氢溴酸伏硫西汀片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号171336-202301对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9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0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.181805481803521805661801201804561804080.11
214.231803791804541804160.03
单位质量响应值RSD%判断
12722.7112678.570.25数据可信
供试品溶液-2025102521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%
2min166034-6603436.77633.869.1336.7833.869.13
261444-6144434.21934.22
362714-6271434.92734.93
462238-6223834.66234.66
549945-4994527.81527.82
662371-6237134.73634.74
5min1118822-11882266.17465.511.4766.1765.511.47
2116247-11624764.74064.74
3117745-11774565.57565.57
4116642-11664264.96064.96
5115924-11592464.56064.56
6120399-12039967.05367.05
10min1135999-13599975.74175.491.3575.7475.491.35
2132882-13288274.00574.00
3135531-13553175.48075.48
4134040-13404074.65074.65
5137264-13726476.44576.45
6137545-13754576.60276.60
15min1142649-14264979.44478.900.6979.4478.900.69
2139920-13992077.92477.92
3141631-14163178.87778.88
4141947-14194779.05379.05
5141469-14146978.78778.79
6142416-14241679.31479.31
20min1142589-14258979.41179.372.5879.4179.372.58
2137194-13719476.40676.41
3144708-14470880.59180.59
4143760-14376080.06380.06
5139450-13945077.66377.66
6147359-14735982.06782.07
30min1146361-14636181.51181.233.3981.5181.233.39
2136808-13680876.19176.19
3149464-14946483.24083.24
4144054-14405480.22780.23
5148455-14845582.67882.68
6149974-14997483.52483.52
45min1147460-14746082.12382.972.2882.1282.972.28
2143684-14368480.02180.02
3152470-15247084.91484.91
4148379-14837982.63582.64
5152783-15278385.08885.09
6149134-14913483.05683.06
60min1146208-14620881.42682.311.7281.4382.321.72
2146333-14633381.49681.50
3151510-15151084.37984.38
4145175-14517580.85180.85
5147275-14727582.02082.02
6150320-15032083.71683.72
90min1136864-13686476.22282.004.6676.2282.004.66
2140809-14080978.41978.42
3149217-14921783.10283.10
4150310-15031083.71183.71
5154405-15440585.99185.99
6151830-15183084.55784.56
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1146735-14673581.72083.622.2881.7283.622.28
2145654-14565481.11881.12
3151989-15198984.64684.65
4149648-14964883.34283.34
5154246-15424685.90385.90
6152632-15263285.00485.00
极限1146425-14642581.54782.322.6381.5582.322.64
2141816-14181678.98078.98
3145815-14581581.20781.21
4149420-14942083.21583.22
5152311-15231184.82584.83
6151106-15110684.15484.15
氢溴酸伏硫西汀片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号171336-202301对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9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0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.181797281799911801811800421801791800240.11
214.231805291801281803280.16
单位质量响应值RSD%判断
12695.6312672.380.13数据可信
供试品溶液-2025102521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%
2min169917-6991738.98937.367.3038.9937.367.31
260793-6079333.90133.90
362067-6206734.61234.61
467112-6711237.42537.42
573824-7382441.16841.17
668274-6827438.07338.07
5min1127979-12797971.36769.592.7171.3769.592.71
2120746-12074667.33467.33
3120397-12039767.13967.14
4126827-12682770.72570.72
5127308-12730870.99370.99
6125547-12554770.01170.01
10min1147859-14785982.45379.942.3582.4579.942.35
2139143-13914377.59377.59
3141258-14125878.77278.77
4143098-14309879.79879.80
5141935-14193579.15079.15
6146801-14680181.86381.86
15min1153894-15389485.81983.004.0385.8283.004.03
2140671-14067178.44578.45
3141719-14171979.02979.03
4152985-15298585.31285.31
5152680-15268085.14285.14
6151063-15106384.24084.24
20min1158240-15824088.24287.751.2688.2487.761.26
2153766-15376685.74785.75
3156948-15694887.52287.52
4157437-15743787.79587.79
5159538-15953888.96688.97
6158267-15826788.25788.26
30min1159605-15960589.00488.671.1889.0088.671.18
2156110-15611087.05587.05
3157243-15724387.68687.69
4160655-16065589.58989.59
5160108-16010889.28489.28
6160340-16034089.41389.41
45min1161794-16179490.22490.151.2990.2290.151.29
2158315-15831588.28488.28
3161549-16154990.08890.09
4164793-16479391.89791.90
5161264-16126489.92989.93
6162211-16221190.45790.46
60min1160817-16081789.67989.321.6489.6889.321.64
2156852-15685287.46887.47
3161049-16104989.80989.81
4164505-16450591.73691.74
5158976-15897688.65388.65
6158793-15879388.55188.55
90min1165377-16537792.22289.712.3892.2289.722.38
2157358-15735887.75187.75
3156402-15640287.21787.22
4165189-16518992.11892.12
5161356-16135689.98089.98
6159596-15959688.99989.00
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
120min1157408-15740887.77889.401.9587.7889.401.95
2158549-15854988.41588.41
3157462-15746287.80987.81
4164908-16490891.96191.96
5163138-16313890.97490.97
6160395-16039589.44489.44
极限1158662-15866288.47889.211.1888.4889.211.18
2157241-15724187.68587.69
3160103-16010389.28189.28
4162611-16261190.68090.68
5160004-16000489.22689.23
6161197-16119789.89189.89
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