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%
19.961520755151788615167811518556152226815192490.15
29.921521877151734915196130.22
单位质量响应值RSD%判断
152535.04153186.790.31数据可信
中间条件24月-供试品溶液-2023010511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%
5min1289689-28968918.87518.102.8718.8818.102.87
2279052-27905218.18218.18
3267787-26778717.44817.45
4273511-27351117.82117.82
5272994-27299417.78817.79
6283448-28344818.46918.47
10min1591171-59117138.51939.232.1038.5639.272.11
2594063-59406338.70838.74
3588674-58867438.35738.39
4609302-60930239.70139.74
5608831-60883139.67039.71
6620478-62047840.42940.47
15min1938781-93878161.16958.113.5161.2858.223.50
2859559-85955956.00756.12
3861119-86111956.10856.22
4877132-87713257.15257.27
5906134-90613459.04159.16
6908367-90836759.18759.30
20min11203629-120362978.42674.455.4278.6674.685.41
21076417-107641770.13770.36
31086271-108627170.77971.00
41098532-109853271.57871.81
51183902-118390277.14077.37
61207354-120735478.66878.90
30min11420991-142099192.58891.331.9492.9891.721.94
21359022-135902288.55188.92
31380361-138036189.94190.31
41402705-140270591.39791.77
51429338-142933893.13293.52
61418048-141804892.39792.79
45min11488752-148875297.00397.050.7197.5897.620.71
21469752-146975295.76596.31
31499449-149944997.70098.25
41496565-149656597.51398.07
51490997-149099797.15097.72
61491439-149143997.17997.76
60min11490565-149056597.12297.000.6897.8997.760.68
21469566-146956695.75396.49
31497755-149775597.59098.33
41496153-149615397.48698.24
51489207-148920797.03397.80
61489318-148931897.04097.81
极限11495708-149570897.45796.691.0898.4297.641.08
21463123-146312395.33496.26
31481235-148123596.51497.45
41485635-148563596.80097.75
51471038-147103895.84996.81
61506892-150689298.18599.15
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%
19.961520985151735215229271520095151840515199530.15
29.921512824151652715146760.18
单位质量响应值RSD%判断
152605.72152689.110.04数据可信
中间条件24月-供试品溶液-2023010511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%
5min1269703-26970317.59818.909.1917.6018.909.19
2270784-27078417.66817.67
3276796-27679618.06018.06
4317394-31739420.70920.71
5273482-27348217.84417.84
6329529-32952921.50121.50
10min1583849-58384938.09540.836.6138.1340.876.61
2599949-59994939.14639.18
3617999-61799940.32340.36
4700359-70035945.69745.74
5610615-61061539.84239.88
6642098-64209841.89641.94
15min1864347-86434756.39759.546.8256.5159.666.82
2885401-88540157.77157.88
3904852-90485259.04059.16
41024713-102471366.86166.99
5857920-85792055.97856.09
6938009-93800961.20461.33
20min11122111-112211173.21675.425.4273.4475.655.42
21112873-111287372.61372.84
31198796-119879678.22078.45
41253095-125309581.76282.03
51083767-108376770.71470.94
61164257-116425775.96676.22
30min11376950-137695089.84492.113.0190.2192.503.02
21394003-139400390.95691.33
31416552-141655292.42892.82
41471441-147144196.00996.44
51362186-136218688.88089.25
61449415-144941594.57294.97
45min11516974-151697498.98097.741.4999.5398.321.49
21494251-149425197.49798.05
31492775-149277597.40197.98
41504742-150474298.18298.80
51458909-145890995.19195.74
61520333-152033399.19999.79
60min11519717-151971799.15997.751.5099.9198.521.50
21492058-149205897.35498.11
31486107-148610796.96697.74
41509332-150933298.48299.30
51462431-146243195.42196.16
61519331-151933199.13499.92
极限11519570-151957099.15098.541.01100.1099.501.00
21523441-152344199.402100.35
31507509-150750998.36399.33
41507135-150713598.33899.35
51482773-148277396.74997.68
61520696-152069699.223100.21
