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100
标示量(mg)100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%
19.661436919143813314387211433641143370914362250.17
29.601442862144186314423620.05
单位质量响应值RSD%判断
148677.54150246.040.75数据可信
长期18月-供试品溶液-2023010711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%
5min1303239-30323920.20822.029.5720.2122.029.56
2331794-33179422.11122.11
3375948-37594825.05425.05
4299250-29925019.94219.94
5312466-31246620.82320.82
6360213-36021324.00524.00
10min1661887-66188744.10947.739.8844.1547.779.88
2715027-71502747.65047.69
3835807-83580755.69955.75
4650771-65077143.36843.41
5675266-67526645.00045.04
6758599-75859950.55450.60
15min1943702-94370262.88968.079.4063.0268.229.40
21015905-101590567.70167.84
31192893-119289379.49679.66
4940274-94027462.66162.79
5973417-97341764.86965.00
61062847-106284770.82970.98
20min11171611-117161178.07782.476.4178.3382.756.42
21237684-123768482.48082.76
31368478-136847891.19791.52
41160379-116037977.32977.58
51199352-119935279.92680.19
61287833-128783385.82286.11
30min11434853-143485395.62097.812.3896.0398.262.40
21492485-149248599.46199.90
31493964-149396499.559100.06
41422133-142213394.77295.18
51456830-145683097.08597.51
61506374-1506374100.386100.85
45min11486087-148608799.034100.141.1499.64100.771.16
21521070-1521070101.366102.00
31506076-1506076100.366101.07
41486890-148689099.08899.68
51491784-149178499.414100.03
61523906-1523906101.555102.22
60min11481644-148164498.73899.921.2499.54100.761.25
21521771-1521771101.412102.25
31494543-149454399.598100.50
41484653-148465398.93999.73
51490191-149019199.308100.12
61523379-1523379101.519102.39
极限11493403-149340399.52299.741.09100.52100.771.10
21512432-1512432100.790101.83
31494940-149494099.624100.73
41479846-147984698.61899.61
51480148-148014898.63899.65
61518986-1518986101.227102.30
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100
标示量(mg)100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%
19.661437472143712914373901434240143836314369190.11
29.601431376143580314335900.22
单位质量响应值RSD%判断
148749.38149332.290.28数据可信
长期18月-供试品溶液-2023010711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%
5min1274983-27498318.37617.386.9018.3817.386.90
2286602-28660219.15319.15
3249348-24934816.66316.66
4242664-24266416.21716.22
5262831-26283117.56417.56
6244027-24402716.30816.31
10min1644557-64455743.07440.156.4543.1140.186.45
2653150-65315043.64843.69
3568410-56841037.98538.02
4562710-56271037.60537.64
5585820-58582039.14939.18
6590050-59005039.43239.46
15min1939786-93978662.80459.564.8562.9359.684.86
2948854-94885463.41063.54
3862406-86240657.63357.74
4842240-84224056.28556.39
5881452-88145258.90559.02
6872925-87292558.33558.45
20min11165928-116592877.91674.254.3278.1674.484.33
21174991-117499178.52278.77
31076482-107648271.93972.16
41059502-105950270.80471.02
51090893-109089372.90273.13
61098509-109850973.41173.64
30min11458755-145875597.48593.103.1697.8993.483.17
21436701-143670196.01196.42
31358667-135866790.79691.16
41352878-135287890.41090.77
51371304-137130491.64192.02
61380524-138052492.25792.63
45min11499391-1499391100.20198.971.13100.8099.541.13
21484517-148451799.20799.81
31493852-149385299.831100.38
41453752-145375297.15197.69
51483643-148364399.14899.71
61470507-147050798.27098.83
60min11503708-1503708100.48999.380.94101.29100.150.94
21478407-147840798.79899.60
31501428-1501428100.337101.09
41467889-146788998.09598.83
51489998-148999899.573100.33
61481115-148111598.97999.74
极限11505829-1505829100.63199.500.78101.63100.460.79
21488405-148840599.467100.46
31494155-149415599.851100.80
41474529-147452998.53999.47
51492457-149245799.737100.70
61477694-147769498.75199.70
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100
