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101278-202405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%
110.554061684406867240687504073181407098340686540.11
210.704161638415978541607120.04
单位质量响应值RSD%判断
385654.41388851.590.59数据可信
供试品溶液-250601批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12880731-288073166.88461.8019.8666.8861.8019.86
23042568-304256870.64270.64
32564628-256462859.54559.54
42279939-227993952.93552.94
51880226-188022643.65543.65
63322758-332275877.14777.15
10min14036354-403635493.71593.543.9593.8393.643.96
24129184-412918495.87095.99
33865625-386562589.75189.85
44001394-400139492.90392.99
53863416-386341689.70089.77
64276305-427630599.28699.41
15min14258733-425873398.87899.011.2299.1599.271.23
24205259-420525997.63797.91
34308899-4308899100.043100.29
44229407-422940798.19798.44
54240779-424077998.46198.68
64343035-4343035100.836101.13
20min14261999-426199998.95499.881.4299.39100.301.41
24225038-422503898.09698.54
34315290-4315290100.191100.61
44266859-426685999.06799.47
54379893-4379893101.691102.08
64361424-4361424101.263101.72
30min14278262-427826299.332100.051.6699.93100.641.64
24215430-421543097.87398.48
34360739-4360739101.247101.83
44251437-425143798.70999.28
54398245-4398245102.117102.67
64351790-4351790101.039101.67
45min14273927-427392799.231100.101.4899.99100.851.47
24222065-422206598.02798.79
34367491-4367491101.403102.15
44271620-427162099.17899.91
54374322-4374322101.562102.29
64357478-4357478101.171101.97
60min14267440-426744099.080100.321.55100.01101.241.53
24220128-422012897.98298.91
34371769-4371769101.503102.42
44314897-4314897100.182101.08
54395362-4395362102.051102.95
64354608-4354608101.104102.07
极限14271777-427177799.181100.051.63100.27101.141.61
24215187-421518797.86798.96
34366222-4366222101.374102.46
44257261-425726198.84499.91
54386880-4386880101.854102.92
64356783-4356783101.155102.29
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101278-202405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%
110.554105711410741641103644101039409777441044610.13
210.704164812417222141685160.13
单位质量响应值RSD%判断
389048.44389580.930.10数据可信
供试品溶液-250601批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12311345-231134553.37955.6713.9753.3855.6813.97
22285199-228519952.77552.78
33040862-304086270.22770.23
42478038-247803857.22957.23
52057326-205732647.51347.51
62291529-229152952.92252.92
10min13742946-374294686.44188.834.8186.5388.924.82
23718051-371805185.86685.95
34099524-409952494.67694.79
44040920-404092093.32393.42
53641764-364176484.10484.18
63834515-383451588.55688.64
15min14093075-409307594.52796.171.2894.7696.411.28
24148563-414856395.80996.04
34152910-415291095.90996.18
44255387-425538798.27698.53
54180038-418003896.53696.75
64155543-415554395.97096.21
20min14176768-417676896.46097.601.0796.8598.001.06
24232407-423240797.74598.14
34169710-416971096.29796.73
44266248-426624898.52798.94
54279416-427941698.83199.21
64230935-423093597.71198.11
30min14178374-417837496.49798.011.3797.0598.571.35
24258776-425877698.35498.91
34171711-417171196.34396.94
44309474-430947499.525100.10
54296177-429617799.21899.76
64247888-424788898.10398.66
45min14186474-418647496.68498.111.3897.4098.831.37
24262751-426275198.44699.16
34168017-416801796.25897.01
44311564-431156499.573100.32
54298660-429866099.27599.99
64260864-426086498.40299.12
60min14203501-420350197.07799.453.5397.95100.343.50
24258212-425821298.34199.22
34154496-415449695.94696.86
44315092-431509299.655100.57
54317106-431710699.701100.58
64587796-4587796105.953106.84
极限14201931-420193197.04198.151.4898.0899.201.47
24266847-426684798.54099.59
34162741-416274196.13697.21
44307624-430762499.482100.56
54327046-432704699.931100.97
64232960-423296097.75898.82
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101278-202405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%
110.554168770417488541748354173438416953541722930.08
210.704219236422345842213470.08
单位质量响应值RSD%判断
395478.01394518.410.18数据可信
供试品溶液-250602批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12910422-291042266.24760.1620.6666.2560.1620.66
22148001-214800148.89348.89
31933332-193333244.00744.01
43275673-327567374.56174.56
52460776-246077656.01356.01
63129199-312919971.22771.23
10min14135646-413564694.13691.813.8694.2591.913.87
24088561-408856193.06493.15
33887779-388777988.49488.57
44181512-418151295.18095.30
53792995-379299586.33786.43
64114183-411418393.64893.77
15min14271587-427158797.23197.030.8497.5097.280.84
24311984-431198498.15098.39
34222148-422214896.10596.33
44249135-424913596.71997.00
54292369-429236997.70497.94
64228280-422828096.24596.52
20min14300144-430014497.88197.621.1198.3198.041.10
