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 11.011943901942051940051945551943771943060.11
2 11.101941401940291940840.05
单位质量响应值RSD%判断
17648.1417485.050.66数据可信
供试品溶液-1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%
5min1137573-13757370.30268.233.4170.3068.233.40
2125056-12505663.90663.91
3133314-13331468.12568.13
4132887-13288767.90767.91
5136845-13684569.93069.93
6135418-13541869.20169.20
10min1167133-16713385.40782.582.7185.5282.702.71
2154055-15405578.72478.83
3162510-16251083.04583.16
4159904-15990481.71381.83
5163182-16318283.38883.51
6162877-16287783.23383.35
15min1180088-18008892.02888.882.4092.2989.132.41
2167437-16743785.56385.80
3173391-17339188.60588.86
4172169-17216987.98188.23
5175472-17547289.66989.92
6175041-17504189.44989.70
20min1187235-18723595.68092.762.2296.0993.162.22
2175216-17521689.53889.92
3182211-18221193.11393.51
4179178-17917891.56391.96
5182834-18283493.43193.84
6182412-18241293.21593.62
30min1194838-19483899.56596.851.57100.1497.401.57
2187089-18708995.60596.13
3189175-18917596.67197.23
4186470-18647095.28995.84
5189519-18951996.84797.41
6190011-19001197.09897.66
45min1195664-19566499.98798.801.22100.7399.511.23
2189981-18998197.08397.77
3195534-19553499.921100.64
4191009-19100997.60898.32
5193676-19367698.97199.69
6194127-19412799.20299.92
60min1201313-201313102.874100.291.63103.78101.171.64
2191962-19196298.09598.95
3197437-197437100.893101.78
4193966-19396699.12099.99
5195977-195977100.147101.03
6196833-196833100.585101.47
极限1202382-202382103.420100.871.48104.50101.921.49
2194788-19478899.540100.55
3198610-198610101.493102.54
4194484-19448499.384100.42
5196418-196418100.373101.43
6197630-197630100.992102.05
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 11.011942731946251943321943541942271943620.08
2 11.101943611941191942400.09
单位质量响应值RSD%判断
17653.2217499.100.63数据可信
供试品溶液-2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%
5min1129729-12972966.25766.512.3666.2666.502.36
2135636-13563669.27469.27
3126728-12672864.72564.72
4130359-13035966.57966.58
5130813-13081366.81166.81
6128040-12804065.39565.39
10min1158576-15857680.99081.142.0381.1081.262.04
2164429-16442983.98084.10
3155671-15567179.50779.61
4155906-15590679.62779.74
5160204-16020481.82281.93
6158482-15848280.94281.05
15min1172409-17240988.05588.191.7388.3088.431.73
2177290-17729090.54890.80
3169483-16948386.56186.80
4169771-16977186.70886.95
5174713-17471389.23289.48
6172326-17232688.01388.26
20min1181567-18156792.73392.381.4193.1292.771.42
2182939-18293993.43393.84
3177029-17702990.41590.80
4178615-17861591.22591.61
5183596-18359693.76994.17
6181508-18150892.70393.09
30min1189273-18927396.66896.671.1597.2297.221.15
2191481-19148197.79698.36
3186046-18604695.02095.56
4187386-18738695.70596.24
5190974-19097497.53798.09
6190535-19053597.31397.86
45min1194921-19492199.55399.591.26100.26100.301.26
2197663-197663100.954101.68
3191036-19103697.56998.26
4193411-19341198.78299.48
5196771-196771100.498101.21
6196184-196184100.198100.91
60min1197553-197553100.897100.910.84101.77101.780.85
2199457-199457101.870102.76
3194944-19494499.565100.42
4196445-196445100.331101.20
5198761-198761101.514102.40
6198289-198289101.273102.15
极限1197569-197569100.906101.461.17101.95102.501.17
2201132-201132102.725103.79
3194923-19492399.554100.58
4197854-197854101.051102.08
5200095-200095102.196103.25
