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10000
标示量(mg)1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%
110.386741967453674866747767593674860.10
210.406809168201681460.12
单位质量响应值RSD%判断
6501.546552.500.56数据可信
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%
5min133985-3398546.71743.0410.4946.7243.0510.49
234844-3484447.89847.90
330514-3051441.94541.95
427033-2703337.16037.16
533461-3346145.99646.00
628041-2804138.54638.55
10min146779-4677964.30460.805.4864.3860.875.48
246589-4658964.04364.12
343603-4360359.93860.01
440999-4099956.35856.42
545402-4540262.41162.49
641989-4198957.71957.78
15min151916-5191671.36569.562.6771.5569.732.68
252053-5205371.55471.74
350037-5003768.78268.95
449224-4922467.66567.82
551354-5135470.59370.77
649028-4902867.39567.56
20min155043-5504375.66474.461.5075.9774.751.51
254713-5471375.21075.52
353826-5382673.99174.28
452979-5297972.82773.10
554792-5479275.31975.62
653629-5362973.72073.99
30min158031-5803179.77179.201.2080.2079.611.21
258177-5817779.97280.40
357372-5737278.86579.27
457422-5742278.93479.32
558255-5825580.07980.50
656447-5644777.59477.99
45min160471-6047183.12582.590.7083.6983.140.71
260064-6006482.56683.13
359387-5938781.63582.17
460150-6015082.68483.21
560526-6052683.20183.76
659913-5991382.35882.88
60min161715-6171584.83584.221.1385.5484.911.12
260669-6066983.39784.10
360312-6031282.90783.58
462065-6206585.31685.98
561764-6176484.90385.60
661100-6110083.99084.65
90min162066-6206685.31885.350.8186.1686.170.79
261402-6140284.40585.25
361734-6173484.86185.67
462736-6273686.23987.04
562561-6256185.99886.84
662040-6204085.28286.08
120min162377-6237785.74585.880.9886.7386.840.96
262145-6214585.42686.41
361585-6158584.65785.61
463332-6333287.05888.00
562920-6292086.49287.47
662487-6248785.89686.84
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163759-6375987.64588.321.1788.7789.431.14
263384-6338487.13088.25
363750-6375087.63388.73
464843-6484389.13590.23
564455-6445588.60289.73
665321-6532189.79290.88
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10000
标示量(mg)1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%
110.386987269557695596974369755696970.20
210.406856368562685620.01
单位质量响应值RSD%判断
6714.556592.501.30数据可信
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%
5min130799-3079941.53542.516.0241.5442.516.02
232754-3275444.17244.17
328832-2883238.88238.88
430911-3091141.68641.69
534404-3440446.39746.40
631436-3143642.39442.39
10min146875-4687563.21562.743.5563.2862.813.55
247860-4786064.54364.62
344024-4402459.37059.43
445088-4508860.80560.87
548288-4828865.12165.20
647007-4700763.39363.46
15min151306-5130669.19170.662.4469.3770.842.44
252914-5291471.35971.54
350476-5047668.07168.24
452442-5244270.72370.89
553602-5360272.28772.47
653636-5363672.33372.51
20min154724-5472473.80075.392.4274.0975.682.42
255876-5587675.35475.65
354390-5439073.35073.63
455561-5556174.92975.22
558003-5800378.22278.53
656850-5685076.66776.96
30min157967-5796778.17480.132.0978.5980.552.09
258629-5862979.06679.49
358685-5868579.14279.54
459460-5946080.18780.60
561009-6100982.27682.71
660775-6077581.96082.39
45min160804-6080481.99983.222.0782.5483.772.07
260926-6092682.16482.72
360587-6058781.70782.24
461423-6142382.83483.38
562724-6272484.58985.16
663784-6378486.01886.58
60min161900-6190083.47884.742.1484.1685.432.14
262010-6201083.62684.32
361360-6136082.74983.42
463008-6300884.97285.66
563825-6382586.07486.79
664895-6489587.51788.22
90min162933-6293384.87185.952.2985.6986.782.29
262137-6213783.79784.63
362599-6259984.42085.23
464088-6408886.42887.26
564634-6463487.16588.02
666019-6601989.03289.88
120min162933-6293384.87186.312.0585.8387.282.05
262756-6275684.63285.61
363111-6311185.11186.06
464108-6410886.45587.43
565093-6509387.78488.79
665979-6597988.97889.98
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163719-6371985.93187.432.0687.0388.552.06
263464-6346485.58786.70
364000-6400086.31087.40
465115-6511587.81388.93
565857-6585788.81489.96
666820-6682090.11391.26
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10000
标示量(mg)1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%
110.386819868036679126798167837679930.21
210.406918169389692850.22
单位质量响应值RSD%判断
6550.396662.021.20数据可信
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%
5min134407-3440746.73347.022.7946.7347.022.79
233432-3343245.40845.41
333729-3372945.81245.81
434852-3485247.33747.34
535983-3598348.87348.87
635317-3531747.96947.97
10min146453-4645363.09463.751.9663.1763.831.97
246540-4654063.21263.29
345892-4589262.33262.41
446667-4666763.38563.46
548382-4838265.71465.80
647701-4770164.78964.87
15min151849-5184970.42371.371.5170.6171.551.51
252275-5227571.00171.18
351995-5199570.62170.80
452063-5206370.71470.90
553719-5371972.96373.15
653358-5335872.47272.66
20min155404-5540475.25175.841.5675.5576.151.56
255921-5592175.95476.25
354806-5480674.43974.74
455325-5532575.14475.45
557262-5726277.77578.09
656325-5632576.50276.81
30min158024-5802478.81080.371.6879.2480.801.68
258887-5888779.98280.41
358592-5859279.58180.00
458738-5873879.78080.21
560473-6047382.13682.58
660321-6032181.93082.37
45min160875-6087582.68283.431.0883.2484.001.08
261597-6159783.66384.22
360720-6072082.47283.03
460996-6099682.84783.41
562215-6221584.50285.08
662152-6215284.41784.99
60min161734-6173483.84984.921.2384.5485.621.23
262074-6207484.31185.01
362349-6234984.68485.38
462112-6211284.36285.06
563789-6378986.64087.36
663068-6306885.66186.37
90min162974-6297485.53386.751.0686.3787.591.06
263272-6327285.93886.78
363759-6375986.59987.43
463989-6398986.91287.75
564524-6452487.63888.50
664689-6468987.86388.72
120min162969-6296985.52687.051.3286.5088.041.31
263401-6340186.11387.10
363708-6370886.53087.51
464774-6477487.97888.96
564693-6469387.86888.88
664997-6499788.28189.28
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164932-6493288.19389.290.7789.3190.430.76
265485-6548588.94490.07
366287-6628790.03391.15
465755-6575589.31090.44
566220-6622089.94291.10
665781-6578189.34690.50
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