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%
19.813060930590305593055030511305640.13
29.913083330750307920.20
单位质量响应值RSD%判断
3115.603107.160.20数据可信
加速6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%
5min17855-785522.65131.8618.1322.6531.8618.13
29560-956027.56827.57
311428-1142832.95432.95
413408-1340838.66438.66
511870-1187034.22934.23
612169-1216935.09135.09
10min115264-1526444.01654.4112.5144.0554.4612.51
217034-1703449.12049.17
318640-1864053.75153.81
421451-2145161.85761.92
520395-2039558.81258.87
620424-2042458.89658.95
15min119896-1989657.37366.229.1057.4866.369.11
221201-2120161.13661.26
322734-2273465.55765.70
425284-2528472.91073.08
524101-2410169.49969.65
624565-2456570.83770.99
20min122518-2251864.93472.568.3165.1472.828.32
223174-2317466.82667.06
324560-2456070.82271.08
427856-2785680.32780.62
526304-2630475.85176.12
626568-2656876.61376.89
30min125822-2582274.46179.765.4574.7880.145.48
226086-2608675.22375.56
327207-2720778.45578.83
429361-2936184.66785.09
528555-2855582.34282.74
628926-2892683.41283.81
45min128021-2802180.80384.544.0481.2485.044.07
228037-2803780.84981.32
328770-2877082.96283.47
430662-3066288.41888.98
530151-3015186.94587.48
630253-3025387.23987.78
60min129041-2904183.74486.613.3284.3287.263.35
228897-2889783.32983.93
329529-2952985.15185.79
431166-3116689.87290.58
530730-3073088.61489.29
630847-3084788.95289.64
90min130062-3006286.68888.532.5987.4089.322.63
229662-2966285.53586.27
330298-3029887.36988.15
431564-3156491.01991.88
531293-3129390.23891.07
631330-3133090.34591.18
120min130277-3027787.30889.062.1388.1790.002.17
230112-3011286.83287.71
330522-3052288.01588.94
431593-3159391.10392.12
531357-3135790.42291.40
631456-3145690.70891.69
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130579-3057988.17989.972.1089.1891.062.14
230484-3048487.90588.93
330791-3079188.79089.87
431965-3196592.17693.34
531690-3169091.38392.51
631687-3168791.37492.51
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%
19.813063430548305243046930474305300.22
29.913057330641306070.16
单位质量响应值RSD%判断
3112.133088.500.54数据可信
加速6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%
5min17352-735221.27731.8118.2821.2831.8118.27
210291-1029129.78229.78
312192-1219235.28335.28
412900-1290037.33237.33
512152-1215235.16835.17
611067-1106732.02832.03
10min114936-1493643.22455.1712.2843.2655.2312.28
217560-1756050.81850.87
320531-2053159.41659.48
420745-2074560.03660.10
520261-2026158.63558.69
620355-2035558.90758.96
15min119362-1936256.03367.079.6956.1467.229.70
221457-2145762.09662.23
324514-2451470.94371.10
424624-2462471.26171.42
524481-2448170.84771.00
624623-2462371.25871.41
20min121826-2182663.16473.078.3463.3673.338.36
223433-2343367.81568.05
326863-2686377.74178.02
426553-2655376.84477.12
526157-2615775.69875.97
626671-2667177.18577.46
30min125235-2523573.02980.526.0873.3480.906.10
226164-2616475.71876.07
329361-2936184.97085.38
428700-2870083.05783.47
528685-2868583.01483.41
628804-2880483.35883.76
45min127664-2766480.05985.153.9980.4985.674.02
228265-2826581.79882.28
330633-3063388.65189.20
430049-3004986.96187.51
529990-2999086.79087.33
629945-2994586.66087.20
60min128698-2869883.05187.233.4483.6187.883.47
229055-2905584.08484.70
331376-3137690.80191.50
430498-3049888.26088.95
530578-3057888.49289.18
630641-3064188.67489.36
90min129741-2974186.07089.072.5186.7789.872.55
229986-2998686.77987.53
331796-3179692.01792.86
431033-3103389.80990.65
530965-3096589.61290.44
631153-3115390.15690.99
120min130192-3019287.37589.762.1488.2290.712.18
230367-3036787.88188.78
332027-3202792.68593.69
431169-3116990.20291.19
531217-3121790.34191.32
631124-3112490.07291.05
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130569-3056988.46690.431.9889.4591.532.02
230531-3053188.35689.40
332150-3215093.04194.20
431549-3154991.30292.44
531322-3132290.64591.78
631364-3136490.76791.90
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%
