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%
110.032983697298424129776732978626298445229817380.12
29.992941626294300529423160.04
单位质量响应值RSD%判断
297281.95294526.130.66数据可信
中间条件24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%
5min1664085-66408522.35322.801.8322.3522.801.83
2669906-66990622.54922.55
3699127-69912723.53323.53
4683447-68344723.00523.01
5673312-67331222.66422.66
6675075-67507522.72322.72
10min11339980-133998045.10446.142.7345.1546.182.72
21318925-131892544.39544.44
31424049-142404947.93447.98
41391135-139113546.82646.87
51378723-137872346.40846.45
61370848-137084846.14346.19
15min11873339-187333963.05764.872.1863.1965.012.18
21917632-191763264.54864.68
31994574-199457467.13867.28
41950729-195072965.66265.80
51926562-192656264.84964.99
61901200-190120063.99564.13
20min12283741-228374176.87178.851.8977.1379.121.89
22342287-234228778.84279.11
32401181-240118180.82481.10
42385842-238584280.30880.58
52317642-231764278.01378.28
62324617-232461778.24778.51
30min12792326-279232693.99194.761.0194.4195.191.01
22828606-282860695.21295.63
32841419-284141995.64396.08
42835808-283580895.45495.89
52769358-276935893.21793.64
62824043-282404395.05895.48
45min12926315-292631598.50198.740.5599.1099.350.55
22926624-292662498.51199.12
32939695-293969598.95199.58
42937452-293745298.87599.50
52911822-291182298.01398.62
62958709-295870999.591100.20
60min12932109-293210998.69699.110.6299.5099.920.62
22958829-295882999.595100.40
32955375-295537599.479100.31
42935921-293592198.82499.64
52918760-291876098.24699.05
62965072-296507299.805100.62
极限12921549-292154998.34099.180.8199.34100.200.81
22973628-2973628100.093101.10
32945674-294567499.152100.18
42930515-293051598.64299.66
52930812-293081298.65299.65
62977718-2977718100.231101.24
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%
110.032976324297754129742922969486296977029734830.13
29.992981317298057629809460.02
单位质量响应值RSD%判断
296458.92298392.990.46数据可信
中间条件24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%
5min1643881-64388121.56222.713.7621.5622.713.77
2680680-68068022.79422.79
3677835-67783522.69922.70
4721655-72165524.16724.17
5680014-68001422.77222.77
6665449-66544922.28422.28
10min11334957-133495744.70547.653.7344.7547.703.73
21400657-140065746.90546.95
31432613-143261347.97548.02
41449420-144942048.53848.59
51426244-142624447.76247.81
61493563-149356350.01650.06
15min11878722-187872262.91465.572.0163.0565.712.01
21966105-196610565.84065.98
31978361-197836166.25166.39
41966260-196626065.84565.99
51979921-197992166.30366.44
61978252-197825266.24766.39
20min12303680-230368077.14579.631.8177.4079.901.81
22385861-238586179.89780.17
32392270-239227080.11280.39
42355811-235581178.89179.17
52423582-242358281.16081.43
62406702-240670280.59580.87
30min12814737-281473794.25994.900.7294.6795.340.72
22840801-284080195.13295.56
32843855-284385595.23495.67
42813625-281362594.22294.66
52865944-286594495.97496.41
62825111-282511194.60695.04
45min12958479-295847999.07398.950.4899.6799.580.48
22966323-296632399.33599.96
32967604-296760499.378100.00
42929880-292988098.11598.74
52959175-295917599.09699.72
62948201-294820198.72899.36
60min12941958-294195898.51998.510.7499.3299.330.73
22935830-293583098.31499.13
32961325-296132599.16899.99
42924483-292448397.93498.75
52971629-297162999.513100.34
62915042-291504297.61898.44
极限12947747-294774798.71398.690.6699.7199.700.65
22964465-296446599.273100.29
32965060-296506099.293100.31
42914880-291488097.61398.63
52954319-295431998.93399.96
62935216-293521698.29499.31
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%
