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(%)99.74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%
111.23 2002891998802001142002131999172000830.09
211.262008252010032009140.07
单位质量响应值RSD%判断
17816.8317843.160.11数据可信
中间条件24月-供试品溶液-2022082601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%
5min164223-6422332.33333.526.6932.3333.526.68
265621-6562133.03733.04
370739-7073935.61435.61
470983-7098335.73735.74
568508-6850834.49134.49
659364-5936429.88729.89
10min1130860-13086065.88265.733.4965.9465.793.49
2131214-13121466.06066.12
3130462-13046265.68265.74
4131946-13194666.42966.49
5136483-13648368.71368.77
6122440-12244061.64361.69
15min1153266-15326677.16376.831.4577.3377.001.45
2152828-15282876.94277.11
3151251-15125176.14876.32
4152565-15256576.81076.98
5156186-15618678.63378.80
6149582-14958275.30875.46
20min1165279-16527983.21182.921.3383.5083.221.33
2165908-16590883.52783.82
3162140-16214081.63081.93
4164894-16489483.01783.32
5167759-16775984.45984.76
6162266-16226681.69481.97
30min1179464-17946490.35290.111.0590.7890.541.05
2180199-18019990.72291.15
3175924-17592488.57089.00
4178268-17826889.75090.19
5181375-18137591.31491.76
6178641-17864189.93890.35
45min1189961-18996195.63795.170.9796.2295.750.97
2189124-18912495.21595.80
3185545-18554593.41493.99
4189405-18940595.35795.94
5190845-19084596.08296.68
6189290-18929095.29995.86
60min1195277-19527798.31397.820.9499.0598.560.94
2195244-19524498.29799.04
3190597-19059795.95796.69
4194907-19490798.12798.87
5194883-19488398.11598.87
6194891-19489198.11998.84
极限1199299-199299100.33899.651.03101.24100.561.03
2198745-198745100.059100.97
3193910-19391097.62598.52
4197873-19787399.620100.53
5198886-198886100.130101.05
6198936-198936100.155101.04
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(%)99.74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%
111.23 2010212009212015732007232014692011410.19
211.262028452026072027260.09
单位质量响应值RSD%判断
17911.0418004.090.37数据可信
中间条件24月-供试品溶液-2022082601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%
5min134412-3441217.20228.7520.2217.2028.7520.22
257701-5770128.84428.84
363202-6320231.59431.59
461935-6193530.96030.96
565920-6592032.95232.95
661935-6193530.96030.96
10min1117604-11760458.78864.275.7958.8264.325.80
2121387-12138760.67960.73
3130873-13087365.42165.47
4133271-13327166.62066.67
5136953-13695368.46068.52
6131290-13129065.62965.68
15min1145449-14544972.70776.283.4672.8376.443.48
2147739-14773973.85274.00
3152811-15281176.38776.55
4155738-15573877.85178.01
5159850-15985079.90680.08
6154045-15404577.00477.17
20min1159829-15982979.89682.532.7980.1482.812.80
2160038-16003880.00080.27
3164560-16456082.26182.55
4167106-16710683.53383.83
5171665-17166585.81286.11
6167359-16735983.66083.95
30min1176391-17639188.17589.752.0188.5690.172.02
2175142-17514287.55087.96
3178939-17893989.44889.87
4180508-18050890.23390.66
5185208-18520892.58293.03
6181067-18106790.51290.94
45min1187514-18751493.73594.891.3594.2695.461.37
2186480-18648093.21893.77
3189345-18934594.65095.23
4191787-19178795.87196.45
5193217-19321796.58697.19
6190573-19057395.26495.84
60min1192961-19296196.45897.551.4497.1498.281.45
2192068-19206896.01196.72
3193831-19383196.89397.63
4195810-19581097.88298.62
5199742-19974299.847100.61
6196430-19643098.19298.93
极限1198568-19856899.26199.500.93100.11100.390.94
2198654-19865499.304100.17
3198102-19810299.02899.92
4196924-19692498.43999.34
5202312-202312101.132102.06
6199761-19976199.857100.76
