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%
111.231862081862291860851859251862951861480.08
211.321859171859941859560.03
单位质量响应值RSD%判断
16575.9616427.210.64数据可信
中间条件6月-供试品溶液-2025061021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%
5min168520-6852037.34237.1522.1937.3437.1522.19
270490-7049038.41538.42
393529-9352950.97150.97
453655-5365529.24129.24
551594-5159428.11828.12
671250-7125038.83038.83
10min1139893-13989376.23875.395.6276.3075.455.63
2142535-14253577.67877.74
3146059-14605979.59979.68
4134080-13408073.07173.12
5124734-12473467.97768.02
6142691-14269177.76377.83
15min1159261-15926186.79486.161.5186.9886.351.52
2159927-15992787.15787.35
3159812-15981287.09487.31
4156200-15620085.12585.30
5154155-15415584.01184.17
6159287-15928786.80887.00
20min1166128-16612890.53690.150.8190.8790.480.83
2166792-16679290.89891.24
3165839-16583990.37890.74
4164166-16416689.46789.78
5163381-16338189.03989.34
6166173-16617390.56090.90
30min1173455-17345594.52994.320.8595.0194.800.84
2174750-17475095.23595.72
3171003-17100393.19393.71
4173377-17337794.48694.95
5171661-17166193.55194.00
6174208-17420894.93995.43
45min1178252-17825297.14396.790.7797.7997.420.75
2178917-17891797.50698.15
3175123-17512395.43896.11
4178315-17831597.17897.80
5177061-17706196.49497.10
6177908-17790896.95697.60
60min1180080-18008098.13998.270.6098.9499.060.59
2181439-18143998.88099.69
3178556-17855697.30998.14
4180500-18050098.36899.15
5179896-17989698.03998.80
6181394-18139498.85699.67
极限1179576-17957697.86598.510.8298.8399.480.81
2182421-18242199.415100.39
3178698-17869897.38698.38
4181032-18103298.65899.60
5180586-18058698.41599.34
6182266-18226699.331100.31
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%
111.231858951861561857331859861858751859290.09
211.321861911859051860480.11
单位质量响应值RSD%判断
16556.4616435.340.52数据可信
中间条件6月-供试品溶液-2025061021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%
5min153565-5356529.20235.6234.4329.2035.6234.43
274941-7494140.85540.85
380322-8032243.78843.79
494184-9418451.34551.35
530814-3081416.79916.80
658235-5823531.74731.75
10min1130999-13099971.41674.328.3171.4674.388.33
2143393-14339378.17278.24
3144913-14491379.00179.07
4145913-14591379.54679.63
5116409-11640963.46263.49
6136298-13629874.30474.36
15min1155279-15527984.65285.342.1984.8285.522.22
2157111-15711185.65185.85
3160710-16071087.61387.82
4158041-15804186.15886.38
5150559-15055982.07982.21
6157525-15752585.87786.05
20min1163569-16356989.17189.511.2589.4889.841.27
2164152-16415289.48989.83
3167347-16734791.23191.58
4164061-16406189.44089.80
5161058-16105887.80388.07
6164953-16495389.92690.25
30min1171817-17181793.66893.890.8194.1394.360.82
2171696-17169693.60294.09
3174561-17456195.16495.67
4170816-17081693.12293.63
5171265-17126593.36793.78
6173177-17317794.40994.88
45min1176970-17697096.47796.530.9997.0997.160.97
2176046-17604695.97396.62
3179167-17916797.67598.34
4174283-17428395.01295.68
5177652-17765296.84997.42
6178311-17831197.20897.84
60min1179130-17913097.65597.730.9398.4398.520.91
2178090-17809097.08897.89
3180757-18075798.54299.37
4176611-17661196.28197.11
5180373-18037398.33299.07
6180642-18064298.47999.27
极限1180340-18034098.31498.131.0599.2599.081.03
2178664-17866497.40198.37
3182124-18212499.287100.28
4176915-17691596.44797.43
5181027-18102798.68999.59
6180907-18090798.62399.58
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%
