非奈利酮片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.153803563805543802683805533801213803700.05
211.103773883777283775580.07
单位质量响应值RSD%判断
34113.9034014.230.21数据可信
供试品溶液-BXJUS91批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17036-70369.28710.6825.119.2910.6825.12
26390-63908.4358.43
311978-1197815.81115.81
46912-69129.1249.12
57863-786310.37910.38
68376-837611.05611.06
10min123365-2336530.84135.5821.9730.8935.6421.98
220673-2067327.28827.33
337887-3788750.01050.10
426959-2695935.58635.64
525227-2522733.29933.36
627628-2762836.46936.53
15min132866-3286643.38347.9118.8443.6148.1718.85
228431-2843137.52937.73
348916-4891664.56864.93
435989-3598947.50547.75
535510-3551046.87347.12
636055-3605547.59247.86
20min139078-3907851.58254.9713.7652.0555.5013.83
234199-3419945.14245.55
351692-5169268.23368.96
442397-4239755.96356.48
540879-4087953.96054.46
641631-4163154.95255.48
30min147587-4758762.81465.6010.5863.5666.4310.67
242735-4273556.41057.07
358852-5885277.68478.79
450572-5057266.75467.58
549419-4941965.23266.04
649037-4903764.72865.56
45min156274-5627474.28175.277.6275.3876.467.74
250410-5041066.54067.51
363884-6388484.32685.86
458423-5842377.11878.31
557126-5712675.40676.57
656018-5601873.94375.14
60min162589-6258982.61783.284.4084.1384.894.56
258866-5886677.70279.04
367246-6724688.76490.77
464250-6425084.80986.43
563704-6370484.08885.67
661892-6189281.69783.30
极限169461-6946191.68890.862.8393.6692.942.92
264970-6497085.75987.53
369355-6935591.54894.04
470468-7046893.01795.11
569337-6933791.52493.58
669425-6942591.64093.70
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.153776893774733776173778053778543776880.05
211.103790013789013789510.02
单位质量响应值RSD%判断
33873.3634139.730.56数据可信
供试品溶液-BXK0LE1批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111320-1132014.96811.4023.2914.9711.4023.30
26368-63688.4208.42
37893-789310.43610.44
49299-929912.29512.30
510254-1025413.55813.56
66589-65898.7128.71
10min130442-3044240.25234.7515.4440.3334.8115.44
219604-1960425.92125.97
324447-2444732.32532.38
426170-2617034.60334.67
530387-3038740.17940.25
626649-2664935.23635.28
15min140356-4035653.36046.6811.1553.6746.9311.18
229441-2944138.92839.12
332760-3276043.31643.55
434542-3454245.67345.93
538376-3837650.74251.04
636335-3633548.04348.29
20min146937-4693762.06253.7010.7062.6754.2210.73
234812-3481246.03046.44
337648-3764849.78050.26
439044-3904451.62552.14
543479-4347957.49058.07
641756-4175655.21155.72
30min153646-5364670.93364.477.7371.8865.287.78
243450-4345057.45158.11
345208-4520859.77660.53
449396-4939665.31366.11
550112-5011266.26067.16
650751-5075167.10567.92
45min160472-6047279.95873.775.9681.3074.946.02
251861-5186168.57269.55
352681-5268169.65770.74
454840-5484072.51173.68
556523-5652374.73776.00
658383-5838377.19678.39
60min165916-6591687.15781.434.9088.9483.014.98
258236-5823677.00278.36
358323-5832377.11778.59
461002-6100280.65982.23
562538-6253882.69084.37
663485-6348583.94285.56
极限171752-7175294.87390.952.9397.1492.983.01
267542-6754289.30691.10
366563-6656388.01289.91
468006-6800689.92091.93
568094-6809490.03692.18
670757-7075793.55795.64
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.153761503763253760453762493764513762440.05
211.103755003756173755580.03
单位质量响应值RSD%判断
33743.8633834.050.19数据可信
供试品溶液-24122701批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19632-963212.81810.6615.2712.8210.6615.28
27068-70689.4069.41
38117-811710.80210.80
48257-825710.98810.99
58798-879811.70811.71
66201-62018.2528.25
10min132891-3289143.76933.3228.1843.8433.3828.15
217403-1740323.15923.21
324239-2423932.25632.32
427428-2742836.49936.56
531896-3189642.44542.51
616356-1635621.76521.81
15min149388-4938865.72261.0113.1766.0461.2613.18
239314-3931452.31652.50
338545-3854551.29351.53
447505-4750563.21663.48
554262-5426272.20872.51
646083-4608361.32461.49
20min157385-5738576.36475.757.4977.0476.337.49
256518-5651875.21075.68
349641-4964166.05966.58
455952-5595274.45775.07
562229-6222982.81083.51
659818-5981879.60280.11
30min165813-6581387.58089.134.7188.6890.144.71
268142-6814290.67991.57
362003-6200382.50983.40
465670-6567087.38988.42
570694-7069494.07595.24
669545-6954592.54693.50
45min171665-7166595.36797.372.2896.9698.872.29
274172-7417298.703100.10
371159-7115994.69496.04
472309-7230996.22497.74
575074-7507499.903101.59
674656-7465699.347100.81
60min170672-7067294.04699.313.0896.17101.352.93
277193-77193102.723104.66
376513-76513101.818103.69
474048-7404898.538100.59
574394-7439498.999101.24
674964-7496499.757101.77
极限177044-77044102.525102.651.26105.17105.241.15
278510-78510104.476106.99
377128-77128102.637105.08
477560-77560103.212105.81
575516-75516100.492103.28
677056-77056102.541105.11
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.151876681874621876611876821874921875930.06
211.101876201874171875180.08
单位质量响应值RSD%判断
16824.4816893.510.29数据可信
供试品溶液-t2批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13497-34979.3279.6913.269.339.6913.26
24413-441311.77011.77
33630-36309.6819.68
43270-32708.7218.72
53066-30668.1778.18
63914-391410.43910.44
10min112615-1261533.64531.6124.6633.7031.6624.64
215007-1500740.02540.09
312840-1284034.24534.30
413856-1385636.95537.00
57108-710818.95819.00
69691-969125.84725.90
15min127146-2714672.40063.0212.4972.6463.2412.49
226670-2667071.13171.42
322562-2256260.17560.42
421885-2188558.36958.62
519446-1944651.86452.01
624057-2405764.16264.36
20min132897-3289787.73977.6211.0988.3878.2011.09
231257-3125783.36584.05
327827-2782774.21774.79
426218-2621869.92570.50
524933-2493366.49866.94
631478-3147883.95484.51
30min136762-3676298.04789.219.0999.1890.239.10
234967-3496793.26094.41
332130-3213085.69386.68
430134-3013480.37081.34
530181-3018180.49581.30
636528-3652897.42398.45
45min137750-37750100.68297.044.79102.3698.544.85
237892-37892101.061102.72
335414-3541494.45295.92
434054-3405490.82592.24
535086-3508693.57794.83
638103-38103101.623103.19
60min138200-38200101.88298.712.87104.11100.762.96
237438-3743899.850102.08
336740-3674097.98899.98
435457-3545794.56696.48
536249-3624996.67998.45
637985-37985101.309103.44
极限137506-37506100.031100.151.07102.83102.741.18
237745-37745100.669103.45
337781-37781100.765103.30
437079-3707998.892101.34
537097-3709798.940101.25
638085-38085101.575104.27
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