依折麦布瑞舒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%
111.054557634557004556694577454584754566700.30
211.074561654570094565870.14
单位质量响应值RSD%判断
41327.6041245.440.15数据可信
供试品溶液-6041001批-瑞舒伐他汀钙-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%
5min1419035-41903586.28881.799.3586.2981.799.35
2346024-34602471.25471.25
3369186-36918676.02376.02
4451194-45119492.91092.91
5392435-39243580.81180.81
6405307-40530783.46183.46
10min1461585-46158595.05093.453.7495.1993.593.75
2430111-43011188.56988.69
3441603-44160390.93591.06
4477560-47756098.34098.49
5462873-46287395.31595.45
6449295-44929592.51992.66
15min1464087-46408795.56596.501.4195.8796.791.41
2458864-45886494.49094.76
3468398-46839896.45396.73
4473480-47348097.50097.82
5477324-47732498.29198.58
6469495-46949596.67996.97
20min1463769-46376995.50096.350.8895.9696.800.89
2462015-46201595.13995.56
3470111-47011196.80697.24
4472624-47262497.32397.80
5469230-46923096.62497.08
6469747-46974796.73197.19
30min1462017-46201795.13996.111.0295.7696.721.02
2459770-45977094.67695.26
3469024-46902496.58297.18
4471956-47195697.18697.83
5468821-46882196.54097.16
6468665-46866596.50897.12
45min1461551-46155195.04396.001.0695.8296.771.07
2458812-45881294.47995.22
3468299-46829996.43397.19
4471428-47142897.07797.88
5467456-46745696.25997.04
6469540-46954096.68897.46
60min1460835-46083594.89696.051.2695.8396.991.26
2458197-45819794.35295.25
3473846-47384697.57598.50
4470035-47003596.79097.76
5467315-46731596.23097.17
6468545-46854596.48397.42
极限1460389-46038994.80495.540.9995.9096.631.00
2456596-45659694.02395.08
3466047-46604795.96997.05
4469122-46912296.60297.73
5465588-46558895.87496.97
6465944-46594495.94897.05
依折麦布瑞舒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%
110.444097134101324099354103174102394100670.06
210.354091694087414089550.08
单位质量响应值RSD%判断
39278.4539512.560.43数据可信
供试品溶液-6041001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%
5min1182857-18285741.67031.8747.3041.6731.8747.30
278863-7886317.97217.97
376838-7683817.51017.51
4246407-24640756.15256.15
5145315-14531533.11533.11
6108897-10889724.81624.82
10min1400579-40057991.28574.7222.5391.3574.7722.55
2252992-25299257.65357.68
3254453-25445357.98658.01
4422054-42205496.17996.27
5349909-34990979.73879.79
6287317-28731765.47565.52
15min1415048-41504894.58392.094.6794.8092.274.71
2383101-38310187.30287.43
3384728-38472887.67387.80
4420682-42068295.86696.12
5426125-42612597.10797.29
6395091-39509190.03590.19
20min1413983-41398394.34094.261.3794.7294.591.42
2406377-40637792.60792.88
3411246-41124693.71693.99
4419385-41938595.57195.98
5420951-42095195.92896.28
6409772-40977293.38093.68
30min1413086-41308694.13594.451.0894.6794.941.12
2408465-40846593.08293.51
3415073-41507394.58895.02
4418375-41837595.34195.91
5420484-42048495.82196.33
6411326-41132693.73494.19
45min1412582-41258294.02194.360.9394.7195.000.96
2408289-40828993.04293.62
3415111-41511194.59795.18
4417490-41749095.13995.87
5418694-41869495.41396.08
6412186-41218693.93094.54
60min1411912-41191293.86894.471.3094.7295.281.31
2406840-40684092.71293.45
3421038-42103895.94896.69
4417055-41705595.04095.93
5419082-41908295.50296.33
6411516-41151693.77894.55
极限1410879-41087993.63294.010.9994.6494.981.03
2406827-40682792.70993.60
3413466-41346694.22295.13
4416579-41657994.93195.98
5417489-41748995.13996.13
6410049-41004993.44394.37
依折麦布瑞舒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%
