玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DQTL-4125-250109对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.109897199116989029892198654989130.17
211.089892698946989360.02
单位质量响应值RSD%判断
8911.088929.240.15数据可信
供试品溶液-25032701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%
5min124858-2485825.02322.669.7925.0222.669.79
223364-2336423.51923.52
321070-2107021.21021.21
421427-2142721.56921.57
519485-1948519.61419.61
624880-2488025.04525.04
10min134247-3424734.47434.073.5534.7534.323.58
233652-3365233.87534.14
333559-3355933.78234.02
434389-3438934.61734.86
531808-3180832.01932.24
635418-3541835.65335.93
15min138394-3839438.64939.442.0639.3140.072.07
238765-3876539.02239.66
339090-3909039.34939.96
439420-3942039.68140.31
538738-3873838.99539.57
640664-4066440.93441.61
20min143222-4322243.50943.171.7144.6044.241.61
242937-4293743.22244.29
343588-4358843.87744.93
443117-4311743.40344.47
542994-4299443.27944.29
641475-4147541.75042.88
30min145466-4546645.76746.190.9447.3447.740.94
245750-4575046.05347.60
345597-4559745.89947.44
446006-4600646.31147.86
545829-4582946.13347.62
646675-4667546.98448.58
45min148214-4821448.53448.610.6150.6250.670.60
248151-4815148.47050.53
348528-4852848.85050.90
448742-4874249.06551.13
547970-4797048.28850.29
648108-4810848.42750.54
60min148803-4880349.12749.911.1451.7552.511.09
249086-4908649.41152.01
349498-4949849.82652.41
450150-5015050.48353.09
549788-4978850.11852.66
650175-5017550.50853.16
极限151195-5119551.53451.711.3654.7054.861.32
251060-5106051.39954.55
350299-5029950.63353.77
452294-5229452.64155.81
551428-5142851.76954.86
651925-5192552.26955.48
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DQTL-4125-250109对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.109889399094991049891498768989550.15
211.089910599356992300.18
单位质量响应值RSD%判断
8914.868955.780.33数据可信
供试品溶液-25032701批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min115962-1596216.04121.4413.3616.0421.4413.36
221281-2128121.38621.39
323589-2358923.70523.71
421661-2166121.76821.77
521616-2161621.72321.72
623873-2387323.99123.99
10min131018-3101831.17135.596.3431.3535.836.38
235660-3566035.83636.07
337375-3737537.55937.82
435941-3594136.11836.36
536591-3659136.77137.01
635937-3593736.11436.38
15min137989-3798938.17640.673.2138.7041.303.28
240783-4078340.98441.62
340859-4085941.06041.74
441264-4126441.46742.11
540281-4028140.47941.13
641620-4162041.82542.49
20min142015-4201542.22244.272.6043.1745.362.67
243920-4392044.13645.23
345161-4516145.38446.52
445051-4505145.27346.38
544354-4435444.57345.67
643824-4382444.04045.17
30min145607-4560745.83247.312.2247.2548.892.25
246857-4685747.08848.67
347181-4718147.41349.05
446674-4667446.90448.51
548797-4879749.03750.63
647350-4735047.58349.21
45min147791-4779148.02649.191.5149.9551.291.60
248996-4899649.23751.34
349407-4940749.65051.82
448384-4838448.62250.75
549327-4932749.57051.71
649784-4978450.02952.18
60min150959-5095951.21050.560.9253.6753.210.75
250344-5034450.59253.24
349783-4978350.02852.75
450470-5047050.71953.39
549778-4977850.02352.71
650532-5053250.78153.49
极限149927-4992750.17350.710.8853.2053.920.95
250265-5026550.51353.73
351169-5116951.42154.70
450721-5072150.97154.20
550492-5049250.74153.99
650177-5017750.42453.69
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DQTL-4125-250109对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.109885599303990769915899115991010.17
211.089884198666987540.13
单位质量响应值RSD%判断
8928.028912.820.13数据可信
供试品溶液-25032701批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119502-1950219.63125.2511.5819.6325.2511.58
225543-2554325.71225.71
325807-2580725.97725.98
425422-2542225.59025.59
528074-2807428.25928.26
626174-2617426.34726.35
10min133841-3384134.06435.713.0134.2835.993.06
235549-3554935.78436.07
334916-3491635.14735.44
435590-3559035.82536.11
537043-3704337.28837.60
635925-3592536.16236.45
15min138535-3853538.78939.843.4139.3940.523.41
239779-3977940.04240.72
337520-3752037.76838.45
441096-4109641.36742.05
540759-4075941.02841.76
639787-3978740.05040.74
20min141635-4163541.91042.310.9542.9443.430.95
242013-4201342.29043.42
342522-4252242.80343.90
442519-4251942.80043.94
541793-4179342.06943.25
641723-4172341.99843.14
30min142524-4252442.80544.472.2044.3046.062.22
244108-4410844.39946.00
344584-4458444.87846.45
445443-4544345.74347.36
544536-4453644.83046.48
643887-4388744.17745.78
45min144999-4499945.29645.401.9747.2647.481.91
244010-4401044.30146.39
345963-4596346.26648.34
445894-4589446.19748.32
545648-4564845.94948.10
644082-4408244.37346.47
60min145691-4569145.99346.921.6948.4649.501.66
247772-4777248.08750.67
345863-4586346.16648.75
446737-4673747.04649.68
546441-4644146.74849.41
647157-4715747.46850.06
极限144059-4405944.35046.283.2347.3349.393.13
244154-4415444.44547.56
347004-4700447.31450.41
447471-4747147.78450.95
546539-4653946.84650.03
646619-4661946.92750.04
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DQTL-4125-250109对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.109929299017991159917099344991880.14
211.089927999026991520.19
单位质量响应值RSD%判断
8935.868948.740.11数据可信
供试品溶液-25032701批-pH6.8(内含0.07%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137615-3761537.77135.7912.7437.7735.7912.74
238209-3820938.36738.37
330352-3035230.47830.48
440843-4084341.01241.01
537149-3714937.30337.30
629701-2970129.82429.82
10min162451-6245162.70965.485.7963.1365.885.81
270233-7023370.52470.95
360648-6064860.89961.24
468590-6859068.87469.33
566340-6634066.61567.03
663025-6302563.28663.62
15min173395-7339573.69976.624.6974.8277.744.71
280109-8010980.44181.65
370993-7099371.28772.30
479155-7915579.48380.70
578364-7836478.68879.84
675779-7577976.09377.13
20min180282-8028280.61483.912.7982.5585.882.82
285934-8593486.29088.39
383660-8366084.00685.81
484514-8451484.86486.97
585718-8571886.07388.10
681278-8127881.61483.49
30min185919-8591986.27589.202.3589.1192.112.29
290189-9018990.56293.62
391388-9138891.76694.51
487659-8765988.02291.07
590248-9024890.62193.61
687602-8760287.96590.75
45min179372-7937279.70090.036.2183.4993.936.03
293922-9392294.31198.38
393846-9384694.23497.99
490392-9039290.76694.79
592697-9269793.08197.07
687744-8774488.10791.87
60min190048-9004890.42191.642.5395.1096.542.50
292624-9262493.00798.12
393875-9387594.26499.07
492822-9282293.20698.24
590582-9058290.95795.98
687596-8759687.95992.70
极限192433-9243392.81693.684.0398.5099.603.79
296408-9640896.807102.96
395790-9579096.186102.04
494646-9464695.038101.11
586162-8616286.51992.56
694323-9432394.713100.43
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