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%
114.941724461723461721941722311721161722670.08
214.991723331721491722410.08
单位质量响应值RSD%判断
11530.5911490.390.25数据可信
供试品溶液-1231323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%
15min115420-154207.9968.184.058.008.184.05
216020-160208.3078.31
315716-157168.1508.15
416120-161208.3598.36
516609-166098.6138.61
614759-147597.6537.65
30min128527-2852714.79315.314.4114.8115.324.41
230517-3051715.82515.84
329226-2922615.15515.17
429941-2994115.52615.54
531236-3123616.19816.21
627709-2770914.36914.38
45min140014-4001420.74921.384.0020.7921.424.00
242551-4255122.06522.11
341168-4116821.34821.39
441681-4168121.61421.65
543191-4319122.39722.44
638723-3872320.08020.12
60min149742-4974225.79426.513.5125.8726.583.51
252510-5251027.22927.31
350819-5081926.35226.43
452071-5207127.00227.08
553140-5314027.55627.63
648442-4844225.12025.19
75min158769-5876930.47531.224.0830.5931.344.07
262766-6276632.54832.67
360013-6001331.12031.24
461237-6123731.75531.88
562241-6224132.27532.40
656185-5618529.13529.25
90min166567-6656734.51935.373.5934.6835.543.60
270792-7079236.71036.89
368169-6816935.34935.52
469183-6918335.87536.05
570230-7023036.41836.60
664277-6427733.33133.49
105min174260-7426038.50839.453.8238.7339.683.82
280546-8054641.76742.01
375431-7543139.11539.34
476559-7655939.70039.93
577571-7757140.22540.46
672084-7208437.37937.60
120min181877-8187742.45842.963.1042.7543.263.11
286045-8604544.61944.93
382318-8231842.68642.98
483616-8361643.35943.66
584616-8461643.87844.18
678635-7863540.77741.05
极限187220-8722045.22846.182.9345.5946.552.94
292729-9272948.08548.47
389280-8928046.29746.66
489389-8938946.35346.73
590523-9052346.94147.32
685209-8520944.18644.53
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%
114.941722901721301721021718131721021720870.11
214.991719651723211721430.15
单位质量响应值RSD%判断
11518.5411483.860.22数据可信
供试品溶液-1231323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%
15min116083-160838.3478.293.708.358.293.73
216526-165268.5778.58
315460-154608.0238.02
415871-158718.2378.24
515185-151857.8817.88
616701-167018.6678.67
30min130385-3038515.76915.978.4515.7815.988.45
231101-3110116.14116.15
329751-2975115.44015.45
429367-2936715.24115.25
528322-2832214.69814.71
635720-3572018.53818.55
45min142654-4265422.13621.773.8022.1821.803.79
243725-4372522.69222.73
341959-4195921.77621.81
440980-4098021.26821.31
539314-3931420.40320.44
643000-4300022.31622.36
60min153010-5301027.51127.063.5427.5927.143.53
254128-5412828.09128.17
352544-5254427.26927.34
450858-5085826.39426.47
549106-4910625.48525.56
653255-5325527.63827.72
75min162179-6217932.26931.763.4232.3931.883.41
263351-6335132.87733.00
361449-6144931.89032.01
459991-5999131.13431.25
557616-5761629.90130.02
662569-6256932.47232.60
90min169959-6995936.30736.042.8836.4836.222.87
271663-7166337.19137.37
369662-6966236.15336.33
468090-6809035.33735.51
566253-6625334.38434.55
671066-7106636.88137.06
105min177728-7772840.33939.852.7840.5840.082.78
278547-7854740.76441.01
377179-7717940.05440.29
475365-7536539.11239.34
573197-7319737.98738.21
678676-7867640.83141.07
120min184749-8474943.98243.582.4544.2943.882.46
285784-8578444.52044.83
384357-8435743.77944.08
482542-8254242.83743.13
580596-8059641.82742.11
685858-8585844.55844.87
极限190753-9075347.09846.782.3047.4847.162.30
292103-9210347.79948.18
390648-9064847.04447.42
488716-8871646.04146.41
586718-8671845.00445.36
691896-9189647.69248.08
