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对照品来源工作对照品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%
19.481672561673891674211676821675551674610.10
29.541677131683771680450.28
单位质量响应值RSD%判断
17664.6617614.780.20数据可信
中间条件6月-供试品溶液-2023121221批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min158341-5834129.69225.9417.8629.6925.9417.87
253946-5394627.45527.46
335199-3519917.91417.91
445083-4508322.94422.94
555344-5534428.16728.17
657920-5792029.47829.48
10min1126883-12688364.57666.815.5064.7466.965.51
2134660-13466068.53468.69
3128256-12825665.27465.37
4120651-12065161.40461.53
5138630-13863070.55470.71
6138580-13858070.52970.69
15min1162311-16231182.60684.083.4283.1384.593.42
2169309-16930986.16886.70
3168648-16864885.83186.29
4155278-15527879.02779.50
5170016-17001686.52887.08
6165638-16563884.29984.86
20min1173852-17385288.48089.871.9589.4690.861.96
2181388-18138892.31593.33
3177618-17761890.39691.34
4171553-17155387.31088.22
5177563-17756390.36891.40
6177551-17755190.36291.39
30min1180086-18008691.65393.381.2193.1394.871.22
2184446-18444693.87295.40
3185304-18530494.30895.75
4181357-18135792.29993.69
5185265-18526594.28895.82
6184464-18446493.88195.41
45min1183147-18314793.21094.190.8595.1996.200.86
2185858-18585894.59096.64
3187099-18709995.22297.19
4183297-18329793.28795.19
5185838-18583894.58096.63
6185247-18524794.27996.33
60min1183890-18389093.58994.001.4896.0996.521.50
2185367-18536794.34096.91
3185700-18570094.51097.00
4179693-17969391.45393.88
5187654-18765495.50498.08
6185871-18587194.59797.17
极限1182188-18218892.72293.030.8895.7496.080.89
2181582-18158292.41495.51
3184930-18493094.11897.14
4180656-18065691.94394.87
5183586-18358693.43496.54
6183845-18384593.56696.66
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%
110.923016993017813019083019823021043018950.06
211.013024773035143029960.25
单位质量响应值RSD%判断
27646.0627520.070.33数据可信
中间条件6月-供试品溶液-2023121221批-阿托伐他汀钙-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1122942-12294236.81663.6826.7236.8263.6826.72
2267717-26771780.17180.17
3250999-25099975.16475.16
4258097-25809777.29077.29
5200763-20076360.12160.12
6175430-17543052.53452.53
10min1295868-29586888.60193.943.3188.8194.293.39
2321974-32197496.41996.86
3320053-32005395.84396.26
4318238-31823895.30095.73
5319741-31974195.75096.08
6306321-30632191.73192.02
15min1323296-32329696.81498.621.7897.5199.501.85
2332524-33252499.578100.56
3333395-33339599.839100.79
4331345-33134599.225100.18
5334749-334749100.244101.11
6320736-32073696.04896.85
20min1325824-32582497.57198.961.1998.81100.381.28
2334656-334656100.216101.75
3329806-32980698.764100.27
4334573-334573100.191101.70
5331760-33176099.349100.77
6326133-32613397.66499.00
30min1326919-32691997.89999.190.9199.68101.160.96
2329890-32989098.789100.88
3332057-33205799.438101.49
4332293-33229399.509101.58
5335935-335935100.599102.57
6330246-33024698.896100.77
45min1328526-32852698.38199.140.82100.70101.660.86
2329782-32978298.757101.40
3333071-33307199.742102.35
4330126-33012698.860101.48
5335577-335577100.492103.03
6329216-32921698.587101.01
60min1330354-33035498.92898.871.34101.80101.941.29
2329090-32909098.550101.74
3330835-33083599.072102.23
4324315-32431597.120100.29
5337816-337816101.163104.25
6328485-32848598.368101.34
极限1327262-32726298.00297.860.98101.42101.480.92
2322576-32257696.599100.33
3328899-32889998.492102.20
4323681-32368196.930100.64
5331121-33112199.158102.81
6327191-32719197.981101.50
