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)1.5补液体积(ml)1.5
对照品批号101028-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.254810304810654807114814684814524811450.07
211.374801684805864803770.07
单位质量响应值RSD%判断
42768.4442249.520.87数据可信
长期24月-供试品溶液-2024030821批-依折麦布-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1423702-42370284.74375.2412.9384.7475.2412.93
2409540-40954081.91181.91
3310878-31087862.17862.18
4364969-36496972.99673.00
5329028-32902865.80865.81
6419103-41910383.82383.82
10min1499884-49988499.98097.092.63100.1297.212.65
2486059-48605997.21597.35
3466487-46648793.30093.40
4474038-47403894.81194.93
5492067-49206798.41798.53
6493961-49396198.79598.94
15min1501278-501278100.25999.261.08100.5799.551.09
2499248-49924899.853100.15
3490187-49018798.04198.30
4489154-48915497.83498.11
5500659-500659100.135100.41
6497224-49722499.44899.75
20min1501870-501870100.37799.380.86100.8599.830.87
2499311-49931199.865100.33
3493596-49359698.72299.14
4490850-49085098.17398.62
5500128-500128100.029100.47
6495497-49549799.10399.57
30min1499896-49989699.98399.300.70100.6299.910.70
2498388-49838899.681100.31
3496700-49670099.34399.93
4490498-49049898.10398.71
5498676-49867699.738100.35
6494604-49460498.92499.56
45min1499462-49946299.89699.320.67100.70100.100.67
2497389-49738999.481100.28
3497720-49772099.547100.30
4490374-49037498.07898.85
5498666-49866699.736100.51
6495763-49576399.15699.96
60min1497111-49711199.42599.190.95100.40100.140.93
2496669-49666999.337100.30
3502953-502953100.594101.51
4489097-48909797.82398.76
5496892-49689299.382100.32
6492737-49273798.55199.52
极限1497049-49704999.41398.870.72100.5599.980.72
2495904-49590499.184100.31
3496763-49676399.356100.44
4487616-48761697.52698.62
5495331-49533199.069100.17
6493287-49328798.66199.79
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)1.5补液体积(ml)0
对照品批号DSMF-387-240606对照品来源中检院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1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.434585924579804580074582064578334581240.07
211.614570104577934574020.13
单位质量响应值RSD%判断
40080.8439397.241.22数据可信
长期24月-供试品溶液-2024030821批-阿托伐他汀钙-pH7.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1228579-22857951.64243.7320.5851.6443.7320.59
2233995-23399552.86652.87
3168225-16822538.00738.01
4200299-20029945.25345.25
5127934-12793428.90428.90
6202260-20226045.69645.70
10min1420551-42055195.01492.822.8695.1092.902.87
2428252-42825296.75496.84
3402745-40274590.99191.05
4409358-40935892.48592.56
5396149-39614989.50189.55
6408099-40809992.20192.28
15min1431494-43149497.48796.621.1797.7396.851.18
2434254-43425498.11098.36
3425494-42549496.13196.35
4425943-42594396.23296.46
5428678-42867896.85097.05
6420070-42007094.90695.14
20min1432668-43266897.75296.491.2498.1696.881.25
2432988-43298897.82498.24
3425883-42588396.21996.59
4425450-42545096.12196.51
5426750-42675096.41596.77
6418770-41877094.61295.00
30min1429493-42949397.03596.221.1697.6096.771.17
2432037-43203797.60998.19
3425884-42588496.21996.75
4424756-42475695.96496.51
5425669-42566996.17196.69
6417556-41755694.33894.88
45min1429041-42904196.93296.191.0797.6696.901.08
2431638-43163897.51998.26
3425425-42542596.11596.81
4424809-42480995.97696.69
5425497-42549796.13296.81
6418234-41823494.49195.19
60min1428573-42857396.82796.221.2397.7297.091.23
2430810-43081097.33298.23
3430702-43070297.30898.16
4423829-42382995.75596.62
5424115-42411595.81996.66
6417282-41728294.27695.14
极限1427667-42766796.62295.811.0697.6896.841.07
2429601-42960197.05998.12
3423630-42363095.71096.73
4423178-42317895.60896.64
5423776-42377695.74396.74
6416573-41657394.11695.13
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)1.5补液体积(ml)1.5
