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对照品来源自制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%
110.521826041820821816561822451819991821170.20
210.471809631812901811260.13
单位质量响应值RSD%判断
17311.5017299.520.05数据可信
加速6月-供试品溶液-2024012021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%
5min18898-88984.6165.5414.564.625.5414.54
28902-89024.6184.62
312079-120796.2666.27
411010-110105.7125.71
512592-125926.5326.53
610556-105565.4765.48
10min117322-173228.9869.532.879.019.562.89
218666-186669.6839.71
318513-185139.6049.64
418759-187599.7329.76
518533-185339.6149.65
618401-184019.5469.58
15min118461-184619.5779.662.689.659.742.63
218929-189299.8209.90
318839-188399.7739.86
419274-192749.99910.08
517872-178729.2719.36
618340-183409.5149.60
20min117974-179749.3249.582.559.459.722.51
219021-190219.86710.00
318271-182719.4789.62
418867-188679.7889.93
517935-179359.3049.45
618734-187349.7199.85
30min117270-172708.9599.242.189.149.432.17
218235-182359.4609.65
317945-179459.3099.50
418041-180419.3599.55
518018-180189.3479.54
617407-174079.0309.22
45min117103-171038.8729.062.329.109.302.32
217761-177619.2149.46
317568-175689.1149.36
418040-180409.3599.61
517317-173178.9839.23
616978-169788.8089.05
60min116998-169988.8188.922.699.109.222.64
217270-172708.9599.25
317172-171728.9089.21
418009-180099.3429.64
517148-171488.8969.19
616598-165988.6108.90
极限116644-166448.6348.652.508.969.002.40
217340-173408.9959.34
316343-163438.4788.83
416500-165008.5608.91
516999-169998.8189.16
616256-162568.4338.77
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
110.743032283026963026483023243020063025800.16
210.733017143018613017880.04
单位质量响应值RSD%判断
28173.1828125.630.12数据可信
加速6月-供试品溶液-2024012021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%
5min1140289-14028941.25240.224.3741.2540.224.36
2134766-13476639.62839.63
3144173-14417342.39442.39
4130169-13016938.27738.28
5141134-14113441.50141.50
6130106-13010638.25838.26
10min1211006-21100662.04763.461.8162.2863.681.81
2218241-21824164.17464.39
3220357-22035764.79765.03
4211039-21103962.05762.27
5217545-21754563.97064.20
6216590-21659063.68963.90
15min1241147-24114770.91072.342.5271.4872.922.50
2249410-24941073.34073.92
3249828-24982873.46374.06
4254231-25423174.75775.31
5237705-23770569.89870.48
6243783-24378371.68572.25
20min1249972-24997273.50577.022.7874.4778.002.74
2263613-26361377.51678.50
3261936-26193677.02378.03
4268085-26808578.83179.80
5258020-25802075.87276.85
6269961-26996179.38380.35
30min1261235-26123576.81780.432.3578.1981.832.33
2276379-27637981.27082.68
3275268-27526880.94382.37
4279238-27923882.11183.52
5272431-27243180.10981.50
6276608-27660881.33782.74
45min1278549-27854981.90884.272.3883.7186.122.34
2284733-28473383.72785.59
3283307-28330783.30785.19
4297045-29704587.34789.21
5283445-28344583.34885.19
6292313-29231385.95587.81
60min1286139-28613984.14086.172.6386.4088.492.59
2288535-28853584.84587.18
3287746-28774684.61386.96
4306253-30625390.05592.41
5291617-29161785.75188.05
6297967-29796787.61889.95
极限1293240-29324086.22887.471.8988.9590.271.85
2299687-29968788.12490.93
3289225-28922585.04787.86
4297428-29742887.46090.31
5300022-30002288.22291.00
6305212-30521289.74892.57
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对照品来源自制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%
110.521828141830331825791828901829251828480.10
210.471841421846211843820.19
单位质量响应值RSD%判断
17380.9917610.510.93数据可信
加速6月-供试品溶液-2024012021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%
5min111302-113025.8005.4012.535.805.4012.52
211605-116055.9555.96
38391-83914.3064.31
49469-94694.8594.86
511611-116115.9585.96
610803-108035.5445.54
10min118459-184599.4729.602.289.509.632.29
218682-186829.5879.62
318322-183229.4029.43
418478-184789.4829.51
518824-188249.6599.69
619501-1950110.00710.04
15min119170-191709.8379.681.519.929.761.50
218856-188569.6769.76
318637-186379.5649.64
419101-191019.8029.88
518426-184269.4559.54
618960-189609.7299.82
20min118223-182239.3519.452.219.499.592.19
218764-187649.6299.77
318332-183329.4079.54
418404-184049.4449.58
517810-178109.1399.28
618957-189579.7289.87
30min117805-178059.1379.142.309.339.332.28
217789-177899.1289.32
317397-173978.9279.11
417886-178869.1789.36
517467-174678.9639.15
618546-185469.5179.71
45min117878-178789.1749.121.379.429.361.37
