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%
111.819910098959991109901798928990230.09
211.799883299437991340.44
单位质量响应值RSD%判断
8384.678408.310.20数据可信
加速6月-供试品溶液-2025062621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%
5min149539-4953952.97858.956.4552.9858.956.45
253517-5351757.23257.23
356925-5692560.87660.88
453921-5392157.66457.66
557162-5716261.13061.13
659660-5966063.80163.80
10min167664-6766472.36175.712.8072.6676.042.81
269629-6962974.46274.78
373133-7313378.20978.55
470493-7049375.38675.71
572281-7228177.29877.64
671571-7157176.53976.89
15min177796-7779683.19684.101.5283.8984.851.53
277000-7700082.34583.08
379340-7934084.84785.62
478421-7842183.86484.60
580394-8039485.97486.74
678895-7889584.37185.15
20min181863-8186387.54588.401.2288.7089.621.23
281393-8139387.04388.23
382529-8252988.25889.50
483517-8351789.31490.52
582574-8257488.30689.55
684101-8410189.93991.19
30min183295-8329589.07791.792.5190.7293.502.49
286224-8622492.20993.88
384389-8438990.24791.98
485751-8575191.70393.40
585719-8571991.66993.41
689624-8962495.84597.59
45min188964-8896495.13993.871.2297.2896.081.17
286709-8670992.72894.91
387298-8729893.35895.59
489233-8923395.42797.64
587505-8750593.57995.83
686926-8692692.96095.24
60min187235-8723593.29094.941.0995.9697.681.10
288678-8867894.83397.53
388751-8875194.91197.67
488402-8840294.53897.28
589665-8966595.88998.66
689914-8991496.15598.95
极限186926-8692692.96096.102.1796.1599.372.12
292449-9244998.866102.09
388478-8847894.62097.90
489776-8977696.00899.27
590634-9063496.925100.22
690923-9092397.234100.57
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%
111.819896798991992099893499321990840.18
211.799947399219993460.19
单位质量响应值RSD%判断
8389.848426.290.31数据可信
加速6月-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%
5min154924-5492458.65660.4811.9258.6660.4811.92
261059-6105965.20865.21
343665-4366546.63246.63
459038-5903863.04963.05
560021-6002164.09964.10
661058-6105865.20765.21
10min170368-7036875.14976.518.6575.4776.858.67
275603-7560380.74081.10
359592-5959263.64163.90
474926-7492680.01780.37
574894-7489479.98380.34
674478-7447879.53879.90
15min177934-7793483.22985.174.8283.9785.934.87
282394-8239487.99288.80
372758-7275877.70178.31
482651-8265188.26789.06
580739-8073986.22587.03
682053-8205387.62888.43
20min182258-8225887.84789.612.4689.0590.852.53
286029-8602991.87493.17
380705-8070586.18887.23
485605-8560591.42192.71
584077-8407789.79091.07
684801-8480190.56391.85
30min183269-8326988.92792.001.9490.6293.731.93
287860-8786093.83095.64
386413-8641392.28493.81
487035-8703592.94894.74
587083-8708393.00094.78
685210-8521090.99992.79
45min188274-8827494.27294.190.3696.4696.440.32
288167-8816794.15796.49
388460-8846094.47096.51
488593-8859394.61296.92
587744-8774493.70696.00
687971-8797193.94896.25
60min187257-8725793.18694.991.7095.9097.761.65
288996-8899695.04397.90
389920-8992096.03098.59
487855-8785593.82496.66
591382-9138297.591100.41
688256-8825694.25297.07
极限186846-8684692.74794.490.9695.9897.780.93
288643-8864394.66698.05
389293-8929395.36098.45
488832-8883294.86898.22
588783-8878394.81598.17
688476-8847694.48797.83
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%
111.819887699063988849870298863988780.13
211.799894198663988020.20
单位质量响应值RSD%判断
8372.408380.150.07数据可信
加速6月-供试品溶液-2025062821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%
5min150773-5077354.42859.467.8454.4359.467.84
249308-4930852.85852.86
356634-5663460.71160.71
457689-5768961.84261.84
558884-5888463.12363.12
659534-5953463.82063.82
10min166588-6658871.38273.773.9471.6874.103.96
265262-6526269.96070.25
370833-7083375.93276.27
470008-7000875.04875.39
572377-7237777.58877.94
667833-6783372.71673.07
15min175361-7536180.78682.472.3681.4983.212.38
274297-7429779.64680.33
377844-7784483.44884.21
476911-7691182.44883.21
579170-7917084.87085.65
678006-7800683.62284.38
20min178926-7892684.60886.792.7585.7687.992.76
278569-7856984.22585.35
