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%
115.344910474905024905394907904904364906630.06
215.224911004909254910120.03
单位质量响应值RSD%判断
31985.8532260.970.61数据可信
供试品溶液-1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%
5min1107077-10707719.92018.734.1719.9218.734.17
2100094-10009418.62118.62
397594-9759418.15618.16
4101199-10119918.82718.83
5102956-10295619.15419.15
695046-9504617.68217.68
10min1166770-16677031.02530.471.2631.0630.501.26
2163154-16315430.35330.38
3162777-16277730.28230.31
4165268-16526830.74630.78
5160854-16085429.92529.96
6163966-16396630.50430.53
15min1196883-19688336.62736.461.5436.7136.541.53
2194684-19468436.21836.30
3195798-19579836.42536.51
4197816-19781636.80136.88
5190999-19099935.53335.61
6199770-19977037.16437.24
20min1217676-21767640.49640.481.3940.6440.621.39
2216885-21688540.34840.49
3217817-21781740.52240.66
4219618-21961840.85741.00
5212318-21231839.49939.64
6221189-22118941.14941.29
30min1244006-24400645.39445.561.2045.6145.771.20
2244396-24439645.46645.68
3245946-24594645.75545.96
4247083-24708345.96646.18
5239786-23978644.60944.82
6248048-24804846.14646.36
45min1267973-26797349.85350.091.0650.1450.381.06
2268743-26874349.99650.28
3272120-27212050.62450.91
4270896-27089650.39650.69
5264460-26446049.19949.48
6271374-27137450.48550.77
60min1283621-28362152.76452.800.8053.1453.170.80
2283311-28331152.70653.07
3286561-28656153.31153.68
4284566-28456652.94053.31
5279824-27982452.05752.42
6285000-28500053.02053.39
极限1295910-29591055.05055.070.5755.5155.520.57
2296543-29654355.16855.62
3297067-29706755.26555.72
4295718-29571855.01455.48
5292950-29295054.49954.95
6297797-29779755.40155.86
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%
115.344915394910414912754903404902454908880.12
215.224912674910464911560.04
单位质量响应值RSD%判断
32000.5232270.430.60数据可信
供试品溶液-1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%
5min1186492-18649234.68133.292.5534.6833.282.55
2176637-17663732.84832.85
3173557-17355732.27632.28
4176176-17617632.76332.76
5180637-18063733.59233.59
6180431-18043133.55433.55
10min1239968-23996844.62644.510.8044.6844.570.80
2241931-24193144.99145.05
3237357-23735744.14044.19
4238715-23871544.39344.45
5240881-24088144.79644.85
6237288-23728844.12744.18
15min1262825-26282548.87749.030.5549.0149.160.54
2265175-26517549.31449.44
3264703-26470349.22649.35
4264229-26422949.13849.27
5263780-26378049.05449.18
6261263-26126348.58648.72
20min1276489-27648951.41851.570.5451.6351.780.53
2278951-27895151.87552.09
3277757-27775751.65351.86
4278705-27870551.83052.04
5276892-27689251.49251.70
6275033-27503351.14751.36
30min1289570-28957053.85054.290.7054.1554.590.70
2293661-29366154.61154.91
3292596-29259654.41354.71
4294663-29466354.79755.09
5291138-29113854.14254.44
6290012-29001253.93254.23
45min1300369-30036955.85856.541.1656.2556.921.15
2304635-30463556.65257.04
3308518-30851857.37457.76
4307598-30759857.20357.59
5302466-30246656.24856.64
6300478-30047855.87956.26
60min1306714-30671457.03857.460.5857.5257.940.57
2310323-31032357.71058.19
3310410-31041057.72658.21
4310749-31074957.78958.27
5308363-30836357.34557.83
6307214-30721457.13157.61
极限1309783-30978357.60958.250.7158.1958.830.70
2313901-31390158.37558.95
3315454-31545458.66459.24
4315564-31556458.68459.26
5312538-31253858.12158.70
6312234-31223458.06558.64
