依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.851647951640891641921643281642991643410.17
29.911630951635841633400.22
单位质量响应值RSD%判断
16684.3716482.340.87数据可信
供试品溶液-2022091403批-依折麦布-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%
5min110492-104925.6765.667.625.685.667.61
211613-116136.2826.28
311185-111856.0506.05
49724-97245.2605.26
59666-96665.2295.23
610083-100835.4545.45
10min116943-169439.1658.623.139.208.663.13
215731-157318.5108.54
315671-156718.4778.51
415842-158428.5708.60
515638-156388.4598.49
615815-158158.5558.59
15min116001-160018.6568.720.598.748.800.57
216253-162538.7928.87
316132-161328.7268.81
416028-160288.6708.75
516175-161758.7508.83
616087-160878.7028.78
20min117755-177559.6048.913.859.739.043.79
216365-163658.8538.98
316120-161208.7208.85
416174-161748.7498.87
516161-161618.7428.87
616267-162678.8008.93
30min116017-160178.6648.641.358.858.821.33
216059-160598.6878.87
315960-159608.6338.81
415798-157988.5468.72
516314-163148.8259.00
615701-157018.4938.67
45min115734-157348.5118.734.518.748.964.44
217466-174669.4489.68
316034-160348.6738.90
415308-153088.2818.50
516266-162668.7999.02
616056-160568.6858.91
60min115967-159678.6378.581.938.928.861.86
215644-156448.4628.74
315972-159728.6408.91
415623-156238.4518.72
516378-163788.8609.13
615599-155998.4388.71
极限116066-160668.6918.581.679.028.901.64
215927-159278.6168.94
315633-156338.4578.78
415530-155308.4018.71
516218-162188.7739.09
615746-157468.5188.84
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.001580881576631577041578101577061577940.11
211.051571411576771574090.25
单位质量响应值RSD%判断
14344.9114245.160.50数据可信
供试品溶液-2022091403批-阿托伐他汀钙-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%
5min128939-2893916.72216.521.3616.7216.521.36
228932-2893216.71816.72
328519-2851916.47916.48
428758-2875816.61716.62
527920-2792016.13316.13
628428-2842816.42716.43
10min153006-5300630.62830.314.4130.7230.404.40
248777-4877728.18528.28
351973-5197330.03230.12
455958-5595832.33432.43
552088-5208830.09830.19
652929-5292930.58430.68
15min165851-6585138.05137.763.9138.3138.023.91
261457-6145735.51235.76
365901-6590138.08038.34
469342-6934240.06840.34
564377-6437737.19937.46
665204-6520437.67737.94
20min175399-7539943.56842.663.6144.0443.133.60
270208-7020840.56841.02
374442-7444243.01543.48
477725-7772544.91245.41
571820-7182041.50041.96
673344-7334442.38042.85
30min179422-7942245.89243.613.7346.6144.323.71
272074-7207441.64742.32
375691-7569143.73744.45
477905-7790545.01645.76
574643-7464343.13143.83
673093-7309342.23542.94
45min185116-8511649.18347.012.6250.1547.962.62
279484-7948445.92846.83
380968-8096846.78647.74
482432-8243247.63248.63
580447-8044746.48547.42
679649-7964946.02446.96
60min187976-8797650.83547.754.5752.0848.964.53
278573-7857345.40246.56
381105-8110546.86548.08
486694-8669450.09451.35
580872-8087246.73047.92
680552-8055246.54547.74
极限192312-9231253.34151.572.7654.8753.052.77
287602-8760250.61952.03
387476-8747650.54652.02
492532-9253253.46855.00
588012-8801250.85652.31
687591-8759150.61352.07
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.851645111640531642171643941643231643000.11
29.911644401653331648860.39
单位质量响应值RSD%判断
16680.2016638.350.18数据可信
供试品溶液-2022091403批-依折麦布-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%
5min110637-106375.7286.498.765.736.498.77
212127-121276.5306.53
312326-123266.6376.64
413459-134597.2477.25
511017-110175.9325.93
612707-127076.8426.84
10min116899-168999.0998.792.119.138.832.08
216266-162668.7598.79
315894-158948.5588.60
416393-163938.8278.87
516086-160868.6628.69
616418-164188.8408.88
15min115796-157968.5058.842.408.598.922.37
216584-165848.9309.01
316125-161258.6838.77
416553-165538.9139.00
516529-165298.9008.98
616908-169089.1049.19
20min116226-162268.7378.812.248.878.942.22
216725-167259.0069.14
316094-160948.6668.80
416563-165638.9189.06
515838-158388.5288.66
616722-167229.0049.14
30min116134-161348.6878.661.488.878.851.49
216025-160258.6298.81
315716-157168.4628.64
416362-163628.8109.00
515988-159888.6098.79
616315-163158.7858.97
45min115314-153148.2468.522.758.478.752.75
216122-161228.6818.91
315407-154078.2968.52
416156-161568.6998.94
515625-156258.4138.64
616344-163448.8019.04
60min115739-157398.4758.622.298.758.902.26
215830-158308.5248.80
315909-159098.5668.84
416223-162238.7359.02
515709-157098.4598.73
616656-166568.9699.25
极限116344-163448.8018.482.489.128.812.41
215671-156718.4388.77
315438-154388.3138.63
415994-159948.6128.95
515263-152638.2188.54
615806-158068.5118.85
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.001591551579661581051581611582711583320.30
211.051584601594611589600.45
单位质量响应值RSD%判断
14393.8214385.520.05数据可信
供试品溶液-2022091403批-阿托伐他汀钙-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%
5min128020-2802016.08416.726.2516.0816.726.26
229478-2947816.92116.92
326197-2619715.03815.04
429400-2940016.87616.88
531423-3142318.03818.04
630264-3026417.37217.37
10min148244-4824427.69327.596.3627.7827.686.36
247391-4739127.20427.30
342811-4281124.57524.66
448256-4825627.70027.79
552119-5211929.91830.02
649524-4952428.42828.52
15min156631-5663132.50733.817.5832.7534.067.57
257462-5746232.98533.23
351958-5195829.82530.05
460501-6050134.72934.98
564028-6402836.75437.02
662804-6280436.05136.31
20min162823-6282336.06237.446.9636.4937.886.95
263988-6398836.73137.16
357919-5791933.24733.63
467717-6771738.87139.31
569272-6927239.76440.23
669653-6965339.98240.44
30min163935-6393536.70038.428.2337.3239.068.21
265204-6520437.42938.06
358112-5811233.35833.93
470897-7089740.69741.35
572245-7224541.47042.16
671162-7116240.84941.53
45min165747-6574737.74041.2910.2538.5742.1410.18
270898-7089840.69741.54
360923-6092334.97135.73
478408-7840845.00845.89
577455-7745544.46145.38
678152-7815244.86145.76
60min167599-6759938.80341.6510.0639.8442.749.99
270279-7027940.34241.41
361487-6148735.29536.25
478858-7885845.26646.40
577743-7774344.62645.80
679428-7942845.59446.75
极限179266-7926645.50147.146.3646.7548.456.40
281919-8191947.02348.31
373191-7319142.01343.16
486638-8663849.73251.12
585828-8582849.26750.68
685845-8584549.27750.68
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