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%
110.413287363279353277673279253280453280820.12
210.483319923320383320150.01
单位质量响应值RSD%判断
31516.0431680.820.37数据可信
供试品溶液-2024010511批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1128020-12802036.31836.875.2236.3236.875.22
2126929-12692936.00836.01
3124310-12431035.26535.27
4138474-13847439.28339.28
5123611-12361135.06735.07
6138473-13847339.28339.28
10min1173474-17347449.21249.580.9849.2949.660.99
2174389-17438949.47249.55
3173243-17324349.14749.23
4176953-17695350.19950.29
5173677-17367749.27049.35
6176878-17687850.17850.27
15min1198627-19862756.34856.000.8556.5456.190.85
2199090-19909056.47956.67
3195678-19567855.51155.70
4198060-19806056.18756.39
5194996-19499655.31855.51
6197885-19788556.13756.34
20min1213059-21305960.44260.000.8360.7660.310.83
2213943-21394360.69361.01
3209658-20965859.47759.79
4211236-21123659.92560.25
5209678-20967859.48359.79
6211331-21133159.95260.28
30min1230643-23064365.43064.850.9365.8865.300.93
2231659-23165965.71966.17
3226453-22645364.24264.68
4228394-22839464.79265.25
5226745-22674564.32564.77
6227653-22765364.58265.04
45min1242652-24265268.83768.890.7169.4369.480.71
2245964-24596469.77770.37
3240960-24096068.35768.94
4242334-24233468.74769.35
5243168-24316868.98469.57
6241849-24184968.60969.21
60min1251520-25152071.35371.330.6372.1072.080.62
2249664-24966470.82671.58
3254285-25428572.13772.88
4251030-25103071.21471.97
5250584-25058471.08771.83
6251653-25165371.39172.14
极限1258480-25848073.32772.840.6774.2373.740.66
2259383-25938373.58474.49
3255408-25540872.45673.35
4255818-25581872.57273.48
5255701-25570172.53973.44
6255797-25579772.56673.48
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%
110.413307063308893303863292983291693300900.25
210.483339223341733340480.06
单位质量响应值RSD%判断
31708.9331874.810.37数据可信
供试品溶液-2024010511批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1132446-13244637.34536.167.2537.3436.167.24
2141694-14169439.95239.95
3125940-12594035.51035.51
4115158-11515832.47032.47
5121972-12197234.39134.39
6132347-13234737.31737.32
10min1169038-16903847.66248.343.1447.7548.423.14
2179430-17943050.59250.68
3163526-16352646.10846.19
4174617-17461749.23549.31
5170029-17002947.94248.02
6172083-17208348.52148.60
15min1197633-19763355.72554.751.1355.9154.941.13
2194246-19424654.77054.97
3191051-19105153.86954.05
4192925-19292554.39754.58
5194851-19485154.94055.12
6194382-19438254.80855.00
20min1209037-20903758.94057.075.0459.2557.385.02
2212053-21205359.79160.11
3186103-18610352.47452.77
4209883-20988359.17959.48
5202720-20272057.15957.46
6194678-19467854.89255.20
30min1229779-22977964.78963.293.1865.2363.733.17
2225830-22583063.67564.13
3210326-21032659.30459.72
4228058-22805864.30364.74
5227772-22777264.22364.65
6225079-22507963.46363.90
45min1240873-24087367.91767.232.5768.5067.812.57
2241592-24159268.11968.72
3226165-22616563.77064.32
4239853-23985367.62968.21
5242577-24257768.39768.97
6239638-23963867.56968.14
60min1246337-24633769.45769.242.7670.2069.972.75
2245625-24562569.25770.01
3232425-23242565.53566.23
4251319-25131970.86271.59
5248586-24858670.09270.82
6249114-24911470.24070.97
极限1245169-24516969.12870.353.3970.0271.233.33
2234235-23423566.04566.95
3252247-25224771.12471.96
4256199-25619972.23873.12
5254895-25489571.87072.75
6254296-25429671.70172.58
