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%
110.193349933515331093351633408334090.53
210.203394433471337081.00
单位质量响应值RSD%判断
3278.613304.710.57数据可信
供试品溶液-H147S批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13223-32238.7859.886.328.799.886.29
23624-36249.8789.88
33666-36669.9939.99
43934-393410.72310.72
53615-36159.8549.85
63676-367610.02010.02
10min16963-696318.97919.842.6218.9919.862.64
27149-714919.48619.50
37373-737320.09720.11
47480-748020.38920.41
57318-731819.94719.96
67398-739820.16520.18
15min19854-985426.86027.593.9126.9127.643.90
29674-967426.36926.42
39883-988326.93926.99
410710-1071029.19329.24
510172-1017227.72627.78
610446-1044628.47328.52
20min111646-1164631.74433.543.3631.8433.643.35
212107-1210733.00133.09
312508-1250834.09434.19
412312-1231233.55933.66
512882-1288235.11335.21
612370-1237033.71833.82
30min115279-1527941.64741.980.7641.7942.130.76
215383-1538341.93042.08
315623-1562342.58442.74
415389-1538941.94742.10
515382-1538241.92842.08
615352-1535241.84642.00
45min118638-1863850.80351.381.4651.0251.601.46
218638-1863850.80351.02
319184-1918452.29152.51
418753-1875351.11651.34
518668-1866850.88451.11
619215-1921552.37552.60
60min120887-2088756.93356.860.6257.2357.170.62
220654-2065456.29856.60
320856-2085656.84857.16
420907-2090756.98757.30
520813-2081356.73157.04
621045-2104557.36357.67
90min123639-2363964.43465.090.9364.8365.490.93
223841-2384164.98565.38
324206-2420665.98066.38
423716-2371664.64465.05
523786-2378664.83565.24
624089-2408965.66166.07
120min125952-2595270.73970.291.0271.2470.801.01
225307-2530768.98169.49
325824-2582470.39070.90
425893-2589370.57871.09
525702-2570270.05770.57
626040-2604070.97971.49
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127226-2722674.21173.030.9874.8373.660.97
226419-2641972.01272.63
326782-2678273.00173.63
426699-2669972.77573.41
526769-2676972.96673.59
626868-2686873.23673.87
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%
110.193320933480332703310532968332060.58
210.203339933265333320.29
单位质量响应值RSD%判断
3258.683267.840.20数据可信
供试品溶液-H149S批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14005-400511.01110.708.9111.0110.708.90
24011-401111.02811.03
33770-377010.36510.37
43831-383110.53310.53
53342-33429.1899.19
64395-439512.08412.08
10min17665-766521.07421.206.5621.0921.226.56
27970-797021.91321.93
37235-723519.89219.91
47979-797921.93821.96
57038-703819.35019.37
68387-838723.05923.08
15min110151-1015127.90928.693.8027.9628.743.80
210538-1053828.97329.03
310181-1018127.99228.04
410595-1059529.13029.18
510043-1004327.61327.66
611104-1110430.53030.59
20min112524-1252434.43434.472.3034.5334.572.30
212201-1220133.54633.65
312444-1244434.21434.31
412490-1249034.34034.44
512485-1248534.32734.42
613073-1307335.94336.05
30min115451-1545142.48142.442.5742.6442.602.57
214966-1496641.14841.31
315422-1542242.40242.56
415585-1558542.85043.01
515105-1510541.53041.68
616091-1609144.24144.41
45min118438-1843850.69451.112.4350.9251.342.43
218030-1803049.57249.80
318826-1882651.76151.99
418723-1872351.47851.71
518239-1823950.14750.37
619282-1928253.01553.26
60min120763-2076357.08657.271.9757.4057.581.97
220501-2050156.36656.68
320627-2062756.71357.02
420990-2099057.71158.03
520513-2051356.39956.70
621575-2157559.31959.65
90min123474-2347464.54065.133.2964.9565.543.29
222720-2272062.46762.87
323737-2373765.26365.67
423720-2372065.21665.63
523385-2338564.29564.69
625086-2508668.97269.40
120min125672-2567270.58371.292.8871.1071.802.88
224938-2493868.56569.07
325514-2551470.14970.66
426359-2635972.47272.99
525983-2598371.43871.94
627100-2710074.51075.05
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127071-2707174.43073.501.9875.0674.131.98
226002-2600271.49172.11
326421-2642172.64373.27
426442-2644272.70073.34
527028-2702874.31274.94
627426-2742675.40676.08
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%
110.193283032951330043324033351330750.65
210.203284632920328830.16
单位质量响应值RSD%判断
3245.833223.820.49数据可信
供试品溶液-H149S批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16222-622217.25817.485.2117.2617.485.19
26751-675118.72518.72
36440-644017.86217.86
46325-632517.54317.54
55746-574615.93715.94
66322-632217.53517.53
10min111708-1170832.47432.893.3632.5032.923.36
212548-1254834.80334.83
311506-1150631.91331.94
412096-1209633.55033.58
511540-1154032.00832.03
611747-1174732.58232.61
15min115405-1540542.72842.941.9342.8143.021.93
215977-1597744.31444.40
315247-1524742.29042.37
415707-1570743.56543.65
515269-1526942.35142.43
615279-1527942.37842.46
20min117966-1796649.83150.352.2449.9950.502.24
218675-1867551.79751.96
317734-1773449.18849.34
418634-1863451.68451.84
517825-1782549.44049.59
618083-1808350.15650.31
30min121543-2154359.75260.652.0659.9960.892.05
222596-2259662.67362.92
321287-2128759.04259.28
422048-2204861.15361.40
521844-2184460.58760.82
621881-2188160.69060.93
45min125433-2543370.54270.591.3870.8870.931.37
225385-2538570.40970.76
324849-2484968.92269.26
425718-2571871.33271.68
525453-2545370.59770.93
625863-2586371.73472.07
60min127007-2700774.90776.501.3975.3676.961.39
228081-2808177.88678.36
327308-2730875.74276.19
427837-2783777.20977.67
527701-2770176.83277.28
627562-2756276.44776.91
90min130015-3001583.25084.001.3283.8384.591.32
230879-3087985.64786.25
329708-2970882.39982.97
430395-3039584.30484.90
530435-3043584.41584.99
630290-3029084.01384.60
120min131554-3155487.51988.351.9488.2489.081.94
232438-3243889.97190.71
330764-3076485.32886.04
432135-3213589.13189.86
531934-3193488.57389.29
632303-3230389.59690.32
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132290-3229089.56089.990.8390.4290.860.83
232827-3282791.05091.94
332107-3210789.05389.91
432501-3250190.14691.03
532289-3228989.55890.43
632655-3265590.57391.45
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