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%
1 10.901939491938411933481931241933411935210.19
2 10.921934891933971934430.04
单位质量响应值RSD%判断
17754.2217714.560.16数据可信
供试品溶液-24091302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%
5min154711-5471127.69340.8316.3827.6940.8316.38
289524-8952445.31445.31
379170-7917040.07340.07
488175-8817544.63244.63
586298-8629843.68143.68
686090-8609043.57643.58
10min185051-8505143.05055.2711.1443.1055.3411.15
2116852-11685259.14759.22
3109016-10901655.18155.25
4116645-11664559.04259.12
5113722-11372257.56357.64
6113907-11390757.65657.73
15min1101316-10131651.28363.449.6251.4063.609.63
2132187-13218766.90967.08
3126101-12610163.82963.99
4133398-13339867.52267.69
5128771-12877165.18065.35
6130268-13026865.93866.11
20min1113720-11372057.56268.818.1857.7669.088.20
2141168-14116871.45571.74
3137143-13714369.41869.68
4143898-14389872.83773.12
5139221-13922170.46970.75
6140529-14052971.13271.41
30min1130138-13013865.87276.116.7666.1776.486.78
2154544-15454478.22578.63
3151634-15163476.75377.13
4158326-15832680.14080.55
5153007-15300777.44877.84
6154489-15448978.19878.59
45min1146592-14659274.20083.055.3274.6183.565.34
2166710-16671084.38484.92
3166789-16678984.42484.93
4170666-17066686.38686.93
5166014-16601484.03184.56
6167633-16763384.85185.38
60min1157160-15716079.55087.714.6380.0888.364.66
2174926-17492688.54289.22
3176188-17618889.18189.83
4179118-17911890.66491.35
5176306-17630689.24189.90
6176020-17602089.09689.76
极限1172866-17286687.50091.822.4988.1692.612.54
2180676-18067691.45392.28
3183105-18310592.68293.48
4186026-18602694.16195.00
5182729-18272992.49293.30
6182969-18296992.61393.43
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%
1 10.901952511945651942321943501945521945900.21
2 10.921937881937421937650.02
单位质量响应值RSD%判断
17852.2917744.050.44数据可信
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%
5min169018-6901834.81035.373.6034.8135.373.61
269721-6972135.16435.16
372304-7230436.46736.47
471185-7118535.90335.90
565892-6589233.23333.23
672708-7270836.67136.67
10min1131412-13141266.27967.001.6466.3467.061.65
2135029-13502968.10368.16
3134180-13418067.67567.74
4134713-13471367.94468.00
5129488-12948865.30965.36
6132237-13223766.69566.76
15min1150626-15062675.97076.391.5376.1476.561.53
2153435-15343577.38677.56
3152594-15259476.96277.14
4153890-15389077.61677.79
5147745-14774574.51774.68
6150447-15044775.87976.05
20min1161588-16158881.49981.951.1881.7982.251.18
2163693-16369382.56082.86
3163420-16342082.42282.72
4164967-16496783.20383.51
5159616-15961680.50480.79
6161655-16165581.53281.83
30min1173940-17394087.72888.711.3288.1689.141.32
2177732-17773289.64190.08
3177038-17703889.29189.73
4178935-17893590.24890.69
5173505-17350587.50987.93
6174133-17413387.82688.26
45min1184212-18421292.90994.101.3493.4994.681.34
2188472-18847295.05895.65
3187734-18773494.68595.27
4189962-18996295.80996.40
5184908-18490893.26093.83
6184099-18409992.85293.43
60min1191183-19118396.42597.041.1197.1697.781.12
2195118-19511898.41099.16
3193006-19300697.34498.09
4194512-19451298.10498.86
5190567-19056796.11496.84
6190008-19000895.83296.57
极限1193894-19389497.79298.621.0798.6999.521.07
2197636-19763699.680100.59
3196369-19636999.04199.95
4197937-19793799.831100.75
5194552-19455298.12499.01
6192847-19284797.26498.16
