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%
110.521809831811011809631810511810441810280.04
210.471819351826531822940.28
单位质量响应值RSD%判断
17207.9817411.080.83数据可信
长期6月-供试品溶液-2024011621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%
5min110968-109685.6895.398.105.695.398.13
210501-105015.4465.45
311412-114125.9195.92
49919-99195.1455.14
59010-90104.6734.67
610516-105165.4545.45
10min118112-181129.3949.313.359.439.343.36
218785-187859.7439.77
318167-181679.4239.46
417856-178569.2619.29
516938-169388.7858.81
617889-178899.2789.31
15min118561-185619.6279.902.889.719.982.87
219827-1982710.28410.37
319528-1952810.12810.21
419367-1936710.04510.12
518536-185369.6149.69
618763-187639.7329.81
20min118031-180319.3529.895.179.4910.025.09
218431-184319.5599.70
318939-189399.8239.96
418711-187119.7059.84
519420-1942010.07210.20
620829-2082910.80310.94
30min117107-171078.8739.171.699.069.361.66
217770-177709.2179.41
317733-177339.1979.39
417794-177949.2299.42
517978-179789.3259.51
617642-176429.1509.35
45min116864-168648.7478.972.028.999.211.98
217904-179049.2869.53
317339-173398.9939.24
417161-171618.9019.14
517132-171328.8869.12
617346-173468.9979.24
60min116662-166628.6428.821.138.939.111.12
217196-171968.9199.22
316961-169618.7979.09
417047-170478.8429.13
517039-170398.8379.12
617156-171568.8989.19
极限116335-163358.4728.641.598.818.981.57
216949-169498.7919.14
316607-166078.6138.96
416978-169788.8069.15
516436-164368.5258.86
616601-166018.6108.96
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%
110.743000953000843000112998922998422999850.04
210.733019273024423021840.13
单位质量响应值RSD%判断
27931.5628162.530.59数据可信
长期6月-供试品溶液-2024011621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%
5min1142011-14201141.91240.513.7641.9140.503.76
2138924-13892441.00141.00
3127135-12713537.52137.52
4138240-13824040.79940.80
5138014-13801440.73240.73
6139172-13917241.07441.07
10min1225162-22516266.45265.321.9066.6965.541.90
2225768-22576866.63166.86
3216402-21640263.86764.08
4218940-21894064.61664.84
5217436-21743664.17264.40
6224153-22415366.15466.38
15min1253328-25332874.76573.782.2875.3774.362.27
2245047-24504772.32172.92
3241450-24145071.25971.82
4250650-25065073.97574.56
5252698-25269874.57975.16
6256715-25671575.76576.36
20min1274704-27470481.07479.245.2582.0980.245.20
2256078-25607875.57776.58
3258517-25851776.29677.26
4262234-26223477.39378.39
5265383-26538378.32379.32
6294001-29400186.76987.79
30min1284966-28496684.10280.942.4485.5782.372.43
2270358-27035879.79181.21
3267515-26751578.95280.33
4268629-26862979.28180.71
5277658-27765881.94583.38
6276289-27628981.54183.04
45min1302364-30236489.23783.543.9591.1785.433.90
2281233-28123383.00184.86
3272942-27294280.55482.38
4271809-27180980.21982.09
5282745-28274583.44785.33
6287327-28732784.79986.75
60min1307842-30784290.85484.504.4993.2886.864.43
2279428-27942882.46884.79
3274273-27427380.94683.22
4275004-27500481.16283.47
5289923-28992385.56587.92
6291494-29149486.02988.45
极限1308644-30864491.09086.782.8594.0389.602.84
2288765-28876585.22388.01
3285231-28523184.18086.90
4290465-29046585.72588.49
5293040-29304086.48589.31
6298069-29806987.96990.87
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%
110.521811831811351811691810331810311811100.05
210.471821671821791821730.01
单位质量响应值RSD%判断
17215.7817399.520.76数据可信
长期6月-供试品溶液-2024011621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%
5min111802-118026.1225.3914.526.125.3914.53
29354-93544.8524.85
311908-119086.1776.18
49804-98045.0855.09
58198-81984.2524.25
611321-113215.8725.87
10min118206-182069.4449.232.429.489.262.46
217414-174149.0339.06
318310-183109.4989.53
417649-176499.1559.18
517250-172508.9488.97
617944-179449.3089.34
15min118190-181909.4359.521.199.529.601.15
218783-187839.7439.82
318288-182889.4869.57
418270-182709.4779.56
518323-183239.5049.58
618242-182429.4629.55
20min117847-178479.2589.341.329.409.481.27
217915-179159.2939.42
317746-177469.2059.34
418037-180379.3569.49
518415-184159.5529.68
618114-181149.3969.53
30min117737-177379.2009.121.419.399.311.38
217721-177219.1929.38
317106-171068.8739.06
417537-175379.0979.28
517739-177399.2029.38
617677-176779.1699.36
45min117381-173819.0168.941.739.269.181.67
