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%
110.521822201816021825251825001823811822460.21
210.491821881820731821300.05
单位质量响应值RSD%判断
17323.7617362.250.16数据可信
加速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%
5min18115-81154.2014.7710.524.204.7710.52
210160-101605.2595.26
38687-86874.4974.50
410195-101955.2775.28
59888-98885.1185.12
68265-82654.2784.28
10min117935-179359.2849.343.069.319.363.08
218819-188199.7429.77
317526-175269.0729.10
417942-179429.2889.32
518562-185629.6099.64
617444-174449.0309.05
15min118634-186349.6469.842.649.729.922.62
219045-190459.8599.94
318534-185349.5949.67
418780-187809.7219.80
519160-191609.91810.00
619907-1990710.30510.38
20min118906-189069.7879.793.439.929.923.39
219090-190909.88210.02
318476-184769.5649.69
418609-186099.6339.77
518310-183109.4789.61
620104-2010410.40710.54
30min117499-174999.0589.361.769.249.551.75
218300-183009.4739.67
318279-182799.4629.64
417951-179519.2929.48
518255-182559.4509.64
618256-182569.4509.64
45min117643-176439.1339.381.809.379.621.74
217859-178599.2459.49
318520-185209.5879.82
418220-182209.4319.67
518150-181509.3959.64
618376-183769.5129.75
60min117601-176019.1119.151.789.399.441.74
217863-178639.2479.54
317345-173458.9799.27
417307-173078.9599.25
517776-177769.2029.50
618121-181219.3809.67
极限117305-173058.9589.141.399.299.481.38
217901-179019.2669.61
317630-176309.1269.46
417527-175279.0739.41
517576-175769.0989.44
617958-179589.2969.64
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%
110.743021373022313022183022663021033021910.03
210.733004103009033006560.12
单位质量响应值RSD%判断
28136.9628020.130.30数据可信
加速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%
5min1133486-13348639.35139.304.3739.3539.304.37
2134781-13478139.73339.73
3127544-12754437.59937.60
4125512-12551237.00037.00
5138345-13834540.78440.78
6140241-14024141.34241.34
10min1223498-22349865.88664.492.1966.1064.712.19
2223435-22343565.86866.09
3216923-21692363.94864.16
4213520-21352062.94563.15
5213338-21333862.89163.12
6221917-22191765.42065.65
15min1256417-25641775.59173.472.7376.1874.042.73
2250205-25020573.75974.35
3247862-24786273.06973.63
4244785-24478572.16272.72
5239226-23922670.52371.10
6256784-25678475.69976.29
20min1275632-27563281.25578.014.1082.2678.994.07
2267455-26745578.84579.84
3266415-26641578.53879.51
4259313-25931376.44477.40
5245792-24579272.45973.43
6273066-27306680.49981.51
30min1280609-28060982.72281.953.8784.1883.363.83
2279627-27962782.43383.87
3284902-28490283.98885.39
4275287-27528781.15482.53
5258309-25830976.14877.52
6289118-28911885.23186.69
45min1297750-29775087.77686.524.2789.6988.394.23
2295773-29577387.19389.09
3305592-30559290.08791.96
4288753-28875385.12386.95
5270813-27081379.83581.63
6302222-30222289.09491.03
60min1303581-30358189.49487.454.9091.9089.804.85
2298725-29872588.06390.44
3308724-30872491.01193.38
4287995-28799584.90087.20
5271644-27164480.08082.32
6309127-30912791.12993.56
极限1306661-30666190.40289.813.4293.3092.653.41
2305003-30500389.91492.78
3316465-31646593.29396.17
4302745-30274589.24892.02
5285883-28588384.27786.96
6311206-31120691.74294.68
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%
110.521824261821561825761823531825851824190.10
210.491828371830641829500.09
单位质量响应值RSD%判断
17340.2117440.420.41数据可信
加速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%
5min112228-122286.3135.3410.746.315.3410.72
210186-101865.2585.26
39212-92124.7564.76
410924-109245.6395.64
510214-102145.2735.27
69359-93594.8314.83
10min118794-187949.7029.452.769.749.482.77
218731-187319.6709.70
317919-179199.2519.28
418449-184499.5249.56
518444-184449.5229.55
617489-174899.0299.06
15min118998-189989.8089.861.969.909.951.94
219074-190749.8479.93
319632-1963210.13510.21
419059-190599.8399.92
519365-193659.99710.08
618525-185259.5639.64
20min118605-186059.6059.671.429.759.811.39
218359-183599.4789.62
318994-189949.8059.94
418751-187519.6809.82
519059-190599.8399.98
618587-185879.5959.73
30min118364-183649.4809.341.299.689.531.30
217904-179049.2439.43
318388-183889.4939.68
418060-180609.3239.52
517941-179419.2629.45
617868-178689.2249.41
45min118105-181059.3479.474.289.609.714.19
217513-175139.0419.28
