多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数10000
标示量(mg)1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%
1 10.073264732835327063314932675328020.64
210.223281932709327640.24
单位质量响应值RSD%判断
3257.403205.871.13数据可信
供试品溶液-2025072522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%
5min14370-437012.13311.9419.4912.1311.9419.49
23734-373410.36710.37
35636-563615.64815.65
43682-368210.22310.22
53489-34899.6879.69
64902-490213.61013.61
10min19014-901425.02724.279.6225.0524.309.63
28521-852123.65923.68
39912-991227.52127.55
48007-800722.23222.25
57670-767021.29621.31
69333-933325.91325.94
15min112095-1209533.58233.035.5033.6433.105.51
211825-1182532.83232.89
312999-1299936.09236.16
411375-1137531.58331.64
511120-1112030.87530.93
611973-1197333.24333.31
20min114169-1416939.34039.214.3139.4639.324.32
214111-1411139.17939.29
315120-1512041.98142.11
413688-1368838.00538.11
513331-1333137.01437.12
614307-1430739.72439.84
30min116954-1695447.07347.083.1847.2647.273.20
216928-1692847.00147.18
317917-1791749.74749.95
416854-1685446.79546.97
516243-1624345.09945.26
616853-1685346.79346.98
45min119979-1997955.47255.082.9555.7355.342.96
219665-1966554.60054.86
320805-2080557.76558.05
420065-2006555.71155.96
519185-1918553.26753.51
619339-1933953.69553.96
60min121780-2178060.47260.691.7960.8361.041.80
221809-2180960.55360.90
322542-2254262.58862.97
422005-2200561.09761.44
521577-2157759.90960.24
621432-2143259.50659.86
90min124118-2411866.96467.091.6767.4267.541.67
223919-2391966.41166.86
324701-2470168.58369.07
424562-2456268.19768.64
524038-2403866.74267.17
623633-2363365.61766.07
120min125425-2542570.59371.321.7671.1671.881.75
225753-2575371.50372.06
326135-2613572.56473.16
426227-2622772.82073.38
525549-2554970.93771.48
625032-2503269.50270.07
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限126310-2631073.05072.732.1473.7373.412.14
226293-2629373.00373.68
326552-2655273.72274.44
426908-2690874.71075.39
525358-2535870.40771.06
625740-2574071.46772.15
多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数10000
标示量(mg)1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%
1 10.073334933337332843328833018332550.41
210.223411734079340980.08
单位质量响应值RSD%判断
3302.383336.400.73数据可信
供试品溶液-2025072522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%
5min14450-445012.02811.7716.4212.0311.7716.44
23368-33689.1049.10
34520-452012.21812.22
45041-504113.62613.63
53638-36389.8349.83
65103-510313.79313.79
10min19221-922124.92424.197.8824.9424.217.89
27908-790821.37521.39
39181-918124.81624.84
49437-943725.50825.53
58254-825422.31122.33
69691-969126.19526.22
15min112261-1226133.14232.305.8433.2032.365.84
210935-1093529.55729.61
312280-1228033.19333.25
412519-1251933.83933.90
511200-1120030.27430.33
612504-1250433.79833.87
20min114746-1474639.85937.933.4139.9838.043.42
213488-1348836.45836.56
313713-1371337.06637.18
414221-1422138.43938.56
513695-1369537.01837.12
614324-1432438.71838.84
30min117906-1790648.40046.223.1048.5846.403.11
216501-1650144.60244.76
317064-1706446.12446.30
417148-1714846.35146.54
516566-1656644.77844.94
617418-1741847.08147.27
45min120347-2034754.99853.441.7955.2653.691.79
219299-1929952.16552.40
319637-1963753.07953.33
419956-1995653.94154.20
519717-1971753.29553.54
619669-1966953.16553.43
60min122409-2240960.57258.611.8760.9358.961.88
221283-2128357.52857.85
321467-2146758.02558.37
421885-2188559.15559.51
521540-2154058.22358.55
621522-2152258.17458.53
90min124698-2469866.75965.111.6967.2265.551.69
223867-2386764.51364.93
323534-2353463.61364.05
424363-2436365.85366.30
523960-2396064.76465.19
624102-2410265.14865.60
120min126464-2646471.53269.111.9272.1069.661.92
225506-2550668.94369.47
324979-2497967.51868.07
425600-2560069.19769.76
525509-2550968.95169.49
625354-2535468.53269.09
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限126444-2644471.47870.491.2372.1771.151.22
226362-2636271.25771.90
325712-2571269.50070.16
426213-2621370.85471.53
526031-2603170.36271.01
625702-2570269.47370.15
多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数10000