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%
115.344883654886844890144890024889774888080.06
215.224937604936654937120.02
单位质量响应值RSD%判断
31864.9332438.371.27数据可信
供试品溶液-1批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1145685-14568527.08127.385.2527.0827.385.24
2151042-15104228.07628.08
3155598-15559828.92328.92
4140662-14066226.14726.15
5136430-13643025.36025.36
6154413-15441328.70328.70
10min1186527-18652734.67234.881.5434.7234.931.54
2188792-18879235.09335.14
3192332-19233235.75135.80
4185635-18563534.50734.55
5184164-18416434.23334.28
6188525-18852535.04435.09
15min1209069-20906938.86339.161.1238.9739.261.12
2211404-21140439.29739.40
3215064-21506439.97740.08
4209076-20907638.86438.96
5209062-20906238.86138.96
6210334-21033439.09839.20
20min1225096-22509641.84242.130.8442.0142.300.84
2227552-22755242.29842.47
3230072-23007242.76742.94
4225293-22529341.87842.04
5226190-22619042.04542.21
6225780-22578041.96942.14
30min1245324-24532445.60245.900.7245.8446.140.72
2247257-24725745.96146.20
3250174-25017446.50346.75
4246567-24656745.83346.07
5246698-24669845.85746.09
6245520-24552045.63845.88
45min1261783-26178348.66149.020.5548.9749.330.56
2263646-26364649.00849.33
3266183-26618349.47949.80
4264014-26401449.07649.39
5263526-26352648.98549.30
6263017-26301748.89149.21
60min1271229-27122950.41750.720.4550.8151.120.46
2272922-27292250.73251.13
3274962-27496251.11151.52
4272917-27291750.73151.12
5272924-27292450.73251.12
6272215-27221550.60051.00
极限1279453-27945351.94652.230.4052.4252.710.41
2280914-28091452.21752.70
3282797-28279752.56753.06
4281496-28149652.32652.80
5280586-28058652.15652.63
6280637-28063752.16652.65
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%
115.344924194920874924844919114922864922370.05
215.224987404982544984970.07
单位质量响应值RSD%判断
32088.4632752.761.45数据可信
供试品溶液-1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%
5min1282271-28227152.03656.728.6852.0456.728.68
2304219-30421956.08256.08
3330116-33011660.85660.86
4295689-29568954.50954.51
5349228-34922864.37964.38
6284616-28461652.46852.47
10min1419619-41961977.35580.243.2877.4480.333.29
2429355-42935579.15079.24
3436501-43650180.46780.57
4449186-44918682.80682.90
5454584-45458483.80183.91
6422230-42223077.83777.92
15min1453738-45373883.64585.741.8483.8685.961.85
2459230-45923084.65784.88
3468486-46848686.36486.60
4466374-46637485.97486.20
5478810-47881088.26788.51
6463904-46390485.51985.74
20min1462314-46231485.22687.942.0285.5888.322.03
2470947-47094786.81787.18
3482037-48203788.86289.24
4479227-47922788.34488.72
5490366-49036690.39790.79
6477468-47746888.02088.38
30min1479039-47903988.30990.351.5988.8190.861.59
2484443-48444389.30589.82
3493669-49366991.00691.53
4491540-49154090.61491.13
5501546-50154692.45893.00
6490340-49034090.39290.90
45min1486627-48662789.70891.801.5590.3592.471.56
2494013-49401391.07091.73
3501349-50134992.42293.10
4498929-49892991.97692.65
5509754-50975493.97194.67
6497151-49715191.64892.31
60min1489710-48971090.27692.221.5391.0793.041.55
2495798-49579891.39992.21
3504013-50401392.91393.75
4500901-50090192.33993.16
5512298-51229894.44095.30
6498769-49876991.94692.76
极限1496873-49687391.59793.621.4292.5494.591.43
2507128-50712893.48794.45
3511900-51190094.36795.36
4511087-51108794.21795.19
5517127-51712795.33196.34
6502960-50296092.71993.68
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