盐酸鲁拉西酮片项目信息
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N877-220209对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.99对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.191973231971671970831968671967111970300.13
211.131970871970581970720.02
单位质量响应值RSD%判断
17607.6917706.380.40数据可信
供试品溶液-2022082701批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min171656-7165636.52132.2013.7136.5232.2013.71
268838-6883835.08435.08
349706-4970625.33325.33
463982-6398232.60932.61
569074-6907435.20535.20
655832-5583228.45628.46
10min1132909-13290967.73965.763.1267.8065.823.13
2132625-13262567.59467.65
3122282-12228262.32362.37
4129096-12909665.79665.85
5130522-13052266.52266.58
6126748-12674864.59964.65
15min1152990-15299077.97477.011.3578.1577.181.37
2153018-15301877.98878.16
3147459-14745975.15575.30
4151385-15138577.15677.32
5151111-15111177.01677.19
6150647-15064776.77976.93
20min1164449-16444983.81483.150.9984.1283.441.00
2164227-16422783.70184.00
3160128-16012881.61281.88
4164032-16403283.60183.89
5162770-16277082.95883.26
6163306-16330683.23183.51
30min1176958-17695890.18990.130.6690.6390.560.66
2177661-17766190.54890.99
3174928-17492889.15589.56
4177909-17790990.67491.11
5176022-17602289.71290.15
6177542-17754290.48790.91
45min1186707-18670795.15895.450.5795.7596.020.56
2187990-18799095.81296.40
3187040-18704095.32895.88
4188359-18835996.00096.58
5185551-18555194.56995.15
6187980-18798095.80796.38
60min1191654-19165497.67998.100.6198.4398.840.60
2192580-19258098.15198.90
3192615-19261598.16998.88
4193471-19347198.60599.35
5190712-19071297.19997.94
6193888-19388898.81899.55
极限1195393-19539399.585100.220.74100.50101.120.72
2196286-196286100.040100.95
3197411-197411100.613101.49
4197825-197825100.824101.73
5194636-19463699.199100.10
6198258-198258101.045101.94
盐酸鲁拉西酮片项目信息
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N877-220209对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.99对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.191966071965501964731966021965511965570.03
211.131966271964981965620.05
单位质量响应值RSD%判断
17565.4217660.560.39数据可信
供试品溶液-2022082701批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min176924-7692439.30332.8611.4939.3032.8611.48
261060-6106031.19831.20
354421-5442127.80627.81
462842-6284232.10832.11
564548-6454832.98032.98
666026-6602633.73533.74
10min1136490-13649069.73865.573.8069.8065.623.80
2131680-13168067.28067.33
3123268-12326862.98263.03
4126624-12662464.69764.75
5125217-12521763.97864.03
6126690-12669064.73164.79
15min1156134-15613479.77576.453.1679.9676.623.16
2155209-15520979.30279.47
3146469-14646974.83774.99
4147201-14720175.21175.37
5145742-14574274.46574.63
6147023-14702375.12075.28
20min1167075-16707585.36582.482.9485.6882.772.94
2167815-16781585.74386.04
3159938-15993881.71981.99
4158028-15802880.74381.03
5157874-15787480.66480.95
6157799-15779980.62680.92
30min1180063-18006392.00189.742.3192.4690.172.31
2181154-18115492.55993.00
3175171-17517189.50289.91
4173485-17348588.64089.06
5172029-17202987.89688.32
6171897-17189787.82988.25
45min1187871-18787195.99194.891.8996.6095.471.89
2191512-19151297.85198.44
3185849-18584994.95895.52
4183743-18374393.88294.45
5182933-18293393.46894.03
6182384-18238493.18793.76
60min1190924-19092497.55197.481.6198.3298.211.61
2195721-195721100.002100.76
3192841-19284198.53099.25
4189341-18934196.74297.47
5188064-18806496.08996.81
6187775-18777595.94296.67
极限1194726-19472699.49399.711.43100.43100.611.42
2198962-198962101.657102.58
3198104-198104101.219102.10
4194054-19405499.150100.04
5192607-19260798.41099.29
6192412-19241298.31199.20
盐酸鲁拉西酮片项目信息
