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(%)99.74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%
110.941935741934491935571931401934681934380.10
211.031936841937571937200.03
单位质量响应值RSD%判断
17681.7217563.010.48数据可信
供试品溶液-2025111511批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146205-4620523.53627.4310.6623.5427.4310.65
262173-6217331.67031.67
354886-5488627.95927.96
458072-5807229.58129.58
551132-5113226.04626.05
650603-5060325.77725.78
10min1138961-13896170.78669.335.4570.8269.375.45
2138634-13863470.61970.67
3140089-14008971.36071.41
4142047-14204772.35872.41
5121686-12168661.98662.03
6135157-13515768.84868.89
15min1162094-16209482.56981.962.7382.7382.122.73
2160760-16076081.89082.06
3164482-16448283.78683.95
4165452-16545284.28084.45
5153271-15327178.07578.22
6159290-15929081.14181.30
20min1172021-17202187.62687.781.9787.9288.081.98
2171655-17165587.44087.75
3175927-17592789.61689.92
4175875-17587589.58989.90
5166747-16674784.94085.22
6171713-17171387.46987.76
30min1182413-18241392.92093.711.4593.3694.161.45
2182793-18279393.11393.57
3186477-18647794.99095.44
4186965-18696595.23995.70
5180110-18011091.74792.17
6185074-18507494.27594.71
45min1190072-19007296.82197.681.4797.4298.281.47
2190388-19038896.98297.59
3193727-19372798.68399.30
4194059-19405998.85299.47
5187640-18764095.58296.15
6194652-19465299.15499.75
60min1192451-19245198.03398.941.5298.7999.701.52
2192741-19274198.18198.95
3196174-19617499.930100.71
4196375-196375100.032100.82
5189981-18998196.77597.51
6197631-197631100.672101.43
极限1192810-19281098.21699.291.5799.14100.221.57
2193355-19335598.49499.43
3196574-196574100.133101.08
4196874-196874100.286101.24
5190855-19085597.22098.11
6199003-199003101.371102.30
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(%)99.74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%
110.941935071931031936091930221930771932640.15
211.031941791938291940040.13
单位质量响应值RSD%判断
17665.8117588.760.31数据可信
供试品溶液-2025111511批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135393-3539318.02423.0334.7118.0223.0334.72
218153-181539.2449.24
353181-5318127.08227.08
454202-5420227.60227.60
560648-6064830.88530.88
649811-4981125.36625.37
10min1135024-13502468.76165.9215.5768.7965.9615.57
289664-8966445.66145.68
3145153-14515373.91973.96
4138853-13885370.71070.76
5138375-13837570.46770.52
6129573-12957365.98566.03
15min1161677-16167782.33479.826.7382.4879.966.76
2135970-13597069.24269.33
3165223-16522384.13984.31
4159781-15978181.36881.53
5161095-16109582.03782.21
6156656-15665679.77779.93
20min1171063-17106387.11385.873.7987.4086.153.82
2155993-15599379.43979.65
3173776-17377688.49588.80
4170578-17057886.86687.17
5171351-17135187.26087.57
6168915-16891586.01986.30
30min1182168-18216892.76991.962.1293.2092.382.16
2173215-17321588.20988.55
3184140-18414093.77394.23
4181286-18128692.31992.76
5182341-18234192.85793.31
6180329-18032991.83292.26
45min1190198-19019896.85895.951.4097.4496.521.44
2183303-18330393.34793.83
3189782-18978296.64697.26
4188142-18814295.81196.41
5190217-19021796.86797.47
6188805-18880596.14896.73
60min1192601-19260198.08197.261.1098.8298.001.14
2187008-18700895.23395.88
3192291-19229197.92498.70
4190467-19046796.99597.75
5192173-19217397.86498.63
6191353-19135397.44698.19
极限1193455-19345598.51697.670.9099.4298.570.94
2188549-18854996.01896.82
3192743-19274398.15499.09
4191584-19158497.56498.48
5192561-19256198.06198.99
6191835-19183597.69198.60
