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%
1 11.069892998798987459884198719988060.09
2 11.049931498895991040.30
单位质量响应值RSD%判断
8933.638976.810.35数据可信
供试品溶液-2025051221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%
5min132620-3262032.70827.9615.6632.7127.9615.66
222831-2283122.89322.89
329936-2993630.01730.02
424448-2444824.51424.51
524884-2488424.95124.95
632606-3260632.69432.69
10min161168-6116861.33356.1410.7461.7056.4510.76
247228-4722847.35547.61
355327-5532755.47655.81
454517-5451754.66454.94
553469-5346953.61353.89
664235-6423564.40864.77
15min175043-7504375.24572.506.7076.2973.446.75
263445-6344563.61664.40
372611-7261172.80773.76
471622-7162271.81572.69
573412-7341273.61074.48
677724-7772477.93379.01
20min180719-8071980.93680.024.8482.8281.764.92
272973-7297373.17074.66
380437-8043780.65482.41
479065-7906579.27880.96
580848-8084881.06682.76
684801-8480185.02986.97
30min187895-8789588.13288.101.2290.9190.731.37
286003-8600386.23588.54
388123-8812388.36091.02
488609-8860988.84891.41
587489-8748987.72590.32
689066-8906689.30692.20
45min188583-8858388.82289.831.0692.5893.440.93
290081-9008190.32493.58
389358-8935889.59993.24
491246-9124691.49295.04
588993-8899389.23392.80
689275-8927589.51693.40
60min187628-8762887.86489.761.7692.6194.371.54
291282-9128291.52895.79
388667-8866788.90693.54
491608-9160891.85596.42
588971-8897189.21193.77
688966-8896689.20694.08
90min186954-8695487.18889.221.8392.9194.831.60
290893-9089391.13896.42
387898-8789888.13593.76
490977-9097791.22296.81
588607-8860788.84694.39
688561-8856188.80094.67
120min185201-8520185.43188.412.0392.1295.001.82
289405-8940589.64695.94
388060-8806088.29794.90
490493-9049390.73797.33
587780-8778088.01794.55
688072-8807288.30995.16
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188286-8828688.52491.752.2496.1699.321.96
294323-9432394.577101.86
390764-9076491.00998.59
492790-9279093.040100.64
591816-9181692.06399.58
691027-9102791.27299.11
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%
1 11.069906799608993919942699176993340.22
2 11.049941399504994580.07
单位质量响应值RSD%判断
8981.379008.880.22数据可信
供试品溶液-2025051321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%
5min135071-3507135.00933.6720.6235.0133.6720.62
229971-2997129.91829.92
341509-4150941.43641.44
428239-2823928.18928.19
525578-2557825.53325.53
642015-4201541.94141.94
10min160805-6080560.69860.5512.9261.0960.9312.96
256694-5669456.59456.93
370239-7023970.11670.58
454359-5435954.26354.58
552001-5200151.91052.19
669849-6984969.72670.19
15min175256-7525675.12474.216.4576.1975.266.57
271635-7163571.50972.47
380006-8000679.86581.10
470592-7059270.46871.38
568798-6879868.67769.54
679784-7978479.64480.88
20min181842-8184281.69880.553.9183.6082.424.08
279297-7929779.15880.91
383298-8329883.15285.28
477599-7759977.46379.16
577182-7718277.04678.67
684903-8490384.75486.88
30min187617-8761787.46386.691.3290.2789.451.52
286049-8604985.89888.53
387781-8778187.62790.68
485049-8504984.90087.46
586603-8660386.45188.93
687930-8793087.77690.84
45min188031-8803187.87688.181.4091.6591.911.41
288797-8879788.64192.23
388949-8894988.79392.82
486130-8613085.97989.48
589749-8974989.59193.03
688382-8838288.22792.27
60min191768-9176891.60788.522.1096.3693.232.04
286837-8683786.68491.26
387606-8760687.45292.46
487234-8723487.08191.54
589666-8966689.50893.94
688934-8893488.77893.80
90min187327-8732787.17487.820.9792.9593.521.13
287522-8752287.36892.91
388794-8879488.63894.62
486930-8693086.77792.20
588252-8825288.09793.53
689044-8904488.88894.90
120min187484-8748487.33085.932.5594.0792.602.44
283851-8385183.70490.21
385423-8542385.27392.24
483511-8351183.36489.75
589053-8905388.89795.31
687173-8717387.02094.02
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187370-8737087.21687.850.5494.9395.480.68
288121-8812187.96695.40
388484-8848488.32996.24
487472-8747287.31894.63
588279-8827988.12495.52
688329-8832988.17496.14
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%
1 11.069897499269992069947699322992490.19
2 11.049937199418993940.04
单位质量响应值RSD%判断
8973.699003.080.24数据可信
供试品溶液-2025051421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%
5min131733-3173331.70137.4220.5331.7037.4220.53
247053-4705347.00647.01
329456-2945629.42629.43
431520-3152031.48831.49
539271-3927139.23139.23
645711-4571145.66545.66
10min160184-6018460.12366.898.8560.4867.308.89
268715-6871568.64669.17
364839-6483964.77465.10
461063-6106361.00161.35
572365-7236572.29272.73
674554-7455474.47974.99
15min172403-7240372.33079.425.7373.3580.585.76
277777-7777777.69978.98
381880-8188081.79782.84
477340-7734077.26278.29
582598-8259882.51583.75
685001-8500184.91586.25
20min179782-7978279.70284.514.3381.5386.554.38
281943-8194381.86084.01
386497-8649786.41088.37
482541-8254182.45884.34
588088-8808887.99990.16
688692-8869288.60390.88
30min186869-8686986.78188.612.2389.4991.592.28
286875-8687586.78789.85
391216-9121691.12494.04
487505-8750587.41790.22
588778-8877888.68991.82
690950-9095090.85894.12
45min189320-8932089.23089.972.1092.9093.942.13
287252-8725287.16491.19
391531-9153191.43995.37
489184-8918489.09492.87
590531-9053190.44094.56
692551-9255192.45896.73
60min187666-8766687.57889.392.3592.2494.362.40
287201-8720187.11392.10
391022-9102290.93095.87
489097-8909789.00793.77
589130-8913089.04094.16
692790-9279092.69698.00
90min185958-8595885.87189.492.9391.5195.452.94
287332-8733287.24493.20
392637-9263792.54498.50
488941-8894188.85194.60
590861-9086190.76996.88
691775-9177591.68298.01
120min187262-8726287.17488.771.4693.7795.721.52
287998-8799887.90994.84
390754-9075490.66397.65
489013-8901388.92395.66
588225-8822588.13695.26
689880-8988089.78997.14
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192278-9227892.18591.501.4399.7599.441.46
291255-9125591.16399.07
392096-9209692.00399.99
489765-8976589.67597.40
590672-9067290.58198.68
693473-9347393.379101.72
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