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RSF-703-230318-D对照品来源中检院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1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.169613196236961779635096297962380.10
211.099558595695956400.09
单位质量响应值RSD%判断
8623.488623.990.01数据可信
供试品溶液-2024040821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%
5min148231-4823147.79047.2010.9647.7947.2010.96
247959-4795947.52147.52
343743-4374343.34343.34
444708-4470844.30044.30
543714-4371443.31543.31
657465-5746556.94056.94
10min180045-8004579.31470.097.7779.5870.357.77
266139-6613965.53565.80
367699-6769967.08167.32
469048-6904868.41768.66
566802-6680266.19266.43
674694-7469474.01274.33
15min173547-7354772.87574.214.3873.5874.864.39
271345-7134570.69371.32
375235-7523574.54875.16
476254-7625475.55776.18
572478-7247871.81672.42
680508-8050879.77380.50
20min173561-7356172.88976.214.4674.0077.274.44
273405-7340572.73573.76
378510-7851077.79378.82
478401-7840177.68578.73
575378-7537874.68975.70
682212-8221281.46182.63
30min178166-7816677.45279.643.9878.9781.133.98
276703-7670376.00277.43
381929-8192981.18182.64
481097-8109780.35681.83
578769-7876978.05079.47
685596-8559684.81486.44
45min177655-7765576.94680.293.4978.8982.223.47
277962-7796277.25079.10
382488-8248881.73583.65
483577-8357782.81484.74
580315-8031579.58181.44
684177-8417783.40885.50
60min179117-7911778.39481.593.0980.7783.963.06
280070-8007079.33981.61
383650-8365082.88685.25
485528-8552884.74787.13
581373-8137380.63082.93
684297-8429783.52786.08
极限183640-8364082.87685.041.8985.6987.871.82
284921-8492184.14586.86
387334-8733486.53689.36
487627-8762786.82789.68
586691-8669185.89988.65
684743-8474383.96986.99
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对照品来源中检院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%
111.108464184686846938452984700846500.09
211.158452784423844750.09
单位质量响应值RSD%判断
7626.137576.230.47数据可信
供试品溶液-2024040821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%
5min19798-979811.60111.1411.5811.6011.1411.58
29648-964811.42411.42
38391-83919.9359.94
48857-885710.48710.49
58473-847310.03210.03
611282-1128213.35813.36
10min116011-1601118.95816.558.4519.0216.618.44
213020-1302015.41615.48
313324-1332415.77615.83
413587-1358716.08816.15
513139-1313915.55715.61
614769-1476917.48717.56
15min114512-1451217.18317.514.7117.3517.674.71
214036-1403616.61916.77
314980-1498017.73717.88
415025-1502517.79017.94
514229-1422916.84816.99
615962-1596218.90019.07
20min114339-1433916.97817.864.5617.2418.114.53
214405-1440517.05617.30
315437-1543718.27818.52
415393-1539318.22618.47
514817-1481717.54417.78
616109-1610919.07419.35
30min115239-1523918.04418.564.2718.4018.914.26
214908-1490817.65217.99
315895-1589518.82019.16
415923-1592318.85319.20
515298-1529818.11318.45
616773-1677319.86020.24
45min115018-1501817.78218.633.5318.2419.083.51
215326-1532618.14718.58
315985-1598518.92719.37
416182-1618219.16019.61
515436-1543618.27718.71
616443-1644319.46919.96
60min115304-1530418.12118.833.4318.6819.383.39
215312-1531218.13018.67
316275-1627519.27019.82
416515-1651519.55420.11
515657-1565718.53919.07
616352-1635219.36119.96
极限116025-1602518.97419.652.4719.6320.312.39
216292-1629219.29019.93
316939-1693920.05620.72
416983-1698320.10920.78
516936-1693620.05320.69
616406-1640619.42520.13
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RSF-703-230318-D对照品来源中检院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1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.169544595537956179558295537955440.07
211.099452394822946720.23
单位质量响应值RSD%判断
8561.298536.700.21数据可信
供试品溶液-2024040821批-瑞舒伐他汀钙
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min149521-4952149.49851.944.7749.5051.944.77
253953-5395353.92853.93
351779-5177951.75551.75
450220-5022050.19650.20
550452-5045250.42850.43
655889-5588955.86355.86
10min165257-6525765.22668.353.1265.5068.643.12
267188-6718867.15667.46
368999-6899968.96769.25
468137-6813768.10568.38
569062-6906269.03069.31
671641-7164171.60771.92
15min169951-6995169.91871.903.0070.5672.572.99
268936-6893668.90469.58
372028-7202871.99472.66
472966-7296672.93273.59
572918-7291872.88473.55
674817-7481774.78275.49
20min172139-7213972.10574.612.1873.1375.682.19
273692-7369273.65774.71
375000-7500074.96576.04
475400-7540075.36576.43
574674-7467474.63975.71
676939-7693976.90378.03
30min172636-7263672.60275.693.3974.0377.173.37
272896-7289672.86274.33
376759-7675976.72378.21
476319-7631976.28377.76
576361-7636176.32577.81
679384-7938479.34780.90
45min175626-7562675.59078.212.8277.4280.112.81
275284-7528475.24977.12
379442-7944279.40581.32
479721-7972179.68481.59
579073-7907379.03680.94
680341-8034180.30382.29
60min175802-7580275.76678.602.4778.0280.942.47
276545-7654576.50978.80
379781-7978179.74482.10
479600-7960079.56381.91
579681-7968179.64481.99
680402-8040280.36482.80
极限179735-7973579.69883.512.8782.3786.282.85
281615-8161581.57784.29
384673-8467384.63387.43
484252-8425284.21287.00
586219-8621986.17888.97
684789-8478984.74987.63
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对照品来源中检院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%
111.108459984762848418475984559847040.15
211.158456884423844960.13
单位质量响应值RSD%判断
7630.997578.120.50数据可信
供试品溶液-2024040821批-依折麦布
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min19564-956411.31911.925.0911.3211.925.09
210688-1068812.64912.65
310004-1000411.84011.84
49646-964611.41611.42
59796-979611.59411.59
610712-1071212.67812.68
10min112847-1284715.20515.692.8815.2715.752.89
213090-1309015.49215.56
313319-1331915.76315.83
413058-1305815.45415.52
513251-1325115.68315.75
613955-1395516.51616.59
15min113491-1349115.96716.413.1416.1116.563.13
213227-1322715.65415.81
313914-1391416.46716.62
414181-1418116.78316.93
513996-1399616.56416.72
614393-1439317.03417.20
20min113996-1399616.56417.072.3716.8017.312.35
214064-1406416.64516.89
314482-1448217.14017.38
414746-1474617.45217.69
514428-1442817.07617.32
614824-1482417.54417.80
30min113815-1381516.35017.244.0716.6817.584.03
214070-1407016.65216.99
314814-1481417.53317.87
414515-1451517.17917.52
514688-1468817.38317.72
615495-1549518.33918.69
45min114525-1452517.19117.713.0317.6118.153.01
214298-1429816.92217.35
315075-1507517.84118.28
415308-1530818.11718.55
515171-1517117.95518.39
615431-1543118.26318.72
60min114713-1471317.41317.972.2617.9318.502.26
214793-1479317.50818.03
315446-1544618.28118.82
415417-1541718.24618.78
515274-1527418.07718.61
615468-1546818.30718.86
极限115409-1540918.23719.122.8418.8519.762.82
215799-1579918.69819.32
316347-1634719.34719.99
416320-1632019.31519.95
516643-1664319.69720.33
616414-1641419.42620.09
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