依折麦布阿托伐他汀片项目信息
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%
19.871627431630391631601635191635821632090.22
29.821627691631551629620.17
单位质量响应值RSD%判断
16535.8716594.910.26数据可信
供试品溶液-2023121221批-依折麦布-shui(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%
5min147657-4765725.80726.9822.3925.8126.9822.39
264581-6458134.97134.97
354176-5417629.33729.34
437506-3750620.31020.31
557934-5793431.37231.37
637068-3706820.07320.07
10min1133354-13335472.21375.446.9772.3675.596.98
2155829-15582984.38384.58
3144800-14480078.41178.57
4132356-13235671.67271.78
5130185-13018570.49770.67
6139353-13935375.46175.57
15min1166546-16654690.18694.283.0290.7394.843.02
2177716-17771696.23596.90
3178392-17839296.60197.20
4175137-17513794.83895.35
5168538-16853891.26591.83
6178265-17826596.53297.06
20min1175503-17550395.03797.251.6196.0898.341.62
2182254-18225498.69299.89
3180697-18069797.84998.98
4182746-18274698.959100.00
5177029-17702995.86396.94
6179288-17928897.08698.15
30min1177360-17736096.04296.281.1197.6297.911.08
2175921-17592195.26397.01
3179880-17988097.40799.09
4179435-17943597.16698.75
5179034-17903496.94998.55
6175124-17512494.83196.44
45min1171252-17125292.73594.141.4394.8496.301.39
2173118-17311893.74596.02
3173303-17330393.84596.07
4177884-17788496.32698.45
5175585-17558595.08197.23
6171889-17188993.08095.21
60min1168562-16856291.27891.802.5593.9094.492.47
2167396-16739690.64793.44
3168106-16810691.03193.77
4170589-17058992.37695.04
5177521-17752196.12998.80
6164986-16498689.34291.99
极限1164991-16499189.34490.101.1792.4793.301.13
2163752-16375288.67391.97
3169135-16913591.58894.84
4167886-16788690.91294.09
5165996-16599689.88993.09
6166574-16657490.20293.35
依折麦布阿托伐他汀片项目信息
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%
110.852993842994612997143002543004452998520.16
210.842993952999942996940.15
单位质量响应值RSD%判断
27636.1327647.050.03数据可信
供试品溶液-2023121221批-阿托伐他汀-shui(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%
5min1112320-11232033.56441.5321.9833.5641.5321.98
2151087-15108745.14945.15
3155036-15503646.32946.33
4104574-10457431.24931.25
5125232-12523237.42237.42
6185617-18561755.46755.47
10min1267699-26769979.99584.687.3780.1884.917.39
2308166-30816692.08892.34
3296414-29641488.57688.83
4270879-27087980.94581.12
5256872-25687276.76076.97
6300298-30029889.73790.04
15min1307024-30702491.74693.882.4492.3894.582.51
2319607-31960795.50796.27
3319603-31960395.50596.25
4309359-30935992.44493.07
5305730-30573091.36091.99
6323615-32361596.70497.51
20min1315385-31538594.24596.601.5295.3997.821.58
2328168-32816898.06599.36
3327544-32754497.87899.16
4321634-32163496.11297.25
5320890-32089095.89097.03
6325918-32591897.39298.74
30min1320545-32054595.78797.611.4997.4599.371.48
2324848-32484897.07398.91
3334063-33406399.826101.65
4325639-32563997.30998.98
5330467-33046798.752100.43
6324239-32423996.89198.78
45min1320139-32013995.66698.181.5097.86100.481.47
2328980-32898098.307100.68
3330077-33007798.635101.01
4331565-33156599.080101.29
5334283-33428399.892102.12
6326303-32630397.50899.93
60min1317079-31707994.75197.823.1197.48100.673.01
2326104-32610497.448100.37
3329455-32945598.449101.38
4325365-32536597.22799.99
5345993-345993103.391106.17
6320114-32011495.65898.62
极限1320032-32003295.63497.651.7098.89101.041.71
2324099-32409996.849100.31
3336406-336406100.527104.00
4324340-32434096.921100.22
5328001-32800198.015101.37
6327771-32777197.946101.44
