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)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%
110.221721651722691723661726471724791723850.11
210.151740781756091748440.62
单位质量响应值RSD%判断
16867.4217226.011.49数据可信
供试品溶液-2023120821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%
5min17179-71793.7783.7216.223.783.7216.23
28148-81484.2884.29
38223-82234.3284.33
47429-74293.9103.91
55458-54582.8722.87
65923-59233.1173.12
10min113584-135847.1497.374.697.177.394.72
214296-142967.5247.55
315224-152248.0128.04
413683-136837.2017.22
513549-135497.1317.15
613697-136977.2087.23
15min115896-158968.3668.431.948.438.491.92
215575-155758.1978.26
316485-164858.6768.74
416017-160178.4298.49
515916-159168.3768.43
616220-162208.5368.59
20min115522-155228.1698.392.308.288.502.28
215492-154928.1538.26
316173-161738.5118.63
416344-163448.6018.71
516218-162188.5358.64
615891-158918.3638.47
30min116193-161938.5228.551.818.678.701.77
215701-157018.2638.42
316245-162458.5498.71
416503-165038.6858.84
516331-163318.5958.74
616488-164888.6778.83
45min115302-153028.0538.273.038.258.472.95
215252-152528.0278.23
315290-152908.0478.26
416229-162298.5418.75
516019-160198.4308.63
616168-161688.5098.71
60min115807-158078.3198.441.788.568.691.81
215667-156678.2458.49
316416-164168.6398.90
416200-162008.5268.78
515942-159428.3908.63
616225-162258.5398.79
极限115021-150217.9058.172.358.208.462.25
215261-152618.0328.32
315361-153618.0848.39
415676-156768.2508.55
515931-159318.3848.67
615878-158788.3568.65
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)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5000
标示量(mg)10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%
110.401561911563441562311563221563181562810.05
210.401582291594911588600.57
单位质量响应值RSD%判断
15027.0215275.001.16数据可信
供试品溶液-2023120821批-瑞舒伐他汀钙-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%
5min191968-9196850.14244.6417.3750.1444.6417.37
292505-9250550.43550.44
388521-8852148.26348.26
489253-8925348.66248.66
557647-5764731.43031.43
671385-7138538.92038.92
10min1120641-12064165.77564.945.6166.0565.195.64
2127824-12782469.69269.97
3116880-11688063.72563.99
4124073-12407367.64667.92
5108716-10871659.27459.45
6116507-11650763.52163.74
15min1138517-13851775.52273.136.6976.1773.746.71
2141453-14145377.12277.79
3128570-12857070.09870.72
4144402-14440278.73079.38
5120556-12055665.72966.23
6131297-13129771.58572.15
20min1140018-14001876.34075.996.7977.4077.006.80
2150335-15033581.96583.06
3132906-13290672.46273.47
4150192-15019281.88782.97
5126912-12691269.19470.06
6135910-13591074.10075.07
30min1148389-14838980.90480.435.6982.3981.865.71
2159245-15924586.82388.37
3140651-14065176.68578.10
4152813-15281383.31684.85
5135767-13576774.02275.28
6148242-14824280.82482.20
45min1148897-14889781.18181.935.9783.1283.825.97
2165166-16516690.05192.08
3141212-14121276.99178.83
4154745-15474584.36986.37
5141530-14153077.16478.83
6150114-15011481.84483.67
60min1152268-15226883.01983.736.2785.4186.076.27
2168483-16848391.85994.39
3145137-14513779.13181.40
4158873-15887386.62089.09
5141810-14181077.31779.41
6154828-15482884.41586.70
极限1175144-17514495.49197.712.7998.34100.512.81
2189041-189041103.068106.11
3176413-17641396.18398.89
4177645-17764596.85599.81
5178567-17856797.35799.88
6178428-17842897.282100.03
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)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%
110.221750751756481756091756861752121754460.17
210.151761681774581768130.52
单位质量响应值RSD%判断
17166.9317420.001.04数据可信
供试品溶液-2023120821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%
5min110929-109295.6695.3413.785.675.3413.83
210948-109485.6795.68
38697-86974.5114.51
48298-82984.3044.30
511465-114655.9475.95
611445-114455.9375.94
10min115371-153717.9747.684.048.017.714.06
215147-151477.8577.89
314300-143007.4187.44
413882-138827.2017.23
514839-148397.6987.73
615289-152897.9317.96
15min116750-167508.6898.372.028.768.442.01
215958-159588.2788.35
315976-159768.2878.35
415849-158498.2218.29
516053-160538.3278.40
616180-161808.3938.47
20min116508-165088.5638.222.518.698.342.52
215567-155678.0758.20
316020-160208.3108.42
415471-154718.0258.13
515549-155498.0668.19
615971-159718.2858.41
30min116272-162728.4418.421.558.618.591.52
215924-159248.2608.43
316451-164518.5348.69
416277-162778.4448.60
515953-159538.2758.44
616533-165338.5768.75
45min115938-159388.2688.211.758.498.421.70
215501-155018.0418.25
