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%
110.163335833283331723315433538333010.48
210.243345533198333260.55
单位质量响应值RSD%判断
3277.663254.490.51数据可信
供试品溶液-2025042721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%
5min16665-666518.30917.9214.8218.3117.9214.81
26411-641117.61217.61
37464-746420.50420.50
46823-682318.74318.74
54691-469112.88712.89
67075-707519.43619.44
10min112170-1217033.43232.228.4733.4632.258.47
211446-1144631.44331.47
312502-1250234.34434.38
412068-1206833.15233.18
59841-984127.03427.06
612346-1234633.91633.95
15min115060-1506041.37140.426.6641.4640.506.66
215296-1529642.02042.10
315297-1529742.02242.11
414818-1481840.70640.79
512750-1275035.02535.09
615065-1506541.38541.47
20min117695-1769548.61047.115.1348.7747.265.14
218089-1808949.69249.84
317476-1747648.00848.17
416945-1694546.54946.70
515556-1555642.73442.86
617137-1713747.07747.23
30min120271-2027155.68654.482.9655.9254.702.97
220053-2005355.08755.32
320419-2041956.09356.33
419629-1962953.92354.15
518789-1878951.61551.81
619826-1982654.46454.70
45min122734-2273462.45261.412.7562.7861.732.75
222370-2237061.45261.78
322567-2256761.99462.33
421876-2187660.09560.42
521437-2143758.88959.17
623139-2313963.56563.89
60min124649-2464967.71366.171.5668.1566.601.57
224221-2422166.53766.97
324187-2418766.44466.88
423947-2394765.78566.21
523511-2351164.58764.97
624017-2401765.97766.41
90min126567-2656772.98271.591.7973.5372.121.81
226397-2639772.51573.05
326233-2623372.06572.61
425660-2566070.49071.02
525344-2534469.62270.11
626162-2616271.86972.41
120min127908-2790876.66674.322.1377.3374.972.13
227528-2752875.62276.28
326980-2698074.11774.79
426487-2648772.76273.41
526446-2644672.65073.25
626978-2697874.11174.77
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128298-2829877.73776.971.3178.5377.741.32
228148-2814877.32578.11
328356-2835677.89778.69
427520-2752075.60076.37
527599-2759975.81776.54
628192-2819277.44678.23
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%
110.163307033510333833333233066332720.60
210.243407734035340560.09
单位质量响应值RSD%判断
3274.803325.781.10数据可信
供试品溶液-2025042721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%
5min17299-729919.84419.092.8619.8419.092.86
27098-709819.29819.30
37039-703919.13719.14
47059-705919.19219.19
56952-695218.90118.90
66687-668718.18018.18
10min112594-1259434.24033.972.0634.2734.002.05
212117-1211732.94332.98
312515-1251534.02534.06
412262-1226233.33733.37
512706-1270634.54434.58
612772-1277234.72434.75
15min115404-1540441.87942.172.5741.9742.262.57
215322-1532241.65741.74
315516-1551642.18442.27
414923-1492340.57240.66
516033-1603343.59043.68
615864-1586443.13043.22
20min117723-1772348.18448.361.3448.3448.521.34
217658-1765848.00848.16
317740-1774048.23048.39
417832-1783248.48148.64
518234-1823449.57349.74
617549-1754947.71147.87
30min120266-2026655.09855.691.3855.3455.931.37
220212-2021254.95155.19
320437-2043755.56355.80
420644-2064456.12656.36
520968-2096857.00757.25
620379-2037955.40555.64
45min122966-2296662.43962.690.6662.7763.020.66
222937-2293762.36062.69
323037-2303762.63262.96
422921-2292162.31662.65
523235-2323563.17063.51
623255-2325563.22463.56
60min124416-2441666.38167.221.5066.8267.661.49
225220-2522068.56769.00
324505-2450566.62367.06
424327-2432766.13966.57
525080-2508068.18668.63
624798-2479867.41967.86
90min126479-2647971.99072.151.6672.5472.701.66
226264-2626471.40571.95
326544-2654472.16672.71
426181-2618171.17971.72
527394-2739474.47775.04
626369-2636971.69072.24
120min128090-2809076.36975.711.3777.0476.381.37
227530-2753074.84775.51
327740-2774075.41876.09
427501-2750174.76875.43
528497-2849777.47678.16
627732-2773275.39676.07
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128622-2862277.81677.320.9078.6178.110.90
228195-2819576.65577.44
328179-2817976.61177.40
428258-2825876.82677.61
528673-2867377.95478.77
628709-2870978.05278.85
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%
