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4000
标示量(mg)2.5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%
119.239502794838950489482995298950080.21
219.229548395224953540.20
单位质量响应值RSD%判断
4940.614961.190.30数据可信
供试品溶液-YAB2158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%
5min195445-9544598.475100.311.3998.48100.311.39
295764-9576498.80598.80
397404-97404100.497100.50
497637-97637100.737100.74
598534-98534101.663101.66
698568-98568101.698101.70
10min196764-9676499.83699.910.57100.00100.080.57
296404-9640499.46599.63
396460-9646099.52399.69
496373-9637399.43399.60
597472-97472100.567100.74
697559-97559100.657100.83
15min1-0.0000.00-0.330.331.55
2-0.0000.33
3-0.0000.33
4-0.0000.33
5-0.0000.34
6-0.0000.34
20min1-0.0000.00-0.330.331.55
2-0.0000.33
3-0.0000.33
4-0.0000.33
5-0.0000.34
6-0.0000.34
30min1-0.0000.00-0.330.331.55
2-0.0000.33
3-0.0000.33
4-0.0000.33
5-0.0000.34
6-0.0000.34
45min1-0.0000.00-0.330.331.55
2-0.0000.33
3-0.0000.33
4-0.0000.33
5-0.0000.34
6-0.0000.34
极限1-0.0000.00-0.330.331.55
2-0.0000.33
3-0.0000.33
4-0.0000.33
5-0.0000.34
6-0.0000.34
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4000
标示量(mg)2.5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%
119.239512995414953749536395002952560.19
219.229533995349953440.01
单位质量响应值RSD%判断
4953.514960.670.11数据可信
供试品溶液-YAB2147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%
5min199703-99703102.740103.060.34102.74103.060.34
299844-99844102.885102.89
3100441-100441103.500103.50
4100448-100448103.508103.51
599812-99812102.852102.85
699819-99819102.859102.86
10min197954-97954100.938102.051.64101.11102.221.64
297672-97672100.647100.82
398190-98190101.181101.35
498143-98143101.132101.30
5101067-101067104.145104.32
6101162-101162104.243104.41
15min1-0.0000.00-0.340.341.20
2-0.0000.34
3-0.0000.34
4-0.0000.34
5-0.0000.34
6-0.0000.35
20min1-0.0000.00-0.340.341.20
2-0.0000.34
3-0.0000.34
4-0.0000.34
5-0.0000.34
6-0.0000.35
30min1-0.0000.00-0.340.341.20
2-0.0000.34
3-0.0000.34
4-0.0000.34
5-0.0000.34
6-0.0000.35
45min1-0.0000.00-0.340.341.20
2-0.0000.34
3-0.0000.34
4-0.0000.34
5-0.0000.34
6-0.0000.35
极限1-0.0000.00-0.340.341.20
2-0.0000.34
3-0.0000.34
4-0.0000.34
5-0.0000.34
6-0.0000.35
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4000
标示量(mg)2.5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%
119.231907031909431906091905701901101905870.16
219.221904611901561903080.12
单位质量响应值RSD%判断
9910.929901.560.07数据可信
供试品溶液-YAB2158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%
5min1197176-197176101.672102.210.89101.67102.210.89
2197246-197246101.708101.71
3196785-196785101.471101.47
4197199-197199101.684101.68
5200112-200112103.186103.19
6200818-200818103.550103.55
10min1198489-198489102.349102.410.11102.52102.580.11
2198456-198456102.332102.50
3198707-198707102.462102.63
4198827-198827102.524102.69
5198808-198808102.514102.69
6198326-198326102.265102.44
15min1197452-197452101.815101.710.82102.15102.050.81
2196950-196950101.556101.90
3198952-198952102.588102.93
4199123-199123102.676103.02
5195202-195202100.654101.00
6195802-195802100.964101.31
20min1196430-196430101.288102.301.04101.80102.811.03
2196246-196246101.193101.70
3200643-200643103.460103.97
4201062-201062103.676104.19
5198089-198089102.143102.65
6197910-197910102.051102.56
30min1-0.0000.00-0.680.680.00
2-0.0000.68
3-0.0000.68
4-0.0000.68