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%
110.413297403297443295743289313294493294880.11
210.483295233292273293750.07
单位质量响应值RSD%判断
31651.1031428.910.50数据可信
供试品溶液-2024010611批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1137952-13795239.20837.2512.2139.2137.2512.21
2140339-14033939.88639.89
3135465-13546538.50138.50
498596-9859628.02228.02
5137767-13776739.15539.16
6136315-13631538.74338.74
10min1179982-17998251.15351.580.4651.2451.660.45
2182476-18247651.86251.95
3181586-18158651.60951.69
4181634-18163451.62351.69
5181422-18142251.56351.65
6181740-18174051.65351.74
15min1204138-20413858.01958.220.4958.2258.420.50
2204169-20416958.02858.23
3206578-20657858.71258.91
4204020-20402057.98558.16
5205443-20544358.39058.59
6204741-20474158.19058.39
20min1217577-21757761.83862.240.7762.1762.570.77
2217733-21773361.88362.22
3221873-22187363.05963.39
4217801-21780161.90262.21
5219352-21935262.34362.67
6219703-21970362.44362.77
30min1238135-23813567.68167.430.9368.1567.900.93
2241050-24105068.51068.98
3235730-23573066.99867.47
4235527-23552766.94067.38
5235391-23539166.90167.37
6237694-23769467.55668.02
45min1249840-24984071.00871.410.7671.6372.020.75
2250116-25011671.08671.71
3254333-25433372.28572.90
4249986-24998671.05071.64
5252874-25287471.87072.49
6250314-25031471.14371.76
60min1258144-25814473.36873.540.2574.1474.310.26
2258997-25899773.61174.39
3259850-25985073.85374.63
4258200-25820073.38474.13
5258846-25884673.56874.35
6258442-25844273.45374.23
极限1263316-26331674.83875.320.4575.7876.260.44
2264174-26417475.08276.03
3266657-26665775.78876.73
4264913-26491375.29276.21
5265742-26574275.52876.47
6265293-26529375.40076.34
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%
110.413298913310223308593307223308703306730.14
210.483349683344543347110.11
单位质量响应值RSD%判断
31764.9431938.070.39数据可信
供试品溶液-2024010611批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1126658-12665835.64637.366.0035.6537.366.00
2128269-12826936.09936.10
3122902-12290234.58934.59
4137727-13772738.76138.76
5143499-14349940.38540.39
6137486-13748638.69338.69
10min1173915-17391548.94549.982.4349.0250.062.43
2179236-17923650.44350.52
3173064-17306448.70648.78
4177232-17723249.87949.97
5185026-18502652.07252.16
6176996-17699649.81349.90
15min1198153-19815355.76756.392.9655.9556.582.96
2205715-20571557.89558.09
3194404-19440454.71254.90
4197084-19708455.46655.66
5209591-20959158.98659.19
6197228-19722855.50655.70
20min1213243-21324360.01460.312.5560.3360.632.55
2219380-21938061.74162.06
3209166-20916658.86659.17
4210988-21098859.37959.70
5222650-22265062.66163.00
6210434-21043459.22359.54
30min1230428-23042864.85064.992.4165.3065.452.41
2236170-23617066.46666.92
3225038-22503863.33363.77
4227804-22780464.11264.56
5239108-23910867.29367.77
6227097-22709763.91364.36
45min1242027-24202768.11468.822.3068.7069.422.30
2250514-25051470.50371.11
3239584-23958467.42768.01
4241550-24155067.98068.57
5252810-25281071.14971.77
6240798-24079867.76968.36
60min1250326-25032670.45071.371.6871.1972.121.69
2257914-25791472.58673.35
3253768-25376871.41972.15
4250165-25016570.40571.15
5259502-25950273.03273.82
6249817-24981770.30771.05
极限1257235-25723572.39472.782.1473.2973.692.14
2264567-26456774.45875.38
3253730-25373071.40872.29
4256006-25600672.04972.95
5266387-26638774.97075.92
6253701-25370171.40072.30
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