110.166554665717661586614566351659830.52
210.246620166038661200.18
单位质量响应值RSD%判断
6494.396457.030.41数据可信
供试品溶液-2025042722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%
5min111755-1175516.28715.1414.4416.2915.1414.46
28643-864311.97511.97
312591-1259117.44517.44
49278-927812.85512.85
511621-1162116.10116.10
611689-1168916.19516.20
10min120725-2072528.71526.968.3228.7426.998.32
217011-1701123.56923.59
320460-2046028.34828.38
417867-1786724.75524.78
519933-1993327.61727.64
620775-2077528.78428.81
15min125029-2502934.67833.734.4934.7533.804.50
222601-2260131.31431.37
325159-2515934.85834.93
423368-2336832.37732.44
524732-2473234.26634.34
625167-2516734.86934.94
20min129078-2907840.28838.983.2740.4239.103.29
226771-2677137.09237.20
328706-2870639.77339.91
427406-2740637.97138.09
527932-2793238.70038.83
628894-2889440.03340.17
30min133378-3337846.24645.252.5746.4545.452.59
231534-3153443.69143.86
332952-3295245.65545.86
431798-3179844.05744.24
532705-3270545.31345.51
633606-3360646.56246.76
45min137633-3763352.14151.341.4552.4251.601.46
236254-3625450.23050.48
337428-3742851.85752.13
436651-3665150.78051.03
536928-3692851.16451.43
637421-3742151.84752.12
60min140670-4067056.34955.701.4456.7156.051.45
239483-3948354.70455.03
340386-4038655.95556.32
439874-3987455.24655.58
539811-3981155.15955.51
640993-4099356.79657.16
90min143640-4364060.46460.241.2460.9260.691.25
243037-4303759.62860.05
343723-4372360.57961.04
443440-4344060.18760.62
542764-4276459.25059.70
644287-4428761.36061.82
120min145896-4589663.58963.450.5964.1564.000.60
245555-4555563.11763.64
345661-4566163.26463.82
445795-4579563.45063.98
545597-4559763.17563.72
646277-4627764.11764.68
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146797-4679764.83864.531.1365.5065.181.14
246689-4668964.68865.31
346708-4670864.71465.38
445963-4596363.68264.32
545962-4596263.68164.33
647318-4731865.56066.23
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%
110.166696866940666396715666761668930.30
210.246794867487677180.49
单位质量响应值RSD%判断
6583.966613.090.32数据可信
供试品溶液-2025042722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%
5min111861-1186116.12814.8910.0516.1314.8910.05
211473-1147315.60015.60
38881-888112.07612.08
411331-1133115.40715.41
511577-1157715.74115.74
610585-1058514.39314.39
10min120395-2039527.73127.024.6327.7627.044.64
220560-2056027.95627.98
318080-1808024.58424.60
420219-2021927.49227.52
520231-2023127.50927.53
619732-1973226.83026.85
15min125688-2568834.92834.162.7735.0034.232.78
225431-2543134.57934.65
323958-2395832.57632.64
425862-2586235.16535.24
524870-2487033.81633.89
624926-2492633.89233.96
20min128735-2873539.07238.891.7639.2039.021.76
229042-2904239.48939.62
327727-2772737.70137.82
429110-2911039.58139.71
528503-2850338.75638.88
628484-2848438.73038.86
30min133219-3321945.16945.191.4145.3645.381.41
233842-3384246.01646.21
332941-3294144.79144.97
433768-3376845.91546.11
532917-3291744.75844.95
632739-3273944.51644.71
45min137287-3728750.70051.060.5450.9751.330.53
237691-3769151.24951.52
337569-3756951.08351.34
437847-3784751.46151.73
537409-3740950.86651.13
637511-3751151.00451.27
60min140375-4037554.89955.310.7655.2555.660.76
240906-4090655.62155.98
340409-4040954.94555.28
441145-4114555.94656.30
540731-4073155.38355.74
640504-4050455.07455.42
90min143825-4382559.59060.370.9960.0460.810.97
244131-4413160.00660.46
344797-4479760.91161.34
444933-4493361.09661.55
544124-4412459.99660.44
644574-4457460.60861.05
120min146538-4653863.27963.480.5163.8364.020.51
246702-4670263.50264.05
346882-4688263.74664.28
446914-4691463.79064.34
546289-4628962.94063.48
646774-4677463.60064.14
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146930-4693063.81264.170.5564.4664.820.55
247234-4723464.22564.88
347556-4755664.66365.30
447396-4739664.44565.11
547162-4716264.12764.78
646890-4689063.75764.41
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