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%
110.422116457211793921137962111970211058321141490.15
210.502118631212135421199920.10
单位质量响应值RSD%判断
202893.38201904.000.35数据可信
供试品溶液-250603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%
5min1455751-45575120.24631.6218.0320.2531.6218.02
2759688-75968833.74733.75
3802823-80282335.66335.66
4773601-77360134.36534.37
5718749-71874931.92931.93
6759620-75962033.74433.74
10min1964220-96422042.83349.347.3042.8849.417.31
21118918-111891849.70549.78
31184939-118493952.63852.72
41178753-117875352.36352.44
51084726-108472648.18648.26
61132401-113240150.30450.38
15min11301114-130111457.79960.753.0057.9460.933.03
21371633-137163360.93161.12
31404927-140492762.41062.61
41410536-141053662.66062.85
51341682-134168259.60159.78
61375419-137541961.10061.29
20min11467166-146716665.17567.161.6065.4467.481.63
21509933-150993367.07567.40
31526173-152617367.79668.13
41538200-153820068.33168.66
51515622-151562267.32867.64
61514240-151424067.26667.59
30min11653278-165327873.44374.871.2073.8675.331.22
21717200-171720076.28276.75
31686514-168651474.91975.40
41685258-168525874.86375.35
51685056-168505674.85475.31
61684905-168490574.84875.32
45min11802374-180237480.06681.242.7880.6481.872.77
21806320-180632080.24180.88
31801856-180185680.04380.69
41931214-193121485.78986.44
51821613-182161380.92181.55
61809629-180962980.38881.03
60min11884452-188445283.71284.100.5584.4784.920.55
21890476-189047683.98084.80
31882371-188237183.62084.45
41892259-189225984.05984.90
51910072-191007284.85085.66
61899922-189992284.39985.22
极限11946907-194690786.48686.910.5187.4387.910.51
21953856-195385686.79587.80
31950093-195009386.62887.64
41959209-195920987.03388.06
51974696-197469687.72188.72
61954032-195403286.80387.81
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%
110.422088919208467420871802080842207732420837880.23
210.502125550212213721238440.12
单位质量响应值RSD%判断
199979.65202270.860.81数据可信
供试品溶液-250603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%
5min1447366-44736619.99929.3126.4420.0029.3126.44
2768645-76864534.36234.36
3477789-47778921.36021.36
4859990-85999038.44638.45
5594333-59433326.57026.57
6785677-78567735.12435.12
10min1969618-96961843.34751.1511.0643.3951.2211.09
21182783-118278352.87652.95
31014918-101491845.37245.42
41268125-126812556.69156.78
51160236-116023651.86851.93
61269866-126986656.76956.85
15min11303303-130330358.26462.454.4458.4062.634.47
21415357-141535763.27363.47
31342645-134264560.02360.17
41449380-144938064.79465.01
51409902-140990263.03063.20
61461687-146168765.34565.55
20min11484054-148405466.34568.572.3866.6168.882.42
21555488-155548869.53869.87
31496665-149666566.90867.19
41556711-155671169.59369.95
51533267-153326768.54568.86
61576151-157615170.46270.81
30min11678812-167881275.05175.861.6775.4776.331.70
21687236-168723675.42875.92
31670826-167082674.69475.12
41736178-173617877.61678.13
51679115-167911575.06575.53
61728712-172871277.28277.79
45min11818026-181802681.27581.531.1281.8682.171.13
21818900-181890081.31481.97
31817163-181716381.23681.83
41821703-182170381.43982.12
51803850-180385080.64181.27
61863258-186325883.29783.97
60min11910716-191071685.41885.171.1086.1885.981.11
21904252-190425285.12985.97
31897178-189717884.81385.59
41902164-190216485.03685.90
51875986-187598683.86684.68
61940049-194004986.73087.59
极限11970849-197084988.10788.111.0289.0689.121.04
21966661-196666187.91988.95
31955350-195535087.41488.38
41973101-197310188.20789.26
51952132-195213287.27088.27
62008056-200805689.77090.83
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%