217412-174129.0329.27
317338-173388.9939.23
417161-171618.9029.14
517421-174219.0379.27
616654-166548.6398.88
60min116392-163928.5038.641.978.798.921.89
217019-170198.8289.11
316260-162608.4348.72
417030-170308.8349.12
516753-167538.6908.97
616494-164948.5568.84
极限116473-164738.5458.671.548.889.001.48
217150-171508.8969.23
316511-165118.5658.90
416672-166728.6488.98
516884-168848.7589.09
616611-166118.6168.95
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%
110.742995552996772995382993992993672995070.05
210.733015783009223012500.16
单位质量响应值RSD%判断
27887.0628075.490.48数据可信
长期6月-供试品溶液-2024011621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%
5min1120316-12031635.59239.535.2835.5939.535.28
2137263-13726340.60640.61
3139648-13964841.31141.31
4132336-13233639.14839.15
5134066-13406639.66039.66
6138053-13805340.83940.84
10min1225385-22538566.67466.161.3166.8766.381.31
2221033-22103365.38765.61
3227462-22746267.28867.52
4221133-22113365.41665.63
5225918-22591866.83267.05
6221031-22103165.38665.61
15min1256236-25623675.80075.591.2276.3776.181.22
2259590-25959076.79377.38
3258581-25858176.49477.10
4252213-25221374.61075.19
5252642-25264274.73775.33
6253910-25391075.11275.70
20min1269290-26929079.66279.981.2780.6580.991.26
2266940-26694078.96779.98
3270904-27090480.14081.17
4267119-26711979.02080.02
5276064-27606481.66682.67
6271938-27193880.44681.45
30min1296754-29675487.78785.271.6989.2286.721.65
2284943-28494384.29385.75
3286173-28617384.65786.13
4283002-28300283.71885.15
5289461-28946185.62987.09
6289134-28913485.53286.99
45min1309247-30924791.48288.942.0393.4090.861.99
2297398-29739887.97789.90
3305158-30515890.27392.22
4298941-29894188.43490.33
5301214-30121489.10691.04
6291859-29185986.33988.27
60min1306268-30626890.60189.250.8993.0391.670.86
2300972-30097289.03491.45
3299773-29977388.68091.13
4303484-30348489.77892.17
5299498-29949888.59891.03
6300160-30016088.79491.20
极限1309538-30953891.56890.950.9194.5093.860.90
2309246-30924691.48294.39
3309076-30907691.43294.37
4302134-30213489.37892.27
5307558-30755890.98393.91
6307054-30705490.83493.74
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%
110.521811761811801812311810781811241811580.04
210.471811211815381813300.17
单位质量响应值RSD%判断
17220.3417319.010.41数据可信
长期6月-供试品溶液-2024011821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%
5min112446-124466.4706.089.996.476.089.95
212474-124746.4856.48
311370-113705.9115.91
49553-95534.9664.97
511614-116146.0376.04
612666-126666.5846.58
10min118483-184839.6089.532.719.649.562.75
218854-188549.8019.84
318178-181789.4509.48
417587-175879.1439.17
518855-188559.8029.84
618040-180409.3789.41
15min117861-178619.2859.472.859.379.552.84
219030-190309.8939.98
317636-176369.1689.25
417942-179429.3279.41
518591-185919.6649.75
618211-182119.4679.56
20min117840-178409.2749.272.559.419.412.55
218728-187289.7369.88
317514-175149.1059.24
417568-175689.1339.26
517609-176099.1549.30
617741-177419.2239.36
30min116811-168118.7398.962.048.939.162.02
217861-178619.2859.48
317255-172558.9709.16
417072-170728.8759.06
517336-173369.0129.20
617134-171348.9079.10
45min117312-173129.0008.961.359.249.201.34
217531-175319.1139.36
317422-174229.0579.29
417123-171238.9019.13
517139-171398.9109.15
616890-168908.7809.02
60min116651-166518.6568.741.498.959.031.50
217265-172658.9759.28
316707-167078.6858.97
416669-166698.6658.95
516616-166168.6388.93
616914-169148.7939.08
极限116773-167738.7198.641.299.068.981.28
216785-167858.7269.08
316871-168718.7709.11
416459-164598.5568.88
516342-163428.4958.84
616520-165208.5888.93
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%
110.742990712992522991482989802989392990780.05
210.732996022995492995760.02
单位质量响应值RSD%判断
27847.1127919.480.19数据可信
长期6月-供试品溶液-2024011821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%
5min1133572-13357239.65241.283.2439.6541.283.24
2140572-14057241.73041.73
3137980-13798040.96140.96
4134664-13466439.97639.98
5142553-14255342.31842.32
6145055-14505543.06143.06
10min1232623-23262369.05667.061.8369.2867.301.82
2228337-22833767.78468.02
3221655-22165565.80066.03
4223537-22353766.35966.58
5226580-22658067.26267.50
6222756-22275666.12766.37
15min1258393-25839376.70675.922.1977.3176.532.18
