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DJ333-221017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(%)99.67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%
110.031657221653151653511653741652871654100.11
210.091659841658151659000.08
单位质量响应值RSD%判断
16491.5316442.020.22数据可信
供试品溶液-2023121221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%
5min110139-101395.5235.373.715.525.373.71
29708-97085.2885.29
39199-91995.0115.01
410165-101655.5375.54
59913-99135.4005.40
610040-100405.4695.47
10min117547-175479.5599.881.949.599.911.93
218231-182319.9319.96
318042-180429.8289.86
418633-1863310.15010.18
518191-181919.9109.94
618145-181459.8859.91
15min119001-1900110.3519.933.0510.4310.013.01
217523-175239.5469.63
318489-1848910.07210.15
417801-178019.6979.78
518567-1856710.11410.20
617943-179439.7749.86
20min117309-173099.4299.832.859.579.972.78
218699-1869910.18610.32
317991-179919.8019.94
418524-1852410.09110.23
518049-180499.8329.97
617707-177079.6469.79
30min116819-168199.1629.512.389.369.702.33
217828-178289.7129.91
317852-178529.7259.92
417690-176909.6379.83
517407-174079.4839.68
617136-171369.3359.53
45min116814-168149.1599.391.649.409.641.63
217646-176469.6139.86
317345-173459.4499.70
417339-173399.4459.70
517264-172649.4059.65
617068-170689.2989.54
60min116054-160548.7459.113.149.049.413.08
217051-170519.2899.59
317123-171239.3289.63
417337-173379.4449.75
516242-162428.8489.15
616492-164928.9849.28
极限116548-165489.0159.162.059.369.511.99
217257-172579.4019.75
316697-166979.0969.45
417240-172409.3929.75
516609-166099.0489.40
616521-165219.0009.35
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%
110.732892852887952884872884342884602886920.13
210.782888822885992887400.07
单位质量响应值RSD%判断
26905.1326784.790.32数据可信
供试品溶液-2023121221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%
5min198480-9848030.30228.2616.5230.3028.2616.52
267208-6720820.68020.68
3108981-10898133.53333.53
481239-8123924.99725.00
5101333-10133331.18031.18
693883-9388328.88728.89
10min1213934-21393465.82667.032.3465.9967.182.34
2211712-21171265.14365.26
3215240-21524066.22866.41
4223324-22332468.71668.85
5224088-22408868.95169.12
6218762-21876267.31267.47
15min1256826-25682679.02477.522.4079.5678.042.40
2245158-24515875.43475.91
3246703-24670375.90976.46
4252274-25227477.62378.14
5260859-26085980.26580.82
6249747-24974776.84677.38
20min1263712-26371281.14382.863.3282.1283.823.28
2268319-26831982.56083.46
3257237-25723779.15080.13
4279407-27940785.97286.92
5279936-27993686.13587.14
6267171-26717182.20783.17
30min1270037-27003783.08985.483.2084.5186.903.18
2271882-27188283.65785.01
3269221-26922182.83884.25
4288219-28821988.68390.11
5288548-28854888.78590.27
6278969-27896985.83787.26
45min1288241-28824188.69088.262.9890.5890.162.95
2284250-28425087.46289.28
3271700-27170083.60185.48
4290154-29015489.27991.20
5297160-29716091.43493.41
6289626-28962689.11691.01
60min1280296-28029686.24687.042.4988.6289.432.47
2277082-27708285.25787.56
3274158-27415884.35786.70
4293234-29323490.22692.64
5286107-28610788.03490.52
6286423-28642388.13190.52
极限1310707-31070795.60394.821.6798.4697.681.67
2306932-30693294.44197.22
3301378-30137892.73295.54
4315055-31505596.94199.86
5311221-31122195.76198.73
6303611-30361193.41996.30
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DJ333-221017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(%)99.67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%
110.031654921655291651761652951654261653840.09
210.091664941664371664660.03
单位质量响应值RSD%判断
16488.9316498.120.04数据可信
供试品溶液-2023121421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%
5min112230-122306.6526.497.556.656.487.57
212359-123596.7226.72
310268-102685.5845.58
412927-129277.0317.03
511956-119566.5026.50
611808-118086.4226.42
10min118614-1861410.12410.152.7010.1610.182.72
219220-1922010.45310.49
317967-179679.7729.80
419101-1910110.38810.43
518171-181719.8839.92
618852-1885210.25310.29
15min117599-175999.5729.952.129.6610.042.12
218620-1862010.12710.22
318329-183299.96910.05
418520-1852010.07210.17
518110-181109.8499.94
618564-1856410.09610.19
20min118048-180489.81610.002.149.9610.142.12
219108-1910810.39210.54
318349-183499.97910.12
418335-183359.97210.12
518023-180239.8029.95
618408-1840810.01210.16
30min117090-170909.2959.542.279.509.742.22
218268-182689.93510.14
317565-175659.5539.75
417298-172989.4089.62
517501-175019.5189.72
617518-175189.5279.73
45min116929-169299.2079.524.359.469.784.27
218561-1856110.09510.36
316799-167999.1369.39
417206-172069.3589.62
517143-171439.3249.58
618354-183549.98210.24
60min116140-161408.7789.283.119.089.583.07
217797-177979.67910.00
317125-171259.3149.61
417134-171349.3199.63
517012-170129.2529.56
617131-171319.3179.63
极限116945-169459.2169.321.879.579.681.87
217533-175339.5369.91
316907-169079.1959.55
417041-170419.2689.63
516844-168449.1619.52
617545-175459.5429.91
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%