110.032958474295950129607142960800296359629606170.07
29.992974270297009329721820.10
单位质量响应值RSD%判断
295176.17297515.720.56数据可信
中间条件24月-供试品溶液-2023011011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%
5min1735371-73537124.71622.964.3024.7222.964.31
2682087-68208722.92522.92
3673129-67312922.62422.62
4670853-67085322.54722.55
5690692-69069223.21423.21
6647520-64752021.76321.76
10min11459257-145925749.04546.963.1049.0947.003.10
21414209-141420947.53147.58
31394636-139463646.87446.92
41370007-137000746.04646.09
51412084-141208447.46047.51
61332256-133225644.77744.82
15min11985359-198535966.72865.922.2566.8866.062.25
22016340-201634067.76967.91
31986100-198610066.75366.89
41944422-194442265.35265.49
51945297-194529765.38165.52
61890956-189095663.55563.69
20min12394166-239416680.46879.682.2880.7579.952.28
22450511-245051182.36182.64
32400526-240052680.68180.95
42342675-234267578.73779.00
52332703-233270378.40278.67
62304027-230402777.43877.70
30min12822854-282285494.87695.221.1395.3295.651.13
22867209-286720996.36796.81
32866731-286673196.35196.78
42845317-284531795.63196.06
52792481-279248193.85594.28
62803562-280356294.22794.64
45min12924239-292423998.28399.321.1598.9299.951.14
22987577-2987577100.412101.05
32980175-2980175100.163100.79
42979043-2979043100.125100.74
52904837-290483797.63198.25
62955456-295545699.33399.94
60min12929266-292926698.45299.201.0499.28100.021.03
22971771-297177199.881100.72
32981516-2981516100.208101.04
42969712-296971299.812100.63
52901657-290165797.52498.34
62954912-295491299.314100.12
极限12924850-292485098.30499.020.8199.33100.040.81
22967338-296733899.732100.77
32961253-296125399.527100.55
42956925-295692599.382100.40
52908574-290857497.75798.76
62958074-295807499.421100.42
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%
110.032976246297341329718152970424297079829725390.08
29.992968033296753029677820.02
单位质量响应值RSD%判断
296364.81297075.280.17数据可信
中间条件24月-供试品溶液-2023011011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%
5min1659308-65930822.13123.023.9822.1323.023.98
2689587-68958723.14723.15
3672557-67255722.57622.58
4673657-67365722.61322.61
5682317-68231722.90322.90
6737447-73744724.75424.75
10min11326926-132692644.54146.983.6244.5947.033.61
21415602-141560247.51847.56
31373588-137358846.10746.15
41387540-138754046.57646.62
51416944-141694447.56347.61
61477796-147779649.60549.65
15min11882308-188230863.18465.822.3563.3265.962.35
21949158-194915865.42765.57
31951341-195134165.50165.64
41974229-197422966.26966.41
52015228-201522867.64567.79
61993049-199304966.90167.05
20min12307379-230737977.45279.722.2077.7179.992.20
22337750-233775078.47178.74
32351829-235182978.94479.21
42397245-239724580.46880.74
52450620-245062082.26082.54
62405076-240507680.73181.01
30min12803015-280301594.08995.441.3394.5095.871.33
22793892-279389293.78394.21
32858065-285806595.93796.36
42871029-287102996.37296.80
52888019-288801996.94297.38
62845167-284516795.50495.95
45min12962214-296221499.43399.531.05100.04100.161.05
22906332-290633297.55798.17
32981236-2981236100.071100.69
42985065-2985065100.200100.82
52990502-2990502100.382101.02
62965881-296588199.556100.19
60min12951121-295112199.06099.691.2299.86100.511.21
22930789-293078998.37899.19
32985814-2985814100.225101.04
43022206-3022206101.447102.27
52992711-2992711100.456101.29
62936618-293661898.57499.41
极限12950881-295088199.05299.191.07100.05100.201.07
22907445-290744597.59498.60
32975376-297537699.875100.89
42974316-297431699.839100.87
52990751-2990751100.391101.43
62930270-293027098.36099.39
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%
