塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
110.043006774300231330001123005053299948530027470.11
210.143000943299916930000560.05
单位质量响应值RSD%判断
299078.39295863.510.77数据可信
供试品溶液-25010701-1-yd1批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1692949-69294923.20222.394.6923.2022.404.68
2636916-63691621.32621.33
3674031-67403122.56922.57
4711531-71153123.82423.82
5630760-63076021.12021.12
6666796-66679622.32622.33
10min11290104-129010443.19743.741.9843.2443.781.98
21277305-127730542.76842.81
31311252-131125243.90543.95
41340471-134047144.88344.93
51286706-128670643.08343.13
61331528-133152844.58444.63
15min11761790-176179058.99059.701.1659.1259.831.17
21756873-175687358.82658.95
31794430-179443060.08360.22
41803329-180332960.38160.52
51777817-177781759.52759.66
61803448-180344860.38560.52
20min12071092-207109269.34770.180.9169.6070.440.91
22073805-207380569.43869.68
32106697-210669770.53970.79
42111715-211171570.70770.97
52100217-210021770.32270.57
62113181-211318170.75671.01
30min12393656-239365680.14780.920.8880.5481.320.88
22420647-242064781.05181.44
32412494-241249480.77881.17
42453291-245329182.14482.54
52399427-239942780.34180.73
62421693-242169381.08681.48
45min12562790-256279085.81186.990.8086.3687.540.80
22596359-259635986.93587.48
32610347-261034787.40387.96
42624435-262443587.87588.44
52601785-260178587.11687.66
62591941-259194186.78787.34
60min12630044-263004488.06289.070.8488.7889.790.84
22662588-266258889.15289.87
32668404-266840489.34790.08
42690420-269042090.08490.82
52670381-267038189.41390.14
62638177-263817788.33589.07
极限12683186-268318689.84290.890.7390.7491.800.73
22697740-269774090.32991.23
32727779-272777991.33592.24
42727946-272794691.34092.26
52719507-271950791.05891.96
62731559-273155991.46192.37
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
110.043011400301385530087073002354300575030084130.16
210.142999306299763129984680.04
单位质量响应值RSD%判断
299642.73295706.900.94数据可信
供试品溶液-25010701-1-yd2批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1499803-49980316.72416.105.1816.7216.105.19
2439113-43911314.69314.69
3493210-49321016.50316.50
4507323-50732316.97516.98
5469385-46938515.70615.71
6477240-47724015.96915.97
10min1972858-97285832.55331.275.7032.5931.305.70
2837566-83756628.02628.06
3937385-93738531.36631.40
4986592-98659233.01233.05
5919247-91924730.75930.79
6953323-95332331.89931.93
15min11416931-141693147.41245.854.7447.5145.944.74
21266346-126634642.37342.46
31331737-133173744.56144.66
41439839-143983948.17848.28
51356114-135611445.37745.47
61410010-141001047.18047.28
20min11770936-177093659.25757.304.4759.4557.494.47
21596130-159613053.40853.58
31667852-166785255.80855.99
41789959-178995959.89360.09
51680737-168073756.23956.42
61769268-176926859.20159.39
30min12163316-216331672.38671.683.0072.7071.983.01
22061348-206134868.97469.25
32070536-207053669.28269.58
42209627-220962773.93674.25
52142512-214251271.69071.99
62205289-220528973.79174.10
45min12425714-242571481.16681.451.5381.6281.901.54
22399497-239949780.28980.70
32383544-238354479.75580.19
42460106-246010682.31782.78
52468508-246850882.59883.04
62468634-246863482.60283.06
60min12538782-253878284.95085.551.1085.5786.161.10
22541243-254124385.03285.61
32519994-251999484.32184.92
42567073-256707385.89686.52
52594185-259418586.80387.41
62579361-257936186.30786.93
极限12615038-261503887.50188.120.8888.2988.890.88
22624415-262441587.81588.56
32607513-260751387.24988.01
42637548-263754888.25489.05
52670828-267082889.36890.15
62645007-264500788.50489.30
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
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%
110.043002700300132729988872999994300241930010650.06
210.142997040299825029976450.03
单位质量响应值RSD%判断
298910.86295625.740.79数据可信
供试品溶液-25010701-1-yd3批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1517295-51729517.33317.954.3517.3317.954.36
2579833-57983319.42819.43
3531441-53144117.80717.81
4540128-54012818.09818.10
5517487-51748717.33917.34
6528157-52815717.69617.70
10min1979572-97957232.82234.953.1932.8634.993.19
21066435-106643535.73235.77
31054855-105485535.34435.38
41065399-106539935.69735.73
51034156-103415634.65134.69
61058539-105853935.46835.50
15min11424157-142415747.71850.943.2847.8251.043.27
21533397-153339751.37851.49
31521401-152140150.97651.08
41534124-153412451.40351.51
51569567-156956752.59052.69
61538928-153892851.56351.67
20min11779535-177953559.62562.272.3359.8262.482.33
21899077-189907763.63163.84
31872340-187234062.73562.94
41892637-189263763.41563.63
51859154-185915462.29362.50
61848701-184870161.94362.15
30min12222036-222203674.45277.351.8874.7777.681.89
22335255-233525578.24578.59
32319863-231986377.73078.06
42313369-231336977.51277.85
52322579-232257977.82178.15
62338076-233807678.34078.67
45min12532064-253206484.84086.151.2985.3086.641.29
22632556-263255688.20788.70
32568177-256817786.05086.54
42564039-256403985.91186.40
52570500-257050086.12786.62
62560561-256056185.79486.28
60min12633053-263305388.22389.120.6288.8689.780.63
22675256-267525689.63790.31
32655734-265573488.98389.64
42655761-265576188.98489.65
52678424-267842489.74490.41
62660774-266077489.15289.81
极限12690729-269072990.15690.790.6090.9791.630.61
22719715-271971591.12791.98
32736444-273644491.68892.53
42705777-270577790.66091.50
52706380-270638090.68091.52
62699260-269926090.44291.28
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