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FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0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%
111.143845113849203846833847283850523847790.06
211.203839163839893839520.02
单位质量响应值RSD%判断
34540.3134281.430.54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%
5min166127-6612717.29516.876.6417.3016.876.64
269694-6969418.22818.23
359363-5936315.52615.53
459153-5915315.47115.47
566794-6679417.47017.47
665837-6583717.22017.22
10min1155948-15594840.78837.9910.9740.8238.0210.98
2168940-16894044.18644.22
3124998-12499832.69332.72
4132623-13262334.68734.71
5141095-14109536.90336.93
6147840-14784038.66738.70
15min1209508-20950854.79752.908.3454.8952.998.34
2230139-23013960.19360.30
3179545-17954546.96047.04
4197492-19749251.65451.74
5194973-19497350.99551.09
6201916-20191652.81152.90
20min1244467-24446763.94062.586.4864.1362.766.49
2265792-26579269.51869.72
3219301-21930157.35857.52
4236668-23666861.90062.07
5231263-23126360.48760.66
6238133-23813362.28362.46
30min1282975-28297574.01273.673.7574.3173.963.76
2300007-30000778.46778.79
3269617-26961770.51870.77
4275614-27561472.08772.36
5276791-27679172.39472.67
6285080-28508074.56274.85
45min1311353-31135381.43481.722.7681.8582.122.76
2321375-32137584.05584.51
3303871-30387179.47779.85
4302827-30282779.20479.60
5311740-31174081.53581.93
6323476-32347684.60585.01
60min1324678-32467884.91985.652.9985.4786.192.99
2331215-33121586.62987.22
3320844-32084483.91684.42
4315629-31562982.55283.08
5328473-32847385.91286.44
6343944-34394489.95890.51
极限1350260-35026091.61091.640.9992.3192.321.01
2352746-35274692.26093.00
3350337-35033791.63092.27
4345474-34547490.35891.02
5348070-34807091.03791.71
6355336-35533692.93893.64
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FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0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%
111.143841083841473835923838393838653839100.06
211.203833913839413836660.11
单位质量响应值RSD%判断
34462.3034255.890.43数据可信
供试品溶液-24070901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%
5min166171-6617117.33331.9729.2917.3331.9629.29
2135794-13579435.57035.57
3138522-13852236.28536.28
4139035-13903536.41936.42
5161543-16154342.31542.31
691137-9113723.87323.87
10min1166647-16664743.65257.5116.1843.6857.5616.19
2231153-23115360.54960.61
3240117-24011762.89762.96
4226190-22619059.24959.31
5264034-26403469.16269.23
6189132-18913249.54249.58
15min1228340-22834059.81268.9910.1959.9169.1410.21
2271231-27123171.04771.21
3282429-28242973.98074.15
4265852-26585269.63869.80
5297221-29722177.85578.04
6235206-23520661.61061.73
20min1262705-26270568.81375.937.4269.0176.197.45
2299706-29970678.50678.78
3303042-30304279.37979.67
4291177-29117776.27176.55
5316715-31671582.96183.28
6265865-26586569.64169.87
30min1299492-29949278.44982.924.5678.7783.314.60
2326836-32683685.61286.02
3325876-32587685.36185.78
4318389-31838983.39983.80
5330829-33082986.65887.11
6297856-29785678.02178.36
45min1331646-33164686.87288.262.8087.3288.782.84
2344266-34426690.17890.73
3344954-34495490.35890.92
4338113-33811388.56689.11
5342120-34212089.61690.21
6320484-32048483.94884.42
60min1341883-34188389.55390.852.1390.1491.522.17
2353058-35305892.48193.18
3353629-35362992.63093.34
4346614-34661490.79391.48
5350991-35099191.93992.69
6334774-33477487.69188.30
极限1353162-35316292.50893.281.6093.2594.101.64
2361786-36178694.76795.62
3361321-36132194.64595.51
4355143-35514393.02793.87
5358358-35835893.86994.77
6346799-34679990.84191.60
