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%
111.171865331867621862641860981863261863970.14
211.081855471862331858900.27
单位质量响应值RSD%判断
16687.2916777.080.38数据可信
加速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%
5min152128-5212828.01724.3328.2228.0224.3428.21
223010-2301012.36712.37
359914-5991432.20132.20
439289-3928921.11621.12
548370-4837025.99726.00
648937-4893726.30226.30
10min1129613-12961369.66264.9612.4669.7165.0112.47
299353-9935353.39853.42
3137149-13714973.71273.77
4105417-10541756.65756.69
5129866-12986669.79869.84
6123848-12384866.56366.61
15min1155458-15545883.55282.711.4383.7282.861.46
2150411-15041180.84080.95
3156330-15633084.02184.20
4152264-15226481.83681.97
5154888-15488883.24683.41
6153972-15397282.75482.91
20min1164791-16479188.56887.970.4888.8788.260.50
2162647-16264787.41687.66
3164378-16437888.34688.66
4163512-16351287.88188.15
5163336-16333687.78688.08
6163452-16345287.84988.14
30min1172019-17201992.45392.170.6892.9092.610.68
2171713-17171392.28992.68
3172845-17284592.89793.36
4172222-17222292.56292.97
5169748-16974891.23391.68
6170457-17045791.61492.05
45min1177895-17789595.61194.790.7496.2295.380.73
2176526-17652694.87695.42
3174671-17467193.87994.50
4177843-17784395.58396.15
5175615-17561594.38694.98
6175678-17567894.42095.01
60min1180793-18079397.16996.410.6497.9397.160.63
2179561-17956196.50797.21
3178156-17815695.75296.53
4180663-18066397.09997.83
5178360-17836095.86196.62
6178802-17880296.09996.85
极限1181360-18136097.47496.830.4198.4097.740.40
2180357-18035796.93597.80
3179498-17949896.47397.41
4180534-18053497.03097.92
5179500-17950096.47497.39
6179756-17975696.61297.52
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%
111.171854101856401854791855911856501855540.06
211.081852871852411852640.02
单位质量响应值RSD%判断
16611.8216720.580.47数据可信
加速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%
5min137548-3754820.26024.0811.4420.2624.0811.45
247144-4714425.43825.44
343553-4355323.50123.50
451838-5183827.97127.97
540705-4070521.96421.96
646917-4691725.31625.32
10min1114316-11431661.68463.696.8661.7263.736.85
2121063-12106365.32465.37
3114872-11487261.98462.02
4126336-12633668.17068.22
5126203-12620368.09868.13
6105442-10544256.89556.94
15min1153167-15316782.64782.840.6382.7882.980.63
2152899-15289982.50382.65
3154486-15448683.35983.50
4154959-15495983.61483.77
5152716-15271682.40482.55
6152872-15287282.48882.63
20min1163477-16347788.21087.840.8088.4888.120.80
2162317-16231787.58487.87
3163539-16353988.24488.53
4164433-16443388.72689.03
5160785-16078586.75887.05
6162171-16217187.50687.78
30min1171643-17164392.61792.671.0093.0493.101.00
2173643-17364393.69694.13
3173184-17318493.44893.88
4171444-17144492.50992.96
5168775-16877591.06991.50
6171770-17177092.68593.11
45min1177566-17756695.81395.411.0396.3996.001.02
2178220-17822096.16696.76
3178135-17813596.12096.70
4176475-17647595.22495.83
5173370-17337093.54994.13
6177177-17717795.60396.18
60min1181286-18128697.82097.070.7398.5697.820.72
2180937-18093797.63298.38
3180187-18018797.22797.97
4179494-17949496.85397.61
5177613-17761395.83896.58
6179863-17986397.05297.79
极限1181240-18124097.79597.490.9898.6998.400.97
2182201-18220198.31499.23
3181003-18100397.66798.57
4180392-18039297.33898.26
5177336-17733695.68996.59
6181913-18191398.15899.05
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%
