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430060-202303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)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%
110.103193903196293193963192743190753193530.07
210.093188713182693185700.14
单位质量响应值RSD%判断
31619.1131572.840.11数据可信
供试品溶液-2024122521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%
5min172736-7273620.63622.209.6720.6422.209.66
287739-8773924.89224.89
372393-7239320.53820.54
479960-7996022.68522.69
570317-7031719.94919.95
686329-8632924.49224.49
10min1127261-12726136.10537.354.7436.1437.394.74
2141162-14116240.04940.09
3128658-12865836.50136.54
4131968-13196837.44037.48
5124433-12443335.30335.34
6136464-13646438.71638.76
15min1154852-15485243.93344.943.5444.0345.043.55
2167407-16740747.49547.60
3155751-15575144.18844.28
4159033-15903345.11945.22
5151677-15167743.03243.12
6161680-16168045.87045.98
20min1173847-17384749.32250.162.8249.4950.342.83
2184787-18478752.42552.61
3174507-17450749.50949.68
4176854-17685450.17550.35
5170826-17082648.46548.63
6180041-18004151.07951.26
30min1198996-19899656.45757.221.8956.7157.481.90
2207600-20760058.89859.17
3201637-20163757.20657.46
4201626-20162657.20357.46
5196553-19655355.76356.01
6203691-20369157.78958.06
45min1223934-22393463.53263.911.3263.8864.261.33
2229711-22971165.17165.54
3225923-22592364.09664.44
4224490-22449063.68964.04
5220831-22083162.65162.99
6226652-22665264.30364.67
60min1240082-24008268.11368.291.0368.5668.751.04
2243592-24359269.10969.59
3242097-24209768.68569.14
4241442-24144268.49968.96
5236339-23633967.05167.49
6240671-24067168.28068.75
极限1254393-25439372.17372.630.7672.7473.200.77
2258864-25886473.44274.04
3256568-25656872.79073.36
4256762-25676272.84573.42
5253367-25336771.88272.44
6256062-25606272.64773.23
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430060-202303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)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%
110.103190993188433190613190373187103189500.06
210.093182013182283182140.01
单位质量响应值RSD%判断
31579.2131537.560.10数据可信
供试品溶液-2024122521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%
5min1119503-11950333.94432.235.7633.9432.235.76
2120479-12047934.22134.22
3102673-10267329.16429.16
4110566-11056631.40631.41
5112663-11266332.00132.00
6115003-11500332.66632.67
10min1182630-18263051.87552.092.4251.9352.152.43
2188846-18884653.64153.70
3175980-17598049.98650.03
4182241-18224151.76551.82
5183927-18392752.24452.30
6186761-18676153.04953.10
15min1211571-21157160.09659.941.5360.2460.081.54
2214262-21426260.86061.01
3204861-20486158.19058.32
4212085-21208560.24260.38
5211010-21101059.93660.08
6212401-21240160.33160.47
20min1226019-22601964.20064.241.6464.4464.481.64
2230466-23046665.46365.71
3219374-21937462.31262.54
4227891-22789164.73164.97
5226715-22671564.39764.64
6226564-22656464.35464.60
30min1243052-24305269.03869.181.3769.3969.521.37
2247759-24775970.37570.73
3237604-23760467.49067.82
4244464-24446469.43969.79
5244414-24441469.42569.77
6243930-24393069.28769.64
45min1258015-25801573.28873.630.6673.7574.100.67
2261832-26183274.37274.85
3256950-25695072.98573.43
4260134-26013473.89074.35
5259614-25961473.74274.21
6258836-25883673.52173.99
60min1266366-26636675.66075.830.9776.2576.420.97
2269708-26970876.60977.21
3262590-26259074.58775.15
4268963-26896376.39876.98
5268092-26809276.15076.74
6266103-26610375.58576.17
极限1273572-27357277.70777.720.6578.4278.440.66
2274977-27497778.10678.83
3270731-27073176.90077.59
4274910-27491078.08778.80
5275163-27516378.15978.87
6272448-27244877.38878.10
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430060-202303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)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%
110.103193203187433190153194013200063192970.15
210.093181273177673179470.09
单位质量响应值RSD%判断
31613.5631511.100.23数据可信
供试品溶液-2024122521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%
5min181519-8151923.15224.648.1723.1524.648.18
275385-7538521.41021.41
389008-8900825.27925.28
492101-9210126.15826.16
594425-9442526.81826.82
688116-8811625.02625.03
10min1144958-14495841.17040.632.7341.2140.672.73
2136930-13693038.89038.93
3144902-14490241.15441.20
4143561-14356140.77340.82
5147815-14781541.98142.03
6140122-14012239.79639.84
15min1170694-17069448.47947.832.0448.5947.942.04
2164353-16435346.67846.78
3169259-16925948.07148.18
4168300-16830047.79947.91
5173192-17319249.18849.30
6164706-16470646.77846.89
20min1185597-18559752.71152.461.6152.9052.661.61
2180795-18079551.34851.53
3185818-18581852.77452.97
4185061-18506152.55952.75
5189078-18907853.70053.90
6182024-18202451.69751.88
30min1206414-20641458.62458.491.3158.9058.761.32
2202103-20210357.39957.66
3206346-20634658.60458.88
4206579-20657958.67158.95
5210072-21007259.66359.95
6204061-20406157.95558.23
45min1226505-22650564.33064.160.8464.7064.530.85
2223308-22330863.42263.78
3225673-22567364.09364.47
4225795-22579564.12864.50
5229072-22907265.05965.44
6225018-22501863.90764.28
60min1238623-23862367.77167.750.7768.2568.230.77
2235672-23567266.93367.40
3239016-23901667.88368.37
4239293-23929367.96268.45
5241082-24108268.47068.96
6237567-23756767.47167.95
极限1250902-25090271.25970.990.7371.8571.590.73
2247570-24757070.31270.89
3249352-24935270.81971.41
4250234-25023471.06971.67
5252825-25282571.80572.41
6248935-24893570.70071.29
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