利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202303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%
111.724758004752154763214762764761874759600.10
211.674770524766604768560.06
单位质量响应值RSD%判断
40610.9240861.700.44数据可信
供试品溶液-2026030522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%
5min1162105-16210529.72630.984.1129.7330.984.11
2175299-17529932.14632.15
3165427-16542730.33530.34
4160783-16078329.48429.48
5173968-17396831.90231.90
6175945-17594532.26432.26
10min1198462-19846236.39337.533.1236.4637.603.12
2213358-21335839.12539.20
3202393-20239337.11437.18
4197944-19794436.29836.36
5204968-20496837.58637.66
6210832-21083238.66238.73
15min1220010-22001040.34540.611.4940.4940.761.50
2224356-22435641.14241.30
3217884-21788439.95540.10
4217717-21771739.92440.07
5224053-22405341.08641.24
6224688-22468841.20241.36
20min1230609-23060942.28842.610.9242.5242.860.92
2233645-23364542.84543.09
3229531-22953142.09142.33
4233875-23387542.88743.12
5231669-23166942.48342.73
6235002-23500243.09443.34
30min1246775-24677545.25345.381.5545.5845.721.55
2249658-24965845.78146.13
3241833-24183344.34644.68
4251393-25139346.10046.43
5244333-24433344.80545.14
6250791-25079145.98946.33
45min1253631-25363146.51046.840.5546.9447.280.56
2256578-25657847.05047.50
3254390-25439046.64947.08
4254652-25465246.69747.13
5257036-25703647.13447.57
6256453-25645347.02747.47
60min1262103-26210348.06347.730.4448.6048.280.44
2260503-26050347.77048.32
3259815-25981547.64448.18
4259767-25976747.63548.17
5258791-25879147.45648.00
6260859-26085947.83548.39
极限1265047-26504748.60348.670.5249.2449.310.51
2264719-26471948.54349.20
3265759-26575948.73449.37
4264520-26452048.50749.15
5267991-26799149.14349.79
6264286-26428648.46449.12
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202303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%
111.724762754760664757584764014751694759340.11
211.674763544761624762580.03
单位质量响应值RSD%判断
40608.7040810.450.36数据可信
供试品溶液-2026030522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%
5min1174424-17442432.00629.635.5732.0129.635.58
2150520-15052027.62027.62
3153971-15397128.25328.25
4160109-16010929.37929.38
5169059-16905931.02231.02
6160650-16065029.47929.48
10min1209134-20913438.37536.803.2338.4536.873.23
2195691-19569135.90935.97
3196498-19649836.05736.12
4196846-19684636.12036.19
5208598-20859838.27738.35
6196481-19648136.05336.12
15min1230942-23094242.37740.632.4642.5340.782.46
2216265-21626539.68439.82
3221252-22125240.59940.74
4215990-21599039.63339.78
5222195-22219540.77240.93
6221959-22195940.72940.87
20min1235301-23530143.17742.411.0943.4342.651.11
2228784-22878441.98142.21
3230638-23063842.32142.55
4229021-22902142.02442.26
5232901-23290142.73642.98
6230147-23014742.23142.47
30min1251324-25132446.11745.071.2646.4645.401.27
2243953-24395344.76445.09
3245465-24546545.04245.37
4242711-24271144.53744.86
5246443-24644345.22145.56
6243780-24378044.73345.06
45min1258259-25825947.38946.800.6747.8447.230.69
2254570-25457046.71347.13
3255000-25500046.79147.22
4253444-25344446.50646.93
5255035-25503546.79847.24
6253931-25393146.59547.02
60min1264387-26438748.51448.050.5849.0748.590.59
2261334-26133447.95448.48
3261443-26144347.97448.51
4262700-26270048.20448.73
5261291-26129147.94648.49
6259982-25998247.70648.24
极限1266553-26655348.91148.850.4149.5749.490.40
2265486-26548648.71649.35
3266604-26660448.92149.56
4265810-26581048.77549.41
5264847-26484748.59849.25
6267903-26790349.15949.80
