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%
110.853722043715823711033720143697123713230.27
210.863682333686953684640.09
单位质量响应值RSD%判断
34223.3233928.550.62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%
5min167506-6750617.81515.5725.0217.8215.5725.03
258624-5862415.47115.47
364865-6486517.11917.12
479033-7903320.85820.86
540611-4061110.71810.72
643401-4340111.45411.45
10min1194289-19428951.27546.2217.1051.3046.2417.10
2173095-17309545.68145.71
3184099-18409948.58648.61
4216775-21677557.20957.24
5141011-14101137.21437.23
6141502-14150237.34437.36
15min1274040-27404072.32266.7214.0772.4466.8214.08
2271659-27165971.69371.80
3269865-26986571.22071.33
4286071-28607175.49775.63
5203457-20345753.69453.77
6211774-21177455.88955.97
20min1303212-30321280.02175.5010.9080.2675.7210.92
2309014-30901481.55281.77
3301139-30113979.47379.70
4310663-31066381.98782.24
5241562-24156263.75163.92
6251011-25101166.24466.42
30min1328015-32801586.56683.837.0286.9484.177.04
2336651-33665188.84589.20
3328713-32871386.75187.11
4333386-33338687.98488.38
5284118-28411874.98175.26
6294929-29492977.83578.12
45min1344999-34499991.04990.053.6991.5690.533.73
2353849-35384993.38493.89
3345432-34543291.16391.67
4351105-35110592.66093.20
5321618-32161884.87885.28
6330361-33036187.18587.60
60min1354933-35493393.67093.182.6894.3493.812.72
2364643-36464396.23396.89
3354466-35446693.54794.20
4359239-35923994.80795.50
5337641-33764189.10789.65
6347636-34763691.74592.30
极限1362170-36217095.58095.382.1396.4096.162.17
2370114-37011497.67798.50
3362467-36246795.65996.47
4364438-36443896.17997.03
5346989-34698991.57492.26
6362215-36221595.59296.30
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%
110.851832551837841837041829231834081834150.20
210.861829531830311829920.04
单位质量响应值RSD%判断
16904.6116850.090.23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%
5min144808-4480823.87520.4616.1523.8820.4716.14
236946-3694619.68619.69
339072-3907220.81920.82
441443-4144322.08222.08
526942-2694214.35614.36
641237-4123721.97221.97
10min1107548-10754857.30554.879.8557.3554.919.85
2100568-10056853.58653.62
3104157-10415755.49855.53
4101085-10108553.86253.90
586766-8676646.23246.26
6117785-11778562.76062.80
15min1141219-14121975.24676.256.3175.3876.386.31
2135077-13507771.97472.10
3149579-14957979.70179.83
4136817-13681772.90173.03
5137743-13774373.39473.50
6158223-15822384.30784.45
20min1158607-15860784.51185.294.5284.7785.554.53
2152445-15244581.22881.47
3167460-16746089.22889.49
4153969-15396982.04082.29
5157699-15769984.02784.25
6170266-17026690.72391.01
30min1177329-17732994.48794.512.1294.8994.902.13
2172038-17203891.66892.05
3181058-18105896.47496.88
4174768-17476893.12293.51
5177022-17702294.32394.69
6181977-18197796.96497.40
45min1188054-188054100.202100.130.96100.76100.680.96
2185231-18523198.69799.23
3188856-188856100.629101.20
4186482-18648299.36499.90
5190204-190204101.347101.87
6188713-188713100.553101.15
60min1193406-193406103.053102.620.90103.78103.340.90
2191927-191927102.265102.96
3192767-192767102.713103.45
4189553-189553101.000101.71
5194615-194615103.697104.39
6193273-193273102.982103.74
极限1194850-194850103.823104.040.65104.72104.930.63
2195984-195984104.427105.29
3195907-195907104.386105.29
4193843-193843103.286104.16
5197024-197024104.981105.84
6193925-193925103.330104.26
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%
110.853684233675983690543690343682933684800.17
210.863689213683633686420.11
单位质量响应值RSD%判断
33961.2933944.940.04数据可信
供试品溶液-24102801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%
5min199276-9927626.29421.6229.7626.2921.6229.77
239923-3992310.57410.57
382190-8219021.76921.77
494751-9475125.09625.10
568498-6849818.14218.14
6105197-10519727.86227.86
10min1217939-21793957.72352.6623.3657.7752.7023.36
2107602-10760228.49928.52
3206562-20656254.71054.75
4223384-22338459.16559.21
5200938-20093853.22053.25
6236599-23659962.66562.71
15min1263590-26359069.81468.8813.2269.9569.0013.24
2193333-19333351.20651.27
3258383-25838368.43568.56
4283283-28328375.03075.17
5276551-27655173.24773.37
6285168-28516875.52975.68
20min1288790-28879076.48976.559.4076.7576.799.43
2236838-23683862.72962.88
3288469-28846976.40476.65
4310213-31021382.16382.43
5302822-30282280.20580.45
6306974-30697481.30581.58
30min1318018-31801884.23084.266.9184.6184.636.94
2275658-27565873.01173.27
3319356-31935684.58484.95
4336537-33653789.13589.54
5328419-32841986.98587.36
6330869-33086987.63488.05
45min1339250-33925089.85489.964.3190.3890.464.36
2311751-31175182.57082.95
3341380-34138090.41890.93
4354317-35431793.84494.40
5344237-34423791.17491.69
6346896-34689691.87992.44
60min1350745-35074592.89893.142.6293.5793.792.67
2335729-33572988.92189.44
3350805-35080592.91493.57
4364019-36401996.41497.12
5354009-35400993.76394.43
6354546-35454693.90594.62
极限1360401-36040195.45695.821.2996.2896.631.34
2355268-35526894.09694.76
3362511-36251196.01496.83
4369387-36938797.83698.70
5363233-36323396.20697.03
6359839-35983995.30796.17
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