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%
110.043000670300514330031372999036300422930024430.09
210.012992825299637129945980.09
单位质量响应值RSD%判断
299048.11299160.640.03数据可信
供试品溶液-20211229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%
5min119012-190120.6330.649.990.630.6410.42
217925-179250.5970.60
317814-178140.5930.59
417187-171870.5720.57
521190-211900.7060.71
621785-217850.7250.73
10min133328-333281.1101.176.691.111.176.82
233211-332111.1061.11
334927-349271.1631.16
433642-336421.1201.12
536517-365171.2161.22
639194-391941.3051.31
15min140433-404331.3461.331.311.351.341.48
239877-398771.3281.33
340439-404391.3471.35
439762-397621.3241.33
539100-391001.3021.30
640304-403041.3421.35
20min141912-419121.3961.287.151.401.287.23
237754-377541.2571.26
335554-355541.1841.19
435442-354421.1801.18
541196-411961.3721.38
638924-389241.2961.30
30min140755-407551.3571.383.841.361.383.85
239301-393011.3091.32
343853-438531.4601.47
441046-410461.3671.37
542507-425071.4151.42
640696-406961.3551.36
45min143059-430591.4341.393.311.441.403.27
243589-435891.4511.46
341959-419591.3971.41
441781-417811.3911.40
540704-407041.3551.36
639919-399191.3291.34
60min141461-414611.3811.351.751.391.361.71
239823-398231.3261.34
340682-406821.3551.37
440480-404801.3481.36
539702-397021.3221.33
641180-411801.3711.38
极限142516-425161.4161.343.171.431.353.13
238929-389291.2961.31
340321-403211.3431.36
440122-401221.3361.35
540272-402721.3411.35
639179-391791.3051.32
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%
110.042978577298173629795092985185297617629802370.12
210.013026479301755230220160.21
单位质量响应值RSD%判断
296836.35301899.701.20数据可信
供试品溶液-20211229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%
5min123753-237530.7900.699.650.790.699.52
220534-205340.6830.68
317661-176610.5880.59
421419-214190.7130.71
520787-207870.6920.69
619763-197630.6580.66
10min137027-370271.2321.128.021.231.127.82
234663-346631.1531.15
332400-324001.0781.08
433268-332681.1071.11
529068-290680.9670.97
634663-346631.1531.15
15min140259-402591.3401.312.091.341.312.04
239079-390791.3001.30
337811-378111.2581.26
439658-396581.3201.32
539328-393281.3091.31
639312-393121.3081.31
20min139176-391761.3031.313.311.311.323.39
241031-410311.3651.37
339640-396401.3191.32
440523-405231.3481.35
537274-372741.2401.24
639252-392521.3061.31
30min140195-401951.3371.343.501.341.343.49
242236-422361.4051.41
341446-414461.3791.39
438766-387661.2901.30
539535-395351.3151.32
638895-388951.2941.30
45min136721-367211.2221.324.561.231.324.66
241189-411891.3701.38
341710-417101.3881.40
439544-395441.3161.32
539560-395601.3161.32
638581-385811.2841.29
60min136557-365571.2161.294.011.231.303.94
238088-380881.2671.28
340287-402871.3401.35
440472-404721.3471.36
539533-395331.3151.33
637851-378511.2591.27
极限136257-362571.2061.273.421.221.283.34
239111-391111.3011.31
337874-378741.2601.27
439636-396361.3191.33
538638-386381.2861.30
636972-369721.2301.24
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%
110.042982019298198329810202982708298054929816560.03
210.012947996295909929535480.27
单位质量响应值RSD%判断
296977.69295059.740.46数据可信
供试品溶液-2026010811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%
5min121990-219900.7400.6415.270.740.6415.06
213865-138650.4670.47
320446-204460.6880.69
419330-193300.6500.65
520797-207970.7000.70
617746-177460.5970.60
10min131958-319581.0751.156.851.081.156.90
230693-306931.0331.03
336655-366551.2331.23
434654-346541.1661.17
536091-360911.2141.22
634776-347761.1701.17
15min138815-388151.3061.331.831.311.331.74
239776-397761.3381.34
339746-397461.3371.34
438873-388731.3081.31
540738-407381.3711.37
639228-392281.3201.32
20min141347-413471.3911.362.111.401.372.07
240842-408421.3741.38
339596-395961.3321.34
441170-411701.3851.39
540812-408121.3731.38
639303-393031.3221.33
30min138044-380441.2801.323.671.291.333.60
240454-404541.3611.37
339303-393031.3221.33
440753-407531.3711.38
540079-400791.3491.36
637118-371181.2491.26
45min140121-401211.3501.325.131.361.335.08
241333-413331.3911.40
336672-366721.2341.24
441453-414531.3951.40
538732-387321.3031.31
637404-374041.2591.27
60min139509-395091.3291.293.591.341.303.63
239704-397041.3361.35
336600-366001.2311.24
439310-393101.3231.33
538687-386871.3021.31
636842-368421.2401.25
极限138413-384131.2921.244.941.311.255.02
237719-377191.2691.28
333273-332731.1201.13
437501-375011.2621.27
537330-373301.2561.27
636787-367871.2381.25
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%
110.042957068295511029571642954348295564429558670.05
210.012997697299185929947780.14
单位质量响应值RSD%判断
294409.06299178.621.14数据可信
供试品溶液-2026010811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%
5min123868-238680.8010.6514.980.800.6515.14
217256-172560.5790.58
321901-219010.7350.74
416456-164560.5520.55
518821-188210.6320.63
617893-178930.6010.60
10min136749-367491.2331.193.911.231.193.85
233524-335241.1251.13
337119-371191.2461.25
434307-343071.1511.15
535558-355581.1931.19
635663-356631.1971.20
15min140004-400041.3431.302.371.351.302.37
237684-376841.2651.27
338407-384071.2891.29
438998-389981.3091.31
539560-395601.3281.33
637965-379651.2741.28
20min141060-410601.3781.362.121.381.372.16
239991-399911.3421.35
342075-420751.4121.42
440141-401411.3471.35
539799-397991.3361.34
640323-403231.3531.36
30min140411-404111.3561.326.011.361.325.93
241212-412121.3831.39
339933-399331.3401.35
434633-346331.1621.17
538984-389841.3081.32
640037-400371.3441.35
45min138942-389421.3071.323.091.321.342.95
237513-375131.2591.27
340466-404661.3581.37
439663-396631.3311.34
540956-409561.3751.38
639251-392511.3171.33
60min138148-381481.2801.283.401.291.293.30
239249-392491.3171.33
335599-355991.1951.21
438365-383651.2881.30
538941-389411.3071.32
638292-382921.2851.30
极限136583-365831.2281.272.461.241.282.45
239228-392281.3171.33
338171-381711.2811.29
437242-372421.2501.26
538178-381781.2811.29
638446-384461.2901.30
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