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%
111.331001201000261000209969999841999410.17
211.349895499107990300.11
单位质量响应值RSD%判断
8820.928732.800.71数据可信
供试品溶液-2025051521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%
5min148537-4853749.65846.518.6049.6646.518.60
238771-3877139.66639.67
344733-4473345.76645.77
450095-5009551.25251.25
545169-4516946.21246.21
645453-4545346.50346.50
10min174467-7446776.18769.888.2776.7470.408.27
257803-5780359.13859.58
368424-6842470.00470.51
471520-7152073.17173.74
568330-6833069.90870.42
669263-6926370.86271.38
15min182403-8240384.30680.285.4985.7081.575.53
270048-7004871.66572.76
379157-7915780.98582.27
479839-7983981.68383.07
578980-7898080.80482.09
680357-8035782.21383.52
20min184306-8430686.25384.023.9388.5986.214.01
275761-7576177.51079.40
383365-8336585.29087.48
484341-8434186.28988.58
582505-8250584.41086.60
682485-8248584.39086.61
30min187179-8717989.19287.701.6692.4990.821.78
283251-8325185.17387.93
386230-8623088.22191.35
485897-8589787.88091.13
586721-8672188.72391.85
685021-8502186.98490.14
45min187067-8706789.07789.131.0893.3693.221.15
285848-8584887.83091.53
388129-8812990.16494.28
486657-8665788.65892.88
588280-8828090.31894.43
686715-8671588.71792.84
60min187276-8727689.29188.810.8694.5793.900.78
287365-8736589.38294.06
386592-8659288.59193.71
486277-8627788.26993.48
587621-8762189.64494.76
685700-8570087.67992.79
90min187930-8793089.96088.961.2896.2395.031.33
285672-8567287.65093.32
387382-8738289.40095.50
486039-8603988.02694.22
588396-8839690.43796.55
686292-8629288.28594.37
120min182747-8274784.65887.031.9991.9294.091.89
283613-8361385.54492.19
387030-8703089.04096.13
484988-8498886.95094.12
586759-8675988.76295.88
685257-8525787.22694.29
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188018-8801890.05091.771.2698.2699.791.05
290725-9072592.820100.42
391186-9118693.292101.37
489327-8932791.39099.52
589529-8952991.59699.70
689395-8939591.45999.49
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%
111.339893899295991759916899199991550.14
211.341001901006131004020.30
单位质量响应值RSD%判断
8751.548853.790.83数据可信
供试品溶液-2025051621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%
5min144345-4434545.23648.804.1945.2448.804.18
247226-4722648.17548.18
348662-4866249.64049.64
447796-4779648.75748.76
550294-5029451.30551.30
648706-4870649.68549.68
10min171081-7108172.51073.871.4173.0174.421.42
272594-7259474.05374.59
372311-7231173.76474.32
472273-7227373.72674.27
574203-7420375.69476.26
672053-7205373.50174.05
15min181682-8168283.32483.101.1684.6384.461.15
282529-8252984.18885.55
379876-7987681.48282.85
481657-8165783.29884.66
582101-8210183.75185.16
680911-8091182.53783.91
20min187339-8733989.09587.501.9791.3389.781.93
287207-8720788.96091.25
383193-8319384.86587.14
484968-8496886.67688.96
587049-8704988.79991.14
684880-8488086.58688.87
30min188670-8867090.45290.321.9793.6893.581.91
288679-8867990.46193.74
389075-8907590.86594.08
485295-8529587.00990.26
588977-8897790.76594.09
690576-9057692.39795.64
45min187259-8725989.01391.051.7393.2495.321.67
289470-8947091.26895.56
387821-8782189.58693.82
491157-9115792.98997.21
590697-9069792.52096.86
689153-8915390.94595.22
60min189053-8905390.84391.312.0396.0696.581.96
288543-8854390.32395.62
386867-8686788.61393.84
490341-9034192.15797.41
592229-9222994.08399.45
690026-9002691.83697.12
90min189635-8963591.43790.511.4197.6696.791.37
288484-8848490.26396.57
386800-8680088.54594.75
488415-8841590.19296.47
590471-9047192.28998.70
688528-8852890.30796.61
120min184723-8472386.42688.811.7793.6796.111.65
287012-8701288.76196.07
386620-8662088.36195.55
488878-8887890.66497.94
586498-8649888.23795.67
688654-8865490.43697.74
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192079-9207993.93092.281.29102.13100.561.15
289010-8901090.79999.09
390323-9032392.139100.31
490394-9039492.211100.49
589484-8948491.28399.70
691503-9150393.342101.66
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%
111.339903698799990889883398838989190.14
211.341005731002931004330.20
单位质量响应值RSD%判断
8730.718856.531.02数据可信
供试品溶液-2025051622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%
5min146756-4675647.74649.633.9947.7549.633.98
251044-5104452.12452.12
346612-4661247.59947.60
447573-4757348.58048.58
550656-5065651.72851.73
648963-4896349.99950.00
10min169206-6920670.67173.804.0771.2074.364.07
274968-7496876.55577.13
368152-6815269.59570.12
473729-7372975.29075.83
574975-7497576.56277.14
672613-7261374.15074.71
15min179931-7993181.62382.183.2882.9483.553.28
281105-8110582.82284.25
375517-7551777.11678.42
482113-8211383.85185.23
582986-8298684.74386.17
681184-8118482.90284.28
20min186160-8616087.98486.172.5290.2188.462.50
283283-8328385.04687.40
380783-8078382.49384.65
486594-8659488.42790.73
584960-8496086.75889.13
684550-8455086.34088.64
30min187928-8792889.78989.071.9592.9992.311.97
286995-8699588.83692.13
383987-8398785.76588.84
488913-8891390.79594.09
587688-8768889.54492.88
687806-8780689.66592.92
45min183508-8350885.27688.123.0989.4792.353.04
286278-8627888.10492.39
382657-8265784.40788.44
487876-8787689.73694.04
588544-8854490.41894.74
688899-8889990.78195.04
60min187474-8747489.32689.032.7294.4794.242.70
286877-8687788.71693.98
382648-8264884.39789.36
488330-8833090.20095.50
588745-8874590.62495.95
689047-8904790.93296.20
90min186921-8692188.76188.342.1094.9094.542.12
286014-8601487.83594.08
383188-8318884.94990.85
488263-8826390.13196.43
587869-8786989.72996.07
686803-8680388.64094.92
120min184535-8453586.32487.322.1293.4594.502.15
285840-8584087.65794.88
382312-8231284.05490.90
487038-8703888.88096.18
586933-8693388.77396.11
686382-8638288.21095.47
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189673-8967391.57191.091.5699.6599.251.44
289025-8902590.90999.11
388954-8895490.83798.62
491501-9150193.438101.73
587240-8724089.08797.41
688838-8883890.71898.96
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