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对照品来源自制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%
19.841659801659791659011656271657781658530.10
29.861658181657881658030.02
单位质量响应值RSD%判断
16854.9816815.720.17数据可信
供试品溶液-2024011221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%
5min111097-110975.9136.038.065.916.038.07
211269-112696.0046.00
311225-112255.9815.98
412029-120296.4096.41
512497-124976.6596.66
69834-98345.2405.24
10min116359-163598.7178.851.408.758.881.43
216751-167518.9258.96
316441-164418.7608.79
416605-166058.8488.88
516988-169889.0529.09
616484-164848.7838.81
15min116176-161768.6198.911.968.708.991.95
217100-171009.1119.19
316876-168768.9929.07
416601-166018.8458.93
516929-169299.0209.11
616621-166218.8568.93
20min116421-164218.7508.742.098.888.882.05
216382-163828.7298.86
316967-169679.0409.17
415889-158898.4668.60
516443-164438.7618.90
616346-163468.7108.84
30min115343-153438.1758.321.778.358.501.78
215442-154428.2288.41
315801-158018.4198.60
415581-155818.3028.48
516089-160898.5738.76
615485-154858.2518.43
45min114963-149637.9738.181.778.208.411.75
215393-153938.2028.43
315573-155738.2988.53
415309-153098.1578.38
515725-157258.3798.61
615200-152008.0998.32
60min115308-153088.1578.141.928.428.411.83
215266-152668.1348.41
315058-150588.0238.30
415759-157598.3978.67
514903-149037.9418.22
615352-153528.1808.45
极限115221-152218.1107.951.598.428.271.50
214789-147897.8808.20
315058-150588.0238.34
414634-146347.7978.12
515105-151058.0488.37
614726-147267.8468.16
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)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%
111.363239583239983236843234273236043237340.08
211.353229153233053231100.09
单位质量响应值RSD%判断
28497.7128467.840.08数据可信
供试品溶液-2024011221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%
5min1122315-12231573.35670.742.4973.3670.742.49
2117251-11725170.31970.32
3118585-11858571.11971.12
4116039-11603969.59269.59
5119605-11960571.73171.73
6113880-11388068.29768.30
10min1154351-15435192.56990.682.1292.9891.072.11
2152837-15283791.66192.05
3148797-14879789.23889.63
4145898-14589887.50087.89
5153071-15307191.80192.20
6152218-15221891.29091.67
15min1163420-16342098.00896.721.7898.9397.621.78
2164108-16410898.42199.32
3161998-16199897.15598.05
4157168-15716894.25995.13
5162683-16268397.56698.47
6158276-15827694.92395.81
20min1168608-168608101.11998.832.14102.59100.262.13
2165555-16555599.288100.74
3166786-166786100.027101.46
4158310-15831094.94396.34
5165326-16532699.151100.60
6164142-16414298.44199.85
30min1165849-16584999.46598.241.15101.49100.221.14
2161376-16137696.78298.78
3163684-16368498.166100.15
4161797-16179797.03598.96
5165420-16542099.208101.21
6164667-16466798.756100.72
45min1164257-16425798.51099.171.11101.09101.701.10
2166190-16619099.669102.21
3167554-167554100.487103.02
4163387-16338797.988100.45
5167106-167106100.219102.77
6163603-16360398.118100.63
60min1170136-170136102.03699.301.54105.16102.381.51
2163110-16311097.822100.91
3164310-16431098.542101.63
4165340-16534099.160102.17
5163914-16391498.304101.41
6166629-16662999.933102.99
极限1169204-169204101.47798.502.44105.17102.132.40
2164621-16462198.728102.36
3164636-16463698.737102.37
4157303-15730394.33997.90
5166612-16661299.922103.58
6163073-16307397.800101.41
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DJ333-221017对照品来源自制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%
19.841660921658921657831656281656531658100.12
29.861659381661141660260.08
单位质量响应值RSD%判断
16850.6116838.340.06数据可信
供试品溶液-2024011221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%
5min110617-106175.6545.7813.175.655.7713.15
28950-89504.7664.77
312511-125116.6636.66
410277-102775.4735.47
512565-125656.6916.69
610149-101495.4055.40
10min116179-161798.6168.743.548.658.783.57
215842-158428.4368.46
317448-174489.2929.33
416158-161588.6058.64
516712-167128.9008.94
616146-161468.5988.63
15min116481-164818.7778.761.708.868.841.76
216173-161738.6138.69
316914-169149.0079.10
416385-163858.7268.80
516540-165408.8088.89
616161-161618.6068.68
20min116314-163148.6888.651.058.828.781.09
216187-161878.6208.74
316169-161698.6118.75
416107-161078.5788.70
516546-165468.8118.95
616098-160988.5738.70
30min115145-151458.0658.241.468.248.411.48
215215-152158.1038.27
315674-156748.3478.53
415625-156258.3218.50
515586-155868.3008.48
615540-155408.2768.45
