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%
110.801899461896611895901897491894891896870.10
210.881886521885511886020.04
单位质量响应值RSD%判断
17563.6117334.740.93数据可信
供试品溶液-2025042521批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min125577-2557713.18221.3422.7013.1821.3422.71
249128-4912825.32025.32
344869-4486923.12523.13
437061-3706119.10119.10
551389-5138926.48626.49
640437-4043720.84120.84
10min193641-9364148.26260.5815.4448.2860.6215.45
2142498-14249873.44273.48
3125446-12544664.65464.69
4101053-10105352.08252.11
5128021-12802165.98166.03
6114634-11463459.08259.12
15min1134431-13443169.28579.118.3469.3979.258.35
2167213-16721386.18086.35
3156544-15654480.68280.83
4141334-14133472.84372.96
5162240-16224083.61783.77
6159218-15921882.06082.19
20min1150110-15011077.36684.685.6077.5884.945.62
2173722-17372289.53589.84
3166144-16614485.62985.91
4156229-15622980.51980.76
5171192-17119288.23188.52
6168396-16839686.79087.06
30min1164364-16436484.71289.253.3585.0689.663.38
2179280-17928092.40092.86
3173181-17318189.25689.68
4168396-16839686.79087.16
5177814-17781491.64492.08
6176007-17600790.71391.13
45min1172859-17285989.09091.812.2189.5892.372.24
2182637-18263794.13094.74
3176595-17659591.01691.59
4175174-17517490.28390.80
5182184-18218493.89694.49
6179396-17939692.45993.03
60min1176341-17634190.88592.692.0091.5293.402.03
2183930-18393094.79695.56
3177795-17779591.63492.36
4176426-17642690.92991.60
5184267-18426794.97095.72
6180337-18033792.94493.66
极限1182409-18240994.01294.810.8894.8095.680.92
2186347-18634796.04296.97
3182561-18256194.09194.97
4182972-18297294.30395.12
5185386-18538695.54796.45
6184072-18407294.86995.74
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%
110.801882431884021879261883761880981882090.11
210.881876701876731876720.01
单位质量响应值RSD%判断
17426.7617249.260.73数据可信
供试品溶液-BXK5AZ2批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138153-3815319.79022.158.5519.7922.158.55
246477-4647724.10724.11
343122-4312222.36722.37
438964-3896420.21020.21
542624-4262422.10922.11
646878-4687824.31524.32
10min182248-8224842.66153.0014.6342.6953.0314.62
287233-8723345.24745.29
3110971-11097157.55957.60
4109246-10924656.66556.70
5101969-10196952.89052.93
6121363-12136362.95062.99
15min1129110-12911066.96876.669.2867.0776.799.28
2134238-13423869.62869.74
3158581-15858182.25482.39
4153272-15327279.50079.63
5147688-14768876.60476.73
6163925-16392585.02685.17
20min1150085-15008577.84785.496.4378.0685.746.44
2153417-15341779.57679.81
3173201-17320189.83790.11
4168763-16876387.53687.80
5167669-16766986.96887.22
6175734-17573491.15191.44
30min1164448-16444885.29790.984.3285.6491.374.34
2167005-16700586.62486.99
3181206-18120693.99094.41
4180307-18030793.52393.93
5178901-17890192.79493.19
6180529-18052993.63894.08
45min1172273-17227389.35693.463.1589.8494.013.17
2173559-17355990.02390.53
3184092-18409295.48696.06
4184172-18417295.52896.09
5184013-18401395.44696.00
6183022-18302294.93195.53
60min1176836-17683691.72394.322.7492.3695.032.76
2174294-17429490.40491.06
3184311-18431195.60096.34
4185965-18596596.45897.18
5185440-18544096.18696.90
6184247-18424795.56796.32
极限1186237-18623796.59997.480.4797.3998.340.50
2187907-18790797.46598.27
3188542-18854297.79598.69
4188572-18857297.81098.69
5188186-18818697.61098.48
6188181-18818197.60798.52
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%
