富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所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2000
标示量(mg)5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%
19.988442484137843338406784207842340.18
210.048417884379842780.17
单位质量响应值RSD%判断
8440.288394.220.39数据可信
供试品溶液-25012003批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min193377-9337799.64397.254.2599.6497.254.25
284253-8425389.90789.91
395759-95759102.185102.18
490307-9030796.36796.37
591419-9141997.55397.55
691679-9167997.83197.83
10min194089-94089100.40399.562.09100.5799.722.09
291983-9198398.15598.31
396881-96881103.382103.55
492754-9275498.97899.14
591722-9172297.87798.04
692341-9234198.53798.70
15min194139-94139100.45699.271.86100.7999.601.86
292155-9215598.33998.65
396074-96074102.521102.86
492131-9213198.31398.64
591745-9174597.90198.23
691943-9194398.11398.44
20min193788-93788100.08199.011.93100.5899.501.93
291856-9185698.02098.50
396007-96007102.449102.96
491892-9189298.05898.55
591668-9166897.81998.31
691504-9150497.64498.13
30min192997-9299799.23798.521.7399.9099.171.73
291601-9160197.74898.39
395288-95288101.682102.37
491444-9144497.58098.23
591343-9134397.47298.12
691252-9125297.37598.03
45min193036-9303699.27998.041.76100.1198.871.76
291121-9112197.23598.04
394648-94648100.999101.85
490978-9097897.08397.90
590699-9069996.78597.60
690788-9078896.88097.70
极限192184-9218498.37097.531.9299.3798.521.92
290656-9065696.73997.70
394633-94633100.983102.01
490451-9045196.52097.50
590003-9000396.04297.02
690480-9048096.55197.53
富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所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2000
标示量(mg)5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%
19.988341683582835728352183741835660.15
210.048350683448834770.05
单位质量响应值RSD%判断
8373.358314.440.50数据可信
供试品溶液-25012004批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min195335-95335102.62799.931.53102.6399.921.53
293001-93001100.115100.11
391298-9129898.28198.28
492115-9211599.16199.16
592010-9201099.04899.05
693192-93192100.320100.32
10min196282-96282103.647100.801.58103.82100.961.58
293195-93195100.323100.49
392242-9224299.29899.46
492461-9246199.53399.70
593458-93458100.607100.77
694177-94177101.381101.55
15min195704-95704103.024100.551.45103.37100.891.45
292739-9273999.833100.17
392147-9214799.19599.52
492203-9220399.25699.59
593718-93718100.886101.22
693933-93933101.118101.45
20min196122-96122103.474100.701.51103.99101.201.50
292674-9267499.763100.26
393520-93520100.673101.17
492172-9217299.22299.72
592881-9288199.985100.49
693901-93901101.083101.59
30min195176-95176102.45699.771.50103.14100.441.50
292269-9226999.32799.99
391517-9151798.51799.18
491452-9145298.44799.11
592404-9240499.472100.14
693246-93246100.378101.05
45min194877-94877102.13499.421.64102.99100.261.64
291911-9191198.94199.77
390778-9077897.72298.55
490999-9099997.95998.79
592467-9246799.540100.37
693096-93096100.217101.06
极限193624-93624100.78598.691.27101.8199.691.27
291609-9160998.61699.61
390604-9060497.53498.52
490579-9057997.50798.50
591285-9128598.26799.27
692357-9235799.421100.43
富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所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2000
标示量(mg)5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%
19.981677851678881679491679401676991678520.07
210.041690231688861689540.06
单位质量响应值RSD%判断
16818.8416828.090.04数据可信
供试品溶液-25012001批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1184155-18415598.32099.631.1398.3299.641.13
2187226-18722699.95999.96
3186724-18672499.69199.69
4189223-189223101.026101.03
5184132-18413298.30898.31
6188230-188230100.495100.50
10min1184735-18473598.630100.301.2798.79100.471.27
2189360-189360101.099101.27
3189408-189408101.124101.29
4190544-190544101.731101.90
5185248-18524898.90399.07
6187891-187891100.314100.48
15min1184288-18428898.391100.111.2098.72100.441.20
2188263-188263100.513100.85
3188798-188798100.799101.13
4190511-190511101.713102.05
5185617-18561799.10099.43
6187590-187590100.154100.49
20min1183344-18334497.88799.661.3398.38100.161.33
2187954-187954100.348100.85
3188717-188717100.755101.26
4189233-189233101.031101.54
5183991-18399198.23298.73
6186783-18678399.723100.22
30min1182735-18273597.56299.361.2298.22100.031.22
2186865-18686599.767100.44
3186987-18698799.832100.50
4188635-188635100.712101.39
5183932-18393298.20198.86
6187469-187469100.089100.76
45min1182054-18205497.19898.971.2598.0299.801.25
2186816-18681699.741100.58
3186490-18649099.567100.40
4188067-188067100.408101.25
5183162-18316297.79098.61
6185689-18568999.13999.97
极限1181427-18142796.86398.481.2397.8499.471.23
2185427-18542798.999100.00
3186247-18624799.437100.44
4187024-18702499.852100.86
5182132-18213297.24098.22
6184458-18445898.48299.48
富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所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2000
标示量(mg)5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%
19.981670641662061666001664261666701665930.20
210.041669001678891673940.42
单位质量响应值RSD%判断
16692.6916672.710.09数据可信
供试品溶液-25012002批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1185848-185848100.06199.411.51100.0699.411.50
2187369-187369100.880100.88
3183107-18310798.58598.59
4181407-18140797.67097.67
5187890-187890101.160101.16
6182164-18216498.07898.08
10min1187385-187385100.889100.931.51101.06101.091.51
2187961-187961101.199101.37
3184633-18463399.40799.57
4188482-188482101.479101.64
5191972-191972103.358103.53
6184293-18429399.22499.39
15min1187290-187290100.837100.601.29101.17100.941.29
2187386-187386100.889101.23
3184753-18475399.47199.80
4187459-187459100.928101.26
5190517-190517102.575102.92
6183691-18369198.90099.23
20min1186613-186613100.473100.081.27100.98100.581.27
2186113-186113100.204100.71
3183894-18389499.00999.50
4185657-18565799.958100.46
5189842-189842102.211102.72
6183186-18318698.62899.12
30min1185799-185799100.03599.851.14100.71100.521.14
2186157-186157100.227100.90
3183109-18310998.58699.25
4186412-186412100.365101.03
5188384-188384101.426102.11
6182922-18292298.48699.14
45min1184494-18449499.33299.261.26100.17100.101.26
2184828-18482899.512100.35
3181897-18189797.93498.76
4185238-18523899.733100.57
5187962-187962101.199102.05
6181766-18176697.86398.69
极限1183527-18352798.81198.841.4499.8199.841.44
2184748-18474899.469100.47
3181095-18109597.50298.49
4184022-18402299.078100.08
5187697-187697101.057102.08
6180407-18040797.13298.12
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