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%
111.041891241892691888351890161890611890610.09
211.021891671889941890800.07
单位质量响应值RSD%判断
17125.0917157.890.14数据可信
供试品溶液-1批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1113677-11367759.53059.421.2559.5359.421.25
2113060-11306059.20759.21
3110891-11089158.07158.07
4114755-11475560.09560.09
5113715-11371559.55059.55
6114669-11466960.05060.05
10min1155921-15592181.65281.750.6281.7581.850.62
2157551-15755182.50682.60
3154911-15491181.12381.22
4155313-15531381.33481.43
5156705-15670582.06382.16
6156275-15627581.83881.94
15min1170065-17006589.05989.450.6589.2989.680.64
2172392-17239290.27890.51
3170608-17060889.34489.58
4169260-16926088.63888.87
5171471-17147189.79590.03
6171052-17105289.57689.81
20min1177355-17735592.87792.980.7793.2693.370.77
2179509-17950994.00594.39
3177346-17734692.87293.25
4175407-17540791.85792.24
5178422-17842293.43693.82
6177303-17730392.85093.24
30min1182962-18296295.81395.790.8996.3596.330.89
2184902-18490296.82997.37
3183343-18334396.01396.55
4180035-18003594.28094.82
5183722-18372296.21196.75
6182537-18253795.59096.13
45min1185247-18524797.01097.250.9697.7197.950.96
2187843-18784398.36999.07
3186209-18620997.51398.21
4182620-18262095.63496.33
5186829-18682997.83898.54
6185456-18545697.11997.82
60min1186267-18626797.54497.641.0898.4098.501.07
2189176-18917699.06799.94
3187058-18705897.95898.82
4183028-18302895.84896.70
5187042-18704297.95098.81
6186149-18614997.48298.34
极限1187205-18720598.03598.050.9699.0699.080.96
2189863-18986399.427100.46
3187467-18746798.17299.19
4184333-18433396.53197.54
5187801-18780198.34799.38
6186760-18676097.80298.83
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%
111.041898841896951897491897331896591897440.05
211.021896281898201897240.08
单位质量响应值RSD%判断
17186.9617216.330.13数据可信
供试品溶液-2批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1123859-12385964.63563.062.5064.6463.062.50
2119617-11961762.42262.42
3119948-11994862.59462.59
4122009-12200963.67063.67
5123698-12369864.55164.55
6115889-11588960.47660.48
10min1163503-16350385.32384.641.0685.4384.741.06
2160493-16049383.75383.86
3161111-16111184.07584.18
4163396-16339685.26885.37
5164252-16425285.71485.82
6160417-16041783.71383.81
15min1176979-17697992.35691.990.9492.6192.240.94
2174175-17417590.89291.14
3175154-17515491.40391.65
4177798-17779892.78393.03
5178317-17831793.05493.30
6175274-17527491.46691.71
20min1184209-18420996.12995.381.0496.5395.781.04
2179887-17988793.87394.27
3181560-18156094.74695.14
4183873-18387395.95396.36
5184934-18493496.50796.91
6182209-18220995.08595.48
30min1187216-18721697.69897.870.8898.2698.430.88
2185122-18512296.60597.16
3186688-18668897.42297.98
4188576-18857698.40898.97
5189914-18991499.10699.67
6187779-18777997.99298.54
45min1189631-18963198.95899.070.8099.6999.790.80
2187609-18760997.90398.62
3188876-18887698.56499.28
4190357-19035799.337100.06
5192028-192028100.209100.94
6190558-19055899.442100.16
60min1190400-19040099.35999.511.02100.25100.391.02
2187951-18795198.08198.96
3189085-18908598.67399.55
4191280-19128099.819100.71
5193082-193082100.759101.66
6192296-192296100.349101.23
极限1190586-19058699.45799.450.84100.51100.500.84
2188723-18872398.48499.52
3188880-18888098.56699.61
4190798-19079899.567100.63
5192868-192868100.647101.71
6191600-19160099.986101.03
