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%
1 11.293817883817403810503809623829253816930.21
2 11.333797793774243786020.44
单位质量响应值RSD%判断
33808.0633415.890.83数据可信
供试品溶液-1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%
5min113996-139963.7457.5938.303.747.5938.33
246889-4688912.54512.55
324773-247736.6286.63
424021-240216.4276.43
531186-311868.3448.34
629367-293677.8577.86
10min172402-7240219.37228.8123.0619.3828.8223.07
2148834-14883439.82239.84
399856-9985626.71726.73
4101317-10131727.10827.12
5109806-10980629.37929.39
6113898-11389830.47430.49
15min1161863-16186343.30854.4712.2843.3554.5312.29
2237377-23737763.51263.60
3192787-19278751.58151.64
4209327-20932756.00756.06
5212101-21210156.74956.81
6207961-20796155.64155.71
20min1225562-22556260.35168.336.7360.4668.486.75
2271235-27123572.57172.76
3244256-24425665.35265.49
4263119-26311970.39970.55
5263700-26370070.55570.71
6264408-26440870.74470.90
30min1283796-28379675.93180.143.1876.1480.403.21
2306806-30680682.08882.40
3292476-29247678.25478.50
4307230-30723082.20182.47
5300930-30093080.51680.79
6305900-30590081.84682.12
45min1313732-31373283.94186.951.9384.2887.361.95
2326272-32627287.29687.75
3326562-32656287.37487.75
4329408-32940888.13588.54
5322722-32272286.34686.76
6331273-33127388.63489.05
60min1329494-32949488.15889.931.2388.6490.471.25
2336690-33669090.08490.68
3335552-33555289.77990.31
4339947-33994790.95591.51
5334096-33409689.39089.94
6340810-34081091.18691.74
极限1347040-34704092.85393.340.8393.4894.040.82
2347268-34726892.91493.66
3349031-34903193.38694.06
4354123-35412394.74895.45
5349563-34956393.52894.23
6346209-34620992.63193.34
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%
1 11.293792863785163797193777923788283788280.20
2 11.333778323781333779820.06
单位质量响应值RSD%判断
33554.3033361.170.41数据可信
供试品溶液-1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%
5min117351-173514.66410.6452.364.6610.6452.35
270514-7051418.95318.95
352518-5251814.11614.12
439242-3924210.54810.55
541168-4116811.06511.07
616656-166564.4774.48
10min184388-8438822.68231.3122.5122.6931.3322.52
2138531-13853137.23537.27
3140167-14016737.67537.70
4123227-12322733.12133.14
5129891-12989134.91334.93
682818-8281822.26022.27
15min1147704-14770439.70044.9012.0239.7544.9712.05
2178114-17811447.87447.97
3186824-18682450.21550.30
4171912-17191246.20746.28
5180815-18081548.60048.68
6136820-13682036.77536.82
20min1184482-18448249.58653.267.1049.7053.417.13
2202362-20236254.39254.56
3213690-21369057.43657.61
4201031-20103154.03454.18
5209440-20944056.29456.45
6177963-17796347.83347.94
30min1228538-22853861.42763.303.8361.6263.543.85
2232193-23219362.41062.67
3246511-24651166.25866.52
4233820-23382062.84763.09
5246550-24655066.26866.52
6225509-22550960.61360.80
45min1263028-26302870.69871.242.2870.9971.582.30
2258134-25813469.38269.75
3272003-27200373.11073.49
4265400-26540071.33571.68
5272235-27223573.17273.53
6259521-25952169.75570.04
60min1279812-27981275.20975.781.8575.6276.241.86
2274651-27465173.82274.31
3287113-28711377.17177.67
4283440-28344076.18476.65
5288081-28808177.43177.92
6278618-27861874.88875.29
极限1293033-29303378.76278.912.0679.3079.492.07
2285747-28574776.80477.41
3299563-29956380.51781.14
4292786-29278678.69679.29
5301440-30144081.02281.63
6288899-28889977.65178.18
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%
1 11.293787153779983765083779213777813777850.22
2 11.333774063769453771760.09
单位质量响应值RSD%判断
33461.9133290.030.37数据可信
供试品溶液-1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%
5min1-0.0000.34244.950.000.34244.95
27573-75732.0402.04
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min112171-121713.2794.5729.033.284.5729.06
226213-262137.0637.07
316767-167674.5184.52
415424-154244.1564.16
517316-173164.6664.67
613812-138123.7223.72
15min126645-266457.1797.5419.337.187.5519.36
238231-3823110.30110.32
326167-261677.0507.06
426252-262527.0737.08
528484-284847.6757.68
622238-222385.9926.00
20min134340-343409.2539.3415.969.279.3616.01
244446-4444611.97612.01
334078-340789.1829.20
433371-333718.9929.01
534528-345289.3039.32
627235-272357.3387.35
30min146093-4609312.41911.8711.9712.4511.9112.00
252978-5297814.27414.33
342951-4295111.57311.61
443227-4322711.64711.68
542038-4203811.32711.36
637047-370479.98210.01
45min157737-5773715.55714.3211.2015.6114.3811.22
262061-6206116.72216.80
352096-5209614.03714.09
451950-5195013.99714.05
549739-4973913.40213.46
645256-4525612.19412.24
60min164972-6497217.50615.949.6117.5916.029.64
266361-6636117.88017.98
357489-5748915.49015.57
459181-5918115.94616.02
555495-5549514.95315.03
651438-5143813.86013.92
极限176764-7676420.68320.241.5020.7920.351.53
275300-7530020.28920.42
375139-7513920.24620.35
475364-7536420.30620.41
574985-7498520.20420.31
673248-7324819.73619.82
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