316182-161828.3948.60
415895-158958.2458.45
515494-154948.0378.25
615975-159758.2878.50
60min115535-155358.0598.071.988.328.321.88
215172-151727.8708.13
315677-156778.1328.38
416011-160118.3068.55
515262-152627.9178.17
615678-156788.1338.40
极限115768-157688.1798.062.278.498.362.18
215391-153917.9848.28
315971-159718.2858.58
415641-156418.1148.41
514955-149557.7588.06
615443-154438.0118.32
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)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5000
标示量(mg)10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%
110.401585551589001588551586801586341587250.10
210.401596741602211599480.25
单位质量响应值RSD%判断
15262.0215379.620.55数据可信
供试品溶液-2023120821批-瑞舒伐他汀钙-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%
5min153456-5345628.82041.1930.2428.8241.2030.24
275900-7590040.92140.92
361533-6153333.17533.18
458381-5838131.47631.48
5106534-10653457.43757.44
6102630-10263055.33255.33
10min187094-8709446.95658.5221.9947.1258.7422.02
2106814-10681457.58857.82
393358-9335850.33350.52
488158-8815847.53047.70
5135192-13519272.88873.21
6140584-14058475.79576.10
15min1104725-10472556.46268.5018.2356.8869.0618.28
2126367-12636768.13068.68
3105388-10538856.81957.28
4115937-11593762.50762.95
5151183-15118381.50982.23
6158768-15876885.59986.33
20min1117734-11773463.47673.5614.8964.2174.4914.97
2141668-14166876.37977.31
3114937-11493761.96862.75
4125480-12548067.65268.44
5154419-15441983.25484.43
6164336-16433688.60189.80
30min1127293-12729368.62980.0512.1969.7281.3912.30
2156586-15658684.42285.77
3132553-13255371.46572.59
4140306-14030675.64576.81
5159620-15962086.05887.70
6174492-17449294.07695.77
45min1134066-13406672.28183.249.8173.7585.039.96
2163503-16350388.15289.97
3142607-14260776.88678.41
4147538-14753879.54481.13
5166239-16623989.62791.74
6172383-17238392.93995.16
60min1139862-13986275.40685.358.0777.2887.608.25
2165980-16598089.48791.80
3147332-14733279.43381.38
4156922-15692284.60486.63
5166285-16628589.65292.27
6173488-17348893.53596.27
极限1174561-17456194.11394.241.5096.4096.961.23
2176308-17630895.05597.86
3179102-17910296.56298.95
4174246-17424693.94496.44
5172161-17216192.82095.93
6172348-17234892.92096.18
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)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%
110.221765191763561758861757271753951759770.27
210.151730241744171737200.57
单位质量响应值RSD%判断
17218.8817115.270.43数据可信
供试品溶液-2023120822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%
5min18669-86694.5303.6624.054.533.6624.04
25328-53282.7842.78
36175-61753.2273.23
49110-91104.7604.76
57550-75503.9453.95
65217-52172.7262.73
10min115797-157978.2548.066.268.288.086.33
213910-139107.2687.28
315011-150117.8447.86
416839-168398.7998.83
515647-156478.1768.20
615360-153608.0268.04
15min115653-156538.1798.403.588.258.473.60
215644-156448.1758.23
315783-157838.2478.31
417162-171628.9689.04
516212-162128.4718.54
616026-160268.3748.43
20min116617-166178.6838.641.688.808.751.72
216606-166068.6778.78
316435-164358.5888.70
416951-169518.8578.98
516471-164718.6078.72
616103-161038.4148.52
30min115668-156688.1878.251.208.358.411.21
215545-155458.1238.27
315721-157218.2158.37
415741-157418.2258.40
516008-160088.3658.53
616008-160088.3658.52
45min115567-155678.1348.322.178.348.522.15
215674-156748.1908.38
316478-164788.6108.81
416175-161758.4528.67
515739-157398.2248.43
615884-158848.3008.50
60min114883-148837.7777.992.538.038.242.46
215007-150077.8428.08
315455-154558.0768.32
415010-150107.8438.11
515888-158888.3028.56
615488-154888.0938.34
极限115375-153758.0348.192.948.338.482.79
215519-155198.1098.39
316515-165158.6308.92
415365-153658.0298.34
515361-153618.0278.33
615877-158778.2968.59
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)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5000
标示量(mg)10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%
110.401590781590011582701581451577911584570.36
210.401566331575081570700.40
单位质量响应值RSD%判断
15236.2515102.880.63数据可信
供试品溶液-2023120822批-瑞舒伐他汀钙-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%
5min170189-7018938.21936.9921.6738.2236.9821.66
260862-6086233.14133.14
347752-4775226.00226.00
468426-6842637.25937.26
592823-9282350.54450.54
667496-6749636.75336.75
10min189024-8902448.47658.6110.0948.6958.8210.07
2106549-10654958.01858.20
3111028-11102860.45760.60
4118419-11841964.48264.69
5117443-11744363.95064.23
6103399-10339956.30356.51
