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%
110.971868051877291874171864491876471872090.30
210.991868891868271868580.03
单位质量响应值RSD%判断
17065.5417002.550.27数据可信
供试品溶液-BXK5AZ2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%
5min139133-3913320.66020.134.7520.6620.144.76
237129-3712919.60219.60
338399-3839920.27220.27
440299-4029921.27521.28
538768-3876820.46720.47
635099-3509918.53018.53
10min184033-8403344.36450.148.4144.4050.178.40
287353-8735346.11746.15
393665-9366549.44949.48
499717-9971752.64452.68
5103594-10359454.69154.72
6101476-10147653.57353.60
15min1127543-12754367.33474.037.0967.4474.157.09
2131992-13199269.68369.79
3139069-13906973.41973.54
4142533-14253375.24875.37
5155731-15573182.21582.34
6144506-14450676.28976.41
20min1149420-14942078.88484.705.3779.1084.945.38
2153357-15335780.96281.19
3157564-15756483.18383.42
4167621-16762188.49388.74
5172036-17203690.82391.09
6162663-16266385.87586.12
30min1167006-16700688.16891.632.7888.5292.022.79
2172677-17267791.16291.52
3170560-17056090.04490.42
4173727-17372791.71692.11
5180910-18091095.50895.92
6176556-17655693.21093.60
45min1177350-17735093.62995.181.6494.1395.721.65
2179825-17982594.93695.45
3178057-17805794.00294.53
4179845-17984594.94695.50
5185644-18564498.00898.58
6180988-18098895.54996.10
60min1180683-18068395.38896.081.3196.0496.781.32
2183012-18301296.61897.29
3178252-17825294.10594.79
4182049-18204996.11096.82
5185317-18531797.83598.57
6182693-18269396.45097.15
极限1192588-192588101.67499.961.15102.49100.811.14
2188967-18896799.762100.59
3187202-18720298.83099.67
4189292-18929299.933100.80
5191008-191008100.839101.74
6186999-18699998.72399.59
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%
110.971874901872011878841877981881641877070.20
210.991866931870851868890.15
单位质量响应值RSD%判断
17110.9417005.370.44数据可信
供试品溶液-BXK5AZ2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%
5min122569-2256911.89815.4016.6111.9015.4016.61
232374-3237417.06717.07
332535-3253517.15217.15
426783-2678314.12014.12
525865-2586513.63613.64
635160-3516018.53618.54
10min171231-7123137.55240.855.5337.5740.885.54
277418-7741840.81440.84
378915-7891541.60341.63
478166-7816641.20841.23
575066-7506639.57439.60
684134-8413444.35544.39
15min1103652-10365254.64456.472.5354.7356.562.54
2105649-10564955.69755.79
3107166-10716656.49756.59
4108149-10814957.01557.11
5106381-10638156.08356.17
6111677-11167758.87558.98
20min1123809-12380965.27166.542.2065.4466.732.20
2124282-12428265.52065.71
3124050-12405065.39865.59
4129425-12942568.23268.42
5125856-12585666.35066.53
6129910-12991068.48768.69
30min1147783-14778377.91078.561.4978.1978.861.48
2146962-14696277.47777.78
3146818-14681877.40177.70
4152322-15232280.30380.60
5150617-15061779.40479.70
6149610-14961078.87379.19
45min1168144-16814488.64488.141.2489.0688.571.24
2165946-16594687.48587.91
3164386-16438686.66387.09
4170389-17038989.82790.26
5167795-16779588.46088.88
6166495-16649587.77488.22
60min1178086-17808693.88593.331.0994.4593.911.08
2177972-17797293.82594.40
3174355-17435591.91892.49
4178861-17886194.29494.88
5178089-17808993.88794.46
6174835-17483592.17192.77
极限1186171-18617198.14797.660.8098.8698.400.79
2186472-18647298.30699.04
3182872-18287296.40897.14
4186610-18661098.37999.12
5185108-18510897.58798.32
6184293-18429397.15797.91
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%
110.971869411867151861671870361864301866580.20
210.991859351858621858980.03
单位质量响应值RSD%判断
17015.3116915.200.42数据可信
供试品溶液-BXK5AZ2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%
5min16211-62113.2922.6424.743.292.6424.74
23983-39832.1112.11
33327-33271.7641.76
46499-64993.4453.44
55091-50912.6992.70
64787-47872.5372.54
10min119425-1942510.2976.7732.6110.306.7732.62
210905-109055.7805.78
38317-83174.4094.41
413892-138927.3647.37
59148-91484.8494.85
614951-149517.9257.93
15min126328-2632813.9569.6925.8613.989.7025.88
216426-164268.7078.72
313964-139647.4027.41
418367-183679.7369.75
513906-139067.3717.38
620649-2064910.94610.96
20min128283-2828314.99211.1121.4115.0411.1421.42
218993-1899310.06810.10
316797-167978.9048.93
420547-2054710.89110.93
516994-169949.0089.03
624097-2409712.77312.81
30min131511-3151116.70313.1616.4616.7713.2116.48
223070-2307012.22912.27
320432-2043210.83110.87
424896-2489613.19713.25
521696-2169611.50111.54
627396-2739614.52214.58
45min134423-3442318.24715.4410.2418.3515.5110.31
227390-2739014.51914.58
326684-2668414.14514.20
429340-2934015.55215.63
526658-2665814.13114.19
630271-3027116.04616.13
60min135898-3589819.02916.877.0119.1616.977.06
230448-3044816.14016.23
331615-3161516.75816.84
430757-3075716.30416.40
529681-2968115.73315.82
632568-3256817.26417.37
极限135984-3598419.07418.525.9119.2418.655.91
236193-3619319.18519.30
336878-3687819.54819.66
433540-3354017.77917.91
531416-3141616.65316.76
635656-3565618.90019.04
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