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%
110.031657681656821658741654601659981657560.13
210.091671201666541668870.20
单位质量响应值RSD%判断
16526.0216539.840.06数据可信
供试品溶液-2023121221批-依折麦布-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min18299-82994.5034.238.474.504.238.50
28178-81784.4374.44
37646-76464.1494.15
47259-72593.9393.94
58550-85504.6394.64
66847-68473.7153.71
10min117201-172019.3339.312.289.369.342.32
217696-176969.6019.63
317335-173359.4059.43
417169-171699.3159.34
517065-170659.2599.28
616499-164998.9528.97
15min117864-178649.6939.545.179.779.625.11
218038-180389.7879.86
317292-172929.3829.46
418998-1899810.30810.38
516847-168479.1419.22
616486-164868.9459.02
20min117524-175249.5089.421.619.649.551.61
217089-170899.2729.40
317642-176429.5729.70
417652-176529.5779.71
517178-171789.3209.45
617063-170639.2589.38
30min116859-168599.1479.051.469.339.231.47
216888-168889.1639.35
316771-167719.0999.28
416821-168219.1279.31
516294-162948.8419.02
616473-164738.9389.11
45min116826-168269.1299.101.799.369.331.76
216656-166569.0379.27
317269-172699.3709.60
416861-168619.1489.38
516592-165929.0029.23
616394-163948.8959.12
60min116642-166429.0299.001.769.319.281.74
216987-169879.2179.50
316484-164848.9449.23
416713-167139.0689.35
516598-165989.0069.28
616105-161058.7389.01
极限116175-161758.7768.851.749.119.181.67
216129-161298.7519.09
316716-167169.0709.40
416124-161248.7489.08
516632-166329.0249.35
616099-160998.7359.05
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%
110.031658731662181660921665091660331661450.15
210.091669551670381669960.04
单位质量响应值RSD%判断
16564.8116550.640.07数据可信
供试品溶液-2023121221批-依折麦布-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min19543-95435.1704.4810.285.174.4810.32
27113-71133.8543.85
38178-81784.4314.43
48224-82244.4554.46
58859-88594.7994.80
67722-77224.1834.18
10min117190-171909.3139.122.149.349.142.14
216502-165028.9408.96
317157-171579.2959.32
417138-171389.2859.31
516502-165028.9408.97
616521-165218.9508.97
15min115855-158558.5908.983.018.679.052.96
216585-165858.9859.06
317381-173819.4169.49
416547-165478.9649.04
516346-163468.8568.93
616720-167209.0589.13
20min116666-166669.0298.922.229.169.042.19
216722-167229.0599.18
316729-167299.0639.19
415992-159928.6648.79
516000-160008.6688.79
616688-166889.0419.16
30min116236-162368.7968.681.948.978.861.88
216154-161548.7528.92
315544-155448.4218.60
416135-161358.7418.92
516345-163458.8559.03
615750-157508.5338.71
45min116056-160568.6988.681.618.938.901.54
216393-163938.8819.10
315642-156428.4748.70
416098-160988.7218.94
515842-158428.5838.81
616120-161208.7338.95
60min116164-161648.7578.611.439.038.881.41
215472-154728.3828.65
315875-158758.6008.87
415961-159618.6478.92
515928-159288.6298.90
615910-159108.6198.89
极限115713-157138.5138.421.648.848.741.58
215694-156948.5028.82
315521-155218.4098.73
415190-151908.2298.55
515302-153028.2908.61
615838-158388.5808.90
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%
110.031657911654321655401658491658571656940.12
210.091667991667591667790.02
单位质量响应值RSD%判断
16519.8416529.140.04数据可信
供试品溶液-2023121421批-依折麦布-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min19817-98175.3295.404.525.335.404.49
29481-94815.1475.15
39463-94635.1375.14
410431-104315.6625.66
59988-99885.4225.42
610499-104995.6995.70
10min116791-167919.1159.131.919.149.161.91
216872-168729.1599.19
316936-169369.1949.22
417295-172959.3899.42
516319-163198.8598.89
616673-166739.0519.08
15min117331-173319.4089.505.499.499.585.42
217119-171199.2939.37
317614-176149.5629.64
417142-171429.3069.39
519293-1929310.47310.55
616461-164618.9369.02
20min116500-165008.9579.083.379.099.213.29
217208-172089.3419.47
317157-171579.3149.45
417100-171009.2839.42
515746-157468.5488.69
616600-166009.0119.14
30min116193-161938.7908.882.228.979.062.17
216557-165578.9889.17
316725-167259.0799.26
416507-165078.9619.15
515707-157078.5278.71
616447-164478.9289.11
45min115929-159298.6478.752.378.888.992.28
216321-163218.8609.09
316726-167269.0809.31
415739-157398.5448.78
516265-162658.8299.06
615780-157808.5668.80
60min115753-157538.5518.651.888.838.941.85
216309-163098.8539.14
316219-162198.8049.09
416033-160338.7038.99
515526-155268.4288.71
615806-158068.5808.86
极限115376-153768.3478.592.558.678.922.50
215980-159808.6759.01
316478-164788.9459.28
415992-159928.6819.01
515515-155158.4228.75
615638-156388.4898.82
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%
110.031683481686251684191685661684551684830.07
210.091676661678951677800.10
单位质量响应值RSD%判断
16797.9116628.340.72数据可信
供试品溶液-2023121421批-依折麦布-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min110089-100895.4155.343.045.425.343.06
29414-94145.0535.05
310234-102345.4935.49
49966-99665.3495.35
510188-101885.4685.47
69840-98405.2815.28
10min115571-155718.3588.702.368.398.732.36
216104-161048.6448.67
316477-164778.8448.87
416631-166318.9268.96
516427-164278.8178.85
616087-160878.6348.66
15min116807-168079.0218.851.489.108.931.46
216524-165248.8698.95
316641-166418.9329.01
416454-164548.8318.91
516456-164568.8338.91
616081-160818.6318.71
20min116314-163148.7568.721.848.888.841.79
216156-161568.6728.80
316796-167969.0159.14
416002-160028.5898.72
516202-162028.6968.82
615989-159898.5828.71
30min116327-163278.7638.592.008.948.761.95
216428-164288.8178.99
315619-156198.3838.56
415988-159888.5818.76
515855-158558.5108.69
615771-157718.4658.64
45min115895-158958.5318.243.028.768.462.96
215407-154078.2698.49
315875-158758.5218.75
414761-147617.9238.15
515010-150108.0568.28
615172-151728.1438.36
60min115326-153268.2268.232.898.508.502.83
216025-160258.6018.87
315435-154358.2858.56
415395-153958.2638.53
515093-150938.1018.37
614677-146777.8788.14
极限115310-153108.2178.261.038.538.571.02
215618-156188.3838.70
315498-154988.3188.64
415364-153648.2468.56
515356-153568.2428.56
615160-151608.1378.45
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