非布司他片项目信息
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
19.781926560192703719257121926562192634319264430.03
29.931945250194542519453380.01
单位质量响应值RSD%判断
196977.81195905.140.39数据可信
供试品溶液-1批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1570332-57033226.13033.4219.8326.1333.4219.82
2850880-85088038.98438.98
3822373-82237337.67737.68
4857167-85716739.27239.27
5744600-74460034.11434.11
6531187-53118724.33724.34
10min11317799-131779960.37661.814.3660.4261.864.38
21414638-141463864.81264.88
31370498-137049862.79062.85
41401561-140156164.21364.28
51333443-133344361.09261.15
61256644-125664457.57457.61
15min11567020-156702071.79471.921.5571.9472.081.57
21603749-160374973.47773.65
31561215-156121571.52871.70
41588690-158869072.78772.96
51565124-156512471.70771.87
61533213-153321370.24570.38
20min11687387-168738777.30977.251.0077.5777.531.02
21709104-170910478.30378.60
31673582-167358276.67676.96
41696283-169628377.71678.01
51689503-168950377.40577.68
61661333-166133376.11576.37
30min11820988-182098883.43083.350.8583.8283.760.86
21838053-183805384.21184.64
31801844-180184482.55282.97
41828104-182810483.75684.18
51826850-182685083.69884.11
61799918-179991882.46482.84
45min11928627-192862788.36188.130.8088.8988.680.81
21937563-193756388.77089.34
31901864-190186487.13587.69
41930911-193091188.46689.03
51935708-193570888.68589.23
61906625-190662587.35387.87
60min11983255-198325590.86490.730.7291.5491.430.72
21994240-199424091.36792.08
31961570-196157089.87090.57
41986994-198699491.03591.75
51992109-199210991.26991.96
61964232-196423289.99290.66
极限12026699-202669992.85492.980.5793.6893.830.57
22038190-203819093.38194.25
32007853-200785391.99192.84
42030960-203096093.04993.91
52036469-203646993.30294.15
62037136-203713693.33294.15
非布司他片项目信息
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
19.781948735195178419488151947572194844719490710.09
29.931968638196787619682570.03
单位质量响应值RSD%判断
199291.51198213.190.39数据可信
供试品溶液-1批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1834732-83473237.79940.997.8737.8040.997.86
2963160-96316043.61543.61
3952205-95220543.11943.12
4883862-88386240.02440.02
5983258-98325844.52544.52
6814476-81447636.88236.88
10min11456419-145641965.95165.921.3066.0165.981.30
21434507-143450764.95965.03
31445829-144582965.47165.54
41469466-146946666.54266.61
51485306-148530667.25967.33
61442501-144250165.32165.38
15min11603764-160376472.62372.460.7672.8072.640.76
21583127-158312771.68871.87
31593884-159388472.17672.36
41616320-161632073.19273.37
51609717-160971772.89373.08
61594048-159404872.18372.35
20min11686693-168669376.37876.240.5676.6776.540.56
21672668-167266875.74376.04
31677800-167780075.97676.28
41698490-169849076.91277.21
51688467-168846776.45976.77
61678034-167803475.98676.28
30min11796269-179626981.34081.070.4381.7681.500.42
21779781-177978180.59381.02
31787488-178748880.94281.37
41801017-180101781.55581.98
51791023-179102381.10381.54
61786529-178652980.89981.32
45min11886808-188680885.44085.170.6486.0085.730.64
21868318-186831884.60385.16
31874056-187405684.86385.43
41901671-190167186.11386.68
51878349-187834985.05785.63
61875547-187554784.93085.48
60min11939679-193967987.83487.470.2888.5388.170.28
21923532-192353287.10387.80
31929948-192994887.39388.10
41934506-193450687.60088.31
51931849-193184987.48088.19
61929756-192975687.38588.08
极限11981569-198156989.73189.360.3790.5890.200.36
21967612-196761289.09989.95
31968830-196883089.15490.00
41982461-198246189.77190.62
51965982-196598289.02589.88
61973212-197321289.35390.19
非布司他片项目信息
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
