玛巴洛沙韦干混悬剂片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DQTL-4125-250109对照品来源自制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)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.251012971007701002951005921006091007130.37
211.179942599834996300.30
单位质量响应值RSD%判断
8952.278919.430.26数据可信
供试品溶液-25020701批-pH6.8(内含0.16%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min131163-3116331.31538.1910.2031.3138.1910.21
238359-3835938.54638.55
340815-4081541.01441.01
436007-3600736.18236.18
540726-4072640.92440.92
640986-4098641.18541.19
10min145152-4515245.37251.697.5845.5551.907.59
252166-5216652.42052.63
355348-5534855.61755.85
448481-4848148.71748.92
554507-5450754.77255.00
652997-5299753.25553.48
15min154268-5426854.53261.096.3954.9661.596.41
260774-6077461.07061.58
364137-6413764.44964.99
458633-5863358.91859.39
562352-6235262.65563.19
664598-6459864.91265.44
20min162202-6220262.50569.535.8963.2370.375.91
268953-6895369.28970.13
373869-7386974.22875.12
467482-6748267.81068.61
571332-7133271.67972.56
671325-7132571.67272.56
30min171850-7185072.20079.975.0173.2881.195.03
280669-8066981.06282.29
382898-8289883.30184.61
479637-7963780.02581.20
580246-8024680.63681.91
682191-8219182.59183.87
45min186819-8681987.24189.261.5188.7290.931.56
290463-9046390.90392.58
388375-8837588.80590.58
488062-8806288.49190.11
589910-8991090.34892.07
689327-8932789.76291.50
60min189865-8986590.30291.701.7392.2693.871.71
291927-9192792.37494.56
390161-9016190.60092.86
492712-9271293.16395.28
593264-9326493.71895.95
689628-8962890.06492.31
90min189652-8965290.08892.352.1892.5595.022.18
293020-9302093.47396.17
389552-8955289.98892.75
492165-9216592.61395.24
594728-9472895.18997.94
692285-9228592.73495.48
120min1-0.0000.00-2.963.193.86
2-0.0003.22
3-0.0003.27
4-0.0003.14
5-0.0003.28
6-0.0003.26
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-2.963.193.86
2-0.0003.22
3-0.0003.27
4-0.0003.14
5-0.0003.28
6-0.0003.26
玛巴洛沙韦干混悬剂片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DQTL-4125-250109对照品来源自制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)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.2599588100727100431100852999151003030.54
211.171007981013711010840.41
单位质量响应值RSD%判断
8915.829049.601.06数据可信
供试品溶液-25020702批-pH6.8(内含0.16%CTAB)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min140959-4095940.94641.568.6840.9541.568.68
246158-4615846.14346.14
341956-4195641.94241.94
439971-3997139.95839.96
535879-3587935.86735.87
644493-4449344.47944.48
10min158412-5841258.39357.037.7258.6257.267.72
262420-6242062.40062.66
356777-5677756.75956.99
455776-5577655.75855.98
549403-4940349.38749.59
659495-5949559.47659.72
15min163503-6350363.48265.525.5564.0366.065.56
269841-6984169.81870.42
365018-6501864.99765.55
465810-6581065.78966.32
560003-6000359.98460.46
669051-6905169.02969.61
20min178076-7807678.05175.244.7478.9676.154.76
277576-7757677.55178.54
375013-7501374.98975.90
473741-7374173.71774.61
568985-6898568.96369.77
678186-7818678.16179.12
30min179751-7975179.72583.602.5181.0684.922.46
283267-8326783.24084.66
383563-8356383.53684.86
484516-8451684.48985.80
584999-8499984.97186.16
685643-8564385.61587.01
45min186919-8691986.89188.761.4788.6790.551.46
289742-8974289.71391.60
387846-8784687.81889.61
490580-9058090.55192.33
588803-8880388.77490.44
688812-8881288.78390.65
60min182939-8293982.91288.214.1985.1890.504.07
286521-8652186.49388.88
386522-8652286.49488.77
493579-9357993.54995.83
590128-9012890.09992.25
689729-8972989.70092.06
90min187316-8731687.28889.921.9790.0192.691.94
289147-8914789.11891.98
391174-9117491.14493.90
492410-9241092.38095.18
589366-8936689.33791.99
690265-9026590.23693.10
120min1-0.0000.00-3.213.282.59
2-0.0003.36
3-0.0003.26
4-0.0003.31
5-0.0003.15
6-0.0003.36
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-3.213.282.59
2-0.0003.36
3-0.0003.26
4-0.0003.31
5-0.0003.15
6-0.0003.36
玛巴洛沙韦干混悬剂片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DQTL-4125-250109对照品来源自制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)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.25996101004751003539962699812999750.42
