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 11.143829313826033829003829833827293828290.05
2 11.093808863811753810300.06
单位质量响应值RSD%判断
34365.2634357.980.02数据可信
供试品溶液-BXJUS91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%
5min190025-9002523.56023.096.0623.5623.096.07
278722-7872220.60220.60
390244-9024423.61823.62
485512-8551222.37922.38
593578-9357824.49024.49
691246-9124623.88023.88
10min1192003-19200350.24956.298.7150.2956.328.70
2196592-19659251.45051.48
3217475-21747556.91656.95
4217044-21704456.80356.84
5243044-24304463.60763.65
6224282-22428258.69758.74
15min1251279-25127965.76272.555.6365.8972.695.63
2268375-26837570.23770.36
3277485-27748572.62172.75
4285344-28534474.67874.81
5295325-29532577.29077.44
6285550-28555074.73174.87
20min1290870-29087076.12480.022.8876.3680.272.89
2300411-30041178.62178.86
3306459-30645980.20480.46
4311223-31122381.45081.71
5314864-31486482.40382.68
6310663-31066381.30481.57
30min1325802-32580285.26687.131.3585.6387.521.36
2329540-32954086.24486.61
3333218-33321887.20787.60
4336942-33694288.18188.57
5337108-33710888.22588.64
6334915-33491587.65188.05
45min1347618-34761890.97591.620.5391.4892.150.54
2348878-34887891.30591.82
3350770-35077091.80092.33
4352810-35281092.33492.87
5350938-35093891.84492.40
6349383-34938391.43791.98
60min1356680-35668093.34793.410.5894.0094.100.58
2355818-35581893.12193.79
3357453-35745393.54994.24
4360781-36078194.42095.11
5355742-35574293.10193.81
6355104-35510492.93493.63
极限1360771-36077194.41893.990.7895.2394.830.77
2358020-35802093.69894.52
3359412-35941294.06294.91
4363533-36353395.14095.99
5355601-35560193.06593.93
6357416-35741693.54094.39
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)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 11.143810713804323812023808373801443807370.12
2 11.093800343804253802300.08
单位质量响应值RSD%判断
34177.4734285.840.23数据可信
供试品溶液-BXJUS91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%
5min198172-9817225.79021.9223.4325.7921.9223.44
2103654-10365427.23027.23
394055-9405524.70924.71
473917-7391719.41819.42
580115-8011521.04721.05
650719-5071913.32413.32
10min1238767-23876762.72557.7111.3662.7757.7411.37
2236362-23636262.09362.14
3222369-22236958.41758.46
4171594-17159445.07945.11
5231733-23173360.87760.91
6217204-21720457.06157.08
15min1293013-29301376.97673.835.9477.1273.965.95
2289224-28922475.98176.13
3281766-28176674.02174.16
4248182-24818265.19965.31
5290917-29091776.42576.56
6283051-28305174.35974.48
20min1316236-31623683.07780.903.5083.3581.153.51
2311701-31170181.88582.16
3309211-30921181.23181.49
4286746-28674675.33075.55
5314537-31453782.63082.89
6309255-30925581.24381.48
30min1338093-33809388.81987.521.9689.2387.921.98
2335469-33546988.12988.54
3334135-33413587.77988.18
4320269-32026984.13684.48
5336835-33683588.48888.89
6334199-33419987.79688.17
45min1350690-35069092.12891.701.0692.6992.231.08
2350252-35025292.01392.57
3350889-35088992.18092.72
4341764-34176489.78390.27
5351761-35176192.40992.96
6348900-34890091.65892.18
60min1356723-35672393.71392.981.6194.4393.671.63
2355624-35562493.42494.14
3354509-35450993.13193.83
4342584-34258489.99890.63
5358228-35822894.10894.81
6355876-35587693.49094.17
极限1358515-35851594.18494.160.5395.0695.000.55
2357855-35785594.01094.88
3358675-35867594.22695.08
4355176-35517693.30694.09
5360766-36076694.77595.63
6359535-35953594.45295.28
