非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.031490516148748514872171485461148314414867650.19
210.201502518150280715026620.02
单位质量响应值RSD%判断
148231.80147319.800.44数据可信
供试品溶液-3785B批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112180-121800.7420.5526.440.740.5626.38
28658-86580.5270.53
39693-96930.5900.59
410685-106850.6510.65
58318-83180.5070.51
65130-51300.3120.31
10min123698-236981.4431.2513.251.441.2613.14
221599-215991.3151.32
319687-196871.1991.20
421942-219421.3361.34
520775-207751.2651.27
615708-157080.9570.96
15min128117-281171.7121.616.651.721.626.63
226837-268371.6341.64
326061-260611.5871.59
428381-283811.7291.73
525819-258191.5721.58
623577-235771.4361.44
20min130049-300491.8301.763.991.841.773.95
229386-293861.7901.80
329137-291371.7751.78
429775-297751.8131.82
528326-283261.7251.73
626916-269161.6391.65
30min130682-306821.8691.831.941.881.842.00
230210-302101.8401.85
329486-294861.7961.81
430619-306191.8651.88
530208-302081.8401.85
629278-292781.7831.79
45min141930-419302.5542.0113.472.572.0213.37
230926-309261.8841.90
331212-312121.9011.92
431872-318721.9411.96
531150-311501.8971.91
630480-304801.8561.87
60min132320-323201.9681.922.421.991.942.39
231679-316791.9291.95
331518-315181.9201.94
432234-322341.9631.98
531330-313301.9081.93
630218-302181.8401.86
极限132800-328001.9981.971.782.021.991.84
231975-319751.9471.97
332169-321691.9591.98
432942-329422.0062.03
532389-323891.9732.00
631376-313761.9111.93
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.031497496149752014973551497876149642414973340.04
210.201505238150452315048800.04
单位质量响应值RSD%判断
149285.54147537.250.84数据可信
供试品溶液-3785B批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117760-177601.0771.0437.971.081.0438.24
214402-144020.8730.87
310133-101330.6150.61
417472-174721.0601.06
514236-142360.8630.86
629317-293171.7781.78
10min124780-247801.5031.446.031.511.446.01
223946-239461.4521.45
321017-210171.2751.28
424830-248301.5061.51
524333-243331.4761.48
623358-233581.4171.42
15min128420-284201.7241.674.571.731.684.53
227876-278761.6911.70
325126-251261.5241.53
428051-280511.7011.71
528514-285141.7291.73
627400-274001.6621.67
20min129789-297891.8071.783.261.821.793.17
230265-302651.8351.84
327518-275181.6691.68
429739-297391.8041.81
529472-294721.7871.80
629579-295791.7941.80
30min130637-306371.8581.861.331.871.871.40
230750-307501.8651.88
329907-299071.8141.82
430973-309731.8781.89
531031-310311.8821.89
630512-305121.8501.87
45min131197-311971.8921.937.311.911.947.28
230410-304101.8441.86
330445-304451.8461.86
430976-309761.8791.90
531264-312641.8961.91
636468-364682.2122.23
60min130611-306111.8561.882.331.881.912.27
231682-316821.9211.94
330974-309741.8781.90
431946-319461.9371.96
529984-299841.8181.84
631321-313211.8991.92
极限131418-314181.9051.930.941.931.951.01
231818-318181.9301.96
331626-316261.9181.94
431557-315571.9141.94
532051-320511.9441.97
632169-321691.9511.98
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.031518824151894815132591508096150475815127770.42
210.201511300151124015112700.01
单位质量响应值RSD%判断
150825.22148163.731.26数据可信
供试品溶液-3786A批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19504-95040.5720.4939.170.570.4939.03
25151-51510.3100.31
313844-138440.8340.83
47508-75080.4520.45
56134-61340.3690.37
66522-65220.3930.39
10min121023-210231.2661.2818.941.271.2918.87
217069-170691.0281.03
322325-223251.3441.35
419732-197321.1881.19
519136-191361.1521.15
628749-287491.7311.73
15min126675-266751.6061.545.951.611.545.93
223000-230001.3851.39
326251-262511.5811.59
425780-257801.5521.56
526895-268951.6191.62
624368-243681.4671.47
20min128437-284371.7121.664.761.721.674.76
227436-274361.6521.66
329182-291821.7571.77
427882-278821.6791.69
525389-253891.5291.54
626933-269331.6221.63
30min129994-299941.8061.792.861.821.802.82
229963-299631.8041.81
330793-307931.8541.87
429908-299081.8011.81
529208-292081.7591.77
628305-283051.7041.72
45min132253-322531.9421.853.981.961.873.99
231332-313321.8861.90
331629-316291.9041.92
430250-302501.8211.84
530364-303641.8281.84
628812-288121.7351.75
60min131235-312351.8811.893.941.901.903.93
231816-318161.9161.93
332196-321961.9381.96
430204-302041.8191.84
529601-296011.7821.80
632868-328681.9792.00
极限132273-322731.9431.891.801.971.911.81
231866-318661.9191.94
331118-311181.8741.90
431062-310621.8701.89
531255-312551.8821.90
630770-307701.8531.88
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.031516348151557115154751514058151321015149320.09
210.201524767152553215251500.04
单位质量响应值RSD%判断
151040.08149524.510.72数据可信
供试品溶液-3786A批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114651-146510.8770.7220.840.880.7220.84
27827-78270.4690.47
313927-139270.8340.83
413465-134650.8060.81
510826-108260.6480.65
611755-117550.7040.70
10min123292-232921.3951.4217.471.401.4217.51
231995-319951.9161.92
321640-216401.2961.30
421944-219441.3141.32
521700-217001.3001.30
621419-214191.2831.28
15min131736-317361.9011.5810.541.911.5810.60
224500-245001.4671.47
324412-244121.4621.47
425823-258231.5471.55
526713-267131.6001.60
624975-249751.4961.50
20min128253-282531.6921.733.311.701.743.32
228098-280981.6831.69
330533-305331.8291.84
428855-288551.7281.74
529132-291321.7451.75
628014-280141.6781.69
30min130195-301951.8081.752.511.821.762.53
228747-287471.7221.73
329515-295151.7681.78
428743-287431.7211.73
529787-297871.7841.80
628288-282881.6941.71
45min128816-288161.7261.8510.011.741.869.94
236950-369502.2132.23
330078-300781.8011.82
429066-290661.7411.76
530647-306471.8351.85
629324-293241.7561.77
60min130899-308991.8511.884.611.871.904.58
231927-319271.9121.93
328912-289121.7321.75
433220-332201.9902.01
531035-310351.8591.88
631918-319181.9121.93
极限132260-322601.9321.834.311.961.864.30
231825-318251.9061.93
328805-288051.7251.75
429723-297231.7801.80
531054-310541.8601.88
630130-301301.8041.83
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