布瑞哌唑口服混悬液项目信息
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430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
111.319691696889964819670596853967690.19
211.369662896566965970.05
单位质量响应值RSD%判断
8556.068503.260.44数据可信
供试品溶液-2810778批-pH4.3
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126439-2643927.75834.0112.5527.7634.0212.54
231011-3101132.55832.56
330783-3078332.31832.32
433873-3387335.56235.56
538622-3862240.54840.55
633662-3366235.34135.34
10min163838-6383867.02265.645.5867.0765.705.57
262044-6204465.13965.19
364885-6488568.12168.18
455699-5569958.47758.54
564501-6450167.71867.79
664175-6417567.37667.43
15min167856-6785671.24076.674.3371.4076.844.33
274423-7442378.13578.30
374413-7441378.12478.29
474599-7459978.32078.48
576316-7631680.12280.30
670566-7056674.08674.26
20min172017-7201775.60981.994.1875.8982.294.17
280310-8031084.31684.61
381276-8127685.33085.63
479023-7902382.96483.25
578316-7831682.22282.54
677634-7763481.50681.80
30min184260-8426088.46387.723.1388.8788.153.11
285344-8534489.60190.03
382728-8272886.85487.29
483948-8394888.13588.56
586230-8623090.53190.98
678832-7883282.76483.19
45min186845-8684591.17790.332.5391.7390.912.52
288508-8850892.92293.51
385707-8570789.98290.57
484737-8473788.96389.54
587848-8784892.23092.83
682599-8259986.71987.29
60min189925-8992594.41091.552.7095.1192.282.66
289190-8919093.63894.38
386483-8648390.79691.53
487946-8794692.33293.05
583436-8343687.59788.35
686220-8622090.52091.23
极限188759-8875993.18693.762.1194.0594.642.10
289359-8935993.81694.71
391642-9164296.21397.10
490372-9037294.87995.75
589662-8966294.13495.04
686046-8604690.33891.20
布瑞哌唑口服混悬液项目信息
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430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
111.319651196402964299667196511965050.11
211.369661396971967920.27
单位质量响应值RSD%判断
8532.718520.420.11数据可信
供试品溶液-2810778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%
5min116416-1641617.24122.2621.8117.2422.2621.81
227011-2701128.36828.37
324417-2441725.64425.64
420498-2049821.52821.53
515360-1536016.13216.13
623489-2348924.66924.67
10min129242-2924230.71135.5411.1130.7435.5711.13
238116-3811640.03140.08
337282-3728239.15539.20
433495-3349535.17835.21
529676-2967631.16731.19
635200-3520036.96937.01
15min136639-3663938.48041.857.8438.5641.957.85
243614-4361445.80545.92
342545-4254544.68344.79
438831-3883140.78240.88
536141-3614137.95738.04
641333-4133343.41043.51
20min142547-4254744.68547.335.6444.8347.505.67
248075-4807550.49150.68
347802-4780250.20450.39
443958-4395846.16746.33
542285-4228544.41044.55
645724-4572448.02248.20
30min151172-5117253.74355.543.7253.9655.793.74
255302-5530258.08158.36
355050-5505057.81658.08
451886-5188654.49354.73
550716-5071653.26453.48
653178-5317855.85056.11
45min159416-5941662.40163.684.7062.7164.024.72
263485-6348566.67567.05
363085-6308566.25566.62
460260-6026063.28863.62
555786-5578658.58958.89
661758-6175864.86165.21
60min167481-6748170.87270.942.3171.2871.382.33
269307-6930772.78973.27
368960-6896072.42572.90
466035-6603569.35369.79
565437-6543768.72569.13
668054-6805471.47471.93
极限171244-7124474.82475.751.5275.3576.321.56
273584-7358477.28177.89
373311-7331176.99577.59
471197-7119774.77475.33
571218-7121874.79775.31
672215-7221575.84476.42
布瑞哌唑口服混悬液项目信息
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430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
111.319655396513966919622996232964440.22
211.369663296314964730.24
单位质量响应值RSD%判断
8527.328492.340.30数据可信
供试品溶液-2810778批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11178-11781.2401.3917.141.241.3917.04
21195-11951.2581.26
31685-16851.7731.77
41374-13741.4461.45
51437-14371.5121.51
61054-10541.1091.11
10min14336-43364.5634.308.154.564.308.12
24029-40294.2404.24
34578-45784.8184.82
43937-39374.1434.15
54019-40194.2294.23
63619-36193.8083.81
15min16228-62286.5546.466.076.566.476.03
25949-59496.2606.27
36218-62186.5436.55
46808-68087.1647.17
55880-58806.1886.20
65778-57786.0806.09
20min17722-77228.1267.645.718.157.665.73
27398-73987.7857.80
37544-75447.9397.96
47310-73107.6927.71
57022-70227.3897.41
