非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
1104135602413482941419734139750413537041375050.08
2104174508417107041727890.06
单位质量响应值RSD%判断
413750.50417278.900.61数据可信
供试品溶液-250601批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12279895-227989549.33444.498.7449.3344.488.74
22079869-207986945.00545.01
31778342-177834238.48138.48
42077428-207742844.95344.95
52188330-218833047.35247.35
61931242-193124241.78941.79
10min13658649-365864979.16875.293.5279.2875.393.52
23503380-350338075.80875.91
33300149-330014971.41171.50
43408553-340855373.75673.86
53545916-354591676.72976.83
63459599-345959974.86174.95
15min14023349-402334987.06085.810.9587.3586.070.96
23974073-397407385.99386.26
33916457-391645784.74784.99
43939120-393912085.23785.50
53983813-398381386.20486.48
63955928-395592885.60185.86
20min14163620-416362090.09589.240.5890.5789.700.59
24118144-411814489.11189.57
34098887-409888788.69489.13
44101732-410173288.75689.21
54129839-412983989.36489.83
64132209-413220989.41589.86
30min14216581-421658191.24191.180.3491.9291.840.35
24206373-420637391.02091.68
34198378-419837890.84791.48
44210311-421031191.10591.76
54239973-423997391.74792.41
64210841-421084191.11791.76
45min14279305-427930592.59892.030.3193.4892.890.32
24251543-425154391.99792.86
34247153-424715391.90392.73
44245656-424565691.87092.72
54244821-424482191.85292.72
64251017-425101791.98692.84
60min14280990-428099092.63592.400.3793.7293.470.37
24264318-426431892.27493.34
34259145-425914592.16293.20
44252250-425225092.01393.07
54270394-427039492.40593.48
64294836-429483692.93493.99
极限14262937-426293792.24492.390.2693.5493.660.25
24264990-426499092.28893.56
34268032-426803292.35493.59
44259861-425986192.17793.44
54271612-427161292.43293.71
64289930-428993092.82894.09
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
1104178476418195141748684184951418288741806270.10
2104169077417086741699720.04
单位质量响应值RSD%判断
418062.70416997.200.19数据可信
供试品溶液-250601批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12112386-211238645.48843.9515.1145.4943.9515.12
22495465-249546553.73753.74
31551745-155174533.41533.41
42077700-207770044.74144.74
51903684-190368440.99440.99
62105084-210508445.33045.33
10min13624563-362456378.05175.274.5178.1575.374.53
23728402-372840280.28780.41
33304126-330412671.15071.22
43422596-342259673.70273.80
53390037-339003773.00073.09
63503748-350374875.44975.55
15min14022367-402236786.61785.441.3986.8985.711.41
24045727-404572787.12087.42
33902527-390252784.03684.27
43930210-393021084.63284.90
53954712-395471285.16085.41
63951764-395176485.09785.36
20min14180319-418031990.01888.840.9890.4989.291.00
24162254-416225489.62990.12
34071763-407176387.68188.10
44097977-409797788.24588.70
54120599-412059988.73289.17
64119517-411951788.70989.17
30min14256054-425605491.64990.790.7292.3291.440.73
24234687-423468791.18991.88
34184752-418475290.11490.73
44202015-420201590.48591.13
54234855-423485591.19391.83
64183552-418355290.08890.74
45min14278695-427869592.13791.450.8293.0192.300.84
24281085-428108592.18893.08
34205567-420556790.56291.38
44247923-424792391.47492.32
54263936-426393691.81992.66
64204068-420406890.53091.38
60min14276121-427612192.08191.720.7493.1692.780.75
24298471-429847192.56293.66
34221718-422171890.91091.93
44264529-426452991.83292.88
54273575-427357592.02693.07
64221492-422149290.90591.96
极限14322814-432281493.08791.990.8494.3793.250.85
24295921-429592192.50893.81
34237318-423731891.24692.46
44259835-425983591.73192.99
54284239-428423992.25693.51
64231522-423152291.12192.38
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
