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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
110.191928755193336019323291930178193080119310850.10
210.281938385194337419408800.19
单位质量响应值RSD%判断
189507.85188801.560.27数据可信
供试品溶液-2024092211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%
5min1197365-1973659.39110.1248.699.3910.1248.71
2139196-1391966.6236.62
3420512-42051220.00820.01
4170589-1705898.1178.12
5175319-1753198.3428.34
6172823-1728238.2238.22
10min1801193-80119338.12140.1818.6738.1440.2118.68
2736567-73656735.04635.06
31162441-116244155.30955.35
4782295-78229537.22237.24
5805958-80595838.34838.37
6778933-77893337.06237.08
15min11274183-127418360.62661.828.2360.7361.948.26
21241130-124113059.05359.15
31515405-151540572.10372.27
41245754-124575459.27359.37
51273577-127357760.59760.70
61246228-124622859.29659.40
20min11508123-150812371.75773.394.0472.0073.644.07
21530819-153081972.83773.06
31667416-166741679.33679.66
41507524-150752471.72871.96
51531535-153153572.87173.11
61509682-150968271.83172.06
30min11701990-170199080.98182.632.3881.3883.042.41
21758538-175853883.67284.06
31809994-180999486.12086.62
41713389-171338981.52481.92
51728184-172818482.22782.63
61707477-170747781.24281.63
45min11808301-180830186.03988.282.1886.6288.882.21
21891611-189161190.00390.57
31914542-191454291.09491.79
41833953-183395387.26087.83
51854747-185474788.24988.83
61829266-182926687.03787.61
60min11856595-185659588.33790.892.1789.1191.682.19
21946923-194692392.63593.41
31967151-196715193.59894.50
41886777-188677789.77390.54
51916027-191602791.16591.94
61888186-188818689.84090.61
极限11921212-192121291.41293.451.7192.3894.451.74
21999157-199915795.12096.10
32009249-200924995.60196.71
41957305-195730593.12994.10
51952299-195229992.89193.87
61945529-194552992.56993.53
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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
110.191946204195118619561561951628194999619510340.19
210.281965707196518419654460.02
单位质量响应值RSD%判断
191465.55191191.250.11数据可信
供试品溶液-2024092211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%
5min1385166-38516618.11816.1345.6618.1216.1345.64
2535051-53505125.16925.17
3165088-1650887.7667.77
4168113-1681137.9087.91
5487520-48752022.93322.93
6316226-31622614.87514.88
10min11090258-109025851.28547.0222.6351.3347.0622.65
21284562-128456260.42560.48
3728048-72804834.24734.26
4745600-74560035.07335.09
51166238-116623854.85954.91
6983023-98302346.24146.27
15min11502214-150221470.66366.0010.0070.8266.1410.04
21583736-158373674.49874.69
31222971-122297157.52857.62
41272474-127247459.85759.95
51472964-147296469.28869.46
61364572-136457264.18964.32
20min11641546-164154677.21875.014.1677.5375.304.21
21685378-168537879.27979.64
31513553-151355371.19771.42
41538847-153884772.38772.62
51624075-162407576.39676.72
61563880-156388073.56473.84
30min11775830-177583083.53483.051.3784.0283.511.43
21807127-180712785.00685.54
31749109-174910982.27782.66
41745631-174563182.11482.50
51770266-177026683.27383.77
61745542-174554282.11082.55
45min11876297-187629788.26088.410.9388.9389.040.97
21906249-190624989.66990.39
31887892-188789288.80689.37
41863290-186329087.64888.22
51883899-188389988.61889.30
61858652-185865287.43088.05
60min11934166-193416690.98291.180.7491.8592.010.78
21962130-196213092.29893.22
31940933-194093391.30192.06
41923903-192390390.50091.27
51944016-194401691.44692.32
61924658-192465890.53591.35
极限11967963-196796392.57292.950.9793.6493.990.99
22002048-200204894.17595.30
31990497-199049793.63294.59
41951710-195171091.80892.78
51983261-198326193.29294.37
61961101-196110192.24993.27