217783-177839.1259.37
317332-173328.8949.13
417858-178589.1649.40
517709-177099.0879.33
618052-180529.2639.51
60min117614-176149.0398.862.589.339.162.50
217467-174678.9639.26
317225-172258.8399.12
417595-175959.0299.32
516420-164208.4268.72
617328-173288.8929.19
极限117073-170738.7618.771.719.109.111.68
217516-175168.9889.33
317042-170428.7459.07
417213-172138.8339.17
516615-166158.5268.86
617090-170908.7709.12
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
110.743024673024453034073023443027233026770.15
210.733062043060243061140.05
单位质量响应值RSD%判断
28182.2228528.800.87数据可信
加速6月-供试品溶液-2024012021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%
5min1130773-13077338.17638.754.9438.1838.754.93
2122688-12268835.81635.82
3129700-12970037.86337.86
4134758-13475839.33939.34
5141613-14161341.34141.34
6136901-13690139.96539.97
10min1220618-22061864.40462.533.9864.6262.743.98
2200641-20064158.57258.77
3208679-20867960.91961.13
4213712-21371262.38862.61
5223939-22393965.37465.60
6217548-21754863.50863.73
15min1250786-25078673.21170.584.6273.7871.154.61
2225467-22546765.82066.34
3231566-23156667.60068.15
4242664-24266470.84071.41
5254044-25404474.16274.75
6246215-24621571.87772.45
20min1264435-26443577.19674.534.7878.1775.484.77
2239487-23948769.91370.80
3242540-24254070.80471.73
4252821-25282173.80574.76
5266936-26693677.92678.93
6265557-26555777.52378.50
30min1281150-28115082.07578.716.3883.4880.086.34
2248934-24893472.67073.95
3249715-24971572.89874.22
4267150-26715077.98879.36
5288157-28815784.12185.56
6282655-28265582.51483.92
45min1302894-30289488.42383.676.6690.2885.486.62
2264286-26428677.15278.83
3263904-26390477.04178.76
4284988-28498883.19585.00
5307847-30784789.86991.77
6295834-29583486.36288.22
60min1308891-30889190.17384.436.1092.5386.706.07
2264091-26409177.09579.21
3272231-27223179.47181.62
4292021-29202185.24987.51
5303911-30391188.72091.12
6294215-29421585.88988.23
极限1311606-31160690.96687.683.6893.8290.423.73
2286310-28631083.58186.12
3288702-28870284.28086.87
4300562-30056287.74290.48
5312380-31238091.19294.09
6302483-30248388.30391.12
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对照品来源自制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%
110.521834001837361832971831921827561832760.20
210.471827861824081825970.15
单位质量响应值RSD%判断
17421.6717440.020.08数据可信
长期6月-供试品溶液-2024012021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%
5min19507-95074.8966.1613.324.906.1613.30
212767-127676.5756.58
313323-133236.8626.86
411734-117346.0436.04
513619-136197.0147.01
610797-107975.5615.56
10min117849-178499.1939.473.119.229.513.12
219022-190229.7979.83
319052-190529.8129.85
418003-180039.2729.31
518600-186009.5809.62
617835-178359.1869.22
15min118540-185409.5499.531.119.639.621.10
218395-183959.4749.57
318226-182269.3879.48
418523-185239.5409.63
518846-188469.7069.80
618471-184719.5139.60
20min118308-183089.4299.391.479.569.521.50
218438-184389.4969.64
318406-184069.4809.62
417951-179519.2459.38
518415-184159.4849.63
617824-178249.1809.31
30min117860-178609.1999.093.059.389.283.03
217721-177219.1279.32
318471-184719.5139.71
417324-173248.9229.11
517673-176739.1029.30
616864-168648.6868.87
45min117414-174148.9698.821.949.209.061.93
217108-171088.8119.06
317171-171718.8449.09
417033-170338.7739.01
517495-174959.0119.26
616563-165638.5318.76
60min117135-171358.8258.612.519.118.902.46
216776-167768.6408.94
316515-165158.5068.81
416298-162988.3948.68
517257-172578.8889.19
616278-162788.3848.67
极限116654-166548.5778.581.388.918.921.39
216556-165568.5278.87
317035-170358.7749.12
416551-165518.5248.86
516769-167698.6378.99
616365-163658.4298.76
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
110.743045923042473040733038053035973040630.13
210.733031153029283030220.05
单位质量响应值RSD%判断
28311.2728240.630.18数据可信
长期6月-供试品溶液-2024012021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%
5min1137669-13766940.30142.914.6040.3042.914.60
2140663-14066341.17741.18
3144876-14487642.41142.41
4155356-15535645.47845.48
5151441-15144144.33244.33
6149528-14952843.77243.77
10min1229420-22942067.16068.061.4167.3868.291.41
2234426-23442668.62568.85
3235589-23558968.96669.20
4235115-23511568.82769.08
5232727-23272768.12868.37
6227617-22761766.63266.88
15min1264266-26426677.36077.841.6977.9678.461.68
2262723-26272376.90977.52
3260023-26002376.11876.74