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(%)99.74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%
110.941942121941381940571941491942701941650.05
211.031930671935741933200.19
单位质量响应值RSD%判断
17748.1717526.750.89数据可信
供试品溶液-2025111611批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min166960-6696034.08129.2348.4134.0829.2348.40
265162-6516233.16633.17
323219-2321911.81811.82
423144-2314411.78011.78
588244-8824444.91444.91
677879-7787939.63839.64
10min1142750-14275072.65666.2617.9772.7166.3117.99
2138613-13861370.55070.61
3106946-10694654.43254.45
494996-9499648.35048.37
5152476-15247677.60677.68
6145361-14536173.98574.05
15min1165545-16554584.25880.937.3084.4481.097.34
2162426-16242682.67082.84
3147791-14779175.22175.33
4141604-14160472.07272.17
5171161-17116187.11687.32
6165530-16553084.25084.44
20min1175486-17548689.31787.703.6089.6487.993.65
2173913-17391388.51788.83
3164566-16456683.75984.00
4164770-16477083.86384.08
5179520-17952091.37091.72
6175541-17554189.34589.68
30min1186545-18654594.94693.841.8795.4194.281.92
2184528-18452893.91994.38
3179244-17924491.23091.61
4181742-18174292.50192.86
5188872-18887296.13096.63
6185335-18533594.33094.81
45min1192335-19233597.89397.391.0598.5297.991.09
2191310-19131097.37197.99
3187843-18784395.60796.13
4191996-19199697.72098.23
5193829-19382998.65399.32
6190756-19075697.08997.73
60min1194331-19433198.90998.781.0499.7099.541.05
2193621-19362198.54799.32
3191187-19118797.30998.00
4196348-19634899.935100.61
5196245-19624599.883100.71
6192725-19272598.09198.89
极限1195153-19515399.32799.140.87100.28100.060.87
2194262-19426298.87499.81
3192200-19220097.82498.67
4197095-197095100.316101.16
5195876-19587699.695100.69
6194081-19408198.78299.74
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(%)99.74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%
110.941941691940811932051933171931221935790.27
211.031954421951711953060.10
单位质量响应值RSD%判断
17694.6117706.800.05数据可信
供试品溶液-2025111611批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min155853-5585328.32529.1125.2828.3229.1125.28
229263-2926314.84014.84
368096-6809634.53434.53
467165-6716534.06234.06
563730-6373032.32032.32
660333-6033330.59730.60
10min1117318-11731859.49664.8111.9359.5464.8611.94
2102956-10295652.21252.24
3141318-14131871.66771.72
4135390-13539068.66168.72
5141723-14172371.87271.93
6128103-12810364.96565.02
15min1152306-15230677.23979.965.7277.3980.125.74
2142832-14283272.43572.55
3165448-16544883.90484.08
4159598-15959880.93781.11
5167296-16729684.84185.01
6158532-15853280.39780.56
20min1167821-16782185.10787.003.6285.3887.293.64
2161842-16184282.07582.31
3177148-17714889.83790.15
4171288-17128886.86687.17
5178785-17878590.66890.98
6172411-17241187.43587.73
30min1182132-18213292.36593.592.4292.7894.022.44
2178979-17897990.76691.14
3189263-18926395.98196.45
4181832-18183292.21392.66
5190295-19029596.50596.97
6184754-18475493.69594.13
45min1190670-19067096.69597.402.0397.2797.992.05
2188266-18826695.47696.00
3196819-19681999.813100.44
4188105-18810595.39496.00
5196670-19667099.738100.36
6191843-19184397.29097.88
60min1193422-19342298.09198.762.0098.8299.512.01
2191776-19177697.25697.94
3199463-199463101.154101.95
4190023-19002396.36797.13
5199252-199252101.047101.84
6194494-19449498.63499.39
极限1195128-19512898.95699.141.9799.85100.061.98
2193047-19304797.90098.74
3199109-199109100.975101.94
4189904-18990496.30697.23
5200318-200318101.588102.55
6195411-19541199.099100.02
