氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数100
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.781855559185735918601101856341185659318571920.10
211.011906500190583919061700.03
单位质量响应值RSD%判断
172281.26173130.790.35数据可信
长期24月-供试品溶液-X0734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%
30min1236128-23612815.78615.236.7915.7915.236.79
2210558-21055814.07614.08
3253521-25352116.94916.95
4217234-21723414.52314.52
5228814-22881415.29715.30
6220588-22058814.74714.75
120min1411007-41100727.47726.673.8327.5026.693.83
2393195-39319526.28626.31
3414219-41421927.69227.72
4380010-38001025.40525.43
5411465-41146527.50827.53
6383505-38350525.63825.66
240min1548484-54848436.66836.033.2236.7336.093.22
2532587-53258735.60535.67
3551824-55182436.89136.96
4511838-51183834.21834.28
5558551-55855137.34137.41
6529937-52993735.42835.49
480min1972225-97222564.99663.545.3665.1263.665.36
2864131-86413157.77057.88
31003510-100351067.08867.21
4939448-93944862.80562.92
5992108-99210866.32566.45
6931575-93157562.27962.39
极限11020059-102005968.19466.485.0768.4166.705.06
2903296-90329660.38860.59
31036732-103673269.30969.53
4988487-98848766.08366.29
51036019-103601969.26169.48
6982327-98232765.67265.88
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数100
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.781860632185893618595351859868185891318595770.04
211.011908530190836919084500.01
单位质量响应值RSD%判断
172502.50173337.870.35数据可信
长期24月-供试品溶液-X0734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%
30min1227458-22745815.18715.148.8715.1915.148.86
2189608-18960812.66012.66
3229537-22953715.32615.33
4246100-24610016.43216.43
5242685-24268516.20416.20
6225047-22504715.02615.03
120min1426984-42698428.51027.016.1928.5327.036.20
2360710-36071024.08524.10
3410943-41094327.43927.46
4417333-41733327.86527.89
5421529-42152928.14628.17
6389852-38985226.03126.05
240min1599446-59944640.02537.145.4440.0937.205.44
2515572-51557234.42534.48
3555286-55528637.07737.14
4553638-55363836.96737.03
5579424-57942438.68838.75
6533774-53377435.64035.70
480min11027623-102762368.61565.605.9568.7465.725.94
21014653-101465367.74967.86
31034600-103460069.08169.20
4991136-99113666.17866.30
5941965-94196562.89563.02
6884878-88487859.08459.20
极限11071762-107176271.56268.625.8071.7968.835.79
21081899-108189972.23972.45
31061600-106160070.88371.11
41034484-103448469.07369.29
5989231-98923166.05166.27
6926845-92684561.88662.09
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数100
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.781863468186535118643011864399186528618645610.05
211.011910903191212219115120.05
单位质量响应值RSD%判断
172964.84173615.990.27数据可信
长期24月-供试品溶液-X0734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%
30min1431982-43198228.78226.738.9228.7826.738.92
2405233-40523327.00027.00
3427102-42710228.45728.46
4334039-33403922.25622.26
5415363-41536327.67527.67
6393756-39375626.23526.23
120min1845814-84581456.35453.186.3256.4053.226.32
2782315-78231552.12452.16
3831533-83153355.40355.45
4719165-71916547.91647.95
5842152-84215256.11056.15
6768272-76827251.18851.23
240min11203920-120392080.21477.825.0380.3477.945.04
21163021-116302177.48977.61
31218670-121867081.19781.32
41066748-106674871.07571.18
51216040-121604081.02281.15
61139474-113947475.92076.04
480min11472777-147277798.12798.891.1598.3899.131.15
21493217-149321799.48999.72
31478761-147876198.52698.77
41482855-148285598.79999.01
51513066-1513066100.812101.06
61464838-146483897.59897.83
极限11465579-146557997.64898.411.0498.0498.791.04
21483542-148354298.84599.23
31467363-146736397.76798.16
41479449-147944998.57298.93
51503363-1503363100.165100.56
61462565-146256597.44797.82
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数100
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.781858299185950018601201860230185811418592530.06
211.011906271190694519066080.03
单位质量响应值RSD%判断
172472.45173170.570.29数据可信
长期24月-供试品溶液-X0734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%
30min1382182-38218225.53326.626.7925.5326.626.79
2408871-40887127.31627.32
3445662-44566229.77429.77
4369321-36932124.67424.67
5400644-40064426.76626.77
6384435-38443525.68325.68
120min1762721-76272150.95653.805.4750.9953.845.48
2797410-79741053.27453.31
3876879-87687958.58358.63
4757854-75785450.63150.67
5811371-81137154.20654.25
6825499-82549955.15055.19
240min11129775-112977575.47879.233.1975.5979.353.19
21182282-118228278.98679.11
31235945-123594582.57182.70
41158803-115880377.41877.53
51200241-120024180.18680.31
61208487-120848780.73780.86
480min11470780-147078098.26099.281.2498.4999.521.23
21466478-146647897.97398.21
31479520-147952098.84499.10
41502728-1502728100.395100.62
51483984-148398499.14299.38
61513064-1513064101.085101.33
极限11464858-146485897.86599.091.2998.2499.481.29
21466017-146601797.94298.33
31475766-147576698.59399.00
41497143-1497143100.022100.40
51481763-148176398.99499.38
61513842-1513842101.137101.53
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数100
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.781869288187024618702821870068187020318700170.03
211.011906941190824719075940.05
单位质量响应值RSD%判断
173470.96173260.130.09数据可信
长期24月-供试品溶液-X0734批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
30min180307-803075.3485.346.575.355.346.55
280846-808465.3845.38
374056-740564.9324.93
474259-742594.9464.95
586215-862155.7425.74
685588-855885.7005.70
120min186376-863765.7535.544.575.765.544.56
286782-867825.7805.79
384553-845535.6315.64
484262-842625.6125.62
578217-782175.2095.22
678597-785975.2345.24
240min1407376-40737627.13126.302.9327.1526.322.93
2407393-40739327.13227.15
3381337-38133725.39625.41
4381930-38193025.43625.45
5395857-39585726.36326.38
6395849-39584926.36326.38
480min1396161-39616126.38426.003.1326.4426.063.12
2395622-39562226.34826.41
3400635-40063526.68226.74
4400179-40017926.65126.71
5374955-37495524.97125.03
6374823-37482324.96325.02
极限1919972-91997261.26961.071.7361.3761.171.72
2919410-91941061.23161.33
3898419-89841959.83359.93
4897909-89790959.79959.89
5932987-93298762.13562.23
6933265-93326562.15462.25
点击查看处理图标(人工保存)
　
原始图谱下载图谱(谢超君 于 2026-02-06 17:04:55 完成)
生成报告数据部分下载报告( 于 2026-02-06 22:03:40 完成)
Current page cost:82 ms