标示量(mg)1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%
1 10.076646266451659686617566065662240.34
210.226602665615658200.45
单位质量响应值RSD%判断
6576.376440.311.48数据可信
供试品溶液-2025072321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%
5min17355-735510.1409.7835.3610.149.7835.35
28787-878712.11512.11
37157-71579.8679.87
42217-22173.0573.06
59094-909412.53812.54
67955-795510.96810.97
10min114426-1442619.88920.3211.6219.9120.3411.64
216199-1619922.33422.35
314472-1447219.95319.97
411632-1163216.03716.04
516156-1615622.27422.30
615567-1556721.46221.48
15min120303-2030327.99227.778.4028.0427.828.42
221767-2176730.01030.07
320140-2014027.76727.82
416957-1695723.37923.41
521344-2134429.42729.49
620348-2034828.05428.11
20min124865-2486534.28232.845.7134.3832.945.74
224660-2466033.99934.11
323589-2358932.52232.62
421204-2120429.23429.30
524492-2449233.76733.87
624109-2410933.23933.34
30min129269-2926940.35339.874.5140.5140.024.53
230721-3072142.35542.52
328826-2882639.74339.89
426696-2669636.80636.93
529283-2928340.37340.54
628708-2870839.58039.74
45min134022-3402246.90646.174.0647.1346.394.08
234099-3409947.01247.25
334124-3412447.04747.26
430718-3071842.35142.53
533980-3398046.84847.08
633980-3398046.84847.07
60min137420-3742051.59150.872.0651.8951.172.08
237499-3749951.70052.01
337303-3730351.43051.72
435458-3545848.88649.14
536856-3685650.81451.12
636862-3686250.82251.12
90min141886-4188657.74857.244.3758.1357.624.38
241445-4144557.14057.54
342082-4208258.01958.40
438470-3847053.03953.37
541147-4114756.73057.12
644082-4408260.77661.16
120min144942-4494261.96260.841.2562.4461.321.27
244008-4400860.67461.17
344365-4436561.16661.64
443262-4326259.64660.07
544215-4421560.95961.45
643987-4398760.64561.13
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限145602-4560262.87262.092.2063.4662.672.22
245497-4549762.72763.32
345929-4592963.32363.90
443151-4315159.49360.01
545107-4510762.18962.78
644937-4493761.95562.54
多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数10000
标示量(mg)1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%
1 10.076558865918656566562566006657590.29
210.226788367717678000.18
单位质量响应值RSD%判断
6530.196634.051.12数据可信
供试品溶液-2025072321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%
5min18720-872011.88712.2017.2111.8912.2017.22
29157-915712.48312.48
36053-60538.2518.25
410153-1015313.84013.84
59337-933712.72812.73
610282-1028214.01614.02
10min116128-1612821.98522.149.5422.0122.169.55
216886-1688623.01923.04
313274-1327418.09518.11
417250-1725023.51523.54
516336-1633622.26922.29
617560-1756023.93823.96
15min121523-2152329.34029.075.5529.4029.125.56
221571-2157129.40529.46
318982-1898225.87625.92
422165-2216530.21530.28
521578-2157829.41529.47
622115-2211530.14730.21
20min124868-2486833.90033.693.9034.0133.803.91
224938-2493833.99534.10
322909-2290931.22931.32
425640-2564034.95235.06
524574-2457433.49933.61
625361-2536134.57234.69
30min129806-2980640.63140.302.6240.7940.462.64
229766-2976640.57740.74
328142-2814238.36338.50
430278-3027841.27541.45
529283-2928339.91840.08
630098-3009841.02941.20
45min134640-3464047.22146.682.0547.4546.912.07
233885-3388546.19246.42
333122-3312245.15145.35
435157-3515747.92648.17
534176-3417646.58846.82
634495-3449547.02347.26
60min137818-3781851.55351.371.8951.8651.681.90
237768-3776851.48551.79
336474-3647449.72150.00
438506-3850652.49152.81
537355-3735550.92251.23
638175-3817552.04052.36
90min141577-4157756.67756.870.8257.0757.260.83
241491-4149156.56056.96
341453-4145356.50856.87
442373-4237357.76258.17
541647-4164756.77357.16
641769-4176956.93957.34
120min145372-4537261.85161.181.2562.3461.671.27
244551-4455160.73161.22
344113-4411360.13460.59
445601-4560162.16362.67
544604-4460460.80461.29
645052-4505261.41461.91
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限146594-4659463.51662.431.3664.1163.021.36
245121-4512161.50862.10
345478-4547861.99562.55
446533-4653363.43364.04
545398-4539861.88662.47
645661-4566162.24462.85
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