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%
110.051723921724431724671724581723981724320.03
210.091730591730081730340.03
单位质量响应值RSD%判断
17157.4117149.060.04数据可信
供试品溶液-X027066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%
5min111181-111815.8526.278.855.856.288.88
212563-125636.5756.58
311565-115656.0536.05
413885-138857.2677.27
511155-111555.8385.84
611583-115836.0626.06
10min117138-171388.9708.923.309.008.963.30
217639-176399.2329.27
316527-165278.6508.68
417775-177759.3039.34
516552-165528.6638.70
616630-166308.7048.74
15min118055-180559.4499.263.069.539.343.04
217382-173829.0979.19
316797-167978.7918.87
417903-179039.3709.46
518313-183139.5849.67
617677-176779.2529.33
20min117895-178959.3669.112.119.509.242.08
216867-168678.8288.97
317181-171818.9929.12
417711-177119.2699.41
517385-173859.0999.23
617405-174059.1099.24
30min117407-174079.1109.181.109.309.371.08
217465-174659.1419.33
317387-173879.1009.28
417565-175659.1939.39
517911-179119.3749.56
617541-175419.1809.36
45min117567-175679.1949.081.469.439.321.45
217385-173859.0999.34
317013-170138.9049.14
417686-176869.2569.50
517151-171518.9769.21
617294-172949.0519.29
60min116969-169698.8818.961.619.179.241.59
217199-171999.0019.29
316711-167118.7469.03
417509-175099.1649.46
517268-172689.0389.32
617028-170288.9129.20
极限117326-173269.0688.911.239.419.251.23
216753-167538.7689.11
316924-169248.8589.19
417210-172109.0079.36
517026-170268.9119.25
616923-169238.8579.19
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%
111.043013963012203015003013023012363013310.04
211.073020513019163019840.04
单位质量响应值RSD%判断
27294.4727279.490.04数据可信
供试品溶液-X027066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%
5min154845-5484516.60215.826.4116.6015.826.42
253147-5314716.08816.09
353594-5359416.22316.22
448857-4885714.78914.79
547412-4741214.35214.35
655681-5568116.85516.86
10min1227405-22740568.83758.6113.9968.9358.6913.98
2209722-20972263.48563.57
3192939-19293958.40458.49
4187743-18774356.83156.91
5146517-14651744.35244.43
6197339-19733959.73659.83
15min1304557-30455792.19288.622.8392.6789.042.84
2289055-28905587.49987.94
3280859-28085985.01885.43
4295853-29585389.55789.96
5288840-28884087.43487.76
6297387-29738790.02290.45
20min1325234-32523498.45195.272.0299.4496.182.04
2306386-30638692.74693.67
3311611-31161194.32795.21
4316079-31607995.68096.58
5312341-31234194.54895.36
6316679-31667995.86196.79
30min1330014-33001499.898100.371.32101.43101.811.26
2329998-32999899.893101.34
3327807-32780799.230100.64
4330875-330875100.159101.59
5340231-340231102.991104.33
6330580-330580100.069101.53
45min1339363-339363102.728100.971.43104.82102.961.43
2333674-333674101.006103.00
3327758-32775899.215101.18
4338212-338212102.380104.36
5333638-333638100.995102.90
6328589-32858999.467101.48
60min1330943-330943100.179100.241.56102.84102.801.51
2333945-333945101.088103.65
3322900-32290097.745100.26
4335248-335248101.482104.03
5336314-336314101.805104.28
6327542-32754299.150101.72
极限1340682-340682103.127101.331.18106.34104.441.18
2329551-32955199.758102.88
3331580-331580100.372103.43
4334654-334654101.303104.42
5337131-337131102.052105.09
6334861-334861101.365104.48
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%
110.051730181732321733571734811734601733100.11
210.091730651744711737680.58
单位质量响应值RSD%判断
17244.7817221.800.10数据可信
供试品溶液-X027066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%
5min110064-100645.2435.878.205.245.878.23
211944-119446.2226.22
312513-125136.5196.52
410642-106425.5445.54
510776-107765.6145.61
611685-116856.0876.09
10min116809-168098.7568.872.758.798.902.76
217167-171678.9438.98
317496-174969.1149.15
416184-161848.4318.46
517198-171988.9598.99
617277-172779.0009.03
15min117029-170298.8719.333.338.959.423.34
218073-180739.4159.50
318646-186469.7139.80
417386-173869.0579.13
518158-181589.4599.54
618211-182119.4879.57
20min117186-171868.9539.312.159.089.442.18
218152-181529.4569.59
318156-181569.4589.60
417663-176639.2019.33
517926-179269.3389.47
618122-181229.4409.58
30min117386-173869.0579.261.569.239.441.60
218191-181919.4769.67
317773-177739.2599.45
417561-175619.1489.33
517868-178689.3089.49
617832-178329.2899.48
45min116956-169568.8339.162.189.069.402.18
217482-174829.1079.35