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N877-220209对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.99对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.191977711978191978751979421979171978650.04
211.131987091986761986920.02
单位质量响应值RSD%判断
17682.3117851.930.68数据可信
供试品溶液-2022082801批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min169809-6980935.35935.427.2435.3635.427.24
269350-6935035.12735.13
371129-7112936.02836.03
462273-6227331.54231.54
578086-7808639.55239.55
668902-6890234.90034.90
10min1135512-13551268.63966.892.1468.7066.952.14
2132276-13227667.00067.06
3132895-13289567.31367.37
4131081-13108166.39466.45
5133444-13344467.59167.66
6127156-12715664.40664.46
15min1155579-15557978.80376.742.0178.9876.912.01
2152348-15234877.16677.34
3152750-15275077.37077.54
4152000-15200076.99077.15
5149762-14976275.85776.04
6146590-14659074.25074.42
20min1165574-16557483.86682.341.6884.1782.641.68
2163614-16361482.87383.17
3164216-16421683.17883.48
4162590-16259082.35482.65
5161633-16163381.86982.17
6157733-15773379.89480.18
30min1177979-17797990.14988.701.3490.5989.131.34
2175548-17554888.91889.35
3176096-17609689.19589.64
4176140-17614089.21789.65
5173614-17361487.93888.38
6171285-17128586.75887.18
45min1186841-18684194.63893.441.2295.2394.021.22
2185209-18520993.81194.40
3185653-18565394.03694.62
4185788-18578894.10494.68
5182083-18208392.22892.82
6181292-18129291.82792.39
60min1191170-19117096.83095.731.3297.5896.471.31
2190042-19004296.25997.00
3190492-19049296.48797.23
4190616-19061696.55097.28
5185952-18595294.18794.93
6185715-18571594.06794.79
极限1193798-19379898.16297.560.9599.0898.460.95
2193274-19327497.89698.80
3194037-19403798.28399.19
4193936-19393698.23199.13
5189796-18979696.13497.03
6190844-19084496.66597.54
盐酸鲁拉西酮片项目信息
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N877-220209对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.99对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.191998051998201997571997351997031997640.03
211.132019192018992019090.01
单位质量响应值RSD%判断
17852.0118140.971.14数据可信
供试品溶液-2022082801批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min169782-6978234.89736.076.8534.9036.076.85
281957-8195740.98540.99
369294-6929434.65334.65
471293-7129335.65235.65
568860-6886034.43534.44
671554-7155435.78335.78
10min1140505-14050570.26468.733.0970.3268.793.09
2142071-14207171.04771.12
3131923-13192365.97266.03
4134113-13411367.06767.13
5135099-13509967.56067.62
6140904-14090470.46370.52
15min1159577-15957779.80177.982.1379.9878.152.13
2158057-15805779.04179.23
3152426-15242676.22576.39
4152280-15228076.15276.32
5154350-15435077.18777.36
6158907-15890779.46679.64
20min1169688-16968884.85882.831.9085.1783.131.90
2167007-16700783.51783.84
3162940-16294081.48381.78
4161756-16175680.89181.19
5164200-16420082.11382.41
6168163-16816384.09584.40
30min1180146-18014690.08788.241.3190.5488.691.32
2176570-17657088.29988.76
3175163-17516387.59588.03
4173550-17355086.78987.22
5175474-17547487.75188.19
6177825-17782588.92789.38
45min1189200-18920094.61592.161.5595.2192.751.54
2182335-18233591.18291.79
3183587-18358791.80892.38
4181874-18187490.95291.53
5182631-18263191.33091.91
6186137-18613793.08393.68
60min1192755-19275596.39394.251.2897.1595.001.28
2187252-18725293.64194.40
3188308-18830894.16994.90
4185828-18582892.92993.66
5187338-18733893.68494.42
6189389-18938994.71095.46
极限1195405-19540597.71895.651.2398.6496.551.23
2189758-18975894.89495.81
3190566-19056695.29896.18
4188758-18875894.39495.28
5190794-19079495.41296.30
6192282-19228296.15697.07
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