盐酸鲁拉西酮片项目信息
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N877-220209对照品来源自制对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.891937151938601939651938711939851938790.06
210.991960021969031964520.33
单位质量响应值RSD%判断
17803.4017875.520.29数据可信
供试品溶液-24071601批-pH3.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1111686-11168656.19956.5415.9756.2056.5415.97
278770-7877039.63639.64
3120821-12082160.79660.80
4114615-11461557.67357.67
5132087-13208766.46566.46
6116241-11624158.49158.49
10min1139502-13950270.19672.517.3770.2972.607.38
2127011-12701163.91163.98
3150264-15026475.61175.71
4143607-14360772.26272.36
5158575-15857579.79379.90
6145619-14561973.27473.37
15min1151336-15133676.15179.174.6676.3679.384.68
2147614-14761474.27874.45
3162790-16279081.91482.14
4155895-15589578.44578.66
5167544-16754484.30684.55
6158817-15881779.91580.13
20min1159450-15945080.23482.883.8080.5783.233.81
2156705-15670578.85279.15
3169835-16983585.45985.82
4163375-16337582.20982.56
5173344-17334487.22587.61
6165578-16557883.31783.67
30min1169721-16972185.40287.922.8385.8788.412.85
2169057-16905785.06885.50
3180008-18000890.57891.08
4173680-17368087.39487.88
5180669-18066990.91191.44
6175273-17527388.19688.69
45min1179784-17978490.46592.342.0091.0892.972.03
2179385-17938590.26590.83
3188135-18813594.66895.32
4182653-18265391.90992.54
5187265-18726594.23094.91
6183792-18379292.48293.12
60min1184624-18462492.90193.251.1393.6794.041.13
2185223-18522393.20293.92
3185718-18571893.45194.27
4181906-18190691.53392.32
5186140-18614093.66494.50
6188291-18829194.74695.54
极限1192106-19210696.66697.931.1497.5998.871.15
2193874-19387497.55598.43
3198637-19863799.952100.92
4194672-19467297.95798.89
5194925-19492598.08499.08
6193452-19345297.34398.29
盐酸鲁拉西酮片项目信息
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N877-220209对照品来源自制对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.891976651968461974751978671971741974050.21
210.991995951989171992560.25
单位质量响应值RSD%判断
18127.1818130.660.02数据可信
供试品溶液-T0704607DD批-pH3.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min143758-4375821.66724.4633.5021.6724.4633.51
218218-182189.0219.02
357676-5767628.55828.56
455019-5501927.24327.24
559811-5981129.61629.62
661917-6191730.65830.66
10min1112291-11229155.60163.068.5455.6463.108.55
2117986-11798658.42158.44
3128954-12895463.85263.90
4126788-12678862.78062.82
5138389-13838968.52468.57
6139669-13966969.15869.21
15min1164062-16406281.23683.853.6181.3684.003.63
2160435-16043579.44079.55
3169890-16989084.12284.28
4170794-17079484.56984.72
5176305-17630587.29887.46
6174615-17461586.46186.63
20min1176400-17640087.34589.823.0487.6190.103.05
2174104-17410486.20886.45
3180856-18085689.55189.85
4189167-18916793.66793.96
5183890-18389091.05491.36
6183940-18394091.07991.39
30min1186871-18687192.53093.711.4992.9494.141.51
2184856-18485691.53291.92
3189440-18944093.80294.25
4191354-19135494.75095.20
5191583-19158394.86395.32
6191369-19136994.75795.22
45min1191855-19185594.99895.591.0595.5696.181.07
2189717-18971793.93994.48
3193624-19362495.87496.47
4195454-19545496.78097.38
5193445-19344595.78596.40
6194249-19424996.18396.80
60min1192666-19266695.39996.091.0796.1296.841.10
2190489-19048994.32195.02
3194701-19470196.40797.17
4195310-19531096.70897.47
5195723-19572396.91397.69
6195452-19545296.77997.56
极限1191830-19183094.98596.040.9695.8796.960.99
2191456-19145694.80095.65
3194323-19432396.22097.14
4195193-19519396.65197.58
5195716-19571696.90997.85
6195285-19528596.69697.64
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