317700-177009.2219.47
417436-174369.0839.31
518016-180169.3859.62
617912-179129.3319.57
60min116579-165798.6378.851.378.919.141.40
216862-168628.7849.08
317056-170568.8859.18
417038-170388.8769.16
517213-172138.9679.26
617161-171618.9409.23
极限116586-165868.6408.811.388.969.151.44
216957-169578.8349.17
317170-171708.9459.29
416700-167008.7009.03
516973-169738.8429.18
617132-171328.9259.27
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%
111.043024863028253028603031323030183028640.09
211.073033053051813042430.44
单位质量响应值RSD%判断
27433.3327483.560.13数据可信
供试品溶液-X027066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%
5min147274-4727414.22114.5424.4714.2214.5424.47
250078-5007815.06415.06
370868-7086821.31821.32
438456-3845611.56811.57
541226-4122612.40212.40
642073-4207312.65612.66
10min1221135-22113566.52154.0124.1266.6054.0924.11
2144884-14488443.58443.67
3245167-24516773.75173.87
4140533-14053342.27542.34
5167899-16789950.50750.58
6157661-15766147.42747.50
15min1294156-29415688.48888.474.7188.9488.854.78
2283574-28357485.30485.63
3320671-32067196.46496.99
4284161-28416185.48185.78
5294490-29449088.58888.94
6287577-28757786.50886.84
20min1316426-31642695.18797.311.5896.1398.181.62
2323275-32327597.24798.05
3332297-33229799.961101.03
4322270-32227096.94597.72
5322636-32263697.05597.90
6324017-32401797.47098.28
30min1331931-33193199.851101.391.03101.32102.801.00
2341424-341424102.707104.05
3338780-338780101.911103.53
4339135-339135102.018103.33
5336329-336329101.174102.55
6334603-334603100.655102.01
45min1330162-33016299.319102.212.03101.34104.191.95
2334241-334241100.546102.46
3337838-337838101.628103.81
4343905-343905103.453105.33
5348179-348179104.739106.68
6344397-344397103.601105.52
60min1326539-32653998.229100.431.49100.80102.981.46
2328884-32888498.934101.40
3335940-335940101.057103.81
4336993-336993101.374103.83
5338993-338993101.975104.50
6335872-335872101.037103.53
极限1328577-32857798.842100.080.98101.96103.180.99
2328588-32858898.845101.86
3335324-335324100.872104.18
4333949-333949100.458103.48
5334040-334040100.485103.58
6335693-335693100.983104.03
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%
110.051752931753131752161753621752771752920.04
210.091727591731411729500.16
单位质量响应值RSD%判断
17441.9917140.731.24数据可信
供试品溶液-X027066批-依折麦布-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min110471-104715.4375.526.525.445.526.49
29929-99295.1555.16
311883-118836.1706.17
410861-108615.6395.64
510487-104875.4455.45
610142-101425.2665.27
10min116096-160968.3588.202.848.398.232.86
215015-150157.7967.82
315971-159718.2938.33
415488-154888.0428.07
516147-161478.3848.41
616027-160278.3228.35
15min116616-166168.6288.411.928.708.481.90
215933-159338.2738.34
316028-160288.3228.40
415849-158498.2298.31
516236-162368.4308.51
616486-164868.5608.64
20min115988-159888.3018.371.638.438.491.56
216432-164328.5328.65
315910-159108.2618.39
416369-163698.4998.62
515780-157808.1938.32
616208-162088.4168.54
30min115888-158888.2508.231.498.428.401.46
216105-161058.3628.53
315886-158868.2488.42
415502-155028.0498.22
515669-156698.1368.30
616090-160908.3548.52
45min115320-153207.9558.051.298.178.261.25
215549-155498.0738.29
315364-153647.9778.20
415327-153277.9588.17
515608-156088.1048.32
615824-158248.2168.43
60min115418-154188.0057.974.178.278.234.05
216258-162588.4428.70
314714-147147.6407.90
414687-146877.6267.88
515141-151417.8628.12
615927-159278.2708.53
极限115320-153207.9557.983.608.268.283.47
215881-158818.2468.55
315141-151417.8628.17
415257-152577.9228.22
514529-145297.5447.85
616072-160728.3458.65
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%
111.043060073058973055473057323054013057170.09
211.073018503026583022540.19
单位质量响应值RSD%判断
27691.7627303.881.00数据可信
供试品溶液-X027066批-阿托伐他汀钙-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min190182-9018227.09125.0017.9027.0925.0017.89
276018-7601822.83622.84
3104858-10485831.50031.50
468132-6813220.46720.47
592158-9215827.68427.68
667966-6796620.41720.42
10min1306219-30621991.98984.908.4992.1485.048.50
2247328-24732874.29874.42
3304186-30418691.37891.55
4264017-26401779.31179.43
5297623-29762389.40789.56
6276333-27633383.01183.12
15min1337187-337187101.29293.348.32101.9593.968.32
2264099-26409979.33679.88
3322905-32290597.00197.68