383741-8374189.77090.99
479814-7981485.56086.78
583340-8334089.34090.59
681386-8138687.24588.47
30min181763-8176387.64990.612.3389.2792.292.35
282939-8293988.91090.50
385365-8536591.51193.23
484021-8402190.07091.76
586286-8628692.49894.25
686792-8679293.04094.75
45min185816-8581691.99492.611.9994.1094.791.99
285249-8524991.38693.47
386414-8641492.63594.86
485934-8593492.12194.31
589759-8975996.22198.48
685181-8518191.31393.54
60min186449-8644992.67392.871.2695.2995.571.27
286080-8608092.27794.87
386113-8611392.31295.06
485264-8526491.40294.11
588037-8803794.37597.17
687849-8784994.17396.91
极限186775-8677593.02293.290.5296.1596.500.58
286341-8634192.55795.66
386843-8684393.09596.35
487246-8724693.52796.74
587377-8737793.66796.99
687550-8755093.85397.11
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%
111.819948099311989289928799345992700.21
211.799933399616994740.21
单位质量响应值RSD%判断
8405.598437.150.27数据可信
中间条件6月-供试品溶液-2025062621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%
5min153005-5300556.51759.886.8156.5259.886.81
254024-5402457.60357.60
351436-5143654.84454.84
458828-5882862.72662.73
558768-5876862.66262.66
660879-6087964.91364.91
10min170319-7031974.97876.282.9075.2976.622.92
270995-7099575.69976.02
368505-6850573.04473.35
472098-7209876.87577.22
572953-7295377.78778.13
674398-7439879.32779.69
15min178280-7828083.46684.801.9684.2085.551.96
277074-7707482.18182.92
380085-8008585.39186.10
481156-8115686.53387.31
580761-8076186.11286.89
679810-7981085.09885.90
20min181033-8103386.40289.351.7087.6090.581.69
284836-8483690.45791.65
384058-8405889.62790.81
484220-8422089.80091.06
584839-8483990.46091.72
683781-8378189.33290.61
30min184180-8418089.75792.812.2691.4394.532.24
285320-8532090.97392.67
389215-8921595.12696.81
488281-8828194.13095.89
588368-8836894.22395.98
686876-8687692.63294.40
45min186777-8677792.52695.242.0794.7097.482.04
288660-8866094.53496.74
391616-9161697.68699.90
490322-9032296.30698.58
590647-9064796.65398.94
687901-8790193.72596.01
60min188009-8800993.84095.892.3496.5398.662.31
288363-8836394.21896.95
389905-8990595.86298.62
493569-9356999.768102.58
591025-9102597.05699.88
688713-8871394.59197.40
极限190119-9011996.09096.511.7299.3099.811.67
289830-8983095.78299.04
392248-9224898.360101.65
492419-9241998.542101.91
590080-9008096.04899.41
688376-8837694.23197.56
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%
111.819972799652991679949199566995210.22
211.799853398907987200.27
单位质量响应值RSD%判断
8426.848373.200.46数据可信
中间条件6月-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%
5min153687-5368757.39057.175.1457.3957.175.14
253368-5336857.04957.05
353860-5386057.57557.57
449766-4976653.19853.20
552077-5207755.66955.67
658140-5814062.15062.15
10min172107-7210777.08074.084.0677.4074.404.06
267760-6776072.43472.75
369886-6988674.70675.03
465083-6508369.57269.87
568463-6846373.18573.49
672520-7252077.52277.87
15min179887-7988785.39784.422.1486.1485.152.16
278259-7825983.65784.38
378708-7870884.13784.87
478001-7800183.38184.06
577116-7711682.43583.15
681878-8187887.52588.30
20min185295-8529591.17889.561.8792.4090.761.88
281989-8198987.64488.83
384257-8425790.06891.27
482838-8283888.55289.70
582534-8253488.22789.40
685780-8578091.69692.96
30min186042-8604291.97793.451.5693.7095.151.54
287254-8725493.27294.94
387320-8732093.34395.05
488641-8864194.75596.39
585956-8595691.88593.55
689323-8932395.48497.26
45min188835-8883594.96295.861.3597.2098.081.34
289134-8913495.28297.47
391626-9162697.946100.17
489900-8990096.10198.26
588271-8827194.35996.53
690309-9030996.53898.84
60min187137-8713793.14795.511.3695.9198.261.32
290797-9079797.06099.78
389668-8966895.85398.62
489195-8919595.34798.04
589468-8946895.63998.34
689814-8981496.00998.85
极限189215-8921595.36896.511.1298.6599.791.12
290853-9085397.119100.38
391781-9178198.111101.41
489501-8950195.67498.90
589551-8955195.72898.96
690787-9078797.049100.42
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