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%
110.951915561915511913781915501912121914490.08
210.961894801896171895480.06
单位质量响应值RSD%判断
17483.9317294.530.78数据可信
供试品溶液-24121601-2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%
5min12476-24761.2801.439.791.281.439.90
23009-30091.5561.56
32823-28231.4601.46
10min12990-29901.5461.0987.041.551.1087.04
23354-33541.7351.74
3-0.0000.00
15min110505-105055.4335.454.785.445.464.78
211066-110665.7235.73
310060-100605.2035.21
20min15468-54682.8282.8716.452.842.8816.53
26501-65013.3623.38
34681-46812.4212.43
30min121075-2107510.89911.564.9610.9211.584.93
223076-2307611.93411.95
322894-2289411.84011.86
45min19999-99995.1715.728.405.215.768.34
211660-116606.0306.07
311549-115495.9736.01
60min125509-2550913.19214.317.0513.2414.367.02
228247-2824714.60814.66
329283-2928315.14415.19
极限120102-2010210.39610.695.8710.4610.765.88
222074-2207411.41611.49
319863-1986310.27210.34
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%
110.951899061898611897501898831897551898310.04
210.961884971884841884900.01
单位质量响应值RSD%判断
17336.1617197.990.57数据可信
供试品溶液-24121601-2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%
5min125461-2546113.26012.9010.2513.2612.9010.25
226901-2690114.01014.01
321966-2196611.44011.44
10min123267-2326712.1188.9457.1312.148.9656.99
25852-58523.0483.07
322348-2234811.63911.66
15min178892-7889241.08839.326.4941.1339.356.48
277694-7769440.46440.49
369877-6987736.39336.43
20min171292-7129237.13029.1949.2837.2429.3049.14
224170-2417012.58812.68
372706-7270637.86637.97
30min1136117-13611770.89269.492.8971.0669.642.88
2135136-13513670.38170.50
3129012-12901267.19167.35
45min1119495-11949562.23550.7441.4562.5351.0041.29
250821-5082126.46826.70
3121940-12194063.50863.78
60min1157151-15715181.84781.420.7882.2481.770.75
2156907-15690781.71982.00
3154942-15494280.69681.08
极限1152077-15207779.20466.8333.6979.7367.3233.54
278430-7843040.84741.26
3154452-15445280.44180.96
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%
110.951883831886101885291886891884391885300.07
210.961881541879381880460.09
单位质量响应值RSD%判断
17217.3517157.480.25数据可信
供试品溶液-24121601-2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%
5min127592-2759214.43711.0654.9914.4411.0654.99
27720-77204.0394.04
328101-2810114.70314.70
10min121548-2154811.27411.374.6911.3011.394.58
222825-2282511.94311.95
320816-2081610.89110.92
15min187164-8716445.60636.8531.1345.6536.8831.13
245616-4561623.86723.89
378489-7848941.06741.11
20min170750-7075037.01836.231.8837.1436.331.93
268528-6852835.85535.92
368476-6847635.82835.94
30min1118982-11898262.25454.6018.0562.4354.7518.04
283106-8310643.48343.61
3110943-11094358.04858.22
45min1112746-11274658.99157.023.1959.2857.273.24
2105919-10591955.41955.62
3108269-10826956.64956.92
60min1133565-13356569.88463.4514.1970.2763.7914.19
2101605-10160553.16253.45
3128620-12862067.29767.66
极限1128438-12843867.20266.231.6367.7066.681.72
2124370-12437065.07365.45
3126961-12696166.42966.90
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