4301045-30104590.43590.99
5325256-32525697.70898.36
6313892-31389294.29494.87
20min1336450-336450101.07094.187.33102.2995.317.34
2269785-26978581.04482.02
3325119-32511997.66798.89
4315257-31525794.70495.76
5321411-32141196.55397.75
6313085-31308594.05195.15
30min1336762-336762101.16494.027.60102.9595.677.61
2268917-26891780.78382.21
3324037-32403797.34199.11
4309217-30921792.89094.47
5326429-32642998.06099.79
6312491-31249193.87395.49
45min1329798-32979899.07292.827.14101.4295.007.15
2266995-26699580.20682.09
3321756-32175696.65698.96
4308773-30877392.75694.86
5317513-31751395.38297.66
6309117-30911792.85995.00
60min1335018-335018100.64093.526.40103.5496.216.43
2276881-27688183.17685.50
3311608-31160893.60896.45
4305750-30575091.84894.46
5325529-32552997.790100.59
6313087-31308794.05296.71
极限1340884-340884102.40298.913.03105.86102.123.17
2312472-31247293.86796.65
3333949-333949100.319103.68
4324114-32411497.365100.49
5334923-334923100.612103.96
6329184-32918498.888102.07
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%
110.051720241722141722641721431721521721590.06
210.091727501726421726960.05
单位质量响应值RSD%判断
17130.2517115.560.07数据可信
供试品溶液-X027066批-依折麦布-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min111242-112425.8946.043.245.896.033.23
211407-114075.9815.98
310968-109685.7505.75
411756-117566.1646.16
511739-117396.1556.15
611961-119616.2716.27
10min116238-162388.5148.551.108.558.591.09
216137-161378.4618.49
316370-163708.5838.61
416588-165888.6978.73
516138-161388.4618.50
616427-164278.6138.65
15min116324-163248.5598.712.278.648.792.25
217279-172799.0599.14
316591-165918.6998.78
416772-167728.7948.88
516249-162498.5198.60
616465-164658.6338.72
20min116404-164048.6018.560.748.738.690.72
216173-161738.4798.61
316481-164818.6418.77
416375-163758.5858.72
516234-162348.5118.64
616244-162448.5178.65
30min116013-160138.3968.521.858.578.691.84
215877-158778.3248.50
316345-163458.5708.75
416587-165878.6978.88
516062-160628.4218.60
616561-165618.6838.86
45min116169-161698.4778.431.598.708.661.55
216010-160108.3948.62
316421-164218.6098.83
416247-162478.5188.75
515689-156898.2268.45
615945-159458.3608.59
60min115527-155278.1418.342.738.418.612.66
215600-156008.1798.45
316632-166328.7208.99
416205-162058.4968.77
515606-156068.1828.45
615909-159098.3418.61
极限115778-157788.2728.162.688.598.482.63
215161-151617.9498.26
315979-159798.3788.70
415980-159808.3788.70
515005-150057.8678.18
615520-155208.1378.46
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%
111.043002723003943004603003253002783003460.03
211.073007323008293007800.03
单位质量响应值RSD%判断
27205.2527170.730.09数据可信
供试品溶液-X027066批-阿托伐他汀钙-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1118548-11854836.01634.5914.5336.0234.6014.53
2101145-10114530.72930.73
3110778-11077833.65633.66
4141829-14182943.08943.09
594244-9424428.63228.63
6116658-11665835.44235.44
10min1302933-30293392.03493.274.3192.2393.464.33
2315106-31510695.73395.90
3306140-30614093.00993.20
4325521-32552198.89799.14
5285847-28584786.84387.00
6306456-30645693.10593.30
15min1329283-329283100.04099.742.60100.75100.452.61
2340247-340247103.371104.07
3322571-32257198.00198.70
4336530-336530102.241103.03
5319820-31982097.16597.81
6321371-32137197.63698.35
20min1332854-332854101.12599.872.21102.39101.142.22
2338721-338721102.907104.18
3320774-32077497.45598.70
4333328-333328101.269102.63
5324930-32493098.71799.90
6321795-32179597.76599.02
30min1330130-330130100.297100.212.02102.13102.032.03
2339619-339619103.180105.03
3323007-32300798.13399.92
4335736-335736102.000103.92
5324719-32471998.653100.38
6325784-32578498.977100.78
45min1335902-335902102.051100.362.31104.44102.742.30
2340456-340456103.434105.86
3325206-32520698.801101.14
4334270-334270101.555104.04
5325109-32510998.772101.05
6321050-32105097.53899.89
60min1330461-330461100.398100.261.65103.35103.191.68
2337564-337564102.556105.55
3328457-32845799.789102.67
4334769-334769101.706104.76
5325349-32534998.845101.67
6323366-32336698.242101.13
极限1344053-344053104.527102.902.02108.04106.392.03
2342234-342234103.974107.54
3336524-336524102.240105.68
4346862-346862105.380109.00
5329252-329252100.030103.41
6333186-333186101.225104.66
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