氟伐他汀缓释片项目信息
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100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
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%
111.111418174141414214153811416827143064114190330.47
211.131424205141374414189740.53
单位质量响应值RSD%判断
127725.74127490.930.14数据可信
长期12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%
240min1241612-24161216.78816.087.7116.7916.087.70
2232337-23233716.14316.14
3199722-19972213.87713.88
4233110-23311016.19716.20
5228380-22838015.86815.87
6253036-25303617.58117.58
480min1412807-41280728.68328.344.7028.7128.374.70
2419012-41901229.11429.14
3375907-37590726.11926.14
4398864-39886427.71427.74
5409104-40910428.42528.45
6431954-43195430.01330.04
720min1555089-55508938.56938.452.7638.6438.522.75
2550709-55070938.26438.33
3562804-56280439.10539.16
4528828-52882836.74436.81
5548797-54879738.13138.20
6574291-57429139.90339.97
960min1935175-93517564.97866.094.2565.1066.214.25
2910374-91037463.25563.38
31006829-100682969.95670.08
4907154-90715463.03163.15
5964092-96409266.98767.11
6983472-98347268.33468.46
1200min1968829-96882967.31668.364.6967.5468.584.68
2951320-95132066.10066.32
31050445-105044572.98773.21
4934258-93425864.91465.13
5967789-96778967.24467.47
61030500-103050071.60171.83
1440min1-0.0000.00-0.320.323.20
2-0.0000.32
3-0.0000.33
4-0.0000.31
5-0.0000.32
6-0.0000.34
极限1-0.0000.00-0.320.323.20
2-0.0000.32
3-0.0000.33
4-0.0000.31
5-0.0000.32
6-0.0000.34
氟伐他汀缓释片项目信息
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100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
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%
111.111410087140065614078721408802140940214073640.28
211.131411213141110514111590.01
单位质量响应值RSD%判断
126675.43126788.770.07数据可信
长期12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%
240min1205506-20550614.37815.647.5014.3815.647.50
2233946-23394616.36716.37
3216891-21689115.17415.17
4229776-22977616.07616.08
5248306-24830617.37217.37
6206991-20699114.48214.48
480min1414617-41461729.00828.664.6529.0328.694.65
2416444-41644429.13529.16
3408903-40890328.60828.63
4400553-40055328.02428.05
5437622-43762230.61730.64
6380075-38007526.59126.61
720min1546285-54628538.21938.642.8538.2838.702.85
2563913-56391339.45339.52
3546955-54695538.26638.33
4543981-54398138.05838.12
5577859-57785940.42840.50
6534683-53468337.40837.47
960min1996374-99637469.70967.073.5569.8367.203.55
2944009-94400966.04566.17
3935540-93554065.45265.58
4935054-93505465.41865.54
51007755-100775570.50570.64
6933230-93323065.29165.41
1200min11045725-104572573.16170.014.2973.3970.244.29
21007583-100758370.49370.72
3959846-95984667.15367.37
4973565-97356568.11368.33
51056618-105661873.92374.16
6960996-96099667.23367.45
1440min1-0.0000.00-0.340.333.84
2-0.0000.33
3-0.0000.32
4-0.0000.32
5-0.0000.35
6-0.0000.32
极限1-0.0000.00-0.340.333.84
2-0.0000.33
3-0.0000.32
4-0.0000.32
5-0.0000.35
6-0.0000.32
氟伐他汀缓释片项目信息
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100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
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%
111.111400826139936813986141400800140445814008130.17
211.131420028141657614183020.18
单位质量响应值RSD%判断
126085.78127430.550.76数据可信
长期12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%
240min1474687-47468733.20428.878.9933.2028.878.98
2366205-36620525.61625.62
3423772-42377229.64329.64
4422256-42225629.53729.54
5393959-39395927.55727.56
6395308-39530827.65227.65
480min1902965-90296563.16258.368.5063.2158.408.50
2698136-69813648.83448.87
3866637-86663760.62160.67
4829751-82975158.04158.09
5857457-85745759.97960.02
6851041-85104159.53059.57
720min11259416-125941688.09684.076.7388.2484.206.73
21042032-104203272.89073.00
31230046-123004686.04286.18
41199341-119934183.89484.03
51233278-123327886.26886.40
61246747-124674787.21087.34
960min11497309-1497309104.737103.962.61105.01104.222.62
21420614-142061499.37299.59
31463897-1463897102.399102.66
41492207-1492207104.380104.64
51522582-1522582106.504106.77
61520900-1520900106.387106.65
1200min11473926-1473926103.101103.311.53103.53103.721.54
21448512-1448512101.323101.69
31459494-1459494102.091102.51
41473123-1473123103.045103.46
51503633-1503633105.179105.60
61503052-1503052105.138105.56
1440min11469685-1469685102.804102.551.71103.39103.111.72
21438754-1438754100.641101.16
31434639-1434639100.353100.92
41469521-1469521102.793103.36
51497091-1497091104.721105.30
61486218-1486218103.961104.54
极限11483128-1483128103.745103.001.62104.49103.721.63
21445244-1445244101.095101.77
31445295-1445295101.098101.82
41467220-1467220102.632103.35
51497732-1497732104.766105.50
61496571-1496571104.685105.42
氟伐他汀缓释片项目信息
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100800-202103对照品来源中检院对照品使用方法直接使用
对照品含量(%)93.4对照品水分(%)0对照品稀释倍数125
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%
111.111411311142135314066261414050140979714126270.40
211.131398064140199614000300.20
单位质量响应值RSD%判断
127149.14125788.860.77数据可信
长期12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%
240min1404013-40401328.32529.6611.7828.3329.6611.77
2420220-42022029.46229.46
3459033-45903332.18332.18
4334192-33419223.43023.43
5463724-46372432.51232.51
6457504-45750432.07632.08
480min1835241-83524158.55958.5111.1158.6058.5611.11
2874360-87436061.30161.35
3878500-87850061.59161.64
4649402-64940245.52945.56
5883272-88327261.92661.97
6886932-88693262.18362.23
720min11213413-121341385.07282.438.8785.2082.578.88
21220554-122055485.57385.71
31198925-119892584.05684.20
4965460-96546067.68867.79
51246666-124666687.40487.55
61209690-120969084.81184.95
960min11501695-1501695105.284103.071.64105.54103.321.65
21474161-1474161103.353103.62
31460533-1460533102.398102.66
41429375-1429375100.213100.42
51478542-1478542103.660103.93
61476274-1476274103.501103.77
1200min11492264-1492264104.622102.461.17105.04102.871.17
21458125-1458125102.229102.65
31439309-1439309100.910101.33
41459260-1459260102.308102.66
51459026-1459026102.292102.72
61460695-1460695102.409102.83
1440min11478295-1478295103.643102.130.82104.22102.700.82
21446902-1446902101.442102.01
31446966-1446966101.447102.02
41451040-1451040101.732102.24
51459917-1459917102.355102.94
61457434-1457434102.180102.76
极限11475894-1475894103.475101.920.86104.20102.640.86
21449623-1449623101.633102.36
31443704-1443704101.218101.94
41445255-1445255101.327101.99
51447129-1447129101.458102.19
61460726-1460726102.411103.14
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