塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.961519435151662215176771516740151576315172470.10
29.921517648151621815169330.07
单位质量响应值RSD%判断
152334.04152916.630.27数据可信
中间条件24月-供试品溶液-2023010511批-pH6.8(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1187560-18756012.24011.588.8312.2411.588.82
2176052-17605211.48911.49
3164686-16468610.74710.75
4155464-15546410.14510.15
5182181-18218111.88911.89
6198754-19875412.97012.97
10min1455529-45552929.72729.106.4029.7529.116.40
2425031-42503127.73727.75
3429776-42977628.04628.06
4417069-41706927.21727.23
5452909-45290929.55629.57
6494785-49478532.28932.31
15min1710284-71028446.35245.546.1546.4145.606.16
2658361-65836142.96343.02
3671073-67107343.79343.85
4671592-67159243.82743.88
5699921-69992145.67645.74
6775834-77583450.62950.70
20min1925681-92568160.40859.855.9660.5459.985.96
2862568-86256856.29056.41
3886708-88670857.86557.99
4898418-89841858.62958.75
5910046-91004659.38859.52
61019773-101977366.54866.69
30min11235323-123532380.61579.952.9080.8480.172.91
21178212-117821276.88877.10
31191219-119121977.73777.95
41235512-123551280.62780.84
51233481-123348180.49580.71
61276648-127664883.31283.56
45min11422164-142216492.80892.431.1393.1592.771.14
21398517-139851791.26591.59
31398171-139817191.24291.57
41439506-143950693.93994.27
51416078-141607892.41192.75
61423919-142391992.92293.29
60min11452317-145231794.77594.530.9395.2695.010.93
21438841-143884193.89694.36
31429030-142903093.25693.72
41467355-146735595.75796.23
51448086-144808694.49994.98
61455809-145580995.00395.51
极限11477776-147777696.43795.950.6497.0696.570.65
21468259-146825995.81696.42
31456317-145631795.03695.64
41480297-148029796.60197.22
51462976-146297695.47196.09
61476052-147605296.32496.97
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.961513806151038115098991512855151510015124080.15
29.921520003151763115188170.12
单位质量响应值RSD%判断
151848.19153106.550.59数据可信
中间条件24月-供试品溶液-2023010511批-pH6.8(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1182098-18209811.89511.587.2711.9011.587.26
2160222-16022210.46610.47
3189126-18912612.35412.35
4192721-19272112.58912.59
5172674-17267411.27911.28
6166567-16656710.88110.88
10min1437003-43700328.54629.055.2528.5629.075.24
2421593-42159327.53927.56
3472355-47235530.85530.87
4474148-47414830.97230.99
5440376-44037628.76628.78
6422914-42291427.62627.64
15min1678316-67831644.30945.404.5644.3745.464.57
2669774-66977443.75143.81
3731007-73100747.75147.82
4738653-73865348.25048.32
5685546-68554644.78144.84
6666538-66653843.54043.60
20min1894710-89471058.44459.954.6958.5760.084.70
2889293-88929358.09158.21
3963222-96322262.92063.06
4981058-98105864.08564.22
5899654-89965458.76758.89
6878895-87889557.41157.53
30min11199349-119934978.34479.791.9278.5680.011.93
21208813-120881378.96279.17
31249599-124959981.62781.86
41252800-125280081.83682.07
51210717-121071779.08779.30
61207787-120778778.89579.10
45min11405067-140506791.78292.670.8092.1193.000.81
21416753-141675392.54692.87
31431739-143173993.52493.88
41423003-142300392.95493.31
51429037-142903793.34893.68
61406215-140621591.85792.18
60min11455692-145569295.08994.620.7395.5695.100.73
21432043-143204393.54494.01
31456011-145601195.11095.60
41453471-145347194.94495.44
51438583-143858393.97294.45
61455627-145562795.08595.55
极限11462367-146236795.52595.770.4896.1496.390.49
21462869-146286995.55896.17
31466154-146615495.77396.41
41475808-147580896.40397.04
51472281-147228196.17396.79
61456874-145687495.16695.77
