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%
111.291930001931131928691929511928641929590.06
211.331913081913111913100.01
单位质量响应值RSD%判断
17091.1416885.260.86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%
5min15087-50872.6936.3754.092.696.3754.12
27959-79594.2134.21
318718-187189.9099.91
419434-1943410.28810.29
55875-58753.1103.11
615084-150847.9857.99
10min123002-2300212.17724.6547.2012.1824.6647.20
234828-3482818.43718.44
370438-7043837.28837.30
464674-6467434.23734.25
523204-2320412.28412.29
663266-6326633.49133.50
15min149273-4927326.08444.4637.6326.1144.5137.64
269558-6955836.82236.86
3116541-11654161.69461.77
4109178-10917857.79657.87
549289-4928926.09226.12
6110080-11008058.27458.34
20min177901-7790141.23963.5631.3141.3163.6931.33
2106560-10656056.41056.51
3157178-15717883.20683.39
4151376-15137680.13580.31
577198-7719840.86740.94
6150212-15021279.51879.68
30min1124923-12492366.13184.6316.3366.2784.8616.38
2162200-16220085.86586.06
3176339-17633993.34993.67
4183423-18342397.10097.40
5130416-13041669.03969.18
6181874-18187496.28096.58
45min1155326-15532682.22695.308.1482.4795.678.21
2181389-18138996.02396.36
3184533-18453397.68798.16
4194092-194092102.747103.21
5171639-17163990.86191.11
6193131-193131102.239102.70
60min1168911-16891189.41799.395.6689.8099.925.73
2187800-18780099.41799.91
3187723-18772399.376100.01
4198049-198049104.842105.48
5186226-18622698.58398.99
6197811-197811104.716105.35
极限1192885-192885102.109104.262.09102.64104.962.11
2197914-197914104.771105.43
3190955-190955101.087101.89
4200969-200969106.388107.20
5198532-198532105.098105.67
6200454-200454106.115106.92
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%
111.291909861909631906941907161908021908320.08
211.331897101896761896930.02
单位质量响应值RSD%判断
16902.7516742.540.68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%
5min114511-145117.7578.6116.807.768.6116.77
211627-116276.2166.22
316732-167328.9458.94
419070-1907010.19410.19
518279-182799.7729.77
616398-163988.7668.77
10min156442-5644230.17331.817.4530.1931.837.46
252496-5249628.06328.07
360396-6039632.28632.30
464532-6453234.49734.51
563169-6316933.76933.79
660048-6004832.10032.11
15min1101396-10139654.20455.843.7054.2755.913.71
2104105-10410555.65255.71
399110-9911052.98253.05
4108955-10895558.24558.32
5108491-10849157.99758.07
6104692-10469255.96656.03
20min1126761-12676167.76470.343.3867.9270.503.38
2132011-13201170.57070.72
3125630-12563067.15967.32
4135051-13505172.19572.37
5136448-13644872.94273.11
6133613-13361371.42671.59
30min1152524-15252481.53684.802.6881.8085.082.69
2157615-15761584.25784.52
3155004-15500482.86283.13
4161854-16185486.52386.82
5162786-16278687.02287.31
6161981-16198186.59186.87
45min1173476-17347692.73695.301.9793.1495.721.98
2176008-17600894.09094.50
3176252-17625294.22094.63
4180150-18015096.30496.74
5182118-18211897.35697.79
6181594-18159497.07697.50
60min1183288-18328897.982100.281.6798.54100.861.68
2185655-18565599.24799.81
3186328-18632899.607100.17
4188089-188089100.548101.14
5191445-191445102.342102.94
6190768-190768101.980102.57
极限1189882-189882101.507103.491.41102.23104.241.42
2192466-192466102.888103.62
3192678-192678103.001103.73
4193023-193023103.186103.95
5197518-197518105.589106.36
6195968-195968104.760105.52
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%
111.291904131903501900991902901905811903470.10
211.331898991900391899690.06
单位质量响应值RSD%判断
16859.7916766.900.40数据可信
供试品溶液-2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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min16418-64183.4333.3711.353.433.3611.28
26215-62153.3243.32
37020-70203.7553.75
46050-60503.2363.24
55078-50782.7162.72
66971-69713.7293.73
15min114120-141207.5526.4915.737.566.4915.75
210597-105975.6685.67
313423-134237.1797.19
412594-125946.7366.74
59077-90774.8554.86
612948-129486.9256.93
20min122034-2203411.78511.1913.5411.8011.2113.54
221717-2171711.61611.63
323250-2325012.43612.45
420438-2043810.93210.95
515478-154788.2798.29
622644-2264412.11112.13
30min130209-3020916.15815.9113.8316.2015.9513.81
233886-3388618.12418.16
332032-3203217.13317.17
428357-2835715.16715.20
522266-2226611.90911.94
631770-3177016.99317.03
45min135119-3511918.78418.5811.0018.8518.6411.01
238741-3874120.72120.79
337068-3706819.82619.89
433958-3395818.16318.22
527705-2770514.81814.86
635847-3584719.17319.24
60min137266-3726619.93219.828.6020.0319.918.61
240196-4019621.49921.60
338983-3898320.85120.95
436700-3670019.63019.72
531066-3106616.61616.69
638092-3809220.37420.47
极限140381-4038121.59821.572.5821.7321.692.62
241911-4191122.41722.55
340016-4001621.40321.54
440648-4064821.74121.86
538689-3868920.69320.79
640294-4029421.55221.68
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