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 11.143791143787493781503792163778283786110.16
2 11.093780753792513786630.22
单位质量响应值RSD%判断
33986.6234144.540.33数据可信
供试品溶液-BXJUS91批-pH4.5(内含%Tween)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1141726-14172637.41438.5617.9337.4138.5617.93
2173616-17361645.83245.83
3136770-13677036.10536.11
4114013-11401330.09830.10
5181303-18130347.86247.86
6128884-12888434.02434.02
10min1287317-28731775.84879.529.0875.9179.599.08
2305003-30500380.51780.59
3302921-30292179.96780.03
4279391-27939173.75573.81
5352345-35234593.01493.09
6280434-28043474.03174.09
15min1331347-33134787.47191.583.7887.6691.783.79
2359055-35905594.78695.00
3346627-34662791.50591.70
4340634-34063489.92390.10
5365650-36565096.52796.76
6338242-33824289.29189.47
20min1354825-35482593.66995.851.4094.0096.201.41
2367766-36776697.08597.45
3360502-36050295.16895.51
4362369-36236995.66095.98
5368310-36831097.22997.62
6364796-36479696.30196.63
30min1366869-36686996.84897.450.5497.3497.960.53
2370487-37048797.80398.33
3367098-36709896.90997.41
4370009-37000997.67798.16
5368668-36866897.32397.88
6371815-37181598.15498.64
45min1365928-36592896.60097.410.6197.2598.080.61
2370608-37060897.83598.53
3367200-36720096.93697.60
4370415-37041597.78498.43
5368163-36816397.19097.91
6371659-37165998.11398.77
60min1365075-36507596.37597.220.6697.1998.060.65
2369828-36982897.63098.49
3366089-36608996.64297.47
4371057-37105797.95498.76
5367520-36752097.02097.90
6370138-37013897.71198.53
极限1365142-36514296.39297.060.5297.3798.060.51
2368672-36867297.32498.34
3366150-36615096.65997.65
4369397-36939797.51698.49
5366874-36687496.85097.89
6369851-36985197.63698.61
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 11.143795763785883806473794683789973794550.21
2 11.093795083792093793580.06
单位质量响应值RSD%判断
34062.3934207.210.30数据可信
供试品溶液-BXJUS91批-pH4.5(内含%Tween)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1159938-15993842.13640.533.0842.1440.533.08
2159286-15928641.96441.96
3150667-15066739.69339.69
4152872-15287240.27440.27
5152038-15203840.05540.05
6148313-14831339.07339.07
10min1305878-30587880.58487.185.6680.6587.245.66
2314827-31482782.94183.01
3325801-32580185.83385.90
4355315-35531593.60893.68
5344037-34403790.63790.70
6339534-33953489.45189.52
15min1347623-34762391.58294.952.5391.7995.162.53
2354701-35470193.44693.65
3355266-35526693.59593.80
4368122-36812296.98297.21
5367022-36702296.69296.91
6369743-36974397.40997.62
20min1368366-36836697.04697.030.8097.4097.400.80
2368014-36801496.95497.32
3362992-36299295.63196.00
4369386-36938697.31597.70
5369265-36926597.28397.66
6371770-37177097.94398.32
30min1369651-36965197.38597.270.6497.9097.800.64
2371608-37160897.90098.43
3365718-36571896.34996.87
4369918-36991897.45598.00
5367133-36713396.72197.26
6371342-37134297.83098.37
45min1368824-36882497.16797.200.6197.8597.890.61
2371219-37121997.79898.49
3366650-36665096.59497.28
4367216-36721696.74397.45
5367617-36761796.84997.55
6372067-37206798.02198.72
60min1366289-36628996.49996.750.6897.3497.600.68
2367797-36779796.89697.75
3365072-36507296.17997.02
4366862-36686296.65097.52
5365527-36552796.29897.16
6371898-37189897.97798.84
极限1368911-36891197.19096.870.5998.1997.890.59
2368776-36877697.15498.17
3365329-36532996.24697.25
4366444-36644496.54097.57
5365851-36585196.38497.41
6370843-37084397.69998.73
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