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101278-202003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对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.201931489193428819327381932668193129719324960.07
210.211935012193516619350890.01
单位质量响应值RSD%判断
189460.39189528.800.03数据可信
供试品溶液-2024112422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%
5min125858-258581.2281.0617.911.231.0617.85
224098-240981.1451.14
323321-233211.1081.11
421528-215281.0221.02
524526-245261.1651.16
614718-147180.6990.70
10min132318-323181.5351.4111.201.541.4211.20
227252-272521.2941.30
328379-283791.3481.35
427351-273511.2991.30
535262-352621.6751.68
627668-276681.3141.32
15min136158-361581.7171.655.851.721.665.82
233105-331051.5721.58
332726-327261.5541.56
433619-336191.5971.60
537967-379671.8031.81
635329-353291.6781.68
20min139015-390151.8531.724.661.861.724.62
236110-361101.7151.72
333760-337601.6031.61
435747-357471.6981.71
536273-362731.7231.73
636077-360771.7131.72
30min139089-390891.8571.765.111.871.785.07
237900-379001.8001.81
334989-349891.6621.67
434610-346101.6441.66
537467-374671.7791.79
638704-387041.8381.85
45min141408-414081.9671.824.801.981.844.72
237216-372161.7681.78
336434-364341.7301.75
436973-369731.7561.77
539001-390011.8521.87
638779-387791.8421.86
60min138481-384811.8281.814.201.851.834.08
237884-378841.7991.82
335722-357221.6971.72
437132-371321.7641.78
539803-398031.8901.91
639894-398941.8951.91
极限139710-397101.8861.815.741.911.845.66
238745-387451.8401.86
336464-364641.7321.76
434534-345341.6401.66
539763-397631.8891.91
639758-397581.8881.91
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101278-202003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对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.201938530194122619382771939574193888819392990.07
210.211948878194863919487580.01
单位质量响应值RSD%判断
190127.35190867.580.28数据可信
供试品溶液-2024112422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%
5min119864-198640.9380.8521.930.940.8521.86
223181-231811.0951.10
318743-187430.8860.89
416510-165100.7800.78
511330-113300.5350.54
618226-182260.8610.86
10min125145-251451.1881.2011.201.191.2111.22
226209-262091.2381.24
326102-261021.2331.24
423283-232831.1001.10
530276-302761.4301.43
622011-220111.0401.04
15min129511-295111.3941.404.941.401.405.16
229410-294101.3891.39
330587-305871.4451.45
428116-281161.3281.33
531765-317651.5011.51
627954-279541.3211.32
20min129600-296001.3981.464.041.411.473.91
231510-315101.4891.50
331800-318001.5021.51
429234-292341.3811.39
531874-318741.5061.51
632033-320331.5131.52
30min132583-325831.5391.552.051.551.562.07
232242-322421.5231.53
332151-321511.5191.53
432244-322441.5231.53
533640-336401.5891.60
633491-334911.5821.59
45min141241-412411.9481.6713.481.961.6813.33
241551-415511.9631.98
331912-319121.5081.52
431014-310141.4651.48
533049-330491.5611.58
633270-332701.5721.59
60min132598-325981.5401.565.561.561.585.43
235030-350301.6551.67
332534-325341.5371.56
430158-301581.4251.44
532744-327441.5471.57
635050-350501.6561.67
极限132943-329431.5561.553.881.581.573.91
232389-323891.5301.55
330713-307131.4511.47
432637-326371.5421.56
532922-329221.5551.58
634666-346661.6381.66
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101278-202003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对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.203887600388577338811733882801388120638837110.08
210.213910954390814039095470.06
单位质量响应值RSD%判断
380755.98382913.520.40数据可信
供试品溶液-2024112521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%
5min124396-243960.5750.5215.840.580.5215.72
222093-220930.5210.52
322083-220830.5210.52
419112-191120.4500.45
526479-264790.6240.62
616943-169430.3990.40
10min137512-375120.8840.807.100.890.807.24
232312-323120.7620.76
332940-329400.7760.78
431735-317350.7480.75
536097-360970.8510.85
632193-321930.7590.76
15min141528-415280.9790.968.930.980.969.16
238695-386950.9120.91
340501-405010.9550.96
437107-371070.8750.88
547191-471911.1121.12
638214-382140.9010.90
20min141995-419950.9900.944.521.000.944.73
240633-406330.9580.96
336766-367660.8670.87
439365-393650.9280.93
539345-393450.9270.93
640860-408600.9630.97
30min141071-410710.9680.934.230.980.944.26
240001-400010.9430.95
336508-365080.8610.87
440143-401430.9460.95
538370-383700.9040.91
640292-402920.9500.96
45min140823-408230.9620.933.250.970.942.93
239287-392870.9260.94
337619-376190.8870.90
438048-380480.8970.91
539223-392230.9250.93
640515-405150.9550.96
60min139589-395890.9330.978.660.950.988.55
240141-401410.9460.96
341056-410560.9680.98
448235-482351.1371.15
538544-385440.9090.92
639400-394000.9290.94
极限139826-398260.9390.922.670.950.932.76
238770-387700.9140.93
337937-379370.8940.91
439020-390200.9200.93
537804-378040.8910.90
640436-404360.9530.97
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101278-202003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对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.203925650392550139275503925218391799139243820.10
210.213890211388998938901000.01
单位质量响应值RSD%判断
384743.33381008.810.69数据可信
供试品溶液-2024112521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%
5min120699-206990.4870.7426.410.490.7426.50
227297-272970.6420.64
344119-441191.0371.04
432079-320790.7540.75
527298-272980.6420.64
637405-374050.8790.88
10min135972-359720.8460.907.540.850.907.51
236188-361880.8510.85
342647-426471.0021.00
441076-410760.9660.97
536229-362290.8520.85
637274-372740.8760.88
15min150527-505271.1881.118.041.191.127.87
243900-439001.0321.04
353597-535971.2601.26
444967-449671.0571.06
545415-454151.0681.07
645942-459421.0801.08
20min148065-480651.1301.047.941.141.057.95
240841-408410.9600.97
348226-482261.1341.14
442616-426161.0021.01
540235-402350.9460.95
645082-450821.0601.07
30min149047-490471.1531.078.311.161.078.44
244334-443341.0421.05
348874-488741.1491.16
438991-389910.9170.92
546631-466311.0961.10
644005-440051.0341.04
45min142786-427861.0061.0912.971.021.1012.72
255849-558491.3131.32
349568-495681.1651.18
442943-429431.0091.02
539108-391080.9190.93
648118-481181.1311.14
60min143591-435911.0251.053.871.041.074.01
242790-427901.0061.02
345575-455751.0711.09
444201-442011.0391.05
544765-447651.0521.06
647738-477381.1221.14
极限140891-408910.9611.055.440.981.075.32
245774-457741.0761.09
345648-456481.0731.09
448139-481391.1321.15
543637-436371.0261.04
644651-446511.0501.07
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