111.054560104564434552254554854557694557860.11
211.074557404560184558790.05
单位质量响应值RSD%判断
41247.6041181.480.12数据可信
供试品溶液-6041301批-瑞舒伐他汀钙
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1453867-45386793.62491.796.6893.6291.796.68
2474044-47404497.78697.79
3406942-40694283.94483.94
4408185-40818584.20184.20
5465254-46525495.97395.97
6461488-46148895.19695.20
10min1467911-46791196.52197.912.4296.6898.072.43
2491487-491487101.384101.55
3458322-45832294.54394.68
4471765-47176597.31697.46
5481605-48160599.34699.51
6476824-47682498.36098.52
15min1469709-46970996.89299.061.7197.2199.371.72
2492314-492314101.555101.89
3474050-47405097.78798.08
4485674-485674100.185100.49
5482110-48211099.45099.78
6477355-47735598.46998.79
20min1467783-46778396.49598.921.9096.9799.401.90
2492306-492306101.553102.05
3473083-47308397.58898.05
4486269-486269100.308100.78
5482466-48246699.523100.01
6475286-47528698.04298.53
30min1465838-46583896.09398.751.8396.7399.401.83
2490770-490770101.236101.91
3473645-47364597.70498.33
4484435-48443599.930100.57
5481426-48142699.30999.97
6476205-47620598.23298.88
45min1465108-46510895.94398.742.1996.7499.552.18
2490727-490727101.228102.07
3472395-47239597.44698.23
4490972-490972101.278102.08
5479218-47921898.85399.68
6473657-47365797.70698.52
60min1465094-46509495.94098.301.7796.9099.281.77
2488734-488734100.816101.82
3471366-47136697.23498.18
4482147-48214799.458100.43
5478680-47868098.74299.73
6473186-47318697.60998.59
极限1464006-46400695.71598.662.5696.8399.802.55
2499330-499330103.002104.18
3470288-47028897.01198.12
4479846-47984698.983100.12
5482078-48207899.443100.60
6474078-47407897.79398.93
依折麦布瑞舒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%
110.444085854089664075764078144077984081480.15
210.354085684086814086240.02
单位质量响应值RSD%判断
39094.6439480.580.70数据可信
供试品溶液-6041301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%
5min1296206-29620667.68754.6337.4267.6954.6337.42
2300176-30017668.59468.59
3124075-12407528.35328.35
4123151-12315128.14228.14
5296976-29697667.86367.86
6293823-29382367.14267.14
10min1417736-41773695.45889.8810.5095.5789.9710.52
2422329-42232996.50896.62
3334259-33425976.38276.43
4346390-34639079.15579.20
5420317-42031796.04896.16
6418940-41894095.73395.85
15min1419572-41957295.87896.010.5396.1596.260.54
2423200-42320096.70796.98
3416894-41689495.26695.44
4421927-42192796.41696.59
5420207-42020796.02396.30
6419210-41921095.79596.07
20min1416949-41694995.27896.020.6695.7196.420.65
2423124-42312496.68997.13
3418122-41812295.54695.88
4423568-42356896.79197.13
5420778-42077896.15396.59
6418553-41855395.64596.08
30min1416369-41636995.14695.860.5095.7496.420.49
2422085-42208596.45297.05
3418898-41889895.72496.22
4421486-42148696.31596.82
5419613-41961395.88796.48
6418540-41854095.64296.23
45min1415705-41570594.99495.831.0795.7496.551.04
2420931-42093196.18896.95
3417444-41744495.39196.04
4427752-42775297.74798.41
5417278-41727895.35396.11
6417067-41706795.30596.06
60min1415165-41516594.87095.360.5195.7896.240.50
2419476-41947695.85696.77
3415712-41571294.99595.81
4420137-42013796.00796.83
5417531-41753195.41196.32
6415921-41592195.04395.95
极限1414700-41470094.76495.741.2495.8396.781.25
2428751-42875197.97599.05
3415113-41511394.85995.83
4418392-41839295.60896.59
5419877-41987795.94797.02
6416966-41696695.28296.35
依折麦布瑞舒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%
111.054554894561344562584553854550894556710.12
