乌帕替尼缓释片项目信息
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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
114.941746551743331741421737011737111741080.24
214.991732241731861732050.02
单位质量响应值RSD%判断
11653.8211554.700.61数据可信
供试品溶液-2025081221批-0.5yc
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min114875-148757.6517.563.957.657.563.95
214000-140007.2017.20
314536-145367.4777.48
414151-141517.2797.28
515538-155387.9927.99
615058-150587.7457.75
30min129375-2937515.11014.843.1215.1214.853.14
227841-2784114.32114.33
328238-2823814.52514.54
428506-2850614.66314.67
530354-3035415.61315.63
628793-2879314.81014.82
45min140725-4072520.94821.003.4120.9921.043.42
239987-3998720.56820.60
339823-3982320.48420.52
440291-4029120.72520.76
543580-4358022.41622.46
640540-4054020.85320.89
60min150920-5092026.19226.283.2226.2626.353.22
250753-5075326.10626.18
349748-4974825.58925.66
450950-5095026.20726.28
554273-5427327.91727.99
649909-4990925.67225.74
75min159730-5973030.72331.093.2430.8431.213.24
261528-6152831.64831.76
359070-5907030.38430.50
460026-6002630.87630.99
563831-6383132.83332.96
658470-5847030.07530.19
90min167654-6765434.79935.023.2334.9735.193.23
267361-6736134.64934.82
366535-6653534.22434.39
467671-6767134.80834.97
572467-7246737.27537.45
666792-6679234.35634.52
105min175212-7521238.68738.872.6838.9139.092.68
275395-7539538.78139.01
374195-7419538.16438.38
474950-7495038.55238.78
579536-7953640.91141.15
674084-7408438.10738.33
120min181725-8172542.03742.382.2042.3342.682.21
282032-8203242.19542.48
381263-8126341.79942.08
482359-8235942.36342.65
585964-8596444.21744.53
681059-8105941.69441.98
极限187287-8728744.89845.302.2145.2645.662.21
288939-8893945.74846.11
386325-8632544.40344.76
487683-8768345.10245.46
591549-9154947.09047.47
686585-8658544.53744.89
乌帕替尼缓释片项目信息
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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
114.941737341736011739901738101736701737610.09
214.991738761740931739840.09
单位质量响应值RSD%判断
11630.5911606.670.15数据可信
供试品溶液-2025081221批-0.5yc
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min114240-142407.3157.524.987.327.524.97
214351-143517.3727.37
313961-139617.1727.17
415926-159268.1828.18
515053-150537.7337.73
614290-142907.3417.34
30min127481-2748114.11814.834.2414.1314.854.24
228222-2822214.49814.51
328583-2858314.68414.70
430786-3078615.81615.83
529891-2989115.35615.37
628296-2829614.53614.55
45min138816-3881619.94120.934.1219.9820.964.12
239432-3943220.25720.29
340125-4012520.61320.65
443039-4303922.11022.15
542450-4245021.80821.85
640542-4054220.82820.86
60min148311-4831124.81926.103.8824.8926.183.88
249426-4942625.39125.46
349694-4969425.52925.60
453201-5320127.33127.41
552763-5276327.10627.18
651493-5149326.45326.52
75min157125-5712529.34730.703.7129.4630.823.71
257751-5775129.66829.78
358780-5878030.19730.31
461410-6141031.54831.67
562737-6273732.23032.35
660782-6078231.22531.34
90min165090-6509033.43934.803.5933.6034.973.59
265894-6589433.85234.01
366876-6687634.35634.52
469677-6967735.79535.97
571539-7153936.75236.93
667387-6738734.61934.79
105min172219-7221937.10138.613.5637.3238.833.55
273267-7326737.63937.86
373673-7367337.84838.07
477564-7756439.84740.08
579086-7908640.62940.86
675084-7508438.57338.80
120min179056-7905640.61342.113.7540.8942.403.75
279562-7956240.87341.15
380280-8028041.24241.53
484549-8454943.43543.74
586782-8678244.58244.88
681603-8160341.92242.21
极限184810-8481043.56945.303.5943.9145.663.59
286366-8636644.36944.72
385733-8573344.04344.40
490311-9031146.39546.77
593126-9312647.84148.22
688789-8878945.61345.97
乌帕替尼缓释片项目信息