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对照品来源工作对照品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%
19.481674841676211675681674651675001675280.04
29.541688611694511691560.25
单位质量响应值RSD%判断
17671.7317731.240.24数据可信
中间条件6月-供试品溶液-2023121421批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145668-4566823.16127.4714.2923.1627.4714.29
260103-6010330.48230.48
360777-6077730.82430.82
443729-4372922.17822.18
554297-5429727.53727.54
660437-6043730.65130.65
10min1125522-12552263.66066.905.0163.7967.065.02
2135476-13547668.70868.88
3128762-12876265.30365.47
4127239-12723964.53164.65
5131128-13112866.50366.66
6143392-14339272.72372.89
15min1164295-16429583.32481.781.7483.8182.301.73
2162165-16216582.24482.80
3156555-15655579.39979.93
4159418-15941880.85181.33
5162082-16208282.20282.72
6162939-16293982.63783.21
20min1179159-17915990.86389.091.4091.8190.071.37
2175311-17531188.91189.92
3171913-17191387.18888.16
4177254-17725489.89790.83
5174659-17465988.58089.56
6175671-17567189.09490.13
30min1181088-18108891.84191.121.1693.2992.591.14
2180127-18012791.35492.86
3176354-17635489.44090.90
4181213-18121391.90493.33
5177900-17790090.22491.70
6181291-18129191.94493.47
45min1183485-18348593.05792.432.3095.0294.412.23
2175269-17526988.89090.90
3182856-18285692.73894.69
4188299-18829995.49897.44
5181934-18193492.27094.24
6181683-18168392.14394.18
60min1184021-18402193.32992.351.0695.8194.841.03
2181692-18169292.14794.65
3179883-17988391.23093.70
4184809-18480993.72896.20
5180685-18068591.63794.12
6181477-18147792.03894.59
极限1183824-18382493.22991.991.2596.2295.001.20
2181418-18141892.00895.02
3178852-17885290.70793.69
4184176-18417693.40796.40
5180933-18093391.76294.76
6179085-17908590.82593.89
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%
110.923014933017543014663014913013443015100.05
211.013041133049663045400.20
单位质量响应值RSD%判断
27610.8127660.310.13数据可信
中间条件6月-供试品溶液-2023121421批-阿托伐他汀钙-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1230701-23070168.95467.7523.4568.9567.7523.45
2265982-26598279.50079.50
3259982-25998277.70677.71
4124765-12476537.29137.29
5258676-25867677.31677.32
6219976-21997665.74965.75
10min1318531-31853195.20691.115.0095.5991.495.06
2310229-31022992.72593.17
3314812-31481294.09494.53
4276863-27686382.75282.96
5309675-30967592.55992.99
6298865-29886589.32889.69
15min1331121-33112198.96994.913.6499.8895.793.64
2316383-31638394.56495.52
3323884-32388496.80697.76
4314558-31455894.01894.69
5321966-32196696.23397.18
6297282-29728288.85589.72
20min1338764-338764101.25397.612.92102.7299.022.88
2323567-32356796.71198.19
3326520-32652097.59499.09
4332939-33293999.512100.70
5327055-32705597.75499.23
6310603-31060392.83694.19
30min1331386-33138699.04896.391.95101.0798.341.92
2321920-32192096.21998.24
3320045-32004595.65897.69
4327367-32736797.84799.59
5320971-32097195.93597.96
6313267-31326793.63395.50
45min1332245-33224599.30597.222.82101.8899.702.70
2310342-31034292.75895.31
3325946-32594697.42299.99
4336859-336859100.684102.97
5324235-32423596.91199.47
6321915-32191596.21798.61
60min1332517-33251799.38696.672.02102.5199.701.96
2321519-32151996.09999.17
3319297-31929795.43598.54
4330223-33022398.701101.55
5321183-32118395.99999.09
6315859-31585994.40797.33
极限1331918-33191899.20796.641.86102.89100.201.78
2319498-31949895.49599.10
3316093-31609394.47798.11
4329108-32910898.367101.76
5321318-32131896.03999.67
6322021-32202196.24999.70