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%
19.961516279151784915154011513551151382715153810.12
29.921508503150872115086120.02
单位质量响应值RSD%判断
152146.69152077.820.04数据可信
中间条件24月-供试品溶液-2023010611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%
5min1261192-26119217.10218.0311.4617.1018.0311.46
2246053-24605316.11116.11
3335977-33597721.99922.00
4274709-27470917.98717.99
5260042-26004217.02717.03
6273940-27394017.93717.94
10min1623072-62307240.79743.124.4540.8343.164.45
2622261-62226140.74440.78
3685605-68560544.89244.94
4685933-68593344.91344.95
5661021-66102143.28243.32
6673352-67335244.09044.13
15min1919263-91926360.19160.804.6460.3160.934.64
2881597-88159757.72557.84
3992698-99269865.00065.13
4964004-96400463.12163.25
5925423-92542360.59560.72
6888691-88869158.19058.31
20min11139013-113901374.58075.833.8374.8276.083.84
21121464-112146473.43173.66
31236852-123685280.98781.25
41182588-118258877.43377.69
51124406-112440673.62473.87
61144234-114423474.92275.16
30min11426990-142699093.43692.402.5993.8292.792.59
21390772-139077291.06591.44
31465464-146546495.95696.38
41408906-140890692.25292.66
51418063-141806392.85293.24
61356669-135666988.83289.22
45min11511008-151100898.93898.260.5799.5198.840.58
21502135-150213598.35798.91
31506391-150639198.63599.25
41497536-149753698.05698.65
51500885-150088598.27598.85
61486052-148605297.30497.87
60min11505431-150543198.57398.500.2699.3499.280.28
21503396-150339698.43999.19
31511488-151148898.96999.78
41503144-150314498.42399.21
51502793-150279398.40099.17
61499920-149992098.21298.97
极限11457283-145728395.42097.071.1996.3998.041.18
21468689-146868996.16797.12
31477134-147713496.72097.73
41493367-149336797.78398.77
51501930-150193098.34399.31
61496222-149622297.97098.93
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%
19.961510267151116615103111510402151205615108400.06
29.921519302152036715198340.05
单位质量响应值RSD%判断
151690.76153209.070.71数据可信
中间条件24月-供试品溶液-2023010611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%
5min1343236-34323622.42522.302.3422.4322.302.35
2346506-34650622.63922.64
3351660-35166022.97622.98
4333925-33392521.81721.82
5330221-33022121.57521.57
6342202-34220222.35822.36
10min1689885-68988545.07344.252.9745.1244.302.97
2703243-70324345.94645.99
3687711-68771144.93144.98
4674339-67433944.05844.10
5652587-65258742.63642.68
6655908-65590842.85342.90
15min1970522-97052263.40961.623.6163.5461.753.61
2977772-97777263.88264.02
3968989-96898963.30863.44
4933315-93331560.97861.11
5901809-90180958.91959.05
6906168-90616859.20459.33
20min11182385-118238577.25175.303.1777.5175.553.17
21165450-116545076.14476.41
31195475-119547578.10678.37
41146840-114684074.92875.18
51096381-109638171.63271.88
61128396-112839673.72373.97
30min11390988-139098890.88090.752.1891.3091.162.18
21397727-139772791.32091.74
31442023-144202394.21494.63
41376775-137677589.95190.35
51352870-135287088.38988.78
61373688-137368889.74990.15
45min11448166-144816694.61595.211.5795.2195.801.57
21461353-146135395.47796.08
31498142-149814297.88098.49
41452864-145286494.92295.51
51429193-142919393.37693.94
61454266-145426695.01495.59
60min11447476-144747694.57095.191.8095.3695.971.80
21461546-146154695.48996.28
31506076-150607698.39999.20
41452300-145230094.88595.66
51430648-143064893.47194.22
61444043-144404394.34695.11
极限11448022-144802294.60695.371.8595.5896.341.85
21462388-146238895.54496.53
31510266-151026698.67399.67
41458214-145821495.27296.23
51431629-143162993.53594.47
61447983-144798394.60395.56