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(%)99.74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%
110.941951021947571953841951121947471950200.14
211.031955051957011956030.08
单位质量响应值RSD%判断
17826.3317733.730.37数据可信
供试品溶液-2025111711批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min162903-6290331.75834.2612.1731.7634.2612.17
272921-7292136.81636.82
363807-6380732.21432.21
479382-7938240.07840.08
556561-5656128.55628.56
671559-7155936.12836.13
10min1131660-13166066.47270.513.9466.5270.573.94
2145538-14553873.47873.54
3136001-13600168.66368.72
4143740-14374072.57072.64
5137288-13728869.31369.36
6143729-14372972.56572.63
15min1159561-15956180.55882.621.5980.7282.791.60
2167236-16723684.43384.62
3162209-16220981.89582.06
4164263-16426382.93283.12
5163607-16360782.60182.76
6164949-16494983.27883.46
20min1172392-17239287.03688.290.9687.3388.610.97
2177267-17726789.49789.82
3173653-17365387.67387.98
4175180-17518088.44488.77
5175526-17552688.61888.92
6175286-17528688.49788.82
30min1184150-18415092.97293.810.6793.4294.270.67
2187032-18703294.42794.90
3185007-18500793.40593.86
4185397-18539793.60294.08
5187419-18741994.62395.07
6185854-18585493.83394.30
45min1190659-19065996.25997.110.8896.8697.720.87
2193116-19311697.49998.13
3191602-19160296.73597.34
4191246-19124696.55597.18
5195304-19530498.60499.21
6192103-19210396.98897.61
60min1194130-19413098.01198.450.7598.7799.220.74
2195313-19531398.60899.40
3194409-19440998.15298.92
4193642-19364297.76598.55
5197716-19771699.822100.59
6194741-19474198.32099.11
极限1194703-19470398.30098.770.8999.2299.710.89
2196014-19601498.96299.92
3194359-19435998.12799.06
4194234-19423498.06499.02
5198881-198881100.410101.35
6195613-19561398.76099.71
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(%)99.74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%
110.941937931934361936161935051934711935640.08
211.031948021949631948820.06
单位质量响应值RSD%判断
17693.2417668.360.10数据可信
供试品溶液-2025111711批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min166782-6678233.90530.6714.2633.9130.6714.27
249425-4942525.09325.09
359489-5948930.20330.20
450880-5088025.83225.83
569342-6934235.20535.21
666573-6657333.79933.80
10min1128826-12882665.40568.646.3865.4668.696.38
2124742-12474263.33263.37
3141452-14145271.81671.87
4128912-12891265.44965.49
5144139-14413973.18073.24
6143110-14311072.65772.71
15min1156881-15688179.64981.503.5979.8181.663.60
2154865-15486578.62678.77
3165437-16543783.99384.16
4154282-15428278.33078.48
5165794-16579484.17484.35
6165934-16593484.24584.42
20min1169613-16961386.11387.612.7586.4187.912.76
2167575-16757585.07885.36
3176585-17658589.65389.96
4167686-16768685.13585.42
5176595-17659589.65889.98
6177304-17730490.01890.34
30min1182233-18223392.52093.492.3492.9693.942.35
2178965-17896590.86191.28
3187959-18795995.42795.89
4179974-17997491.37391.80
5186785-18678594.83195.30
6188908-18890895.90996.38
45min1189860-18986096.39397.022.1796.9997.622.18
2185908-18590894.38694.96
3194226-19422698.60999.23
4186857-18685794.86895.44
5194153-19415398.57299.20
6195555-19555599.28499.91
60min1192778-19277897.87498.312.0898.6399.082.09
2188155-18815595.52796.26
3196689-19668999.860100.64
4190136-19013696.53397.27
5195435-19543599.223100.02
6198632-198632100.846101.64
极限1194020-19402098.50598.792.0899.4299.722.09
2188912-18891295.91196.80
3197889-197889100.469101.42
4190746-19074696.84297.74
5197628-197628100.336101.29
6198309-198309100.682101.64
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