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%
19.893037914303993930386623039534303872530389550.03
29.943027547302449330260200.08
单位质量响应值RSD%判断
307275.53304428.570.66数据可信
供试品溶液-8149401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%
5min112125-121250.3950.6827.450.390.6827.57
228920-289200.9420.94
319905-199050.6480.65
418934-189340.6170.62
520098-200980.6550.65
624982-249820.8140.81
10min133307-333071.0851.247.351.091.257.33
240769-407691.3281.33
337449-374491.2201.22
437788-377881.2311.23
538945-389451.2681.27
640973-409731.3341.34
15min140935-409351.3331.361.701.341.371.78
241696-416961.3581.36
341169-411691.3411.34
442176-421761.3731.38
542394-423941.3811.38
642760-427601.3921.40
20min142533-425331.3851.381.951.391.381.92
240618-406181.3231.33
342312-423121.3781.38
442703-427031.3911.40
542486-424861.3841.39
642876-428761.3961.40
30min143053-430531.4021.372.241.411.382.15
240511-405111.3191.33
341321-413211.3461.35
442488-424881.3841.39
542091-420911.3711.38
642583-425831.3871.39
45min142821-428211.3941.352.311.401.362.12
240453-404531.3171.33
340436-404361.3171.33
442023-420231.3681.38
541731-417311.3591.37
642127-421271.3721.38
60min142181-421811.3741.332.161.381.342.08
239987-399871.3021.31
340329-403291.3131.32
441848-418481.3631.37
540605-406051.3221.33
640688-406881.3251.34
极限144412-444121.4461.315.381.461.325.41
238679-386791.2601.27
338621-386211.2581.27
440270-402701.3111.32
539993-399931.3021.32
639255-392551.2781.29
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%
19.893026326302419930239613024788302536930249290.04
29.943020193301969330199430.02
单位质量响应值RSD%判断
305857.33303817.200.48数据可信
供试品溶液-8149401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%
5min126443-264430.8640.6426.170.860.6426.28
216311-163110.5330.53
324401-244010.7970.80
412640-126400.4130.41
519200-192000.6270.63
618329-183290.5990.60
10min139717-397171.2981.225.091.301.225.23
236296-362961.1861.19
338724-387241.2651.27
434395-343951.1241.12
537680-376801.2311.23
636578-365781.1951.20
15min141361-413611.3511.351.451.351.361.39
241472-414721.3551.36
341602-416021.3591.36
441970-419701.3711.37
541805-418051.3661.37
640266-402661.3161.32
20min139851-398511.3021.352.981.311.362.89
242322-423221.3831.39
341640-416401.3611.37
442992-429921.4051.41
541028-410281.3411.35
640170-401701.3121.32
30min137401-374011.2221.324.831.231.334.70
242668-426681.3941.40
340950-409501.3381.35
441866-418661.3681.37
540744-407441.3311.34
638877-388771.2701.28
45min136200-362001.1831.285.861.191.295.81
241997-419971.3721.38
340015-400151.3071.32
440803-408031.3331.34
539051-390511.2761.28
636706-367061.1991.21
60min135306-353061.1541.255.971.161.265.97
241064-410641.3421.35
339152-391521.2791.29
439723-397231.2981.31
538852-388521.2691.28
635745-357451.1681.18
极限134243-342431.1191.215.141.131.225.10
239162-391621.2801.29
337223-372231.2161.23
438437-384371.2561.27
537144-371441.2141.23
635090-350901.1471.16
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%
19.893025942302986730248703022188302143230248600.12
29.943032195303186230320280.01
单位质量响应值RSD%判断
305850.35305033.000.19数据可信
供试品溶液-20211228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%
5min138453-384531.2541.224.891.251.224.79
237333-373331.2171.22
338577-385771.2581.26
434601-346011.1281.13
536051-360511.1761.18
639526-395261.2891.29
10min143581-435811.4211.412.051.421.412.18
243779-437791.4281.43
343648-436481.4231.43
441741-417411.3611.36
542374-423741.3821.38
643853-438531.4301.43
15min144383-443831.4471.460.901.451.460.94
245348-453481.4791.48
345151-451511.4721.48
444628-446281.4551.46
544468-444681.4501.45
644530-445301.4521.46
20min145159-451591.4731.480.981.481.490.92
246144-461441.5051.51
345617-456171.4881.49
445416-454161.4811.49
544907-449071.4641.47
645161-451611.4731.48
30min145986-459861.5001.481.061.511.491.08
245317-453171.4781.49
345365-453651.4791.49
445972-459721.4991.51
545229-452291.4751.48
644737-447371.4591.47
45min145328-453281.4781.471.891.491.481.84
243695-436951.4251.44
345473-454731.4831.49
445861-458611.4951.51
545514-455141.4841.49
644225-442251.4421.45
60min145464-454641.4831.471.081.501.481.14
244456-444561.4501.46
345622-456221.4881.50
444912-449121.4651.48
544803-448031.4611.47
644541-445411.4521.47
极限144800-448001.4611.506.531.481.526.35
244383-443831.4471.46
352105-521051.6991.71
445171-451711.4731.49
544677-446771.4571.47
644864-448641.4631.48
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%
19.893031213303051630278083027221302775730289030.07
29.943003895300284730033710.03
单位质量响应值RSD%判断
306259.15302150.000.96数据可信
供试品溶液-20211228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%
5min138883-388831.2731.232.821.271.242.75
238395-383951.2571.26
337638-376381.2321.23
436638-366381.2001.20
538335-383351.2551.26
636199-361991.1851.19
10min143364-433641.4201.401.211.421.401.23
243111-431111.4121.41
342891-428911.4041.41
442192-421921.3811.38
542987-429871.4081.41
642119-421191.3791.38
15min145279-452791.4831.461.521.491.461.66
244630-446301.4611.47
344696-446961.4631.47
444581-445811.4601.46
545191-451911.4801.48
643395-433951.4211.42
20min145743-457431.4981.490.801.501.500.82
245661-456611.4951.50
345708-457081.4971.50
445797-457971.5001.51
545147-451471.4781.48
644955-449551.4721.48
30min145658-456581.4951.535.941.501.546.00
246171-461711.5121.52
352165-521651.7081.72
445455-454551.4881.50
545637-456371.4941.50
644610-446101.4611.47
45min144578-445781.4601.462.551.471.472.59
245812-458121.5001.51
342762-427621.4001.41
444104-441041.4441.45
545763-457631.4981.51
644469-444691.4561.47
60min144420-444201.4541.482.001.471.501.78
245814-458141.5001.51
346728-467281.5301.54
444385-443851.4531.47
545477-454771.4891.50
644977-449771.4731.49
极限145209-452091.4801.481.211.501.501.12
245715-457151.4971.51
345903-459031.5031.52
444340-443401.4521.47
545206-452061.4801.50
645440-454401.4881.50
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