对照品批号101028-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.254806314806254806394800054802404804280.07
211.374785454783764784600.03
单位质量响应值RSD%判断
42704.7142080.911.05数据可信
长期24月-供试品溶液-2024030921批-依折麦布
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1455753-45575391.40580.738.4991.4080.728.49
2428322-42832285.90385.90
3372968-37296874.80274.80
4389128-38912878.04378.04
5402096-40209680.64480.64
6366787-36678773.56273.56
10min1479755-47975596.21996.382.2296.3796.512.21
2489778-48977898.22998.37
3471238-47123894.51194.64
4485906-48590697.45297.58
5464993-46499393.25893.39
6491566-49156698.58898.71
15min1480348-48034896.33897.861.4296.6598.161.42
2499760-499760100.231100.54
3486611-48661197.59497.88
4488102-48810297.89398.19
5482287-48228796.72797.02
6490563-49056398.38698.67
20min1479871-47987196.24298.041.3196.7298.501.31
2499671-499671100.213100.69
3489467-48946798.16798.61
4487541-48754197.78098.24
5487005-48700597.67398.12
6489359-48935998.14598.60
30min1478535-47853595.97498.111.3796.6198.731.36
2498753-498753100.029100.67
3491198-49119898.51499.12
4486427-48642797.55798.18
5491774-49177498.62999.24
6488444-48844497.96198.58
45min1477795-47779595.82697.851.4096.6298.641.40
2498610-498610100.000100.81
3490875-49087598.44999.22
4485641-48564197.39998.18
5486528-48652897.57798.36
6487911-48791197.85498.63
60min1477854-47785495.83797.701.3896.7998.651.37
2497891-49789199.856100.83
3490367-49036798.34799.28
4485821-48582197.43598.38
5484063-48406397.08398.02
6486996-48699697.67198.61
极限1476321-47632195.53097.511.4696.6498.621.46
2497728-49772899.823100.96
3489098-48909898.09399.19
4483101-48310196.89098.00
5484473-48447397.16598.27
6486583-48658397.58898.69
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)1.5补液体积(ml)0
对照品批号DSMF-387-240606对照品来源中检院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1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.434576314578204581244578814576494578210.05
211.614564214555614559910.14
单位质量响应值RSD%判断
40054.3339275.711.39数据可信
长期24月-供试品溶液-2024030921批-阿托伐他汀钙
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1257387-25738758.26143.7824.0458.2643.7824.04
2229989-22998952.05952.06
3167651-16765137.94937.95
4211158-21115847.79747.80
5154467-15446734.96434.96
6139762-13976231.63631.64
10min1419709-41970995.00390.383.4195.1090.463.42
2395433-39543389.50889.59
3396272-39627289.69889.76
4410235-41023592.85992.94
5392687-39268788.88788.94
6381467-38146786.34786.40
15min1425905-42590596.40695.950.9396.6696.170.94
2423995-42399595.97396.21
3421627-42162795.43795.65
4430289-43028997.39897.63
5422503-42250395.63695.84
6418958-41895894.83395.03
20min1425034-42503496.20896.350.8496.6296.740.85
2426366-42636696.51096.91
3424057-42405795.98796.36
4431790-43179097.73898.13
5425824-42582496.38796.75
6420938-42093895.28195.64
30min1424241-42424196.02996.871.4996.6197.421.48
2427227-42722796.70597.26
3424709-42470996.13596.67
4429299-42929997.17497.73
5439994-43999499.595100.12
6422377-42237795.60796.12
45min1423472-42347295.85596.260.5996.5996.970.60
2427821-42782196.83997.56
3424515-42451596.09196.78
4428673-42867397.03297.75
5424922-42492296.18396.88
6422285-42228595.58696.26
60min1423381-42338195.83496.090.6796.7396.950.68
2426677-42667796.58097.46
3423395-42339595.83796.69
4429126-42912697.13598.02
5422636-42263695.66696.52
6421781-42178195.47296.30
极限1423949-42394995.96395.980.6697.0297.000.68
2427590-42759096.78797.83
3422876-42287695.72096.73
4426914-42691496.63497.68
5422393-42239395.61196.62
6420296-42029695.13696.13
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)1.5补液体积(ml)1.5