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(%)99.74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%
111.23 2009202009881999661996772006592004420.30
211.262003022005152004080.08
单位质量响应值RSD%判断
17848.8017798.220.21数据可信
中间条件24月-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%
5min173480-7348037.00733.5615.3037.0133.5615.29
271658-7165836.09036.09
358139-5813929.28129.28
458193-5819329.30829.31
557098-5709828.75728.76
681217-8121740.90440.90
10min1126584-12658463.75362.582.9763.8162.642.98
2125877-12587763.39763.46
3122638-12263861.76561.81
4119031-11903159.94960.00
5122127-12212761.50861.56
6129306-12930665.12465.19
15min1143746-14374672.39672.131.6472.5672.291.64
2143603-14360372.32472.49
3144515-14451572.78372.94
4138671-13867169.84069.99
5143422-14342272.23372.38
6145344-14534473.20173.38
20min1155062-15506278.09578.031.4878.3878.311.49
2154664-15466477.89578.18
3155967-15596778.55178.82
4150638-15063875.86776.13
5157304-15730479.22479.50
6155941-15594178.53878.84
30min1168195-16819584.71085.201.2785.1385.621.27
2168586-16858684.90785.32
3170572-17057285.90786.31
4165932-16593283.57083.96
5172195-17219586.72487.13
6169590-16959085.41285.84
45min1179471-17947190.38991.011.3690.9591.571.35
2180081-18008190.69691.25
3182972-18297292.15292.70
4177599-17759989.44689.98
5184238-18423892.78993.34
6179920-17992090.61591.19
60min1185356-18535693.35393.841.4794.0694.541.46
2185732-18573293.54294.25
3189689-18968995.53596.24
4183881-18388192.61093.29
5189666-18966695.52396.23
6183574-18357492.45593.18
极限1193179-19317997.29397.230.9798.1698.090.95
2192758-19275897.08097.95
3191985-19198596.69197.55
4193510-19351097.45998.29
5196231-19623198.83099.69
6190656-19065696.02296.90
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(%)99.74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%
111.23 2009862010522009962016742005952010610.20
211.262023202024002023600.03
单位质量响应值RSD%判断
17903.9217971.580.27数据可信
中间条件24月-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%
5min158847-5884729.44934.9811.5429.4534.9711.54
283735-8373541.90441.90
369746-6974634.90334.90
467128-6712833.59333.59
571346-7134635.70435.70
668541-6854134.30034.30
10min1125227-12522762.66863.371.9162.7263.431.91
2130012-13001265.06265.13
3124173-12417362.14062.20
4127815-12781563.96364.02
5128286-12828664.19864.26
6124282-12428262.19562.25
15min1145821-14582172.97472.920.8773.1373.080.88
2146395-14639573.26173.44
3144958-14495872.54272.70
4147422-14742273.77573.94
5145919-14591973.02373.19
6143723-14372371.92472.08
20min1158574-15857479.35678.750.7979.6379.030.79
2156713-15671378.42478.72
3157283-15728378.71078.99
4158850-15885079.49479.78
5157258-15725878.69778.99
6155489-15548977.81278.09
30min1174035-17403587.09385.800.9487.5086.220.93
2169878-16987885.01285.44
3171254-17125485.70186.11
4172733-17273386.44186.86
5170496-17049685.32285.74
6170367-17036785.25785.67
45min1185722-18572292.94191.561.1193.4992.121.10
2179929-17992990.04290.62
3183323-18332391.74192.30
4184387-18438792.27392.84
5181784-18178490.97191.53
6182609-18260991.38391.94
60min1192927-19292796.54794.781.2497.2595.491.22
2186231-18623193.19693.92
3189633-18963394.89995.61
4190687-19068795.42696.14
5187678-18767893.92094.63
6189197-18919794.68095.39
极限1198995-19899599.58497.411.48100.4598.281.47
2190400-19040095.28296.16
3195005-19500597.58798.45
4195635-19563597.90298.78
5192839-19283996.50397.37
6195043-19504397.60698.47
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