利伐沙班颗项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202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1000
标示量(mg)10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%
19.983257843261433260883261893262793260970.06
210.043265853262873264360.07
单位质量响应值RSD%判断
32675.0532513.550.36数据可信
长期6月-供试品溶液-2024010612批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1227738-22773862.63266.219.9862.6366.219.98
2248609-24860968.37268.37
3267695-26769573.62173.62
4200099-20009955.03155.03
5243220-24322066.89066.89
6257154-25715470.72270.72
10min1297752-29775281.88781.344.6182.0381.484.62
2296535-29653581.55381.70
3304963-30496383.87184.03
4268989-26898973.97774.10
5300438-30043882.62682.77
6305833-30583384.11084.27
15min1323675-32367589.01788.772.3689.3489.092.37
2325764-32576489.59189.92
3328791-32879190.42490.77
4307618-30761884.60184.89
5324966-32496689.37289.70
6325756-32575689.58989.93
20min1334333-33433391.94892.141.4292.4792.661.43
2335618-33561892.30192.83
3341433-34143393.90194.45
4326867-32686789.89590.37
5336817-33681792.63193.16
6335074-33507492.15292.69
30min1343162-34316294.37694.900.9395.1095.630.93
2343458-34345894.45895.19
3350780-35078096.47197.23
4345257-34525794.95295.63
5346011-34601195.16095.90
6341748-34174893.98794.74
45min1348725-34872595.90696.240.9796.8497.180.97
2347583-34758395.59296.54
3355981-35598197.90298.88
4351488-35148896.66697.55
5349087-34908796.00696.95
6346730-34673095.35796.31
60min1350791-35079196.47496.540.7697.6297.690.74
2349107-34910796.01197.17
3353818-35381897.30798.50
4353279-35327997.15898.26
5352202-35220296.86298.02
6346933-34693395.41396.58
极限1352216-35221696.86697.280.7598.2398.650.74
2354908-35490897.60698.98
3356152-35615297.94999.36
4355869-35586997.87199.19
5353879-35387997.32398.70
6349204-34920496.03897.42
利伐沙班颗项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202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1000
标示量(mg)10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%
19.983252723254083253293251713251043252570.04
210.043259623263313261460.09
单位质量响应值RSD%判断
32590.8832484.660.24数据可信
加速6月-供试品溶液-2024010612批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15031-50311.38645.2175.891.3945.2175.88
25287-52871.4571.46
3224807-22480761.93361.93
4256533-25653370.67470.67
5270958-27095874.64874.65
6221912-22191261.13661.14
10min1291506-29150680.30981.623.3180.3181.723.32
2300820-30082082.87582.88
3288521-28852179.48679.62
4304606-30460683.91884.07
5308462-30846284.98085.15
6283732-28373278.16778.30
15min1315431-31543186.90088.121.8087.0888.411.83
2321597-32159788.59988.79
3316934-31693487.31487.63
4323588-32358889.14789.49
5328509-32850990.50390.86
6313192-31319286.28386.59
20min1326270-32627089.88691.291.5590.2691.771.60
2330492-33049291.04991.43
3333021-33302191.74692.25
4334452-33445292.14092.68
5338779-33877993.33293.89
6325231-32523189.60090.10
30min1335517-33551792.43493.681.1693.0194.361.19
2341843-34184394.17694.76
3342996-34299694.49495.21
4341904-34190494.19394.94
5343423-34342394.61295.37
6334638-33463892.19192.89
45min1341288-34128894.02395.581.4094.8096.471.43
2348305-34830595.95796.75
3350055-35005596.43997.36
4347420-34742095.71396.67
5353350-35335097.34698.32
6341295-34129594.02594.93
60min1342772-34277294.43295.911.4395.4297.011.46
2349871-34987196.38897.40
3352250-35225097.04398.18
4349625-34962596.32097.49
5353067-35306797.26998.46
6341226-34122694.00695.12
极限1345055-34505595.06196.361.4296.2697.681.46
2348615-34861596.04297.27
3354486-35448697.65999.01
4351841-35184196.93198.31
5355292-35529297.88299.29
6343324-34332494.58495.91
利伐沙班颗项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202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1000
标示量(mg)10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%
19.984784034786024787774795884803674791470.18
210.044772704770674771680.04
单位质量响应值RSD%判断
48010.7247526.690.72数据可信
长期6月-供试品溶液-2024010911批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1318081-31808159.69160.472.5959.6960.482.59
2323277-32327760.66660.67
3326439-32643961.25961.26
4309075-30907558.00158.00
5322655-32265560.54960.55
6334011-33401162.68062.68
10min1388249-38824972.85874.012.2972.9974.142.29
2395234-39523474.16974.30
3391288-39128873.42973.56
4383524-38352471.97272.10
5398713-39871374.82274.96
6409227-40922776.79576.93
15min1420198-42019878.85479.822.1079.1580.122.10
2427662-42766280.25580.55
3419677-41967778.75679.06
4414547-41454777.79378.08
5430838-43083880.85181.15
6439037-43903782.38982.70
20min1440721-44072182.70583.332.0083.1883.812.00
2447755-44775584.02584.50
3435378-43537881.70382.18
4433737-43373781.39581.86
5450898-45089884.61585.10
6455818-45581885.53886.03
30min1461416-46141686.58986.881.8387.2487.541.83
2467397-46739787.71188.38
3454032-45403285.20385.86
4452515-45251584.91985.56
5468811-46881187.97788.65
6473546-47354688.86589.55
45min1472685-47268588.70489.441.8889.5590.301.88
2482818-48281890.60591.46
3467824-46782487.79188.64
4465832-46583287.41888.25
5484524-48452490.92591.79
6486100-48610091.22192.10
60min1482807-48280790.60390.831.8191.6591.881.81
2490295-49029592.00893.07
3476187-47618789.36190.40
4471573-47157388.49589.52
5489226-48922691.80892.87
6493909-49390992.68693.77
极限1488020-48802091.58191.911.6892.8393.161.68
2495818-49581893.04594.31
3483165-48316590.67091.91
4477784-47778489.66090.88
5494822-49482292.85894.13
6498946-49894693.63294.92
利伐沙班颗项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202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1000
标示量(mg)10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%
19.984788144784974795724790064788554789490.09
210.044794664792194793420.04
单位质量响应值RSD%判断
47990.8847743.230.37数据可信
加速6月-供试品溶液-2024010911批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
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