依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)0
对照品批号RSF-703-230318-D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(%)98.9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0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.539752097426975279757197542975170.06
211.639752597503975140.02
单位质量响应值RSD%判断
8457.688384.690.62数据可信
供试品溶液-2023122321批-瑞舒伐他汀钙-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%
5min143722-4372244.45843.842.1644.4643.842.16
243784-4378444.52144.52
344070-4407044.81244.81
442317-4231743.02943.03
541714-4171442.41642.42
643070-4307043.79543.79
10min167272-6727268.40468.322.6768.9068.802.65
270334-7033471.51872.01
365248-6524866.34666.84
465787-6578766.89467.37
566819-6681967.94468.41
667676-6767668.81569.30
15min175234-7523476.50075.562.9277.7576.802.90
277303-7730378.60479.89
370642-7064271.83173.07
473867-7386775.11076.33
574274-7427475.52476.75
674514-7451475.76877.02
20min176423-7642377.70977.252.4179.8179.342.40
279133-7913380.46582.63
373607-7360774.84676.88
475439-7543976.70978.76
575222-7522276.48878.55
676008-7600877.28779.38
30min176545-7654577.83377.942.5780.8080.882.54
279480-7948080.81883.87
373739-7373974.98077.84
477977-7797779.28982.20
575656-7565676.92979.84
676521-7652177.80980.76
45min177302-7730278.60378.272.7482.4482.082.71
280016-8001681.36385.32
374054-7405475.30079.00
476630-7663077.92081.71
575460-7546076.73080.50
678357-7835779.67683.49
60min178181-7818179.49779.212.6484.2083.892.61
280168-8016881.51786.38
374971-7497176.23380.77
477689-7768978.99783.65
576323-7632377.60882.23
680069-8006981.41786.12
极限182238-8223883.62283.722.4189.2189.282.38
284013-8401385.42791.19
379279-7927980.61385.99
481857-8185783.23588.77
581692-8169283.06788.55
684945-8494586.37591.98
依折麦布瑞舒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ZT-705-231101-1-D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(%)100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%
111.108792887999879868798387986879760.04
211.078814988130881400.02
单位质量响应值RSD%判断
7925.777962.060.33数据可信
供试品溶液-2023122321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%
5min13402-34023.8543.851.943.853.851.89
23399-33993.8513.85
33497-34973.9623.96
43318-33183.7593.76
53341-33413.7853.79
63443-34433.9013.90
10min16047-60476.8517.082.996.877.102.95
26489-64897.3527.37
36077-60776.8856.91
46152-61526.9706.99
56277-62777.1127.13
66436-64367.2927.31
15min17647-76478.6648.712.898.728.772.86
27909-79098.9609.02
37297-72978.2678.33
47812-78128.8518.91
57617-76178.6308.69
67834-78348.8768.94
20min18436-84369.5589.542.399.679.662.38
28733-87339.89410.01
38138-81389.2209.33
48425-84259.5459.65
58297-82979.4009.51
68518-85189.6509.76
30min19226-922610.45310.622.8410.6110.782.83
29705-970510.99511.16
39005-900510.20210.36
49624-962410.90311.07
59232-923210.45910.62
69432-943210.68610.85
45min110096-1009611.43811.542.5011.6611.762.49
210530-1053011.93012.16
39845-984511.15411.37
410181-1018111.53511.76
510032-1003211.36611.58
610423-1042311.80912.03
60min110465-1046511.85611.863.4212.1412.143.38
210802-1080212.23812.53
39933-993311.25411.53
410474-1047411.86712.15
510237-1023711.59811.88
610900-1090012.34912.64
极限112220-1222013.84513.742.6814.1914.092.64
212164-1216413.78114.14
311705-1170513.26113.60
411922-1192213.50713.86
512103-1210313.71214.06
612670-1267014.35414.71
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)0
对照品批号RSF-703-230318-D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(%)98.9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0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.539709597170971159709097069971080.04
211.639680996691967500.09
单位质量响应值RSD%判断
8422.208319.000.88数据可信
供试品溶液-2023122321批-瑞舒伐他汀钙-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%
5min143742-4374244.74841.8510.1944.7541.8510.19
242030-4203042.99643.00
346656-4665647.72947.73
438940-3894039.83539.84
534726-3472635.52535.52
639373-3937340.27840.28
10min163925-6392565.39566.174.0265.8966.634.05
264239-6423965.71666.19
369249-6924970.84171.37
463795-6379565.26265.70
561416-6141662.82863.22
665446-6544666.95167.40
15min171270-7127072.90972.874.1774.1374.074.19
270119-7011971.73172.94
376475-7647578.23479.55
470684-7068472.30973.48
567378-6737868.92770.02
671453-7145373.09674.29
20min172493-7249374.16074.693.8076.1976.703.83
271310-7131072.95074.95
377969-7796979.76281.95
472232-7223273.89375.86
570017-7001771.62773.49
674073-7407375.77677.78
30min174315-7431576.02476.153.6578.8878.983.69
273264-7326474.94977.76
379365-7936581.19084.26
473272-7327274.95777.75
571355-7135572.99675.65
675036-7503676.76179.61
45min175366-7536677.09976.863.1180.8080.543.17
273768-7376875.46479.11
379145-7914580.96584.94
475587-7558777.32580.95
572159-7215973.81877.28
674751-7475176.47080.17
60min176644-7664478.40678.002.6882.9782.542.75
274529-7452976.24380.73
379842-7984281.67886.55
476132-7613277.88382.37
574072-7407275.77580.06
676273-7627378.02782.58
极限179414-7941481.24082.022.2986.6787.432.34
279413-7941381.23986.57
383700-8370085.62591.41
480433-8043382.28387.63
579573-7957381.40386.53
678526-7852680.33285.75
依折麦布瑞舒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ZT-705-231101-1-D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(%)100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%
111.108793287951878398781787810878700.08
211.078784187832878360.01
单位质量响应值RSD%判断
7916.227934.600.17数据可信
供试品溶液-2023122321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%
5min14739-47395.3825.0910.315.385.0910.32
24576-45765.1965.20
35158-51585.8575.86
44260-42604.8384.84
53796-37964.3114.31
64359-43594.9504.95
10min18019-80199.1068.844.039.148.874.04
27596-75968.6268.65
38172-81729.2809.31
47556-75568.5818.61
57392-73928.3948.42
67994-79949.0789.11
15min19155-915510.39610.383.9510.4810.463.96
28847-884710.04710.12
39730-973011.04911.13
49011-901110.23310.31
58744-87449.93010.00
69351-935110.61910.70
20min19977-997711.33011.283.7511.4711.423.79
29688-968811.00211.13
310613-1061312.05212.20
49811-981111.14111.27
59545-954510.83910.96
69991-999111.34611.48
30min110722-1072212.17612.263.4612.3812.463.48
210582-1058212.01712.21
311345-1134512.88313.10
410540-1054011.96912.16
510428-1042811.84212.03
611172-1117212.68712.89
45min111801-1180113.40113.242.4113.6713.512.45
211373-1137312.91513.18
312074-1207413.71114.00
411777-1177713.37413.63
511336-1133612.87313.12
611617-1161713.19213.46
60min112416-1241614.09913.753.4414.4414.103.44
211540-1154013.10513.44
312650-1265014.36514.73
411990-1199013.61613.95
511779-1177913.37613.70
612295-1229513.96214.31
极限113548-1354815.38515.551.3115.8115.971.29
213650-1365015.50115.91
313957-1395715.84916.29
413767-1376715.63416.04
513784-1378415.65316.05
613459-1345915.28415.71
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