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%
110.051750701754241755751756291754821754360.13
210.091736581746021741300.39
单位质量响应值RSD%判断
17456.3217257.680.81数据可信
供试品溶液-X027068批-依折麦布-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19054-90544.6835.1710.814.685.1710.85
29479-94794.9034.90
38974-89744.6424.64
411678-116786.0406.04
510899-108995.6375.64
69935-99355.1395.14
10min116016-160168.2848.532.888.318.552.86
215928-159288.2398.27
316367-163678.4668.49
416976-169768.7818.81
517059-170598.8248.85
616550-165508.5608.59
15min116537-165378.5548.791.778.638.861.78
216763-167638.6718.74
317312-173128.9559.03
416971-169718.7788.86
517275-172758.9359.02
617077-170778.8338.91
20min116302-163028.4328.622.188.558.742.19
216416-164168.4918.61
316964-169648.7758.90
416883-168838.7338.86
517104-171048.8478.98
616306-163068.4348.56
30min116284-162848.4238.501.568.598.681.54
216435-164358.5018.67
316560-165608.5668.74
416581-165818.5768.76
516734-167348.6568.83
616014-160148.2838.46
45min116159-161598.3588.511.278.578.731.30
216462-164628.5158.73
316701-167018.6388.86
416559-165598.5658.79
516617-166178.5958.82
616272-162728.4178.63
60min116281-162818.4218.451.808.688.721.77
216221-162218.3908.65
316842-168428.7118.98
416199-161998.3798.65
516515-165158.5428.82
616010-160108.2818.55
极限116560-165608.5668.621.948.878.941.90
216874-168748.7289.04
316966-169668.7769.09
416557-165578.5648.89
516925-169258.7549.08
616121-161218.3388.65
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%
111.041523341526251527461527751526661526290.12
211.071512701519241515970.31
单位质量响应值RSD%判断
13825.0913694.400.68数据可信
供试品溶液-X027068批-阿托伐他汀钙-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133209-3320919.93619.2510.8519.9419.2610.84
231672-3167219.01319.01
327113-2711316.27616.28
429783-2978317.87917.88
537318-3731822.40322.40
633352-3335220.02220.02
10min156861-5686134.13535.555.3834.2535.665.38
259134-5913435.49935.60
358520-5852035.13035.22
457605-5760534.58134.68
565516-6551639.33039.45
657668-5766834.61934.73
15min173748-7374844.27245.184.7544.5745.494.76
274069-7406944.46544.77
374161-7416144.52044.81
472744-7274443.66943.96
582454-8245449.49849.84
674402-7440244.66544.97
20min175960-7596045.60045.915.1746.1546.465.17
274621-7462144.79645.35
374385-7438544.65445.19
474978-7497845.01045.54
584442-8444250.69251.31
674449-7444944.69345.24
30min184255-8425550.58050.165.3251.3850.975.32
282188-8218849.33950.14
379066-7906647.46548.25
481771-8177149.08849.87
591967-9196755.20956.11
682076-8207649.27150.07
45min183035-8303549.84749.944.7550.9351.034.76
282555-8255549.55950.63
378476-7847647.11048.16
481361-8136148.84249.90
590394-9039454.26555.47
683279-8327949.99451.07
60min185480-8548051.31550.974.1552.6752.344.17
284517-8451750.73752.09
380927-8092748.58249.89
482297-8229749.40450.73
591125-9112554.70456.21
685083-8508351.07752.43
极限192369-9236955.45155.802.9457.0957.453.00
291482-9148254.91856.55
390520-9052054.34155.92
492348-9234855.43857.04
598275-9827558.99660.81
692740-9274055.67357.31
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%
110.051736861735721737001737161736531736650.04
210.091743321749581746450.26
单位质量响应值RSD%判断
17280.1017308.720.12数据可信
供试品溶液-X027068批-依折麦布-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112509-125096.4935.6812.426.495.6812.43
210457-104575.4285.43
312493-124936.4856.49
410023-100235.2035.20
59129-91294.7394.74
611070-110705.7465.75
10min116586-165868.6108.581.298.658.611.33
216475-164758.5528.58
316849-168498.7468.78
416262-162628.4428.47
516349-163498.4878.51
616644-166448.6408.67
15min116999-169998.8248.841.728.918.911.70
217562-175629.1169.19
316812-168128.7278.81
417043-170438.8478.92
516722-167228.6808.75
616983-169838.8168.90
20min117066-170668.8598.820.858.998.940.87
217117-171178.8859.01
316888-168888.7678.90
416853-168538.7488.87
516841-168418.7428.86
617163-171638.9099.04
30min116760-167608.7008.780.808.888.960.79
216810-168108.7268.90
317142-171428.8989.08
416926-169268.7868.96
516975-169758.8128.98
616914-169148.7808.96
45min116670-166708.6538.651.158.888.871.10
216493-164938.5618.79
316567-165678.6008.83
