利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号430060-202202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800
标示量(mg)15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%
112.724931764931854930924933404930044931590.03
212.654911174910754910960.01
单位质量响应值RSD%判断
38770.3638821.820.10数据可信
影响因素30天-供试品溶液-2024010711批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1149997-14999728.88129.183.4328.8829.183.43
2153650-15365029.58529.58
3146647-14664728.23628.24
4145280-14528027.97327.97
5155100-15510029.86429.86
6158755-15875530.56830.57
10min1191609-19160936.89337.331.4836.9437.381.49
2195329-19532937.61037.66
3192252-19225237.01737.06
4190391-19039136.65936.71
5195889-19588937.71737.77
6197749-19774938.07638.13
15min1212019-21201940.82341.151.0540.9341.261.05
2213833-21383341.17341.28
3212385-21238540.89441.00
4211394-21139440.70340.81
5215800-21580041.55141.66
6216978-21697841.77841.89
20min1223590-22359043.05143.460.8443.2343.630.85
2225785-22578543.47443.65
3224138-22413843.15743.33
4224858-22485843.29543.47
5227262-22726243.75843.94
6228492-22849243.99544.18
30min1238360-23836045.89546.230.7346.1446.480.74
2240015-24001546.21446.47
3238206-23820645.86546.11
4239776-23977646.16846.42
5241630-24163046.52546.78
6242532-24253246.69846.96
45min1249213-24921347.98548.290.6248.3148.620.62
2250005-25000548.13748.47
3249589-24958948.05748.38
4250724-25072448.27648.60
5252290-25229048.57748.91
6253059-25305948.72549.06
60min1255876-25587649.26849.490.4749.6749.900.47
2256512-25651249.39049.80
3255706-25570649.23549.64
4257341-25734149.55049.95
5258493-25849349.77250.18
6258226-25822649.72050.14
极限1263705-26370550.77550.570.4751.2651.060.47
2261179-26117950.28950.78
3261257-26125750.30450.79
4262347-26234750.51451.00
5263888-26388850.81051.31
6263460-26346050.72851.23
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号430060-202202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800
标示量(mg)15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%
112.724929624930774928134928554929524929320.03
212.654928604930104929350.03
单位质量响应值RSD%判断
38752.5238967.190.40数据可信
影响因素30天-供试品溶液-2024010711批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1147301-14730128.31626.913.8128.3226.913.81
2144839-14483927.84327.84
3135971-13597126.13826.14
4133736-13373625.70825.71
5137050-13705026.34526.35
6140937-14093727.09227.09
10min1190655-19065536.65035.711.9236.7035.761.92
2187516-18751636.04636.09
3184052-18405235.38035.42
4180387-18038734.67634.72
5184658-18465835.49735.54
6187477-18747736.03936.08
15min1212614-21261440.87140.151.4040.9840.251.40
2208314-20831440.04440.15
3207925-20792539.97040.07
4204177-20417739.24939.35
5208968-20896840.17040.27
6211116-21111640.58340.69
20min1225011-22501143.25442.841.0343.4343.011.04
2220873-22087342.45942.63
3223115-22311542.89043.06
4219414-21941442.17842.34
5223534-22353442.97043.14
6225162-22516243.28343.46
30min1240269-24026946.18745.930.9246.4446.180.92
2236108-23610845.38745.63
3239163-23916345.97446.22
4236395-23639545.44245.68
5240469-24046946.22646.47
6241198-24119846.36646.61
45min1251078-25107848.26548.160.7948.5948.480.79
2247100-24710047.50047.82
3250930-25093048.23648.55
4249497-24949747.96148.27
5252271-25227148.49448.81
6252273-25227348.49548.82
60min1257558-25755849.51149.390.6949.9249.800.70
2253968-25396848.82049.22
3257526-25752649.50449.90
4255828-25582849.17849.57
5258937-25893749.77650.18
6257885-25788549.57349.98
极限1261496-26149650.26850.230.5950.7650.710.59
2258894-25889449.76750.25
3261641-26164150.29550.78
4260126-26012650.00450.48
5262923-26292350.54251.02
6262672-26267250.49450.98
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号430060-202202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800
标示量(mg)15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%
112.724873264869274867674867284864604868420.07
212.654918884916154917520.04
单位质量响应值RSD%判断
38273.7438873.681.10数据可信
影响因素30天-供试品溶液-2024010711批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1143034-14303427.70126.783.7627.7026.783.76
2141955-14195527.49227.49
3135056-13505626.15626.16
4130904-13090425.35225.35
5135366-13536626.21626.22
6143322-14332227.75727.76
10min1186028-18602836.02735.602.0036.0735.652.00
2185506-18550635.92635.97
3182640-18264035.37135.41
4178101-17810134.49234.53
5182199-18219935.28635.33
6188604-18860436.52636.57
15min1208937-20893740.46440.081.6140.5740.191.60
2207285-20728540.14440.25
3206794-20679440.04940.15
4202144-20214439.14939.25
5204872-20487239.67739.78
6211791-21179141.01741.12
20min1223196-22319643.22642.821.3443.4042.991.34
2220319-22031942.66942.84
3220947-22094742.79042.96
4217075-21707542.04042.21
5219381-21938142.48742.66
6225539-22553943.67943.85
30min1238830-23883046.25345.881.2046.5046.121.20
2236057-23605745.71645.96
3237109-23710945.92046.16
4233239-23323945.17145.41
5234974-23497445.50745.75
6241206-24120646.71446.96
45min1249996-24999648.41648.190.8448.7448.510.84
2247621-24762147.95648.28
3249486-24948648.31748.63
4246686-24668647.77548.09
5247170-24717047.86948.18
6252117-25211748.82749.15
60min1255466-25546649.47549.360.7349.8849.760.73
2253883-25388349.16949.57
3255216-25521649.42749.82
4252841-25284148.96749.36
5253827-25382749.15849.55
6258107-25810749.98750.39
极限1261648-26164850.67350.360.7351.1650.840.73
2258821-25882150.12550.61
3260570-26057050.46450.94
4257563-25756349.88150.35
5258995-25899550.15950.64
6262523-26252350.84251.33
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