1104190486418723841898764188964418842541889980.04
2104245942424618042460610.01
单位质量响应值RSD%判断
418899.80424606.100.96数据可信
供试品溶液-250602批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12092432-209243244.60940.905.8544.6140.905.84
21954968-195496841.67841.68
31831265-183126539.04139.04
41768276-176827637.69837.70
51914623-191462340.81840.82
61950098-195009841.57441.57
10min13458875-345887573.74069.594.6873.8469.684.68
23233984-323398468.94669.04
33038641-303864164.78164.87
43175668-317566867.70367.79
53401912-340191272.52672.62
63274863-327486369.81769.91
15min13907214-390721483.29881.461.9883.5681.711.99
23813319-381331981.29781.54
33723314-372331479.37879.61
43744563-374456379.83180.07
53892510-389251082.98583.24
63845825-384582581.99082.24
20min14083451-408345187.05685.861.1587.5086.291.16
24017009-401700985.63986.07
33965705-396570584.54584.95
43985104-398510484.95985.37
54054021-405402186.42886.86
64059090-405909086.53686.97
30min14176436-417643689.03888.700.8189.6889.320.82
24140837-414083788.27988.90
34117619-411761987.78488.38
44137687-413768788.21288.81
54186178-418617889.24689.87
64205424-420542489.65690.28
45min14243383-424338390.46589.880.8891.3090.690.89
24198075-419807589.49990.31
34181376-418137689.14389.93
44171227-417122788.92789.72
54241298-424129890.42191.25
64259146-425914690.80191.62
60min14276796-427679691.17890.590.7792.2291.600.78
24214213-421421389.84390.86
34226278-422627890.10191.09
44220218-422021889.97190.97
54289345-428934591.44592.47
64267526-426752690.98092.00
极限14274142-427414291.12190.680.7992.3691.890.80
24238092-423809290.35291.56
34208994-420899489.73290.92
44227694-422769490.13191.32
54277373-427737391.19092.42
64294345-429434591.55292.78
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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%
1104142108414682741389064136379413730441403050.11
2104184201418421241842060.01
单位质量响应值RSD%判断
414030.50418420.600.75数据可信
供试品溶液-250602批-pH6.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.00034.3250.800.0034.3250.80
22157121-215712146.59846.60
32170694-217069446.89146.89
41671104-167110436.09936.10
51763770-176377038.10138.10
61770537-177053738.24738.25
10min11583741-158374134.21265.0324.0834.2165.1124.12
23552102-355210276.73276.84
33497252-349725275.54775.65
43076448-307644866.45766.54
53204360-320436069.22069.30
63148398-314839868.01168.10
15min13329273-332927371.91980.755.8871.9980.975.96
23973548-397354885.83686.11
33868211-386821183.56183.83
43767527-376752781.38681.61
53767415-376741581.38381.62
63723356-372335680.43180.67
20min13835348-383534882.85186.192.4883.0986.592.56
24133939-413393989.30189.77
34029524-402952487.04587.50
44008492-400849286.59187.00
53989936-398993686.19086.61
63941649-394164985.14785.56
30min14030260-403026087.06189.331.7287.4889.921.79
24241705-424170591.62992.29
34143586-414358689.50990.16
44170849-417084990.09890.70
54127270-412727089.15789.77
64098127-409812788.52789.13
45min14174678-417467890.18190.981.4890.7991.771.52
24320284-432028493.32694.19
34204043-420404390.81591.67
44240459-424045991.60292.40
54187237-418723790.45291.26
64142616-414261689.48890.29
60min14231893-423189391.41791.670.9992.2392.661.02
24322580-432258093.37694.45
34225267-422526791.27492.33
44249818-424981891.80492.81
54232287-423228791.42592.44
64200212-420021290.73291.73
极限14263924-426392492.10991.811.1993.1393.001.19
24341401-434140193.78295.06
34225258-422525891.27392.53
44252140-425214091.85493.06
54216080-421608091.07592.29
64201063-420106390.75191.95
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