奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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)120供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.424502164493344504094506274501814501530.11
213.594487704487234487460.01
单位质量响应值RSD%判断
33543.4433020.311.12数据可信
供试品溶液-M2449M1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%
5min165895-6589514.77616.5315.4914.7816.5315.48
275145-7514516.85016.85
361138-6113813.70913.71
490409-9040920.27320.27
566198-6619814.84414.84
683420-8342018.70618.71
10min1165182-16518237.04040.196.8337.2040.386.87
2185169-18516941.52141.71
3167880-16788037.64537.80
4192892-19289243.25343.48
5172568-17256838.69638.86
6191725-19172542.99143.20
15min1239968-23996853.80957.315.2454.3857.945.28
2254852-25485257.14757.80
3241668-24166854.19054.76
4266012-26601259.64960.36
5256827-25682757.59058.18
6274222-27422261.49062.18
20min1295558-29555866.27468.783.4867.4570.053.52
2299791-29979167.22468.51
3297810-29781066.77967.95
4313779-31377970.36071.73
5311088-31108869.75770.99
6322425-32242572.29973.67
30min1344923-34492377.34481.853.2479.2583.883.25
2365031-36503181.85383.88
3362257-36225781.23183.15
4380333-38033385.28487.43
5372094-37209483.43685.45
6365470-36547081.95184.12
45min1395734-39573488.73790.222.9791.5193.162.96
2390064-39006487.46690.41
3394977-39497788.56891.38
4420930-42093094.38797.49
5412740-41274092.55195.49
6399502-39950289.58292.66
60min1397914-39791489.22693.713.0292.9897.653.02
2414920-41492093.04096.95
3418840-41884093.91997.72
4436346-43634697.844101.99
5424024-42402495.08199.05
6415350-41535093.13697.21
极限1422271-42227194.68895.312.0999.43100.292.13
2419262-41926294.01398.96
3415192-41519293.10197.95
4439912-43991298.644103.88
5430579-43057996.551101.57
6422948-42294894.84099.95
奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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)120供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.424496354495204490924493894487984492870.08
213.594493064493634493340.01
单位质量响应值RSD%判断
33478.9133063.580.89数据可信
供试品溶液-M2449M1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%
5min143618-436189.78414.6919.469.7814.6919.47
258565-5856513.13613.14
371370-7137016.00816.01
476715-7671517.20717.21
565970-6597014.79714.80
676655-7665517.19417.19
10min1151576-15157633.99938.057.0134.1138.217.06
2161820-16182036.29636.44
3173284-17328438.86839.05
4173345-17334538.88239.07
5171090-17109038.37638.54
6186682-18668241.87342.06
15min1225444-22544450.56754.784.9951.0555.365.04
2235097-23509752.73353.28
3245168-24516854.99255.60
4250508-25050856.18956.81
5249636-24963655.99456.58
6259552-25955258.21858.87
20min1277789-27778962.30866.524.1963.3667.724.25
2287941-28794164.58665.72
3295802-29580266.34967.57
4302372-30237267.82369.07
5302400-30240067.82969.04
6313187-31318770.24871.55
30min1346683-34668377.76280.493.8979.5082.423.92
2341637-34163776.63078.48
3352794-35279479.13281.09
4365426-36542681.96683.97
5369313-36931382.83784.80
6377214-37721484.61086.69
45min1385505-38550586.46989.622.7589.0792.442.80
2393922-39392288.35791.06
3391621-39162187.84190.68
4403301-40330190.46193.37
5413828-41382892.82295.71
6409088-40908891.75994.78
60min1409539-40953991.86092.991.9195.4396.811.97
2411061-41106192.20295.89
3404602-40460290.75394.57
4415487-41548793.19497.11
5420049-42004994.21898.14
6426606-42660695.68899.73
极限1422613-42261394.79394.842.8199.3899.702.80
2402406-40240690.26094.97
3416526-41652693.42798.25
4431291-43129196.739101.69
5433566-43356697.250102.21
6430555-43055596.574101.68
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