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%
111.171926721923421923691922931921611923670.10
211.121903341901571902460.07
单位质量响应值RSD%判断
17221.7517108.450.47数据可信
供试品溶液-2025042521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%
5min148392-4839225.35331.4315.0625.3531.4215.06
268926-6892636.11136.11
358670-5867030.73830.74
462425-6242532.70532.70
570359-7035936.86136.86
651139-5113926.79226.79
10min1131572-13157268.93171.973.4468.9772.023.45
2140339-14033973.52473.58
3135170-13517070.81670.87
4143288-14328875.06975.12
5140703-14070373.71573.78
6133154-13315469.76069.80
15min1156299-15629981.88682.221.2982.0482.391.29
2157179-15717982.34782.53
3156617-15661782.05382.22
4160685-16068584.18484.36
5156097-15609781.78081.96
6154706-15470681.05181.21
20min1164198-16419886.02486.071.1886.3286.371.18
2164306-16430686.08186.40
3164684-16468486.27986.58
4167662-16766287.83988.16
5162573-16257385.17385.49
6162237-16223784.99785.29
30min1172386-17238690.31489.771.1690.7590.231.15
2171100-17110089.64090.10
3172014-17201490.11990.57
4174203-17420391.26691.73
5168586-16858688.32388.79
6169848-16984888.98489.42
45min1177220-17722092.84792.251.1793.4392.861.17
2175071-17507191.72192.33
3176970-17697092.71693.32
4179068-17906893.81594.43
5173291-17329190.78891.40
6174900-17490091.63192.22
60min1179573-17957394.07993.491.1694.8294.251.16
2177390-17739092.93693.70
3179565-17956594.07594.83
4181296-18129694.98295.76
5175561-17556191.97792.74
6177315-17731592.89693.64
极限1180806-18080694.72594.081.1895.6294.981.17
2178472-17847293.50394.42
3180974-18097494.81395.72
4182223-18222395.46896.40
5176576-17657692.50993.42
6178342-17834293.43494.33
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%
111.171904641903531901581900661903181902720.09
211.121895341894011894680.05
单位质量响应值RSD%判断
17034.2017038.490.02数据可信
供试品溶液-2025042521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%
5min163616-6361633.58030.7716.2633.5830.7716.26
274076-7407639.10239.10
355212-5521229.14429.14
449485-4948526.12126.12
549099-4909925.91725.92
658262-5826230.75430.75
10min1141875-14187574.89072.304.4274.9572.354.43
2142827-14282775.39375.46
3136949-13694972.29072.34
4134677-13467771.09171.13
5126286-12628666.66166.70
6139214-13921473.48573.54
15min1158195-15819583.50582.661.2083.6982.841.21
2158751-15875183.79883.99
3156118-15611882.40882.58
4155237-15523781.94382.11
5153853-15385381.21381.37
6157440-15744083.10683.28
20min1165017-16501787.10686.440.6587.4386.750.67
2164492-16449286.82987.16
3163195-16319586.14486.45
4162534-16253485.79586.09
5162759-16275985.91486.20
6164570-16457086.87087.18
30min1172329-17232990.96690.320.5191.4390.770.52
2171312-17131290.42990.90
3170690-17069090.10090.55
4170083-17008389.78090.22
5170424-17042489.96090.39
6171799-17179990.68691.14
45min1176750-17675093.29992.920.3593.9293.520.36
2175825-17582592.81193.44
3176261-17626193.04193.64
4175334-17533492.55293.14
5175394-17539492.58393.17
6176597-17659793.21893.83
60min1179170-17917094.57794.160.4095.3594.920.41
2178199-17819994.06494.84
3177801-17780193.85494.61
4177692-17769293.79694.54
5178072-17807293.99794.73
6179338-17933894.66595.43
极限1180126-18012695.08194.630.3596.0195.540.35
2178897-17889794.43395.37
3179021-17902194.49895.41
4178377-17837794.15895.06
5179502-17950294.75295.65
6179672-17967294.84295.76
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