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%
110.126606166007660896622665715660200.29
210.306709767483672900.41
单位质量响应值RSD%判断
6523.726533.010.11数据可信
供试品溶液-1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%
5min119001-1900126.11435.5620.1226.1135.5620.13
229247-2924740.19540.19
329101-2910139.99439.99
429109-2910940.00540.01
519320-1932026.55226.55
629489-2948940.52840.53
10min133937-3393746.64152.8310.3846.6852.8910.39
241099-4109956.48356.55
340322-4032255.41655.48
441259-4125956.70356.77
532738-3273844.99345.04
641300-4130056.76056.83
15min142107-4210757.86961.665.9457.9961.805.96
246488-4648863.89064.05
346059-4605963.30063.46
446819-4681964.34564.51
540860-4086056.15556.27
646848-4684864.38464.55
20min146174-4617463.45866.394.2163.6866.644.23
249709-4970968.31668.58
348972-4897267.30467.57
450039-5003968.77069.04
545319-4531962.28362.50
649642-4964268.22468.49
30min150559-5055969.48571.312.7269.8171.672.75
252681-5268172.40172.78
352752-5275272.49872.88
453066-5306672.93073.31
549668-4966868.26068.58
652578-5257872.25972.64
45min153937-5393774.12774.751.9974.5775.232.02
255500-5550076.27576.78
353984-5398474.19274.69
455118-5511875.75076.25
552630-5263072.33172.76
655157-5515775.80476.31
60min155188-5518875.84676.092.1576.4176.702.17
256322-5632277.40578.03
354802-5480275.31675.94
456336-5633677.42478.05
553334-5333473.29873.85
656216-5621677.25977.89
90min156582-5658277.76277.831.7578.4578.561.78
257643-5764379.22079.98
355875-5587576.79177.54
457356-5735678.82679.59
555077-5507775.69476.37
657242-5724278.66979.43
120min156962-5696278.28479.031.8179.1079.891.84
258522-5852280.42881.32
357052-5705278.40879.28
458536-5853680.44881.34
555921-5592176.85477.65
658038-5803879.76380.65
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158704-5870480.67880.921.4681.6381.921.49
259712-5971282.06483.09
358044-5804479.77180.78
459551-5955181.84382.87
557720-5772079.32680.25
659563-5956381.85982.88
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%
110.126600166486664486679766406664280.43
210.306786367491676770.39
单位质量响应值RSD%判断
6564.036570.580.08数据可信
供试品溶液-1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%
5min128515-2851538.95741.259.0038.9641.258.99
225689-2568935.09635.10
330021-3002141.01441.01
432545-3254544.46244.46
531916-3191643.60343.60
632486-3248644.38244.38
10min143935-4393560.02359.583.8860.0959.653.89
240459-4045955.27455.33
343105-4310558.88958.96
444559-4455960.87560.95
545157-4515761.69261.77
644457-4445760.73660.81
15min149933-4993368.21767.572.0768.3867.742.08
247938-4793865.49265.64
348420-4842066.15066.32
450015-5001568.32968.50
549990-4999068.29568.47
650475-5047568.95869.13
20min152822-5282272.16471.831.3372.4472.101.34
251628-5162870.53370.79
351800-5180070.76871.04
453107-5310772.55472.84
552777-5277772.10372.39
653320-5332072.84573.13
30min155953-5595376.44276.181.2576.8476.581.25
255046-5504675.20375.58
354748-5474874.79575.19
456211-5621176.79477.20
556182-5618276.75577.16
656429-5642977.09277.50
45min157892-5789279.09178.581.0979.6279.101.10
256968-5696877.82878.33
356509-5650977.20177.72
457846-5784679.02879.57
557853-5785379.03779.57
658029-5802979.27879.82
60min159060-5906080.68680.331.0981.3480.981.10
258170-5817079.47180.10
357815-5781578.98679.63
459239-5923980.93181.60
559243-5924380.93681.61
659257-5925780.95681.63
90min160253-6025382.31681.720.9383.1182.510.93
259532-5953281.33182.10
359014-5901480.62481.40
459911-5991181.84982.65
560566-6056682.74483.55
659629-5962981.46482.27
120min161444-6144483.94382.901.1984.8783.831.18
260446-6044682.58083.48
359497-5949781.28382.20
461090-6109083.46084.40
561205-6120583.61784.56
660391-6039182.50583.45
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161863-6186384.51684.270.7585.5985.330.76
261400-6140083.88384.92
361006-6100683.34584.39
462174-6217484.94186.02
562147-6214784.90485.99
661493-6149384.01085.09
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%