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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
110.193913630391759739178573918688390940339154350.10
210.283966579399050439785420.43
单位质量响应值RSD%判断
384242.89387017.700.51数据可信
供试品溶液-2024091313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%
5min1727249-72724916.97316.5314.4616.9716.5214.46
2597192-59719213.93813.94
3657821-65782115.35315.35
4635087-63508714.82214.82
5881636-88163620.57620.58
6749549-74954917.49417.49
10min11846012-184601243.08445.847.9543.1245.877.96
21830978-183097842.73342.76
31859391-185939143.39643.43
41958749-195874945.71545.75
52228760-222876052.01652.06
62059812-205981248.07348.11
15min12497482-249748258.28863.765.3258.4263.905.32
22691340-269134062.81262.94
32696910-269691062.94263.07
42759933-275993364.41364.55
52931870-293187068.42668.59
62813303-281330365.65965.80
20min12915595-291559568.04672.643.4668.3172.923.47
23111098-311109872.60972.87
33099702-309970272.34372.61
43150189-315018973.52173.80
53233804-323380475.47375.79
63164761-316476173.86174.15
30min13311003-331100377.27580.502.1977.6980.942.20
23472329-347232981.04081.47
33424555-342455579.92580.36
43480760-348076081.23681.68
53527489-352748982.32782.81
63479585-347958581.20981.66
45min13585433-358543383.67986.461.9084.2787.081.92
23724046-372404686.91487.52
33670072-367007285.65586.26
43732383-373238387.10987.73
53793636-379363688.53989.20
63721722-372172286.86087.50
60min13726362-372636286.96989.731.8687.7490.541.88
23871109-387110990.34791.15
33810983-381098388.94389.74
43863595-386359590.17190.99
53940458-394045891.96592.83
63854376-385437689.95690.79
极限13827435-382743589.32792.231.8590.2993.241.87
23982962-398296292.95793.96
33908703-390870391.22492.22
43969089-396908992.63393.65
54033840-403384094.14595.21
63988107-398810793.07794.11
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101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
110.193964106395976739537803963946395202639587250.15
210.283927935393790839329220.18
单位质量响应值RSD%判断
388491.17382579.961.09数据可信
供试品溶液-2024091313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%
5min1806266-80626618.82314.5027.4018.8214.5027.40
2806902-80690218.83818.84
3680669-68066915.89115.89
4404620-4046209.4469.45
5552704-55270412.90312.90
6476448-47644811.12311.12
10min12060436-206043648.10243.4715.2748.1443.5015.27
22154793-215479350.30550.35
32108990-210899049.23549.27
41480996-148099634.57534.60
51751085-175108540.88040.91
61616403-161640337.73637.76
15min12780132-278013264.90462.457.3865.0562.587.40
22852572-285257266.59566.75
32888634-288863467.43767.58
42406704-240670456.18656.28
52625681-262568161.29861.42
62495874-249587458.26758.38
20min13125497-312549772.96671.793.3873.2672.063.41
23171191-317119174.03374.33
33178260-317826074.19874.49
42921174-292117468.19668.42
53066259-306625971.58371.84
62987753-298775369.75169.99
30min13434398-343439880.17879.911.1080.6380.331.14
23454766-345476680.65381.12
33470969-347096981.03281.49
43371420-337142078.70879.08
53410433-341043379.61880.03
63394867-339486779.25579.65
45min13670491-367049185.69085.660.7686.3286.260.80
23692860-369286086.21286.86
33688225-368822586.10486.74
43632069-363206984.79385.34
53693374-369337486.22486.82
63637600-363760084.92285.49
60min13797323-379732388.65088.900.4189.4789.690.44
23829328-382932889.39890.23
33814861-381486189.06089.89
43800777-380077788.73189.47
53817528-381752889.12289.91
63787156-378715688.41389.17
极限13886015-388601590.72191.320.5691.7492.310.57
23925161-392516191.63592.67
33928450-392845091.71292.74
43895685-389568590.94791.88
53938060-393806091.93692.92
63895605-389560590.94591.90
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