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)0
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%
1 11.143883893884013885553883573880833883570.05
2 11.093846333847693847010.03
单位质量响应值RSD%判断
34861.4934689.000.36数据可信
供试品溶液-BXK0LE1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%
5min1126327-12632732.66824.6820.9932.6724.6820.99
2108825-10882528.14228.14
398230-9823025.40225.40
481406-8140621.05221.05
586653-8665322.40822.41
671155-7115518.40118.40
10min1257012-25701266.46359.637.5766.5259.677.58
2241692-24169262.50162.55
3228518-22851859.09559.14
4207764-20776453.72853.76
5231148-23114859.77559.81
6217408-21740856.22256.25
15min1303989-30398978.61174.893.3678.7875.033.38
2294406-29440676.13376.28
3289174-28917474.78074.92
4275003-27500371.11671.24
5290768-29076875.19275.33
6284296-28429673.51973.64
20min1326474-32647484.42682.092.1384.7282.352.14
2322654-32265483.43883.72
3317081-31708181.99782.26
4307402-30740279.49479.74
5317681-31768182.15282.41
6313287-31328781.01681.26
30min1350648-35064890.67788.621.8191.1189.031.82
2345368-34536889.31289.73
3344869-34486989.18389.59
4338115-33811587.43687.81
5344198-34419889.00989.41
6333046-33304686.12586.51
45min1365921-36592194.62793.800.6995.2294.350.71
2364299-36429994.20794.77
3363627-36362794.03494.58
4358710-35871092.76293.28
5361572-36157293.50294.05
6362237-36223793.67494.20
60min1371741-37174196.13295.810.6596.8896.520.67
2371542-37154296.08196.80
3372557-37255796.34397.05
4365888-36588894.61895.29
5371163-37116395.98396.69
6370089-37008995.70596.39
极限1373612-37361296.61696.560.5697.5297.430.57
2372953-37295396.44597.33
3376761-37676197.43098.30
4370193-37019395.73296.57
5373386-37338696.55797.42
6373456-37345696.57597.42
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)0
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%
1 11.143854293848913850253846163850203849960.08
2 11.093826093823733824910.05
单位质量响应值RSD%判断
34559.7834489.720.15数据可信
供试品溶液-BXK0LE1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%
5min185762-8576222.33922.7210.4222.3422.7210.42
294580-9458024.63624.64
393350-9335024.31524.32
470062-7006218.24918.25
587358-8735822.75522.75
692138-9213824.00024.00
10min1192871-19287150.23853.6811.9350.2853.7211.93
2229220-22922059.70659.75
3207511-20751154.05154.09
4163904-16390442.69342.72
5226552-22655259.01159.05
6216459-21645956.38256.42
15min1256336-25633666.76970.665.8866.8970.795.89
2288057-28805775.03175.17
3270574-27057470.47870.61
4248876-24887664.82664.93
5286256-28625674.56274.70
6277533-27753372.29072.42
20min1292916-29291676.29779.153.9076.5379.403.91
2317235-31723582.63282.90
3302645-30264578.83179.08
4287596-28759674.91175.12
5314694-31469481.97082.23
6308152-30815280.26680.52
30min1332937-33293786.72287.382.0887.0887.762.10
2344590-34459089.75790.16
3333578-33357886.88887.27
4324881-32488184.62384.96
5341606-34160688.98089.38
6335245-33524587.32387.71
45min1358726-35872693.43993.011.2693.9493.531.28
2362609-36260994.45095.00
3355666-35566692.64293.17
4349501-34950191.03691.51
5359800-35980093.71994.26
6356236-35623692.79093.32
60min1368542-36854295.99695.560.7996.6696.240.80
2370803-37080396.58597.29
3366850-36685095.55596.23
4362354-36235494.38495.01
5367362-36736295.68896.39
6365399-36539995.17795.87
极限1377274-37727498.27096.731.0999.0997.571.09
2373590-37359097.31198.18
3366119-36611995.36596.20
4367818-36781895.80796.59
5372539-37253997.03797.90
6370903-37090396.61197.46
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)0
