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430060-202202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%
110.53 3286163289073283843289423288033287300.08
210.573277153276953277050.01
单位质量响应值RSD%判断
31218.4231003.310.49数据可信
供试品溶液-2024010511批-pH4.5(内含0.2%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1242880-24288069.98278.617.3769.9878.617.38
2276668-27666879.71879.72
3291142-29114283.88883.89
4253924-25392473.16473.16
5291659-29165984.03784.04
6280619-28061980.85680.86
10min1308289-30828988.82993.352.7488.9893.522.76
2330375-33037595.19295.37
3330330-33033095.17995.37
4318569-31856991.79191.95
5327110-32711094.25294.44
6329214-32921494.85895.04
15min1333470-33347096.08498.341.7596.4498.721.76
2347779-347779100.207100.60
3343306-34330698.91899.32
4337907-33790797.36397.73
5337441-33744197.22897.62
6347916-347916100.247100.64
20min1339781-33978197.90399.541.8398.47100.141.84
2354128-354128102.036102.65
3346392-34639299.807100.43
4340260-34026098.04198.62
5340464-34046498.09998.71
6351683-351683101.332101.95
30min1343992-34399299.116100.361.5199.90101.181.52
2354931-354931102.268103.11
3348422-348422100.392101.23
4343546-34354698.98799.79
5344435-34443599.244100.07
6354444-354444102.127102.97
45min1344137-34413799.158100.591.40100.16101.631.40
2356116-356116102.609103.67
3349642-349642100.744101.81
4347322-347322100.075101.10
5344143-34414399.159100.21
6353196-353196101.768102.83
60min1344825-34482599.356100.761.60100.58102.031.61
2357341-357341102.962104.26
3351520-351520101.285102.57
4345712-34571299.611100.85
5344124-34412499.154100.43
6354606-354606102.174103.47
极限1349588-349588100.728100.572.22102.17102.062.20
2358890-358890103.409104.93
3355183-355183102.340103.85
4347788-347788100.210101.67
5346133-34613399.733101.22
6336585-33658596.98298.50
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430060-202202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%
110.53 3272603271433272183284073268483273750.19
210.573271443268353269900.07
单位质量响应值RSD%判断
31089.7430935.670.36数据可信
供试品溶液-2024010511批-pH4.5(内含0.2%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1207874-20787460.08567.7810.8760.0867.7810.87
2221179-22117963.93163.93
3233457-23345767.47967.48
4273965-27396579.18879.19
5255265-25526573.78373.78
6215273-21527362.22462.22
10min1274085-27408579.22382.786.1679.3682.926.17
2271893-27189378.58978.73
3286045-28604582.68082.83
4314962-31496291.03891.21
5299359-29935986.52886.69
6271915-27191578.59678.73
15min1295855-29585585.51588.553.6085.8288.883.61
2299543-29954386.58186.90
3307746-30774688.95289.29
4325177-32517793.99194.37
5311518-31151890.04390.40
6298254-29825486.20986.52
20min1304194-30419487.92690.722.6388.4391.252.65
2313196-31319690.52891.04
3314157-31415790.80591.34
4328376-32837694.91595.50
5315014-31501491.05391.61
6308142-30814289.06789.57
30min1307364-30736488.84291.812.4089.5492.552.42
2319554-31955492.36593.08
3317617-31761791.80592.54
4330176-33017695.43696.23
5318278-31827891.99792.76
6312842-31284290.42591.13
45min1308088-30808889.05192.042.4689.9492.982.48
2319584-31958492.37493.29
3318367-31836792.02292.96
4331446-33144695.80396.81
5319818-31981892.44293.40
6313262-31326290.54791.45
60min1308643-30864389.21291.382.6090.3092.522.62
2312443-31244390.31091.43
3316978-31697891.62192.76
4330516-33051695.53496.76
5319201-31920192.26393.43
6309144-30914489.35690.46
极限1335120-33512096.86597.361.0598.1598.701.08
2338298-33829897.78399.10
3336750-33675097.33698.68
4343115-34311599.176100.61
5333957-33395796.52897.90
6333826-33382696.49197.79
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