依折麦布阿托伐他汀片项目信息
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%
19.871632231640101644471646871649441642620.42
29.821644121650001647060.26
单位质量响应值RSD%判断
16642.5516772.510.56数据可信
供试品溶液-2023121421批-依折麦布-shui(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%
5min153504-5350428.72729.0313.5328.7329.0313.53
267374-6737436.17436.17
347165-4716525.32325.32
456192-5619230.17030.17
548337-4833725.95325.95
651809-5180927.81727.82
10min1141995-14199576.23970.686.2276.4070.846.22
2140763-14076375.57775.78
3123841-12384166.49166.63
4122715-12271565.88766.05
5130194-13019469.90270.05
6130386-13038670.00670.16
15min1173514-17351493.16188.244.0593.7488.804.04
2163502-16350287.78688.41
3159929-15992985.86786.38
4154462-15446282.93283.47
5166744-16674489.52690.06
6167954-16795490.17690.72
20min1173875-17387593.35591.831.1494.4692.871.16
2169758-16975891.14592.25
3169129-16912990.80791.79
4169448-16944890.97891.97
5172803-17280392.78093.81
6171201-17120191.91992.96
30min1168314-16831490.36991.720.9891.9993.280.91
2169226-16922690.85992.47
3171728-17172892.20293.69
4171882-17188292.28593.78
5172489-17248992.61194.16
6171378-17137892.01593.57
45min1164179-16417988.14988.541.6290.2790.601.55
2161997-16199786.97889.10
3162770-16277087.39389.40
4169317-16931790.90892.92
5166411-16641189.34891.41
6164773-16477388.46890.53
60min1155658-15565883.57484.062.2586.1986.622.17
2152243-15224381.74184.34
3153224-15322482.26784.76
4161055-16105586.47288.99
5159774-15977485.78488.34
6157433-15743384.52787.09
极限1151630-15163081.41282.431.0384.4985.460.95
2152109-15210981.66984.73
3154805-15480583.11686.06
4154848-15484883.13986.14
5152642-15264281.95584.99
6155174-15517483.31486.34
依折麦布阿托伐他汀片项目信息
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%
110.853001053009803016133019723023663014070.30
210.843017353029303023320.28
单位质量响应值RSD%判断
27779.4527890.410.29数据可信
供试品溶液-2023121421批-阿托伐他汀-shui(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%
5min1107588-10758831.92738.6218.7431.9338.6218.74
2172571-17257151.21151.21
3132758-13275839.39639.40
4140342-14034241.64741.65
5110804-11080432.88132.88
6116809-11680934.66334.66
10min1261298-26129877.54079.087.1177.7279.307.13
2291103-29110386.38586.67
3261577-26157777.62377.84
4283032-28303283.99084.22
5264709-26470978.55378.74
6237185-23718570.38570.58
15min1307530-30753091.26090.512.7091.8791.162.73
2310208-31020892.05492.82
3304662-30466290.40991.06
4311804-31180492.52893.23
5306720-30672091.01991.64
6289006-28900685.76386.35
20min1313390-31339092.99993.792.4194.1194.942.44
2318528-31852894.52395.80
3319093-31909394.69195.84
4323893-32389396.11597.33
5319265-31926594.74295.87
6302106-30210689.65090.71
30min1314351-31435193.28495.541.5694.9297.221.58
2322935-32293595.83197.63
3325958-32595896.72898.41
4325676-32567696.64598.39
5325640-32564096.63498.28
6317182-31718294.12495.68
45min1318123-31812394.40396.021.5196.5598.231.52
2321490-32149095.40297.74
3321695-32169595.46397.68
4331288-33128898.310100.59
5327634-32763497.22699.41
6321179-32117995.31097.39
60min1315806-31580693.71695.001.8996.3997.741.85
2315077-31507793.49996.36
3315048-31504893.49196.24
4327828-32782897.283100.11
5327422-32742297.16399.89
6319653-31965394.85797.47
极限1315741-31574193.69695.471.2496.8998.741.25
2323572-32357296.02099.40
3327268-32726897.117100.38
4323416-32341695.97499.34
5320496-32049695.10798.38
6319724-31972494.87898.02
依折麦布阿托伐他汀片项目信息