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FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0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%
111.143832563834373835083830263833303833110.05
211.203833873832443833160.03
单位质量响应值RSD%判断
34408.5334224.640.38数据可信
供试品溶液-BXJUS91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%
5min121765-217655.7085.957.795.715.957.81
220987-209875.5045.50
325772-257726.7596.76
423591-235916.1876.19
521470-214705.6315.63
622532-225325.9095.91
10min155773-5577314.62717.2210.3314.6417.2310.31
273676-7367619.32319.33
372916-7291619.12319.13
464781-6478116.99017.00
561994-6199416.25916.27
664802-6480216.99517.01
15min188459-8845923.20026.288.6923.2326.318.69
2112372-11237229.47129.51
3108369-10836928.42128.46
497472-9747225.56425.60
596539-9653925.31925.36
697911-9791125.67925.72
20min1113234-11323429.69733.307.8429.7733.387.84
2141726-14172637.17037.26
3134763-13476335.34435.43
4123233-12323332.32032.40
5123657-12365732.43132.51
6125207-12520732.83832.92
30min1150194-15019439.39143.346.1739.5143.486.18
2180260-18026047.27647.43
3172249-17224945.17545.32
4162186-16218642.53642.67
5162629-16262942.65242.78
6163994-16399443.01043.15
45min1187914-18791449.28353.424.7249.4753.624.73
2217000-21700056.91257.14
3208657-20865754.72454.95
4201098-20109852.74152.95
5202280-20228053.05153.25
6205087-20508753.78753.99
60min1213909-21390956.10160.214.1156.3760.514.12
2242103-24210363.49563.82
3234811-23481161.58361.90
4226288-22628859.34859.64
5231281-23128160.65760.95
6229109-22910960.08760.38
极限1250044-25004465.57866.571.6565.9466.971.67
2261260-26126068.52068.95
3256016-25601667.14467.56
4250749-25074965.76366.16
5252545-25254566.23466.63
6252440-25244066.20666.60
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FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0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%
111.143828613827863829523826893831853828950.05
211.203831303825843828570.11
单位质量响应值RSD%判断
34371.1834183.660.39数据可信
供试品溶液-24070901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%
5min172590-7259019.06018.279.0519.0618.279.04
276221-7622120.01320.01
374772-7477219.63319.63
459287-5928715.56715.57
566402-6640217.43517.43
668196-6819617.90617.91
10min1138552-13855236.37933.3710.6236.4133.4110.61
2132135-13213534.69434.73
3140907-14090736.99737.03
4105045-10504527.58127.61
5118378-11837831.08231.11
6127645-12764533.51533.55
15min1172114-17211445.19142.547.0545.2842.627.06
2165938-16593843.57043.66
3173260-17326045.49245.59
4142446-14244637.40137.47
5157159-15715941.26541.35
6161161-16116142.31542.40
20min1191952-19195250.40048.385.1950.5748.535.20
2186286-18628648.91249.08
3195168-19516851.24451.41
4168005-16800544.11244.25
5182524-18252447.92448.07
6181532-18153247.66447.82
30min1216528-21652856.85355.513.5157.1055.753.52
2212495-21249555.79456.04
3220464-22046457.88658.14
4199016-19901652.25552.46
5211948-21194855.65055.88
6208039-20803954.62454.86
45min1240897-24089763.25162.002.6663.6062.332.68
2237497-23749762.35962.70
3244219-24421964.12364.48
4226559-22655959.48759.78
5235153-23515361.74362.07
6232397-23239761.01961.35
60min1256531-25653167.35666.162.0567.8166.592.07
2253405-25340566.53566.98
3258449-25844967.86068.32
4246061-24606164.60765.00
5251076-25107665.92466.35
6246252-24625264.65765.09
极限1266331-26633169.92968.291.8070.4968.831.81
2261806-26180668.74169.29
3263785-26378569.26169.83
4254706-25470666.87767.38
5258244-25824467.80668.34
6255559-25555967.10167.64
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