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对照品来源工作对照品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%
19.481682431687651687901687351684541685970.15
29.541677731691661684700.59
单位质量响应值RSD%判断
17784.4917659.330.50数据可信
中间条件6月-供试品溶液-2023121621批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min149295-4929524.97222.3822.0724.9722.3822.07
247235-4723523.92823.93
352894-5289426.79526.80
446287-4628723.44823.45
544090-4409022.33522.34
625228-2522812.78012.78
10min1131059-13105966.39261.2414.9466.5361.3614.95
2123279-12327962.45162.58
3134455-13445568.11368.26
4117119-11711959.33059.46
5132881-13288167.31567.44
686567-8656743.85343.92
15min1159897-15989781.00179.217.8281.5179.687.87
2165378-16537883.77884.26
3165339-16533983.75884.29
4149029-14902975.49575.96
5163747-16374782.95183.45
6134821-13482168.29868.61
20min1174955-17495588.62986.624.1989.5987.534.26
2177079-17707989.70590.65
3176134-17613489.22690.22
4168764-16876485.49386.37
5171157-17115786.70587.66
6157890-15789079.98480.68
30min1180444-18044491.41091.451.6792.8692.841.72
2184088-18408893.25694.70
3184053-18405393.23894.73
4176589-17658989.45790.81
5179078-17907890.71892.16
6178934-17893490.64591.78
45min1181156-18115691.77092.381.6193.7394.271.57
2185308-18530893.87495.84
3184678-18467893.55595.56
4178355-17835590.35292.20
5179964-17996491.16793.11
6184666-18466693.54995.19
60min1173961-17396188.12690.611.7890.5993.021.70
2182668-18266892.53695.02
3179688-17968891.02793.55
4176978-17697889.65492.01
5178378-17837890.36392.81
6181543-18154391.96794.13
极限1177087-17708789.70990.391.1292.6793.301.13
2181298-18129891.84294.84
3178815-17881590.58593.62
4175427-17542788.86891.72
5179109-17910990.73493.69
6178860-17886090.60793.28
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100590-202005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%
110.923025263030923030773028573025603028220.09
211.013024753047343036040.53
单位质量响应值RSD%判断
27730.9527575.300.40数据可信
中间条件6月-供试品溶液-2023121621批-阿托伐他汀钙-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1252702-25270275.48359.3320.9875.4859.3320.98
2251105-25110575.00675.01
3161768-16176848.32148.32
4178546-17854653.33253.33
5175779-17577952.50652.51
6171799-17179951.31751.32
10min1311969-31196993.18689.003.7093.6189.333.76
2310457-31045792.73493.15
3291763-29176387.15087.42
4297039-29703988.72689.02
5284734-28473485.05185.34
6291757-29175787.14987.43
15min1321416-32141696.00894.682.9796.9495.512.99
2326555-32655597.54398.47
3319090-31909095.31396.07
4311861-31186193.15493.94
5300546-30054689.77490.54
6322430-32243096.31197.08
20min1330175-33017598.62496.683.34100.0998.033.34
2329704-32970498.48499.96
3332377-33237799.282100.56
4319254-31925495.36296.67
5303734-30373490.72691.99
6326761-32676197.60498.91
30min1329492-32949298.42098.022.98100.4499.912.96
2330401-33040198.692100.71
3341828-341828102.105103.94
4316547-31654794.55396.39
5317215-31721594.75396.52
6333512-33351299.621101.47
45min1327096-32709697.70598.143.27100.27100.573.23
2332593-33259399.346101.92
3342079-342079102.180104.58
4314666-31466693.99296.35
5318006-31800694.98997.28
6336871-336871100.624103.02
60min1314104-31410493.82496.172.8196.9399.152.76
2327481-32748197.820100.94
3332859-33285999.426102.39
4311576-31157693.06995.95
5316312-31631294.48397.30
6329508-32950898.425101.38
极限1319448-31944895.42095.862.3299.0599.372.30
2325587-32558797.254100.92
3329667-32966798.472101.99
4308524-30852492.15795.56
5317923-31792394.96598.31
6324401-32440196.899100.41
