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DSMF-387-240606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(%)99.75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%
110.011791611797641795851797901799061796410.17
210.011787091786831786960.02
单位质量响应值RSD%判断
17946.1517851.750.38数据可信
供试品溶液-2023120823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%
5min110624-106245.3295.314.915.335.314.94
211083-110835.5595.56
310845-108455.4405.44
411064-110645.5495.55
59995-99955.0135.01
69912-99124.9724.97
10min115418-154187.7337.781.737.767.801.73
215797-157977.9237.95
315308-153087.6787.71
415320-153207.6847.71
515886-158867.9688.00
615289-152897.6687.70
15min115935-159357.9937.811.808.077.881.79
215108-151087.5787.65
315552-155527.8007.87
415437-154377.7437.82
515714-157147.8827.95
615640-156407.8457.91
20min115949-159498.0007.872.198.127.982.17
215276-152767.6627.78
315548-155487.7987.91
415420-154207.7347.85
516191-161918.1218.24
615732-157327.8918.00
30min115617-156177.8337.864.277.998.024.18
215038-150387.5437.70
315752-157527.9018.06
415145-151457.5967.76
516909-169098.4818.64
615558-155587.8037.96
45min115363-153637.7067.622.807.917.822.77
214610-146107.3287.53
315106-151067.5777.78
414939-149397.4937.69
515872-158727.9618.17
615225-152257.6367.84
60min116207-162078.1297.833.318.388.073.24
215249-152497.6487.89
315338-153387.6937.94
415041-150417.5447.79
516266-162668.1598.41
615512-155127.7808.02
极限115511-155117.7807.772.148.078.062.11
215303-153037.6767.96
315542-155427.7958.08
414945-149457.4967.78
515834-158347.9428.24
615797-157977.9238.21
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2500
标示量(mg)20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%
111.211594101595391596761596031596781595810.08
211.241613371613831613600.03
单位质量响应值RSD%判断
14235.5914355.870.60数据可信
供试品溶液-2023120823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%
5min1108755-10875562.83960.677.1862.8460.677.18
292120-9212053.22753.23
3113220-11322065.41965.42
4103019-10301959.52559.52
5110220-11022063.68663.69
6102693-10269359.33759.34
10min1141806-14180681.93681.373.6382.2981.713.62
2137644-13764479.53179.83
3135800-13580078.46678.83
4136219-13621978.70879.04
5147879-14787985.44585.80
6145638-14563884.15084.48
15min1150384-15038486.89384.593.7887.7085.383.76
2145647-14564784.15684.89
3139925-13992580.84981.65
4139704-13970480.72281.49
5151259-15125987.39888.23
6151475-15147587.52388.32
20min1155996-15599690.13586.504.4691.4287.764.43
2148275-14827585.67486.88
3143324-14332482.81384.06
4140590-14059081.23482.45
5154484-15448489.26290.58
6155517-15551789.85991.14
30min1162774-16277494.05289.224.5495.8490.964.50
2154845-15484589.47091.15
3154222-15422289.11090.82
4141589-14158981.81183.48
5155557-15555789.88291.69
6157438-15743890.96892.75
45min1161518-16151893.32690.904.7195.6493.134.64
2159006-15900691.87494.05
3165033-16503395.35797.56
4143715-14371583.03985.16
5155159-15515989.65291.96
6159463-15946392.13994.43
60min1165075-16507595.38192.846.0298.2195.585.90
2166358-16635896.12398.81
3171114-17111498.871101.60
4143547-14354782.94285.53
5157144-15714490.79993.61
6160847-16084792.93895.74
极限1170428-17042898.47498.691.18101.83101.941.23
2170806-17080698.693101.92
3172983-17298399.950103.23
4167149-16714996.58099.62
5171312-17131298.985102.30
6172093-17209399.436102.75
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DSMF-387-240606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(%)99.75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%
110.011732131733731733701733851733941733470.05
210.011749071753641751360.19
单位质量响应值RSD%判断
17317.3817496.100.73数据可信
供试品溶液-2023120823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%
5min111570-115705.9676.0210.335.976.0210.33
212900-129006.6536.65
312985-129856.6976.70
410089-100895.2045.20
511988-119886.1836.18
610484-104845.4075.41
10min114946-149467.7097.992.127.748.022.14
215843-158438.1718.21
315813-158138.1568.19
415396-153967.9417.97
515493-154937.9918.03
615435-154357.9617.99
15min115263-152637.8728.071.477.958.151.46
215716-157168.1068.19
315796-157968.1478.23
415933-159338.2188.29
515599-155998.0458.12
615588-155888.0408.11
20min115572-155728.0318.051.048.158.181.03
215436-154367.9618.09
315888-158888.1948.32
415533-155338.0118.13
515727-157278.1118.23
615550-155508.0208.14
30min115341-153417.9127.801.218.087.971.19
214972-149727.7227.89
315209-152097.8448.02
415300-153007.8918.05
514922-149227.6967.86
614991-149917.7327.90
45min114898-148987.6847.902.397.898.112.36
215190-151907.8348.05
315498-154987.9938.21
415897-158978.1998.41
515394-153947.9408.15
614999-149997.7367.94
60min115043-150437.7597.921.918.018.171.87
215272-152727.8778.13
315688-156888.0918.35
415724-157248.1108.36
515314-153147.8988.15
615082-150827.7798.03
极限115089-150897.7827.871.788.088.171.69
215091-150917.7838.09
315068-150687.7728.08
415769-157698.1338.43
515356-153567.9208.22
615186-151867.8328.13
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2500
标示量(mg)20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%
111.211587231586191586421586301588091586850.06
211.241605321607311606320.09
单位质量响应值RSD%判断
14155.6614291.100.68数据可信
供试品溶液-2023120823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%
5min1111167-11116764.56051.6026.6864.5651.6026.68
2110717-11071764.29964.30
3105369-10536961.19361.19
456147-5614732.60732.61
581810-8181047.51147.51
667872-6787239.41639.42
10min1146749-14674985.22477.996.9385.5878.286.99
2135465-13546578.67179.03
3141934-14193482.42882.77
4120972-12097270.25470.44
5132404-13240476.89377.16
6128258-12825874.48574.70
15min1152124-15212488.34682.254.7389.1882.974.80
2141630-14163082.25183.05
3145315-14531584.39185.19
4135355-13535578.60779.18
5141528-14152882.19282.88
6133843-13384377.72978.36
20min1154313-15431389.61784.654.1390.9485.824.19
2147414-14741485.61086.86
3147517-14751785.67086.94
4144115-14411583.69484.70
5145373-14537384.42585.57
6135807-13580778.87079.93
30min1154211-15421189.55884.524.3091.3886.164.30
2144885-14488584.14285.87
3145697-14569784.61386.36
4149775-14977586.98188.45
5142799-14279982.93084.55
6135825-13582578.88080.38
45min1155530-15553090.32487.363.6792.6489.483.67
2154483-15448389.71691.91
3148651-14865186.32988.54
4154597-15459789.78291.74
5148036-14803685.97188.05
6141310-14131082.06584.01
60min1155784-15578490.47187.753.9393.2990.353.94
2158399-15839991.99094.68
3149503-14950386.82389.52
4153829-15382989.33691.79
5146047-14604784.81687.37
6143006-14300683.05085.45
极限1167755-16775597.42395.931.65100.7599.021.67
2168293-16829397.736100.94
3161689-16168993.90097.08
4162348-16234894.28397.23
5165297-16529795.99699.02
6165684-16568496.22099.08
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