5-0.0000.68
6-0.0000.68
45min1-0.0000.00-0.680.680.00
2-0.0000.68
3-0.0000.68
4-0.0000.68
5-0.0000.68
6-0.0000.68
极限1-0.0000.00-0.680.680.00
2-0.0000.68
3-0.0000.68
4-0.0000.68
5-0.0000.68
6-0.0000.68
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4000
标示量(mg)2.5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%
119.239487294604949009512194761948520.21
219.229495395031949920.06
单位质量响应值RSD%判断
4932.504942.350.15数据可信
供试品溶液-YAB2158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%
5min191453-9145394.61489.956.1694.6189.956.16
285591-8559188.54988.55
380176-8017682.94782.95
482198-8219885.03985.04
588113-8811391.15891.16
694114-9411497.36797.37
10min198880-98880102.298101.520.63102.46101.680.63
297850-97850101.232101.38
397169-97169100.527100.67
498482-98482101.886102.03
597930-97930101.315101.47
698478-98478101.882102.04
15min197957-97957101.343101.450.50101.67101.770.51
297714-97714101.091101.41
397472-97472100.841101.15
498370-98370101.770102.08
598008-98008101.395101.72
698845-98845102.261102.59
20min197472-97472100.841101.140.42101.34101.630.42
297955-97955101.341101.83
397141-97141100.498100.97
498197-98197101.591102.07
597675-97675101.051101.54
698112-98112101.503102.01
30min197518-97518100.889101.140.60101.55101.800.60
297838-97838101.220101.87
397058-97058100.413101.05
498736-98736102.149102.80
597434-97434100.802101.46
698003-98003101.390102.06
45min197469-97469100.838100.830.34101.67101.650.35
297441-97441100.809101.63
396935-96935100.285101.09
497938-97938101.323102.14
597348-97348100.713101.54
697637-97637101.012101.85
极限197052-97052100.406100.520.35101.41101.520.35
296965-96965100.316101.31
396688-96688100.030101.01
497536-97536100.907101.90
597186-97186100.545101.54
697536-97536100.907101.92
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4000
标示量(mg)2.5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%
119.239528595252954069534995197952980.09
219.229473094761947460.03
单位质量响应值RSD%判断
4955.694929.550.38数据可信
供试品溶液批-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%
5min189360-8936092.35293.221.1992.3593.221.19
288851-8885191.82691.83
390807-9080793.84793.85
490550-9055093.58293.58
591798-9179894.87294.87
689837-8983792.84592.84
10min199158-99158102.478101.990.90102.63102.140.90
298142-98142101.428101.58
399778-99778103.119103.28
497396-97396100.657100.81
598320-98320101.612101.77
699301-99301102.626102.78
15min199370-99370102.697101.830.95103.02102.150.94
297903-97903101.181101.50
399667-99667103.004103.33
497540-97540100.806101.13
597692-97692100.963101.29
699009-99009102.324102.65
20min199372-99372102.699101.750.98103.19102.240.98
297718-97718100.990101.48
399593-99593102.928103.43
497383-97383100.644101.14
597706-97706100.977101.47
698955-98955102.268102.76
30min1100130-100130103.482101.901.28104.15102.571.27
297527-97527100.792101.45
399611-99611102.946103.62
497212-97212100.467101.13
597720-97720100.992101.66
699416-99416102.745103.41
45min199658-99658102.995101.601.19103.83102.441.18
297383-97383100.644101.47
399337-99337102.663103.51
496991-96991100.238101.07
597443-97443100.706101.54
699040-99040102.356103.19
极限199886-99886103.230101.301.32104.24102.301.31
296958-96958100.204101.20
398880-98880102.191103.20
496638-9663899.874100.87
597164-97164100.417101.42
698593-98593101.894102.90
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