66563-65636.9066.92
30min19538-953810.0379.703.1610.079.733.15
29194-91949.6759.71
39540-954010.03910.07
49151-91519.6309.66
58768-87689.2279.26
69118-91189.5959.62
45min111150-1115011.73311.705.8411.7811.755.82
211828-1182812.44712.50
310054-1005410.58010.63
411721-1172112.33412.38
511145-1114511.72811.78
610798-1079811.36311.41
60min113146-1314613.83413.637.5313.9013.707.52
213650-1365014.36414.43
313381-1338114.08114.15
413578-1357814.28814.36
512909-1290913.58413.65
611042-1104211.62011.68
极限114198-1419814.94114.923.0415.0315.003.01
213651-1365114.36514.46
314615-1461515.38015.47
413760-1376014.48014.57
514703-1470315.47215.56
614118-1411814.85714.94
布瑞哌唑口服混悬液项目信息
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430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
111.319617695859960109605596081960360.13
211.369696496808968860.12
单位质量响应值RSD%判断
8491.258528.700.32数据可信
供试品溶液-25040201批-pH4.3
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min183776-8377688.15787.026.0688.1687.026.06
283165-8316587.51587.51
374406-7440678.29778.30
481924-8192486.20986.21
582800-8280087.13087.13
690081-9008194.79294.79
10min182761-8276187.08995.4811.1487.2495.6211.13
287792-8779292.38492.53
376682-7668280.69280.82
494632-9463299.58199.72
599867-99867105.090105.24
6102664-102664108.033108.19
15min194142-9414299.066101.155.0699.36101.455.07
292035-9203596.84897.15
390240-9024094.96095.22
497746-97746102.858103.17
599450-99450104.651104.97
6103123-103123108.516108.85
20min195514-95514100.509103.875.74100.97104.345.75
297356-97356102.448102.91
389864-8986494.56494.99
4101035-101035106.319106.80
5102901-102901108.283108.78
6105581-105581111.103111.62
30min1100368-100368105.617102.526.35106.24103.176.35
290612-9061295.35195.98
389226-8922693.89394.47
497917-97917103.038103.70
5102310-102310107.661108.34
6104130-104130109.576110.28
45min192617-9261797.46198.6411.2598.2699.4611.21
294985-9498599.953100.74
373830-7383077.69178.43
496235-96235101.268102.10
5101689-101689107.007107.86
6103075-103075108.466109.35
60min1100482-100482105.737102.892.28106.70103.872.27
296540-96540101.589102.55
396049-96049101.072101.94
497530-97530102.631103.63
5100559-100559105.818106.85
695500-95500100.495101.56
极限197617-97617102.722101.685.53103.86102.835.54
292481-9248197.31898.44
388603-8860393.23794.27
496863-96863101.929103.10
5101756-101756107.078108.29
6102439-102439107.797109.03
布瑞哌唑口服混悬液项目信息
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430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
111.319659596384962779687296241964740.28
211.369739297648975200.19
单位质量响应值RSD%判断
8529.978584.510.46数据可信
供试品溶液-25040202批-pH4.3
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min162099-6209964.98665.898.9764.9965.898.97
268775-6877571.97371.97
367548-6754870.68970.69
455163-5516357.72857.73
566652-6665269.75169.75
657551-5755160.22760.23
10min180941-8094184.70487.032.0484.8187.142.04
283923-8392387.82587.94
384894-8489488.84188.96
485045-8504588.99989.10
581972-8197285.78385.90
682229-8222986.05286.15
15min183603-8360387.49091.664.0787.7491.914.06
283182-8318287.04987.32
388642-8864292.76393.03
488729-8872992.85493.10
588847-8884792.97893.24
692509-9250996.81097.05
20min188401-8840192.51194.711.4992.9195.121.49
291110-9111095.34695.76
390271-9027194.46894.89
491754-9175496.02096.42
591878-9187896.15096.56
689615-8961593.78194.19
30min189493-8949393.65496.311.9994.2096.881.98
294019-9401998.39098.96
392592-9259296.89797.47
491485-9148595.73896.30
590637-9063794.85195.43
693973-9397398.34298.90
45min183844-8384487.74294.195.2588.4594.925.22
294054-9405498.42799.16
384895-8489588.84289.58
493803-9380398.16498.88
589387-8938793.54394.28
694049-9404998.42299.15
60min171557-7155774.88490.489.8375.7491.369.75
291913-9191396.18697.08
380926-8092684.68885.58
490034-9003494.22095.10
592669-9266996.97797.87
691649-9164995.91096.80
极限179530-7953083.22889.524.6684.2090.564.63
288775-8877592.90293.96
388481-8848192.59593.62
482692-8269286.53787.58
584425-8442588.35089.40
689372-8937293.52794.58
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