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%
111.041890721889161888871888061890551889470.07
211.021894961897071896020.08
单位质量响应值RSD%判断
17114.7617205.260.38数据可信
供试品溶液-6022402批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1112273-11227358.73259.002.3958.7359.002.40
2113112-11311259.17159.17
3116382-11638260.88160.88
4114732-11473260.01860.02
5108568-10856856.79456.79
6111598-11159858.37958.38
10min1147819-14781977.32677.861.5377.4277.961.54
2149990-14999078.46278.56
3152316-15231679.67979.78
4149665-14966578.29278.39
5145961-14596176.35476.45
6147258-14725877.03377.13
15min1163273-16327385.41186.091.5685.6486.321.56
2166066-16606686.87287.10
3168314-16831488.04888.28
4165195-16519586.41686.65
5160880-16088084.15984.38
6163722-16372285.64585.87
20min1171617-17161789.77590.301.5090.1490.671.50
2174241-17424191.14891.52
3176542-17654292.35292.73
4172871-17287190.43190.81
5169065-16906588.44088.80
6171353-17135389.63790.01
30min1179426-17942693.86094.601.4894.3895.121.48
2182969-18296995.71496.24
3184684-18468496.61197.15
4181078-18107894.72595.25
5177312-17731292.75593.26
6179561-17956193.93194.45
45min1184392-18439296.45897.231.4697.1397.911.47
2188042-18804298.36899.05
3189661-18966199.21599.91
4186160-18616097.38398.07
5182077-18207795.24795.91
6184854-18485496.70097.37
60min1186564-18656497.59498.271.5798.4399.111.57
2190520-19052099.664100.51
3191822-191822100.345101.21
4188326-18832698.51699.36
5184051-18405196.28097.10
6185878-18587897.23698.07
极限1187644-18764498.15998.951.5599.1699.961.55
2191781-191781100.324101.34
3193151-193151101.040102.07
4189000-18900098.86999.88
5185076-18507696.81697.80
6188290-18829098.49799.49
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%
111.041902271899681904271902731901821902150.09
211.021912721910961911840.07
单位质量响应值RSD%判断
17229.6217348.820.49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%
5min1142202-14220273.83272.671.6073.8372.671.60
2138424-13842471.87171.87
3142935-14293574.21374.21
4139803-13980372.58772.59
5139354-13935472.35472.35
6137087-13708771.17771.18
10min1168396-16839687.43386.771.6887.5686.891.68
2165156-16515685.75085.87
3171378-17137888.98189.10
4168568-16856887.52287.64
5165124-16512485.73485.85
6164061-16406185.18285.30
15min1178152-17815292.49891.791.3492.7792.061.35
2174481-17448190.59290.85
3180610-18061093.77494.05
4177235-17723592.02292.29
5175704-17570491.22791.49
6174590-17459090.64990.91
20min1182158-18215894.57893.941.3095.0094.361.30
2178834-17883492.85293.27
3184645-18464595.86996.30
4181737-18173794.35994.78
5179691-17969193.29793.71
6178562-17856292.71193.12
30min1184583-18458395.83795.701.3996.4296.281.39
2182553-18255394.78395.35
3188494-18849497.86898.46
4185822-18582296.48097.06
5182882-18288294.95495.52
6181565-18156594.27094.84
45min1186653-18665396.91296.571.2197.6597.301.21
2184513-18451395.80196.53
3189819-18981998.55699.31
4186744-18674496.95997.70
5184301-18430195.69196.42
6183880-18388095.47296.20
60min1186143-18614396.64796.841.3797.5597.731.37
2184725-18472595.91196.80
3190720-19072099.02399.94
4188330-18833097.78398.68
5185098-18509896.10496.99
6184046-18404695.55896.44
极限1186606-18660696.88796.971.1397.9598.021.13
2184778-18477895.93896.98
3190694-19069499.010100.09
4186927-18692797.05498.12
5186325-18632596.74197.79
6185217-18521796.16697.21
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%
