盐酸鲁拉西酮口崩片项目信息
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对照品来源自制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%
110.961963391961831965351967071968721965270.15
211.011960881963641962260.10
单位质量响应值RSD%判断
17931.3017822.520.44数据可信
供试品溶液-24120501批-pH3.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1126981-12698163.76264.222.1863.7664.222.18
2123217-12321761.87261.87
3128518-12851864.53464.53
4128267-12826764.40864.41
5128590-12859064.57064.57
6131767-13176766.16566.17
10min1152578-15257876.61577.631.5776.7277.741.57
2151532-15153276.09076.19
3157250-15725078.96179.07
4153501-15350177.07977.19
5155688-15568878.17778.28
6157103-15710378.88779.00
15min1164651-16465182.67883.831.5382.9184.061.53
2165443-16544383.07583.31
3170140-17014085.43485.67
4164406-16440682.55582.79
5167230-16723083.97384.21
6169799-16979985.26385.50
20min1172404-17240486.57187.541.4886.9487.911.48
2172738-17273886.73887.11
3178318-17831889.54089.92
4171660-17166086.19786.57
5174602-17460287.67488.05
6176267-17626788.51088.89
30min1180721-18072190.74791.741.3991.2692.261.39
2183529-18352992.15792.67
3186605-18660593.70294.23
4179294-17929490.03090.55
5182618-18261891.70092.22
6183425-18342592.10592.64
45min1186371-18637193.58494.832.0294.2595.502.01
2191957-19195796.38997.06
3194045-19404597.43798.12
4183456-18345692.12092.79
5188983-18898394.89695.57
6188297-18829794.55195.24
60min1189601-18960195.20696.512.1096.0397.342.09
2194895-19489597.86498.69
3197159-19715999.00199.85
4187714-18771494.25895.08
5195235-19523598.03598.87
6188545-18854594.67695.52
极限1190673-19067395.74497.231.8596.7398.231.84
2195916-19591698.37799.37
3199014-19901499.933100.95
4189074-18907494.94195.92
5193431-19343197.12998.13
6193718-19371897.27398.27
盐酸鲁拉西酮口崩片项目信息
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对照品来源自制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%
110.961962731963551963151960541967601963510.14
211.011982881986481984680.13
单位质量响应值RSD%判断
17915.2418026.160.44数据可信
供试品溶液-24112801批-pH6.8(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min197905-9790548.90542.9512.3348.9142.9512.34
282191-8219141.05641.06
396010-9601047.95947.96
468546-6854634.24034.24
585097-8509742.50742.51
686142-8614243.02943.03
10min1134121-13412166.99660.919.1867.0860.989.19
2117735-11773558.81158.88
3132350-13235066.11166.19
4103191-10319151.54651.60
5121700-12170060.79160.86
6122494-12249461.18861.26
15min1150217-15021775.03669.317.6375.2369.487.63
2136123-13612367.99668.16
3148309-14830974.08374.27
4120674-12067460.27960.42
5139736-13973669.80169.97
6137505-13750568.68668.86
20min1159831-15983179.83874.456.7280.1674.746.73
2146674-14667473.26673.55
3158726-15872679.28679.60
4132562-13256266.21766.46
5150664-15066475.25975.55
6145847-14584772.85373.14
30min1171804-17180485.81980.795.6886.2781.205.69
2159820-15982079.83380.23
3170166-17016685.00185.45
4147181-14718173.52073.87
5164624-16462482.23382.65
6156788-15678878.31878.73
45min1180464-18046490.14586.204.8690.7486.744.88
2172264-17226486.04986.58
3180058-18005889.94290.53
4159215-15921579.53180.01
5176809-17680988.31988.87
6166540-16654083.19083.73
60min1186537-18653793.17989.454.2893.9290.144.29
2178867-17886789.34790.03
3185693-18569392.75793.49
4168078-16807883.95884.57
5183461-18346191.64292.34
6171804-17180485.81986.50
极限1190792-19079295.30492.173.0296.2093.013.05
2184346-18434692.08492.91
3189071-18907194.44495.34
4177576-17757688.70289.45
5187155-18715593.48794.34
6178207-17820789.01889.84
盐酸鲁拉西酮口崩片项目信息