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%
19.871633131640351644321648141651261643440.44
29.821628951638041633500.40
单位质量响应值RSD%判断
16650.8616634.420.07数据可信
供试品溶液-2023121621批-依折麦布-shui(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%
5min163664-6366434.31531.7021.4934.3131.7021.49
270332-7033237.90937.91
335095-3509518.91618.92
458741-5874131.66131.66
567610-6761036.44136.44
657380-5738030.92830.93
10min1138070-13807074.41978.268.4874.6178.438.50
2161347-16134786.96587.18
3126011-12601167.91968.02
4153799-15379982.89783.07
5146840-14684079.14679.35
6145066-14506678.19078.36
15min1161705-16170587.15889.943.9187.7690.563.95
2169470-16947091.34492.04
3156179-15617984.18084.66
4170485-17048591.89192.53
5170119-17011991.69392.34
6173285-17328593.40094.01
20min1166776-16677689.89192.091.9990.9893.202.03
2170429-17042991.86093.06
3166882-16688289.94990.90
4173009-17300993.25194.40
5173450-17345093.48994.64
6174556-17455694.08595.21
30min1168389-16838990.76190.301.1792.3591.921.21
2170562-17056291.93293.64
3165601-16560189.25890.71
4165643-16564389.28190.95
5168473-16847390.80692.48
6166517-16651789.75291.40
45min1162273-16227387.46487.310.5789.5689.440.55
2163207-16320787.96890.19
3162513-16251387.59489.54
4161346-16134686.96589.13
5160575-16057586.54988.72
6162039-16203987.33889.48
60min1156422-15642284.31183.421.1786.8986.031.13
2154693-15469383.37986.09
3154460-15446083.25385.69
4151997-15199781.92684.57
5153976-15397682.99285.65
6157032-15703284.63987.27
极限1148798-14879880.20180.890.7783.2583.970.78
2149915-14991580.80383.98
3149833-14983380.75983.65
4149514-14951480.58783.69
5150229-15022980.97384.09
6152219-15221982.04585.15
依折麦布阿托伐他汀片项目信息
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%
110.852997813006613013163017553023833011790.34
210.842990643004692997660.34
单位质量响应值RSD%判断
27758.4327653.690.27数据可信
供试品溶液-2023121621批-阿托伐他汀-shui(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%
5min1130140-13014038.79954.3934.7638.8054.3934.76
2260904-26090477.78477.78
3109806-10980632.73732.74
4237589-23758970.83370.83
5140296-14029641.82741.83
6215879-21587964.36064.36
10min1280513-28051383.63084.899.4883.8585.209.55
2310863-31086392.67893.11
3258266-25826676.99777.18
4305215-30521590.99491.39
5247737-24773773.85874.09
6305919-30591991.20491.56
15min1308829-30882992.07192.313.5892.7593.083.68
2312653-31265393.21194.16
3302327-30232790.13390.74
4316351-31635194.31495.21
5292965-29296587.34287.98
6324698-32469896.80297.67
20min1312062-31206293.03594.431.7594.2395.721.85
2315575-31557594.08395.55
3312836-31283693.26694.38
4321552-32155295.86597.29
5312954-31295493.30194.43
6325471-32547197.03398.43
30min1320558-32055895.56894.981.0397.2896.801.08
2322972-32297296.28898.28
3313974-31397493.60595.23
4315886-31588694.17596.13
5319732-31973295.32296.97
6318438-31843894.93696.88
45min1320575-32057595.57395.830.3897.8198.170.44
2323101-32310196.32698.85
3321851-32185195.95498.10
4319760-31976095.33097.81
5321214-32121495.76497.94
6322195-32219596.05698.52
60min1320469-32046995.54295.111.1898.3197.981.12
2317383-31738394.62297.68
3318807-31880795.04697.73
4313017-31301793.32096.33
5320013-32001395.40698.11
6324367-32436796.70499.71
极限1312359-31235993.12494.631.2396.4398.031.18
2314822-31482293.85897.44
3317599-31759994.68697.90
4315896-31589694.17897.71
5321516-32151695.85499.09
6322268-32226896.07899.62
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