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(%)0.00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%
119.262013252015292015422016602016282015370.07
219.172018702024432021560.21
单位质量响应值RSD%判断
10464.0210545.440.55数据可信
供试品溶液-YBA2321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%
5min1116720-11672056.75866.2612.3656.7666.2612.36
2115323-11532356.07856.08
3150881-15088173.36973.37
4149203-14920372.55372.55
5134555-13455565.43065.43
6150848-15084873.35373.35
10min1207381-207381100.843100.730.76100.94100.850.77
2205407-20540799.88499.98
3209768-209768102.004102.13
4206172-206172100.256100.38
5206258-206258100.297100.41
6207956-207956101.123101.25
15min1210455-210455102.338101.720.64102.60102.000.64
2208792-208792101.530101.79
3210352-210352102.288102.58
4207087-207087100.701100.99
5208385-208385101.332101.61
6210052-210052102.142102.43
20min1210745-210745102.479101.530.75102.91101.980.74
2209089-209089101.674102.10
3208908-208908101.586102.05
4206085-206085100.213100.67
5208400-208400101.339101.78
6209579-209579101.912102.37
30min1210038-210038102.136101.430.72102.74102.050.71
2209332-209332101.792102.39
3209499-209499101.873102.51
4206057-206057100.200100.82
5207563-207563100.932101.55
6209019-209019101.640102.27
45min1209294-209294101.774100.740.98102.55101.520.96
2208873-208873101.569102.34
3208059-208059101.173101.98
4205064-20506499.717100.51
5207259-207259100.784101.57
6204411-20441199.399100.20
极限1209305-209305101.779100.871.31102.72101.821.29
2208561-208561101.417102.35
3208648-208648101.460102.43
4202338-20233898.39199.35
5206458-206458100.395101.34
6209258-209258101.756102.72
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(%)0.00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%
119.262025832024892025652023932020142024090.12
219.172022392023212022800.03
单位质量响应值RSD%判断
10509.2910551.900.29数据可信
供试品溶液-YBA2321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%
5min1132225-13222564.13960.6918.0364.1460.6918.03
2136903-13690366.40866.41
3126234-12623461.23361.23
4156869-15686976.09376.09
5100013-10001348.51348.51
698412-9841247.73747.74
10min1204975-20497599.42899.910.9599.53100.000.96
2205416-20541699.64199.75
3208167-208167100.976101.08
4208470-208470101.123101.25
5203555-20355598.73998.82
6205176-20517699.52599.60
15min1207211-207211100.512101.090.42100.78101.350.42
2207602-207602100.702100.98
3209125-209125101.441101.71
4209411-209411101.579101.87
5208294-208294101.037101.28
6208728-208728101.248101.49
20min1207821-207821100.808101.300.54101.25101.740.53
2207671-207671100.735101.18
3209260-209260101.506101.95
4208683-208683101.226101.69
5210770-210770102.239102.65
6208851-208851101.308101.72
30min1207120-207120100.468100.970.50101.08101.580.49
2206955-206955100.388101.00
3208126-208126100.956101.56
4208342-208342101.061101.69
5209782-209782101.759102.34
6208622-208622101.197101.78
45min1206660-206660100.245100.750.55101.02101.530.54
2206353-206353100.096100.88
3207709-207709100.754101.53
4207917-207917100.855101.66
5209516-209516101.630102.38
6208110-208110100.948101.70
极限1206016-20601699.933100.610.57100.88101.550.56
2206064-20606499.956100.90
3207371-207371100.590101.53
4208063-208063100.925101.90
5208943-208943101.352102.28
6208041-208041100.915101.83
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(%)0.00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%
119.262024032023102025792026642025992025110.08
219.172022742023382023060.03
单位质量响应值RSD%判断
10514.5910553.260.26数据可信
供试品溶液-YBA2321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%
5min1132330-13233064.16958.3422.4764.1758.3422.48
269011-6901133.46533.46
3143460-14346069.56669.57
4134751-13475165.34365.34
5113038-11303854.81454.81
6129285-12928562.69362.69
10min1213243-213243103.405101.001.92103.51101.101.93
2202878-20287898.37998.43
3211925-211925102.766102.88
4208746-208746101.225101.33
5204837-20483799.32999.42
6208064-208064100.894101.00
15min1213508-213508103.534102.560.90103.81102.820.90
2213197-213197103.383103.60
3212779-212779103.180103.47
4210497-210497102.074102.35
5209935-209935101.801102.06
6209046-209046101.370101.64
20min1213676-213676103.615102.581.03104.07103.011.02
2214001-214001103.773104.16
3212671-212671103.128103.59
4210235-210235101.947102.39
5209274-209274101.481101.91
6209332-209332101.509101.95
30min1213117-213117103.344102.490.98103.97103.100.97
2213828-213828103.689104.25
3212402-212402102.998103.63
4210556-210556102.102102.72
5209351-209351101.518102.11
6208874-208874101.287101.90
45min1212792-212792103.187102.271.09103.98103.041.08
2214189-214189103.864104.60
3211459-211459102.540103.34
4209497-209497101.589102.38
5208644-208644101.175101.94
6208779-208779101.241102.02
极限1212307-212307102.951102.040.97103.92102.990.96
2213127-213127103.349104.26
3210963-210963102.300103.27
4208993-208993101.344102.30
5207968-207968100.847101.78
6209219-209219101.454102.40
