-59927027.73527.83
4613417-61341728.38928.48
5586359-58635927.13727.22
6611004-61100428.27828.37
30min1657753-65775330.44130.511.8530.5830.651.85
2651673-65167330.16030.28
3650970-65097030.12730.27
4683444-68344431.63031.77
5655191-65519130.32330.45
6656735-65673530.39430.53
45min1714426-71442633.06433.211.0233.2533.391.03
2715965-71596533.13533.30
3714105-71410533.04933.24
4731117-73111733.83734.03
5710321-71032132.87433.05
6719402-71940233.29433.48
60min1743551-74355134.41234.832.6134.6635.072.57
2789751-78975136.55036.77
3743199-74319934.39634.64
4759580-75958035.15435.40
5738242-73824234.16634.40
6741472-74147234.31634.56
90min1766253-76625335.46335.511.1535.7635.801.15
2755874-75587434.98235.27
3770060-77006035.63935.94
4782302-78230236.20636.51
5765817-76581735.44335.73
6762970-76297035.31135.61
120min1786797-78679736.41436.650.7836.7737.010.77
2795639-79563936.82337.16
3790399-79039936.58036.94
4801200-80120037.08037.45
5784428-78442836.30436.66
6793409-79340936.72037.08
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1785587-78558736.35836.641.0536.7837.061.04
2795307-79530736.80737.21
3783817-78381736.27636.70
4805048-80504837.25837.69
5785364-78536436.34736.76
6795027-79502736.79437.21
非布司他片项目信息
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430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.772101800210333120832132070836208481520887990.66
210.652081308208234420818260.04
单位质量响应值RSD%判断
193946.05195476.620.56数据可信
供试品溶液-250601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%
5min1230772-23077210.6569.1217.3410.669.1217.35
2147660-1476606.8186.82
3164454-1644547.5947.59
4198913-1989139.1859.19
5221318-22131810.22010.22
6222282-22228210.26410.26
10min1432360-43236019.96518.978.4519.9818.988.45
2370588-37058817.11317.12
3363049-36304916.76416.78
4426101-42610119.67619.69
5444092-44409220.50720.52
6428672-42867219.79519.81
15min1530722-53072224.50723.597.5024.5623.637.50
2493206-49320622.77522.81
3440605-44060520.34620.39
4526267-52626724.30124.35
5543512-54351225.09825.15
6530325-53032524.48924.54
20min1591697-59169727.32326.655.8127.4126.735.81
2547802-54780225.29625.37
3523093-52309324.15524.23
4595294-59529427.48927.58
5601202-60120227.76227.85
6603625-60362527.87327.96
30min1660984-66098430.52229.836.2730.6629.966.27
2642560-64256029.67129.79
3566539-56653926.16126.28
4664100-66410030.66630.80
5663919-66391930.65830.80
6677504-67750431.28531.42
45min1700918-70091832.36631.916.5832.5532.096.58
2701094-70109432.37432.54
3599534-59953427.68527.84
4713723-71372332.95733.14
5712019-71201932.87933.07
6719094-71909433.20533.39
60min1736067-73606733.98933.276.7334.2333.506.73
2740447-74044734.19134.41
3621874-62187428.71628.92
4736911-73691134.02834.27
5742870-74287034.30334.55
6745049-74504934.40434.65
90min1766415-76641535.39134.337.5835.6934.627.57
2763105-76310535.23835.52
3629402-62940229.06429.32
4755358-75535834.88035.18
5775106-77510635.79236.09
6771880-77188035.64335.95
120min1793406-79340636.63735.886.3536.9936.226.35
2807601-80760137.29237.63
3679681-67968131.38531.69
4785842-78584236.28836.64
5814360-81436037.60537.97
6781201-78120136.07336.43
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1775399-77539935.80535.426.1136.2235.826.11
2787239-78723936.35236.75
3673580-67358031.10431.46
4774169-77416935.74936.16
5801582-80158237.01437.44
6789820-78982036.47136.89
非布司他片项目信息
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430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.772120253212168321183902118000211964221195940.07
210.652083984208547320847280.06
单位质量响应值RSD%判断
196805.39195749.110.39数据可信
供试品溶液-250602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%
5min1222656-22265610.1999.5512.3310.209.5412.34
2170936-1709367.8307.83
3231123-23112310.58710.59
4221025-22102510.12510.12
5223917-22391710.25710.26
6180608-1806088.2738.27
10min1444163-44416320.34619.604.9720.3619.614.97
2387686-38768617.75917.77
3430987-43098719.74319.76
4444362-44436220.35520.37
5436452-43645219.99320.01
6423359-42335919.39319.41
15min1542850-54285024.86724.563.2524.9224.603.26
2501801-50180122.98623.03
3538260-53826024.65724.71
4546204-54620425.02125.07
5549713-54971325.18125.23
6537556-53755624.62424.67
20min1600396-60039627.50327.361.9327.6027.451.95
2576579-57657926.41226.49
3594799-59479927.24727.34
4596933-59693327.34427.44
5609824-60982427.93528.03
6605160-60516027.72127.81
30min1660601-66060130.26130.351.7730.4030.481.78
2644764-64476429.53529.66
3664463-66446330.43830.57
4663474-66347430.39230.53
5660098-66009830.23830.38
6681388-68138831.21331.35
45min1713929-71392932.70432.572.0832.8932.762.08
2681831-68183131.23331.41
3715038-71503832.75432.94
4713755-71375532.69632.88
5718977-71897732.93533.12
6722978-72297833.11833.30
60min1738984-73898433.85134.010.7334.0934.240.74
2735586-73558633.69633.92
3738352-73835233.82234.06
4745475-74547534.14934.39
5746979-74697934.21834.46
6748820-74882034.30234.54
90min1801944-80194436.73535.532.5537.0335.822.55
2743970-74397034.08034.36
3774334-77433435.47135.77
4789340-78934036.15836.46
5767210-76721035.14435.45
6776528-77652835.57135.87
120min1782394-78239435.84036.141.4136.2036.501.40
2786930-78693036.04836.39
3777047-77704735.59535.95
4790252-79025236.20036.56
5787571-78757136.07736.44
6809511-80951137.08237.44
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1789321-78932136.15736.531.9136.5836.941.90
2790466-79046636.21036.61
3784009-78400935.91436.33
4787685-78768536.08236.50
5811859-81185937.19037.61
6821101-82110137.61338.03
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