奥利司他胶囊项目信息
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520027-202102对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
113.784564914567754562734565844569824566210.06
213.814573444589934581680.26
单位质量响应值RSD%判断
33136.5033176.540.09数据可信
供试品溶液-2024102121批-pH2.0(内含3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113408-134083.0182.7222.223.022.7222.17
214144-141443.1833.18
312768-127682.8742.87
413932-139323.1363.14
57049-70491.5871.59
611189-111892.5182.52
10min139130-391308.8078.6414.688.818.6514.67
243859-438599.8719.88
339014-390148.7818.79
442645-426459.5989.60
527926-279266.2856.29
637844-378448.5188.52
15min166882-6688215.05314.6913.8715.0714.7013.86
273545-7354516.55316.57
366398-6639814.94414.96
471370-7137016.06316.08
547962-4796210.79510.81
665361-6536114.71114.73
20min192613-9261320.84420.4913.0020.8920.5413.00
2101204-10120422.77822.83
392602-9260220.84220.89
499270-9927022.34322.39
568196-6819615.34915.38
692360-9236020.78720.83
30min1142898-14289832.16231.3511.1032.2431.4311.11
2151476-15147634.09334.18
3140766-14076631.68231.76
4149541-14954133.65733.74
5108994-10899424.53124.59
6142173-14217331.99932.08
45min1203967-20396745.90744.798.7746.0444.928.78
2211770-21177047.66347.81
3199504-19950444.90245.03
4211250-21125047.54647.69
5164801-16480137.09237.19
6202661-20266145.61345.74
60min1250215-25021556.31654.937.1256.5355.137.14
2256551-25655157.74257.97
3243983-24398354.91355.12
4256501-25650157.73057.95
5210119-21011947.29147.45
6246918-24691855.57455.78
极限1284755-28475564.09063.035.0564.3963.325.07
2289753-28975365.21465.53
3279771-27977162.96863.27
4289607-28960765.18265.50
5252226-25222656.76857.01
6284079-28407963.93764.24
奥利司他胶囊项目信息
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520027-202102对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
113.784544384538204551304541464553144545700.15
213.814548824570414559620.34
单位质量响应值RSD%判断
32987.6633016.800.07数据可信
供试品溶液-2024102121批-pH2.0(内含3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112411-124112.8062.6015.752.812.6015.70
213461-134613.0443.04
313092-130922.9602.96
48747-87471.9781.98
511058-110582.5002.50
610302-103022.3292.33
10min139851-398519.0118.458.529.028.458.55
239040-390408.8288.83
338797-387978.7738.78
431539-315397.1327.13
539163-391638.8568.86
635826-358268.1018.10
15min167803-6780315.33214.527.3415.3514.547.35
267845-6784515.34115.36
365734-6573414.86414.88
455848-5584812.62812.64
566578-6657815.05515.07
661586-6158613.92613.94
20min195882-9588221.68120.386.9421.7320.426.94
293652-9365221.17721.22
392312-9231220.87420.92
478762-7876217.81017.85
592819-9281920.98821.03
687229-8722919.72419.76
30min1145235-14523532.84131.195.4332.9231.265.44
2141649-14164932.03032.11
3139454-13945431.53331.61
4124234-12423428.09228.16
5141850-14185032.07532.15
6135108-13510830.55130.62
45min1206615-20661546.72044.614.3546.8644.744.36
2198727-19872744.93645.07
3199582-19958245.13045.26
4181926-18192641.13741.25
5202565-20256545.80445.94
6194291-19429143.93344.06
60min1255050-25505057.67254.913.9557.8955.123.96
2241805-24180554.67754.89
3244854-24485455.36755.57
4226662-22666251.25351.43
5248744-24874456.24656.46
6240008-24000854.27154.47
极限1285595-28559564.57962.612.6164.8962.902.62
2276946-27694662.62362.92
3278657-27865763.01063.31
4264515-26451559.81260.08
5281473-28147363.64763.95
6274172-27417261.99662.28
奥利司他胶囊项目信息
