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)0
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%
111.159937898841996649951099578993940.33
211.029948799401994440.07
单位质量响应值RSD%判断
8914.269023.960.87数据可信
中间条件6月-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%
5min129104-2910429.13833.2420.9429.1433.2420.94
230570-3057030.60630.61
332533-3253332.57132.57
437795-3779537.83937.84
524795-2479524.82424.82
644411-4441144.46344.46
10min156720-5672056.78760.5011.5957.1160.8711.64
257229-5722957.29657.64
362514-6251462.58762.95
463219-6321963.29363.71
551278-5127851.33851.61
671614-7161471.69872.19
15min172242-7224272.32774.716.3573.2875.756.46
272374-7237472.45973.44
375455-7545575.54476.60
475937-7593776.02677.15
568935-6893569.01669.86
682781-8278182.87884.17
20min180603-8060380.69882.333.7882.4684.203.93
279947-7994780.04181.82
384282-8428284.38186.28
483202-8320283.30085.27
578503-7850378.59580.21
686837-8683786.93989.15
30min188405-8840588.50988.570.6791.1691.350.79
288566-8856688.67091.34
388979-8897989.08391.92
489157-8915789.26292.16
587523-8752387.62690.11
688148-8814888.25191.43
45min188773-8877388.87789.230.8792.5293.000.83
288934-8893489.03892.69
390337-9033790.44394.27
488084-8808488.18792.07
589644-8964489.74993.21
688989-8898989.09393.25
60min191834-9183491.94291.042.0096.5795.801.68
293129-9312993.23897.88
390613-9061390.71995.55
489287-8928789.39294.26
592261-9226192.36996.83
688450-8845088.55493.70
90min187613-8761387.71688.853.0493.3694.632.74
291272-9127291.37997.06
389547-8954789.65295.49
484405-8440584.50490.36
591662-9166291.77097.25
688002-8800288.10594.24
120min190085-9008590.19188.890.8996.8195.650.67
288781-8878188.88595.58
388787-8878788.89195.72
488396-8839688.50095.30
588976-8897689.08095.58
687691-8769187.79494.90
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194581-9458194.69292.141.99102.3299.901.75
289927-8992790.03397.72
390379-9037990.48598.31
492946-9294693.055100.84
593211-9321193.320100.81
691178-9117891.28599.37
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)0
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%
111.159925099311995159920599226993010.13
211.0299689100077998830.28
单位质量响应值RSD%判断
8905.929063.791.25数据可信
中间条件6月-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%
5min131540-3154031.52328.5310.2231.5228.5310.22
230364-3036430.34830.35
327813-2781327.79827.80
431165-3116531.14831.15
525646-2564625.63225.63
624742-2474224.72924.73
10min159339-5933959.30757.355.1159.6657.675.13
261031-6103160.99861.34
358463-5846358.43158.74
457657-5765757.62657.97
553599-5359953.57053.85
654200-5420054.17154.45
15min174737-7473774.69772.173.4975.7173.133.51
275260-7526075.21976.23
371510-7151071.47172.43
471698-7169871.65972.65
568349-6834968.31269.19
671713-7171371.67472.55
20min181737-8173781.69380.271.7183.5382.021.75
280817-8081780.77382.62
381543-8154381.49983.25
479535-7953579.49281.27
578094-7809478.05279.69
680155-8015580.11281.78
30min187277-8727787.23087.031.1189.9889.681.14
288064-8806488.01690.76
385788-8578885.74288.40
488209-8820988.16190.83
586862-8686286.81589.32
686276-8627686.22988.79
45min184890-8489084.84489.202.4788.5692.822.31
289822-8982289.77393.50
390523-9052390.47494.08
489220-8922089.17292.82
590283-9028390.23493.71
690746-9074690.69794.22
60min190149-9014990.10090.190.8594.7694.790.78
290144-9014490.09594.82
390758-9075890.70995.32
489576-8957689.52894.16
591432-9143291.38395.86
689358-8935889.31093.84
90min186435-8643586.38889.732.0892.0595.341.93
291065-9106591.01696.74
390181-9018190.13295.76
489556-8955689.50895.14
591830-9183091.78097.27
689632-8963289.58395.10
120min188367-8836788.31988.671.3894.9495.271.25
288780-8878088.73295.47
387917-8791787.86994.49
488079-8807988.03194.66
591117-9111791.06897.58
688027-8802787.97994.50
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190704-9070490.65590.410.4798.2698.000.44
290035-9003589.98697.71
391126-9112691.07798.68
490541-9054190.49298.10
590319-9031990.27097.79
690042-9004289.99397.49
