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500
标示量(mg)20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 11.173761653778363779703756533781233771490.31
2 11.233762143732533747340.56
单位质量响应值RSD%判断
33764.4633369.010.84数据可信
供试品溶液-2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%
5min150501-5050113.53012.4915.3113.5312.4915.32
242336-4233611.34311.34
357366-5736615.36915.37
448105-4810512.88812.89
544746-4474611.98811.99
636629-366299.8149.81
10min1133701-13370135.82134.898.0435.8434.918.04
2121868-12186832.65132.67
3143948-14394838.56638.59
4139383-13938337.34337.36
5125210-12521033.54633.57
6117259-11725931.41631.43
15min1189748-18974850.83750.215.1950.9250.295.20
2172928-17292846.33046.40
3201971-20197154.11254.20
4191854-19185451.40151.48
5185152-18515249.60549.68
6182884-18288448.99849.07
20min1218430-21843058.52157.224.4958.6957.384.50
2197320-19732052.86553.02
3226425-22642560.66360.84
4215075-21507557.62257.79
5212280-21228056.87457.03
6211901-21190156.77256.92
30min1242740-24274065.03464.552.8465.3064.812.84
2229759-22975961.55661.80
3251030-25103067.25567.54
4240402-24040264.40864.67
5239836-23983664.25664.51
6241913-24191364.81365.06
45min1266241-26624171.33170.101.7971.7070.461.81
2254127-25412768.08568.43
3266571-26657171.41971.81
4262513-26251370.33270.70
5259014-25901469.39469.75
6261404-26140470.03570.39
60min1278405-27840574.59073.462.2675.0873.952.27
2262920-26292070.44170.90
3279866-27986674.98175.49
4275417-27541773.78974.28
5271793-27179372.81873.29
6276823-27682374.16674.64
极限1285316-28531676.44175.381.5577.0675.981.57
2274459-27445973.53274.10
3285326-28532676.44477.08
4282069-28206975.57176.18
5277846-27784674.44075.04
6283111-28311175.85076.44
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500
标示量(mg)20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 11.173766683773333740523767523737463757100.45
2 11.233732413687333709870.86
单位质量响应值RSD%判断
33635.6333035.351.28数据可信
供试品溶液-t2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%
5min144879-4487912.10814.1711.5812.1114.1711.57
249828-4982813.44313.44
350972-5097213.75213.75
458542-5854215.79415.79
561090-6109016.48116.48
649857-4985713.45113.45
10min1120395-12039532.48134.603.5732.5034.633.57
2127838-12783834.48934.51
3129107-12910734.83234.85
4132885-13288535.85135.88
5132513-13251335.75035.78
6126830-12683034.21734.24
15min1159831-15983143.12145.112.2243.1945.202.23
2167818-16781845.27545.36
3170078-17007845.88545.97
4169125-16912545.62845.71
5168112-16811245.35545.44
6168340-16834045.41645.50
20min1184784-18478449.85351.511.6350.0051.671.63
2191931-19193151.78151.94
3193421-19342152.18352.34
4191126-19112651.56451.73
5192221-19222151.85952.02
6192175-19217551.84752.00
30min1212152-21215257.23659.001.6157.4759.251.61
2221851-22185159.85360.09
3220126-22012659.38759.63
4217537-21753758.68958.94
5220790-22079059.56759.82
6219763-21976359.29059.53
45min1232975-23297562.85464.691.8463.1865.031.84
2243718-24371865.75266.09
3243149-24314965.59965.94
4236018-23601863.67564.02
5240044-24004464.76165.11
6242849-24284965.51865.86
60min1253178-25317868.30468.931.3768.7369.381.37
2261745-26174570.61671.07
3251682-25168267.90168.35
4254273-25427368.60069.05
5255902-25590269.03969.50
6256239-25623969.13069.58
极限1262770-26277070.89271.751.1271.4472.311.12
2268349-26834972.39772.97
3266919-26691972.01272.58
4261660-26166070.59371.16
5268303-26830372.38572.96
6267646-26764672.20872.77
