利伐沙班口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号430060-202202对照品来源中检所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)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%
115.024781514783504780624779414782474781500.04
215.044757794759894758840.04
单位质量响应值RSD%判断
31834.2231641.220.43数据可信
供试品溶液-2024122921批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1105382-10538219.84320.584.9519.8420.584.95
2104903-10490319.75319.75
3106669-10666920.08520.09
4118575-11857522.32722.33
5113052-11305221.28721.29
6107254-10725420.19520.20
10min1164717-16471731.01531.421.6531.0531.461.65
2164032-16403230.88630.92
3165179-16517931.10231.14
4171113-17111332.22032.26
5168764-16876431.77731.81
6167423-16742331.52531.56
15min1197750-19775037.23537.481.1437.3237.561.15
2196711-19671137.04037.12
3197696-19769637.22537.31
4202695-20269538.16638.26
5200793-20079337.80837.90
6198592-19859237.39437.48
20min1218260-21826041.09741.590.9241.2441.740.93
2219052-21905241.24641.39
3220301-22030141.48241.63
4223477-22347742.08042.23
5222379-22237941.87342.02
6221888-22188841.78041.93
30min1246507-24650746.41646.980.8246.6347.200.82
2247546-24754646.61246.83
3249795-24979547.03547.25
4251546-25154647.36547.59
5250478-25047847.16447.39
6251179-25117947.29647.51
45min1269736-26973650.79051.580.9451.0851.880.95
2272343-27234351.28151.57
3274010-27401051.59551.89
4276881-27688152.13552.44
5275517-27551751.87852.18
6275213-27521351.82152.12
60min1285055-28505553.67454.460.9254.0554.840.92
2287863-28786354.20354.58
3291613-29161354.90955.29
4292141-29214155.00955.40
5290146-29014654.63355.02
6288603-28860354.34354.73
极限1294867-29486755.52256.270.7855.9956.740.78
2299855-29985556.46156.93
3299014-29901456.30356.78
4301932-30193256.85257.33
5299079-29907956.31556.79
6298267-29826756.16256.64
利伐沙班口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号430060-202202对照品来源中检所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)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%
115.024770624766124772534771154775294771140.08
215.044791154790874791010.01
单位质量响应值RSD%判断
31765.2531855.120.20数据可信
供试品溶液-2024122921批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1132890-13289024.96521.6210.2224.9721.6210.23
2104770-10477019.68319.68
3101897-10189719.14319.14
4110758-11075820.80820.81
5116617-11661721.90821.91
6123603-12360323.22123.22
10min1182234-18223434.23531.915.1934.2831.955.20
2163561-16356130.72730.76
3158388-15838829.75629.79
4167154-16715431.40231.44
5170534-17053432.03732.07
6177354-17735433.31933.36
15min1210010-21001039.45337.803.0139.5537.893.01
2197017-19701737.01337.10
3194658-19465836.56936.65
4198017-19801737.20037.29
5200622-20062237.69037.78
6207028-20702838.89338.99
20min1227798-22779842.79541.642.1542.9641.792.16
2220128-22012841.35441.50
3215761-21576140.53440.68
4218435-21843541.03641.19
5220864-22086441.49341.65
6226877-22687742.62242.78
30min1254399-25439947.79346.891.2648.0347.111.27
2250197-25019747.00347.22
3247158-24715846.43246.64
4246428-24642846.29546.51
5247528-24752846.50246.72
6251862-25186247.31647.55
45min1276830-27683052.00751.420.7352.3251.720.73
2274768-27476851.61951.91
3274117-27411751.49751.78
4271250-27125050.95851.25
5272656-27265651.22251.52
6272545-27254551.20251.51
60min1289085-28908554.30954.020.6154.7154.410.60
2289049-28904954.30254.68
3288922-28892254.27854.65
4287267-28726753.96754.35
5286031-28603153.73554.12
6285080-28508053.55653.95
极限1297542-29754255.89855.830.5556.3956.310.53
2298324-29832456.04556.51
3298557-29855756.08856.55
4298018-29801855.98756.46
5296468-29646855.69656.17
6294278-29427855.28455.77
