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%
111.191968631966091962001961181962931964170.16
211.131959431957071958250.09
单位质量响应值RSD%判断
17552.9017594.340.17数据可信
长期18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%
5min154811-5481128.06827.9614.3128.0727.9614.30
248154-4815424.65924.66
343812-4381222.43522.44
454763-5476328.04328.04
561526-6152631.50631.51
664545-6454533.05233.05
10min1123149-12314963.06263.457.5763.1163.507.58
2120878-12087861.89961.94
3107923-10792355.26555.30
4126330-12633064.69164.74
5129523-12952366.32666.38
6135604-13560469.44069.50
15min1151416-15141677.53776.893.5677.6977.043.58
2145505-14550574.51074.65
3142390-14239072.91573.04
4151723-15172377.69477.85
5152562-15256278.12478.29
6157284-15728480.54280.71
20min1164989-16498984.48883.262.4484.7783.542.45
2158676-15867681.25581.52
3156916-15691680.35480.60
4164338-16433884.15484.44
5163508-16350883.72984.02
6167172-16717285.60685.91
30min1179019-17901991.67290.521.3292.0990.941.33
2174867-17486789.54689.95
3173324-17332488.75689.14
4177658-17765890.97591.40
5176584-17658490.42590.86
6179114-17911491.72192.17
45min1189526-18952697.05395.580.8997.6396.160.90
2186055-18605595.27595.83
3184809-18480994.63795.17
4187303-18730395.91496.49
5185503-18550394.99395.58
6186752-18675295.63296.23
60min1195055-19505599.88498.130.94100.6298.860.94
2190680-19068097.64498.36
3191085-19108597.85198.54
4191805-19180598.22098.96
5189936-18993697.26398.00
6191205-19120597.91298.67
极限1198170-198170101.479100.000.98102.38100.890.96
2194899-19489999.804100.68
3196912-196912100.835101.69
4194674-19467499.689100.59
5193166-19316698.91799.82
6193848-19384899.266100.19
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%
111.191956281954911953091951081950991953270.12
211.131966341965241965790.04
单位质量响应值RSD%判断
17455.5017662.080.84数据可信
长期18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%
5min135269-3526918.07625.9417.0018.0825.9417.00
259141-5914130.31230.31
352855-5285527.09027.09
454494-5449427.93027.93
555490-5549028.44028.44
646385-4638523.77423.77
10min1115539-11553959.21763.123.4159.2563.163.42
2126996-12699665.08965.14
3122938-12293863.00963.05
4125869-12586964.51264.56
5125627-12562764.38864.44
6121914-12191462.48562.52
15min1142012-14201272.78576.572.7472.9176.722.75
2148753-14875376.24076.40
3150674-15067477.22577.38
4153691-15369178.77178.93
5152233-15223378.02478.18
6148984-14898476.35976.50
20min1155055-15505579.47082.922.3979.7283.202.40
2160421-16042182.22182.51
3162880-16288083.48183.76
4165828-16582884.99285.28
5164934-16493484.53484.82
6161589-16158982.81983.09
30min1170780-17078087.53090.071.8387.9190.481.84
2172876-17287688.60489.03
3177120-17712090.77991.20
4179054-17905491.77192.20
5178011-17801191.23691.66
6176545-17654590.48590.89
45min1182415-18241593.49395.491.4994.0296.051.50
2183485-18348594.04294.61
3187244-18724495.96896.54
4189691-18969197.22297.80
5187656-18765696.17996.76
6187356-18735696.02696.59
60min1187233-18723395.96397.891.4796.6598.611.48
2187783-18778396.24496.97
3192113-19211398.46499.19
4194146-19414699.506100.25
5192052-19205298.43299.17
6192601-19260198.71499.43
极限1191937-19193798.37499.901.4199.22100.791.41
2191207-19120797.99998.89
3195244-195244100.068100.96
4197753-197753101.354102.26
5196227-196227100.572101.47
6197184-197184101.063101.95