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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
114.941743291744081745121747801740701744200.15
214.991740881741691741280.04
单位质量响应值RSD%判断
11674.7011616.280.36数据可信
供试品溶液-2025081321批-0.5yc
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min114473-144737.4187.8511.277.427.8511.27
214342-143427.3517.35
318768-187689.6199.62
414819-148197.5957.60
515229-152297.8067.81
614280-142807.3197.32
30min128013-2801314.35815.113.0214.3715.133.02
228903-2890314.81414.83
330420-3042015.59215.61
429715-2971515.23015.24
530171-3017115.46415.48
629691-2969115.21815.23
45min139887-3988720.44421.042.1120.4821.082.12
241336-4133621.18721.22
341366-4136621.20221.24
440716-4071620.86920.91
542429-4242921.74721.79
640614-4061420.81720.85
60min149824-4982425.53726.362.3525.6126.432.35
252412-5241226.86426.94
351664-5166426.48026.56
451007-5100726.14326.22
553077-5307727.20427.28
650541-5054125.90525.98
75min158718-5871830.09631.132.3830.2131.252.38
261659-6165931.60331.72
361112-6111231.32331.44
460512-6051231.01531.13
562778-6277832.17732.30
659684-5968430.59130.71
90min166953-6695334.31635.342.0934.4835.502.09
269998-6999835.87736.05
368651-6865135.18735.36
469419-6941935.58035.75
570844-7084436.31136.48
667791-6779134.74634.91
105min173766-7376637.80839.132.1538.0339.362.15
277288-7728839.61439.84
376699-7669939.31239.54
477891-7789139.92340.15
577496-7749639.72039.95
674921-7492138.40038.62
120min180931-8093141.48142.821.8241.7643.121.82
284712-8471243.41943.71
383514-8351442.80543.10
484544-8454443.33343.63
584844-8484443.48643.79
682761-8276142.41942.71
极限186661-8666144.41845.661.5544.7746.021.55
289432-8943245.83846.21
389144-8914445.69046.06
490374-9037446.32146.69
590315-9031546.29146.66
688554-8855445.38845.75
乌帕替尼缓释片项目信息
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D5124-1-24101对照品来源自制对照品使用方法直接使用
对照品含量(%)99.48对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
114.941738011739501741291742461735081739270.17
214.991743621739341741480.18
单位质量响应值RSD%判断
11641.7011617.610.15数据可信
供试品溶液-2025081321批-0.5yc
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
15min114105-141057.2397.8811.507.247.8811.49
218907-189079.7049.70
314807-148077.6007.60
414563-145637.4747.47
514748-147487.5697.57
615026-150267.7127.71
30min127715-2771514.22414.914.2314.2414.924.23
231006-3100615.91415.93
329448-2944815.11415.13
429282-2928215.02915.04
529126-2912614.94914.96
627745-2774514.24014.25
45min140044-4004420.55221.213.1720.5921.253.17
243744-4374422.45122.49
341478-4147821.28821.33
441209-4120921.15021.19
541111-4111121.10021.14
640346-4034620.70720.74
60min149028-4902825.16326.303.8325.2326.373.85
254139-5413927.78627.87
352028-5202826.70326.78
451069-5106926.21126.28
552098-5209826.73926.81
649107-4910725.20425.27
75min157743-5774329.63631.023.4729.7531.143.46
262688-6268832.17432.30
362655-6265532.15732.27
460192-6019230.89331.01
561040-6104031.32831.45
658379-5837929.96230.08
90min165912-6591233.82935.133.2933.9935.303.29
271305-7130536.59736.78
370034-7003435.94436.12
468430-6843035.12135.29
569293-6929335.56435.73
665728-6572833.73433.90
105min173837-7383737.89639.122.8138.1139.352.82
278781-7878140.43440.67
377929-7792939.99640.23
475975-7597538.99339.22
577194-7719439.61939.85
673623-7362337.78638.01
120min181173-8117341.66142.742.6141.9443.032.62
285860-8586044.06744.38
385095-8509543.67443.97
483055-8305542.62742.92
584042-8404243.13443.43
680376-8037641.25241.53
极限186355-8635544.32145.322.4144.6745.682.42
290793-9079346.59946.98
389919-8991946.15046.52
487925-8792545.12745.49
589448-8944845.90846.27
685385-8538543.82344.17
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