富马酸伏诺拉生片项目信息
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17570对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.78对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7485
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.941230981236391228371231961231521231840.24
214.981224271228601226440.25
单位质量响应值RSD%判断
8245.258187.180.50数据可信
中间条件24月-供试品溶液-2023031211批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1111002-11100290.81289.084.3990.8189.084.39
2103403-10340384.59584.59
3103128-10312884.37084.37
4109681-10968189.73189.73
5110723-11072390.58490.58
6115395-11539594.40694.41
10min1122775-122775100.443100.211.10100.59100.361.09
2120725-12072598.76698.91
3123802-123802101.284101.42
4122803-122803100.466100.62
5123825-123825101.302101.45
6121016-12101699.00499.16
15min1125254-125254102.471101.041.24102.79101.351.23
2124517-124517101.869102.17
3123888-123888101.354101.66
4122806-122806100.469100.79
5123678-123678101.182101.50
6120872-12087298.88799.21
20min1124853-124853102.143101.011.36102.63101.491.35
2125203-125203102.430102.91
3123891-123891101.356101.83
4122483-122483100.205100.69
5123701-123701101.201101.69
6120678-12067898.72899.21
30min1125000-125000102.264100.931.30102.92101.581.29
2124788-124788102.090102.74
3123886-123886101.352102.00
4122531-122531100.244100.90
5123301-123301100.874101.53
6120709-12070998.75399.40
45min1124715-124715102.031100.721.34102.86101.541.33
2124761-124761102.068102.88
3123133-123133100.736101.55
4121941-12194199.761100.58
5123574-123574101.097101.92
6120522-12052298.60099.42
60min1124762-124762102.069100.451.42103.07101.441.42
2124145-124145101.564102.55
3122841-122841100.497101.48
4121929-12192999.751100.74
5123183-123183100.777101.77
6119862-11986298.06099.04
极限1123659-123659101.167100.111.23102.34101.271.22
2123862-123862101.333102.49
3122710-122710100.390101.54
4121469-12146999.375100.53
5122671-122671100.358101.52
6119853-11985398.05399.20
富马酸伏诺拉生片项目信息
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17570对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.78对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7485
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.941229611232441228631231061228141229980.15
214.981224751225881225320.07
单位质量响应值RSD%判断
8232.808179.710.46数据可信
中间条件24月-供试品溶液-2023031212批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1109737-10973789.88688.314.6289.8988.314.62
2109475-10947589.67189.67
3109234-10923489.47489.47
497731-9773180.05280.05
5110987-11098790.91090.91
6109697-10969789.85389.85
10min1122710-122710100.51299.722.84100.6699.862.84
2121257-12125799.32299.47
3125971-125971103.183103.33
4116497-11649795.42395.56
5124521-124521101.995102.15
6119473-11947397.86098.01
15min1123054-123054100.794100.832.32101.11101.142.32
2122780-122780100.569100.88
3127224-127224104.209104.53
4121042-12104299.14699.44
5125206-125206102.556102.88
6119261-11926197.68798.00
20min1122848-122848100.625100.852.33101.11101.332.33
2122685-122685100.491100.97
3127332-127332104.298104.79
4121206-12120699.28099.74
5125335-125335102.662103.15
6119320-11932097.73598.21
30min1122920-122920100.684100.782.28101.34101.442.28
2122723-122723100.523101.17
3127319-127319104.287104.96
4121136-12113699.22399.85
5124852-124852102.266102.93
6119300-11930097.71998.36
45min1121364-12136499.409100.332.31100.23101.152.31
2122192-122192100.088100.91
3126808-126808103.869104.71
4120822-12082298.96599.75
5124728-124728102.165103.00
6119034-11903497.50198.30
60min1122069-12206999.987100.272.38100.97101.252.37
2121973-12197399.908100.89
3126705-126705103.784104.80
4120626-12062698.80599.76
5124605-124605102.064103.07
6118489-11848997.05498.02
极限1121879-12187999.831100.112.33100.98101.262.33
2121855-12185599.812100.96
3126363-126363103.504104.69
4120423-12042398.63999.76
5124436-124436101.926103.10
6118385-11838596.96998.09