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%
1 10.901943011946061944201942291942131943540.09
2 10.921951461954731953100.12
单位质量响应值RSD%判断
17830.6417885.530.22数据可信
供试品溶液-24091302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%
5min113073-130736.5717.7752.506.577.7752.46
220947-2094710.52910.53
328239-2823914.19514.19
414694-146947.3867.39
55163-51632.5952.60
610620-106205.3385.34
10min145493-4549322.86820.0245.0522.8820.0345.06
250684-5068425.47725.49
365819-6581933.08533.11
434380-3438017.28217.29
515575-155757.8297.83
626970-2697013.55713.57
15min169419-6941934.89431.1735.5734.9431.2235.59
275572-7557237.98738.05
392947-9294746.72146.80
457634-5763428.97129.01
531642-3164215.90515.92
644844-4484422.54122.57
20min187437-8743743.95140.9029.1744.0641.0029.20
296477-9647748.49648.62
3114254-11425457.43157.59
480103-8010340.26540.35
548991-4899124.62624.67
660918-6091830.62130.69
30min1119458-11945860.04756.9320.9160.2357.0920.95
2128617-12861764.65164.86
3141350-14135071.05271.30
4118742-11874259.68759.84
576013-7601338.20938.29
695309-9530947.90848.03
45min1150634-15063475.71871.7812.6576.0072.0412.71
2151380-15138076.09376.41
3162285-16228581.57581.95
4150953-15095375.87976.13
5114467-11446757.53857.69
6127101-12710163.88964.09
60min1166473-16647383.68079.2510.0784.0979.6310.13
2162268-16226881.56682.01
3174404-17440487.66788.17
4166872-16687283.88184.26
5134875-13487567.79768.04
6141037-14103770.89471.20
极限1176055-17605588.49785.605.6889.0486.125.76
2171925-17192586.42187.00
3181190-18119091.07891.73
4175694-17569488.31588.84
5157280-15728079.05979.42
6159628-15962880.23980.66
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%
1 10.901945101946261946421948211947141946630.06
2 10.921935201936721935960.06
单位质量响应值RSD%判断
17858.9917728.570.52数据可信
供试品溶液-2022082601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%
5min165411-6541132.99932.967.1333.0032.967.13
264547-6454732.56332.56
362612-6261231.58731.59
469593-6959335.10935.11
558505-5850529.51529.51
671284-7128435.96235.96
10min1130047-13004765.60765.573.6565.6665.623.66
2131822-13182266.50266.56
3130324-13032465.74765.80
4134816-13481668.01368.07
5120923-12092361.00461.05
6131868-13186866.52666.59
15min1148639-14863974.98675.283.2375.1575.443.24
2150313-15031375.83176.00
3151127-15112776.24276.40
4154868-15486878.12978.30
5140360-14036070.81070.96
6149972-14997275.65975.83
20min1161421-16142181.43580.772.9181.7281.062.92
2160845-16084581.14481.44
3162086-16208681.77082.06
4164368-16436882.92183.22
5150968-15096876.16176.43
6160889-16088981.16681.46
30min1174474-17447488.02087.642.7688.4488.062.77
2175326-17532688.45088.88
3175778-17577888.67889.10
4178926-17892690.26690.71
5164794-16479483.13683.53
6173000-17300087.27687.71
45min1184796-18479693.22792.822.4093.8093.392.41
2185476-18547693.57094.14
3185444-18544493.55494.13
4189057-18905795.37795.97
5175866-17586688.72289.26
6183241-18324192.44393.02
60min1190282-19028295.99595.502.0996.7296.222.10
2190248-19024895.97896.71
3191331-19133196.52497.25
4193698-19369897.71898.47
5182139-18213991.88792.57
6188110-18811094.89995.63
极限1192428-19242897.07797.061.4997.9697.941.50
2193176-19317697.45598.34
3193285-19328597.51098.40
4196767-19676799.266100.18
5188389-18838995.04095.88
6190295-19029596.00196.89
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