塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
110.173011951300980130090513006958300705730089640.07
210.113007511300523430063720.06
单位质量响应值RSD%判断
295866.67297366.170.36数据可信
供试品溶液-yd1批-pH12.0(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1802847-80284726.95925.423.2726.9625.423.28
2745102-74510225.02025.02
3755839-75583925.38025.38
4752852-75285225.28025.28
5728775-72877524.47124.47
6755855-75585525.38125.38
10min11602297-160229753.80352.023.8853.8452.063.87
21504596-150459650.52350.56
31532558-153255851.46251.50
41487371-148737149.94449.98
51641936-164193655.13455.17
61527006-152700651.27551.31
15min12214107-221410774.34772.423.5474.4772.543.54
22094591-209459170.33470.45
32156893-215689372.42672.54
42050222-205022268.84468.96
52259118-225911875.85975.98
62165053-216505372.70072.82
20min12596134-259613487.17586.671.9487.4186.891.94
22523807-252380784.74784.97
32610877-261087787.67087.89
42514255-251425584.42684.64
52635818-263581888.50888.74
62605420-260542087.48787.71
30min12989120-2989120100.37199.430.79100.7399.780.79
22968697-296869799.686100.03
32981335-2981335100.110100.47
42935270-293527098.56398.91
52932698-293269898.47798.84
62959554-295955499.37999.73
45min13070523-3070523103.105100.531.43103.62101.041.43
23014783-3014783101.233101.73
32969795-296979599.723100.23
42986345-2986345100.278100.77
52956527-295652799.27799.79
62965674-296567499.584100.09
60min13000033-3000033100.738100.140.79101.41100.800.79
23015585-3015585101.260101.91
32968817-296881799.690100.34
42990647-2990647100.423101.06
52955715-295571599.25099.91
62963029-296302999.495100.15
极限12996837-2996837100.631100.320.90101.45101.120.89
23017398-3017398101.321102.12
32956090-295609099.262100.07
42992489-2992489100.485101.28
52953942-295394299.190100.00
63008233-3008233101.013101.82
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
110.173011641300277530089953009800300929630085010.12
210.113002179300217630021780.01
单位质量响应值RSD%判断
295821.14296951.340.27数据可信
供试品溶液-yd2批-pH12.0(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1453900-45390015.25315.717.7515.2515.717.75
2491543-49154316.51816.52
3447025-44702515.02215.02
4454358-45435815.26915.27
5528602-52860217.76417.76
6429168-42916814.42214.42
10min11088817-108881736.59037.244.9736.6137.264.97
21108859-110885937.26337.29
31133018-113301838.07538.10
41073569-107356936.07736.10
51201653-120165340.38140.41
61043331-104333135.06135.08
15min11633510-163351054.89455.564.2754.9755.644.27
21625450-162545054.62354.70
31736379-173637958.35158.43
41588096-158809653.36853.44
51746281-174628158.68458.77
61590870-159087053.46153.54
20min12105785-210578570.76570.804.4870.9270.964.48
22102988-210298870.67170.83
32215876-221587674.46474.63
42003528-200352867.32867.49
52210919-221091974.29874.47
62002051-200205167.27967.43
30min12695207-269520790.57290.342.5990.8490.612.59
22667713-266771389.64889.92
32743766-274376692.20492.48
42616004-261600487.91188.17
52790248-279024893.76694.05
62617719-261771987.96888.22
45min12905754-290575497.64897.490.9098.0597.890.90
22853656-285365695.89796.30
32899046-289904697.42297.84
42899760-289976097.44697.84
52927741-292774198.38798.81
62920106-292010698.13098.52
60min12898393-289839397.40097.710.8597.9598.260.85
22871758-287175896.50597.05
32891813-289181397.17997.74
42918601-291860198.07998.62
52938029-293802998.73299.31
62927170-292717098.36798.90
极限12891477-289147797.16897.670.9997.8698.370.99
22863040-286304096.21296.90
32897777-289777797.38098.09
42918079-291807998.06298.75
52944341-294434198.94499.67
62924323-292432398.27298.95
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
