他达拉非片项目信息
介质体积(ml)1000取样体积(ml) 0补液体积(ml) 0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数2500
标示量(mg)5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%
112.152489302486052489312486182486202487410.07
212.172493642490492492060.09
单位质量响应值RSD%判断
20472.5120477.070.02数据可信
供试品溶液-2025091622批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12654-26541.0364.6157.501.044.6157.42
220158-201587.8717.87
313923-139235.4365.44
417198-171986.7156.71
511568-115684.5174.52
65266-52662.0562.06
10min124841-248419.69912.7919.709.7012.7919.70
240404-4040415.77615.78
334738-3473813.56313.56
438446-3844615.01115.01
532536-3253612.70412.70
625630-2563010.00710.01
15min140118-4011815.66417.4210.4115.6617.4210.42
250474-5047419.70819.71
345796-4579617.88117.88
449082-4908219.16419.16
543114-4311416.83416.83
639166-3916615.29215.29
20min148949-4894919.11220.767.8319.1120.767.82
258940-5894023.01323.01
353518-5351820.89620.90
456669-5666922.12622.13
552498-5249820.49820.50
648421-4842118.90618.91
30min161205-6120523.89824.964.8223.9024.964.82
269754-6975427.23627.24
364394-6439425.14325.14
463561-6356124.81724.82
562782-6278224.51324.51
661845-6184524.14724.15
45min172875-7287528.45429.603.3828.4529.603.38
279860-7986031.18131.18
375765-7576529.58329.58
477582-7758230.29230.29
574889-7488929.24029.24
673857-7385728.83828.84
极限185093-8509333.22534.312.3933.2234.312.39
291365-9136535.67435.67
387651-8765134.22334.22
488577-8857734.58534.58
587876-8787634.31134.31
686676-8667633.84333.84
他达拉非片项目信息
介质体积(ml)1000取样体积(ml) 0补液体积(ml) 0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数2500
标示量(mg)5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%
112.152485602488672487132487872490102487870.07
212.172512912506452509680.19
单位质量响应值RSD%判断
20476.3020621.860.51数据可信
供试品溶液-2025091721批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min12555-25550.9945.2451.820.995.2451.87
27951-79513.0933.09
315787-157876.1426.14
419363-193637.5337.53
520767-207678.0798.08
614453-144535.6235.62
10min119448-194487.56612.0022.247.5712.0022.21
226362-2636210.25610.26
331406-3140612.21812.22
437068-3706814.42114.42
536914-3691414.36114.36
633890-3389013.18513.18
15min132646-3264612.70116.5213.4712.7016.5213.48
239594-3959415.40415.40
341943-4194316.31816.32
446335-4633518.02618.03
547707-4770718.56018.56
646481-4648118.08318.08
20min141713-4171316.22819.779.9616.2319.779.96
249341-4934119.19619.20
350287-5028719.56419.56
453553-5355320.83420.83
555057-5505721.42021.42
654974-5497421.38721.39
30min154090-5409021.04324.257.4621.0424.257.46
261541-6154123.94223.94
360972-6097223.72123.72
464924-6492425.25825.26
565902-6590225.63925.64
666581-6658125.90325.90
45min165298-6529825.40428.595.7825.4028.585.79
274291-7429128.90228.90
372921-7292128.36928.37
475707-7570729.45329.45
575628-7562829.42329.42
677032-7703229.96929.97
极限179075-7907530.76433.344.0430.7633.344.04
286492-8649233.64933.65
385775-8577533.37033.37
487244-8724433.94233.94
586407-8640733.61633.62
689203-8920334.70434.70
他达拉非片项目信息
介质体积(ml)1000取样体积(ml) 0补液体积(ml) 0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数2500
标示量(mg)5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%
112.152509572510692515032519242514212513750.16
212.172517712514582516140.09
单位质量响应值RSD%判断
20689.3020674.940.05数据可信
供试品溶液-2025091722批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min15388-53882.0833.1941.242.083.1841.21
24103-41031.5861.59
39946-99463.8443.84
411615-116154.4904.49
56339-63392.4502.45
612060-120604.6624.66
10min127117-2711710.48210.7219.0610.4810.7219.05
218308-183087.0777.08
330153-3015311.65511.66
432420-3242012.53212.53
526163-2616310.11310.11
632218-3221812.45312.45
15min140320-4032015.58515.729.4515.5915.729.45
234362-3436213.28213.28
342403-4240316.39016.39
443887-4388716.96416.96
538460-3846014.86614.87
644626-4462617.25017.25
20min148991-4899118.93719.465.3818.9419.465.38
245691-4569117.66117.66
351292-5129219.82619.83
452285-5228520.21020.21
550509-5050919.52419.52
653237-5323720.57820.58
30min161300-6130023.69523.883.9523.6923.883.95
258523-5852322.62122.62
362954-6295424.33424.33
464061-6406124.76224.76
559418-5941822.96722.97
664371-6437124.88224.88
45min173159-7315928.27928.512.5428.2828.512.54
271837-7183727.76827.77
375158-7515829.05129.05
475301-7530129.10729.11
571432-7143227.61127.61
675670-7567029.24929.25
极限186065-8606533.26733.440.9933.2733.440.98
285842-8584233.18133.18
387973-8797334.00534.00
486437-8643733.41133.41
585723-8572333.13533.14
686971-8697133.61733.62
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