6200341-200341102.321103.36
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 11.011946751947041943931942501946171945280.11
2 11.101937231941611939420.16
单位质量响应值RSD%判断
17668.3017472.250.79数据可信
供试品溶液-3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%
5min1124862-12486263.79464.825.2163.7964.825.21
2122876-12287662.77962.78
3120847-12084761.74261.74
4133670-13367068.29468.29
5122317-12231762.49362.49
6136627-13662769.80469.80
10min1155440-15544079.41679.943.4979.5280.053.50
2155157-15515779.27279.38
3149794-14979476.53276.63
4162429-16242982.98783.10
5152448-15244877.88877.99
6163533-16353383.55183.67
15min1171656-17165687.70187.382.7387.9487.622.73
2171102-17110287.41887.65
3164205-16420583.89484.12
4175821-17582189.82990.08
5167335-16733585.49485.73
6175996-17599689.91990.17
20min1180349-18034992.14391.772.0792.5392.162.08
2180719-18071992.33292.71
3173654-17365488.72289.09
4183425-18342593.71494.12
5176890-17689090.37590.75
6182718-18271893.35393.76
30min1188993-18899396.55995.911.7897.1096.451.78
2189978-18997897.06297.60
3182224-18222493.10193.62
4190967-19096797.56798.13
5185189-18518994.61595.14
6188960-18896096.54297.10
45min1194509-19450999.37798.761.47100.0899.461.47
2195629-19562999.949100.65
3189104-18910496.61697.29
4196435-196435100.361101.08
5190905-19090597.53698.22
6193207-19320798.71299.43
60min1196399-196399100.34399.931.70101.21100.791.70
2199795-199795102.078102.94
3191959-19195998.07498.91
4198952-198952101.647102.54
5192593-19259398.39899.25
6193793-19379399.01199.90
极限1198034-198034101.178100.431.36102.21101.461.36
2198880-198880101.610102.65
3193057-19305798.63599.63
4199570-199570101.963103.02
5194159-19415999.198100.21
6195700-19570099.986101.04
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 11.011932511932321931311931071932161931870.04
2 11.101946681946531946600.01
单位质量响应值RSD%判断
17546.5017536.940.04数据可信
供试品溶液-1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%
5min163157-6315732.31935.6610.0532.3235.6610.05
267691-6769134.63934.64
370575-7057536.11536.12
481254-8125441.58041.58
572981-7298137.34637.35
662413-6241331.93931.94
10min1104486-10448653.46855.096.0853.5255.156.09
2111342-11134256.97757.03
3107319-10731954.91854.98
4116281-11628159.50459.57
5109460-10946056.01456.08
697041-9704149.65949.71
15min1120767-12076761.80064.835.6861.9464.985.69
2124640-12464063.78263.93
3129638-12963866.33966.49
4137398-13739870.31070.48
5130176-13017666.61566.77
6117540-11754060.14960.28
20min1136553-13655369.87872.454.9170.1272.704.91
2137513-13751370.36970.63
3145193-14519374.29974.56
4151622-15162277.58977.87
5145373-14537374.39274.66
6133178-13317868.15168.39
30min1156717-15671780.19782.603.7880.5682.983.79
2158073-15807380.89081.27
3165092-16509284.48284.87
4169977-16997786.98287.40
5164642-16464284.25284.64
6153997-15399778.80579.15
45min1174415-17441589.25391.472.6189.7591.992.63
2176972-17697290.56291.07
3182799-18279993.54394.07
4184155-18415594.23794.80
5181321-18132192.78793.32
6172875-17287588.46588.95
60min1185025-18502594.68396.181.9995.3396.862.01
2185337-18533794.84295.50
3191640-19164098.06898.75
4191925-19192598.21498.93
5190298-19029897.38198.07
6183528-18352893.91794.55
极限1191580-19158098.03799.441.5198.84100.271.53
2192131-19213198.31999.14
3197644-197644101.140101.99
4196687-196687100.650101.53
5196519-196519100.564101.41
6191331-19133197.91098.69
