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%
110.021751171748801746561745351745891747550.14
210.111749171745831747500.14
单位质量响应值RSD%判断
17440.6217284.870.64数据可信
供试品溶液-X007293批-依折麦布-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%
5min19902-99025.1164.5013.105.124.5013.11
27029-70293.6323.63
37929-79294.0974.10
48284-82844.2804.28
59401-94014.8574.86
69702-97025.0135.01
10min117884-178849.2409.131.969.279.152.02
217255-172558.9158.93
317612-176129.0999.12
417280-172808.9288.95
518094-180949.3489.38
617881-178819.2389.27
15min118578-185789.5989.401.359.689.481.37
218323-183239.4679.54
318204-182049.4059.48
417859-178599.2279.30
518049-180499.3259.40
618128-181289.3669.45
20min118135-181359.3699.301.249.509.431.24
218261-182619.4359.56
317946-179469.2729.40
417610-176109.0989.22
518061-180619.3319.46
618021-180219.3119.44
30min118119-181199.3619.241.609.559.431.58
218060-180609.3319.51
318161-181619.3839.56
417407-174078.9939.17
517856-178569.2259.41
617763-177639.1779.36
45min116828-168288.6949.022.328.939.252.25
217677-176779.1339.36
317559-175599.0729.30
417136-171368.8539.08
517622-176229.1049.34
617935-179359.2669.50
60min117968-179689.2839.122.229.579.412.16
218154-181549.3799.66
317854-178549.2249.50
417165-171658.8689.14
517521-175219.0529.34
617310-173108.9439.23
极限117209-172098.8919.081.909.239.421.83
218005-180059.3029.63
317573-175739.0799.41
417180-171808.8769.20
517711-177119.1509.49
617823-178239.2089.54
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%
110.991542931545841543101545861544091544360.10
211.091547171543401545280.18
单位质量响应值RSD%判断
14052.4113933.990.60数据可信
供试品溶液-X007293批-阿托伐他汀钙-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%
5min177433-7743345.70829.1534.6745.7129.1634.68
248158-4815828.42828.43
334903-3490320.60320.60
453971-5397131.85931.86
553272-5327231.44631.45
628601-2860116.88316.88
10min1136751-13675180.72474.858.5580.9875.018.60
2128117-12811775.62775.79
3121642-12164271.80571.92
4137461-13746181.14381.32
5128553-12855375.88476.06
6108270-10827063.91164.01
15min1153171-15317190.41688.633.8991.1289.203.93
2149143-14914388.03988.62
3146498-14649886.47786.99
4160216-16021694.57595.20
5148039-14803987.38787.98
6143782-14378284.87485.32
20min1157228-15722892.81193.062.4994.0294.132.54
2157019-15701992.68893.76
3154881-15488191.42692.42
4165328-16532897.59398.75
5156746-15674692.52793.61
6154649-15464991.28992.21
30min1164619-16461997.17496.551.1598.8998.141.22
2163058-16305896.25397.83
3162167-16216795.72797.23
4166886-16688698.512100.21
5162461-16246195.90097.50
6162163-16216395.72497.15
45min1157085-15708592.72796.402.4894.9998.522.42
2164246-16424696.95499.07
3159915-15991594.39796.43
4168135-16813599.250101.49
5165040-16504097.42399.55
6165421-16542197.64899.61
60min1166578-16657898.33197.791.45101.11100.451.50
2165933-16593397.950100.61
3161401-16140195.27597.83
4168306-16830699.351102.14
5166994-16699498.576101.25
6164785-16478597.27299.77
极限1163116-16311696.28797.881.4699.61101.081.43
2167192-16719298.693101.89
3163181-16318196.32599.41
4168894-16889499.698103.04
5165020-16502097.411100.63
6167511-16751198.881101.92
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%
110.021759221760151759461758871753221758180.17
210.111804381798151801260.25
单位质量响应值RSD%判断
17546.7117816.621.08数据可信
供试品溶液-X007293批-依折麦布-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%
5min16767-67673.4333.6219.013.433.6219.05
28881-88814.5064.51
38029-80294.0744.07
47754-77543.9343.93
56361-63613.2273.23
65073-50732.5742.57
10min116787-167878.5178.553.268.548.573.28
217580-175808.9198.94
317359-173598.8078.83
416790-167908.5188.54
516589-165898.4168.43
616048-160488.1428.16
15min118079-180799.1728.991.829.249.061.87
218037-180379.1519.23
317544-175448.9018.97
417709-177098.9859.05
517710-177108.9859.05
617210-172108.7328.79
20min117629-176298.9448.870.819.068.990.80
217569-175698.9149.04
317485-174858.8718.99
417223-172238.7388.86
517545-175458.9019.02
617492-174928.8758.98
30min117027-170278.6398.702.288.818.872.19
217301-173018.7788.95
316667-166678.4568.63
416793-167938.5208.69
517444-174448.8509.01
617676-176768.9689.13
45min117313-173138.7848.720.929.008.940.96
217370-173708.8139.04
317061-170618.6568.87
417077-170778.6648.88
517300-173008.7778.99
617004-170048.6278.83
60min116982-169828.6168.660.558.888.920.54
217185-171858.7198.99
316941-169418.5958.86
417107-171078.6798.94
517124-171248.6888.95
617106-171068.6798.93
极限117069-170698.6608.641.348.978.951.30
217253-172538.7539.07
316880-168808.5648.88
416778-167788.5128.82
517332-173328.7939.10
616860-168608.5548.86
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%
110.991563641557441553981552661553621556270.29
211.091591351588541589940.13
单位质量响应值RSD%判断
14160.7814336.700.88数据可信
供试品溶液-X007293批-阿托伐他汀钙-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%
5min136029-3602920.88722.2930.3420.8922.3030.33
258260-5826033.77533.77
336440-3644021.12521.13
444380-4438025.72825.73
530702-3070217.79917.80
624920-2492014.44714.45
10min195417-9541755.31563.7917.3955.4363.9117.41
2135341-13534178.46078.65
3118625-11862568.77068.89
4121927-12192770.68470.83
5106136-10613661.52961.63
682750-8275047.97248.05
15min1147411-14741185.45784.595.1685.8885.075.23
2158032-15803291.61592.24
3142738-14273882.74883.25
4148683-14868386.19586.73
5143071-14307182.94183.38
6135541-13554178.57678.92
20min1159082-15908292.22390.632.7393.1291.582.77
2162280-16228094.07795.21
3150053-15005386.98987.95
4156207-15620790.55791.57
5156918-15691890.96991.87
6153473-15347388.97289.76
30min1162234-16223494.05193.532.8395.4694.982.80
2164489-16448995.35897.01
3152927-15292788.65590.10
4160137-16013792.83594.35
5165754-16575496.09197.50
6162519-16251994.21695.49
45min1168417-16841797.63595.612.6099.5797.582.59
2167508-16750897.10899.29
3157403-15740391.25093.18
4163603-16360394.84496.88
5168625-16862597.75699.70
6164020-16402095.08696.89
60min1165844-16584496.14395.632.1998.6298.142.15
2164981-16498195.64398.37
3158154-15815491.68594.13
4165517-16551795.95498.51
5168933-16893397.934100.42
6166347-16634796.43598.76
极限1166265-16626596.38895.792.0999.4098.822.06
2166005-16600596.23799.49
3159550-15955092.49595.45
4164315-16431595.25798.35
5170169-17016998.651101.68
6165077-16507795.69998.56
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