玛巴洛沙韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)0
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%
111.049858698987989479853998750987620.21
211.059861898354984860.19
单位质量响应值RSD%判断
8945.838912.760.27数据可信
影响因素30天-供试品溶液-2025062721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%
5min167069-6706967.44552.3717.3867.4452.3717.37
255162-5516255.47155.47
347364-4736447.62947.63
452904-5290453.20053.20
550054-5005450.33450.33
639915-3991540.13940.14
10min180206-8020680.65568.3211.2281.0368.6111.25
270702-7070271.09871.41
364138-6413864.49764.76
468621-6862169.00669.30
566793-6679367.16767.45
657161-5716157.48157.70
15min185207-8520785.68478.086.7286.5178.766.78
280514-8051480.96581.67
373612-7361274.02474.65
478495-7849578.93579.61
577727-7772778.16378.82
670333-7033370.72771.27
20min186602-8660287.08784.303.4888.3985.403.56
285533-8553386.01287.17
380842-8084281.29582.33
485675-8567586.15587.27
584787-8478785.26286.35
679519-7951979.96580.90
30min189929-8992990.43389.851.3592.2291.421.45
290938-9093891.44893.08
389224-8922489.72491.21
489658-8965890.16091.76
589018-8901889.51791.08
687313-8731387.80289.18
45min191157-9115791.66892.040.6493.9594.110.66
292505-9250593.02395.16
391601-9160192.11494.10
491762-9176292.27694.37
590818-9081891.32793.38
691345-9134591.85793.72
60min188859-8885989.35792.441.8992.1595.021.73
293020-9302093.54196.20
393296-9329693.81996.31
492283-9228392.80095.41
590955-9095591.46594.03
693108-9310893.63096.01
极限190328-9032890.83492.081.5294.1295.181.46
292937-9293793.45896.63
392258-9225892.77595.79
492692-9269293.21196.34
589466-8946689.96793.04
691720-9172092.23495.13
玛巴洛沙韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)0
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%
111.049928598723990429922398903990350.24
211.059939399734995640.25
单位质量响应值RSD%判断
8970.569010.320.32数据可信
影响因素30天-供试品溶液-2025062721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%
5min174106-7410674.01557.0626.8074.0157.0626.80
268450-6845068.36668.37
368864-6886468.77968.78
437661-3766137.61537.61
543180-4318043.12743.13
650505-5050550.44350.44
10min186715-8671586.60872.4218.3787.0272.7418.40
281776-8177681.67582.05
383528-8352883.42583.81
455633-5563355.56455.77
559369-5936959.29659.54
668045-6804567.96168.24
15min190876-9087690.76481.7512.1491.6682.4712.23
288062-8806287.95388.79
392288-9228892.17493.02
469463-6946369.37769.89
571802-7180271.71372.28
678644-7864478.54779.20
20min191766-9176691.65387.286.9093.0588.467.04
291106-9110690.99492.32
394330-9433094.21495.57
481346-8134681.24682.15
579463-7946379.36580.33
686324-8632486.21787.31
30min191644-9164491.53191.422.5993.4493.082.74
291635-9163591.52293.35
394997-9499794.88096.76
488964-8896488.85490.21
588905-8890588.79590.20
693083-9308392.96894.54
45min193492-9349293.37794.881.9895.7997.052.01
296441-9644196.32298.66
396605-9660596.48698.89
496551-9655196.43298.28
592140-9214092.02693.93
694753-9475394.63696.73
60min191910-9191091.79794.592.0294.7397.291.96
295190-9519095.07397.94
396330-9633096.21199.16
496182-9618296.06398.45
592742-9274292.62895.04
695910-9591095.79298.41
极限193956-9395693.84094.681.5197.2897.901.53
293736-9373693.62097.02
396449-9644996.33099.81
495429-9542995.31198.23
593006-9300692.89195.82
696227-9622796.10899.26