211.074558504553224555860.09
单位质量响应值RSD%判断
41237.1941155.010.15数据可信
供试品溶液-6042001批-瑞舒伐他汀钙
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1383442-38344279.13291.409.7479.1391.409.74
2469071-46907196.80496.80
3394181-39418181.34881.35
4487668-487668100.642100.64
5464286-46428695.81695.82
6458622-45862294.64794.65
10min1482023-48202399.477100.051.6399.61100.211.64
2485243-485243100.141100.30
3470763-47076397.15397.29
4492688-492688101.678101.85
5491002-491002101.330101.49
6487199-487199100.545100.70
15min1485890-485890100.275100.561.01100.57100.881.02
2484577-484577100.004100.33
3479489-47948998.95499.25
4492733-492733101.687102.02
5490508-490508101.228101.56
6490424-490424101.210101.54
20min1487342-487342100.574100.480.58101.04100.970.59
2484664-484664100.022100.52
3483587-48358799.799100.26
4490940-490940101.317101.82
5489238-489238100.966101.46
6485551-485551100.205100.70
30min1485689-485689100.233100.470.54100.87101.130.54
2483899-48389999.864100.53
3484604-484604100.009100.64
4490721-490721101.272101.95
5488317-488317100.776101.44
6487891-487891100.688101.35
45min1482486-48248699.572100.100.65100.37100.920.67
2482119-48211999.496100.32
3482826-48282699.642100.44
4489531-489531101.026101.87
5488126-488126100.736101.57
6485129-485129100.118100.95
60min1484800-484800100.050100.010.48101.02101.000.49
2482130-48213099.499100.49
3482078-48207899.488100.45
4487980-487980100.706101.72
5486039-486039100.305101.31
6484703-484703100.030101.03
极限1479945-47994599.04899.520.52100.18100.680.53
2480360-48036099.133100.29
3480410-48041099.144100.27
4485409-485409100.175101.36
5485094-485094100.110101.28
6482278-48227899.529100.69
依折麦布瑞舒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%
110.444079054077204081074080374081544079850.05
210.354078274078354078310.01
单位质量响应值RSD%判断
39079.0239403.960.59数据可信
供试品溶液-6042001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%
5min1111563-11156325.52356.3531.3825.5256.3431.38
2283463-28346364.85164.85
3196906-19690645.04845.05
4315858-31585872.26272.26
5289788-28978866.29866.30
6280144-28014464.09164.09
10min1344130-34413078.73090.326.9578.7790.426.98
2405734-40573492.82492.93
3384631-38463187.99688.07
4402279-40227992.03392.15
5418591-41859195.76595.88
6413474-41347494.59494.70
15min1394508-39450890.25595.182.6690.4395.432.69
2419294-41929495.92696.19
3417331-41733195.47795.70
4416986-41698695.39895.67
5422771-42277196.72196.99
6425394-42539497.32197.59
20min1408733-40873393.51095.801.3193.8396.201.34
2419477-41947795.96896.39
3421450-42145096.41996.80
4416807-41680795.35795.79
5421774-42177496.49396.92
6424095-42409597.02497.45
30min1414965-41496594.93696.100.9695.4296.660.98
2418843-41884395.82396.41
3424027-42402797.00997.55
4416599-41659995.30995.90
5420804-42080496.27196.86
6425117-42511797.25897.85
45min1415308-41530895.01495.920.8695.6596.640.87
2417858-41785895.59796.34
3422648-42264896.69397.40
4415327-41532795.01895.77
5421121-42112196.34497.10
6423223-42322396.82597.58
60min1418387-41838795.71895.890.8496.5296.770.83
2417383-41738395.48996.39
3422336-42233696.62297.49
4413724-41372494.65295.56
5419640-41964096.00596.92
6423299-42329996.84297.75
极限1416061-41606195.18695.540.9096.1496.580.90
2416150-41615095.20796.27
3420950-42095096.30597.33
4411953-41195394.24695.31
5418194-41819495.67496.75
6422315-42231596.61797.69
依折麦布瑞舒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%
