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%
110.123222293223523221113212853215333219020.15
210.123237103239613238360.06
单位质量响应值RSD%判断
31808.5031999.600.43数据可信
加速6月-供试品溶液-2023073011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%
5min1206349-20634957.97858.977.5557.9858.977.55
2186758-18675852.47352.47
3228723-22872364.26464.26
4197684-19768455.54355.54
5220520-22052061.95961.96
6219355-21935561.63261.63
10min1253338-25333871.18071.764.3071.3171.904.31
2239419-23941967.27067.39
3268809-26880975.52775.67
4249034-24903469.97170.09
5266480-26648074.87375.01
6255432-25543271.76971.91
15min1273519-27351976.85178.202.8377.1478.492.84
2266796-26679674.96275.23
3286040-28604080.36980.68
4275792-27579277.48977.77
5287455-28745580.76681.07
6280283-28028378.75179.05
20min1288135-28813580.95781.951.4681.4282.411.48
2285697-28569780.27280.70
3295446-29544683.01183.50
4290677-29067781.67282.12
5296531-29653183.31683.80
6293451-29345182.45182.92
30min1302306-30230684.93985.731.1985.5886.381.20
2304234-30423485.48186.09
3303608-30360885.30585.98
4302691-30269185.04785.68
5312057-31205787.67988.35
6305843-30584385.93386.59
45min1311808-31180887.60987.900.5588.4488.740.53
2315001-31500188.50689.31
3310270-31027087.17788.04
4312459-31245987.79288.61
5314077-31407788.24689.11
6313417-31341788.06188.91
60min1313323-31332388.03488.680.6789.0689.720.65
2319080-31908089.65290.65
3313877-31387788.19089.25
4314873-31487388.47089.49
5316626-31662688.96290.02
6316037-31603788.79789.84
极限1319608-31960889.80090.080.7591.0291.310.72
2324041-32404191.04692.24
3317031-31703189.07690.33
4320855-32085590.15191.36
5322110-32211090.50391.76
6320068-32006889.92991.17
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%
110.123229433222333217773220723212373220520.20
210.123253023238563245790.32
单位质量响应值RSD%判断
31823.3232073.020.56数据可信
长期6月-供试品溶液-2023073011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%
5min1223855-22385562.81060.608.1562.8160.608.15
2190911-19091153.56753.57
3199524-19952455.98355.98
4235577-23557766.09966.10
5215747-21574760.53560.54
6230235-23023564.60064.60
10min1256410-25641071.94472.643.9172.0872.773.91
2244612-24461268.63468.75
3253106-25310671.01771.14
4274054-27405476.89577.04
5260411-26041173.06773.20
6264733-26473374.28074.42
15min1282290-28229079.20679.002.0679.5179.302.07
2271023-27102376.04576.32
3281313-28131378.93279.21
4288700-28870081.00581.32
5283751-28375179.61679.91
6282318-28231879.21479.52
20min1291117-29111781.68382.401.3882.1682.871.39
2288702-28870281.00581.45
3290506-29050681.51181.97
4297215-29721583.39483.89
5298152-29815283.65784.13
6296378-29637883.15983.64
30min1303781-30378185.23685.920.8785.8986.580.85
2307053-30705386.15486.77
3306365-30636585.96186.60
4305506-30550685.72086.40
5310888-31088887.23087.89
6303820-30382085.24785.92
45min1311991-31199187.54087.980.8688.3988.820.85
2314228-31422888.16788.98
3314688-31468888.29689.13
4310924-31092487.24088.11
5318090-31809089.25190.10
6311415-31141587.37888.24
60min1314083-31408388.12788.640.8889.1789.680.86
2317659-31765989.13090.14
3317597-31759789.11390.14
4312049-31204987.55688.62
5319448-31944889.63290.68
6314719-31471988.30589.36
极限1319758-31975889.71990.340.5390.9691.580.52
2321896-32189690.31991.52
3323951-32395190.89592.12
4320654-32065489.97091.23
5323877-32387790.87592.13
6321709-32170990.26691.52
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%
110.123242743245003241393224603225983235940.31
210.123252753240763246760.27
单位质量响应值RSD%判断
31975.6932082.610.24数据可信
中间条件6月-供试品溶液-2023073011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%
5min1210102-21010258.80158.637.3958.8058.637.39
2224858-22485862.93162.93
3220674-22067461.76061.76
4209525-20952558.64058.64
5211044-21104459.06559.07
6180659-18065950.56150.56
10min1256545-25654571.79972.114.6771.9372.244.67
2273631-27363176.58176.72
3266194-26619474.50074.64
4254845-25484571.32471.45
5256749-25674971.85771.99
6238058-23805866.62566.74
15min1282278-28227879.00178.832.9679.2979.122.97
2294382-29438282.38982.70
3286207-28620780.10180.40
4278859-27885978.04578.33
5278754-27875478.01578.31
6269489-26948975.42275.68
20min1294199-29419982.33882.351.8182.8082.821.83
2303398-30339884.91285.41
3296706-29670683.03983.52
4291098-29109881.47081.93
5291922-29192281.70082.16
6288199-28819980.65881.09
30min1304120-30412085.11485.531.1985.7686.181.20
2312361-31236187.42188.10
3307167-30716785.96786.63
4302883-30288384.76885.41
5303244-30324484.86985.52
6303954-30395485.06885.68
45min1312714-31271487.52088.061.2488.3688.901.25
2318574-31857489.16090.04
3320176-32017689.60890.46
4310072-31007286.78087.61
5312578-31257887.48188.32
6313816-31381687.82888.62
60min1316252-31625288.51088.541.0189.5489.581.02
2322232-32223290.18391.26
3316445-31644588.56489.62
4312616-31261687.49288.52
5315622-31562288.33389.36
6315053-31505388.17489.17
极限1320301-32030189.64389.871.0890.8791.101.09
2326890-32689091.48792.76
3321170-32117089.88691.14
4316090-31609088.46489.68
5321299-32129989.92291.15
6320831-32083189.79190.98
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