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%
110.424067127406513040670874065710406601940662150.03
210.504142544414489041437170.05
单位质量响应值RSD%判断
390231.77394639.710.80数据可信
供试品溶液-250601批-pH1.0(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%
5min1644746-64474614.77222.5221.0614.7722.5221.07
2892990-89299020.46020.46
3952273-95227321.81821.82
41041172-104117223.85523.85
51242848-124284828.47528.48
61124045-112404525.75425.75
10min12056777-205677747.12449.005.7147.1649.045.72
22035165-203516546.62946.67
32038102-203810246.69646.74
42130273-213027348.80848.86
52328480-232848053.34953.41
62241954-224195451.36651.42
15min12707398-270739862.03063.053.4862.1763.213.49
22702129-270212961.91062.06
32652171-265217160.76560.92
42707753-270775362.03962.20
52894770-289477066.32366.51
62846635-284663565.22165.39
20min13064085-306408570.20370.661.2970.4870.961.31
23061626-306162670.14670.43
33045128-304512869.76870.06
43069408-306940870.32570.62
53150161-315016172.17572.50
63113033-311303371.32471.64
30min13386626-338662677.59377.750.7978.0278.200.80
23389009-338900977.64778.09
33354837-335483776.86477.31
43428193-342819378.54579.00
53419351-341935178.34278.83
63381703-338170377.48077.95
45min13635267-363526783.28983.100.4383.8983.730.44
23625755-362575583.07183.69
33606914-360691482.64083.25
43631218-363121883.19783.83
53649877-364987783.62484.29
63613084-361308482.78183.43
60min13785405-378540586.72986.370.5287.5287.180.52
23771821-377182186.41887.22
33743507-374350785.76986.57
43783888-378388886.69487.51
53785495-378549586.73187.58
63747684-374768485.86586.70
极限13901097-390109789.38088.860.4990.3689.870.48
23859969-385996988.43889.43
33863882-386388288.52789.51
43896735-389673589.28090.29
53887476-388747689.06890.11
63862413-386241388.49489.52
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%
110.424097743409692340934444091377408854440936060.10
210.504089966408779040888780.04
单位质量响应值RSD%判断
392860.46389416.950.63数据可信
供试品溶液-250601批-pH1.0(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%
5min11081247-108124724.85519.7733.0824.8519.7633.08
2457796-45779610.52310.52
3965081-96508122.18422.18
4925122-92512221.26621.27
5566477-56647713.02213.02
61163791-116379126.75226.75
10min12260430-226043051.96150.0211.0052.0250.0711.02
21893745-189374543.53243.56
32322236-232223653.38253.43
42207779-220777950.75150.80
51888623-188862343.41443.44
62483652-248365257.09257.15
15min12878132-287813266.16063.556.5166.3363.706.54
22590895-259089559.55759.68
32891645-289164566.47166.64
42745444-274544463.11063.27
52515486-251548657.82457.95
62965196-296519668.16168.35
20min13146135-314613572.32171.512.7772.6471.802.80
23045342-304534270.00470.26
33132239-313223972.00172.32
43168984-316898472.84673.15
52971096-297109668.29768.55
63200519-320051973.57173.91
30min13418585-341858578.58478.620.8679.0679.080.89
23435468-343546878.97279.38
33407619-340761978.33278.81
43419113-341911378.59679.06
53376044-337604477.60678.01
63464683-346468379.64380.14
45min13656680-365668084.05784.210.6984.7184.840.69
23695482-369548284.94985.53
33633204-363320483.51784.17
43659795-365979584.12884.77
53643494-364349483.75484.33
63690753-369075384.84085.52
60min13789520-378952087.11087.430.6687.9588.250.65
23838469-383846988.23689.01
33772280-377228086.71487.55
43807685-380768587.52888.35
53787702-378770287.06987.83
63825096-382509687.92888.79
极限13898729-389872989.62190.010.7790.6591.020.76
23962161-396216191.07992.05
33877610-387761089.13590.16
43916152-391615290.02191.04
53902289-390228989.70390.66
63936095-393609590.48091.54
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%