110.126602666085661026594665968660250.11
210.306794767932679400.02
单位质量响应值RSD%判断
6524.216596.120.78数据可信
供试品溶液-2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%
5min132627-3262744.62442.2511.7944.6242.2511.79
233049-3304945.20145.20
327887-2788738.14138.14
433153-3315345.34445.34
524874-2487434.02034.02
633774-3377446.19346.19
10min144097-4409760.31259.005.9260.3959.075.93
244771-4477161.23461.31
341599-4159956.89556.96
444078-4407860.28660.36
538687-3868752.91252.97
645576-4557662.33562.41
15min149217-4921767.31466.463.6167.4966.633.62
249757-4975768.05368.23
347597-4759765.09965.26
448861-4886166.82767.00
545620-4562062.39562.54
650508-5050869.08069.26
20min152209-5220971.40770.782.7171.6971.062.72
252745-5274572.14072.43
350782-5078269.45569.72
451634-5163470.62070.91
549629-4962967.87868.13
653519-5351973.19873.49
30min155590-5559076.03175.122.1976.4475.512.20
256074-5607476.69377.10
354145-5414574.05474.44
454389-5438974.38874.79
553185-5318572.74173.10
656143-5614376.78777.21
45min157870-5787079.14978.012.5179.6878.542.52
258594-5859480.13980.68
356072-5607276.69077.20
456096-5609676.72377.25
555189-5518975.48275.97
658404-5840479.87980.43
60min159207-5920780.97879.582.5881.6480.232.59
259832-5983281.83382.50
356921-5692177.85178.49
457258-5725878.31278.97
556380-5638077.11177.72
659517-5951781.40282.08
90min160414-6041482.62980.723.0683.4381.503.06
261558-6155884.19385.00
357638-5763878.83279.60
457398-5739878.50479.29
557340-5734078.42479.16
659757-5975781.73082.54
120min160676-6067682.98781.373.0583.9282.293.05
262117-6211784.95885.91
357824-5782479.08679.98
458122-5812279.49480.41
557848-5784879.11979.99
660383-6038382.58683.54
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161532-6153284.15883.781.6885.2384.841.69
262705-6270585.76286.85
361388-6138883.96184.99
460013-6001382.08083.13
560144-6014482.25983.26
661774-6177484.48985.58
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%
110.126768667647679176804567475677540.34
210.306811867959680380.17
单位质量响应值RSD%判断
6695.066605.630.96数据可信
供试品溶液-3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%
5min130552-3055241.22037.9320.0041.2237.9320.01
216991-1699122.92422.92
329345-2934539.59239.59
429948-2994840.40540.41
528950-2895039.05939.06
632885-3288544.36844.37
10min144036-4403659.41255.5913.2759.4855.6513.27
230159-3015940.69040.73
342946-4294657.94258.01
443206-4320658.29358.36
542365-4236557.15857.22
644501-4450160.04060.11
15min149925-4992567.35863.8010.4767.5363.9610.48
237260-3726050.27050.38
349048-4904866.17566.34
448872-4887265.93766.10
548590-4859065.55765.72
650047-5004767.52267.70
20min152805-5280571.24368.058.7971.5268.328.81
241447-4144755.91956.11
352063-5206370.24270.52
451880-5188069.99570.27
551667-5166769.70869.98
652779-5277971.20871.49
30min156237-5623775.87473.397.4476.2773.767.47
246171-4617162.29362.58
356156-5615675.76476.15
456099-5609975.68876.08
555316-5531674.63175.02
656391-5639176.08276.49
45min158638-5863879.11376.956.3179.6477.446.34
249695-4969567.04767.43
358396-5839678.78779.30
458503-5850378.93179.45
558457-5845778.86979.38
658502-5850278.93079.46
60min159751-5975180.61578.795.4581.2779.425.49
251929-5192970.06270.56
359529-5952980.31580.96
459847-5984780.74481.39
559316-5931680.02880.67
660035-6003580.99881.66
90min161182-6118282.54580.634.5383.3481.404.57
254273-5427373.22473.84
360922-6092282.19582.98
460905-6090582.17282.96
560416-6041681.51282.29
660895-6089582.15882.96
120min162274-6227484.01981.774.1584.9582.664.19
255552-5555274.95075.69
361284-6128482.68383.60
461268-6126882.66183.58
561289-6128982.69083.60
661959-6195983.59484.53
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162709-6270984.60682.623.8885.6783.653.93
256536-5653676.27777.14
361648-6164883.17484.23
461962-6196283.59884.66
561562-6156283.05884.11
663010-6301085.01286.09
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