416502-165028.5668.79
516711-167118.6758.89
617005-170058.8279.05
60min116735-167358.6878.591.448.978.861.40
216684-166848.6618.93
316134-161348.3758.65
416455-164558.5428.81
516759-167598.7008.97
616499-164998.5658.84
极限116350-163508.4878.590.918.818.910.83
216667-166678.6528.97
316464-164648.5468.87
416597-165978.6158.93
516755-167558.6979.01
616466-164668.5478.87
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%
111.041507581506491507581508181506811507330.05
211.071515151518621516880.17
单位质量响应值RSD%判断
13653.3513702.620.26数据可信
供试品溶液-X027068批-阿托伐他汀钙-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min132575-3257519.67216.9221.6519.6716.9221.67
234343-3434320.73920.74
329833-2983318.01618.02
424757-2475714.95114.95
517610-1761010.63510.63
628972-2897217.49617.50
10min153835-5383532.51133.224.0932.6233.314.08
256800-5680034.30134.42
353574-5357432.35332.45
451867-5186731.32231.41
556277-5627733.98534.04
657688-5768834.83734.93
15min167534-6753440.78341.955.1941.0742.235.16
272082-7208243.53043.84
365116-6511639.32339.60
466619-6661940.23140.49
574469-7446944.97145.22
670974-7097442.86143.15
20min176949-7694946.46947.126.5646.9947.636.50
278499-7849947.40547.95
372822-7282243.97744.47
473059-7305944.12044.60
586536-8653652.25852.76
680290-8029048.48649.02
30min184916-8491651.28051.537.1452.0552.307.08
284914-8491451.27952.09
379399-7939947.94848.69
479474-7947447.99448.72
595895-9589557.91058.70
687367-8736752.76053.56
45min183232-8323250.26350.276.8551.3251.326.80
283688-8368850.53951.63
377630-7763046.88047.89
476801-7680146.38047.37
592349-9234955.76956.88
685720-8572051.76652.86
60min184718-8471851.16151.206.6352.5052.546.59
286427-8642752.19353.57
378277-7827747.27148.54
479388-7938847.94249.19
593835-9383556.66658.09
686103-8610351.99753.38
极限188603-8860353.50755.033.9555.1356.653.97
292525-9252555.87557.54
389195-8919553.86455.40
487314-8731452.72854.24
597240-9724058.72260.46
691841-9184155.46257.13
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%
110.051754831757461757451755571760411757140.13
210.091728711735631732170.29
单位质量响应值RSD%判断
17483.9817167.201.30数据可信
供试品溶液-X027066批-依折麦布-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110574-105745.4806.029.855.486.029.88
210217-102175.2955.29
313371-133716.9296.93
411454-114545.9365.94
512052-120526.2456.25
612074-120746.2576.26
10min116686-166868.6478.571.868.688.611.86
216320-163208.4578.49
316991-169918.8058.84
416418-164188.5088.54
516150-161508.3698.40
616711-167118.6608.69
15min117085-170858.8548.861.438.938.941.45
217022-170228.8218.90
317587-175879.1149.20
417001-170018.8108.89
516945-169458.7818.86
616962-169628.7908.87
20min117318-173188.9748.782.249.108.912.24
216908-169088.7628.89
317382-173829.0079.15
416866-168668.7408.87
516333-163338.4648.59
616881-168818.7488.88
30min116722-167228.6658.572.168.848.742.14
216159-161598.3748.55
317066-170668.8449.03
416557-165578.5808.76
516116-161168.3518.53
616565-165658.5848.76
45min116909-169098.7628.573.458.998.803.40
216210-162108.4008.62
317163-171638.8949.13
416349-163498.4728.70
515659-156598.1158.34
616969-169698.7939.02
60min116607-166078.6068.581.118.888.851.15
216340-163408.4688.73
316729-167298.6698.96
416658-166588.6328.90
516308-163088.4518.72
616685-166858.6468.92
极限116843-168438.7288.523.739.058.843.63
216542-165428.5728.89
317226-172268.9279.26
416386-163868.4918.81
515442-154428.0028.32
616160-161608.3748.70
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%
111.043106763112513112033107773114283110670.11
211.073062333071943067140.23
单位质量响应值RSD%判断
28176.3627706.781.19数据可信
供试品溶液-X027066批-阿托伐他汀钙-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130402-304028.98812.0827.088.9912.0827.05
256668-5666816.75316.75
352831-5283115.61915.62
433474-334749.8969.90
534394-3439410.16810.17
637330-3733011.03611.04
10min183750-8375024.76028.5811.1924.8128.6511.23
2110017-11001732.52532.62
3109216-10921632.28832.38
489928-8992826.58626.64
590603-9060326.78626.84
696621-9662128.56528.63
15min1112944-11294433.39136.106.9633.5836.327.01
2132087-13208739.05039.32
3133263-13326339.39839.66
4118253-11825334.96035.16
