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QTL-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)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%
111.249786397993980219791797912979410.07
211.339788397791978370.07
单位质量响应值RSD%判断
8713.618635.220.64数据可信
供试品溶液-01批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19613-96139.95111.2436.929.9511.2436.90
218135-1813518.77318.77
37640-76407.9097.91
49197-91979.5209.52
512742-1274213.19013.19
67830-78308.1058.11
10min126323-2632327.24930.0214.3227.3630.1514.40
235391-3539136.63636.84
326010-2601026.92527.01
428663-2866329.67129.78
532628-3262833.77533.92
625009-2500925.88925.98
15min136270-3627037.54638.976.1837.9639.436.33
240754-4075442.18742.80
336799-3679938.09338.48
437363-3736338.67739.11
540040-4004041.44841.97
634654-3465435.87336.25
20min141871-4187143.34444.093.5544.1744.983.73
244658-4465846.22947.31
341696-4169643.16243.97
442804-4280444.30945.17
543913-4391345.45746.44
640583-4058342.01042.79
30min145624-4562447.22947.442.5248.5448.822.70
247234-4723448.89550.49
345568-4556847.17148.46
445787-4578747.39748.75
546807-4680748.45349.94
643938-4393845.48346.73
45min148956-4895650.67850.321.0552.5152.221.15
249162-4916250.89153.03
348874-4887450.59352.41
448634-4863450.34452.23
548178-4817849.87251.90
647833-4783349.51551.26
60min148038-4803849.72751.441.7952.1353.911.79
249833-4983351.58654.29
350259-5025952.02754.40
449560-4956051.30353.75
550571-5057152.35054.93
649915-4991551.67053.97
极限150559-5055952.33752.761.1255.2955.800.89
250470-5047052.24555.52
351160-5116052.95955.91
451589-5158953.40356.42
550404-5040452.17755.34
651643-5164353.45956.33
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QTL-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)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%
111.249816098124981849808797968981050.09
211.339781897947978820.10
单位质量响应值RSD%判断
8728.208639.190.73数据可信
供试品溶液-02批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113826-1382614.29715.128.7514.3015.128.76
212660-1266013.09113.09
314249-1424914.73414.73
415624-1562416.15616.16
515356-1535615.87915.88
616040-1604016.58616.59
10min129735-2973530.74831.172.0330.9131.342.04
229686-2968630.69730.84
330335-3033531.36831.53
431303-3130332.36932.55
529930-2993030.95031.13
629890-2989030.90831.09
15min138193-3819339.49439.072.1939.9939.582.15
238273-3827339.57740.06
337573-3757338.85339.37
438282-3828239.58640.13
536185-3618537.41837.94
638181-3818139.48240.01
20min141309-4130942.71642.312.9143.6643.262.86
241935-4193543.36444.29
340840-4084042.23143.18
442290-4229043.73144.71
539143-3914340.47741.41
639992-3999241.35442.32
30min144377-4437745.88946.700.9947.3048.120.98
245713-4571347.27048.68
345344-4534446.88948.30
445336-4533646.88148.35
545053-4505346.58847.97
645164-4516446.70348.13
45min148126-4812649.76649.711.0051.6951.650.93
248639-4863950.29652.23
347461-4746149.07851.01
447791-4779149.41951.40
548612-4861250.26852.17
647812-4781249.44151.39
60min147561-4756149.18150.021.1551.6652.511.11
248302-4830249.94852.44
348202-4820249.84452.32
449031-4903150.70153.24
548974-4897450.64253.10
648149-4814949.78952.28
极限149980-4998051.68352.150.8254.7155.200.81
250208-5020851.91954.97
350699-5069952.42655.46
451084-5108452.82455.92
550137-5013751.84554.87
650497-5049752.21755.26
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QTL-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)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%
111.249800797851979239794397988979420.07
211.339788697853978700.03
单位质量响应值RSD%判断
8713.708638.130.62数据可信
供试品溶液-01批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112845-1284513.29411.3917.9313.2911.3917.94
210688-1068811.06211.06
313807-1380714.29014.29
410244-1024410.60210.60
59982-998210.33110.33
68456-84568.7528.75
10min130288-3028831.34830.444.7931.5030.574.83
228452-2845229.44729.57
331861-3186132.97633.13
428191-2819129.17729.30
528625-2862529.62729.74
629059-2905930.07630.17
15min137448-3744838.75837.891.7439.2538.351.79
236122-3612237.38637.84
337049-3704938.34538.87
436491-3649137.76838.21
536841-3684138.13038.57
635700-3570036.94937.38
20min141066-4106642.50342.112.0243.4343.002.06
241199-4119942.64043.51
341779-4177943.24144.19
440585-4058542.00542.87
539638-3963841.02541.89
639876-3987641.27142.11
30min144186-4418645.73245.221.3947.1346.581.35
242812-4281244.31045.65
343484-4348445.00546.44
444385-4438545.93847.27
543279-4327944.79346.12
644031-4403145.57246.87
45min145546-4554647.14046.642.2949.0548.502.26
244681-4468146.24448.08
345720-4572047.32049.25
445593-4559347.18849.03
545712-4571247.31149.13
643112-4311244.62046.43
60min147134-4713448.78348.510.5151.2150.880.47
247047-4704748.69351.04
346520-4652048.14850.61
446940-4694048.58250.95
546647-4664748.27950.63
646912-4691248.55350.86
极限147232-4723248.88548.931.6251.8651.851.53
245943-4594347.55050.44
347652-4765249.31952.31
446963-4696348.60651.51
547878-4787849.55352.44
648002-4800249.68252.52
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QTL-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)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%
111.249791597830980549785097609978520.17
211.339800797927979670.06
单位质量响应值RSD%判断
8705.698646.690.49数据可信
供试品溶液-02批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119308-1930819.98319.578.0519.9819.578.05
220178-2017820.88320.88
318255-1825518.89318.89
417976-1797618.60418.60
516815-1681517.40317.40
620940-2094021.67221.67
10min133134-3313434.29234.581.8634.5134.791.88
234339-3433935.53935.77
333088-3308834.24434.45
432654-3265433.79534.00
533297-3329734.46134.65
633945-3394535.13135.37
15min139307-3930740.68140.351.4141.2840.951.42
239645-3964541.03041.66
338084-3808439.41540.01
438725-3872540.07840.66
538902-3890240.26240.84
639249-3924940.62141.25
20min141406-4140642.85342.861.5743.9143.901.48
240160-4016041.56342.65
341833-4183343.29544.32
441657-4165743.11344.14
541954-4195443.42044.44
641440-4144042.88843.97
30min144175-4417545.71945.670.9447.2547.200.91
244745-4474546.30947.85
343757-4375745.28646.80
444489-4448946.04447.55
543838-4383845.37046.88
643781-4378145.31146.87
45min145536-4553647.12747.611.4849.1749.651.40
246708-4670848.34050.40
346549-4654948.17650.19
446010-4601047.61849.64
546313-4631347.93249.94
644909-4490946.47848.54
60min146625-4662548.25448.261.0250.8250.831.00
247336-4733648.99051.59
345973-4597347.58050.13
446810-4681048.44650.99
546273-4627347.89050.43
646792-4679248.42751.01
极限146362-4636247.98248.621.3951.0851.721.31
247643-4764349.30852.45
346631-4663148.26151.34
447043-4704348.68751.77
547839-4783949.51152.59
646328-4632847.94751.06
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