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 11.201923711924001919981922561921221922290.09
2 11.181909001920381914690.43
单位质量响应值RSD%判断
17163.3017126.030.16数据可信
供试品溶液-25040101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%
5min129595-2959515.52323.0264.3615.5223.0264.37
225049-2504913.13913.14
326180-2618013.73213.73
498180-9818051.49851.50
533143-3314317.38417.38
651199-5119926.85526.86
10min198902-9890251.87756.7919.5851.9056.8319.61
297408-9740851.09351.11
390652-9065247.54947.57
4149309-14930978.31678.40
5102202-10220253.60853.64
6111166-11116658.30958.35
15min1139540-13954073.19273.108.9173.3073.238.95
2133349-13334969.94570.05
3128744-12874467.52967.63
4163067-16306785.53385.75
5131723-13172369.09269.21
6139769-13976973.31273.45
20min1153371-15337180.44780.025.9080.6880.275.95
2149878-14987878.61578.84
3144313-14431375.69675.91
4169225-16922588.76389.12
5145432-14543276.28376.52
6153080-15308080.29480.56
30min1164264-16426486.16186.563.6986.5386.953.74
2165406-16540686.76087.11
3160040-16004083.94584.29
4175918-17591892.27392.78
5158715-15871583.25083.61
6165809-16580986.97187.37
45min1170556-17055689.46190.152.6589.9790.682.70
2172875-17287590.67791.18
3169754-16975489.04089.52
4179907-17990794.36695.03
5166274-16627487.21587.71
6171798-17179890.11290.66
60min1172935-17293590.70991.742.3991.3792.432.43
2175472-17547292.03992.69
3173983-17398391.25891.89
4181933-18193395.42896.25
5169302-16930288.80389.45
6175827-17582792.22692.92
极限1182011-18201195.46995.840.7796.2896.680.80
2184671-18467196.86597.67
3182628-18262895.79396.57
4184100-18410096.56597.54
5181049-18104994.96595.76
6181851-18185195.38596.23
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 11.201904981906131906501905811909681906620.10
2 11.181902471901951902210.02
单位质量响应值RSD%判断
17023.3917014.400.04数据可信
供试品溶液-25040101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%
5min138947-3894720.58024.3315.5020.5824.3315.50
239823-3982321.04321.04
345665-4566524.12924.13
453106-5310628.06128.06
556205-5620529.69929.70
642561-4256122.48922.49
10min180500-8050042.53646.167.6442.5746.207.64
288470-8847046.74846.78
386216-8621645.55745.60
489251-8925147.16047.21
598693-9869352.14952.20
680979-8097942.78942.83
15min1103477-10347754.67757.105.2254.7857.225.23
2110885-11088558.59258.70
3107425-10742556.76356.88
4108630-10863057.40057.53
5116963-11696361.80361.94
6101013-10101353.37553.48
20min1118586-11858662.66164.253.9162.8664.463.92
2124752-12475265.91966.13
3120929-12092963.89964.11
4122668-12266864.81865.04
5128071-12807167.67367.91
6114519-11451960.51260.71
30min1138906-13890673.39873.292.7773.7073.612.78
2141505-14150574.77175.09
3138407-13840773.13473.45
4139168-13916873.53673.87
5142634-14263475.36875.72
6131628-13162869.55269.85
45min1155108-15510881.95980.611.7982.3881.051.80
2154302-15430281.53381.98
3151976-15197680.30480.74
4152217-15221780.43280.88
5154111-15411181.43281.91
6147573-14757377.97878.39
60min1163247-16324786.26084.551.2186.8285.121.20
2161110-16111085.13185.71
3158742-15874283.87984.45
4158938-15893883.98384.57
5159993-15999384.54085.15
6157983-15798383.47884.02
极限1171528-17152890.63688.961.4591.3489.681.44
2170400-17040090.04090.76
3168653-16865389.11689.83
4167661-16766188.59289.32
5167157-16715788.32689.08
6164711-16471187.03387.72
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 11.201898411898981895841896501896831897310.07
2 11.181899421906481902950.27
单位质量响应值RSD%判断
16940.2717021.020.34数据可信
供试品溶液-25040101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%
5min19115-91154.8274.3450.644.834.3450.66
29877-98775.2315.23
310766-107665.7025.70
413124-131246.9506.95
53679-36791.9481.95
62615-26151.3851.38
10min116464-164648.7198.3730.938.738.3830.94
217873-178739.4659.47
319618-1961810.39010.40
421223-2122311.24011.25
510036-100365.3155.32
69666-96665.1195.12
15min121204-2120411.23010.5523.4311.2510.5723.46
221215-2121511.23511.26
324267-2426712.85212.88
424447-2444712.94712.98
513745-137457.2797.29
614630-146307.7487.76
20min123988-2398812.70412.1018.2112.7512.1418.25
224638-2463813.04813.09
326436-2643614.00014.05
426691-2669114.13514.19
517395-173959.2129.24
617890-178909.4749.50
30min128404-2840415.04314.4612.8315.1114.5212.90
229552-2955215.65115.72
330189-3018915.98816.06
429967-2996715.87015.95
522587-2258711.96212.00
623133-2313312.25112.29
45min133239-3323917.60317.167.9017.6917.247.96
233645-3364517.81817.91
334702-3470218.37818.48
434462-3446218.25118.35
529415-2941515.57815.64
628940-2894015.32615.39
60min135658-3565818.88418.735.0719.0018.845.15
235211-3521118.64818.77
337380-3738019.79619.93
437237-3723719.72119.85
533812-3381217.90717.99
632929-3292917.43917.52
极限137468-3746819.84320.012.2719.9920.152.26
236842-3684219.51119.66
337111-3711119.65419.82
439221-3922120.77120.94
538162-3816220.21020.33
637848-3784820.04420.16
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