111.171849691849821851581852221849631850590.07
211.081858211855741856980.10
单位质量响应值RSD%判断
16567.5016759.750.82数据可信
加速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%
5min155192-5519229.78630.342.0229.7930.342.02
255768-5576830.09730.10
357361-5736130.95730.96
455093-5509329.73329.73
556061-5606130.25530.26
657810-5781031.19931.20
10min1137419-13741974.16372.744.2174.2172.794.20
2140922-14092276.05376.10
3127362-12736268.73568.79
4139525-13952575.29975.35
5134811-13481172.75572.81
6128609-12860969.40869.46
15min1172573-17257393.13591.132.4793.3191.302.47
2172437-17243793.06293.24
3166107-16610789.64589.81
4170186-17018691.84792.02
5169984-16998491.73891.91
6161824-16182487.33487.50
20min1179953-17995397.11896.091.5697.4596.411.56
2179450-17945096.84697.18
3177192-17719295.62895.94
4178962-17896296.58396.91
5179935-17993597.10897.43
6172771-17277193.24293.56
30min1183918-18391899.25898.611.3399.7599.091.34
2183755-18375599.17099.66
3182506-18250698.49698.97
4184127-18412799.37099.86
5184056-18405699.33299.82
6177910-17791096.01596.48
45min1184419-18441999.52899.310.88100.1899.950.88
2184630-18463099.642100.30
3183772-18377299.17999.82
4184994-18499499.838100.49
5185336-185336100.023100.67
6180908-18090897.63398.26
60min1185078-18507899.88499.471.31100.71100.281.31
2185040-18504099.863100.69
3184653-18465399.654100.46
4186198-186198100.488101.31
5185349-185349100.030100.85
6179510-17951096.87997.67
极限1185192-18519299.94599.370.93100.93100.350.94
2185114-18511499.903100.89
3183351-18335198.95299.92
4184466-18446699.553100.54
5185615-185615100.174101.16
6181045-18104597.70798.66
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%
111.171846921846321845421846111847421846440.05
211.081848891847311848100.07
单位质量响应值RSD%判断
16530.3516679.600.64数据可信
加速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%
5min155074-5507429.82729.347.8929.8329.347.89
257224-5722430.99230.99
352553-5255328.46228.46
458722-5872231.80331.80
546603-4660325.23925.24
654909-5490929.73829.74
10min1131357-13135771.14169.405.8671.1969.445.86
2126886-12688668.71968.77
3122096-12209666.12566.17
4138208-13820874.85174.90
5117592-11759263.68663.73
6132684-13268471.85971.91
15min1169547-16954791.82490.441.5691.9990.611.57
2165047-16504789.38789.55
3165077-16507789.40389.56
4169982-16998292.05992.24
5163981-16398188.80988.96
6168365-16836591.18491.35
20min1177671-17767196.22495.660.5196.5595.970.51
2175204-17520494.88895.20
3175970-17597095.30295.61
4177076-17707695.90196.23
5176750-17675095.72596.02
6177072-17707295.89996.22
30min1183283-18328399.26398.560.5099.7499.040.49
2180812-18081297.92598.40
3182341-18234198.75399.22
4181602-18160298.35398.84
5182538-18253898.86099.32
6181348-18134898.21598.70
45min1184543-18454399.94599.500.92100.59100.140.91
2185012-185012100.199100.84
3183645-18364599.459100.09
4183008-18300899.11499.77
5185343-185343100.379101.00
6180769-18076997.90298.55
60min1184168-18416899.74299.450.63100.56100.250.62
2181935-18193598.53399.34
3184802-184802100.086100.88
4183155-18315599.194100.01
5184779-184779100.073100.86
6182905-18290599.05899.87
极限1184059-18405999.68399.350.74100.66100.320.73
2182241-18224198.69999.67
3183739-18373999.510100.47
4181655-18165598.38199.37
5185460-185460100.442101.40
6183502-18350299.382100.35
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