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520027-202102对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
113.784543864572494553414550044556174555190.24
213.814534864558594546720.37
单位质量响应值RSD%判断
33056.5332923.390.29数据可信
供试品溶液-2024102221批-pH2.0(内含3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114278-142783.2303.0529.543.233.0529.55
220117-201174.5514.55
314173-141733.2063.21
410101-101012.2852.28
58698-86981.9681.97
613622-136223.0813.08
10min144482-4448210.0629.6712.4710.079.6812.48
251162-5116211.57311.58
344730-4473010.11810.12
436472-364728.2508.25
537820-378208.5558.56
641924-419249.4839.49
15min173923-7392316.72216.479.2016.7416.499.22
283297-8329718.84218.87
376746-7674617.36017.38
464699-6469914.63514.65
567578-6757815.28715.30
670685-7068515.98916.01
20min1102467-10246723.17922.976.5423.2323.026.55
2110474-11047424.99025.05
3107361-10736124.28624.34
492682-9268220.96521.01
596870-9687021.91321.96
699308-9930822.46422.51
30min1154900-15490035.03934.894.6435.1334.984.65
2161843-16184336.61036.71
3162226-16222636.69736.79
4143364-14336432.43032.51
5150807-15080734.11334.19
6152348-15234834.46234.55
45min1218380-21838049.39949.312.8749.5549.452.88
2221149-22114950.02550.19
3227000-22700051.34951.50
4207996-20799647.05047.18
5216109-21610948.88549.02
6217164-21716449.12449.27
60min1266657-26665760.31959.931.9760.5560.161.98
2263922-26392259.70159.95
3272863-27286361.72361.96
4256772-25677258.08358.29
5263686-26368659.64759.87
6265672-26567260.09760.32
极限1299353-29935367.71567.111.3968.0567.441.40
2294318-29431866.57766.92
3302538-30253868.43668.78
4290700-29070065.75866.06
5295567-29556766.85967.18
6297501-29750167.29767.62
奥利司他胶囊项目信息
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520027-202102对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
113.784535814546494539834549504557214545770.19
213.814507364503904505630.06
单位质量响应值RSD%判断
32988.1732625.850.79数据可信
供试品溶液-2024102221批-pH2.0(内含3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112909-129092.9363.259.222.943.259.14
214462-144623.2903.29
314670-146703.3373.34
416110-161103.6653.66
514940-149403.3983.40
612605-126052.8672.87
10min140888-408889.3019.519.419.319.519.40
246216-4621610.51310.52
345832-4583210.42610.43
439791-397919.0519.06
542260-422609.6139.62
635773-357738.1378.14
15min167112-6711215.26616.036.9415.2916.056.93
276741-7674117.45717.48
376176-7617617.32817.35
468876-6887615.66715.69
568932-6893215.68015.70
664890-6489014.76114.78
20min193076-9307621.17222.176.8621.2222.226.86
2105697-10569724.04324.10
3105072-10507223.90123.95
495057-9505721.62321.67
596891-9689122.04022.09
688974-8897420.23920.28
30min1140475-14047531.95433.435.7032.0433.515.71
2157983-15798335.93736.03
3157048-15704835.72435.82
4143586-14358632.66232.75
5143490-14349032.64032.72
6139120-13912031.64631.72
45min1199608-19960845.40647.254.2745.5447.394.27
2218985-21898549.81349.97
3218492-21849249.70149.85
4206286-20628646.92547.06
5200583-20058345.62745.77
6202257-20225746.00846.14
60min1241374-24137454.90657.233.6655.1257.453.67
2262851-26285159.79260.03
3261771-26177159.54659.78
4251664-25166457.24757.46
5242464-24246455.15455.37
6249334-24933456.71756.92
极限1271835-27183561.83564.233.1662.1464.553.17
2292823-29282366.60966.94
3290637-29063766.11266.45
4284590-28459064.73765.05
5272165-27216561.91062.22
6282139-28213964.17964.48
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