玛巴洛沙韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)0
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%
111.049879498735988259862098745987440.08
211.059895698679988180.20
单位质量响应值RSD%判断
8944.208942.810.02数据可信
影响因素30天-供试品溶液-2025062721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%
5min159520-5952059.75849.7710.9359.7649.7710.94
249535-4953549.73349.73
348151-4815148.34448.34
445482-4548245.66445.66
544259-4425944.43644.44
650503-5050350.70550.71
10min176759-7675977.06666.558.7377.4066.838.75
266648-6664866.91567.19
364754-6475465.01365.28
460678-6067860.92161.17
561525-6152561.77162.02
667366-6736667.63667.92
15min183457-8345783.79178.104.1184.5578.754.15
277936-7793678.24878.90
376799-7679977.10677.74
475212-7521275.51376.11
574581-7458174.88075.47
678760-7876079.07579.73
20min189336-8933689.69486.252.0390.9287.332.09
285381-8538185.72386.81
385576-8557685.91986.98
484873-8487385.21386.22
584559-8455984.89785.90
685688-8568886.03187.13
30min190470-9047090.83292.331.2792.5693.891.22
292754-9275493.12594.68
391228-9122891.59393.13
492396-9239692.76694.25
591314-9131491.67993.16
693617-9361793.99295.57
45min192865-9286593.23794.411.4495.4796.481.37
294522-9452294.90096.98
395514-9551495.89697.94
495539-9553995.92197.92
593319-9331993.69395.68
692433-9243392.80394.90
60min193706-9370694.08194.510.7196.8397.110.68
293869-9386994.24596.85
394271-9427194.64897.23
495226-9522695.60798.14
593308-9330893.68196.19
694416-9441694.79497.41
极限193650-9365094.02595.051.3897.2998.171.29
295159-9515995.54098.67
395064-9506495.44498.55
496742-9674297.129100.19
594380-9438094.75897.79
693036-9303693.40896.55
玛巴洛沙韦干混悬剂项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)0
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%
111.049875898888986789865098557987060.13
211.059871399283989980.41
单位质量响应值RSD%判断
8940.768959.100.15数据可信
影响因素30天-供试品溶液-B0012B01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%
5min149181-4918149.34255.4718.3049.3455.4718.31
268873-6887369.09969.10
367696-6769667.91867.92
448903-4890349.06449.06
547086-4708647.24147.24
649997-4999750.16150.16
10min169542-6954269.77072.9011.6270.0473.2011.64
283960-8396084.23684.62
382571-8257182.84283.22
464138-6413864.34964.62
566987-6698767.20767.47
668742-6874268.96869.25
15min180803-8080381.06883.636.2981.7384.346.36
289340-8934089.63390.49
390447-9044790.74491.58
477879-7787978.13578.76
579878-7987880.14080.78
681763-8176382.03182.69
20min186934-8693487.21988.112.6588.3389.292.73
292390-9239092.69394.04
387643-8764387.93189.27
486010-8601086.29287.36
586418-8641886.70287.78
687532-8753287.81988.94
30min190108-9010890.40491.471.1892.0093.131.20
292859-9285993.16495.03
389981-8998190.27692.11
491662-9166291.96393.51
591398-9139891.69893.26
690988-9098891.28792.89
45min192772-9277293.07792.790.3795.1894.970.43
292242-9224292.54594.93
392999-9299993.30495.64
492092-9209292.39494.45
592421-9242192.72494.80
692411-9241192.71494.83
60min189410-8941089.70492.551.6092.3295.241.62
293437-9343793.74496.64
392800-9280093.10595.95
493194-9319493.50096.07
592563-9256392.86795.45
692098-9209892.40095.03
极限190107-9010790.40392.601.6693.5295.801.63
291926-9192692.22895.65
392781-9278193.08696.45
491643-9164391.94495.03
592534-9253492.83895.94
694763-9476395.07498.22
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