19.783890701392849438986643885635387572738958440.52
29.933897765390115738994610.07
单位质量响应值RSD%判断
398348.06392694.961.02数据可信
供试品溶液-2批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11233029-123302928.05929.729.1228.0629.729.12
21133170-113317025.78625.79
31418319-141831932.27532.28
41390888-139088831.65131.65
51416007-141600732.22332.22
61244905-124490528.32928.33
10min12559357-255935758.24158.372.8058.2958.422.80
22484707-248470756.54256.58
32651466-265146660.33760.39
42476635-247663556.35856.41
52615681-261568159.52259.58
62602105-260210559.21359.26
15min12990163-299016368.04468.511.2368.1968.651.23
22969431-296943167.57267.71
33066856-306685669.78969.94
42982510-298251067.87068.02
53018159-301815968.68168.83
63035578-303557869.07769.22
20min13216059-321605973.18473.370.6873.4473.630.69
23195859-319585972.72572.97
33259176-325917674.16674.44
43233710-323371073.58673.85
53228626-322862673.47073.74
63210724-321072473.06373.32
30min13458962-345896278.71279.020.6779.0979.400.67
23450207-345020778.51378.88
33508383-350838379.83780.23
43492318-349231879.47179.85
53468608-346860878.93179.32
63455569-345556978.63579.02
45min13660124-366012483.29083.650.7783.8084.160.78
23651044-365104483.08383.58
33723636-372363684.73585.26
43693616-369361684.05284.57
53673317-367331783.59084.11
63652982-365298283.12783.64
60min13771837-377183785.83286.080.6586.4886.730.66
23763793-376379385.64986.29
33825453-382545387.05287.72
43798909-379890986.44887.10
53766839-376683985.71886.38
63768893-376889385.76586.42
极限13879835-387983588.28988.170.7889.0888.960.79
23859275-385927587.82188.60
33923887-392388789.29290.11
43889848-388984888.51789.32
53854311-385431187.70888.51
63839760-383976087.37788.17
非布司他片项目信息
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101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
19.783880254387997538780123877463387693038785270.04
29.933965490396326939643800.04
单位质量响应值RSD%判断
396577.40399232.630.48数据可信
供试品溶液-2批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11577873-157787335.68935.957.6235.6935.967.62
21580698-158069835.75335.75
31566449-156644935.43135.43
41410618-141061831.90631.91
51612217-161221736.46636.47
61789641-178964140.47940.48
10min12717589-271758961.46864.122.9261.5364.182.93
22869446-286944664.90364.96
32884231-288423165.23865.30
42741166-274116662.00262.05
52901071-290107165.61865.68
62895532-289553265.49365.56
15min13184764-318476472.03572.710.7772.2072.880.77
23211614-321161472.64372.81
33246510-324651073.43273.60
43189395-318939572.14072.30
53235103-323510373.17473.34
63221433-322143372.86573.04
20min13390635-339063576.69276.780.5476.9777.070.54
23378346-337834676.41476.70
33430014-343001477.58377.87
43386656-338665676.60276.88
53396366-339636676.82177.11
63385890-338589076.58476.88
30min13599843-359984381.42481.080.6081.8381.490.59
23565293-356529380.64281.06
33604704-360470481.53481.95
43592559-359255981.25981.66
53593633-359363381.28381.70
63550714-355071480.31380.74
45min13765780-376578085.17784.750.6385.7285.300.62
23717395-371739584.08384.63
33764230-376423085.14285.70
43764667-376466785.15285.69
53751430-375143084.85385.41
63716999-371699984.07484.63
60min13868077-386807787.49186.920.6788.1887.610.67
23816006-381600686.31387.00
33855339-385533987.20387.90
43860928-386092887.32988.01
53850710-385071087.09887.80
63805424-380542486.07486.77
极限13951036-395103689.36788.980.5690.2089.820.55
23902188-390218888.26289.10
33943255-394325589.19190.03
43951706-395170689.38390.21
53944971-394497189.23090.07
63910491-391049188.45089.29
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