111.054561804567994556814563174556934561340.11
211.074563764559204561480.08
单位质量响应值RSD%判断
41279.1041205.780.13数据可信
供试品溶液-6042201批-瑞舒伐他汀钙
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1456410-45641094.08593.057.8394.0893.057.83
2494741-494741101.987101.99
3473016-47301697.50897.51
4407249-40724983.95183.95
5410332-41033284.58684.59
6466468-46646896.15896.16
10min1481388-48138899.234100.342.9599.39100.502.96
2507140-507140104.542104.71
3493301-493301101.690101.85
4485902-485902100.164100.30
5463610-46361095.56995.71
6489249-489249100.854101.01
15min1478042-47804298.544101.542.6498.87101.862.64
2515839-515839106.336106.68
3493729-493729101.778102.11
4494343-494343101.904102.21
5484067-48406799.786100.09
6489424-489424100.890101.22
20min1476520-47652098.230101.331.9598.72101.821.95
2506195-506195104.348104.87
3491460-491460101.310101.81
4494628-494628101.963102.44
5491494-491494101.317101.78
6488930-488930100.789101.29
30min1477398-47739898.411101.331.8399.06101.991.83
2504132-504132103.922104.62
3491348-491348101.287101.96
4492834-492834101.593102.24
5496276-496276102.303102.94
6487248-487248100.442101.11
45min1474698-47469897.855101.072.0698.67101.902.05
2504322-504322103.962104.83
3489816-489816100.971101.81
4490908-490908101.196102.01
5496661-496661102.382103.19
6485309-485309100.042100.87
60min1475876-47587698.098100.931.9399.07101.921.93
2502677-502677103.622104.66
3489230-489230100.850101.86
4491031-491031101.222102.21
5495795-495795102.204103.18
6482968-48296899.560100.56
极限1472343-47234397.369100.481.9298.51101.651.91
2500188-500188103.109104.32
3486751-486751100.339101.52
4486778-486778100.345101.50
5493544-493544101.740102.89
6485091-48509199.997101.16
依折麦布瑞舒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%
110.444087204087544082854083604083834085000.06
210.354085794080354083070.10
单位质量响应值RSD%判断
39128.3539449.950.58数据可信
供试品溶液-6042201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%
5min1204579-20457946.74755.7024.3746.7555.7024.37
2311399-31139971.15571.16
3325052-32505274.27574.28
4184655-18465542.19442.19
5226987-22698751.86751.87
6209929-20992947.96947.97
10min1416105-41610595.08193.603.0195.1693.693.02
2417963-41796395.50595.62
3410036-41003693.69493.82
4389192-38919288.93189.00
5422616-42261696.56996.66
6401774-40177491.80691.89
15min1420946-42094696.18797.151.3796.4297.401.39
2432677-43267798.86899.15
3427466-42746697.67797.96
4423073-42307396.67396.89
5429705-42970598.18898.44
6417120-41712095.31395.55
20min1420361-42036196.05396.800.9596.4597.210.97
2425808-42580897.29897.74
3425747-42574797.28497.73
4423598-42359896.79397.17
5428630-42863097.94398.35
6417645-41764595.43395.82
30min1421141-42114196.23296.601.0196.7997.181.02
2424470-42447096.99297.60
3425020-42502097.11897.72
4423569-42356996.78697.33
5427333-42733397.64698.22
6415085-41508594.84895.40
45min1419012-41901295.74596.401.0696.4697.141.08
2423986-42398696.88297.65
3425014-42501497.11797.88
4421547-42154796.32497.03
5427003-42700397.57198.31
6414747-41474794.77195.48
60min1420503-42050396.08696.281.1296.9697.171.13
2423504-42350496.77297.70
3423858-42385896.85297.78
4421562-42156296.32897.19
5426088-42608897.36298.26
6412605-41260594.28195.15
极限1417036-41703695.29495.830.8496.3396.890.85
2420825-42082596.15997.25
3422011-42201196.43097.52
4418506-41850695.62996.65
5423781-42378196.83597.90
6414250-41425094.65795.68
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