盐酸鲁拉西酮口崩片项目信息
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(%)99.99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%
111.331977981976471979001976311973801976710.10
211.321992391979711986050.46
单位质量响应值RSD%判断
17446.6917544.610.40数据可信
高温10天-供试品溶液-24041201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%
5min1107306-10730655.19558.885.6755.1958.885.68
2113207-11320758.23058.23
3112942-11294258.09458.09
4126134-12613464.87964.88
5116566-11656659.95859.96
6110627-11062756.90356.90
10min1136318-13631870.11773.013.5670.2173.103.56
2141260-14126072.65972.76
3141808-14180872.94173.04
4151184-15118477.76477.87
5142221-14222173.15473.25
6138808-13880871.39871.49
15min1149427-14942776.86079.312.4977.0779.522.49
2154507-15450779.47379.69
3155946-15594680.21380.43
4160414-16041482.51282.75
5153492-15349278.95179.17
6151299-15129977.82378.04
20min1157207-15720780.86282.822.5781.2083.182.57
2161575-16157583.10983.46
3162959-16295983.82184.17
4167870-16787086.34786.72
5159722-15972282.15682.51
6156799-15679980.65281.00
30min1166841-16684185.81787.431.6486.2987.921.65
2170701-17070187.80388.29
3171073-17107387.99488.49
4174543-17454389.77990.30
5169005-16900586.93087.42
6167652-16765286.23586.71
45min1174132-17413289.56891.231.4590.1891.861.46
2179377-17937792.26592.90
3179229-17922992.18992.83
4180304-18030492.74293.41
5175547-17554790.29590.93
6175589-17558990.31790.94
60min1179323-17932392.23893.241.1793.0094.031.17
2183216-18321694.24095.03
3183279-18327994.27395.06
4183061-18306194.16094.98
5179026-17902692.08592.87
6179733-17973392.44993.22
极限1184579-18457994.94195.480.7895.8696.430.78
2187505-18750596.44697.39
3187181-18718196.28097.23
4185572-18557295.45296.43
5183949-18394994.61795.56
6185019-18501995.16896.09
盐酸鲁拉西酮口崩片项目信息
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(%)99.99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%
111.331988191983631978691994111983241985570.30
211.321978361975531976940.11
单位质量响应值RSD%判断
17524.8917464.130.25数据可信
高温10天-供试品溶液-24041501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%
5min1109426-10942656.28852.284.5656.2952.284.56
299800-9980051.33751.34
3105054-10505454.03954.04
499556-9955651.21151.21
598075-9807550.45050.45
697837-9783750.32750.33
10min1135293-13529369.59465.423.9469.6965.503.94
2126018-12601864.82364.91
3131001-13100167.38767.48
4124967-12496764.28364.37
5122060-12206062.78762.87
6123694-12369463.62863.71
15min1147755-14775576.00572.492.9176.2172.682.91
2138619-13861971.30571.50
3143744-14374473.94274.14
4140392-14039272.21772.41
5138032-13803271.00371.19
6136993-13699370.46970.66
20min1156392-15639280.44876.762.7480.7877.082.74
2147941-14794176.10076.41
3151195-15119577.77478.10
4148428-14842876.35176.66
5146398-14639875.30775.61
6145019-14501974.59774.90
30min1166026-16602685.40382.262.1985.8782.712.19
2158662-15866281.61582.05
3161166-16116682.90383.36
4160096-16009682.35382.79
5157426-15742680.97981.41
6156161-15616180.32980.76
45min1175306-17530690.17787.311.8090.7987.891.81
2167918-16791886.37786.95
3170297-17029787.60088.19
4170188-17018887.54488.12
5167322-16732286.07086.64
6167312-16731286.06586.63
60min1179900-17990092.54090.451.2993.3091.181.30
2174542-17454289.78490.50
3176157-17615790.61591.35
4176471-17647190.77691.50
5174100-17410089.55790.27
6173860-17386089.43390.14
极限1186879-18687996.13094.111.1197.0594.991.12
2181797-18179793.51694.38
3182115-18211593.67994.57
4183351-18335194.31595.19
5182034-18203493.63894.50
6181560-18156093.39494.25
盐酸鲁拉西酮口崩片项目信息
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(%)99.99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%
111.331981141988231987581982321978891983630.21
211.322001471997271999370.15
单位质量响应值RSD%判断
17507.7717662.280.63数据可信
高温10天-供试品溶液-24041502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%
5min1109943-10994356.26452.735.5256.2652.735.52
299176-9917650.75450.75
3105259-10525953.86753.87
494202-9420248.20948.21
5107025-10702554.77154.77
6102611-10261152.51252.51
10min1141561-14156172.44568.973.5372.5469.063.53
2131439-13143967.26567.35
3136570-13657069.89169.98
4129431-12943166.23766.32
5138259-13825970.75570.85
6131374-13137467.23267.32
15min1156429-15642980.05477.162.6980.2777.362.69
2148602-14860276.04876.24
3151735-15173577.65277.86
4148446-14844675.96876.16
5153967-15396778.79479.00
6145423-14542374.42174.62
20min1164986-16498684.43381.892.4084.7882.222.41
2158468-15846881.09781.42
3161163-16116382.47682.81
4157446-15744680.57480.89
5163318-16331883.57983.92
6154754-15475479.19779.52
30min1173589-17358988.83687.081.9389.3287.541.93
2168955-16895586.46486.92
3171074-17107487.54888.02
4169328-16932886.65587.11
5173249-17324988.66289.14
6164728-16472884.30184.76
45min1180238-18023892.23891.611.6592.8792.221.65
2179068-17906891.63992.24
3179781-17978192.00492.62
4178226-17822691.20991.80
5182813-18281393.55694.18
6173901-17390188.99589.59
60min1184859-18485994.60393.911.6095.3994.671.61
2183764-18376494.04394.80
3183792-18379294.05794.83
4182696-18269693.49694.24
5187383-18738395.89596.68
6178479-17847991.33892.08
极限1188254-18825496.34096.271.6297.2997.201.62
2189403-18940396.92897.84
3189371-18937196.91297.84
4187153-18715395.77796.68
5191787-19178798.14999.09
6182770-18277093.53494.43
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