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.961517368151712115180411515467151516215166320.09
29.921503462150771715055900.20
单位质量响应值RSD%判断
152272.29151773.190.24数据可信
中间条件24月-供试品溶液-2023010611批-pH6.8(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1219778-21977814.39912.2415.1814.4012.2415.19
2186354-18635412.20912.21
3208168-20816813.63813.64
4191495-19149512.54612.55
5176702-17670211.57711.58
6138328-1383289.0639.06
10min1519443-51944334.03230.289.7134.0530.309.71
2442665-44266529.00229.02
3493431-49343132.32832.35
4468023-46802330.66330.68
5460660-46066030.18130.20
6388782-38878225.47225.49
15min1786562-78656251.53346.827.1051.6146.897.11
2682044-68204444.68544.75
3741208-74120848.56148.63
4719305-71930547.12647.19
5720710-72071047.21947.28
6638145-63814541.80941.86
20min11015135-101513566.50861.075.9866.6661.205.99
2891581-89158158.41358.54
3949796-94979662.22762.37
4936704-93670461.37061.51
5947258-94725862.06162.19
6852058-85205855.82455.94
30min11327496-132749686.97381.604.4287.2281.834.43
21197659-119765978.46778.68
31257522-125752282.38982.62
41251026-125102681.96382.19
51267787-126778783.06183.29
61171852-117185276.77676.97
45min11486841-148684197.41394.502.2397.7994.852.24
21414213-141421392.65592.99
31432544-143254493.85694.21
41464167-146416795.92796.28
51454720-145472095.30895.66
61401665-140166591.83292.15
60min11508571-150857198.83796.571.7999.3697.061.80
21454864-145486495.31895.79
31456872-145687295.44995.95
41499776-149977698.26098.75
51479590-147959096.93897.43
61443880-144388094.59895.05
极限11515415-151541599.28597.651.6899.9698.291.68
21474750-147475096.62197.24
31467930-146793096.17496.82
41524135-152413599.856100.50
51494131-149413197.89198.53
61466403-146640396.07496.67
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
19.961513772151158815105531510585151261215118220.10
29.921503105150422015036620.06
单位质量响应值RSD%判断
151789.36151578.830.10数据可信
中间条件24月-供试品溶液-2023010611批-pH6.8(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1203454-20345413.35912.2710.1813.3612.2710.19
2200359-20035913.15613.16
3158148-15814810.38410.38
4204179-20417913.40713.41
5182631-18263111.99211.99
6172510-17251011.32711.33
10min1476190-47619031.26830.514.9231.2930.534.93
2482129-48212931.65831.68
3425750-42575027.95627.97
4488329-48832932.06532.09
5458368-45836830.09830.12
6456918-45691830.00330.02
15min1724934-72493447.60146.963.6847.6747.023.69
2728743-72874347.85147.92
3683634-68363444.88944.95
4755868-75586849.63249.70
5700520-70052045.99846.06
6697359-69735945.79145.85
20min1948807-94880762.30160.783.7962.4460.913.79
2945905-94590562.11162.25
3906094-90609459.49759.62
4969891-96989163.68663.83
5906842-90684259.54659.68
6875837-87583757.51057.64
30min11265456-126545683.09381.712.3883.3381.942.39
21251591-125159182.18382.42
31226481-122648180.53480.75
41288075-128807584.57984.82
51227107-122710780.57580.80
61207717-120771779.30279.52
45min11456337-145633795.62794.751.8695.9895.101.87
21445751-144575194.93295.29
31426177-142617793.64793.98
41487929-148792997.70298.07
51428103-142810393.77394.12
61413169-141316992.79393.13
60min11479827-147982797.17096.511.3397.6797.001.34
21481025-148102597.24897.75
31463462-146346296.09596.57
41495950-149595098.22898.74
51456766-145676695.65596.14
61441899-144189994.67995.15
极限11496809-149680998.28597.721.3998.9398.351.40
21494674-149467498.14598.79
31485021-148502197.51198.13
41516885-151688599.603100.26
51481118-148111897.25497.88
61454617-145461795.51496.13
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