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%
19.943127331753312473167831492314890.73
210.003138131248313140.31
单位质量响应值RSD%判断
3167.913131.400.82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%
5min115392-1539243.84742.608.2043.8542.608.20
217252-1725249.14649.15
314132-1413240.25840.26
414413-1441341.05841.06
514502-1450241.31241.31
614024-1402439.95039.95
10min121927-2192762.46362.744.5862.5462.814.59
223900-2390068.08468.17
321354-2135460.83160.90
421218-2121860.44460.51
521420-2142061.01961.09
622326-2232663.60063.67
15min125466-2546672.54571.152.4272.7271.332.42
225916-2591673.82774.02
324552-2455269.94170.11
424487-2448769.75669.93
524452-2445269.65669.83
624993-2499371.19771.37
20min126546-2654675.62175.551.6175.9275.841.62
227186-2718677.44577.76
326509-2650975.51675.80
426056-2605674.22674.51
526076-2607674.28374.57
626753-2675376.21176.50
30min128435-2843581.00380.630.7881.4381.050.78
228331-2833180.70681.15
328161-2816180.22280.63
427982-2798279.71280.12
528297-2829780.61081.02
628616-2861681.51881.94
45min129142-2914283.01783.691.0783.5884.251.06
229188-2918883.14883.73
329521-2952184.09684.64
428991-2899182.58783.13
529692-2969284.58385.13
629739-2973984.71785.27
60min129835-2983584.99184.860.7285.6985.550.70
229551-2955184.18284.90
330124-3012485.81486.50
429675-2967584.53585.21
529914-2991485.21685.90
629629-2962984.40485.10
90min130042-3004285.58086.321.1986.4287.161.18
229989-2998985.43086.29
330764-3076487.63788.47
430195-3019586.01686.84
530065-3006585.64686.47
630751-3075187.60088.44
120min130759-3075987.62387.241.2088.6088.221.19
230516-3051686.93187.93
330856-3085687.89988.87
429989-2998985.43086.39
531052-3105288.45889.43
630572-3057287.09088.07
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130897-3089788.01687.540.7789.1488.660.76
230707-3070787.47588.62
330725-3072587.52688.65
431072-3107288.51589.62
530403-3040386.60987.73
630566-3056687.07388.20
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%
19.943153031583314923155031900316110.53
210.003165631703316800.11
单位质量响应值RSD%判断
3180.183168.000.28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%
5min18325-832523.53228.9516.4623.5328.9516.47
210714-1071430.28530.29
39585-958527.09427.09
48580-858024.25324.25
512243-1224334.60734.61
612003-1200333.92933.93
10min117828-1782850.39454.9411.0350.4354.9911.03
221495-2149560.75960.81
318094-1809451.14651.19
416919-1691947.82547.86
520105-2010556.83056.89
622181-2218162.69962.76
15min122990-2299064.98566.474.8665.1166.614.87
224516-2451669.29969.45
322985-2298564.97165.10
421845-2184561.74961.87
523806-2380667.29267.44
624957-2495770.54570.71
20min125957-2595773.37273.443.6873.6073.703.70
226283-2628374.29474.56
325559-2555972.24772.49
424511-2451169.28569.51
526155-2615573.93274.20
627431-2743177.53977.82
30min127960-2796079.03479.212.3279.3979.582.33
228489-2848980.52980.92
328462-2846280.45380.81
426889-2688976.00776.35
527742-2774278.41878.81
628589-2858980.81281.22
45min129911-2991184.54983.291.0685.0383.791.07
229557-2955783.54884.07
329163-2916382.43482.93
429054-2905482.12682.59
529572-2957283.59184.11
629527-2952783.46384.01
60min130370-3037085.84685.141.5486.4785.781.56
230341-3034185.76486.43
329780-2978084.17884.81
429397-2939783.09683.70
530137-3013785.18885.85
630688-3068886.74587.43
90min131111-3111187.94186.901.5588.7187.691.53
230673-3067386.70387.51
329955-2995584.67385.44
430907-3090787.36488.10
531285-3128588.43389.23
630531-3053186.30187.13
120min131498-3149889.03587.591.6789.9588.521.66
230365-3036585.83286.78
330695-3069586.76587.68
430599-3059986.49487.38
531131-3113187.99788.94
631636-3163689.42590.39
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131528-3152889.12088.362.4090.1889.442.39
230359-3035985.81586.91
331512-3151289.07490.13
430570-3057086.41287.44
531162-3116288.08589.18
632433-3243391.67892.80
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%
19.943131931595316933154631777315860.56
210.003145831420314390.09
单位质量响应值RSD%判断
3177.673143.900.76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%
5min112822-1282236.39733.178.4336.4033.178.43
211974-1197433.99033.99
312177-1217734.56634.57
411602-1160232.93432.93
59891-989128.07728.08
611641-1164133.04533.04
10min119966-1996656.67653.684.7756.7453.744.78
219198-1919854.49654.55
319325-1932554.85754.91
418782-1878253.31653.37
517274-1727449.03549.08
618918-1891853.70253.76
15min123425-2342566.49564.413.6366.6564.553.63
223265-2326566.04166.19
322400-2240063.58663.73
422420-2242063.64363.79
521299-2129960.46060.59
623331-2333166.22966.37
20min124763-2476370.29371.172.0170.5671.422.02
225751-2575173.09873.36
325283-2528371.77072.02
425249-2524971.67371.92
524277-2427768.91469.14
625107-2510771.27071.52
30min127305-2730577.50977.381.8277.8977.751.82
226806-2680676.09376.47
327869-2786979.11079.48
427509-2750978.08878.46
526546-2654675.35575.70
627527-2752778.14078.51
45min129062-2906282.49782.630.7683.0183.130.76
229058-2905882.48582.99
329402-2940283.46283.97
429316-2931683.21883.72
529024-2902482.38982.86
628789-2878981.72282.23
60min129743-2974384.43085.151.0685.0885.791.06
230059-3005985.32785.97
330193-3019385.70786.35
430379-3037986.23586.87
529510-2951083.76984.38
630104-3010485.45586.09
90min130962-3096287.89087.941.5888.6888.721.58
230995-3099587.98488.77
331130-3113088.36789.16
431689-3168989.95490.74
530170-3017085.64286.39
630930-3093087.79988.58
120min131486-3148689.37888.651.0090.3189.581.00
231154-3115488.43589.37
331375-3137589.06390.00
431570-3157089.61690.55
530736-3073687.24988.14
631064-3106488.18089.11
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131426-3142689.20788.651.6290.2989.731.62
231082-3108288.23189.31
331237-3123788.67189.76
431864-3186490.45191.53
530351-3035186.15687.19
631425-3142589.20590.28
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