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%
111.021895461886821888051893061891851891050.19
210.881870951880361875660.36
单位质量响应值RSD%判断
17160.1617239.520.33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%
5min149955-4995526.11926.1814.9126.1226.1814.91
254268-5426828.37428.37
362789-6278932.82932.83
445876-4587623.98623.99
544699-4469923.37123.37
642824-4282422.39022.39
10min1128596-12859667.23667.094.7967.2867.134.80
2125756-12575665.75165.80
3138227-13822772.27172.33
4132253-13225369.14869.19
5123221-12322164.42564.46
6121797-12179763.68163.72
15min1152491-15249179.72980.591.4679.8880.751.47
2154799-15479980.93681.09
3156522-15652281.83782.01
4155569-15556981.33881.49
5155023-15502381.05381.20
6150458-15045878.66678.81
20min1161999-16199984.70085.590.8884.9985.880.88
2163565-16356585.51985.81
3163224-16322485.34185.65
4164318-16431885.91386.20
5166177-16617786.88587.17
6162929-16292985.18785.46
30min1169831-16983188.79589.670.5889.2290.100.57
2171635-17163589.73890.17
3170896-17089689.35289.81
4172018-17201889.93990.37
5172169-17216990.01890.44
6172461-17246190.17090.59
45min1174744-17474491.36492.870.9391.9493.460.92
2176770-17677092.42393.01
3178707-17870793.43694.04
4178570-17857093.36493.95
5177841-17784192.98393.56
6179132-17913293.65894.23
60min1176543-17654392.30594.001.0893.0394.741.07
2179861-17986194.03994.78
3178694-17869493.42994.19
4180859-18085994.56195.30
5182045-18204595.18195.91
6180715-18071594.48695.21
极限1178816-17881693.49394.780.9194.3895.680.90
2181575-18157594.93695.83
3179712-17971293.96194.88
4182366-18236695.34996.25
5182647-18264795.49696.39
6182600-18260095.47196.35
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%
111.021885961890981894501883781889541888950.23
210.881875791879581877680.15
单位质量响应值RSD%判断
17141.1117258.090.49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%
5min199017-9901751.77239.6021.6051.7739.6021.60
254453-5445328.47128.47
384041-8404143.94143.94
473637-7363738.50238.50
560800-6080031.79031.79
682486-8248643.12843.13
10min1160799-16079984.07577.805.3384.1677.875.35
2138323-13832372.32372.37
3147111-14711176.91876.99
4151396-15139679.15879.22
5142679-14267974.60074.65
6152499-15249979.73579.81
15min1170420-17042089.10585.613.0589.3385.813.06
2156256-15625681.69981.87
3159999-15999983.65683.86
4165939-16593986.76286.96
5163985-16398585.74085.92
6165839-16583986.71086.91
20min1176179-17617992.11689.072.5692.4989.412.58
2164229-16422985.86886.17
3166285-16628586.94387.28
4172136-17213690.00290.34
5172173-17217390.02290.34
6171129-17112989.47689.83
30min1181028-18102894.65192.042.1995.1892.522.20
2170767-17076789.28689.73
3172565-17256590.22790.71
4176697-17669792.38792.88
5178982-17898293.58294.05
6176157-17615792.10592.60
45min1185580-18558097.03294.402.4497.7295.042.44
2175293-17529391.65392.25
3175464-17546491.74292.38
4180791-18079194.52895.17
5184634-18463496.53797.16
6181507-18150794.90295.55
60min1187082-18708297.81795.162.3898.6695.962.38
2177740-17774092.93293.68
3176507-17650792.28893.08
4182183-18218395.25596.06
5186344-18634497.43198.22
6182129-18212995.22796.04
极限1183169-18316995.77195.381.9896.7896.331.98
2178464-17846493.31194.21
3177795-17779592.96193.90
4183880-18388096.14397.10
5187140-18714097.84798.80
6184050-18405096.23297.20
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%