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202303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%
111.724776474776094781794769084780034776690.11
211.674755394772314763850.26
单位质量响应值RSD%判断
40756.7440821.340.12数据可信
供试品溶液-2026031021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%
5min1153862-15386228.17828.353.9528.1828.363.95
2148634-14863427.22027.22
3152901-15290128.00228.00
4163429-16342929.93029.93
5160949-16094929.47629.48
6149164-14916427.31827.32
10min1192424-19242435.24035.031.6635.3035.091.66
2190887-19088734.95935.02
3189175-18917534.64534.71
4195688-19568835.83835.90
5192932-19293235.33335.40
6186582-18658234.17034.23
15min1215828-21582839.52639.711.3639.6739.851.34
2214848-21484839.34739.48
3218200-21820039.96140.10
4215423-21542339.45239.60
5214544-21454439.29139.44
6222225-22222540.69840.83
20min1225632-22563241.32242.002.1741.5542.222.16
2223431-22343140.91941.14
3231587-23158742.41242.64
4227116-22711641.59341.83
5230913-23091342.28942.52
6237225-23722543.44543.67
30min1240826-24082644.10444.012.0144.4244.332.00
2240056-24005643.96344.28
3237126-23712643.42743.75
4241763-24176344.27644.60
5233913-23391342.83843.16
6248237-24823745.46245.79
45min1251760-25176046.10746.420.7046.5346.840.70
2252243-25224346.19546.61
3253916-25391646.50246.92
4255213-25521346.73947.16
5255805-25580546.84847.27
6251855-25185546.12446.55
60min1259139-25913947.45847.921.0147.9848.451.01
2258900-25890047.41447.93
3266102-26610248.73349.26
4262548-26254848.08248.61
5261350-26135047.86348.39
6262087-26208747.99848.53
极限1264583-26458348.45548.690.3749.0849.320.36
2266555-26655548.81649.44
3266487-26648748.80449.43
4264700-26470048.47749.11
5266700-26670048.84349.47
6266128-26612848.73849.37
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202303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%
111.724758384759924760214763024769424762190.10
211.674747204755324751260.13
单位质量响应值RSD%判断
40633.0240713.450.14数据可信
供试品溶液-2026031021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%
5min1161124-16112429.59227.4324.4829.5927.4324.49
2167216-16721630.71130.71
3163326-16332629.99630.00
4160318-16031829.44429.44
575046-7504613.78313.78
6168990-16899031.03731.04
10min1196238-19623836.04134.935.5836.1135.005.61
2193518-19351835.54135.61
3198798-19879836.51136.58
4194479-19447935.71835.78
5169718-16971831.17031.20
6188499-18849934.62034.69
15min1217110-21711039.87438.844.0940.0238.984.12
2212051-21205138.94539.09
3220303-22030340.46140.61
4213986-21398639.30039.45
5195517-19551735.90836.01
6209846-20984638.54038.69
20min1226824-22682441.65841.053.2641.8941.273.30
2227912-22791241.85842.09
3228937-22893742.04642.28
4225743-22574341.46041.69
5209425-20942538.46338.64
6222164-22216440.80241.03
30min1246384-24638445.25143.953.1045.5844.273.13
2240107-24010744.09844.42
3243195-24319544.66545.00
4242131-24213144.47044.79
5225147-22514741.35041.62
6238915-23891543.87944.20
45min1254746-25474646.78646.172.7947.2146.592.82
2253306-25330646.52246.95
3255487-25548746.92247.35
4253681-25368146.59147.01
5237229-23722943.56943.93
6254007-25400746.65147.07
60min1261839-26183948.08947.622.0048.6248.142.04
2260338-26033847.81348.34
3262829-26282948.27148.81
4262215-26221548.15848.68
5249037-24903745.73846.19
6259616-25961647.68148.20
极限1271757-27175749.91148.812.5850.5549.432.61
2267947-26794749.21149.85
3268743-26874349.35750.00
4265407-26540748.74449.38
5252396-25239646.35546.91
6268195-26819549.25649.89