110.801874251873131871171875221876601874070.12
210.881877991878651878320.03
单位质量响应值RSD%判断
17352.5017263.970.37数据可信
供试品溶液-2025042521批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min125663-2566313.33413.2737.1713.3313.2737.19
230636-3063615.91815.92
316953-169538.8088.81
441313-4131321.46521.47
522951-2295111.92511.92
615769-157698.1938.19
10min180723-8072341.94140.9325.0741.9640.9525.08
290204-9020446.86746.89
352976-5297627.52527.54
4109528-10952856.90856.94
573827-7382738.35838.38
665383-6538333.97133.98
15min1131675-13167568.41564.9214.8868.5165.0114.90
2127305-12730566.14466.25
393906-9390648.79148.85
4150881-15088178.39378.52
5127015-12701565.99366.08
6118869-11886961.76161.83
20min1151652-15165278.79476.038.3279.0076.238.35
2148284-14828477.04477.26
3126421-12642165.68565.83
4162826-16282684.60084.86
5148438-14843877.12477.32
6140392-14039272.94473.12
30min1166918-16691886.72685.024.3287.0685.354.36
2164656-16465685.55085.89
3151077-15107778.49578.75
4172343-17234389.54489.95
5164834-16483485.64385.97
6161995-16199584.16884.46
45min1178201-17820192.58891.641.4493.0792.111.48
2174481-17448190.65591.14
3173999-17399990.40590.79
4180591-18059193.83094.38
5175227-17522791.04391.51
6175812-17581291.34791.78
60min1183051-18305195.10894.621.0595.7495.241.06
2181452-18145294.27794.91
3183124-18312495.14695.68
4184716-18471695.97396.68
5179339-17933993.17993.80
6180993-18099394.03994.63
极限1184750-18475095.99196.200.6896.7996.980.70
2186858-18685897.08697.88
3185574-18557496.41997.11
4186129-18612996.70797.58
5183763-18376395.47896.25
6183846-18384695.52196.27
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%
110.801875601881521880521878251878581878890.13
210.881872741874921873830.09
单位质量响应值RSD%判断
17397.1317222.700.72数据可信
供试品溶液-BXK5AZ2批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min149275-4927525.60021.1831.4125.6021.1831.41
247055-4705524.44724.45
316419-164198.5308.53
444570-4457023.15523.16
550146-5014626.05226.05
637194-3719419.32319.32
10min1113416-11341658.92353.1516.9458.9753.1816.94
2121779-12177963.26863.31
371146-7114636.96336.98
4100086-10008651.99852.04
5106650-10665055.40855.45
6100712-10071252.32352.36
15min1159157-15915782.68777.078.6682.8377.198.67
2162471-16247184.40984.55
3125979-12597965.45065.53
4145756-14575675.72575.85
5147830-14783076.80276.94
6148828-14882877.32177.44
20min1174515-17451590.66687.025.0890.9487.275.10
2177767-17776792.35592.64
3154588-15458880.31380.50
4166363-16636386.43186.68
5161833-16183384.07784.34
6169948-16994888.29388.54
30min1182675-18267594.90594.243.1895.3494.643.20
2188562-18856297.96498.40
3173623-17362390.20290.52
4182915-18291595.03095.43
5175434-17543491.14391.55
6185187-18518796.21096.61
45min1188686-18868698.02899.442.0598.6299.992.06
2195909-195909101.781102.38
3189028-18902898.20698.67
4186379-18637996.83097.38
5195398-195398101.515102.07
6192963-192963100.250100.81
60min1191080-19108099.272100.782.04100.02101.502.03
2197843-197843102.785103.56
3195331-195331101.480102.11
4187701-18770197.51698.23
5197608-197608102.663103.39
6194324-194324100.957101.68
极限1192684-192684100.105101.301.38101.02102.191.38
2198174-198174102.957103.90
3195900-195900101.776102.58
4191829-19182999.661100.54
5197777-197777102.751103.65
6193583-193583100.572101.46
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