利伐沙班口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号430060-202202对照品来源中检所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)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%
115.024771344775074760534788004777014774390.21
215.044765084759034762060.09
单位质量响应值RSD%判断
31786.8831662.630.28数据可信
供试品溶液-2024122921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%
5min1193085-19308536.37234.676.0836.3734.676.08
2193571-19357136.46336.46
3194116-19411636.56636.57
4180593-18059334.01834.02
5174538-17453832.87832.88
6168296-16829631.70231.70
10min1242532-24253245.68645.042.1245.7545.102.12
2241849-24184945.55745.62
3246167-24616746.37146.43
4234871-23487144.24344.30
5234444-23444444.16244.22
6234746-23474644.21944.27
15min1266159-26615950.13749.571.3950.2749.701.40
2263566-26356649.64849.78
3268591-26859150.59550.73
4260474-26047449.06649.20
5259128-25912848.81248.94
6260983-26098349.16249.29
20min1278416-27841652.44552.121.0152.6752.331.02
2277881-27788152.34552.56
3280638-28063852.86453.09
4273055-27305551.43651.65
5274809-27480951.76651.98
6275213-27521351.84252.05
30min1293907-29390755.36454.930.8255.6755.240.83
2293136-29313655.21855.52
3294187-29418755.41655.73
4289388-28938854.51254.81
5289024-28902454.44454.74
6290089-29008954.64454.94
45min1304198-30419857.30256.930.6157.7057.320.62
2302785-30278557.03657.43
3304460-30446057.35157.75
4300455-30045556.59756.99
5300426-30042656.59256.98
6301052-30105256.70957.10
60min1309374-30937458.27758.020.7058.7758.510.71
2309365-30936558.27558.77
3310529-31052958.49558.99
4307292-30729257.88558.37
5304679-30467957.39357.87
6306837-30683757.79958.28
极限1315313-31531359.39659.120.5559.9959.700.56
2314696-31469659.28059.87
3315357-31535759.40460.00
4314215-31421559.18959.77
5312067-31206758.78459.36
6311324-31132458.64459.22
利伐沙班口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号430060-202202对照品来源中检所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)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%
115.024725184746844725104743364738174735730.22
215.044826124838264832190.18
单位质量响应值RSD%判断
31529.4932128.921.34数据可信
供试品溶液-2024122921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%
5min1214953-21495340.36136.647.0440.3636.647.05
2186319-18631934.98534.98
3205764-20576438.63638.64
4199227-19922737.40937.41
5180195-18019533.83533.83
6184228-18422834.59234.59
10min1259658-25965848.75646.413.2248.8246.473.23
2241424-24142445.33245.39
3252695-25269547.44847.51
4246866-24686646.35446.42
5237667-23766744.62644.68
6244672-24467245.94246.00
15min1276154-27615451.85350.372.1252.0050.502.12
2267572-26757250.24250.38
3271907-27190751.05651.20
4269628-26962850.62850.77
5260371-26037148.89049.02
6263760-26376049.52649.66
20min1285643-28564353.63552.521.4453.8752.741.45
2277637-27763752.13252.35
3283173-28317353.17153.40
4279584-27958452.49752.72
5274973-27497351.63151.84
6277129-27712952.03652.25
30min1296156-29615655.60955.020.8755.9355.330.88
2292623-29262354.94555.25
3295971-29597155.57455.89
4292397-29239754.90355.21
5290291-29029154.50854.81
6290616-29061654.56954.87
45min1304935-30493557.25756.761.0557.6757.161.06
2302648-30264856.82857.22
3305909-30590957.44057.85
4301962-30196256.69957.10
5301278-30127856.57156.96
6296904-29690455.74956.14
60min1310193-31019358.24557.870.7558.7658.370.76
2308873-30887357.99758.49
3311004-31100458.39758.90
4307925-30792557.81958.32
5306413-30641357.53558.02
6304869-30486957.24557.73
极限1312739-31273958.72358.660.4959.3359.250.49
2311914-31191458.56859.16
3314205-31420558.99859.60
4311290-31129058.45159.04
5313833-31383358.92859.51
6310288-31028858.26258.85
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