111.021891191884511892881885431891781889160.21
210.881888521881231884880.28
单位质量响应值RSD%判断
17143.0117324.260.75数据可信
供试品溶液-2025042521批-pH4.4
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min159957-5995731.28737.4126.3831.2937.4126.38
284074-8407443.87243.87
384063-8406343.86743.87
453337-5333727.83327.83
552075-5207527.17427.17
696624-9662450.42150.42
10min1133976-13397669.91373.385.9669.9673.445.97
2144664-14466475.49075.56
3150098-15009878.32678.40
4130852-13085268.28368.33
5134999-13499970.44770.49
6149157-14915777.83577.92
15min1156464-15646481.64883.751.7781.8283.941.79
2162429-16242984.76184.96
3163957-16395785.55885.76
4160400-16040083.70283.86
5157952-15795282.42482.59
6161805-16180584.43584.65
20min1162987-16298785.05287.321.7085.3687.651.71
2169413-16941388.40588.75
3168948-16894888.16288.51
4170547-17054788.99789.30
5165342-16534286.28186.58
6166798-16679887.04087.39
30min1170221-17022188.82790.811.6689.2791.281.66
2174838-17483891.23691.72
3176091-17609191.89092.38
4178123-17812392.95093.40
5172635-17263590.08690.53
6172194-17219489.85690.36
45min1174064-17406490.83293.281.9091.4393.901.89
2177528-17752892.64093.28
3181262-18126294.58895.23
4183875-18387595.95296.55
5178198-17819892.98993.58
6177599-17759992.67793.33
60min1177925-17792592.84794.501.3793.5995.281.36
2181588-18158894.75895.55
3182078-18207895.01495.82
4185128-18512896.60697.37
5180250-18025094.06094.81
6179608-17960893.72594.53
极限1177411-17741192.57995.232.0493.4896.172.01
2182586-18258695.27996.23
3182808-18280895.39596.36
4187792-18779297.99698.92
5184881-18488196.47797.38
6179502-17950293.67094.63
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%
111.021876571892861884201880251891981885170.38
210.881882201887681884940.21
单位质量响应值RSD%判断
17106.8117324.820.90数据可信
供试品溶液-2025042521批-pH4.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min176612-7661240.02031.0432.2240.0231.0432.22
266065-6606534.51134.51
341030-4103021.43321.43
438660-3866020.19520.20
584472-8447244.12644.13
649666-4966625.94425.94
10min1140826-14082673.56468.717.4673.6368.767.48
2137683-13768371.92371.98
3122592-12259264.03964.08
4118398-11839861.84961.88
5141262-14126273.79273.87
6128430-12843067.08967.13
15min1157875-15787582.47079.782.6982.6679.952.72
2155096-15509681.01981.20
3149948-14994878.33078.47
4147280-14728076.93677.07
5155775-15577581.37381.57
6150403-15040378.56778.72
20min1164141-16414185.74484.151.4286.0784.451.44
2161266-16126684.24284.55
3160643-16064383.91684.19
4157328-15732882.18582.45
5162510-16251084.89285.22
6160679-16067983.93584.22
30min1170824-17082489.23588.211.0589.7088.651.06
2168127-16812787.82688.28
3169601-16960188.59689.01
4165731-16573186.57486.98
5169582-16958288.58689.06
6169279-16927988.42888.85
45min1176970-17697092.44591.151.1093.0691.731.11
2174041-17404190.91591.51
3175681-17568191.77292.33
4171260-17126089.46290.01
5174679-17467991.24891.87
6174296-17429691.04891.62
60min1180270-18027094.16992.750.9494.9493.490.95
2176657-17665792.28293.03
3178270-17827093.12493.84
4175356-17535691.60292.30
5177078-17707892.50293.28
6177704-17770492.82993.55
极限1179441-17944193.73692.840.8594.6793.740.86
2176950-17695092.43593.34
3178960-17896093.48594.35
4175860-17586091.86592.71
5176406-17640692.15193.08
6178781-17878193.39194.27
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