多替诺雷片项目信息
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D241101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(%)99.69对照品水分(%)0对照品稀释倍数10000
标示量(mg)1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%
1 10.023196732053320683195431932319950.20
2 9.953212031992320560.29
单位质量响应值RSD%判断
3193.113221.710.64数据可信
加速3月-供试品溶液-2025072421批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110120-1012028.30935.0917.0428.3135.0917.03
214411-1441140.31340.31
314011-1401139.19439.19
49549-954926.71226.71
513874-1387438.81138.81
613293-1329337.18537.19
10min118832-1883252.68056.806.8352.7356.866.84
221222-2122259.36659.43
321717-2171760.75060.82
418340-1834051.30451.35
520605-2060557.64057.70
621106-2110659.04159.10
15min123209-2320964.92467.173.5665.0667.323.57
224515-2451568.57768.74
324865-2486569.55669.72
422795-2279563.76663.90
523937-2393766.96067.12
624745-2474569.22169.38
20min125766-2576672.07773.142.4572.3273.402.46
226356-2635673.72774.01
327129-2712975.89076.17
425314-2531470.81271.05
525839-2583972.28172.55
626471-2647174.04974.32
30min128375-2837579.37578.891.4579.7479.281.45
228044-2804478.44978.85
328767-2876780.47280.88
427794-2779477.75078.10
527748-2774877.62178.01
628481-2848179.67280.07
45min129659-2965982.96782.571.7083.4683.091.70
229054-2905481.27481.81
330317-3031784.80885.35
429248-2924881.81782.30
529036-2903681.22481.75
629791-2979183.33683.87
60min130312-3031284.79483.991.4985.4384.641.49
229564-2956482.70183.37
330677-3067785.81586.50
429787-2978783.32583.95
529595-2959582.78883.45
630203-3020384.48985.16
90min131107-3110787.01785.571.5387.7986.361.51
229979-2997983.86284.67
331069-3106986.91187.74
430458-3045885.20285.96
530176-3017684.41385.21
630739-3073985.98886.80
120min131125-3112587.06885.931.4487.9986.861.44
230099-3009984.19885.14
331295-3129587.54388.52
430469-3046985.23386.13
530556-3055685.47686.41
630757-3075786.03886.99
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132759-3275991.63989.221.6992.7090.301.67
231222-3122287.33988.43
332190-3219090.04791.17
431653-3165388.54589.59
531583-3158388.34989.43
631951-3195189.37890.48
多替诺雷片项目信息
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D241101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(%)99.69对照品水分(%)0对照品稀释倍数10000
标示量(mg)1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%
1 10.023254132543324813255832328324900.30
2 9.953194231744318430.44
单位质量响应值RSD%判断
3242.513200.300.93数据可信
加速3月-供试品溶液-2025072521批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113586-1358637.84136.3812.2437.8436.3812.24
212916-1291635.97535.97
313724-1372438.22538.23
414965-1496541.68241.68
510161-1016128.30128.30
613025-1302536.27836.28
10min122737-2273763.32959.845.0563.3959.905.05
221859-2185960.88360.94
321479-2147959.82559.89
421951-2195161.13961.21
519502-1950254.31854.37
621383-2138359.55759.62
15min126174-2617472.90270.213.2473.0770.373.25
225250-2525070.32870.49
324974-2497469.55969.72
425897-2589772.13072.30
523848-2384866.42366.56
625108-2510869.93370.09
20min127933-2793377.80175.531.9478.0975.811.95
226991-2699175.17775.46
326934-2693475.01875.30
427393-2739376.29776.59
526353-2635373.40073.65
627103-2710375.48975.77
30min129805-2980583.01580.801.5083.4381.211.50
228942-2894280.61181.02
328597-2859779.65080.05
429153-2915381.19981.62
528727-2872780.01280.38
628843-2884380.33580.74
45min130995-3099586.32983.981.5886.8984.521.58
230046-3004683.68684.22
329575-2957582.37482.91
430292-3029284.37184.93
530063-3006383.73484.24
629939-2993983.38883.92
60min131280-3128087.12385.361.2087.8386.041.21
230465-3046584.85385.53
330177-3017784.05184.73
430703-3070385.51686.21
530718-3071885.55886.20
630537-3053785.05485.73
90min131931-3193188.93686.741.3389.7887.561.33
230929-3092986.14686.96
330770-3077085.70386.52
431167-3116786.80887.65
531112-3111286.65587.44
630936-3093686.16586.98
120min132123-3212389.47187.141.4090.4788.111.40
231041-3104186.45887.42
330929-3092986.14687.10
431320-3132087.23588.22
531275-3127587.10988.04
631031-3103186.43087.39
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132811-3281191.38789.830.8892.5390.940.89
232036-3203689.22990.34
332115-3211589.44990.55
432188-3218889.65290.78
532121-3212189.46690.54
632246-3224689.81490.92
多替诺雷片项目信息
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D241101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(%)99.69对照品水分(%)0对照品稀释倍数10000
标示量(mg)1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%
1 10.023273832772323873263832663326400.47
2 9.953262732656326420.07
单位质量响应值RSD%判断
3257.493280.600.50数据可信
加速3月-供试品溶液-2025072522批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114288-1428839.21534.9110.6739.2134.9110.67
213135-1313536.05036.05
311784-1178432.34232.34
412554-1255434.45634.46
510657-1065729.24929.25
613906-1390638.16638.17
10min120828-2082857.16457.304.0357.2357.364.03
221602-2160259.28959.35
321430-2143058.81758.87
421029-2102957.71657.77
519261-1926152.86452.91
621112-2111257.94458.01
15min123996-2399665.85966.973.2166.0267.123.21
225232-2523269.25269.41
325266-2526669.34569.50
424107-2410766.16466.32
523243-2324363.79363.93
624562-2456267.41367.57
20min126164-2616471.81072.412.4672.0872.682.46
226868-2686873.74274.02
327239-2723974.76075.03
426194-2619471.89272.16
525367-2536769.62269.87
626465-2646572.63672.91
30min127726-2772676.09777.621.9676.4978.011.96
228634-2863478.58978.99
329173-2917380.06880.46
427759-2775976.18776.57
528109-2810977.14877.51
628291-2829177.64778.04
45min129338-2933880.52182.492.3181.0483.002.29
230069-3006982.52783.06
331261-3126185.79986.32
429463-2946380.86481.37
530280-3028083.10683.59
629914-2991482.10282.62
60min129877-2987782.00083.822.5782.6584.472.56
230457-3045783.59284.26
331887-3188787.51788.19
429763-2976381.68782.33
530929-3092984.88885.51
630322-3032283.22283.88
90min130383-3038383.38985.182.8984.1885.972.87
230787-3078784.49885.30
332686-3268689.71090.52
430330-3033083.24484.03
531404-3140486.19186.96
630615-3061584.02684.82
120min130408-3040883.45885.332.8984.3886.272.87
230961-3096184.97685.92
332522-3252289.26090.22
430112-3011282.64583.57
531759-3175987.16688.08
630788-3078884.50185.44
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131546-3154686.58187.571.9187.6588.651.90
231623-3162386.79287.88
332998-3299890.56691.68
431507-3150786.47487.53
532256-3225688.53089.59
631511-3151186.48587.56
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