5116593-11659334.46934.67
6119456-11945635.31635.54
20min1126973-12697337.53839.195.1337.9139.625.20
2140440-14044041.51942.01
3141332-14133241.78342.27
4131525-13152538.88439.28
5125344-12534437.05637.45
6129814-12981438.37838.79
30min1120912-12091235.74637.754.2636.3338.404.35
2133220-13322039.38540.11
3134956-13495639.89840.62
4127096-12709637.57438.19
5123691-12369136.56837.17
6126258-12625837.32737.96
45min1126513-12651337.40239.604.8138.1840.464.87
2139321-13932141.18942.13
3141965-14196541.97042.91
4131054-13105438.74539.57
5127659-12765937.74138.55
6137266-13726640.58141.42
60min1123683-12368336.56539.163.6737.5540.233.74
2138508-13850840.94842.12
3134538-13453839.77540.95
4132556-13255639.18940.23
5132755-13275539.24740.26
6132685-13268539.22740.29
极限1138402-13840240.91743.584.2742.1144.874.31
2151881-15188144.90246.30
3155189-15518945.88047.27
4150099-15009944.37545.63
5142078-14207842.00443.24
6146763-14676343.38944.67
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%
110.051737631739711742311743561743321741310.15
210.091754091755681754880.07
单位质量响应值RSD%判断
17326.4717392.270.27数据可信
供试品溶液-X027066批-依折麦布-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111351-113515.8706.007.975.876.007.95
212061-120616.2376.24
312422-124226.4246.42
411100-111005.7405.74
512558-125586.4946.49
610133-101335.2405.24
10min116379-163798.4718.621.768.508.651.79
216506-165068.5368.57
316923-169238.7528.79
416356-163568.4598.49
517046-170468.8158.85
616796-167968.6868.72
15min116998-169988.7918.852.118.878.932.11
216885-168858.7328.81
316900-169008.7408.82
416852-168528.7158.79
517765-177659.1879.27
617327-173278.9619.04
20min116892-168928.7368.932.008.869.061.99
217019-170198.8028.93
317712-177129.1609.29
417037-170378.8118.94
517322-173228.9589.09
617637-176379.1219.25
30min116595-165958.5828.741.938.768.921.94
216774-167748.6758.85
317446-174469.0229.21
416724-167248.6498.83
517165-171658.8779.06
616745-167458.6608.84
45min116305-163058.4328.651.468.668.881.45
216868-168688.7238.95
316774-167748.6758.91
416637-166378.6048.83
517022-170228.8039.04
616769-167698.6728.90
60min116570-165708.5698.691.558.848.971.50
216921-169218.7519.03
317075-170758.8309.11
417019-170198.8029.07
516810-168108.6938.98
616420-164208.4928.77
极限116833-168338.7058.662.109.028.992.08
216444-164448.5048.83
317043-170438.8149.15
416211-162118.3848.70
516882-168828.7319.06
617101-171018.8449.17
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%
111.043074843078293081713082493081863079840.11
211.073104373105093104730.02
单位质量响应值RSD%判断
27897.1028046.340.38数据可信
供试品溶液-X027066批-阿托伐他汀钙-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136357-3635710.73610.7212.2010.7410.7212.18
235038-3503810.34710.35
341355-4135512.21212.21
428702-287028.4768.48
539916-3991611.78711.79
636410-3641010.75210.75
10min190079-9007926.60026.416.3326.6626.476.32
295588-9558828.22728.28
392653-9265327.36027.43
478896-7889623.29823.35
589659-8965926.47626.54
689818-8981826.52326.58
15min1114980-11498033.95433.065.1434.1633.265.14
2119144-11914435.18335.40
3111225-11122532.84533.06
4101835-10183530.07230.25
5111570-11157032.94733.16
6112959-11295933.35733.56
20min1127894-12789437.76736.625.0838.1637.005.08
2130440-13044038.51938.93
3127433-12743337.63138.03
4113326-11332633.46533.81
5120137-12013735.47735.87
6124747-12474736.83837.23
30min1124897-12489736.88236.094.4237.4936.694.43
2128915-12891538.06938.69
3125523-12552337.06737.68
4113701-11370133.57634.11
5121014-12101435.73536.33
6119280-11928035.22335.82
45min1128110-12811037.83137.145.2738.6437.945.26
2136866-13686640.41741.25
3126334-12633437.30638.12
4116985-11698534.54635.26
5122726-12272636.24137.03
6123699-12369936.52837.32
60min1129704-12970438.30237.055.3939.3238.045.37
2135758-13575840.08941.15
3127667-12766737.70038.72
4118002-11800234.84635.75
5120906-12090635.70436.70
6120660-12066035.63136.63
极限1145798-14579843.05441.085.9644.2942.285.93
2148448-14844843.83745.12
3140682-14068241.54342.78
4125220-12522036.97838.08
5135118-13511839.90041.09
6139319-13931941.14142.33
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