110.032967908297036629691172967349296785629685190.05
29.992967362296758729674740.01
单位质量响应值RSD%判断
295964.01297044.440.26数据可信
中间条件24月-供试品溶液-2023011111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%
5min1669735-66973522.49722.773.5122.5022.773.51
2657888-65788822.09922.10
3644655-64465521.65521.65
4698440-69844023.46223.46
5698418-69841823.46123.46
6698079-69807923.45023.45
10min11355739-135573945.54146.203.6645.5946.243.66
21324693-132469344.49844.54
31315201-131520144.18044.22
41410446-141044647.37947.43
51435845-143584548.23248.28
61409321-140932147.34147.39
15min11893855-189385563.61864.423.6863.7564.563.68
21830112-183011261.47661.61
31845686-184568661.99962.13
41974378-197437866.32266.46
51985429-198542966.69466.84
61977430-197743066.42566.57
20min12328432-232843278.21678.653.3178.4878.923.31
22253362-225336275.69475.95
32252688-225268875.67175.93
42435700-243570081.81982.09
52370345-237034579.62479.90
62408287-240828780.89881.17
30min12820803-282080394.75594.412.4295.1794.832.42
22750195-275019592.38392.79
32716165-271616591.24091.65
42903594-290359497.53697.97
52848968-284896895.70196.14
62822914-282291494.82695.26
45min12942042-294204298.82898.492.0099.4499.102.01
22889407-288940797.06097.65
32858427-285842796.01996.61
43019080-3019080101.416102.05
52973597-297359799.888100.52
62909466-290946697.73398.36
60min12932903-293290398.52198.481.8699.3399.291.86
22891509-289150997.13097.92
32869049-286904996.37697.16
43027074-3027074101.684102.52
52940247-294024798.76799.59
62929036-292903698.39199.21
极限12932117-293211798.49498.641.9199.5099.651.91
22900502-290050297.43298.41
32879721-287972196.73497.71
43039481-3039481102.101103.14
52949177-294917799.067100.09
62917730-291773098.01199.03
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%
110.032964150296450429644782965815296576929649430.03
29.992986142298401329850780.06
单位质量响应值RSD%判断
295607.48298806.610.77数据可信
中间条件24月-供试品溶液-2023011111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%
5min1703946-70394623.59122.803.6423.5922.803.64
2699642-69964223.44723.45
3699924-69992423.45723.46
4645960-64596021.64821.65
5656961-65696122.01722.02
6675942-67594222.65322.65
10min11402778-140277847.01146.103.4947.0646.153.49
21438853-143885348.22048.27
31405562-140556247.10547.15
41318187-131818744.17644.22
51327425-132742544.48644.53
61361214-136121445.61845.66
15min11970361-197036166.03364.353.5066.1764.493.50
21989021-198902166.65866.80
31972753-197275366.11366.25
41850825-185082562.02762.16
51833441-183344161.44461.58
61905276-190527663.85163.99
20min12403611-240361180.55278.443.3480.8378.703.34
22376822-237682279.65479.93
32428553-242855381.38881.66
42268572-226857276.02776.28
52230069-223006974.73674.99
62335580-233558078.27278.54
30min12821119-282111994.54494.651.6994.9895.081.70
22823636-282363694.62895.06
32900996-290099697.22197.66
42828465-282846594.79095.20
52750356-275035692.17392.58
62821594-282159494.56094.98
45min12924242-292424298.00098.321.9098.6298.941.90
22943040-294304098.63099.26
33025734-3025734101.401102.03
42866791-286679196.07596.67
52889364-288936496.83197.42
62953937-295393798.99599.61
60min12910833-291083397.55198.221.8798.3799.031.87
22939908-293990898.52599.35
33026383-3026383101.423102.26
42871557-287155796.23497.02
52890510-289051096.87097.65
62945338-294533898.70799.51
极限12919654-291965497.84698.311.9498.8699.321.94
22944885-294488598.69299.71
33036130-3036130101.750102.79
42883732-288373296.64297.62
52881072-288107296.55397.53
62936023-293602398.39599.40
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