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202303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%
111.724753344747674757304754564757644754100.09
211.674770374780194775280.15
单位质量响应值RSD%判断
40563.9940919.280.62数据可信
供试品溶液-2026040221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%
5min1166756-16675630.57527.1327.3430.5827.1327.34
2161324-16132429.57929.58
3169868-16986831.14631.15
4163894-16389430.05130.05
565735-6573512.05312.05
6160220-16022029.37729.38
10min1202302-20230237.09335.206.8937.1635.266.92
2190789-19078934.98235.05
3205233-20523337.63037.70
4199826-19982636.63936.71
5170953-17095331.34531.37
6182750-18275033.50833.57
15min1218905-21890540.13739.253.5140.2939.393.54
2212893-21289339.03539.18
3220622-22062240.45240.60
4220858-22085840.49540.64
5202226-20222637.07937.18
6208836-20883638.29138.43
20min1229646-22964642.10741.053.1042.3541.273.14
2222156-22215640.73340.96
3230922-23092242.34042.58
4228297-22829741.85942.10
5213481-21348139.14339.32
6218661-21866140.09240.32
30min1241277-24127744.23943.482.8244.5743.792.86
2238032-23803243.64443.96
3241893-24189344.35244.69
4241882-24188244.35044.68
5224726-22472641.20441.47
6234879-23487943.06643.38
45min1252965-25296546.38245.832.8546.8146.242.88
2251472-25147246.10846.53
3252181-25218146.23846.67
4257506-25750647.21547.64
5236610-23661043.38343.74
6248960-24896045.64846.06
60min1259333-25933347.55046.812.5748.0847.332.61
2256156-25615646.96747.49
3261179-26117947.88848.43
4257614-25761447.23547.77
5242758-24275844.51144.96
6254859-25485946.72947.24
极限1260423-26042347.75047.421.7748.3948.041.82
2259854-25985447.64548.27
3260281-26028147.72448.37
4261982-26198248.03548.68
5249447-24944745.73746.29
6259725-25972547.62248.24
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202303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%
111.724841444834114845814849434856014845360.18
211.674885634831054858340.80
单位质量响应值RSD%判断
41342.6641631.020.50数据可信
供试品溶液-2026040221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%
5min1182674-18267432.89231.117.2832.8931.107.27
2162774-16277429.30929.31
3165683-16568329.83329.83
4163508-16350829.44129.44
5168288-16828830.30230.30
6193624-19362434.86434.86
10min1209876-20987637.79036.902.8037.8636.972.81
2197791-19779135.61435.68
3204275-20427536.78236.85
4201183-20118336.22536.29
5203052-20305236.56136.63
6213325-21332538.41138.49
15min1226151-22615140.72139.702.1640.8839.852.17
2215002-21500238.71338.86
3217620-21762039.18439.33
4217769-21776939.21139.36
5219875-21987539.59139.74
6226406-22640640.76640.93
20min1234603-23460342.24241.561.8342.4941.791.84
2225816-22581640.66040.89
3227905-22790541.03641.27
4228512-22851241.14641.38
5231075-23107541.60741.84
6236810-23681042.64042.89
30min1246492-24649244.38343.621.1144.7243.961.11
2238628-23862842.96743.29
3241935-24193543.56343.89
4242251-24225143.62043.94
5243753-24375343.89044.22
6240626-24062643.32743.68
45min1257771-25777146.41445.841.8146.8546.271.81
2249471-24947144.92045.34
3252146-25214645.40145.82
4253109-25310945.57546.00
5252877-25287745.53345.96
6262242-26224247.21947.66
60min1259342-25934246.69746.610.3347.2447.140.32
2258440-25844046.53547.05
3259016-25901646.63847.16
4258528-25852846.55047.07
5260135-26013546.84047.37
6257677-25767746.39746.95
极限1264165-26416547.56547.570.6848.2148.200.65
2265668-26566847.83648.46
3262542-26254247.27347.90
4266565-26656547.99748.62
5264300-26430047.59048.22
6261899-26189947.15747.81
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