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(%)0.00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%
119.262023542024932024182024822022852024060.05
219.172018172019582018880.05
单位质量响应值RSD%判断
10509.1410531.460.16数据可信
供试品溶液-YBA2321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%
5min1122663-12266359.55858.4611.5659.5658.4611.55
2130893-13089363.55463.55
392590-9259044.95744.96
4125255-12525560.81760.82
5124112-12411260.26260.26
6126831-12683161.58261.58
10min1209869-209869101.901101.950.96102.00102.040.97
2209206-209206101.579101.68
3207980-207980100.984101.06
4213193-213193103.515103.62
5208150-208150101.066101.17
6211372-211372102.631102.73
15min1212801-212801103.324102.810.64103.59103.070.64
2211128-211128102.512102.79
3211477-211477102.682102.92
4213061-213061103.451103.72
5209439-209439101.692101.96
6212489-212489103.173103.45
20min1212137-212137103.002102.640.74103.44103.080.74
2210911-210911102.407102.85
3211511-211511102.698103.11
4213173-213173103.505103.95
5208591-208591101.280101.72
6212020-212020102.945103.39
30min1212171-212171103.019102.540.76103.63103.140.76
2210381-210381102.149102.77
3211259-211259102.576103.16
4212909-212909103.377104.00
5208429-208429101.202101.81
6211901-211901102.888103.50
45min1211819-211819102.848102.480.81103.63103.260.81
2210887-210887102.395103.18
3210562-210562102.237102.99
4213448-213448103.639104.43
5208263-208263101.121101.90
6211417-211417102.652103.44
极限1212925-212925103.385102.350.77104.34103.300.76
2209863-209863101.898102.86
3210464-210464102.190103.12
4211904-211904102.889103.85
5208353-208353101.165102.11
6211205-211205102.550103.51
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(%)0.00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%
119.262022022024722023392024582022132023370.07
219.172013462016322014890.11
单位质量响应值RSD%判断
10505.5610510.640.04数据可信
供试品溶液-YBA2321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%
5min186563-8656342.07957.5824.8042.0857.5824.79
2139665-13966567.89267.89
387980-8798042.76842.77
4104150-10415050.62850.63
5136918-13691866.55766.56
6155490-15549075.58575.58
10min1209869-209869102.019100.970.98102.09101.060.97
2204322-20432299.32399.44
3207692-207692100.961101.03
4209614-209614101.895101.98
5206790-206790100.522100.63
6207944-207944101.083101.21
15min1212916-212916103.500102.110.97103.74102.370.96
2206864-206864100.558100.84
3209944-209944102.056102.30
4211412-211412102.769103.02
5209468-209468101.824102.10
6209726-209726101.950102.24
20min1213006-213006103.544101.831.14103.96102.271.12
2206412-206412100.339100.78
3210322-210322102.239102.65
4210948-210948102.544102.97
5208171-208171101.194101.64
6208047-208047101.133101.60
30min1212574-212574103.334101.661.14103.92102.261.12
2206081-206081100.178100.79
3209822-209822101.996102.58
4210767-210767102.456103.05
5207562-207562100.898101.51
6207953-207953101.088101.72
45min1212311-212311103.206101.661.19103.96102.441.17
2205178-20517899.739100.52
3209439-209439101.810102.56
4210290-210290102.224102.99
5210134-210134102.148102.93
6207467-207467100.851101.65
极限1212026-212026103.068101.251.18104.00102.201.16
2205192-20519299.746100.69
3209104-209104101.647102.57
4209623-209623101.899102.84
5206663-206663100.461101.42
6207124-207124100.685101.65
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(%)0.00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%
119.262020792025182025212025472023042023940.10
219.172018322018452018380.01
单位质量响应值RSD%判断
10508.5210528.850.14数据可信
供试品溶液-YBA2321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%
5min1142371-14237169.13865.0918.8169.1465.1018.81
2124145-12414560.28760.29
388117-8811742.79142.79
4156767-15676776.12976.13
5140162-14016268.06568.07
6152699-15269974.15474.15
10min1209867-209867101.916101.851.45102.03101.961.46
2211820-211820102.864102.96
3204069-20406999.10099.17
4211605-211605102.760102.89
5208975-208975101.482101.60
6212026-212026102.964103.09
15min1211481-211481102.699102.721.18102.98102.991.20
2214051-214051103.947104.22
3207008-207008100.527100.76
4212541-212541103.214103.51
5210859-210859102.397102.68
6213167-213167103.518103.81
20min1213558-213558103.708102.881.17104.16103.331.18
2213809-213809103.830104.28
3207369-207369100.702101.11
4212156-212156103.027103.50
5210820-210820102.378102.83
6213437-213437103.649104.12
30min1210321-210321102.136102.371.17102.77103.001.18
2213824-213824103.837104.46
3206931-206931100.490101.06
4211388-211388102.654103.30
5209621-209621101.796102.42
6212758-212758103.319103.96
45min1210158-210158102.057102.201.15102.86102.981.16
2213275-213275103.571104.36
3206530-206530100.295101.03
4211157-211157102.542103.35
5209184-209184101.584102.38
6212349-212349103.121103.93
极限1209860-209860101.912102.011.20102.88102.971.21
2212856-212856103.367104.33
3205898-20589899.988100.89
4210974-210974102.453103.44
5208755-208755101.376102.34
6212018-212018102.960103.94
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