110.732880312880672878932878682881922880100.05
210.782887492887062887280.02
单位质量响应值RSD%判断
26841.5726783.670.16数据可信
供试品溶液-2023121421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%
5min196096-9609629.60430.1624.3029.6030.1624.30
2113087-11308734.83834.84
353686-5368616.53916.54
4122272-12227237.66837.67
597581-9758130.06130.06
6104732-10473232.26432.26
10min1208972-20897264.37767.474.5564.5467.644.59
2220806-22080668.02268.22
3205316-20531663.25163.34
4231689-23168971.37571.58
5223193-22319368.75868.92
6224084-22408469.03269.21
15min1238299-23829973.41178.383.9073.9378.923.91
2250916-25091677.29877.87
3252710-25271077.85178.29
4265294-26529481.72882.33
5264342-26434281.43481.98
6254957-25495778.54379.11
20min1262529-26252980.87685.092.7981.8186.062.79
2273503-27350384.25785.26
3277987-27798785.63886.51
4281832-28183286.82287.88
5284396-28439687.61288.61
6276938-27693885.31586.31
30min1265580-26558081.81686.773.5083.1988.223.49
2279772-27977286.18887.66
3283051-28305187.19888.55
4287887-28788788.68890.23
5294835-29483590.82892.32
6278781-27878185.88287.36
45min1275681-27568184.92789.313.2286.7691.243.22
2287678-28767888.62390.57
3285607-28560787.98589.82
4290469-29046989.48391.52
5301579-30157992.90694.90
6298371-29837191.91793.87
60min1265750-26575081.86889.034.6684.1791.464.61
2283129-28312987.22289.66
3295894-29589491.15493.48
4300347-30034792.52695.06
5301311-30131192.82395.33
6287556-28755688.58691.05
极限1303283-30328393.43194.951.3096.1997.871.36
2305241-30524194.03496.96
3307915-30791594.85897.69
4312304-31230496.21099.26
5313514-31351496.58299.61
6306956-30695694.56297.52
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DJ333-221017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(%)99.67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%
110.031650241655661658621655511655371655080.19
210.091672031670211671120.08
单位质量响应值RSD%判断
16501.3016562.140.27数据可信
供试品溶液-2023121621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%
5min112457-124576.7596.643.086.766.643.06
212388-123886.7226.72
312056-120566.5426.54
412585-125856.8296.83
512417-124176.7386.74
611567-115676.2766.28
10min118557-1855710.0699.902.0510.119.942.04
218431-1843110.00110.04
318742-1874210.17010.21
418003-180039.7699.81
517892-178929.7089.75
617878-178789.7019.74
15min118408-184089.9889.962.1710.0810.052.16
218921-1892110.26710.36
318689-1868910.14110.23
418074-180749.8079.90
517845-178459.6839.77
618234-182349.8949.98
20min117862-178629.6929.831.939.849.981.90
218369-183699.96710.12
318678-1867810.13510.28
418112-181129.8289.97
517789-177899.6539.80
617882-178829.7039.85
30min117577-175779.5389.512.619.749.722.60
217928-179289.7289.93
318196-181969.87310.08
417345-173459.4129.61
517132-171329.2969.49
617030-170309.2419.44
45min117784-177849.6509.522.559.919.782.52
217896-178969.7119.97
318032-180329.78410.04
417467-174679.4789.73
516824-168249.1299.38
617312-173129.3949.64
60min116822-168229.1289.172.139.449.482.12
217133-171339.2979.61
317512-175129.5029.82
416678-166789.0509.36
516517-165178.9629.26
616789-167899.1109.41
极限117545-175459.5209.274.379.889.634.26
217963-179639.74710.11
317445-174459.4669.83
417144-171449.3039.66
515940-159408.6499.00
616493-164938.9499.30
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%
110.732856672868852876952871312873922869540.28
210.782892712891922892320.02
单位质量响应值RSD%判断
26743.1526830.430.24数据可信
供试品溶液-2023121621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%
5min178575-7857524.23031.1712.2124.2331.1712.21
2111066-11106634.24934.25
3112203-11220334.59934.60
499160-9916030.57730.58
5106023-10602332.69332.69
699439-9943930.66330.66
10min1210055-21005564.77367.173.0164.9167.343.03
2220097-22009767.87068.06
3229188-22918870.67370.87
4215646-21564666.49766.67
5213919-21391965.96466.15
6218018-21801867.22867.40
15min1256587-25658779.12279.012.0379.6279.562.04
2258017-25801779.56380.13
3264307-26430781.50282.09
4252710-25271077.92678.47
5248911-24891176.75577.30
6256802-25680279.18879.73
20min1267510-26751082.49083.692.3683.4284.682.36
2266801-26680182.27183.28
3282843-28284387.21888.26
4273664-27366484.38885.36
5265742-26574281.94582.92
6271944-27194483.85784.84
30min1283054-28305487.28386.712.3588.6888.162.34
2277886-27788685.68987.16
3293120-29312090.38791.91
4281694-28169486.86488.30
5275146-27514684.84586.27
6276298-27629885.20086.65
45min1297858-29785891.84889.502.8093.7391.432.76
2284519-28451987.73589.68
3300700-30070092.72494.75
4290169-29016989.47791.40
5278942-27894286.01587.92
6289185-28918589.17491.10
60min1288451-28845188.94788.272.7691.3390.702.73
2277840-27784085.67588.11
3299105-29910592.23394.77
4287721-28772188.72291.14
5278029-27802985.73488.11
6286400-28640088.31590.73
极限1308077-30807794.99994.492.7397.8897.402.69
2313018-31301896.52399.43
3313240-31324096.59199.64
4310928-31092895.87898.79
5291927-29192790.01992.87
6301297-30129792.90895.82
点击查看处理图标(人工保存)
 
原始图谱下载图谱(姜进硙 于 2024-06-26 20:03:54 完成)
生成报告数据部分(等待生成报告)
Current page cost:79 ms