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%
111.031901931902681899971901751902341901730.06
211.161912011907081909540.19
单位质量响应值RSD%判断
17241.4317110.570.54数据可信
供试品溶液-24111501批-pH4.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1106994-10699455.91854.782.8655.9254.782.86
2101346-10134652.96752.97
3102935-10293553.79753.80
4104583-10458354.65854.66
5109562-10956257.26157.26
6103431-10343154.05654.06
10min1133381-13338169.70969.862.5069.8069.952.50
2132250-13225069.11869.21
3129441-12944167.65067.74
4138066-13806672.15872.25
5137209-13720971.71071.81
6131687-13168768.82468.91
15min1146884-14688476.76676.431.4576.9876.641.45
2145751-14575176.17476.38
3142793-14279374.62874.83
4147995-14799577.34777.56
5148661-14866177.69577.91
6145402-14540275.99276.20
20min1154188-15418880.58480.781.3680.9281.111.37
2154862-15486280.93681.27
3151039-15103978.93879.26
4156313-15631381.69482.03
5156999-15699982.05382.40
6153936-15393680.45280.78
30min1162546-16254684.95286.141.4285.4286.611.42
2166367-16636786.94987.41
3161722-16172284.52184.98
4167341-16734187.45887.93
5166671-16667187.10887.59
6164268-16426885.85286.32
45min1171427-17142789.59390.331.3790.2190.941.37
2174866-17486691.39192.00
3169056-16905688.35488.95
4174843-17484391.37992.00
5174611-17461191.25791.88
6172166-17216689.97990.59
60min1175090-17509091.50892.821.8492.2793.591.84
2179468-17946893.79694.56
3173079-17307990.45791.20
4178999-17899993.55194.33
5182113-18211395.17895.96
6176886-17688692.44693.20
极限1177526-17752692.78195.261.8093.7096.181.79
2185178-18517896.78097.70
3179027-17902793.56594.46
4185307-18530796.84797.78
5183882-18388296.10397.04
6182688-18268895.47996.39
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%
111.031912091909311910441912341913471911530.09
211.161898981901751900360.11
单位质量响应值RSD%判断
17330.2817028.321.25数据可信
供试品溶液-24111501批-pH6.8(内含0.1%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min197639-9763951.02344.3216.0551.0244.3216.05
287321-8732145.63145.63
378976-7897641.27041.27
460226-6022631.47231.47
591173-9117347.64447.64
693534-9353448.87848.88
10min1121544-12154463.51559.589.9463.6059.669.95
2110384-11038457.68357.76
3116493-11649360.87560.94
495245-9524549.77249.82
5111975-11197558.51458.59
6128494-12849467.14667.23
15min1133334-13333469.67666.688.9869.8766.858.98
2121537-12153763.51163.68
3133068-13306869.53769.71
4110925-11092557.96558.10
5123062-12306264.30864.48
6143638-14363875.06075.25
20min1141268-14126873.82271.228.5174.1371.508.51
2128628-12862867.21667.49
3143232-14323274.84875.13
4120453-12045362.94463.18
5131515-13151568.72569.01
6152587-15258779.73780.06
30min1152810-15281079.85377.307.8580.2877.707.86
2138909-13890972.58972.98
3156641-15664181.85582.27
4134223-13422370.14070.48
5140983-14098373.67374.07
6163937-16393785.66886.12
45min1166206-16620686.85383.087.3587.4283.617.36
2148467-14846777.58478.09
3168577-16857788.09288.64
4147048-14704876.84277.30
5150188-15018878.48379.00
6173395-17339590.61091.20
60min1174181-17418191.02186.586.7491.7387.266.75
2155516-15551681.26781.91
3174974-17497491.43592.13
4154883-15488380.93681.52
5156355-15635581.70682.36
6178222-17822293.13393.88
极限1181532-18153294.86291.974.2495.7292.784.26
2175901-17590191.92092.70
3180921-18092194.54395.39
4162565-16256584.95185.67
5173193-17319390.50591.29
6181839-18183995.02395.92
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