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对照品来源自制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%
110.961972471975321974811975721973561974380.07
211.011951081954081952580.11
单位质量响应值RSD%判断
18014.4217734.601.11数据可信
供试品溶液-24120501批-pH6.8(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min158457-5845729.35914.8454.5329.3614.8454.53
232053-3205316.09816.10
316054-160548.0638.06
415205-152057.6367.64
522224-2222411.16211.16
633281-3328116.71516.71
10min1107139-10713953.80933.3031.5853.8633.3231.60
262639-6263931.45931.49
354053-5405327.14727.16
449539-4953924.88024.89
557451-5745128.85428.87
666956-6695633.62733.66
15min1129175-12917564.87649.8515.1565.0149.9315.18
290863-9086345.63445.71
398399-9839949.41949.48
491130-9113045.76845.82
589891-8989145.14645.21
696059-9605948.24448.33
20min1143463-14346372.05260.679.6672.3060.849.70
2111524-11152456.01156.17
3121425-12142560.98461.12
4117408-11740858.96659.10
5112962-11296256.73356.88
6118025-11802559.27659.44
30min1161435-16143581.07873.125.8581.4473.395.89
2138329-13832969.47369.72
3147189-14718973.92374.17
4144262-14426272.45372.68
5138475-13847569.54769.78
6143885-14388572.26472.53
45min1176608-17660888.69883.793.2889.2084.183.33
2162664-16266481.69582.06
3167057-16705783.90184.27
4167374-16737484.06184.41
5160828-16082880.77381.13
6166510-16651083.62784.01
60min1185279-18527993.05389.871.9793.7090.402.02
2176945-17694588.86789.37
3178464-17846489.63090.14
4179519-17951990.16090.65
5174818-17481887.79988.29
6178597-17859789.69790.22
极限1190081-19008195.46593.141.5496.2793.821.58
2185106-18510692.96693.61
3184634-18463492.72993.38
4186431-18643193.63294.27
5181314-18131491.06291.70
6185155-18515592.99193.66
盐酸鲁拉西酮口崩片项目信息
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对照品来源自制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%
110.961974701975381971851966111976291972870.21
211.011975071973801974440.05
单位质量响应值RSD%判断
18000.6417933.150.27数据可信
供试品溶液-24120502批-pH6.8(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min193185-9318546.55736.8621.1846.5636.8621.18
281685-8168540.81240.81
369474-6947434.71134.71
447951-4795123.95723.96
568419-6841934.18434.18
681990-8199040.96440.96
10min1127029-12702963.46654.0515.1663.5454.1115.17
2116119-11611958.01558.08
3103525-10352551.72351.78
480028-8002839.98440.02
5104376-10437652.14852.21
6118018-11801858.96459.03
15min1145895-14589572.89263.2413.2473.0863.4013.25
2135708-13570867.80367.97
3121110-12111060.50960.65
498013-9801348.96949.08
5122842-12284261.37461.52
6135936-13593667.91668.08
20min1160633-16063380.25669.5812.7480.5669.8412.75
2147419-14741973.65473.93
3133025-13302566.46266.71
4109497-10949754.70754.90
5135351-13535167.62467.87
6149689-14968974.78875.07
30min1171963-17196385.91676.8011.3386.3577.1711.35
2163476-16347681.67682.08
3149371-14937174.62974.98
4122844-12284461.37561.65
5150689-15068975.28775.65
6163969-16396981.92282.33
45min1184476-18447692.16883.9510.1892.7584.4510.20
2177415-17741588.64089.18
3164748-16474882.31282.79
4136558-13655868.22768.61
5166922-16692283.39883.88
6178070-17807088.96789.51
60min1191077-19107795.46688.129.0296.2088.769.04
2184673-18467392.26692.95
3173298-17329886.58387.20
4146735-14673573.31273.81
5176560-17656088.21388.84
6185871-18587192.86593.55
极限1194394-19439497.12391.745.1798.0292.535.23
2188478-18847894.16795.01
3179922-17992289.89390.65
4167387-16738783.63084.25
5182275-18227591.06891.84
6189237-18923794.54795.39
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