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DJ333-221017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(%)99.67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%
19.851640661639561640671641211640191640460.04
29.911649751651401650580.08
单位质量响应值RSD%判断
16654.4216655.700.01数据可信
供试品溶液-2022091403批-依折麦布-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%
5min111964-119646.4446.175.436.446.175.43
210941-109415.8935.89
311550-115506.2216.22
410477-104775.6435.64
511769-117696.3396.34
612040-120406.4856.48
10min115263-152638.2218.105.008.268.144.97
215588-155888.3968.43
313545-135457.2957.33
415451-154518.3228.35
515136-151368.1528.19
615277-152778.2288.26
15min115288-152888.2348.301.368.328.381.32
215617-156178.4118.49
315214-152148.1948.27
415479-154798.3378.41
515694-156948.4538.53
615215-152158.1958.28
20min114736-147367.9378.091.228.068.211.20
215236-152368.2068.33
315015-150158.0878.21
414989-149898.0738.20
515199-151998.1868.31
614931-149318.0428.17
30min114489-144897.8047.721.687.977.891.64
214524-145247.8237.99
313939-139397.5077.67
414568-145687.8468.01
514282-142827.6927.87
614219-142197.6587.83
45min114476-144767.7977.711.938.017.921.91
214503-145037.8118.03
313877-138777.4747.68
414433-144337.7747.99
514510-145107.8158.03
614046-140467.5657.78
60min114169-141697.6317.621.687.897.881.63
214026-140267.5547.81
314187-141877.6417.89
414539-145397.8318.09
514202-142027.6497.91
613818-138187.4427.70
极限114004-140047.5427.662.077.847.962.01
214443-144437.7798.08
314293-142937.6987.99
414432-144327.7738.07
514415-144157.7648.07
613725-137257.3927.69
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%
111.001553271554271554841555791554021554440.07
211.051566401566731566560.02
单位质量响应值RSD%判断
14131.2714177.010.23数据可信
供试品溶液-2022091403批-阿托伐他汀钙-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%
5min192889-9288954.20850.0316.5054.2150.0316.50
263923-6392337.30437.30
398393-9839357.42057.42
472015-7201542.02642.03
592938-9293854.23654.24
694225-9422554.98754.99
10min1107254-10725462.59163.462.3362.8963.742.38
2106115-10611561.92662.13
3112290-11229065.53065.85
4106463-10646362.12962.36
5109458-10945863.87764.18
6110895-11089564.71665.02
15min1109562-10956263.93866.625.2864.5967.255.28
2110157-11015764.28564.84
3125438-12543873.20373.89
4110193-11019364.30664.88
5114477-11447766.80667.46
6115138-11513867.19267.86
20min1107635-10763562.81366.825.5163.8267.825.50
2111381-11138164.99965.91
3125336-12533673.14374.23
4110938-11093864.74165.68
5113874-11387466.45467.48
6117846-11784668.77269.81
30min1111795-11179565.24167.534.9166.5968.904.92
2110968-11096864.75866.03
3126352-12635273.73675.23
4113183-11318366.05167.35
5114728-11472866.95368.35
6117283-11728368.44469.86
45min1112896-11289665.88368.645.5467.6070.395.53
2113702-11370266.35467.98
3129521-12952175.58577.49
4112759-11275965.80367.47
5116497-11649767.98569.75
6120351-12035170.23472.03
60min1111107-11110764.83969.306.2266.9271.426.19
2113090-11309065.99767.99
3131081-13108176.49678.82
4116019-11601967.70669.73
5117836-11783668.76670.91
6123355-12335571.98774.18
极限1148827-14882786.85289.382.2389.2991.892.30
2150267-15026787.69290.06
3158309-15830992.38595.14
4153848-15384889.78292.19
5152644-15264489.07991.61
6155014-15501490.46293.05
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