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%
111.191959231961511964811959581961311961290.12
211.131983581980301981940.12
单位质量响应值RSD%判断
17527.1717807.191.13数据可信
长期18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%
5min130589-3058915.58229.8226.8315.5829.8226.82
274270-7427037.83337.83
369794-6979435.55335.55
463560-6356032.37732.38
561175-6117531.16331.16
651836-5183626.40526.41
10min1108152-10815255.09366.499.5255.1266.549.53
2144011-14401173.35973.42
3138202-13820270.40070.46
4132303-13230367.39567.45
5133880-13388068.19968.25
6126614-12661464.49764.54
15min1138198-13819870.39878.365.6870.5278.525.69
2163519-16351983.29783.48
3160090-16009081.55081.73
4152305-15230577.58477.75
5154690-15469078.79978.96
6154134-15413478.51678.67
20min1153114-15311477.99684.284.4278.2384.574.44
2173784-17378488.52688.85
3171616-17161687.42187.73
4162777-16277782.91983.21
5165349-16534984.22984.53
6166059-16605984.59184.87
30min1169675-16967586.43290.592.8186.8091.032.83
2184506-18450693.98794.46
3180172-18017291.78092.24
4175458-17545889.37889.81
5177957-17795790.65191.09
6179306-17930691.33991.76
45min1180719-18071992.05895.282.3292.5795.862.34
2191623-19162397.61398.24
3191027-19102797.30997.92
4183582-18358293.51794.10
5186184-18618494.84295.43
6189070-18907096.31296.89
60min1186377-18637794.94097.521.9395.6098.261.95
2193857-19385798.75199.54
3194738-19473899.20099.97
4187745-18774595.63796.38
5191031-19103197.31198.06
6194873-19487399.268100.00
极限1191925-19192597.76799.191.3298.59100.091.34
2195914-19591499.799100.75
3196855-196855100.278101.22
4191395-19139597.49798.39
5194697-19469799.179100.09
6197504-197504100.609101.51
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%
111.191952881948971950651949091949391950200.09
211.131972431973551972990.05
单位质量响应值RSD%判断
17428.0617726.771.21数据可信
长期18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%
5min131048-3104815.89730.2027.4415.9030.2027.44
277902-7790239.88639.89
362495-6249531.99832.00
465648-6564833.61233.61
550882-5088226.05226.05
665982-6598233.78333.78
10min1116432-11643259.61467.716.8259.6467.766.83
2141834-14183472.62072.69
3135379-13537969.31569.37
4133359-13335968.28168.34
5128185-12818565.63265.67
6138268-13826870.79470.85
15min1147539-14753975.54179.483.4275.6779.643.44
2161251-16125182.56282.75
3158659-15865981.23481.40
4154359-15435979.03379.20
5150790-15079077.20577.36
6158819-15881981.31681.49
20min1162723-16272383.31585.172.3883.5785.472.39
2170822-17082287.46287.79
3169987-16998787.03487.34
4164092-16409284.01684.32
5161763-16176382.82483.11
6168688-16868886.36986.68
30min1179348-17934891.82789.876.0592.2290.306.03
2181585-18158592.97393.44
3182033-18203393.20293.65
4175740-17574089.98090.42
5154344-15434479.02579.44
6180051-18005192.18792.64
45min1190081-19008197.32396.071.6597.8796.661.65
2189185-18918596.86497.49
3190732-19073297.65698.26
4183672-18367294.04194.63
5183943-18394394.18094.73
6188175-18817596.34796.95
60min1195104-19510499.89497.951.63100.6098.701.63
2191648-19164898.12598.91
3193728-19372899.19099.96
4188125-18812596.32197.07
5187155-18715595.82596.53
6192110-19211098.36299.13
极限1198278-198278101.52099.261.58102.39100.171.56
2193274-19327498.95899.91
3195585-195585100.141101.07
4190463-19046397.51898.43
5190587-19058797.58298.45
6195019-19501999.851100.78
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