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%
1 11.171921301917811918791914351912781917010.18
2 11.231899471895251897360.16
单位质量响应值RSD%判断
17162.1316895.461.11数据可信
供试品溶液-2025060821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%
5min158721-5872131.01237.0327.6431.0137.0327.65
261738-6173832.60532.61
3105535-10553555.73655.74
451263-5126327.07327.07
577325-7732540.83740.84
666126-6612634.92334.92
10min1138675-13867573.23876.634.0173.2976.694.02
2140432-14043274.16674.22
3154269-15426981.47381.57
4142221-14222175.11175.16
5148393-14839378.37078.44
6146601-14660177.42477.48
15min1161566-16156685.32786.371.3285.5086.561.34
2163448-16344886.32186.50
3166938-16693888.16488.39
4160945-16094584.99985.17
5164317-16431786.78086.98
6164077-16407786.65386.84
20min1169294-16929489.40990.030.7289.7290.360.74
2171349-17134990.49490.82
3172377-17237791.03791.41
4169220-16922089.37089.68
5170367-17036789.97590.32
6170230-17023089.90390.23
30min1176137-17613793.02393.310.6393.4993.790.65
2177115-17711593.53994.01
3178462-17846294.25094.78
4175128-17512892.49092.95
5176820-17682093.38393.88
6176394-17639493.15893.64
45min1180275-18027595.20895.630.3895.8396.270.40
2181407-18140795.80696.43
3182070-18207096.15696.84
4180497-18049795.32595.94
5180760-18076095.46496.11
6181415-18141595.81096.45
60min1181934-18193496.08496.440.4896.8697.240.50
2183043-18304396.67097.46
3183871-18387197.10797.95
4181413-18141395.80996.58
5182834-18283496.55997.37
6182549-18254996.40997.21
极限1182630-18263096.45296.890.5097.3997.850.51
2184287-18428797.32798.28
3184252-18425297.30898.31
4182111-18211196.17897.11
5183565-18356596.94597.91
6183929-18392997.13898.09
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%
1 11.171900661899911900701898801897231899460.08
2 11.231893571894381893980.04
单位质量响应值RSD%判断
17005.0116865.360.59数据可信
供试品溶液-2025060921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%
5min188895-8889547.20537.7416.8647.2137.7416.86
253803-5380328.57128.57
369150-6915036.72036.72
465813-6581334.94834.95
579266-7926642.09242.09
669460-6946036.88536.88
10min1150232-15023279.77675.843.6679.8675.913.67
2134081-13408171.20071.25
3144568-14456876.76976.83
4143830-14383076.37776.44
5141918-14191875.36275.43
6142334-14233475.58275.64
15min1162284-16228486.17685.430.7386.3985.620.74
2159606-15960684.75484.92
3162056-16205686.05586.24
4161212-16121285.60785.79
5159594-15959484.74884.94
6160522-16052285.24185.43
20min1169358-16935889.93389.210.7190.2989.540.71
2167694-16769489.04989.36
3168415-16841589.43289.76
4168998-16899889.74290.07
5166136-16613688.22288.56
6167390-16739088.88889.22
30min1175895-17589593.40493.100.5293.9193.580.51
2175685-17568593.29393.75
3175927-17592793.42193.90
4175776-17577693.34193.82
5173614-17361492.19392.68
6175008-17500892.93393.41
45min1180034-18003495.60295.390.7296.2696.030.71
2179414-17941495.27395.88
3180197-18019795.68996.33
4181288-18128896.26896.90
5177417-17741794.21294.85
6179482-17948295.30995.94
60min1181625-18162596.44796.660.4997.2797.460.49
2182250-18225096.77997.55
3182648-18264896.99097.79
4183182-18318297.27498.07
5180611-18061195.90896.70
6181888-18188896.58697.38
极限1183754-18375497.57797.100.7098.5698.060.70
2182783-18278397.06297.99
3183107-18310797.23498.19
4184462-18446297.95398.91
5180777-18077795.99796.95
6182283-18228396.79697.75
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%
1 11.171887531885661889091887171890721888030.11
2 11.231881191882171881680.04
单位质量响应值RSD%判断
16902.6916755.830.62数据可信
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%
5min176596-7659640.93034.9924.3340.9334.9924.33
263971-6397134.18434.18
376513-7651340.88640.89
474530-7453039.82639.83
534860-3486018.62818.63
666363-6636335.46235.46
10min1145714-14571477.86474.526.1677.9374.586.17
2137097-13709773.26073.32
3143966-14396676.93077.00
4144456-14445677.19277.26
5123064-12306465.76165.79
6142482-14248276.13776.20
15min1160308-16030885.66384.912.2085.8685.092.23
2161233-16123386.15786.34
3160058-16005885.52985.73
4160510-16051085.77185.97
5151870-15187081.15481.29
6159406-15940685.18185.37
20min1167439-16743989.47489.261.1289.8189.581.14
2169210-16921090.42090.74
3166573-16657389.01189.35
4168476-16847690.02890.37
5163852-16385287.55787.83
6166696-16669689.07789.40
30min1173797-17379792.87193.090.9393.3693.560.94
2176722-17672294.43494.91
3173303-17330392.60793.09
4175154-17515493.59694.08
5172040-17204091.93292.35
6174240-17424093.10893.58
45min1178080-17808095.16095.610.9395.8096.240.93
2181838-18183897.16897.80
3177981-17798195.10795.75
4179415-17941595.87396.52
5177138-17713894.65695.23
6179117-17911795.71496.35
60min1180727-18072796.57496.890.9497.3897.670.95
2184456-18445698.56799.36
3180398-18039896.39897.20
4181701-18170197.09597.90
5179540-17954095.94096.67
6181034-18103496.73897.53
极限1182095-18209597.30597.460.7098.2798.410.70
2184176-18417698.41799.37
3180550-18055096.48097.44
4183247-18324797.92198.89
5181640-18164097.06297.95
6182581-18258197.56598.52
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