标示量(mg)100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%
19.662874436286825428673742868883286590328689700.12
29.602859017286297828609980.10
单位质量响应值RSD%判断
296994.82298020.620.25数据可信
长期18月-供试品溶液-2023010811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%
5min1558775-55877518.70719.171.9018.7119.171.90
2568671-56867119.03819.04
3580351-58035119.42919.43
4580433-58043319.43219.43
5562256-56225618.82318.82
6585019-58501919.58519.59
10min11199287-119928740.15040.591.1040.1940.631.10
21216110-121611040.71340.75
31215751-121575140.70140.74
41211561-121156140.56140.60
51197922-119792240.10440.14
61234129-123412941.31641.36
15min11702533-170253356.99857.810.9457.1257.930.93
21730939-173093957.94958.07
31741401-174140158.29958.42
41711126-171112657.28557.41
51735077-173507758.08758.21
61739412-173941258.23258.35
20min12136010-213601071.51071.842.4971.7472.072.48
22107494-210749470.55570.79
32252617-225261775.41475.65
42128313-212831371.25271.49
52121746-212174671.03271.27
62128319-212831971.25271.49
30min12658845-265884589.01387.881.3289.3988.261.32
22598807-259880787.00387.38
32644771-264477188.54288.93
42583936-258393686.50686.88
52600844-260084487.07287.45
62663539-266353989.17189.55
45min12901020-290102097.12194.692.7697.6795.242.75
22744969-274496991.89792.45
32826318-282631894.62095.18
42772655-277265592.82493.37
52782535-278253593.15493.70
62942233-294223398.50199.06
60min12864090-286409095.88594.551.6996.6395.301.69
22764379-276437992.54693.28
32874442-287444296.23196.99
42790424-279042493.41894.15
52790957-279095793.43694.17
62861595-286159595.80196.56
极限12904783-290478397.24796.961.3998.1997.891.39
22856670-285667095.63696.56
32924401-292440197.90498.85
42843585-284358595.19896.12
52897453-289745397.00297.92
62949844-294984498.75699.70
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100
标示量(mg)100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%
19.662876544286593428712852866404286994428700220.15
29.602861994285925728606260.07
单位质量响应值RSD%判断
297103.73297981.880.21数据可信
长期18月-供试品溶液-2023010811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%
5min1563362-56336218.85819.051.9418.8619.051.94
2552286-55228618.48718.49
3570268-57026819.08919.09
4577633-57763319.33619.34
5583678-58367819.53819.54
6567129-56712918.98418.98
10min11208553-120855340.45540.861.6640.4940.901.66
21192653-119265339.92339.96
31217029-121702940.73940.78
41235875-123587541.37041.41
51249973-124997341.84241.88
61219971-121997140.83840.88
15min11747955-174795558.51158.911.3958.6359.031.39
21732608-173260857.99858.11
31758324-175832458.85958.98
41780119-178011959.58859.71
51797194-179719460.16060.28
61743376-174337658.35858.48
20min12179660-217966072.96272.981.2773.2073.211.27
22144734-214473471.79372.03
32174054-217405472.77573.01
42213890-221389074.10874.35
52210064-221006473.98074.22
62158005-215800572.23872.47
30min12719034-271903491.01890.661.0491.4091.041.05
22691847-269184790.10890.48
32708315-270831590.65991.04
42748597-274859792.00792.40
52717227-271722790.95791.35
62665080-266508089.21289.59
45min12953984-295398498.88298.811.0899.4599.371.08
22940813-294081398.44299.00
32973711-297371199.543100.11
43000969-3000969100.455101.03
52926010-292601097.94698.52
62914836-291483697.57298.13
60min12962559-296255999.16999.211.1399.9399.971.12
22956132-295613298.95499.71
33007249-3007249100.665101.43
42997879-2997879100.352101.13
52930623-293062398.10098.87
62927524-292752497.99798.75
极限12962084-296208499.15499.081.00100.11100.041.00
22946181-294618198.62199.57
32992373-2992373100.167101.13
42997084-2997084100.325101.30
52936650-293665098.30299.27
62925761-292576197.93898.89
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