非奈利酮片项目信息
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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.971889481889341889621888261889141889170.03
210.991878671876971877820.07
单位质量响应值RSD%判断
17221.2417086.620.56数据可信
供试品溶液-25041101批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min135965-3596518.85514.3635.1718.8514.3635.18
213131-131316.8846.88
332426-3242616.99917.00
417949-179499.4109.41
529120-2912015.26615.27
635721-3572118.72718.73
10min1106229-10622955.69047.7226.6755.7247.7426.66
253207-5320727.89427.91
3101808-10180853.37353.40
469472-6947236.42136.44
599151-9915151.98052.01
6116248-11624860.94360.97
15min1148968-14896878.09671.1012.6678.2271.2012.68
2108788-10878857.03257.09
3145598-14559876.33076.45
4119158-11915862.46962.54
5144290-14429075.64475.76
6146939-14693977.03377.17
20min1161834-16183484.84179.548.5385.1079.768.56
2132045-13204569.22569.38
3159302-15930283.51483.76
4138516-13851672.61772.80
5159576-15957683.65883.90
6159026-15902683.36983.63
30min1173943-17394391.19086.975.7191.5987.325.75
2151754-15175479.55779.83
3170886-17088689.58789.97
4156027-15602781.79782.10
5172177-17217790.26490.64
6170536-17053689.40389.80
45min1181009-18100994.89491.784.1295.4492.284.16
2164986-16498686.49486.89
3178492-17849293.57494.11
4166850-16685087.47187.91
5180760-18076094.76395.29
6178346-17834693.49894.05
60min1184502-18450296.72593.813.5797.4394.463.61
2170597-17059789.43589.98
3181548-18154895.17695.87
4171244-17124489.77590.36
5184583-18458396.76897.45
6181158-18115894.97295.68
极限1187718-18771898.41196.941.3899.2897.751.42
2185457-18545797.22697.92
3185571-18557197.28598.13
4180299-18029994.52295.25
5186329-18632997.68398.53
6184130-18413096.53097.39
非奈利酮片项目信息
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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.971876201875991875201874181874681875250.05
210.991865451865011865230.02
单位质量响应值RSD%判断
17094.3516972.070.51数据可信
供试品溶液-25041101批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min126317-2631713.89417.2238.7713.8917.2238.78
225454-2545413.43913.44
351787-5178727.34227.34
426537-2653714.01114.01
545103-4510323.81323.81
620460-2046010.80210.80
10min179185-7918541.80742.0915.8041.8342.1215.81
278914-7891441.66441.69
397632-9763251.54651.59
470873-7087337.41837.44
589324-8932447.16047.20
662393-6239332.94132.96
15min1103316-10331654.54753.9210.6454.6454.0210.66
2102594-10259454.16654.26
3117164-11716461.85861.99
493544-9354449.38849.47
5109362-10936257.73957.86
686778-8677845.81645.89
20min1117272-11727261.91561.407.8662.1061.597.88
2116826-11682661.68061.86
3129354-12935468.29468.53
4108759-10875957.42157.59
5121848-12184864.33164.55
6103742-10374254.77254.92
30min1134596-13459671.06270.565.2271.3570.855.25
2133244-13324470.34870.63
3143576-14357675.80376.15
4127853-12785367.50267.77
5138291-13829173.01373.33
6124274-12427465.61265.85
45min1149146-14914678.74478.273.5979.1578.683.63
2146960-14696077.59077.99
3155495-15549582.09682.57
4144869-14486976.48676.86
5152357-15235780.43980.88
6140638-14063874.25274.60
60min1158125-15812583.48482.803.0484.0283.343.08
2155083-15508381.87882.41
3162389-16238985.73686.35
4155420-15542082.05682.56
5160883-16088384.94085.52
6149116-14911678.72879.20
极限1166380-16638087.84387.551.3288.5288.221.37
2164625-16462586.91687.58
3167812-16781288.59989.35
4165352-16535287.30087.94
5168330-16833088.87289.59
6162414-16241485.74986.35
非奈利酮片项目信息
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1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.971869721869311868811869011867711868910.05
210.991864211864991864600.03
单位质量响应值RSD%判断
17036.5516966.330.30数据可信
供试品溶液-25041101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%
5min112333-123336.5235.3452.646.525.3452.63
212483-124836.6036.60
3-0.0000.00
414138-141387.4787.48
513162-131626.9626.96
68442-84424.4654.47
10min127590-2759014.59410.9328.4014.6010.9428.39
222831-2283112.07612.09
310201-102015.3965.40
422156-2215611.71911.73
522540-2254011.92211.93
618622-186229.8509.86
15min131951-3195116.90013.1322.1716.9413.1622.19
226653-2665314.09814.13
315213-152138.0478.06
425735-2573513.61213.64
526093-2609313.80213.83
623290-2329012.31912.34
20min134202-3420218.09114.3520.0018.1514.4020.02
229339-2933915.51915.57
317748-177489.3889.41
426413-2641313.97114.03
528829-2882915.24915.30
626224-2622413.87113.92
30min136306-3630619.20416.0416.1319.3016.1116.17
232837-3283717.36917.45
321718-2171811.48811.53
428877-2887715.27415.35
531346-3134616.58016.66
630863-3086316.32516.39
45min138468-3846820.34717.5712.7920.4717.6612.84
235555-3555518.80718.92
326117-2611713.81413.87
431271-3127116.54116.64
532929-3292917.41817.53
634912-3491218.46718.56
60min139029-3902920.64418.4610.5120.8018.5910.57
236881-3688119.50819.65
328649-2864915.15415.23
432853-3285317.37717.51
535517-3551718.78718.92
636523-3652319.31919.44
极限138909-3890920.58120.461.4820.7720.621.51
239635-3963520.96521.14
338661-3866120.45020.56
437902-3790220.04820.21
538552-3855220.39220.56
638473-3847320.35020.51
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