319769-1976910.20610.45
418248-182489.4209.66
518536-185369.5699.81
617846-178469.2139.45
60min117777-177779.1779.162.379.489.452.34
217375-173758.9709.26
317948-179489.2659.56
417911-179119.2469.54
518293-182939.4449.74
617134-171348.8459.13
极限117356-173568.9608.931.989.319.281.92
216774-167748.6599.00
317811-178119.1959.54
417127-171278.8429.19
517395-173958.9809.33
617332-173328.9479.28
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%
110.743010563012713012733014123013933012810.05
210.733014033021353017690.18
单位质量响应值RSD%判断
28052.2328123.860.19数据可信
加速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%
5min1143726-14372642.35540.194.6242.3640.204.62
2143546-14354642.30242.30
3135865-13586540.03940.04
4136058-13605840.09640.10
5129799-12979938.25138.25
6129350-12935038.11938.12
10min1225473-22547366.44665.561.6166.6865.781.61
2227566-22756667.06367.30
3222863-22286365.67765.90
4218104-21810464.27464.50
5219870-21987064.79565.01
6220833-22083365.07965.29
15min1256115-25611575.47675.291.4976.0875.871.49
2257797-25779775.97276.58
3260595-26059576.79677.38
4251833-25183374.21474.79
5256112-25611275.47576.05
6250366-25036673.78274.36
20min1268620-26862079.16179.521.2280.1880.531.19
2267517-26751778.83679.87
3272225-27222580.22381.24
4265479-26547978.23579.23
5274380-27438080.85981.85
6270895-27089579.83280.81
30min1284864-28486483.94883.830.8685.4185.280.86
2285706-28570684.19685.66
3284107-28410783.72585.18
4279935-27993582.49683.92
5287135-28713584.61786.06
6285038-28503883.99985.43
45min1301575-30157588.87390.784.1290.8092.694.04
2299132-29913288.15390.09
3330479-33047997.39199.32
4298338-29833887.91989.80
5315723-31572393.04294.95
6302978-30297889.28691.18
60min1309841-30984191.30991.152.5193.7393.572.47
2308255-30825590.84193.27
3310418-31041891.47993.94
4302501-30250189.14691.52
5323221-32322195.25297.68
6301659-30165988.89891.29
极限1309816-30981691.30190.991.7294.2393.911.70
2303782-30378289.52392.45
3312898-31289892.21095.18
4301360-30136088.80991.68
5315223-31522392.89595.85
6309440-30944091.19194.07
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%
110.521835161826091834861832661831071831970.21
210.491834981842101838540.28
单位质量响应值RSD%判断
17414.1617526.600.46数据可信
加速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%
5min110346-103465.3175.407.215.325.407.17
210743-107435.5215.52
39708-97084.9894.99
49862-98625.0685.07
511821-118216.0756.07
610561-105615.4275.43
10min118093-180939.2989.242.089.339.272.07
218543-185439.5299.56
317762-177629.1279.16
417752-177529.1229.15
518181-181819.3439.38
617506-175068.9969.03
15min118232-182329.3699.582.299.459.662.27
219374-193749.95610.04
318917-189179.7219.80
418587-185879.5519.63
518422-184229.4679.55
618364-183649.4379.52
20min118052-180529.2769.402.179.419.542.16
218888-188889.7069.84
318668-186689.5939.73
418035-180359.2689.40
518283-182839.3959.53
617887-178879.1929.32
30min117026-170268.7499.152.988.939.342.92
217581-175819.0349.23
318654-186549.5869.77
417869-178699.1829.37
517943-179439.2209.41
617776-177769.1359.32
45min117096-170968.7859.031.779.029.261.75
217769-177699.1319.37
317884-178849.1909.43
417594-175949.0419.28
517758-177589.1259.37
617286-172868.8839.12
60min116848-168488.6588.872.408.949.162.38
217696-176969.0949.39
317388-173888.9359.23
417117-171178.7969.08
517760-177609.1269.42
616805-168058.6368.92
极限116631-166318.5468.985.888.889.325.71
219467-1946710.00410.35
317371-173718.9279.27
417181-171818.8299.16
517422-174228.9539.30
616783-167838.6248.96
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%
110.743024043020513022613021453018843021490.07
210.733021753033063027400.27
单位质量响应值RSD%判断
28133.0528214.350.21数据可信
加速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%
5min1125716-12571636.93538.423.2336.9438.423.22
2134582-13458239.54039.54
3131490-13149038.63238.63
4136567-13656740.12340.12
5128864-12886437.86037.86
6127459-12745937.44737.45
10min1213913-21391362.84863.381.6863.0563.591.68
2213584-21358462.75162.97
3216008-21600863.46363.68
4220941-22094164.91265.14
5218759-21875964.27164.48
6211128-21112862.02962.24
15min1252222-25222274.10373.360.5874.6673.920.57
2248722-24872273.07473.64
