玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号115240801对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.189894259896009906389887769909769898830.10
2 11.149900329914959907640.11
单位质量响应值RSD%判断
88540.5288937.520.32数据可信
供试品溶液-B0012N01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%
5min1231110-23111023.58022.4717.4823.5822.4717.49
2147650-14765015.06515.06
3257138-25713826.23626.24
4215137-21513721.95021.95
5244770-24477024.97424.97
6225776-22577623.03623.04
10min1359115-35911536.64137.835.0536.6837.875.06
2339841-33984134.67434.70
3390386-39038639.83139.87
4371330-37133037.88737.92
5385188-38518839.30139.34
6378874-37887438.65738.69
15min1411597-41159741.99543.212.2542.1043.312.26
2411823-41182342.01842.10
3433285-43328544.20844.32
4425974-42597443.46243.56
5431082-43108243.98344.09
6427285-42728543.59643.70
20min1440554-44055444.95045.701.2545.1245.871.26
2441502-44150245.04645.20
3452267-45226746.14546.33
4450744-45074445.98946.16
5453610-45361046.28246.46
6448563-44856345.76745.94
30min1466957-46695747.64447.820.4547.8948.070.46
2467417-46741747.69147.92
3471439-47143948.10148.36
4469825-46982547.93648.19
5470185-47018547.97348.23
6466267-46626747.57347.82
45min1481614-48161449.13949.080.3049.4649.410.30
2480528-48052849.02849.34
3480473-48047349.02349.36
4483073-48307349.28849.62
5481660-48166049.14449.48
6478934-47893448.86649.20
60min1488261-48826149.81749.540.4350.2249.950.41
2486357-48635749.62350.01
3483922-48392249.37549.80
4486598-48659849.64850.06
5485713-48571349.55749.98
6482441-48244149.22349.64
90min1491833-49183350.18250.020.3750.6750.520.36
2490958-49095850.09250.56
3488948-48894849.88750.39
4492715-49271550.27250.77
5488786-48878649.87150.37
6488528-48852849.84550.34
120min1493857-49385750.38850.240.4050.9650.810.38
2493297-49329750.33150.89
3491194-49119450.11750.70
4493704-49370450.37350.95
5493238-49323850.32550.91
6488963-48896349.88950.47
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1494716-49471650.47650.220.3851.1350.880.36
2492817-49281750.28250.92
3490596-49059650.05650.73
4493864-49386450.38951.05
5491220-49122050.11950.79
6490275-49027550.02350.68
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号115240801对照品来源原料对照品使用方法直接使用
对照品含量(%)100.6对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.189897309881309909899905249902049899150.12
2 11.149959259967449963340.06
单位质量响应值RSD%判断
88543.3889437.520.72数据可信
供试品溶液-B0012N01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%
5min1311326-31132631.67525.9323.1931.6825.9323.19
2253090-25309025.75025.75
3270874-27087427.56027.56
4147737-14773715.03115.03
5242484-24248424.67124.67
6303588-30358830.88830.89
10min1656490-65649066.79462.1110.5866.8562.1510.58
2625115-62511563.60263.64
3668740-66874068.04068.09
4490255-49025549.88049.91
5592931-59293160.32760.37
6629056-62905664.00364.05
15min1816418-81641883.06581.193.8583.2381.333.87
2806989-80698982.10682.26
3833224-83322484.77584.93
4743859-74385975.68375.79
5787254-78725480.09880.24
6799910-79991081.38681.54
20min1878453-87845389.37789.541.4489.6889.821.46
2890745-89074590.62890.91
3898382-89838291.40591.71
4863001-86300187.80588.04
5875488-87548889.07589.35
6874021-87402188.92689.22
30min1927842-92784294.40295.090.8094.8595.530.81
2938763-93876395.51395.95
3947311-94731196.38396.84
4929109-92910994.53194.91
5934721-93472195.10295.53
6930135-93013594.63595.08
45min1941342-94134295.77697.050.9096.3897.640.90
2961711-96171197.84898.44
3963332-96333298.01398.63
4955266-95526697.19297.73
5955298-95529897.19697.78
6946511-94651196.30296.90
60min1944765-94476596.12497.280.8996.8998.040.89
2965336-96533698.21798.98
3964361-96436198.11898.89
4956350-95635097.30398.00
5958518-95851897.52398.27
6947641-94764196.41797.18
90min1942775-94277595.92297.070.9796.8597.980.96
2964755-96475598.15899.08
3960449-96044997.72098.66
4954483-95448397.11397.98
5958503-95850397.52298.43
6943217-94321795.96796.89
120min1941740-94174095.81696.680.7396.9097.760.72
2955489-95548997.21598.30
3955735-95573597.24098.34
4951946-95194696.85597.88
5955331-95533197.19998.27
6941347-94134795.77696.86
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1937867-93786795.42296.541.2796.6797.781.25
2966304-96630498.31599.56
3954203-95420397.08498.35
4947000-94700096.35197.54
5954276-95427697.09298.32
6933667-93366794.99596.24
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