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%
114.941714621713631716861719221715861716040.13
214.991716421719361717890.13
单位质量响应值RSD%判断
11486.2111460.240.17数据可信
供试品溶液-1234026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%
15min115262-152627.9408.303.957.948.303.95
216301-163018.4808.48
316121-161218.3878.39
416720-167208.6988.70
515121-151217.8677.87
616242-162428.4508.45
30min127421-2742114.26515.095.3114.2815.105.31
229348-2934815.26815.28
329872-2987215.54115.55
431219-3121916.24116.26
527124-2712414.11114.12
629053-2905315.11415.13
45min137646-3764619.58520.745.4319.6220.785.44
240861-4086121.25721.30
340632-4063221.13821.18
442651-4265122.18922.23
536903-3690319.19819.23
640459-4045921.04821.09
60min146357-4635724.11725.465.4324.1925.535.42
249515-4951525.76025.83
349998-4999826.01126.09
452311-5231127.21427.29
545203-4520323.51623.58
650258-5025826.14626.22
75min154480-5448028.34330.075.7128.4530.195.71
258133-5813330.24330.36
359119-5911930.75630.87
462138-6213832.32732.45
553380-5338027.77027.88
659578-5957830.99531.11
90min162445-6244532.48634.005.5332.6434.165.53
265846-6584634.25634.42
366618-6661834.65734.83
470119-7011936.47936.66
559971-5997131.19931.35
667108-6710834.91235.08
105min169189-6918935.99537.645.0636.2137.865.06
273187-7318738.07538.30
373808-7380838.39838.63
476529-7652939.81340.05
566754-6675434.72834.93
674659-7465938.84039.07
120min175727-7572739.39641.184.9939.6741.474.99
279725-7972541.47641.76
380826-8082642.04942.34
483714-8371443.55143.86
573203-7320338.08338.35
681754-8175442.53242.82
极限182523-8252342.93244.354.6743.2744.704.68
286640-8664045.07345.43
386372-8637244.93445.30
489392-8939246.50546.88
578602-7860240.89241.22
687945-8794545.75246.12
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%
114.941709021714331715861714781709211712640.20
214.991717851721641719740.16
单位质量响应值RSD%判断
11463.4511472.580.06数据可信
供试品溶液-1234026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%
15min116220-162208.4428.255.358.448.255.33
214828-148287.7187.72
315120-151207.8707.87
417163-171638.9338.93
515597-155978.1188.12
616155-161558.4088.41
30min128305-2830514.73215.245.6414.7515.265.63
226989-2698914.04714.06
328346-2834614.75314.77
431129-3112916.20216.22
530816-3081616.03916.05
630141-3014115.68815.70
45min139307-3930720.45820.674.1220.5020.724.12
237240-3724019.38219.42
339025-3902520.31120.35
442125-4212521.92521.97
540192-4019220.91920.96
640450-4045021.05321.09
60min148819-4881925.40925.614.1925.4825.694.20
245784-4578423.82923.90
348846-4884625.42325.49
452101-5210127.11727.20
549748-4974825.89325.97
649965-4996526.00526.08
75min157474-5747429.91430.103.3130.0330.213.31
254618-5461828.42728.54
357419-5741929.88530.00
460426-6042631.45031.57
558335-5833530.36230.48
658667-5866730.53530.65
90min165318-6531833.99633.973.6334.1634.143.63
261047-6104731.77331.93
364795-6479533.72433.89
468155-6815535.47335.65
565975-6597534.33834.51
666348-6634834.53234.70
105min172362-7236237.66337.723.0337.8837.953.04
268456-6845635.63035.84
372160-7216037.55737.78
474817-7481738.94039.18
573355-7335538.17938.41
673720-7372038.36938.60
120min179321-7932141.28441.133.3841.5741.423.38
273991-7399138.51038.78
378587-7858740.90241.19
481305-8130542.31742.62
580008-8000841.64241.93
680969-8096942.14242.43
极限185429-8542944.46444.213.2444.8244.573.23
279627-7962741.44441.78
384816-8481644.14444.50
487364-8736445.47145.84
586159-8615944.84345.20
686282-8628244.90845.27
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