3250534-25053473.60774.17
4249206-24920673.21773.80
5248801-24880173.09873.67
6248627-24862773.04773.60
20min1262964-26296477.25977.790.9478.2278.760.93
2262376-26237677.08678.06
3268220-26822078.80379.78
4263595-26359577.44478.43
5267501-26750178.59279.57
6263987-26398777.55978.52
30min1278281-27828181.75982.771.7383.1584.171.71
2275824-27582481.03782.44
3287366-28736684.42885.84
4282076-28207682.87484.29
5287519-28751984.47385.88
6279208-27920882.03183.42
45min1297287-29728787.34387.420.8589.1989.280.84
2295498-29549886.81788.67
3302412-30241288.84990.73
4297526-29752687.41389.29
5296528-29652887.12089.00
6295962-29596286.95488.80
60min1304598-30459889.49188.971.2191.8391.321.19
2298989-29898987.84390.18
3301374-30137488.54490.92
4303883-30388389.28191.65
5308669-30866990.68793.05
6299463-29946387.98290.31
极限1305809-30580989.84789.770.7992.6892.620.78
2303726-30372689.23592.06
3307333-30733390.29493.16
4304018-30401889.32092.18
5309307-30930790.87493.74
6303130-30313089.06091.88
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%
110.521821831815661820321820241821721819950.14
210.491835411837781836600.10
单位质量响应值RSD%判断
17299.9017508.100.85数据可信
加速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%
5min112291-122916.3406.469.026.346.469.03
214616-146167.5407.54
312077-120776.2306.23
412872-128726.6406.64
511615-116155.9925.99
611633-116336.0016.00
10min118482-184829.53410.015.719.5710.045.69
219486-1948610.05210.09
319309-193099.96110.00
421532-2153211.10711.14
518750-187509.6729.71
618843-188439.7209.75
15min119105-191059.8559.921.129.9410.011.18
219449-1944910.03310.13
319130-191309.8689.96
419555-1955510.08710.19
519064-190649.8349.92
619073-190739.8399.93
20min118997-189979.8009.641.259.949.791.19
218835-188359.7169.87
318378-183789.4809.63
418468-184689.5279.68
518682-186829.6379.78
618770-187709.6829.82
30min117651-176519.1059.242.629.309.452.55
218569-185699.5799.79
317853-178539.2099.41
417210-172108.8789.09
518192-181929.3849.58
618058-180589.3159.51
45min117923-179239.2469.261.029.499.511.01
217971-179719.2709.53
317655-176559.1079.36
418228-182289.4039.66
517950-179509.2599.51
617983-179839.2769.52
60min117394-173948.9739.052.269.279.352.21
217877-178779.2229.53
316805-168058.6698.97
417754-177549.1589.47
517640-176409.1009.40
617761-177619.1629.46
极限117189-171898.8678.994.389.229.354.23
217699-176999.1309.49
316060-160608.2858.63
417523-175239.0399.40
518252-182529.4159.76
617898-178989.2339.58
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%
110.743002023003733001522998052998833000830.08
210.733015553025843020700.25
单位质量响应值RSD%判断
27940.6928151.910.54数据可信
加速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%
5min1130163-13016338.41640.985.7538.4240.985.74
2153861-15386145.41045.41
3138925-13892541.00241.00
4135460-13546039.97939.98
5137778-13777840.66440.66
6136819-13681940.38040.38
10min1222181-22218165.57465.525.3965.7965.755.37
2219666-21966664.83265.08
3227873-22787367.25467.48
4241581-24158171.30071.52
5207149-20714961.13861.36
6213566-21356663.03163.26
15min1256504-25650475.70474.082.4076.2874.672.39
2250085-25008573.81074.42
3259365-25936576.54877.15
4249410-24941073.61074.23
5247782-24778273.13073.70
6242870-24287071.68072.25
20min1273509-27350980.72378.292.0981.7279.292.07
2266098-26609878.53679.56
3269857-26985779.64580.67
4260026-26002676.74477.77
5261160-26116077.07878.05
6260904-26090477.00377.98
30min1286192-28619284.46683.431.5885.9184.871.57
2284591-28459183.99485.45
3288288-28828885.08586.55
4276685-27668581.66083.11
5278855-27885582.30183.70
6281556-28155683.09884.50
45min1306699-30669990.51988.951.2192.4390.861.21
2300272-30027288.62290.55
3303821-30382189.66991.61
4300969-30096988.82790.73
5295927-29592787.33989.20
6300708-30070888.75090.61
60min1311046-31104691.80189.721.4194.2292.121.40
2305488-30548890.16192.58
3302860-30286089.38591.83
4303426-30342689.55391.95
5297914-29791487.92690.27
6303183-30318389.48191.84
极限1312709-31270992.29290.601.7695.2293.491.73
2307094-30709490.63593.55
3304968-30496890.00892.94
4308660-30866091.09794.00
5297519-29751987.80990.64
6310901-31090191.75994.61
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