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 11.011952431949231948991948511950761949980.09
2 11.101945551948711947130.12
单位质量响应值RSD%判断
17710.9917541.710.68数据可信
供试品溶液-2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%
5min163700-6370032.44134.594.8832.4434.594.88
267992-6799234.62734.63
364310-6431032.75232.75
470023-7002335.66235.66
572110-7211036.72436.72
669356-6935635.32235.32
10min199041-9904150.44052.234.4950.4952.294.49
2103331-10333152.62552.68
397721-9772149.76849.82
4109766-10976655.90255.96
5105721-10572153.84253.90
699787-9978750.82050.88
15min1121146-12114661.69863.063.4061.8463.213.40
2124874-12487463.59663.74
3119108-11910860.66060.80
4126798-12679864.57664.73
5130189-13018966.30366.45
6120869-12086961.55761.70
20min1140176-14017671.38971.172.1671.6371.422.16
2140376-14037671.49171.74
3136338-13633869.43569.67
4141930-14193072.28372.54
5143616-14361673.14173.40
6136092-13609269.30969.56
30min1158541-15854180.74281.202.1581.1081.572.16
2160396-16039681.68782.06
3155364-15536479.12479.48
4161835-16183582.42082.80
5164326-16432683.68884.07
6156177-15617779.53879.90
45min1176879-17687990.08290.301.8390.5890.801.84
2177982-17798290.64391.15
3173802-17380288.51489.00
4179375-17937591.35391.87
5182075-18207592.72893.25
6173752-17375288.48988.98
60min1187773-18777395.63096.332.4996.2796.982.49
2187586-18758695.53496.19
3187045-18704595.25995.89
4191750-19175097.65598.33
5197143-197143100.402101.08
6183613-18361393.51194.15
极限1195449-19544999.53999.742.04100.34100.562.04
2201042-201042102.387103.20
3192168-19216897.86898.66
4196279-19627999.962100.79
5199416-199416101.559102.40
6190741-19074197.14197.94
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 11.011956111956971953261952651954081954610.10
2 11.101954421951241952830.12
单位质量响应值RSD%判断
17753.0417593.060.65数据可信
供试品溶液-3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%
5min161069-6106931.01935.237.9631.0235.237.96
267316-6731634.19234.19
372327-7232736.73836.74
469877-6987735.49335.49
577629-7762939.43139.43
667963-6796334.52134.52
10min199627-9962750.60451.863.9650.6651.923.96
2100967-10096751.28551.34
3106731-10673154.21354.27
4100602-10060251.09951.16
5107379-10737954.54254.61
697336-9733649.44049.50
15min1123222-12322262.58963.162.7062.7263.312.71
2123769-12376962.86763.01
3128278-12827865.15765.31
4123032-12303262.49262.64
5128230-12823065.13365.29
6119604-11960460.75160.89
20min1140237-14023771.23171.542.1471.4771.792.15
2140093-14009371.15871.41
3144599-14459973.44773.71
4138421-13842170.30970.56
5144349-14434973.32073.59
6137373-13737369.77770.02
30min1161150-16115081.85481.611.6182.2181.981.61
2161209-16120981.88482.25
3163112-16311282.85083.23
4159400-15940080.96581.33
5162916-16291682.75183.14
6156179-15617979.32979.69
45min1178803-17880390.82190.231.2791.3290.741.27
2178595-17859590.71591.22
3179311-17931191.07991.60
4176823-17682389.81590.32
5178898-17889890.86991.39
6173404-17340488.07888.57
60min1190005-19000596.51096.302.5197.1696.952.49
2187616-18761695.29795.95
3187678-18767895.32896.00
4198888-198888101.022101.67
5187555-18755595.26695.94
6185760-18576094.35494.99
极限1194235-19423598.65998.351.0999.4799.171.10
2193856-19385698.46699.28
3196954-196954100.040100.87
4192452-19245297.75398.57
5193747-19374798.41199.25
6190565-19056596.79597.59
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