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)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%
110.979398393820941339394893891939550.13
211.049385194007939290.12
单位质量响应值RSD%判断
8564.728508.060.47数据可信
加速3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%
5min144610-4461046.92557.0619.1746.9357.0619.17
254430-5443057.25557.25
339179-3917941.21241.21
459213-5921362.28662.29
565532-6553268.93368.93
662522-6252265.76765.77
10min162460-6246065.70173.8312.2265.9674.1512.25
270296-7029673.94474.26
357517-5751760.50260.73
474403-7440378.26478.61
578070-7807082.12282.50
678386-7838682.45482.82
15min173265-7326577.06783.347.0877.6984.067.15
279634-7963483.76784.50
371469-7146975.17875.74
482462-8246286.74187.52
584208-8420888.57889.42
684320-8432088.69689.52
20min181572-8157285.80588.422.9686.8689.613.08
283269-8326987.59088.78
381070-8107085.27786.26
485040-8504089.45390.72
586350-8635090.83192.16
687042-8704291.55992.88
30min184973-8497389.38391.051.9390.9192.732.04
286484-8648490.97292.65
384967-8496789.37690.83
486854-8685491.36193.12
586563-8656391.05592.89
689518-8951894.16495.99
45min187218-8721891.74492.151.9693.7794.341.98
284905-8490589.31191.50
387823-8782392.38194.33
487725-8772592.27894.54
587693-8769392.24494.59
690277-9027794.96297.31
60min188306-8830692.88993.511.1395.4396.211.22
290199-9019994.88097.56
387325-8732591.85794.32
489250-8925093.88296.66
589463-8946394.10696.96
688832-8883293.44296.32
极限188101-8810192.67393.041.3595.7396.261.34
287224-8722491.75194.96
389035-8903593.65696.63
488028-8802892.59695.90
587751-8775192.30595.68
690551-9055195.25098.64
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)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%
110.979397594254944729405393898941300.25
211.049373693874938050.11
单位质量响应值RSD%判断
8580.678496.830.70数据可信
加速3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%
5min150711-5071153.32960.1615.9253.3360.1615.92
247517-4751749.97049.97
349210-4921051.75051.75
466315-6631569.73869.74
561746-6174664.93364.93
667722-6772271.21871.22
10min166494-6649469.92674.5011.2270.2274.8311.25
262315-6231565.53265.81
362577-6257765.80766.09
478895-7889582.96883.35
575730-7573079.63980.00
679040-7904083.12083.52
15min175060-7506078.93582.427.1779.6283.177.23
271934-7193475.64776.29
373065-7306576.83777.49
484144-8414488.48789.34
582468-8246886.72587.53
683589-8358987.90488.76
20min180822-8082284.99486.933.8586.1288.143.94
280017-8001784.14785.21
378720-7872082.78383.86
485598-8559890.01791.36
584751-8475189.12690.41
686064-8606490.50791.85
30min183315-8331587.61690.361.7689.2192.051.84
284997-8499789.38490.91
386342-8634290.79992.34
486657-8665791.13092.97
587403-8740391.91593.69
686851-8685191.33493.18
45min186717-8671791.19392.590.8293.2894.790.83
288524-8852493.09495.12
388375-8837592.93794.98
488027-8802792.57194.92
588718-8871893.29895.59
687935-8793592.47494.83
60min188671-8867193.24892.440.7395.8495.140.75
287031-8703191.52394.07
387895-8789592.43294.99
487340-8734091.84894.71
587955-8795592.49595.30
688500-8850093.06895.94
极限189158-8915893.76093.061.1396.8796.281.09
287385-8738591.89694.95
389156-8915693.75896.83
487074-8707491.56994.94
589328-8932893.93997.26
688852-8885293.43896.83
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)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%
110.979383793990946329454594285942580.37
211.049356093898937290.26
单位质量响应值RSD%判断
8592.348489.950.85数据可信
加速3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%
5min152913-5291355.62963.948.8955.6363.948.89
269184-6918472.73672.74
362603-6260365.81765.82
459275-5927562.31862.32
562432-6243265.63765.64
658517-5851761.52161.52
10min169414-6941472.97878.544.4273.2978.904.44
279009-7900983.06583.47
375154-7515479.01279.38
475950-7595079.84980.20
576069-7606979.97480.34
672651-7265176.38176.72
15min177837-7783781.83385.102.8482.5585.892.87
284258-8425888.58489.45
381480-8148085.66386.47
480561-8056184.69785.49
582370-8237086.59987.41
679142-7914283.20583.97
20min181870-8187086.07388.502.4987.2489.762.51