2262648-26264877.97078.58
3250382-25038274.32874.92
4247828-24782873.57074.16
5258715-25871576.80277.41
6256594-25659476.17276.78
20min1271439-27143980.57979.811.9881.6180.841.97
2276829-27682982.17983.22
3266358-26635879.07180.08
4261731-26173177.69778.70
5265826-26582678.91379.95
6270999-27099980.44981.48
30min1281120-28112083.45384.651.3684.9386.121.35
2288194-28819485.55387.05
3283963-28396384.29785.74
4282061-28206183.73385.16
5284312-28431284.40185.87
6291264-29126486.46587.94
45min1306533-30653390.99790.170.9692.9492.110.93
2303701-30370190.15792.13
3306948-30694891.12093.03
4303444-30344490.08091.98
5302977-30297789.94291.88
6298916-29891688.73690.69
60min1305234-30523490.61291.111.1293.0693.551.09
2309118-30911891.76594.24
3306414-30641490.96293.38
4307899-30789991.40393.80
5301498-30149889.50391.94
6311379-31137992.43694.89
极限1309078-30907891.75391.421.3694.7094.361.31
2308299-30829991.52294.51
3313981-31398193.20896.13
4308410-30841091.55494.46
5301025-30102589.36292.30
6306942-30694291.11994.08
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%
110.521824571825861828831830101831841828240.17
210.471818491822611820550.17
单位质量响应值RSD%判断
17378.7117388.250.04数据可信
长期6月-供试品溶液-2024011821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%
5min110571-105715.4596.096.845.466.086.83
211486-114865.9325.93
312042-120426.2196.22
411347-113475.8605.86
512584-125846.4996.50
612667-126676.5426.54
10min117634-176349.1079.391.969.149.421.93
218610-186109.6119.64
318192-181929.3959.43
418218-182189.4089.44
518488-184889.5489.58
617956-179569.2739.31
15min118379-183799.4929.531.449.579.621.43
218426-184269.5169.60
318308-183089.4559.54
418982-189829.8039.89
518274-182749.4379.53
618341-183419.4729.56
20min117848-178489.2179.261.559.359.401.54
218450-184509.5289.67
317627-176279.1039.24
417937-179379.2639.40
517947-179479.2699.41
617807-178079.1969.34
30min116981-169818.7709.012.368.959.202.36
217632-176329.1069.30
317084-170848.8239.01
418101-181019.3489.54
517598-175989.0889.28
617327-173278.9489.14
45min116629-166298.5888.742.698.828.982.65
217378-173788.9759.22
316512-165128.5278.77
417614-176149.0979.34
516631-166318.5898.83
616832-168328.6938.93
60min116358-163588.4488.662.178.738.952.15
217213-172138.8899.18
316792-167928.6728.96
417185-171858.8759.17
516687-166878.6188.91
616429-164298.4858.77
极限116410-164108.4758.591.948.808.931.93
216698-166988.6238.97
316525-165258.5348.87
417182-171828.8739.22
516712-167128.6318.97
616250-162508.3928.73
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%
110.743009263013303015613017593019303015010.13
210.733010163007763008960.06
单位质量响应值RSD%判断
28072.7228042.500.08数据可信
长期6月-供试品溶液-2024011821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%
5min1131691-13169138.85139.703.5538.8539.703.56
2128329-12832937.85937.86
3136182-13618240.17640.18
4133187-13318739.29239.29
5135628-13562840.01240.01
6142384-14238442.00542.01
10min1216351-21635163.82764.942.0564.0465.162.04
2223174-22317465.84066.05
3220272-22027264.98465.21
4216473-21647363.86364.08
5227516-22751667.12167.34
6217028-21702864.02664.26
15min1256092-25609275.55175.160.7676.1275.740.76
2253015-25301574.64375.22
3255233-25523375.29875.88
4254330-25433075.03175.60
5257527-25752775.97476.57
6252357-25235774.44975.04
20min1269942-26994279.63779.021.7780.6380.021.75
2272887-27288780.50681.50
3262012-26201277.29778.30
4263755-26375577.81278.80
5272883-27288380.50581.52
6265550-26555078.34179.34
30min1281405-28140583.01984.042.3484.4585.472.31
2283703-28370383.69785.13
3274736-27473681.05182.48
4292153-29215386.18987.61
5292139-29213986.18587.65
6285026-28502684.08785.52
45min1296538-29653887.48388.142.4089.3890.052.36
2303984-30398489.68091.58
3287232-28723284.73886.62
4307077-30707790.59292.49
5302225-30222589.16191.10
6295608-29560887.20989.11
60min1305059-30505989.99790.281.6092.3892.671.58
2310799-31079991.69094.09
3299535-29953588.36790.72
4309331-30933191.25793.66
5310246-31024691.52793.97
6301102-30110288.83091.22
极限1311883-31188392.01091.431.4794.8994.331.46
2309483-30948391.30294.21
3304377-30437789.79692.64
4311299-31129991.83894.75
5316894-31689493.48896.44
6305664-30566490.17593.06
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