富马酸伏诺拉生片项目信息
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17570对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.78对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7485
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.941226921227201225881221441222991224890.21
214.981225481222281223880.19
单位质量响应值RSD%判断
8198.738170.090.25数据可信
中间条件24月-供试品溶液-2023031311批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1107156-10715688.00583.9813.4088.0183.9913.40
2101304-10130483.19983.20
3112483-11248392.38092.38
479383-7938365.19665.20
5117737-11773796.69596.70
695492-9549278.42678.43
10min1122102-122102100.28097.205.35100.4397.345.36
2121628-12162899.891100.03
3118586-11858697.39297.55
4106121-10612187.15587.26
5123408-123408101.353101.51
6118234-11823497.10397.23
15min1122108-122108100.28599.132.37100.6099.432.38
2122826-122826100.875101.18
3118792-11879297.56297.88
4115889-11588995.17795.43
5123361-123361101.314101.64
6121245-12124599.57699.87
20min1121622-12162299.88699.441.41100.3799.911.42
2122652-122652100.732101.21
3118669-11866997.46197.94
4119487-11948798.13298.54
5122937-122937100.966101.46
6121122-12112299.47599.93
30min1121477-12147799.76799.451.38100.41100.081.39
2122712-122712100.781101.42
3118299-11829997.15797.80
4120237-12023798.74899.32
5122712-122712100.781101.45
6121134-12113499.485100.11
45min1121644-12164499.90499.281.46100.72100.081.46
2122249-122249100.401101.21
3117952-11795296.87297.67
4120209-12020998.72599.47
5122816-122816100.866101.70
6120417-12041798.89699.69
60min1121141-12114199.49199.071.34100.47100.031.34
2122206-122206100.365101.34
3117877-11787796.81097.77
4120216-12021698.73199.64
5122117-122117100.292101.30
6120205-12020598.72299.68
极限1121030-12103099.40098.811.36100.5599.941.37
2121901-121901100.115101.26
3117581-11758196.56797.69
4119516-11951698.15699.23
5121776-121776100.012101.18
6120061-12006198.60499.72
富马酸伏诺拉生片项目信息
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17570对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.78对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7485
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.942450212450702450872453512453242451710.07
214.982459362452472455920.20
单位质量响应值RSD%判断
16410.3716394.660.07数据可信
中间条件24月-供试品溶液-2023030911批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1216774-21677488.83380.5015.7988.8380.5115.79
2214217-21421787.78587.79
3216393-21639388.67788.68
4144696-14469659.29659.30
5171124-17112470.12670.13
6215495-21549588.30988.31
10min1244730-244730100.28995.526.43100.4495.666.44
2234407-23440796.05996.21
3243233-24323399.67699.82
4211963-21196386.86286.96
5217403-21740389.09189.21
6246867-246867101.165101.31
15min1245444-245444100.58298.193.03100.9098.483.06
2240271-24027198.46298.77
3243802-24380299.909100.22
4230996-23099694.66194.90
5230380-23038094.40994.67
6246789-246789101.133101.45
20min1245589-245589100.64199.121.80101.1299.571.83
2240915-24091598.72699.20
3243667-24366799.854100.33
4236991-23699197.11897.52
5236886-23688697.07597.50
6247173-247173101.290101.77
30min1244957-244957100.38299.371.13101.03100.001.15
2241096-24109698.80099.44
3242739-24273999.473100.12
4242195-24219599.25099.81
5238233-23823397.62798.21
6245764-245764100.713101.37
45min1245094-245094100.43899.421.32101.26100.211.34
2240288-24028898.46999.27
3243381-24338199.736100.55
4242742-24274299.475100.20
5237683-23768397.40198.15
6246442-246442100.991101.81
60min1244882-244882100.35299.191.34101.34100.141.35
2238898-23889897.89998.86
3242185-24218599.246100.23
4242360-24236099.318100.21
5237849-23784997.47098.38
6246085-246085100.845101.83
极限1243765-24376599.89499.061.04101.05100.181.05
2238812-23881297.86498.99
3241415-24141598.931100.08
4241583-24158399.000100.06
5239398-23939898.10499.18
6245356-245356100.546101.70
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