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%
110.143215132074321473211032143321250.11
210.203210332140321220.09
单位质量响应值RSD%判断
3168.153149.220.43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%
5min114026-1402639.84136.899.2439.8436.899.23
212977-1297736.86136.86
312050-1205034.22834.23
413691-1369138.88938.89
511102-1110231.53531.54
614075-1407539.98039.98
10min122043-2204362.61358.978.1262.6859.038.12
221582-2158261.30361.36
319230-1923054.62254.68
421231-2123160.30660.37
518144-1814451.53851.59
622326-2232663.41763.48
15min125318-2531871.91571.062.5772.0971.222.58
225700-2570073.00073.16
324710-2471070.18870.34
424858-2485870.60970.77
523965-2396568.07268.21
625549-2554972.57272.74
20min127298-2729877.54077.082.3277.8377.352.33
227778-2777878.90379.19
326927-2692776.48676.75
426929-2692976.49176.77
526111-2611174.16874.42
627766-2776678.86979.16
30min129506-2950683.81183.271.8384.2383.681.83
229160-2916082.82883.25
329979-2997985.15585.55
429147-2914782.79283.20
528436-2843680.77281.15
629663-2966384.25784.68
45min130981-3098188.00187.212.2588.5687.752.25
230500-3050086.63587.19
331475-3147589.40489.94
430460-3046086.52187.07
529555-2955583.95084.46
631240-3124088.73789.30
60min131075-3107588.26889.162.5988.9789.852.59
232112-3211291.21491.91
332156-3215691.33992.02
430917-3091787.81988.51
530135-3013585.59886.25
631934-3193490.70891.42
90min131422-3142289.25489.522.9390.1190.362.92
231218-3121888.67489.53
332415-3241592.07492.91
430994-3099488.03888.88
530278-3027886.00486.80
632759-3275993.05193.92
120min131677-3167789.97890.152.9590.9891.142.94
231328-3132888.98789.99
332575-3257592.52993.52
431755-3175590.20091.19
530241-3024185.89986.84
632855-3285593.32494.34
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131941-3194190.72891.891.7991.8893.031.80
232462-3246292.20893.36
332871-3287193.37094.51
432191-3219191.43892.57
531545-3154589.60390.68
633087-3308793.98395.16
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%
110.143238532436325303259432565325020.28
210.203239232454324230.14
单位质量响应值RSD%判断
3205.333178.730.59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%
5min112100-1210034.01137.5712.4834.0137.5712.48
214395-1439540.46240.46
314281-1428140.14240.14
415749-1574944.26844.27
512037-1203733.83433.83
611645-1164532.73232.73
10min121144-2114459.43260.198.7059.4960.258.71
222794-2279464.07064.14
322363-2236362.85962.93
423625-2362566.40666.48
518815-1881552.88652.94
619734-1973455.46955.52
15min124714-2471469.46771.345.2169.6271.515.22
226082-2608273.31273.49
326326-2632673.99874.17
426895-2689575.59775.78
525005-2500570.28570.43
623267-2326765.40065.55
20min127019-2701975.94676.685.0076.2276.965.01
227738-2773877.96778.26
327000-2700075.89376.19
429577-2957783.13683.45
526956-2695675.76976.03
625393-2539371.37671.63
30min129819-2981983.81682.653.4084.2183.063.41
229823-2982383.82884.25
329018-2901881.56581.99
430646-3064686.14186.59
529436-2943682.74083.13
627685-2768577.81878.19
45min131499-3149988.53886.583.3989.0887.123.39
231281-3128187.92688.49
330087-3008784.57085.13
431823-3182389.44990.04
531070-3107087.33387.86
629046-2904681.64482.15
60min132138-3213890.33589.572.6291.0290.262.63
232476-3247691.28592.00
331824-3182489.45290.15
432684-3268491.86992.61
531728-3172889.18289.85
630341-3034185.28485.92
90min132530-3253091.43689.543.4192.2790.383.41
232297-3229790.78291.65
331213-3121387.73588.58
432982-3298292.70793.60
532110-3211090.25691.08
629993-2999384.30585.09
120min132890-3289092.44890.373.6893.4491.363.68
232471-3247191.27192.29
331630-3163088.90789.90
433344-3334493.72494.77
532541-3254191.46792.44
630035-3003584.42385.35
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132661-3266191.80592.081.9492.9593.221.95
232908-3290892.49993.67
333556-3355694.32095.46
433239-3323993.42994.63
532435-3243591.16992.29
631759-3175989.26990.33
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%
110.143272632591327813262232631326700.25
210.203273632745327400.02
单位质量响应值RSD%判断
3221.893209.800.27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%
5min19088-908825.35527.8914.6625.3627.8914.67
211405-1140531.82031.82
312045-1204533.60533.61
410168-1016828.36828.37
58624-862424.06124.06
68648-864824.12824.13
10min118943-1894352.85056.246.4752.8956.286.48
221772-2177260.74360.80
321819-2181960.87460.93
419664-1966454.86254.91
519069-1906953.20253.24
619678-1967854.90154.94
15min124080-2408067.18369.413.7467.3169.553.75
226263-2626373.27373.43
325765-2576571.88472.04
424563-2456368.53068.67
523977-2397766.89567.02
624632-2463268.72368.85
20min127050-2705075.46976.792.3175.7177.052.32
228511-2851179.54579.82
328120-2812078.45478.73
427124-2712475.67575.93
527027-2702775.40575.64
627312-2731276.20076.45
30min129910-2991083.44883.891.3383.8284.271.35
230788-3078885.89886.31
330250-3025084.39784.80
429678-2967882.80183.18
529946-2994683.54983.91
629835-2983583.23983.61
45min131917-3191789.04888.310.6889.5588.840.68
231943-3194389.12089.67
331520-3152087.94088.49
431516-3151687.92988.45
531546-3154688.01288.52
631484-3148487.84088.35
60min132652-3265291.09890.590.6991.7591.260.68
232783-3278391.46492.16
332178-3217889.77690.47
432323-3232390.18090.84
532493-3249390.65591.31
632380-3238090.33991.00
90min133351-3335193.04892.080.8893.8692.900.88
233383-3338393.13893.99
332826-3282691.58492.43
432778-3277891.45092.26
532944-3294491.91392.72
632741-3274191.34792.16
120min133400-3340093.18592.221.1594.1593.191.15
233622-3362293.80494.81
332881-3288191.73792.73
432616-3261690.99891.96
532967-3296791.97792.93
632834-3283491.60692.57
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133609-3360993.76892.840.9794.8993.970.97
233742-3374294.13995.30
333104-3310492.35993.51
432936-3293691.89193.01
533194-3319492.61093.72
633076-3307692.28193.40
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