苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.03对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.582030942030682029502031242030182030510.04
219.632027542026792027160.03
单位质量响应值RSD%判断
10370.3310326.850.30数据可信
供试品溶液-YBA2320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%
5min1117608-11760858.03465.568.8058.0365.568.80
2121794-12179460.10060.10
3145779-14577971.93571.94
4135088-13508866.66066.66
5145281-14528171.69071.69
6131573-13157364.92564.93
10min1206881-206881102.086102.461.03102.18102.571.04
2204145-204145100.736100.84
3209826-209826103.540103.66
4207262-207262102.275102.39
5209866-209866103.559103.68
6207819-207819102.549102.66
15min1210261-210261103.754103.560.32104.02103.840.32
2209241-209241103.251103.52
3210579-210579103.911104.20
4209384-209384103.322103.60
5210523-210523103.884104.18
6209201-209201103.231103.51
20min1210051-210051103.651103.430.35104.09103.880.35
2209200-209200103.231103.67
3210135-210135103.692104.16
4209336-209336103.298103.75
5210393-210393103.820104.28
6208477-208477102.874103.33
30min1209737-209737103.496103.240.34104.11103.870.35
2208645-208645102.957103.57
3209741-209741103.498104.14
4208879-208879103.072103.70
5210024-210024103.637104.28
6208305-208305102.789103.41
45min1209340-209340103.300103.020.18104.08103.820.18
2208567-208567102.918103.70
3209103-209103103.183103.99
4208542-208542102.906103.70
5208732-208732103.000103.81
6208353-208353102.813103.61
60min1208554-208554102.912102.890.31103.87103.860.31
2207859-207859102.569103.52
3208957-208957103.111104.09
4208300-208300102.787103.76
5209480-209480103.369104.35
6207896-207896102.587103.55
极限1208409-208409102.840102.680.25103.97103.820.25
2208089-208089102.683103.81
3208881-208881103.073104.23
4207581-207581102.432103.57
5208033-208033102.655103.81
6207514-207514102.399103.54
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.03对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.582015132019582018762017122016412017400.09
219.632015932013642014780.09
单位质量响应值RSD%判断
10303.3710263.780.28数据可信
供试品溶液-YBA2320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%
5min1112502-11250255.86655.4613.3355.8755.4713.33
2111104-11110455.17155.17
3115260-11526057.23557.24
4136920-13692067.99167.99
592894-9289446.12946.13
6101486-10148650.39550.40
10min1207981-207981103.278103.520.79103.37103.620.80
2207586-207586103.082103.17
3210733-210733104.645104.74
4210329-210329104.444104.56
5206775-206775102.679102.76
6207442-207442103.010103.09
15min1209231-209231103.899104.070.37104.16104.340.38
2209609-209609104.086104.35
3209090-209090103.829104.10
4210796-210796104.676104.96
5208679-208679103.625103.87
6210077-210077104.319104.57
20min1208615-208615103.593103.770.31104.03104.200.31
2208981-208981103.775104.21
3208951-208951103.760104.20
4209821-209821104.192104.65
5207997-207997103.286103.71
6209419-209419103.992104.42
30min1208181-208181103.377103.530.29103.99104.140.30
2208454-208454103.513104.12
3208368-208368103.470104.09
4209402-209402103.984104.62
5207652-207652103.115103.71
6208869-208869103.719104.32
45min1207543-207543103.061103.330.32103.84104.120.33
2208231-208231103.402104.18
3208227-208227103.400104.19
4208774-208774103.672104.48
5207092-207092102.837103.60
6208695-208695103.633104.41
60min1207382-207382102.981103.080.31103.94104.040.32
2207166-207166102.873103.83
3207517-207517103.048104.01
4208526-208526103.549104.53
5206759-206759102.671103.61
6208100-208100103.337104.29
极限1206761-206761102.672102.800.33103.80103.930.34
2207032-207032102.807103.93
3207473-207473103.026104.16
4207595-207595103.086104.24
5205808-205808102.199103.31
6207459-207459103.019104.14
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.03对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.582026802027642026272026392024332026290.07
