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DSMF-387-240606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(%)99.75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%
110.051773841777701783171785271786941781380.31
210.091776061782911779480.28
单位质量响应值RSD%判断
17725.1717636.080.36数据可信
供试品溶液-X007293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%
5min110303-103035.2315.433.345.235.443.31
210611-106115.3885.39
310912-109125.5415.54
411313-113135.7445.74
510528-105285.3465.35
610549-105495.3565.36
10min116586-165868.4228.412.218.458.442.23
216469-164698.3628.39
317210-172108.7398.77
416564-165648.4118.44
516411-164118.3338.36
616098-160988.1748.20
15min117031-170318.6488.591.838.728.661.84
216824-168248.5438.62
317345-173458.8078.89
417041-170418.6538.73
516417-164178.3368.41
616831-168318.5468.62
20min117148-171488.7078.592.258.838.722.24
216775-167758.5188.64
317427-174278.8498.98
417088-170888.6778.80
516343-163438.2988.42
616753-167538.5078.63
30min116138-161388.1948.512.308.378.682.26
216524-165248.3908.56
317095-170958.6808.86
417182-171828.7248.90
516773-167738.5178.69
616822-168228.5428.71
45min116699-166998.4798.451.948.708.661.94
216352-163528.3038.52
317184-171848.7258.95
416772-167728.5168.74
516422-164228.3388.55
616373-163738.3148.53
60min116102-161028.1768.282.578.448.542.53
215869-158698.0588.32
316691-166918.4758.75
416728-167288.4948.76
515820-158208.0338.29
616584-165848.4218.68
极限116633-166338.4468.491.828.768.811.80
216521-165218.3898.70
317331-173318.8009.12
416613-166138.4358.75
516543-165438.4008.71
616717-167178.4888.80
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%
111.041534651539551542411543111545391541020.27
211.071536941542621539780.27
单位质量响应值RSD%判断
13958.5113909.490.25数据可信
供试品溶液-X007293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%
5min133874-3387420.08019.019.4720.0819.019.47
229433-2943317.44817.45
333526-3352619.87419.87
433059-3305919.59719.60
527294-2729416.18016.18
635222-3522220.87920.88
10min172736-7273643.11836.5111.7543.2336.6211.74
257849-5784934.29334.39
364534-6453438.25638.37
458271-5827134.54334.65
551795-5179530.70430.79
664370-6437038.15838.27
15min189852-8985253.26444.9611.8253.6245.2711.81
270641-7064141.87642.16
377695-7769546.05746.38
472973-7297343.25843.56
563717-6371737.77138.03
680224-8022447.55747.88
20min197332-9733257.69849.1011.4758.3549.6611.47
278179-7817946.34446.86
386024-8602450.99551.57
479849-7984947.33447.88
569168-6916841.00341.47
686451-8645151.24851.84
30min189051-8905152.78947.838.1953.7648.668.24
277825-7782546.13446.91
383079-8307949.24950.11
479608-7960847.19148.00
569869-6986941.41842.12
684684-8468450.20051.08
45min191343-9134354.14849.297.7955.4150.387.84
281386-8138648.24549.28
387229-8722951.70952.84
480407-8040747.66548.73
572744-7274443.12244.05
685746-8574650.83051.99
60min186514-8651451.28548.107.5752.8549.487.62
278481-7848146.52347.83
385402-8540250.62652.05
480055-8005547.45648.79
570596-7059641.84943.02
685829-8582950.87952.32
极限195316-9531656.50353.375.7958.3555.015.89
286908-8690851.51953.08
395239-9523956.45758.16
487236-8723651.71353.31
582604-8260448.96750.37
692865-9286555.05056.77
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DSMF-387-240606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(%)99.75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%
110.051752331757031757481759181757901756780.15
210.091744981747881746430.12
单位质量响应值RSD%判断
17480.4017308.520.70数据可信
供试品溶液-X007293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%
5min111019-110195.6875.206.095.695.206.11
210391-103915.3635.36
310172-101725.2505.25
49750-97505.0325.03
59205-92054.7514.75
69930-99305.1255.13
10min116946-169468.7468.552.278.788.582.30
216634-166348.5858.62
316792-167928.6678.70
416617-166178.5768.60
516521-165218.5278.55
615860-158608.1868.21
15min117213-172138.8848.891.668.968.971.62
217179-171798.8678.94
317250-172508.9038.98
417765-177659.1699.24
516998-169988.7738.85
616982-169828.7658.84
20min117294-172948.9268.980.939.069.110.90
217694-176949.1329.26
317280-172808.9199.05
417415-174158.9889.11
517272-172728.9159.04
617428-174288.9959.12
30min117450-174509.0068.811.869.198.991.87
217207-172078.8819.06
316947-169478.7478.92
417303-173038.9319.11
516960-169608.7538.93
616561-165618.5488.72
45min116881-168818.7138.811.828.949.041.77
216786-167868.6648.89
316793-167938.6678.89
417431-174318.9979.22
517466-174669.0159.24
617102-171028.8279.05
60min116874-168748.7098.732.158.999.002.11
217261-172618.9099.18
316679-166798.6088.88
417325-173258.9429.22
516942-169428.7449.01
616355-163558.4418.71
极限116951-169518.7498.811.869.079.141.83
217585-175859.0769.40
317165-171658.8599.18
417232-172328.8949.22
516746-167468.6438.96
616778-167788.6608.98
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%
111.041510011515191515351515571515491514320.16
211.071503511505271504390.09
单位质量响应值RSD%判断
13716.6713589.790.66数据可信
供试品溶液-X007293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%
5min131320-3132018.94917.6317.9518.9517.6317.95
228028-2802816.95716.96
335166-3516621.27521.28
433907-3390720.51420.51
522312-2231213.49913.50
624128-2412814.59714.60
10min156656-5665634.27733.458.6034.3833.558.63
253018-5301832.07632.17
363256-6325638.27038.39
457000-5700034.48534.60
551630-5163031.23631.31
650171-5017130.35330.43
15min171669-7166943.36042.637.1043.6642.927.13
266279-6627940.09940.37
377562-7756246.92547.26
474678-7467845.18045.49
565014-6501439.33339.58
667606-6760640.90241.15
20min179355-7935548.01047.676.0148.5548.206.04
275466-7546645.65746.15
385241-8524151.57152.16
483151-8315150.30650.86
572810-7281044.05044.52
676774-7677446.44846.93
30min184934-8493451.38550.606.2252.1951.396.25
280801-8080148.88449.63
390219-9021954.58255.46
488010-8801053.24654.08
575866-7586645.89946.61
682012-8201249.61750.35
45min179509-7950948.10348.917.3349.1949.987.31
277778-7777847.05648.08
386117-8611752.10153.28
489607-8960754.21255.34
573458-7345844.44245.41
678616-7861647.56348.57
60min180743-8074348.84949.556.1450.2150.896.16
281100-8110049.06550.35
386914-8691452.58354.05
488030-8803053.25854.69
574188-7418844.88446.10
680414-8041448.65049.93
极限189607-8960754.21254.174.3255.8455.784.39
289015-8901553.85455.41
394127-9412756.94758.71
492468-9246855.94357.67
582850-8285050.12451.59
689166-8916653.94555.49
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