111.041898611894851897061894901896791896440.09
211.021925441921411923420.15
单位质量响应值RSD%判断
17177.9017453.901.13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%
5min1143902-14390274.60473.512.8574.6073.512.85
2137318-13731871.19071.19
3140258-14025872.71572.71
4148760-14876077.12277.12
5139378-13937872.25872.26
6141139-14113973.17173.17
10min1170989-17098988.64787.762.1588.7787.892.15
2166056-16605686.08986.21
3167499-16749986.83786.96
4175926-17592691.20691.33
5167552-16755286.86586.99
6167702-16770286.94387.06
15min1179853-17985393.24292.461.8193.5192.731.81
2175903-17590391.19491.46
3176955-17695591.74092.01
4184223-18422395.50895.79
5177182-17718291.85792.12
6176005-17600591.24791.51
20min1183763-18376395.26994.781.5795.7095.211.57
2180297-18029793.47293.89
3181100-18110093.88994.31
4188102-18810297.51997.96
5182409-18240994.56794.99
6181268-18126893.97694.39
30min1187421-18742197.16696.441.4897.7597.021.48
2185242-18524296.03696.61
3183393-18339395.07795.65
4190760-19076098.89799.50
5185520-18552096.18096.76
6183742-18374295.25895.83
45min1187728-18772897.32597.041.1498.0797.781.14
2186297-18629796.58397.31
3185291-18529196.06196.80
4191057-19105799.05199.82
5187168-18716897.03497.77
6185499-18549996.16996.90
60min1189297-18929798.13897.371.4099.0598.271.40
2187253-18725397.07997.97
3185258-18525896.04496.94
4192323-19232399.707100.64
5186824-18682496.85697.75
6185887-18588796.37097.26
极限1189907-18990798.45497.431.3399.5398.501.33
2187359-18735997.13398.19
3185295-18529596.06397.12
4191914-19191499.495100.59
5186520-18652096.69997.76
6186610-18661096.74597.80
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%
111.041910901907081911641912371911671910730.12
211.021933761931331932540.09
单位质量响应值RSD%判断
17307.3417536.660.94数据可信
供试品溶液-6022402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%
5min1138075-13807571.14670.722.6371.1570.722.63
2132953-13295368.50668.51
3137992-13799271.10371.10
4142089-14208973.21473.21
5139337-13933771.79671.80
6133077-13307768.57068.57
10min1165485-16548585.26984.812.5585.3984.932.55
2157810-15781081.31481.43
3166832-16683285.96386.08
4169526-16952687.35187.47
5166302-16630285.69085.81
6161605-16160583.27083.38
15min1175084-17508490.21589.872.7590.4890.132.75
2167020-16702086.06086.31
3176488-17648890.93991.20
4180361-18036192.93493.20
5176840-17684091.12091.38
6170653-17065387.93288.19
20min1179743-17974392.61692.692.3793.0393.102.37
2172477-17247788.87289.26
3182343-18234393.95594.37
4184694-18469495.16795.59
5181817-18181793.68494.10
6178230-17823091.83692.24
30min1183577-18357794.59195.162.5795.1695.722.57
2176245-17624590.81391.35
3187643-18764396.68697.26
4189148-18914897.46298.04
5187829-18782996.78297.35
6183637-18363794.62295.17
45min1186819-18681996.26296.472.7196.9897.192.71
2177989-17798991.71292.40
3190635-19063598.22898.96
4191291-19129198.56699.31
5190737-19073798.28199.01
6185825-18582595.75096.46
60min1187615-18761596.67297.022.3897.5697.902.38
2180025-18002592.76193.61
3191628-19162898.74099.63
4191635-19163598.74399.65
5191194-19119498.51699.41
6187629-18762996.67997.55
极限1187936-18793696.83797.392.4497.8898.442.44
2180600-18060093.05794.06
3193040-19304099.467100.53
4192340-19234099.107100.18
5191568-19156898.70999.77
6188573-18857397.16698.20
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