211.171005811010171007990.31
单位质量响应值RSD%判断
8886.679024.081.09数据可信
供试品溶液-25020701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%
5min132542-3254232.63133.213.5532.6333.213.55
233056-3305633.14633.15
333121-3312133.21133.21
434431-3443134.52534.53
534301-3430134.39534.39
631261-3126131.34631.35
10min139315-3931539.42240.482.5739.6040.662.56
241280-4128041.39341.58
340176-4017640.28640.47
441817-4181741.93142.12
539233-3923339.34039.53
640372-4037240.48240.66
15min139303-3930339.41042.804.1539.8143.214.12
243723-4372343.84244.26
343317-4331743.43543.84
442910-4291043.02743.45
542538-4253842.65443.06
644325-4432544.44644.85
20min143451-4345143.57043.301.0744.1943.941.05
243881-4388144.00144.66
343065-4306543.18343.83
443059-4305943.17743.84
542507-4250742.62343.27
643115-4311543.23343.88
30min142594-4259442.71044.162.2643.5745.052.23
244613-4461344.73545.64
345174-4517445.29746.19
443701-4370143.82044.72
544825-4482544.94745.83
643347-4334743.46544.35
45min144359-4435944.48045.811.8445.5846.941.83
246666-4666646.79347.94
345674-4567445.79946.94
446026-4602646.15247.30
546277-4627746.40347.54
645120-4512045.24346.37
60min143382-4338243.50044.831.6744.8546.211.65
244342-4434244.46345.87
345179-4517945.30246.70
444943-4494345.06646.47
544909-4490945.03246.42
645466-4546645.59046.97
90min144558-4455844.68046.612.3346.2748.252.29
245923-4592346.04847.71
347257-4725747.38649.03
447110-4711047.23948.89
546694-4669446.82248.46
647376-4737647.50549.14
120min144159-4415944.28046.442.7946.1248.342.72
246791-4679146.91948.83
345477-4547745.60147.51
446848-4684846.97648.89
546808-4680846.93648.84
647799-4779947.93049.83
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限144894-4489445.01746.662.0747.1048.822.04
246850-4685046.97849.15
346197-4619746.32348.49
447144-4714447.27349.45
546443-4644346.57048.73
647685-4768547.81549.98
玛巴洛沙韦干混悬剂片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DQTL-4125-250109对照品来源自制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)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.259974810018810019710014999672999910.26
211.171003141008231005680.36
单位质量响应值RSD%判断
8888.099003.400.92数据可信
供试品溶液-B2013B01批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136577-3657736.71636.225.5736.7236.225.58
237040-3704037.18037.18
338072-3807238.21638.22
432810-3281032.93432.93
537454-3745437.59637.60
634524-3452434.65534.65
10min144533-4453344.70243.286.7244.9143.486.70
246163-4616346.33846.54
345958-4595846.13246.34
439907-3990740.05840.24
542423-4242342.58442.79
639692-3969239.84340.04
15min143586-4358643.75144.597.5744.2045.037.55
249114-4911449.30049.76
347948-4794848.13048.60
440568-4056840.72241.13
543020-4302043.18343.63
642288-4228842.44842.86
20min149722-4972249.91147.906.0450.6148.596.03
250662-5066250.85451.59
350168-5016850.35851.09
444178-4417844.34644.98
544582-4458244.75145.44
647019-4701947.19747.85
30min147538-4753847.71847.326.8448.6948.276.82
250377-5037750.56851.59
351113-5111351.30752.32
442637-4263742.79943.68
545171-4517145.34246.28
645995-4599546.16947.08
45min151232-5123251.42649.856.2852.6651.066.26
253975-5397554.18055.48
351643-5164351.83953.14
447206-4720647.38548.50
548128-4812848.31149.50
645764-4576445.93847.11
60min148894-4889449.07948.456.1550.6049.946.14
250949-5094951.14252.74
352291-5229152.48954.08
444712-4471244.88246.26
546800-4680046.97748.43
645951-4595146.12547.55
90min150535-5053550.72749.766.6252.5251.526.59
253499-5349953.70255.59
352269-5226952.46754.35
444349-4434944.51746.15
548424-4842448.60850.32
648333-4833348.51650.20
120min149928-4992850.11749.847.3352.2051.887.26
252361-5236152.56054.74
355147-5514755.35657.53
445557-4555745.73047.61
546444-4644446.62048.61
648444-4844448.62850.58
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限152688-5268852.88850.665.3655.2452.985.37
254150-5415054.35556.83
351463-5146351.65854.14
447422-4742247.60249.73
548983-4898349.16951.41
648114-4811448.29650.52
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