24336606-433660698.71199.11
34268119-426811997.15297.53
44248083-424808396.69697.14
54347887-434788798.96799.37
64231217-423121796.31296.75
30min14302818-430281897.94197.741.0498.5398.321.02
24331758-433175898.60099.16
34278192-427819297.38197.92
44248809-424880996.71297.32
54356117-435611799.15599.72
64247133-424713396.67497.27
45min14288837-428883797.62397.691.0098.3898.430.98
24320863-432086398.35299.08
34284830-428483097.53298.24
44252313-425231396.79297.56
54358680-435868099.21399.94
64244746-424474696.62097.38
60min14297448-429744897.81997.511.0898.7498.421.06
24325140-432514098.45099.34
34257692-425769296.91497.78
44251054-425105496.76397.69
54345057-434505798.90399.80
64227282-422728296.22297.14
极限14282725-428272597.48497.410.9998.5798.470.98
24322126-432212698.38199.44
34251833-425183396.78197.81
44251904-425190496.78397.87
54336087-433608798.69999.76
64230910-423091096.30597.38
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101278-202405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%
110.554228151422608242281464227659422930142278680.03
210.704202241420403242031360.04
单位质量响应值RSD%判断
400745.78392816.451.42数据可信
供试品溶液-250602批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12933480-293348066.47966.9411.3966.4866.9411.39
22476582-247658256.12556.12
32730197-273019761.87261.87
42920069-292006966.17566.17
53329107-332910775.44575.44
63334591-333459175.56975.57
10min13824687-382468786.67592.624.8986.7992.734.89
23840476-384047687.03387.13
34157169-415716994.21094.31
44211110-421111095.43395.54
54245452-424545296.21196.34
64243592-424359296.16996.29
15min14178370-417837094.69197.061.5394.9597.331.53
24243665-424366596.17096.41
34278174-427817496.95297.21
44344815-434481598.46398.73
54302843-430284397.51297.80
64350323-435032398.58898.87
20min14222486-422248695.69097.671.4096.1098.101.40
24299985-429998597.44797.85
34300875-430087597.46797.89
44407148-440714899.875100.31
54294241-429424197.31797.77
64333798-433379898.21398.66
30min14210049-421004995.40997.591.3795.9898.181.38
24311848-431184897.71698.28
34283377-428337797.07097.65
44356422-435642298.72699.33
54299599-429959997.43898.05
64376468-437646899.18099.79
45min14203360-420336095.25797.491.2395.9998.241.24
24313929-431392997.76398.49
34301250-430125097.47598.22
44341249-434124998.38299.15
54298816-429881697.42098.19
64352077-435207798.62799.41
60min14212222-421222295.45897.341.1196.3598.251.11
24305734-430573497.57798.46
34285074-428507497.10998.02
44351758-435175898.62099.55
54289779-428977997.21598.15
64326143-432614398.04098.98
极限14206634-420663495.33197.221.3096.3898.301.30
24308503-430850397.64098.69
34263975-426397596.63197.70
44350923-435092398.60199.69
54263713-426371396.62597.72
64345861-434586198.48699.59
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101278-202405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%
110.554195002418900541994644188788417026341885040.27
210.704258032425620742571200.04
单位质量响应值RSD%判断
397014.60397861.680.16数据可信
供试品溶液-250603批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12836117-283611764.16057.4017.1964.1657.4017.20
21670686-167068637.79537.79
32720620-272062061.54761.55
42644365-264436559.82259.82
52559364-255936457.89957.90
62791816-279181663.15863.16
10min14162991-416299194.17790.774.6694.2890.864.67
23722692-372269284.21684.28
34167597-416759794.28194.38
44045477-404547791.51891.62
53843770-384377086.95587.05
64130994-413099493.45393.56
15min14255910-425591096.27995.971.7296.5496.221.74
24111155-411115593.00493.21
34319703-431970397.72297.98
44233552-423355295.77396.03
54234923-423492395.80496.05
64298045-429804597.23297.49
20min14262035-426203596.41896.651.4596.8497.061.47
24185129-418512994.67895.04
34334915-433491598.06698.49
44247049-424704996.07996.49
54253000-425300096.21396.61
64352994-435299498.47598.90
30min14266439-426643996.51796.731.5097.1097.301.52
24193492-419349294.86795.38
34344552-434455298.28498.87
44240158-424015895.92396.49
54250963-425096396.16796.73
64359445-435944598.62199.21
45min14266552-426655296.52096.981.3397.2797.711.34
24214487-421448795.34296.02
34338812-433881298.15498.90
44274931-427493196.70997.44
54256647-425664796.29697.02
64369205-436920598.84299.59
60min14247834-424783496.09696.641.3797.0097.531.38
24198126-419812694.97295.80
34319748-431974897.72398.64
44261054-426105496.39597.29
54244050-424405096.01196.89
64359533-435953398.62399.54
极限14252457-425245796.20196.731.3797.2797.781.39
24205687-420568795.14396.13
34337638-433763898.12899.20
44266071-426607196.50997.56
54237891-423789195.87196.91
64355149-435514998.52499.60
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