45min115265-152658.1298.100.798.358.320.71
215317-153178.1578.37
315155-151558.0718.30
415316-153168.1568.38
515003-150037.9908.22
615208-152088.0998.32
60min115003-150037.9908.080.748.268.340.75
215177-151778.0828.34
315327-153278.1628.44
415116-151168.0508.32
515246-152468.1198.39
615126-151268.0558.32
极限114965-149657.9697.952.698.288.262.57
215491-154918.2508.55
314891-148917.9308.25
414810-148107.8878.20
515131-151318.0588.38
614274-142747.6017.91
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)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%
111.363242893242633238693235943235343239100.12
211.353235993238043237020.05
单位质量响应值RSD%判断
28513.2028520.000.02数据可信
供试品溶液-2024011221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%
5min1116977-11697770.07271.763.3870.0771.763.38
2114877-11487768.81468.81
3121060-12106072.51772.52
4122271-12227173.24373.24
5125891-12589175.41175.41
6117676-11767670.49070.49
10min1149782-14978289.72290.932.0490.1191.332.04
2149825-14982589.74890.13
3157370-15737094.26894.67
4150320-15032090.04590.45
5153555-15355591.98292.40
6149972-14997289.83690.23
15min1158837-15883795.14695.772.1696.0396.682.16
2156595-15659593.80394.68
3165225-16522598.97399.90
4159744-15974495.69096.60
5162478-16247897.32798.26
6156403-15640393.68894.58
20min1163427-16342797.89698.261.5899.3199.701.59
2162511-16251197.34798.75
3165189-16518998.951100.43
4162045-16204597.06898.51
5168778-168778101.101102.57
6162282-16228297.21098.62
30min1160163-16016395.94197.651.7797.9099.631.76
2158958-15895895.21997.16
3164914-16491498.787100.81
4166262-16626299.594101.57
5164671-16467198.641100.67
6163130-16313097.71899.67
45min1162298-16229897.22098.481.0899.71101.001.06
2165483-16548399.128101.60
3163074-16307497.685100.26
4166992-166992100.031102.56
5165150-16515098.928101.51
6163419-16341997.891100.39
60min1162134-16213497.12199.082.30100.15102.152.28
2161224-16122496.57699.60
3170112-170112101.900105.02
4165274-16527499.002102.09
5169825-169825101.728104.86
6163847-16384798.148101.19
极限1162272-16227297.20497.912.47100.78101.532.41
2165672-16567299.241102.80
3165815-16581599.326103.01
4162503-16250397.342100.98
5167906-167906100.579104.27
6156494-15649493.74397.33
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对照品来源自制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%
19.841659661659001657911659561657851658800.06
29.861656171653941655060.10
单位质量响应值RSD%判断
16857.7216785.600.31数据可信
供试品溶液-2024011222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%
5min112580-125806.7086.914.016.716.913.99
212960-129606.9116.91
313326-133267.1067.11
412613-126136.7266.73
512449-124496.6396.64
613787-137877.3527.35
10min116895-168959.0099.201.279.059.241.25
217248-172489.1989.24
317294-172949.2229.26
417231-172319.1899.23
517312-173129.2329.27
617577-175779.3739.41
15min117316-173169.2349.132.409.329.222.40
217128-171289.1349.22
316922-169229.0249.11
417287-172879.2189.31
516450-164508.7728.86
617658-176589.4169.51
20min116961-169619.0458.951.919.189.091.87
217017-170179.0759.21
316311-163118.6988.84
417153-171539.1479.29
516550-165508.8258.96
616695-166958.9039.05
30min115212-152128.1128.442.728.308.632.67
216087-160878.5798.77
316050-160508.5598.75
416404-164048.7488.94
515693-156938.3688.55
615554-155548.2948.49
45min115390-153908.2078.341.158.448.581.10
215756-157568.4028.64
315707-157078.3768.61
415467-154678.2488.49
515862-158628.4598.69
615632-156328.3368.58
60min115337-153378.1798.091.328.468.381.26
214932-149327.9638.25
315338-153388.1798.46
415349-153498.1858.47
514940-149407.9678.25
615132-151328.0698.36
极限114885-148857.9388.041.958.268.371.86
214956-149567.9758.30
314679-146797.8288.16
415265-152658.1408.47
515467-154678.2488.57
615259-152598.1378.47
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)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%
111.363235923237563234833235983231923235240.07
211.353231903229773230840.05
单位质量响应值RSD%判断
28479.2328465.550.04数据可信
供试品溶液-2024011222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%
5min1105289-10528963.16865.833.3863.1765.833.38
2111615-11161566.96366.96
3107262-10726264.35264.35
4110658-11065866.38966.39
5107910-10791064.74164.74
6115647-11564769.38269.38
10min1140365-14036584.21285.761.2584.5686.121.26
2145630-14563087.37187.74
3141906-14190685.13685.49
4143926-14392686.34886.72
5143036-14303685.81486.17
6142799-14279985.67286.06