287114-8711491.58692.94
385057-8505789.42490.70
485693-8569390.09291.35
583083-8308387.34888.64
682269-8226986.49287.72
30min183807-8380788.10990.771.7189.7692.521.75
287587-8758792.08393.95
387108-8710891.58093.36
487456-8745691.94693.71
586688-8668891.13892.91
685365-8536589.74791.46
45min187065-8706591.53592.370.6493.6794.630.67
287853-8785392.36394.74
388390-8839092.92895.21
488567-8856793.11495.39
587536-8753692.03094.31
687736-8773692.24094.45
60min184676-8467689.02391.621.5591.6794.401.57
288131-8813192.65595.55
386558-8655891.00293.80
487660-8766092.16094.95
587662-8766292.16294.96
688208-8820892.73695.46
极限186496-8649690.93692.831.0494.0896.121.07
288645-8864593.19696.60
388433-8843392.97396.28
488381-8838192.91896.22
588963-8896393.53096.84
688881-8888193.44496.68
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)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%
110.979457794791941909456594451945150.24
211.049497294747948600.17
单位质量响应值RSD%判断
8615.778592.390.20数据可信
中间条件3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%
5min146496-4649648.52463.7814.5148.5263.7814.51
264094-6409466.88966.89
354142-5414256.50356.50
466634-6663469.54069.54
566038-6603868.91868.92
669290-6929072.31272.31
10min164517-6451767.33179.689.3967.6080.049.41
280600-8060084.11584.49
370350-7035073.41873.73
480546-8054684.05984.45
580457-8045783.96684.35
681639-8163985.19985.60
15min176851-7685180.20386.624.3480.8587.424.40
285183-8518388.89889.74
380363-8036383.86884.59
485196-8519688.91289.76
585704-8570489.44290.29
684721-8472188.41689.29
20min183788-8378887.44290.402.0488.5391.682.13
286890-8689090.67992.01
385429-8542989.15590.34
486949-8694990.74192.09
588380-8838092.23493.58
688280-8828092.13093.50
30min189549-8954993.45493.870.7795.0395.650.77
288840-8884092.71494.55
390632-9063294.58596.27
490558-9055894.50796.36
590306-9030694.24496.10
689774-8977493.68995.57
45min190718-9071894.67493.870.9696.7796.170.90
289648-8964893.55895.91
389662-8966293.57295.78
490753-9075394.71197.09
590375-9037594.31696.70
688500-8850092.36094.76
60min189936-8993693.85895.102.3096.4897.922.29
290679-9067994.63497.51
390363-9036394.30497.03
490073-9007394.00196.90
595368-9536899.527102.43
690331-9033194.27097.18
极限192584-9258496.62295.441.5299.7698.791.48
291834-9183495.83999.24
389096-8909692.98296.23
492737-9273796.781100.21
590588-9058894.53998.00
691865-9186595.87199.31
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)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%
110.979376693666943119392194004939340.27
211.049357693459935180.09
单位质量响应值RSD%判断
8562.818470.830.77数据可信
中间条件3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%
5min141258-4125843.50059.7318.6943.5059.7318.69
250710-5071053.46553.47
350689-5068953.44353.44
467400-6740071.06271.06
565303-6530368.85168.85
664547-6454768.05468.05
10min159664-5966462.90675.2012.0963.1575.5312.12
264550-6455068.05768.35
367118-6711870.76571.06
479588-7958883.91284.31
578852-7885283.13683.52
678183-7818382.43182.81
15min171180-7118075.04784.117.1875.6484.867.24
275973-7597380.10180.78
377657-7765781.87682.57
484974-8497489.59190.45
584053-8405388.62089.46
684820-8482089.42890.26
20min179913-7991384.25589.124.2185.2690.344.31
282277-8227786.74787.87
382108-8210886.56987.71
486668-8666891.37792.74
587464-8746492.21693.55
688740-8874093.56194.89
30min186969-8696991.69493.281.3293.1794.991.44
288571-8857193.38394.99
387377-8737792.12493.75
488699-8869993.51895.38
589035-8903593.87395.72
690187-9018795.08796.94
45min191852-9185296.84394.671.6398.8396.901.56
289613-8961394.48296.60
387836-8783692.60894.75
490991-9099195.93598.32
589731-8973194.60696.98
688746-8874693.56895.95
60min190553-9055395.47395.171.2198.0097.931.25
290152-9015295.05097.70
388533-8853393.34396.00
491234-9123496.19199.11
589634-8963494.50497.40
691483-9148396.45499.35
极限189688-8968894.56194.870.5797.6198.160.61
289986-8998694.87598.05
390105-9010595.00198.17
489892-8989294.77698.23
590878-9087895.81699.24
689363-8936394.21897.65
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