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5000
标示量(mg)2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%
19.993242932478322613205132318323070.52
210.063211932345322320.50
单位质量响应值RSD%判断
3233.933203.980.66数据可信
影响因素30天-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%
5min114030-1403039.10639.074.8339.1139.074.83
214705-1470540.98840.99
313252-1325236.93836.94
414778-1477841.19141.19
514119-1411939.35439.35
613216-1321636.83736.84
10min121095-2109558.79959.242.7158.8659.312.71
221689-2168960.45460.52
320730-2073057.78157.84
422037-2203761.42461.49
521442-2144259.76659.83
620534-2053457.23557.30
15min124145-2414567.30069.421.9367.4669.581.93
225251-2525170.38370.55
325110-2511069.99070.15
425342-2534270.63770.81
525095-2509569.94870.11
624484-2448468.24568.40
20min126406-2640673.60275.021.5473.8875.301.54
226991-2699175.23375.52
327183-2718375.76876.04
427119-2711975.59075.88
527386-2738676.33476.62
626410-2641073.61373.88
30min127819-2781977.54180.362.3177.9480.762.30
228849-2884980.41280.82
329648-2964882.63983.04
428642-2864279.83580.25
529469-2946982.14082.55
628555-2855579.59279.99
45min128856-2885680.43183.922.6380.9684.462.61
229727-2972782.85983.40
330971-3097186.32686.86
429903-2990383.35083.90
530861-3086186.02086.57
630328-3032884.53485.06
60min129988-2998883.58685.141.4284.2585.821.42
230414-3041484.77485.46
331157-3115786.84587.53
430343-3034384.57685.26
530966-3096686.31387.00
630409-3040984.76085.43
90min129976-2997683.55386.652.2584.3587.472.24
231388-3138887.48988.31
331224-3122487.03287.86
430841-3084185.96486.79
532096-3209689.46290.30
630990-3099086.37987.19
120min129755-2975582.93786.672.7083.8887.642.68
231120-3112086.74287.71
331746-3174688.48789.46
430634-3063485.38786.36
532129-3212989.55490.54
631183-3118386.91787.87
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131151-3115186.82888.421.2587.9189.541.25
232034-3203489.28990.40
332088-3208889.44090.56
431462-3146287.69588.81
532069-3206989.38790.52
631539-3153987.91089.01
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5000
标示量(mg)2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%
19.993266232730330323310232970328990.59
210.063278532976328800.42
单位质量响应值RSD%判断
3293.193268.390.54数据可信
影响因素30天-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%
5min115038-1503841.12640.338.0641.1340.338.06
215879-1587943.42643.43
315289-1528941.81241.81
414916-1491640.79240.79
512436-1243634.01034.01
614915-1491540.78940.79
10min122706-2270662.09659.814.4362.1659.884.43
222652-2265261.94862.02
322321-2232161.04361.11
421619-2161959.12359.19
520109-2010954.99455.05
621811-2181159.64859.72
15min125594-2559469.99468.712.5570.1768.882.55
225851-2585170.69770.87
325319-2531969.24269.41
424743-2474367.66767.83
524074-2407465.83765.99
625175-2517568.84869.02
20min127585-2758575.43973.762.7775.7374.042.77
227417-2741774.97975.27
327499-2749975.20475.49
426219-2621971.70371.98
525844-2584470.67870.94
627266-2726674.56674.85
30min129149-2914979.71677.812.4380.1378.212.43
228836-2883678.86079.28
328770-2877078.67979.09
427682-2768275.70476.10
527484-2748475.16375.54
628788-2878878.72979.14
45min130280-3028082.80981.212.4683.3681.752.47
230009-3000982.06882.62
330269-3026982.77983.32
428799-2879978.75979.28
528730-2873078.57079.07
630090-3009082.28982.83
60min131092-3109285.03081.872.5985.7182.542.59
230141-3014182.42983.12
330245-3024582.71383.39
429068-2906879.49480.15
529065-2906579.48680.12
630010-3001082.07182.75
90min130732-3073284.04582.702.1784.8783.502.17
230558-3055883.56984.39
330712-3071283.99084.81
429397-2939780.39481.18
529400-2940080.40281.17
630632-3063283.77284.58
120min131381-3138185.82083.432.2186.7984.382.21
230849-3084984.36585.33
330877-3087784.44285.40
429559-2955980.83781.76
529923-2992381.83382.73
630460-3046083.30184.25
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131053-3105384.92385.000.7586.0386.080.76
230845-3084584.35485.46
331331-3133185.68386.78
430974-3097484.70785.76
530885-3088584.46485.50
631398-3139885.86686.96
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5000
标示量(mg)2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%
19.993150131914319923165031686317490.64
210.063188431859318720.06
单位质量响应值RSD%判断
3178.083168.190.23数据可信
影响因素30天-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%
5min19346-934626.42635.2915.1126.4335.3015.10
213814-1381439.05939.06
311119-1111931.43931.44
413139-1313937.15137.15
514339-1433940.54440.54
613138-1313837.14837.15
10min120197-2019757.10860.565.4957.1560.625.50
221860-2186061.81061.87
319899-1989956.26556.32
423050-2305065.17465.24
521867-2186761.83061.90
621627-2162761.15161.21
15min124027-2402767.93770.553.4168.0870.723.42
225100-2510070.97171.14
323898-2389867.57267.72
425975-2597573.44573.62
525711-2571172.69972.87
625005-2500570.70270.87
20min126699-2669975.49276.311.6875.7476.581.70
227238-2723877.01677.30
326310-2631074.39274.65
427596-2759678.02878.32
527190-2719076.88077.17
626888-2688876.02776.31
30min129309-2930982.87282.720.7983.2583.120.80
229229-2922982.64683.06
328896-2889681.70482.09
429460-2946083.29983.72
529517-2951783.46083.88
629118-2911882.33282.74
45min130821-3082187.14786.181.3587.6686.721.34
231125-3112588.00788.56
330038-3003884.93385.45
430222-3022285.45486.02
530288-3028885.64086.20
630386-3038685.91786.46
60min131188-3118888.18587.521.3488.8588.201.34
231460-3146088.95489.65
330531-3053186.32786.99
431121-3112187.99588.70
531034-3103487.74988.45
630382-3038285.90686.59
90min131924-3192490.26688.991.3091.0789.821.29
232039-3203990.59191.44
331073-3107387.86088.66
431334-3133488.59889.45
531290-3129088.47389.32
631171-3117188.13788.97
120min132367-3236791.51988.922.1292.4889.902.10
231988-3198890.44791.45
330883-3088387.32388.27
431190-3119088.19189.19
531620-3162089.40690.40
630635-3063586.62187.60
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132961-3296193.19890.641.6894.3191.771.66
232352-3235291.47692.63
331520-3152089.12490.22
431963-3196390.37691.52
531951-3195190.34291.49
631585-3158589.30790.43
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