219.632018652016212017430.09
单位质量响应值RSD%判断
10348.7710277.280.50数据可信
供试品溶液-YBA2320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%
5min1118075-11807558.46665.138.8458.4765.138.84
2118546-11854658.69958.70
3147024-14702472.80072.80
4134923-13492366.80966.81
5140082-14008269.36369.36
6130572-13057264.65464.65
10min1207803-207803102.896102.990.58102.99103.100.58
2206789-206789102.394102.49
3207782-207782102.885103.01
4207386-207386102.689102.80
5210280-210280104.122104.24
6207889-207889102.938103.05
15min1210689-210689104.325103.940.47104.59104.220.47
2209179-209179103.577103.85
3209474-209474103.723104.02
4209447-209447103.710103.99
5211546-211546104.749105.04
6209150-209150103.563103.84
20min1209890-209890103.929103.870.33104.37104.320.33
2209900-209900103.934104.38
3209363-209363103.668104.13
4208673-208673103.327103.78
5210714-210714104.337104.80
6210049-210049104.008104.46
30min1210035-210035104.001103.640.36104.62104.270.35
2209024-209024103.500104.11
3208576-208576103.279103.92
4208601-208601103.291103.92
5210348-210348104.156104.79
6209258-209258103.616104.24
45min1209224-209224103.599103.420.34104.39104.220.34
2209359-209359103.666104.45
3208045-208045103.016103.83
4207949-207949102.968103.77
5209658-209658103.814104.63
6208949-208949103.463104.26
60min1208707-208707103.343103.170.35104.31104.140.35
2208397-208397103.190104.15
3207750-207750102.870103.85
4207391-207391102.692103.66
5209464-209464103.718104.70
6208389-208389103.186104.16
极限1208706-208706103.343102.990.33104.48104.140.33
2208286-208286103.135104.27
3207283-207283102.638103.79
4207296-207296102.645103.79
5208789-208789103.384104.54
6207633-207633102.812103.95
苯磺酸美洛加巴林片项目信息
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D405-1-240701对照品来源原料对照品使用方法直接使用
对照品含量(%)99.66对照品水分(%)0.03对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.5695
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.582018912019062021502018942021092019900.07
219.632012812014962013880.08
单位质量响应值RSD%判断
10316.1410259.200.40数据可信
供试品溶液-YBA2320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%
5min167022-6702233.26855.6227.9833.2755.6227.97
2118436-11843658.78958.79
3143905-14390571.43171.43
4137760-13776068.38168.38
580357-8035739.88839.89
6124805-12480561.95161.95
10min1204482-204482101.501102.270.97101.56102.360.99
2205739-205739102.124102.22
3208346-208346103.419103.54
4207028-207028102.764102.88
5203074-203074100.802100.87
6207493-207493102.995103.10
15min1211312-211312104.891103.970.59105.12104.230.59
2208923-208923103.705103.97
3210004-210004104.242104.53
4209668-209668104.075104.36
5207611-207611103.054103.29
6209231-209231103.858104.13
20min1210847-210847104.660103.890.53105.06104.330.53
2208343-208343103.417103.86
3209907-209907104.193104.66
4209859-209859104.170104.63
5207883-207883103.189103.59
6208949-208949103.718104.17
30min1210534-210534104.505103.650.54105.08104.260.53
2208029-208029103.261103.87
3208955-208955103.721104.36
4209483-209483103.983104.62
5207417-207417102.957103.54
6208456-208456103.473104.09
45min1209842-209842104.161103.490.52104.91104.270.52
2207961-207961103.227104.01
3209285-209285103.885104.70
4209017-209017103.752104.56
5206993-206993102.747103.50
6207782-207782103.139103.93
60min1209643-209643104.062103.280.54104.98104.240.53
2207749-207749103.122104.08
3208654-208654103.571104.56
4208481-208481103.486104.46
5206466-206466102.485103.41
6207405-207405102.951103.92
极限1209118-209118103.802103.000.50104.90104.120.50
2207002-207002102.751103.88
3207990-207990103.242104.40
4207810-207810103.152104.30
5206216-206216102.361103.45
6206832-206832102.667103.80
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