110.173001801299894529952512993600299783129974860.11
210.113000100299855729993280.04
单位质量响应值RSD%判断
294738.05296669.440.47数据可信
供试品溶液-yd3批-pH12.0(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1543876-54387618.31919.784.5818.3219.784.59
2625702-62570221.07521.08
3585963-58596319.73719.74
4576538-57653819.41919.42
5593578-59357819.99319.99
6597166-59716620.11420.11
10min11225408-122540841.27543.443.1041.3043.473.10
21293074-129307443.55443.59
31326146-132614644.66844.70
41307594-130759444.04344.07
51260733-126073342.46542.49
61325918-132591844.66144.69
15min11794008-179400860.42762.612.6860.5262.712.67
21841857-184185762.03962.14
31912170-191217064.40764.50
41871698-187169863.04463.14
51818409-181840961.24961.34
61915297-191529764.51264.61
20min12255411-225541175.96878.052.4876.1578.242.48
22288295-228829577.07677.27
32338097-233809778.75378.95
42348993-234899379.12079.31
52266623-226662376.34676.53
62405649-240564981.02981.22
30min12828248-282824895.26395.980.7395.5696.290.73
22838984-283898495.62595.93
32867081-286708196.57196.88
42855877-285587796.19496.50
52829659-282965995.31195.61
62878140-287814096.94497.26
45min12972348-2972348100.11799.740.73100.55100.190.73
22921058-292105898.38998.84
32955350-295535099.544100.00
42962745-296274599.793100.25
52980281-2980281100.384100.83
62975077-2975077100.209100.67
60min12976366-2976366100.25299.850.99100.84100.450.98
22919294-291929498.33098.93
32950664-295066499.38699.99
42960014-296001499.701100.30
53006694-3006694101.274101.87
62973139-2973139100.143100.75
极限12966363-296636399.91599.670.45100.65100.420.45
22938234-293823498.96899.71
32951464-295146499.413100.17
42955335-295533599.544100.30
52973352-2973352100.151100.90
62970067-2970067100.040100.80
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
110.172995509300057129954882991294299187529949470.13
210.113003340300217530027580.03
单位质量响应值RSD%判断
294488.40297008.700.61数据可信
供试品溶液-24081301批-pH12.0(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1816329-81632927.49226.253.5427.4926.253.54
2803785-80378527.07027.07
3782546-78254626.35426.35
4741691-74169124.97924.98
5760303-76030325.60525.61
6772699-77269926.02326.02
10min11621449-162144954.60753.732.2454.6553.772.24
21610709-161070954.24554.29
31616225-161622554.43154.47
41546843-154684352.09452.13
51623876-162387654.68954.73
61552822-155282252.29652.33
15min12171470-217147073.13074.062.6473.2574.182.64
22234566-223456675.25575.38
32246204-224620475.64775.77
42116613-211661371.28371.40
52264852-226485276.27576.40
62161267-216126772.78772.90
20min12589508-258950887.20987.901.7187.4488.131.72
22633506-263350688.69188.93
32662390-266239089.66489.90
42549776-254977685.87186.09
52648245-264824589.18789.42
62576409-257640986.76886.99
30min12967477-296747799.93899.370.61100.3099.740.61
22947909-294790999.27999.65
32951240-295124099.39199.76
42970317-2970317100.034100.39
52946376-294637699.22899.60
62920442-292044298.35498.71
45min13010211-3010211101.377100.421.04101.89100.931.03
22970290-2970290100.033100.55
32967023-296702399.923100.44
43028397-3028397101.990102.49
52967933-296793399.954100.47
62946503-294650399.23299.74
60min13015930-3015930101.570100.461.11102.24101.131.10
22976186-2976186100.232100.90
32959863-295986399.682100.35
43031478-3031478102.094102.75
52964292-296429299.831100.50
62950933-295093399.381100.03
极限12998296-2998296100.976100.250.99101.79101.070.98
22979801-2979801100.353101.17
32953408-295340899.464100.28
43023112-3023112101.812102.62
52956180-295618099.558100.37
62950407-295040799.363100.17
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