111.231855721857711854231856091853561855460.09
211.321857831858551858190.03
单位质量响应值RSD%判断
16522.3516415.110.47数据可信
中间条件6月-供试品溶液-BXK5AZ2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%
5min154762-5476229.90330.842.3129.9030.842.31
257419-5741931.35431.35
356585-5658530.89930.90
458133-5813331.74431.74
556866-5686631.05231.05
655154-5515430.11730.12
10min1139987-13998776.44175.124.1576.4975.174.14
2140177-14017776.54576.60
3137751-13775175.22075.27
4144232-14423278.75978.81
5135737-13573774.12074.17
6127474-12747469.60869.66
15min1168389-16838991.95090.822.2092.1391.002.20
2168428-16842891.97292.15
3165071-16507190.13890.32
4170554-17055493.13393.32
5165220-16522090.22090.40
6160229-16022987.49487.66
20min1176904-17690496.60096.061.2896.9396.391.29
2176843-17684396.56796.90
3175262-17526295.70396.03
4178808-17880897.64097.98
5175580-17558095.87796.20
6172099-17209993.97694.29
30min1182410-18241099.60799.720.75100.10100.200.76
2182920-18292099.885100.38
3181569-18156999.14799.63
4185109-185109101.080101.58
5182410-18241099.607100.09
6181272-18127298.98599.45
45min1183923-183923100.433100.720.58101.09101.380.58
2184321-184321100.650101.31
3183531-183531100.219100.87
4186505-186505101.843102.51
5184449-184449100.720101.37
6184006-184006100.478101.11
60min1182861-18286199.853100.740.64100.68101.560.64
2184745-184745100.882101.71
3184106-184106100.533101.35
4186468-186468101.823102.66
5184560-184560100.781101.60
6184150-184150100.557101.36
极限1183101-18310199.984100.400.33100.98101.390.33
2184007-184007100.479101.48
3183619-183619100.267101.25
4184887-184887100.959101.97
5183671-183671100.295101.28
6183867-183867100.402101.37
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%
111.231855571853531856101854991853351854710.07
211.321858901860301859600.06
单位质量响应值RSD%判断
16515.6716427.560.38数据可信
中间条件6月-供试品溶液-BXK5AZ2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%
5min164061-6406134.97532.2313.3034.9732.2313.29
248703-4870326.59026.59
355851-5585130.49230.49
468266-6826637.27137.27
565008-6500835.49235.49
652344-5234428.57828.58
10min1144920-14492079.12176.395.6779.1876.455.67
2138732-13873275.74275.79
3129177-12917770.52670.58
4150934-15093482.40482.47
5142491-14249177.79577.85
6133296-13329672.77472.82
15min1169742-16974292.67391.072.1192.8691.252.12
2165783-16578390.51190.68
3162379-16237988.65388.82
4171312-17131293.53093.73
5168068-16806891.75991.95
6163553-16355389.29489.46
20min1177943-17794397.15095.951.1297.4996.281.13
2174841-17484195.45695.78
3173282-17328294.60594.92
4177960-17796097.15997.51
5176237-17623796.21996.56
6174196-17419695.10495.42
30min1183392-183392100.12599.440.61100.6399.930.62
2180644-18064498.62599.11
3181672-18167299.18699.66
4182756-18275699.778100.29
5183091-18309199.961100.46
6181278-18127898.97199.45
45min1185299-185299101.166100.320.66101.84100.980.67
2181946-18194699.33599.98
3183552-183552100.212100.85
4184065-184065100.492101.18
5184659-184659100.817101.49
6182976-18297699.898100.54
60min1185735-185735101.404100.610.50102.25101.440.51
2183104-18310499.968100.78
3184112-184112100.518101.32
4184258-184258100.598101.45
5184784-184784100.885101.72
6183695-183695100.290101.10
极限1185517-185517101.285100.350.69102.30101.350.69
2182133-18213399.438100.41
3183814-183814100.355101.33
4183072-18307299.950100.97
5184992-184992100.998102.00
6183332-183332100.092101.07
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