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%
113.484522004519924521614521244519004520750.03
213.434509974506734508350.06
单位质量响应值RSD%判断
33536.7233569.250.07数据可信
供试品溶液-2024081821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%
5min114666-146663.2623.194.443.263.194.41
214269-142693.1743.17
314095-140953.1353.13
413623-136233.0303.03
513963-139633.1063.11
615434-154343.4333.43
10min145205-4520510.0549.649.8010.069.659.79
237639-376398.3718.38
344426-444269.8819.89
438485-384858.5598.56
547059-4705910.46610.47
647283-4728310.51610.52
15min174611-7461116.59415.8211.0816.6215.8411.08
260748-6074813.51113.53
373322-7332216.30816.33
461784-6178413.74113.76
577843-7784317.31317.34
678395-7839517.43617.46
20min183519-8351918.57521.5511.2818.6321.6011.26
295360-9536021.20921.25
3101503-10150322.57522.62
484954-8495418.89518.94
5109108-10910824.26724.32
6107034-10703423.80523.86
30min1154032-15403234.25832.839.9834.3432.919.97
2127101-12710128.26828.35
3153500-15350034.14034.23
4131480-13148029.24229.32
5163765-16376536.42336.51
6155719-15571934.63334.73
45min1220728-22072849.09247.368.4149.2347.508.42
2184343-18434341.00041.12
3219697-21969748.86349.01
4197661-19766143.96244.08
5230428-23042851.24951.40
6224709-22470949.97750.13
60min1262813-26281358.45257.556.9658.6757.776.97
2231026-23102651.38251.57
3268560-26856059.73059.96
4244134-24413454.29854.49
5280654-28065462.42062.66
6265372-26537259.02159.25
极限1298902-29890266.47964.397.1066.8064.707.10
2254354-25435456.57156.85
3298206-29820666.32466.65
4276480-27648061.49261.78
5311176-31117669.20869.55
6297871-29787166.24966.58
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%
113.484486824554114503774529564528184520490.58
213.434547754541264544500.11
单位质量响应值RSD%判断
33534.7933838.420.64数据可信
供试品溶液-2024081821批-pH4.5(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%
5min136407-364078.0657.5317.688.077.5317.71
239936-399368.8478.85
337594-375948.3288.33
428898-288986.4026.40
536654-366548.1208.12
624338-243385.3925.39
10min1110716-11071624.52723.2511.8824.5423.2611.88
2120208-12020826.63026.64
3109942-10994224.35624.37
494783-9478320.99721.01
5108343-10834324.00124.01
685686-8568618.98218.99
15min1179158-17915839.68937.629.7839.7437.679.78
2188511-18851141.76141.82
3172915-17291538.30638.36
4156351-15635134.63734.68
5178286-17828639.49639.55
6143782-14378231.85231.89
20min1226577-22657750.19449.047.8250.3149.167.83
2242588-24258853.74153.87
3224647-22464749.76649.88
4210577-21057746.64946.75
5230865-23086551.14451.26
6193061-19306142.76942.86
30min1308758-30875868.40066.675.5368.6066.865.54
2322910-32291071.53571.75
3302527-30252767.01967.22
4292131-29213164.71664.90
5305438-30543867.66467.87
6273818-27381860.65960.82
45min1376540-37654083.41680.912.8583.7381.222.86
2368685-36868581.67582.01
3371771-37177182.35982.67
4366940-36694081.28981.58
5360362-36036279.83280.15
6347039-34703976.88077.15
60min1409559-40955990.73089.972.3691.1990.422.36
2419530-41953092.93993.41
3392042-39204286.85087.30
4408084-40808490.40490.83
5408978-40897890.60291.05
6398638-39863888.31188.71
极限1427493-42749394.70393.141.3495.3193.731.35
2424408-42440894.02094.65
3418451-41845192.70093.30
4423417-42341793.80094.38
5412563-41256391.39692.00
6416199-41619992.20192.74
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%
113.484558504560874552104548754549354553910.13
213.434537294540514538900.06
单位质量响应值RSD%判断
33782.7233796.720.03数据可信
供试品溶液-2024081821批-pH6.0(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%
5min194850-9485020.94818.0214.5920.9518.0214.58
292150-9215020.35120.35
376413-7641316.87616.88
467626-6762614.93514.94
569593-6959315.37015.37
689021-8902119.66019.66
10min1202292-20229244.67641.797.3144.7141.827.31
2195683-19568343.21743.25
3195858-19585843.25543.28
4176877-17687739.06339.09
5167311-16731136.95136.98
6197293-19729343.57243.61
15min1274169-27416960.55158.484.9460.6658.584.95
2274530-27453060.63060.74
3273421-27342160.38560.49
4255550-25555056.43956.53
5242467-24246753.54953.64
6268560-26856059.31259.42
20min1320897-32089770.87068.493.3671.0868.683.37
2316382-31638269.87370.08
3316907-31690769.98970.19
4307894-30789467.99968.18
5292249-29224964.54464.72
6306255-30625567.63767.84
30min1388483-38848385.79782.623.0486.1382.933.05
2382667-38266784.51284.84
3373077-37307782.39582.71
4371000-37100081.93682.23
5355285-35528578.46578.75
6374058-37405882.61182.93
45min1414825-41482591.61589.614.7592.0990.064.75
2409143-40914390.36090.82
3423987-42398793.63894.09
4412500-41250091.10191.54
5368569-36856981.39981.81
6405407-40540789.53589.99
60min1443448-44344897.93694.832.4098.5695.422.39
2429599-42959994.87795.49
3433389-43338995.71496.33
4431970-43197095.40195.99
5425500-42550093.97294.52
6412293-41229391.05591.66
极限1445264-44526498.33796.962.4599.1297.712.45
2446761-44676198.66899.44
3445948-44594898.48899.26
4443609-44360997.97298.72
5432680-43268095.55896.26
6419800-41980092.71393.47
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