4266575-26657578.03678.67
5269660-26966078.94079.56
6272142-27214279.66680.28
20min1281383-28138382.37182.470.4483.4083.520.44
2280395-28039582.08283.12
3282259-28225982.62883.67
4280942-28094282.24283.31
5283873-28387383.10084.16
6281528-28152882.41483.47
30min1296773-29677386.87686.690.7488.3688.190.72
2299858-29985887.78089.27
3295913-29591386.62588.13
4293468-29346885.90987.43
5296131-29613186.68988.21
6294573-29457386.23287.75
45min1311048-31104891.05590.310.9893.0292.300.96
2307900-30790090.13492.11
3303582-30358288.87090.85
4309431-30943190.58292.58
5311886-31188691.30193.31
6307175-30717589.92291.91
60min1316715-31671592.71491.701.6095.1994.201.57
2314536-31453692.07694.56
3304797-30479789.22591.70
4313085-31308591.65294.16
5319246-31924693.45595.97
6311194-31119491.09893.59
极限1312840-31284091.58091.940.6594.5794.940.62
2315373-31537392.32195.31
3313780-31378091.85594.83
4316459-31645992.63995.65
5310798-31079890.98294.02
6315103-31510392.24295.24
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对照品来源自制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%
110.521823101834601837741833751842231834280.39
210.471815741817121816430.06
单位质量响应值RSD%判断
17436.1217348.900.36数据可信
长期6月-供试品溶液-2024012021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%
5min112343-123436.3716.414.046.376.424.05
211542-115425.9585.96
313070-130706.7466.75
412448-124486.4256.43
512642-126426.5256.53
612506-125066.4556.46
10min118291-182919.4419.532.209.489.572.18
217751-177519.1639.20
318901-189019.7569.79
418682-186829.6439.68
518528-185289.5649.60
618664-186649.6349.67
15min118277-182779.4349.441.359.529.531.33
217906-179069.2439.33
318476-184769.5379.63
418349-183499.4719.56
518125-181259.3569.45
618588-185889.5959.68
20min117600-176009.0859.412.929.229.552.91
217655-176559.1139.25
318708-187089.6579.80
418881-188819.7469.89
518365-183659.4809.62
618130-181309.3589.50
30min117561-175619.0658.991.589.269.181.56
217428-174288.9969.18
317349-173498.9559.15
417733-177339.1539.35
516926-169268.7378.93
617530-175309.0499.24
45min117324-173248.9428.811.659.189.051.63
216511-165118.5238.76
317120-171208.8379.08
417094-170948.8239.07
517118-171188.8369.08
617192-171928.8749.12
60min116822-168228.6838.623.268.978.913.21
216043-160438.2818.56
317672-176729.1229.42
416420-164208.4768.77
516628-166288.5838.87
616629-166298.5838.88
极限116882-168828.7148.612.909.058.952.84
216079-160798.3008.63
316869-168698.7079.06
417431-174318.9979.34
516417-164178.4748.81
616375-163758.4528.79
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
110.743029803045413044513039913049763041880.25
210.733015413007023011220.20
单位质量响应值RSD%判断
28322.9128063.560.66数据可信
长期6月-供试品溶液-2024012021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%
5min1139719-13971941.02242.733.0541.0242.723.06
2143191-14319142.04142.04
3148634-14863443.63943.64
4151451-15145144.46644.47
5142419-14241941.81441.81
6147715-14771543.36943.37
10min1228294-22829467.02868.271.7367.2668.501.73
2227657-22765766.84167.07
3234163-23416368.75168.99
4233415-23341568.53168.78
5233136-23313668.44968.68
6238418-23841870.00070.24
15min1259548-25954876.20477.591.3276.8078.211.32
2261384-26138476.74377.35
3265857-26585778.05678.68
4263227-26322777.28477.91
5267089-26708978.41879.03
6268541-26854178.84479.47
20min1273829-27382980.39782.841.8181.4283.891.80
2280273-28027382.28983.32
3284001-28400183.38384.44
4284140-28414083.42484.48
5289165-28916584.89985.95
6281566-28156682.66883.74
30min1292443-29244385.86287.321.5687.3388.821.54
2300529-30052988.23689.72
3290784-29078485.37586.90
4301748-30174888.59490.11
5298673-29867387.69189.21
6300191-30019188.13789.66
45min1309289-30928990.80891.040.9492.7693.040.93
2310922-31092291.28793.27
3304843-30484389.50291.50
4312386-31238691.71793.73
5312879-31287991.86293.87
6310238-31023891.08693.10
60min1314072-31407292.21292.250.7094.6694.750.69
2311495-31149591.45593.94
3317992-31799293.36395.86
4314378-31437892.30294.82
5314523-31452392.34594.86
6312724-31272491.81694.34
极限1318048-31804893.37993.702.2596.3496.712.19
2316472-31647292.91795.91
3317435-31743593.19996.21
4332545-33254597.636100.67
5319284-31928493.74296.77
6311030-31103091.31994.35
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原始图谱下载图谱(谢鑫慧 于 2024-08-20 11:02:22 完成)
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