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%
110.093273832505328033256333059327340.67
210.123297832957329680.05
单位质量响应值RSD%判断
3244.203257.710.30数据可信
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%
5min116269-1626944.90042.7416.8044.9042.7416.80
217351-1735147.88647.89
312427-1242734.29734.30
418359-1835950.66850.67
516383-1638345.21545.21
612123-1212333.45833.46
10min123759-2375965.57164.397.9265.6564.467.93
224331-2433167.15067.23
321962-2196260.61260.67
425348-2534869.95770.04
524256-2425666.94367.02
620321-2032156.08356.14
15min126610-2661073.44073.505.2473.6273.685.25
226599-2659973.40973.60
326352-2635272.72772.89
428412-2841278.41378.61
527555-2755576.04876.23
624263-2426366.96267.11
20min128316-2831678.14878.483.7478.4578.783.76
228414-2841478.41878.73
328272-2827278.02678.31
429928-2992882.59782.93
528996-2899680.02580.34
626684-2668473.64473.90
30min130453-3045384.04683.452.8284.4883.882.84
230091-3009183.04783.49
330210-3021083.37583.78
430928-3092885.35785.83
531058-3105885.71586.16
628684-2868479.16379.55
45min131869-3186987.95486.942.0488.5387.512.06
231244-3124486.22986.81
331367-3136786.56887.12
432030-3203088.39889.01
532092-3209288.56989.16
630402-3040283.90584.42
60min132036-3203688.41487.762.3389.1488.472.34
231020-3102085.61086.34
332235-3223588.96489.66
432518-3251889.74590.50
532253-3225389.01389.75
630722-3072284.78885.44
90min132563-3256389.86989.221.8490.7490.081.86
232007-3200788.33489.20
332158-3215888.75189.59
432696-3269690.23691.14
533112-3311291.38492.27
631423-3142386.72387.52
120min132889-3288990.76990.461.7491.7991.471.76
232890-3289090.77191.79
332441-3244189.53290.52
433364-3336492.08093.14
533251-3325191.76892.81
631828-3182887.84088.78
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133179-3317991.56991.241.1792.7492.401.20
233103-3310391.35992.53
332891-3289190.77491.91
433436-3343692.27893.49
533374-3337492.10793.30
632383-3238389.37290.46
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%
110.093319233500334903344333092333430.57
210.123380133980338900.38
单位质量响应值RSD%判断
3304.563348.810.95数据可信
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%
5min115803-1580342.62338.8315.8642.6238.8315.86
214978-1497840.39840.40
39833-983326.52126.52
415616-1561642.11842.12
514567-1456739.28939.29
615577-1557742.01342.01
10min123128-2312862.37958.669.3962.4558.729.40
221938-2193859.17059.24
317709-1770947.76347.81
422663-2266361.12561.20
522002-2200259.34259.41
623049-2304962.16662.24
15min126270-2627070.85468.165.6171.0368.325.62
225731-2573169.40069.57
322507-2250760.70460.83
425552-2555268.91769.09
525247-2524768.09468.26
626312-2631270.96771.14
20min127805-2780574.99473.483.6775.2973.753.69
227409-2740973.92674.21
325331-2533168.32168.55
427411-2741173.93174.22
527272-2727273.55673.83
628224-2822476.12476.42
30min130189-3018981.42479.262.8581.8479.662.87
229402-2940279.30179.71
327769-2776974.89775.24
429684-2968480.06280.47
529557-2955779.71980.12
629710-2971080.13280.55
45min131262-3126284.31882.512.4484.8783.042.47
230543-3054382.37882.92
329157-2915778.64079.10
430689-3068982.77283.32
530879-3087983.28583.82
631013-3101383.64684.20
60min132040-3204086.41683.542.6687.1184.212.68
231209-3120984.17584.85
329623-2962379.89780.49
430600-3060082.53283.21
531457-3145784.84485.52
630921-3092183.39884.09
90min132808-3280888.48785.272.5589.3386.082.57
231622-3162285.28986.10
330383-3038381.94782.67
431496-3149684.94985.77
532058-3205886.46587.28
631323-3132384.48285.31
120min132791-3279188.44185.612.1689.4386.562.18
231631-3163185.31386.27
330690-3069082.77583.64
431633-3163385.31886.28
532052-3205286.44887.41
631650-3165085.36486.34
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133143-3314389.39187.181.2890.5288.271.29
232164-3216486.75087.85
332090-3209086.55187.55
432077-3207786.51687.62
532344-3234487.23688.34
632122-3212286.63787.75
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%
110.093439034225344003408334095342390.45
210.123449034523345060.07
单位质量响应值RSD%判断
3393.363409.680.34数据可信
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%
5min114206-1420637.47138.657.8337.4738.657.83
214582-1458238.46338.46
315141-1514139.93739.94
416138-1613842.56742.57
512728-1272833.57233.57
615120-1512039.88239.88
10min121331-2133156.26557.073.7656.3357.143.77
221820-2182057.55457.62
321850-2185057.63357.70
422674-2267459.80759.88
520229-2022953.35853.41
621916-2191657.80857.87
15min125275-2527566.66866.442.3766.8266.602.37
225336-2533666.82866.99
325328-2532866.80766.97
425642-2564267.63667.81
524012-2401263.33663.48
625547-2554767.38567.55
20min127539-2753972.63971.831.9172.9172.101.91
227722-2772273.12273.39
327150-2715071.61371.89
427164-2716471.65071.93
526281-2628169.32169.57
627536-2753672.63172.91
30min129543-2954377.92577.460.9578.3177.840.95
229660-2966078.23478.63
329219-2921977.07177.46
429173-2917376.94977.35
528983-2898376.44876.81
629612-2961278.10778.50
45min130485-3048580.41080.161.6580.9380.681.65
230765-3076581.14881.67
330383-3038380.14180.66
430188-3018879.62780.16
529543-2954377.92578.42
630972-3097281.69482.22
60min131443-3144382.93781.761.7983.5982.411.79
231128-3112882.10682.76
331097-3109782.02482.68
430571-3057180.63781.30
530132-3013279.47980.10
631606-3160683.36784.03
90min131909-3190984.16682.742.3184.9683.532.30
231484-3148483.04583.84
331333-3133382.64783.44
430660-3066080.87281.67
530460-3046080.34481.10
632363-3236385.36386.16
120min132373-3237385.39083.392.4186.3284.322.40
231878-3187884.08485.02
331992-3199284.38585.31
430804-3080481.25182.18
530528-3052880.52381.41
632120-3212084.72385.67
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132207-3220784.95284.011.4386.0385.081.44
231958-3195884.29585.37
332032-3203284.49085.56
431389-3138982.79483.86
531194-3119482.28083.30
632320-3232085.25086.33
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