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500
标示量(mg)20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 11.173690213741443689093720603715773711420.60
2 11.233713073761673737370.92
单位质量响应值RSD%判断
33226.6833280.230.12数据可信
供试品溶液-2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%
5min139540-3954010.6939.2821.8810.699.2821.88
231594-315948.5448.54
336262-362629.8069.81
444496-4449612.03312.03
522935-229356.2026.20
631128-311288.4188.42
10min1140744-14074438.06232.9816.4638.0833.0016.46
2112754-11275430.49230.51
3128551-12855134.76434.78
4143609-14360938.83738.86
589843-8984324.29624.31
6116320-11632031.45731.47
15min1248098-24809867.09456.9512.5167.1757.0212.51
2203919-20391955.14655.21
3221023-22102359.77259.85
4217683-21768358.86858.95
5167879-16787945.40045.45
6204880-20488055.40655.47
20min1287440-28744077.73374.116.6077.9374.286.62
2271723-27172373.48373.64
3289582-28958278.31278.49
4274292-27429274.17774.36
5240022-24002264.91065.04
6281186-28118676.04276.20
30min1316783-31678385.66885.773.4685.9986.063.47
2323380-32338087.45287.73
3326525-32652588.30388.61
4314504-31450485.05285.36
5296975-29697580.31280.55
6324804-32480487.83788.12
45min1335980-33598090.86092.331.9391.3392.771.93
2348285-34828594.18794.61
3346284-34628493.64694.10
4342279-34227992.56393.01
5331209-33120989.57089.94
6344556-34455693.17993.61
60min1345064-34506493.31695.161.6093.9395.751.60
2358147-35814796.85497.44
3352402-35240295.30195.91
4356981-35698196.53997.14
5345343-34534393.39293.91
6353426-35342695.57896.17
极限1351821-35182195.14497.381.6495.9298.121.62
2367541-36754199.395100.14
3357049-35704996.55897.32
4366172-36617299.02599.79
5359008-35900897.08797.76
6358943-35894397.07097.82
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500
标示量(mg)20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 11.173753583765643723923750713763113751390.45
2 11.233753693741653747670.23
单位质量响应值RSD%判断
33584.5133371.950.45数据可信
供试品溶液-t2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%
5min132247-322478.66210.6612.248.6610.6612.23
246922-4692212.60412.60
341571-4157111.16711.17
438084-3808410.23010.23
541094-4109411.03911.04
638253-3825310.27510.28
10min1141064-14106437.89237.756.1337.9137.776.13
2140851-14085137.83537.86
3155050-15505041.64941.67
4128413-12841334.49434.51
5140845-14084537.83437.85
6137027-13702736.80836.83
15min1222004-22200459.63558.872.6459.7158.952.65
2224058-22405860.18660.27
3226525-22652560.84960.94
4213748-21374857.41757.49
5215613-21561357.91858.00
6212902-21290257.19057.27
20min1265470-26547071.31069.382.3771.4969.562.37
2265032-26503271.19371.38
3259179-25917969.62069.81
4254959-25495968.48768.66
5250081-25008167.17767.35
6255036-25503668.50868.68
30min1299204-29920480.37280.260.9580.6780.550.95
2303892-30389281.63181.93
3295574-29557479.39779.70
4297115-29711579.81180.10
5297974-29797480.04180.33
6298876-29887680.28480.57
45min1323360-32336086.86187.451.0387.2987.881.03
2328088-32808888.13188.57
3324211-32421187.08987.53
4330646-33064688.81889.24
5325459-32545987.42487.85
6321459-32145986.35086.77
60min1331358-33135889.00990.461.3289.5891.031.32
2336352-33635290.35190.94
3343644-34364492.30992.89
4339978-33997891.32591.89
5333621-33362189.61790.19
6335561-33556190.13890.70
极限1352223-35222394.61493.441.2595.3494.171.24
2348390-34839093.58494.32
3342517-34251792.00792.74
4353500-35350094.95795.67
5345790-34579092.88693.60
6344785-34478592.61693.33
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