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对照品来源工作对照品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%
19.481684461685271686821689161692141687570.19
29.541667551681141674340.58
单位质量响应值RSD%判断
17801.3717550.731.01数据可信
长期6月-供试品溶液-2023121621批-依折麦布-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min142028-4202821.34723.2513.4221.3523.2513.42
238104-3810419.35419.35
353224-5322427.03327.03
453099-5309926.97026.97
543364-4336422.02522.03
644863-4486322.78722.79
10min1129692-12969265.87366.176.8465.9966.306.85
2120717-12071761.31461.42
3145413-14541373.85874.01
4135251-13525168.69668.85
5126039-12603964.01764.14
6124564-12456463.26863.39
15min1170583-17058386.64282.884.6587.1383.384.66
2157209-15720979.84980.30
3174694-17469488.73089.29
4160735-16073581.64082.17
5156560-15656079.51980.00
6159314-15931480.91881.40
20min1175470-17547089.12489.801.7290.0990.761.75
2175774-17577489.27890.17
3181014-18101491.94092.99
4180047-18004791.44992.43
5175250-17525089.01289.93
6173288-17328888.01688.94
30min1181852-18185292.36693.161.1493.8394.611.16
2184806-18480693.86695.25
3186272-18627294.61196.17
4184408-18440893.66495.16
5180820-18082091.84193.26
6182282-18228292.58494.00
45min1177737-17773790.27592.021.3192.2593.991.27
2180232-18023291.54393.45
3179579-17957991.21193.30
4182954-18295492.92594.94
5184017-18401793.46595.39
6182461-18246192.67594.61
60min1180924-18092491.89492.171.2794.3794.651.25
2179023-17902390.92993.35
3180150-18015091.50194.10
4184734-18473493.82996.36
5183863-18386393.38795.83
6180070-18007091.46093.91
极限1182209-18220992.54791.751.6195.5394.741.56
2180101-18010191.47694.40
3177978-17797890.39893.50
4183500-18350093.20396.25
5183448-18344893.17696.14
6176604-17660489.70092.65
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%
110.923016293017463019693023263025133020370.13
211.013007943028313018120.48
单位质量响应值RSD%判断
27659.0727412.530.64数据可信
长期6月-供试品溶液-2023121621批-阿托伐他汀钙-pH6.8(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1247085-24708574.12065.7216.4574.1265.7216.45
2183413-18341355.02055.02
3195661-19566158.69458.69
4269280-26928080.77880.78
5233852-23385270.15170.15
6185166-18516655.54655.55
10min1311942-31194293.57692.143.2393.9992.513.28
2299000-29900089.69490.00
3303679-30367991.09791.42
4320474-32047496.13696.58
5313760-31376094.12194.51
6294174-29417488.24688.55
15min1324884-32488497.45895.912.0998.3996.792.13
2309975-30997592.98693.79
3320761-32076196.22297.05
4322916-32291696.86897.85
5326577-32657797.96698.88
6313233-31323393.96394.76
20min1325249-32524997.56898.181.8499.0499.591.88
2324881-32488197.45898.78
3327035-32703598.10499.47
4334987-334987100.489102.01
5333040-33304099.905101.36
6318493-31849395.54196.86
30min1325710-32571097.70698.621.1899.72100.581.13
2331606-33160699.475101.34
3334431-334431100.322102.23
4329932-32993298.973101.05
5324458-32445897.33199.34
6326483-32648397.93899.79
45min1315534-31553494.65496.781.2397.2199.281.20
2324227-32422797.26199.68
3321753-32175396.51998.99
4324500-32450097.34399.97
5327196-32719698.152100.70
6322543-32254396.75699.15
60min1320575-32057596.16696.911.0499.2599.951.08
2322450-32245096.72899.68
3323052-32305296.90999.91
4327088-32708898.120101.29
5326597-32659797.972101.07
6318554-31855495.56098.49
极限1322499-32249996.74396.401.57100.3699.981.57
2324370-32437097.304100.80
3319470-31947095.83499.38
4323811-32381197.137100.85
5325904-32590497.764101.41
6312129-31212993.63297.10
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