15min1155279-15527993.16092.542.2493.9893.382.23
2155497-15549793.29094.15
3150189-15018990.10690.94
4155308-15530893.17794.03
5150197-15019790.11190.95
6159012-15901295.39996.26
20min1158918-15891895.34394.682.0496.6896.042.02
2157818-15781894.68396.06
3152058-15205891.22792.56
4161916-16191697.14198.51
5158412-15841295.03996.38
6157796-15779694.67096.06
30min1152142-15214291.27894.472.3893.1496.362.33
2157674-15767494.59696.50
3160453-16045396.26498.10
4161761-16176197.04898.95
5158862-15886295.30997.17
6153934-15393492.35394.27
45min1159845-15984595.89996.160.8698.2798.560.83
2160053-16005396.02498.45
3160758-16075896.44798.82
4159689-15968995.80598.25
5162697-16269797.610100.00
6158612-15861295.15997.59
60min1162260-16226097.34895.151.83100.2598.091.75
2155944-15594493.55996.52
3160470-16047096.27499.18
4160055-16005596.02599.00
5158205-15820594.91597.85
6154652-15465292.78395.74
极限1158692-15869295.20794.931.5198.6598.401.46
2156786-15678694.06497.54
3156269-15626993.75497.20
4159538-15953895.71599.23
5162128-16212897.269100.73
6155968-15596893.57397.05
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对照品来源自制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%
19.841657291660111654661657811660071657990.14
29.861659691662501661100.12
单位质量响应值RSD%判断
16849.4916846.860.02数据可信
供试品溶液-2024011222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%
5min112500-125006.6556.828.946.666.828.91
210721-107215.7085.71
313435-134357.1537.15
414055-140557.4837.48
513014-130146.9296.93
613154-131547.0037.00
10min116972-169729.0369.102.469.079.142.47
216409-164098.7368.77
317258-172589.1889.23
417166-171669.1409.18
517097-170979.1039.14
617699-176999.4239.46
15min117133-171339.1229.082.009.219.171.99
216868-168688.9819.06
317033-170339.0699.16
417678-176789.4129.50
516689-166898.8868.97
616932-169329.0159.11
20min116631-166318.8558.851.898.998.991.86
216355-163558.7088.84
317041-170419.0739.21
416679-166798.8809.02
516186-161868.6188.76
616850-168508.9719.11
30min115273-152738.1328.210.668.328.400.63
215519-155198.2638.44
315417-154178.2088.40
415448-154488.2258.42
515541-155418.2748.46
615352-153528.1748.36
45min115160-151608.0718.131.358.308.361.28
215635-156358.3248.55
315153-151538.0688.30
415060-150608.0188.26
515250-152508.1198.35
615362-153628.1798.42
60min115035-150358.0058.031.618.288.301.63
214863-148637.9138.18
315336-153368.1658.45
415302-153028.1478.43
514739-147397.8478.12
615195-151958.0908.37
极限115432-154328.2168.041.228.548.371.15
215184-151848.0848.40
314927-149277.9478.27
414980-149807.9768.31
515110-151108.0458.37
615011-150117.9928.32
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)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%
111.363233933233843233343234253234693234010.02
211.353238303238813238560.02
单位质量响应值RSD%判断
28468.4028533.570.17数据可信
供试品溶液-2024011222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%
5min1114280-11428068.49467.684.2168.4967.684.21
2103467-10346762.01362.01
3116769-11676969.98569.99
4114993-11499368.92168.92
5114073-11407368.36968.37
6113936-11393668.28768.29
10min1144739-14473986.74986.252.4787.1386.622.48
2137291-13729182.28582.63
3145638-14563887.28887.68
4143305-14330585.89086.27
5144709-14470986.73187.11
6147723-14772388.53888.92
15min1156783-15678393.96892.861.8394.8393.721.83
2151918-15191891.05291.85
3154231-15423192.43893.31
4158948-15894895.26596.13
5151781-15178190.97091.83
6155945-15594593.46594.34
20min1159979-15997995.88394.691.1397.2796.061.13
2156136-15613693.58094.89
3158816-15881695.18696.57
4156176-15617693.60494.99
5156971-15697194.08095.45
6159825-15982595.79197.18
30min1155669-15566993.30093.201.8995.2295.101.86
2152489-15248991.39493.22
3152524-15252491.41593.33
4155040-15504092.92394.83
5160193-16019396.01197.90
6157104-15710494.16096.08
45min1158173-15817394.80195.141.6897.2497.561.64
2158794-15879495.17397.51
3154423-15442392.55394.98
4158393-15839394.93397.36
5160084-16008495.94698.37
6162548-16254897.42399.87
60min1157803-15780394.57994.851.6197.5497.791.60
2154368-15436892.52095.38
3158263-15826394.85597.79
4160225-16022596.03198.98
5157157-15715794.19297.15
6161720-16172096.92799.91
极限1160536-16053696.21795.251.9499.7098.721.90
2156663-15666393.89697.27
3155058-15505892.93496.40
4157115-15711594.16797.65
5161374-16137496.719100.20
6162828-16282897.591101.12
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