110.424156251415732641585474156542415906941575470.03
210.504238992423828542386380.02
单位质量响应值RSD%判断
398996.83403679.810.83数据可信
供试品溶液-250602批-pH1.0(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%
5min11283029-128302928.74428.513.2528.7428.513.25
21272530-127253028.50928.51
31216982-121698227.26427.26
41324503-132450329.67329.67
51305723-130572329.25329.25
61233506-123350627.63527.63
10min12423974-242397454.30550.913.4354.3750.973.42
22225782-222578249.86549.93
32258637-225863750.60150.66
42273376-227337650.93151.00
52242775-224277550.24650.31
62208938-220893849.48849.55
15min12845563-284556363.75062.691.8163.9362.861.80
22802268-280226862.78062.95
32858145-285814564.03264.20
42769808-276980862.05362.23
52720623-272062360.95161.13
62792305-279230562.55762.73
20min13072741-307274168.84068.640.8169.1768.960.82
23078210-307821068.96269.28
33094664-309466469.33169.65
43056851-305685168.48468.80
53021822-302182267.69968.01
63059489-305948968.54368.85
30min13318895-331889574.35474.840.7374.8375.310.72
23355832-335583275.18275.65
33374573-337457375.60276.07
43352827-335282775.11475.58
53312390-331239074.20874.67
63330233-333023374.60875.07
45min13539439-353943979.29580.060.7779.9480.700.77
23590929-359092980.44981.08
33603979-360397980.74181.38
43597102-359710280.58781.22
53547029-354702979.46580.09
63563470-356347079.83480.46
60min13676914-367691482.37583.310.7283.2084.120.71
23730493-373049383.57584.39
33750429-375042984.02284.84
43737130-373713083.72484.54
53701044-370104482.91683.72
63714955-371495583.22784.03
极限13786769-378676984.83685.780.7285.8486.780.72
23840684-384068486.04487.04
33860411-386041186.48687.49
43850322-385032286.26087.26
53808480-380848085.32386.31
63828007-382800785.76086.75
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%
110.424200441419956841980824198492419626141985690.04
210.504222023422062742213250.03
单位质量响应值RSD%判断
402933.69402030.950.16数据可信
供试品溶液-250602批-pH1.0(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%
5min11363794-136379430.46626.1516.0730.4726.1516.07
21314520-131452029.36529.36
3861302-86130219.24119.24
41198992-119899226.78426.78
51245109-124510927.81427.81
61040842-104084223.25123.25
10min12427003-242700354.21752.157.3354.2852.217.34
22450912-245091254.75154.82
32110158-211015847.13947.18
42325234-232523451.94352.00
52538318-253831856.70356.77
62154917-215491748.13848.19
15min12845546-284554663.56663.042.6063.7563.212.62
22871743-287174364.15264.34
32763103-276310361.72561.87
42770394-277039461.88862.06
52932636-293263665.51265.70
62747799-274779961.38361.54
20min13046318-304631868.05168.831.4668.3869.141.47
23110970-311097069.49669.83
33078797-307879768.77769.06
43084520-308452068.90569.22
53145842-314584270.27570.61
63019940-301994067.46267.76
30min13422718-342271876.46075.900.8976.9476.360.91
23438130-343813076.80477.29
33389549-338954975.71976.16
43375038-337503875.39575.86
53403306-340330676.02676.52
63356473-335647374.98075.42
45min13539458-353945879.06880.530.9879.7281.170.96
23597942-359794280.37481.03
33629459-362945981.07881.68
43616449-361644980.78781.42
53637252-363725281.25281.91
63610091-361009180.64581.26
60min13667173-366717381.92183.631.2482.7584.441.22
23714710-371471082.98383.82
33776962-377696284.37385.16
43791427-379142784.69685.51
53768594-376859484.18685.03
63742591-374259183.60584.40
极限13792089-379208984.71186.080.9085.7287.080.89
23854305-385430586.10187.12
33895596-389559687.02388.00
43857851-385785186.18087.18
53873565-387356586.53187.56
63847217-384721785.94386.92
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