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)0
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%
111.159896599053988999916099141990440.12
211.029897498750988620.17
单位质量响应值RSD%判断
8882.878971.140.70数据可信
中间条件6月-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%
5min144490-4449044.75233.7428.1244.7533.7428.11
222275-2227522.40622.41
331232-3123231.41631.42
426491-2649126.64726.65
531466-3146631.65131.65
645310-4531045.57745.58
10min170506-7050670.92160.0215.6671.4260.4015.73
250307-5030750.60350.85
355673-5567356.00056.35
452135-5213552.44252.74
557377-5737757.71558.07
672038-7203872.46272.97
15min180186-8018680.65872.919.8981.9473.9610.02
264205-6420564.58365.39
368517-6851768.92069.89
466059-6605966.44867.33
575575-7557576.02077.01
680383-8038380.85682.17
20min184020-8402084.51480.655.7286.7082.515.93
274875-7487575.31576.84
378918-7891879.38281.12
475356-7535675.79977.42
581886-8188682.36884.21
686035-8603586.54188.75
30min189121-8912189.64587.232.5592.7789.982.78
284223-8422384.71887.08
386155-8615586.66289.28
484346-8434684.84287.30
589196-8919689.72192.47
687294-8729487.80890.98
45min186306-8630686.81489.932.5590.9393.642.18
289469-8946989.99593.30
390208-9020890.73994.32
491804-9180492.34495.75
591529-9152992.06795.82
687088-8708887.60091.75
60min189428-8942889.95489.802.4795.0494.522.12
291759-9175992.29996.61
388727-8872789.24993.84
489667-8966790.19494.62
590742-9074291.27696.05
685343-8534385.84590.97
90min185429-8542985.93289.752.8792.0195.472.49
290411-9041190.94396.28
389936-8993690.46596.05
490067-9006790.59796.03
592504-9250493.04898.84
687013-8701387.52593.60
120min186275-8627586.78388.712.6993.8295.422.33
289825-8982590.35396.70
386703-8670387.21393.80
489790-8979090.31896.75
591181-9118191.71798.54
685347-8534785.84992.90
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190054-9005490.58490.991.0798.5898.691.07
289285-8928589.81097.16
391689-9168992.22899.78
490118-9011890.64898.09
591578-9157892.11799.96
690026-9002690.55698.56
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)0
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%
111.159890698719989079874098835988210.10
211.029888899041989640.11
单位质量响应值RSD%判断
8862.878980.400.94数据可信
中间条件6月-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%
5min136837-3683737.07735.6725.0637.0835.6725.06
218131-1813118.24918.25
336944-3694437.18437.18
443796-4379644.08144.08
537417-3741737.66037.66
639533-3953339.79039.79
10min162518-6251862.92562.0214.6863.3462.4214.75
244516-4451644.80645.01
363722-6372264.13764.55
471662-7166272.12872.62
562608-6260863.01563.43
664702-6470265.12365.57
15min173186-7318673.66275.919.5074.7776.999.62
262686-6268663.09463.79
378516-7851679.02780.15
484034-8403484.58185.87
577368-7736877.87178.99
676718-7671877.21778.38
20min179858-7985880.37880.495.8682.3182.426.02
272550-7255073.02274.42
383396-8339683.93985.94
485893-8589386.45288.68
580789-8078981.31583.30
677341-7734177.84479.87
30min183522-8352284.06587.202.9586.8990.023.14
283334-8333483.87686.09
388821-8882189.39992.34
488904-8890489.48392.67
587678-8767888.24991.14
687546-8754688.11691.00
45min185298-8529885.85388.362.6189.6192.152.62
287783-8778388.35491.50
387388-8738887.95791.89
490141-9014190.72894.91
590698-9069891.28895.16
685402-8540285.95889.83
60min188437-8843789.01288.801.7393.7293.581.61
289362-8936289.94394.07
385407-8540785.96390.87
489461-8946190.04395.24
588963-8896389.54294.42
687742-8774288.31393.14
90min184355-8435584.90489.122.6190.6094.882.46
290127-9012790.71395.84
387474-8747488.04393.91
489574-8957490.15796.35
590493-9049391.08296.96
689231-8923189.81295.62
120min187324-8732487.89288.791.6994.5495.541.64
288608-8860889.18595.32
386538-8653887.10193.94
488585-8858589.16196.36
590787-9078791.37898.27
687443-8744388.01294.81
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189417-8941789.99990.560.7197.6298.300.60
290484-9048491.07398.20
389535-8953590.11897.93
489561-8956190.14498.33
589849-8984990.43498.34
690992-9099291.58499.36
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