对照品批号101028-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.254792354793304789904789534790494791110.04
211.374819024815224817120.06
单位质量响应值RSD%判断
42587.6442366.930.37数据可信
长期24月-供试品溶液-2024031021批-依折麦布
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1486050-48605097.28390.598.9597.2890.598.95
2426042-42604285.27285.27
3438140-43814087.69487.69
4484990-48499097.07197.07
5391188-39118878.29678.30
6489205-48920597.91497.91
10min1506065-506065101.289100.751.69101.45100.911.69
2506498-506498101.375101.52
3505995-505995101.275101.42
4507493-507493101.575101.74
5486209-48620997.31597.45
6508102-508102101.696101.86
15min1507894-507894101.655101.601.27101.99101.921.27
2513274-513274102.732103.04
3512228-512228102.522102.84
4508916-508916101.859102.19
5495356-49535699.14599.44
6508097-508097101.695102.03
20min1506515-506515101.379101.991.64101.88102.481.63
2523414-523414104.761105.24
3512324-512324102.542103.03
4508010-508010101.678102.18
5497970-49797099.669100.13
6509314-509314101.939102.44
30min1504646-504646101.005101.460.88101.67102.120.88
2511259-511259102.328102.99
3511792-511792102.435103.09
4507565-507565101.589102.26
5499906-499906100.056100.68
6506455-506455101.367102.04
45min1504407-504407100.957101.281.01101.79102.101.01
2511448-511448102.366103.19
3510430-510430102.162102.99
4506357-506357101.347102.19
5497213-49721399.517100.31
6506172-506172101.310102.15
60min1504163-504163100.908101.150.89101.91102.150.89
2509888-509888102.054103.05
3509686-509686102.014103.01
4505116-505116101.099102.11
5497701-49770199.615100.57
6505761-505761101.228102.24
极限1505290-505290101.134100.930.85102.31102.100.85
2509262-509262101.929103.10
3506417-506417101.359102.53
4503139-503139100.703101.88
5496642-49664299.403100.53
6504908-504908101.057102.24
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)1.5补液体积(ml)0
对照品批号DSMF-387-240606对照品来源中检院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1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.434555984561254562464559814563474560590.07
211.614581664579324580490.04
单位质量响应值RSD%判断
39900.1739452.970.80数据可信
长期24月-供试品溶液-2024031021批-阿托伐他汀钙
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1278060-27806062.91850.2221.5562.9250.2221.55
2185799-18579942.04242.04
3161343-16134336.50836.51
4265560-26556060.08960.09
5193982-19398243.89343.89
6246890-24689055.86555.86
10min1417198-41719894.40193.023.5694.5193.113.57
2422345-42234595.56695.64
3398646-39864690.20390.26
4426065-42606596.40896.51
5388347-38834787.87387.95
6414030-41403093.68493.78
15min1431272-43127297.58696.941.6297.8597.181.63
2433346-43334698.05598.28
3427037-42703796.62796.84
4434015-43401598.20698.47
5415307-41530793.97394.19
6429597-42959797.20797.46
20min1431859-43185997.71997.941.9798.1498.341.97
2448159-448159101.407101.80
3429891-42989197.27397.65
4432501-43250197.86498.29
5422043-42204395.49795.87
6432704-43270497.91098.32
30min1430872-43087297.49597.440.4598.0898.000.46
2430914-43091497.50598.07
3430902-43090297.50298.04
4432598-43259897.88698.47
5426978-42697896.61497.15
6431419-43141997.61998.19
45min1429917-42991797.27997.280.6098.0398.000.61
2430987-43098797.52198.25
3430438-43043897.39798.09
4431917-43191797.73298.48
5424865-42486596.13696.83
6431339-43133997.60198.34
60min1430285-43028597.36297.160.5898.2798.050.59
2429661-42966197.22198.11
3429628-42962897.21498.07
4431505-43150597.63898.55
5424569-42456996.06996.93
6430706-43070697.45898.36
极限1431592-43159297.65897.100.6398.7398.150.65
2429172-42917297.11198.16
3427915-42791596.82697.85
4431268-43126897.58598.66
5424408-42440896.03397.05
6430389-43038997.38698.45
点击查看处理图标(人工保存)
 
原始图谱下载图谱(王丹 于 2026-04-09 11:32:29 完成)
生成报告数据部分(等待生成报告)
Current page cost:92 ms