塞来昔布胶囊项目信息
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%
19.893014077302120530133933015961301247330154220.12
29.943032023303457930333010.06
单位质量响应值RSD%判断
304896.06305161.070.07数据可信
供试品溶液-8145830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%
5min137661-376611.2301.375.811.231.365.79
242716-427161.3951.39
343552-435521.4221.42
440180-401801.3121.31
544044-440441.4381.44
642692-426921.3941.39
10min145535-455351.4871.511.111.491.511.14
246299-462991.5121.51
346611-466111.5221.52
446089-460891.5051.51
546985-469851.5341.54
645893-458931.4991.50
15min147706-477061.5581.531.241.561.531.15
246609-466091.5221.53
346506-465061.5191.52
447147-471471.5391.54
547160-471601.5401.54
646082-460821.5051.51
20min147111-471111.5381.512.521.541.522.40
245965-459651.5011.51
345346-453461.4811.49
448146-481461.5721.58
546274-462741.5111.52
644984-449841.4691.48
30min144366-443661.4491.452.681.461.462.69
244906-449061.4661.48
344298-442981.4461.46
446608-466081.5221.53
544098-440981.4401.45
643005-430051.4041.41
45min142885-428851.4001.391.391.411.401.41
242680-426801.3941.40
342752-427521.3961.41
443389-433891.4171.43
542973-429731.4031.41
641627-416271.3591.37
60min141051-410511.3401.361.601.351.371.42
241979-419791.3711.38
341224-412241.3461.36
442555-425551.3901.40
541674-416741.3611.37
640803-408031.3321.35
极限140018-400181.3071.341.861.321.351.79
241234-412341.3461.36
342248-422481.3801.39
440669-406691.3281.34
540632-406321.3271.34
640669-406691.3281.34
塞来昔布胶囊项目信息
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%
19.893018778302191130240663025942302543630232270.10
29.943015149302285230190000.19
单位质量响应值RSD%判断
305685.24303722.330.46数据可信
供试品溶液-8145830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%
5min142964-429641.4041.297.921.401.297.76
243183-431831.4121.41
339270-392701.2841.28
438472-384721.2581.26
538757-387571.2671.27
634803-348031.1381.14
10min147222-472221.5441.511.791.551.511.80
246727-467271.5271.53
346224-462241.5111.51
444802-448021.4641.47
545950-459501.5021.50
646244-462441.5121.51
15min145980-459801.5031.511.171.511.521.14
246492-464921.5201.52
346431-464311.5181.52
446713-467131.5271.53
546955-469551.5351.54
645473-454731.4861.49
20min144825-448251.4651.470.911.471.480.90
245472-454721.4861.49
345530-455301.4881.49
444554-445541.4561.46
545246-452461.4791.49
644749-447491.4631.47
30min143870-438701.4341.431.791.441.431.91
244077-440771.4411.45
344389-443891.4511.46
444146-441461.4431.45
542980-429801.4051.41
642413-424131.3861.39
45min143255-432551.4141.372.221.421.382.09
240972-409721.3391.35
342437-424371.3871.40
442797-427971.3991.41
541561-415611.3591.37
641163-411631.3461.36
60min142856-428561.4011.362.211.411.372.12
241829-418291.3671.38
341048-410481.3421.35
442120-421201.3771.39
541274-412741.3491.36
640222-402221.3151.33
极限142407-424071.3861.342.991.401.353.00
242020-420201.3741.39
340176-401761.3131.33
440913-409131.3371.35
540414-404141.3211.34
639124-391241.2791.29
塞来昔布胶囊项目信息
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%
19.893003962300949730240003014036301519230133370.25
29.943024291302154830229200.07
单位质量响应值RSD%判断
304685.24304116.700.14数据可信
供试品溶液-20211227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%
5min142380-423801.3871.366.861.391.366.98
243800-438001.4331.43
344305-443051.4501.45
442083-420831.3771.38
536807-368071.2041.20
639520-395201.2931.29
10min146795-467951.5311.513.381.531.513.37
248063-480631.5731.57
346805-468051.5311.53
446760-467601.5301.53
543446-434461.4221.42
645792-457921.4981.50
15min147703-477031.5611.561.771.571.561.70
249179-491791.6091.61
346959-469591.5361.54
447095-470951.5411.55
547009-470091.5381.54
647492-474921.5541.56
20min148292-482921.5801.571.591.591.581.59
248919-489191.6011.61
346763-467631.5301.54
448503-485031.5871.59
547625-476251.5581.56
647898-478981.5671.57
30min148235-482351.5781.571.521.591.581.54
248426-484261.5851.59
346982-469821.5371.55
447162-471621.5431.55
548819-488191.5971.61
647757-477571.5631.57
45min147817-478171.5651.542.181.581.562.03
246593-465931.5251.54
345680-456801.4951.51
447074-470741.5401.55
548701-487011.5931.60
647024-470241.5391.55
60min146884-468841.5341.541.741.551.551.71
247398-473981.5511.56
346000-460001.5051.52
446964-469641.5371.55
548199-481991.5771.59
646160-461601.5101.52
极限147585-475851.5571.532.151.571.542.08
246828-468281.5321.55
345278-452781.4811.50
446189-461891.5111.53
548046-480461.5721.59
646402-464021.5181.53
塞来昔布胶囊项目信息
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%
19.893022969301728730199193017872301144930178990.15
29.943020183301928130197320.03
单位质量响应值RSD%判断
305146.51303795.980.32数据可信
供试品溶液-20211227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%
5min137804-378041.2371.335.691.241.335.77
238030-380301.2441.24
343639-436391.4281.43
440779-407791.3341.33
541837-418371.3691.37
641785-417851.3671.37
10min144834-448341.4671.522.401.471.522.38
246310-463101.5151.52
347938-479381.5681.57
446864-468641.5331.54
547245-472451.5461.55
645695-456951.4951.50
15min146645-466451.5261.551.941.531.561.88
247110-471101.5411.55
348482-484821.5861.59
448061-480611.5721.58
548294-482941.5801.58
646325-463251.5151.52
20min147679-476791.5601.551.381.571.551.45
246951-469511.5361.54
346485-464851.5211.53
447272-472721.5461.55
548312-483121.5801.59
646833-468331.5321.54
30min146853-468531.5331.4711.051.541.4811.09
245302-453021.4821.49
334977-349771.1441.15
448062-480621.5721.58
547584-475841.5571.57
646703-467031.5281.54
45min147820-478201.5641.513.421.581.533.54
244429-444291.4531.46
344517-445171.4561.47
448154-481541.5751.59
546560-465601.5231.53
646387-463871.5171.53
60min147683-476831.5601.513.581.571.523.45
244769-447691.4651.48
343481-434811.4221.44
447502-475021.5541.57
546618-466181.5251.54
646517-465171.5221.54
极限147375-473751.5501.475.461.571.495.47
243500-435001.4231.44
343671-436711.4291.44
447131-471311.5421.56
547068-470681.5401.56
641582-415821.3601.38
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