19.813104230988309983091731073310040.20
29.913145931509314840.12
单位质量响应值RSD%判断
3160.453176.990.37数据可信
加速6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%
5min113628-1362838.58734.4414.8938.5934.4414.89
213943-1394339.47939.48
39621-962127.24227.24
413105-1310537.10737.11
512433-1243335.20435.20
610251-1025129.02529.03
10min120258-2025857.36054.018.8057.4254.068.81
220860-2086059.06559.13
317175-1717548.63148.68
419969-1996956.54256.60
519347-1934754.78154.84
616835-1683547.66847.72
15min124300-2430068.80565.646.3168.9665.786.32
224659-2465969.82169.99
321943-2194362.13162.26
423965-2396567.85668.01
523293-2329365.95466.10
620926-2092659.25159.38
20min125728-2572872.84871.584.8573.1271.844.87
226653-2665375.46775.75
324732-2473270.02870.26
426023-2602373.68473.95
525406-2540671.93772.20
623144-2314465.53265.76
30min127707-2770778.45278.374.1978.8578.754.19
229118-2911882.44782.85
327880-2788078.94279.29
428193-2819379.82880.22
527578-2757878.08678.47
625602-2560272.49172.83
45min128926-2892681.90382.263.8982.4382.773.89
230364-3036485.97586.52
329842-2984284.49784.98
429269-2926982.87583.40
528835-2883581.64682.16
627077-2707776.66877.12
60min129515-2951583.57183.953.5884.2384.603.58
230954-3095487.64688.33
330527-3052786.43787.06
429728-2972884.17484.84
529245-2924582.80783.45
627930-2793079.08379.67
90min129854-2985484.53185.293.5185.3386.083.52
231469-3146989.10489.94
331073-3107387.98288.75
430149-3014985.36686.17
529686-2968684.05584.84
628510-2851080.72581.44
120min129773-2977384.30285.273.4585.2586.203.46
231426-3142688.98289.96
331074-3107487.98588.90
430123-3012385.29386.24
529761-2976184.26885.19
628530-2853080.78281.63
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130819-3081987.26387.771.8888.3588.841.90
231795-3179590.02791.16
331486-3148689.15290.21
430960-3096087.66388.75
530785-3078587.16788.23
630140-3014085.34186.33
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%
19.813130831269312203123431093312250.26
29.913115931135311470.06
单位质量响应值RSD%判断
3182.983142.990.90数据可信
加速6月-供试品溶液-H147S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%
5min112382-1238235.12434.028.6835.1234.028.68
212143-1214334.44634.45
312696-1269636.01536.01
412379-1237935.11635.12
512450-1245035.31735.32
69898-989828.07828.08
10min120393-2039357.84955.977.3357.9156.037.33
219774-1977456.09356.15
320436-2043657.97158.03
420283-2028357.53757.60
520654-2065458.58958.65
616841-1684147.77347.82
15min124765-2476570.25168.106.0770.4168.266.07
224040-2404068.19468.35
324442-2444269.33569.49
424650-2465069.92570.08
525034-2503471.01471.17
621116-2111659.90060.03
20min127152-2715277.02274.895.2677.2975.155.27
226668-2666875.64975.91
326761-2676175.91376.19
426877-2687776.24276.51
527326-2732677.51677.79
623611-2361166.97867.20
30min129799-2979984.53182.614.2184.9383.004.22
229429-2942983.48283.87
329218-2921882.88383.28
429582-2958283.91684.31
530012-3001285.13585.54
626686-2668675.70076.04
45min131885-3188590.44887.663.6390.9988.183.64
231266-3126688.69389.22
330760-3076087.25787.79
431181-3118188.45188.99
531568-3156889.54990.10
628750-2875081.55582.02
60min132761-3276192.93389.893.2393.6390.563.24
232155-3215591.21491.89
331356-3135688.94889.63
431843-3184390.32991.01
532184-3218491.29791.99
629825-2982584.60585.20
90min133199-3319994.17691.142.9895.0291.962.99
232891-3289193.30294.13
331756-3175690.08390.91
432075-3207590.98791.82
532354-3235491.77992.63
630499-3049986.51787.26
120min133355-3335594.61891.533.0795.6292.513.08
233097-3309793.88794.87
331756-3175690.08391.06
432108-3210891.08192.07
532636-3263692.57993.58
630655-3065586.95987.84
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133562-3356295.20693.212.1996.3794.332.21
233308-3330894.48595.63
332847-3284793.17794.31
433086-3308693.85594.99
532831-3283193.13294.29
631508-3150889.37990.41
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