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%
1 11.143846833844543845783843683839463844060.08
2 11.093829933829783829860.01
单位质量响应值RSD%判断
34506.8234534.360.06数据可信
供试品溶液-BXK2XG1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%
5min1116865-11686530.44428.6213.9230.4428.6213.92
2132390-13239034.48834.49
391543-9154323.84723.85
4116781-11678130.42230.42
595159-9515924.78924.79
6106382-10638227.71327.71
10min1236193-23619361.53060.078.7261.5860.128.72
2255705-25570566.61366.67
3244716-24471663.75063.79
4226017-22601758.87958.93
5197658-19765851.49151.53
6223352-22335258.18458.23
15min1286125-28612574.53775.312.7574.6975.462.76
2300762-30076278.35078.52
3296782-29678277.31377.46
4287276-28727674.83774.99
5280701-28070173.12473.25
6282955-28295573.71173.85
20min1313486-31348681.66582.161.4381.9482.431.43
2320995-32099583.62183.92
3320095-32009583.38683.66
4315102-31510282.08682.36
5313537-31353781.67881.93
6309088-30908880.51980.79
30min1338628-33862888.21488.960.6188.6389.380.61
2342485-34248589.21989.66
3343495-34349589.48289.90
4341922-34192289.07389.48
5343222-34322289.41189.80
6339270-33927088.38288.78
45min1354664-35466492.39293.160.5992.9593.720.58
2356948-35694892.98793.57
3358037-35803793.27193.83
4358785-35878593.46594.02
5360732-36073293.97394.51
6356508-35650892.87293.42
60min1362023-36202394.30995.040.7795.0295.760.75
2362708-36270894.48795.23
3364658-36465894.99595.71
4365284-36528495.15895.87
5369967-36996796.37897.07
6364442-36444294.93995.64
极限1362428-36242894.41495.620.9095.2996.500.88
2364292-36429294.90095.80
3367580-36758095.75796.63
4369848-36984896.34797.22
5371148-37114896.68697.54
6367077-36707795.62696.49
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)0
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%
1 11.143819273820933819863824473822473821400.06
2 11.093830103828953829520.03
单位质量响应值RSD%判断
34303.4134531.290.47数据可信
供试品溶液-BXK2XG1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%
5min1133002-13300234.75228.2713.6834.7528.2713.68
2102140-10214026.68826.69
3111014-11101429.00729.01
4110907-11090728.97928.98
5104156-10415627.21527.21
687925-8792522.97422.97
10min1248452-24845264.91861.927.8664.9861.977.86
2251898-25189865.81865.86
3250753-25075365.51965.57
4240784-24078462.91462.96
5225294-22529458.86758.91
6204747-20474753.49853.54
15min1295819-29581977.29475.605.2277.4675.755.22
2302940-30294079.15579.31
3297155-29715577.64477.80
4295458-29545877.20077.35
5283085-28308573.96774.11
6261545-26154568.33968.47
20min1319137-31913783.38782.532.5083.6882.812.51
2323480-32348084.52284.81
3318485-31848583.21783.50
4320607-32060783.77184.05
5311557-31155781.40781.67
6301957-30195778.89879.14
30min1340889-34088989.07188.990.9689.5089.410.97
2345057-34505790.16090.59
3338078-33807888.33688.76
4343903-34390389.85890.28
5337968-33796888.30888.71
6337651-33765188.22588.60
45min1355702-35570292.94193.100.6893.5293.660.67
2358062-35806293.55894.14
3352794-35279492.18192.75
4359398-35939893.90794.48
5354698-35469892.67993.23
6357123-35712393.31393.83
60min1361035-36103594.33594.830.8195.0795.540.80
2365514-36551495.50596.24
3358303-35830393.62194.35
4364731-36473195.30096.03
5362244-36224494.65195.35
6365711-36571195.55796.23
极限1365274-36527495.44295.510.9896.3496.380.96
2368515-36851596.28997.18
3358974-35897493.79694.68
4367002-36700295.89496.78
5364924-36492495.35196.21
6368465-36846596.27697.11
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