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%
19.961511791150973415119891510042151241315111940.09
29.921514264151537015148170.06
单位质量响应值RSD%判断
151726.31152703.330.46数据可信
中间条件24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%
5min1247282-24728216.18119.1112.9616.1819.1012.96
2310016-31001620.28620.29
3356749-35674923.34423.34
4271002-27100217.73317.73
5278282-27828218.20918.21
6288509-28850918.87818.88
10min1551905-55190536.11440.209.3336.1540.249.33
2600516-60051639.29439.34
3721624-72162447.21947.27
4587644-58764438.45238.49
5605490-60549039.62039.66
6619190-61919040.51640.55
15min1823322-82332253.87459.587.4953.9859.707.50
2934207-93420761.12961.25
31023158-102315866.95067.09
4866551-86655156.70256.81
5892942-89294258.42958.54
6922929-92292960.39160.51
20min11032796-103279667.58174.116.6367.7974.346.64
21176553-117655376.98777.23
31251625-125162581.89982.17
41093661-109366171.56371.79
51108428-110842872.52972.76
61132286-113228674.09174.33
30min11348968-134896888.26992.623.3688.6293.013.37
21446308-144630894.63895.03
31481386-148138696.93497.37
41377749-137774990.15290.52
51413088-141308892.46592.84
61425572-142557293.28293.67
45min11482822-148282297.02898.781.0197.5599.351.02
21528386-1528386100.009100.59
31506735-150673598.59299.23
41517903-151790399.32399.87
51513011-151301199.00399.57
61508476-150847698.70699.28
60min11485288-148528897.18998.720.9397.9199.490.93
21516880-151688099.256100.04
31500319-150031998.17399.00
41522799-152279999.644100.39
51518155-151815599.340100.10
61508445-150844598.70499.48
极限11489165-148916597.44398.840.8998.3699.810.89
21519317-151931799.416100.40
31499040-149904098.08999.12
41523195-152319599.670100.62
51514678-151467899.112100.07
61517823-151782399.318100.29
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%
19.961518518152138615190811521594152008715201330.09
29.921521491151795915197250.17
单位质量响应值RSD%判断
152623.80153198.080.27数据可信
中间条件24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%
5min1301082-30108219.61119.3112.0019.6119.3112.01
2256077-25607716.68016.68
3356268-35626823.20623.21
4272772-27277217.76717.77
5279942-27994218.23418.23
6312515-31251520.35620.36
10min1596313-59631338.84240.049.7338.8840.089.72
2553568-55356836.05736.09
3623164-62316440.59140.64
4723564-72356447.13047.17
5571961-57196137.25537.29
6620142-62014240.39440.43
15min1990164-99016464.49659.708.8764.6159.828.86
2827541-82754153.90354.01
3905749-90574958.99759.12
41025182-102518266.77666.91
5828791-82879153.98454.10
6921614-92161460.03060.15
20min11198325-119832578.05473.957.5678.3074.197.56
21036381-103638167.50667.72
31136174-113617474.00674.25
41259140-125914082.01682.28
51047735-104773568.24568.46
61134579-113457973.90274.14
30min11471864-147186495.87291.614.8496.2791.994.85
21338320-133832087.17387.52
31372524-137252489.40189.79
41492838-149283897.23897.67
51334846-133484686.94787.30
61427892-142789293.00793.40
45min11511278-151127898.43997.241.5699.0397.801.57
21505545-150554598.06598.59
31477316-147731696.22796.80
41500664-150066497.74898.37
51452463-145246394.60895.14
61509504-150950498.32398.90
60min11509056-150905698.29497.341.4599.0898.101.46
21497157-149715797.51998.24
31463453-146345395.32496.09
41512119-151211998.49499.31
51471885-147188595.87396.59
61512449-151244998.51599.29
极限11509855-150985598.34697.801.1799.3398.761.17
21518342-151834298.89999.81
31486279-148627996.81197.77
41512051-151205198.48999.50
51473627-147362795.98696.90
61508609-150860998.26599.23
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