15min1108613-10861359.14264.0316.4359.6264.5616.36
2124101-12410167.57668.08
384119-8411945.80546.28
4140866-14086676.70577.27
5124529-12452967.80968.44
6123358-12335867.17167.69
20min1105577-10557757.48968.6715.8658.3069.5615.78
2138679-13867975.51476.40
398405-9840553.58454.32
4150215-15021581.79582.79
5130497-13049771.05872.07
6133246-13324672.55573.45
30min1110048-11004859.92472.1414.3961.0573.4114.34
2142226-14222677.44578.75
3109671-10967159.71860.75
4156971-15697185.47486.92
5133691-13369172.79874.21
6142320-14232077.49678.79
45min1117208-11720863.82276.1612.1665.2877.8312.14
2145393-14539379.17080.90
3126427-12642768.84270.21
4165198-16519889.95491.87
5136756-13675674.46776.28
6148238-14823880.71982.44
60min1116481-11648163.42676.6211.8165.2478.7111.80
2146992-14699280.04082.21
3127472-12747269.41171.16
4162771-16277188.63291.05
5140300-14030076.39678.62
6150221-15022181.79983.97
极限1173516-17351694.48397.873.0396.65100.382.91
2181716-18171698.948101.56
3188642-188642102.720104.85
4180572-18057298.325101.24
5174767-17476795.16497.81
6179196-17919697.576100.20
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)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%
110.221744841756361762631763611761681757820.45
210.151723661732541728100.37
单位质量响应值RSD%判断
17199.8017025.620.72数据可信
供试品溶液-2023120822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%
5min111950-119506.2645.5814.826.265.5814.84
27848-78484.1144.11
310241-102415.3685.37
411034-110345.7845.78
510589-105895.5515.55
612260-122606.4276.43
10min116641-166418.7238.337.558.768.367.58
214039-140397.3597.38
314878-148787.7997.83
416177-161778.4808.51
517255-172559.0459.08
616361-163618.5768.61
15min116441-164418.6188.771.958.708.841.92
217076-170768.9519.02
316405-164058.6008.67
416577-165778.6908.77
517170-171709.0019.08
616684-166848.7468.83
20min116765-167658.7888.722.368.928.852.30
217199-171999.0169.13
316016-160168.3968.52
416563-165638.6828.81
516789-167898.8018.93
616487-164878.6438.77
30min116565-165658.6838.671.748.868.841.71
216459-164598.6288.79
316483-164838.6408.81
416798-167988.8068.98
516868-168688.8429.02
616064-160648.4218.60
45min116119-161198.4508.431.038.688.650.97
216121-161218.4518.66
316105-161058.4428.66
416308-163088.5498.77
516037-160378.4078.64
615800-158008.2828.51
60min116454-164548.6258.561.308.908.831.23
216328-163288.5598.82
316622-166228.7138.98
416154-161548.4688.74
516030-160308.4038.68
616370-163708.5818.85
极限116051-160518.4148.451.778.748.771.70
216181-161818.4828.79
316281-162818.5358.85
416572-165728.6879.01
515839-158398.3038.63
615823-158238.2948.61
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)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5000
标示量(mg)10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%
110.401578691586831589781589531591891587340.33
210.401556701560481558590.18
单位质量响应值RSD%判断
15262.8814986.441.30数据可信
供试品溶液-2023120822批-瑞舒伐他汀钙-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%
5min144928-4492824.53837.5626.8024.5437.5626.80
264921-6492135.45835.46
373949-7394940.38940.39
491711-9171150.09050.09
585290-8529046.58346.58
651779-5177928.28028.28
10min1119568-11956865.30565.8410.1765.4466.0510.13
2124166-12416667.81668.01
398058-9805853.55753.78
4126445-12644569.06169.34
5120492-12049265.81066.07
6134570-13457073.49973.66
15min1128572-12857270.22373.896.9970.7274.466.97
2135201-13520173.84374.42
3123665-12366567.54368.06
4131301-13130171.71372.38
5146196-14619679.84880.47
6146740-14674080.14680.71
20min1136160-13616074.36776.295.7275.2677.285.72
2139604-13960476.24877.23
3128854-12885470.37771.27
4135610-13561074.06775.13
5149720-14972081.77382.84
6148148-14814880.91581.93
30min1139391-13939176.13278.353.3277.4379.763.38
2141396-14139677.22778.63
3138292-13829275.53176.82
4143648-14364878.45779.93
5150535-15053582.21883.74
6147427-14742780.52181.98
45min1143772-14377278.52480.732.8080.2582.572.82
2142310-14231077.72679.56
3148068-14806880.87182.58
4148409-14840981.05782.96
5152560-15256083.32485.30
6151759-15175982.88784.79
60min1149791-14979181.81282.361.9883.9784.651.95
2145257-14525779.33681.60
3153237-15323783.69485.85
4151607-15160782.80485.16
5151853-15185382.93885.38
6152970-15297083.54885.92
极限1170865-17086593.32292.351.2395.9495.101.22
2166283-16628390.81993.53
3167288-16728891.36893.99
4170817-17081793.29696.11
5168342-16834291.94494.85
6170969-17096993.37996.21
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