托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号TAAF230001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(%)99.8对照品水分(%)0对照品稀释倍数10000
标示量(mg)15供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.679918799221993609921899278992530.07
216.739955099609995800.05
单位质量响应值RSD%判断
5953.995952.180.03数据可信
供试品溶液-1批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19447-94479.50210.284.119.5010.284.12
210135-1013510.19410.19
310488-1048810.55010.55
410639-1063910.70110.70
510242-1024210.30210.30
610387-1038710.44810.45
10min129921-2992130.09630.123.8730.1530.183.87
231598-3159831.78331.84
330301-3030130.47930.54
430512-3051230.69130.75
528330-2833028.49628.55
628989-2898929.15929.22
15min145716-4571645.98445.772.7346.2046.002.73
247665-4766547.94548.18
345056-4505645.32045.55
445475-4547545.74245.97
545255-4525545.52045.74
643854-4385444.11144.33
20min155141-5514155.46454.471.7355.9454.951.72
253353-5335353.66654.17
354991-5499155.31455.79
454402-5440254.72155.21
554264-5426454.58255.05
652744-5274453.05353.52
30min165428-6542865.81263.673.6766.6064.453.64
264852-6485265.23266.03
359857-5985760.20861.00
463965-6396564.34065.13
564755-6475565.13565.91
660928-6092861.28562.05
45min171879-7187972.30172.202.3673.4573.332.34
271643-7164372.06373.22
371523-7152371.94273.06
473373-7337373.80374.95
573439-7343973.87075.00
668792-6879269.19570.30
60min178217-7821778.67678.353.4980.2379.883.46
280372-8037280.84382.40
377982-7798278.43979.96
478167-7816778.62580.18
579874-7987480.34281.89
672729-7272973.15674.64
90min184685-8468585.18285.062.3087.1787.032.30
286849-8684987.35889.37
384586-8458685.08287.04
484653-8465385.14987.14
585583-8558386.08588.08
681015-8101581.49083.38
120min183578-8357884.06883.821.6186.5386.261.62
284053-8405384.54687.04
381855-8185582.33584.76
484377-8437784.87287.34
584630-8463085.12687.59
681474-8147481.95284.30
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187050-8705087.56186.133.4290.4989.043.37
288275-8827588.79391.76
383665-8366584.15687.04
487468-8746887.98190.92
586687-8668787.19590.14
680603-8060381.07683.87
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号TAAF230001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(%)99.8对照品水分(%)0对照品稀释倍数10000
标示量(mg)15供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.679981199595996089962599499996280.12
216.731002311000611001460.13
单位质量响应值RSD%判断
5976.485986.010.12数据可信
供试品溶液-2批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111619-1161911.63211.394.9511.6311.394.95
210702-1070210.71410.71
311313-1131311.32611.33
410989-1098911.00111.00
511297-1129711.31011.31
612329-1232912.34312.34
10min131689-3168931.72531.662.2331.7931.722.22
230851-3085130.88630.95
331258-3125831.29331.36
432025-3202532.06132.12
532775-3277532.81232.87
631119-3111931.15431.22
15min146499-4649946.55244.742.4646.7944.982.45
243933-4393343.98344.21
344990-4499045.04145.28
443271-4327143.32043.56
544519-4451944.56944.81
644913-4491344.96445.21
20min154938-5493855.00053.032.6455.5053.522.62
252083-5208352.14252.62
350963-5096351.02151.51
452863-5286352.92353.40
553987-5398754.04854.54
652974-5297453.03453.53
30min163419-6341963.49163.592.0164.3064.382.00
263031-6303163.10263.87
363361-6336163.43364.20
462384-6238462.45463.23
566008-6600866.08366.88
662917-6291762.98863.77
45min171433-7143371.51468.667.7272.6769.807.61
269681-6968169.76070.88
357867-5786757.93259.06
470488-7048870.56871.69
571482-7148271.56372.72
670564-7056470.64471.78
60min179000-7900079.08977.381.7080.6478.901.70
276922-7692277.00978.51
376719-7671976.80678.25
477088-7708877.17578.69
578602-7860278.69180.25
675437-7543775.52277.05
90min184838-8483884.93482.801.4486.9384.751.44
283175-8317583.26985.20
382277-8227782.37084.24
481796-8179681.88883.83
582590-8259082.68384.68
681568-8156881.66083.61
120min184127-8412784.22283.162.8886.6985.572.81
283291-8329183.38585.78
384825-8482584.92187.25
483055-8305583.14985.55
584703-8470384.79987.25
678413-7841378.50280.90
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189375-8937589.47686.332.7892.4189.202.72
286157-8615786.25489.11
386709-8670986.80789.61
485655-8565585.75288.61
587386-8738687.48590.41
682127-8212782.22085.06
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