110.424189346418763341830594180980417907041840180.11
210.504250447424850842494780.04
单位质量响应值RSD%判断
401537.24404712.190.56数据可信
供试品溶液-250603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%
5min1890699-89069919.86624.1913.1119.8724.1913.11
21311798-131179829.25829.26
31113491-111349124.83524.83
41076610-107661024.01224.01
5988539-98853922.04822.05
61126327-112632725.12125.12
10min12270713-227071350.64549.314.3850.6949.364.38
22380902-238090253.10353.17
32165917-216591748.30848.36
42130306-213030647.51447.57
52150099-215009947.95548.00
62166047-216604748.31148.37
15min12793966-279396662.31662.511.6962.4762.681.71
22895691-289569164.58464.77
32779723-277972361.99862.16
42761259-276125961.58661.75
52787887-278788762.18062.34
62797587-279758762.39662.56
20min13100655-310065569.15669.540.9369.4569.840.95
23170981-317098170.72471.05
33129934-312993469.80970.11
43096125-309612569.05569.35
53096831-309683169.07169.36
63113189-311318969.43569.74
30min13375086-337508675.27776.050.7775.7376.500.78
23438520-343852076.69177.18
33434472-343447276.60177.06
43413365-341336576.13076.58
53382295-338229575.43775.88
63413988-341398876.14476.60
45min13602708-360270880.35381.280.8380.9781.910.83
23664592-366459281.73482.39
33680236-368023682.08382.71
43650287-365028781.41582.03
53614282-361428280.61281.23
63654196-365419681.50282.13
60min13745886-374588683.54784.340.7284.3485.150.73
23794322-379432284.62785.46
33811823-381182385.01785.83
43806853-380685384.90785.71
53756752-375675283.78984.58
63773478-377347884.16284.97
极限13862635-386263586.15186.740.6587.1387.740.66
23907684-390768487.15588.18
33927605-392760587.60088.60
43884391-388439186.63687.62
53864435-386443586.19187.17
63887853-388785386.71387.71
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%
110.424224717422793142275204227479422540542266100.04
210.504182587418131641819520.03
单位质量响应值RSD%判断
405624.76398281.141.30数据可信
供试品溶液-250603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%
5min1778128-77812817.40721.9119.1017.4121.9219.10
21255573-125557328.08728.09
31125054-112505425.16825.17
4960561-96056121.48821.49
5788615-78861517.64117.64
6969413-96941321.68621.69
10min12053071-205307145.92850.508.0745.9750.558.08
22511593-251159356.18556.25
32378140-237814053.19953.26
42189438-218943848.97849.03
52073831-207383146.39246.43
62338490-233849052.31252.36
15min12711896-271189660.66663.514.2560.8163.674.27
22988315-298831566.84967.04
32937162-293716265.70565.88
42804165-280416562.73062.89
52696646-269664660.32460.47
62895540-289554064.77464.94
20min13050589-305058968.24270.171.9668.5270.471.98
23196105-319610571.49771.83
33202895-320289571.64971.97
43117554-311755469.74070.04
53088501-308850169.09069.37
63163899-316389970.77771.09
30min13365646-336564675.29076.841.1575.7277.301.17
23455236-345523677.29477.79
33483282-348328277.92278.40
43430581-343058176.74377.19
53447895-344789577.13077.56
63428119-342811976.68877.15
45min13590955-359095580.33082.291.6780.9282.921.68
23672073-367207382.14582.81
33782413-378241384.61385.27
43674247-367424782.19382.81
53684718-368471882.42883.03
63667604-366760482.04582.68
60min13743490-374349083.74285.090.9984.5285.911.00
23798079-379807984.96485.81
33851812-385181286.16687.01
43791234-379123484.81085.61
53805563-380556385.13185.92
63833386-383338685.75386.57
极限13926432-392643287.83587.850.5488.7988.860.53
23899252-389925287.22788.26
33956333-395633388.50489.54
43917517-391751787.63588.63
53946840-394684088.29189.27
63917334-391733487.63188.64
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