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对照品来源自制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%
111.872038102039432039282041032041452039860.07
211.842062472065922064200.12
单位质量响应值RSD%判断
17185.0017434.121.02数据可信
供试品溶液-2024011621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%
5min112222-122226.3395.2115.056.345.2115.06
210601-106015.4985.50
310619-106195.5085.51
49832-98325.1005.10
59190-91904.7674.77
67755-77554.0224.02
10min119502-1950210.1159.872.2610.159.902.30
219521-1952110.12510.16
319143-191439.9299.96
418821-188219.7629.79
518515-185159.6039.63
618662-186629.6799.70
15min119793-1979310.26610.043.1610.3610.123.16
220345-2034510.55210.64
318838-188389.7719.86
418896-188969.8019.88
519352-1935210.03710.12
618894-188949.8009.88
20min118860-188609.7829.812.859.939.952.83
219625-1962510.17910.32
319043-190439.87710.02
418297-182979.4909.63
519356-1935610.03910.17
618322-183229.5039.63
30min117885-178859.2769.401.409.489.601.39
218240-182409.4619.66
318186-181869.4339.63
418130-181309.4049.59
518524-185249.6089.80
617830-178309.2489.43
45min118153-181539.4159.391.789.679.641.75
218310-183109.4979.75
317991-179919.3319.58
417814-178149.2409.48
518620-186209.6589.90
617777-177779.2209.46
60min117768-177689.2169.191.389.529.491.36
217794-177949.2299.54
317482-174829.0679.37
417413-174139.0329.32
518088-180889.3829.68
617759-177599.2119.50
极限116669-166698.6469.043.199.009.393.11
218256-182569.4699.83
317315-173158.9819.33
417274-172748.9609.30
517876-178769.2729.62
617227-172278.9359.27
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%
110.923076283078103096463098203097713089350.37
211.013136843136553136700.01
单位质量响应值RSD%判断
28290.7528489.550.50数据可信
供试品溶液-2024011621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%
5min1156341-15634145.48744.584.7445.4944.584.74
2149636-14963643.53743.54
3151187-15118743.98843.99
4151687-15168744.13344.13
5165892-16589248.26648.27
6144625-14462542.07942.08
10min1238692-23869269.44769.003.0369.7069.243.03
2237379-23737969.06569.31
3244654-24465471.18271.43
4238527-23852769.39969.64
5240147-24014769.87170.14
6223471-22347165.01965.25
15min1272909-27290979.40378.693.2280.0479.323.21
2278059-27805980.90181.53
3273688-27368879.62980.27
4271464-27146478.98279.61
5273245-27324579.50180.16
6253302-25330273.69874.29
20min1281069-28106981.77782.923.9482.8683.993.92
2292107-29210784.98886.06
3297549-29754986.57287.65
4283593-28359382.51183.58
5290132-29013284.41485.51
6265551-26555177.26278.27
30min1295070-29507085.85087.323.8587.3888.853.83
2303546-30354688.31789.86
3309225-30922589.96991.53
4308412-30841289.73291.26
5305558-30555888.90290.47
6279001-27900181.17582.61
45min1319151-31915192.85791.533.8894.8793.543.87
2321280-32128093.47695.51
3323746-32374694.19496.26
4317617-31761792.41194.44
5315285-31528591.73293.79
6290413-29041384.49686.38
60min1322846-32284693.93292.973.2696.4695.493.26
2326162-32616294.89797.45
3325373-32537394.66797.25
4323490-32349094.11996.66
5320618-32061893.28495.85
6298687-29868786.90389.26
极限1320980-32098093.38994.223.0296.4497.263.02
2336093-33609397.786100.87
3326953-32695395.12798.24
4324936-32493694.54097.60
5327431-32743195.26698.35
6306692-30669289.23292.07
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对照品来源自制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%
111.872039472045222048122048782049582046230.21
211.842044242058342051290.49
单位质量响应值RSD%判断
17238.6717325.080.36数据可信
供试品溶液-2024011621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%
5min17113-71133.6954.2825.343.704.2825.32
210910-109105.6685.67
38766-87664.5544.55
44961-49612.5772.58
59754-97545.0675.07
67950-79504.1304.13
10min117594-175949.1409.565.369.169.585.38
220063-2006310.42210.45
318604-186049.6649.69
418100-181009.4039.42
518741-187419.7369.76
617305-173058.9909.01
15min118701-187019.71510.134.399.7910.214.37
220036-2003610.40810.50
320911-2091110.86310.94
419511-1951110.13610.20
519188-191889.96810.05
618696-186969.7129.79
20min118504-185049.6129.803.919.749.933.85
218155-181559.4319.58
320280-2028010.53510.67
418727-187279.7289.85
518856-188569.7959.93
618628-186289.6779.80
30min117817-178179.2569.573.989.439.763.99
218431-184319.5759.77
319863-1986310.31810.52
418214-182149.4629.64
518236-182369.4739.67
618010-180109.3569.54
45min117622-176229.1549.505.029.389.744.98
218166-181669.4379.69
320054-2005410.41810.67
418190-181909.4499.68
518160-181609.4349.68
617510-175109.0969.33
60min117185-171858.9279.273.849.219.563.81
217767-177679.2309.53
319152-191529.94910.26
417856-178569.2769.56
517519-175199.1019.40
617562-175629.1239.41
极限117246-172468.9599.283.309.299.633.32
218634-186349.68010.04
318439-184399.5799.95
418031-180319.3679.70
517330-173309.0039.35
617519-175199.1019.43
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%
110.923094543101983106283105233107223103050.17
211.013112713128763120740.37
单位质量响应值RSD%判断
28416.2128344.600.18数据可信
供试品溶液-2024011621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%
5min1155450-15545045.24343.504.6845.2443.504.68
2147420-14742042.90642.91
3152466-15246644.37544.37
4150034-15003443.66743.67
5154876-15487645.07645.08
6136579-13657939.75139.75
10min1231911-23191167.49766.604.9667.7566.844.95
2213968-21396862.27562.51
3236242-23624268.75769.00
4240175-24017569.90270.14
5235515-23551568.54668.80
6215256-21525662.64962.87
15min1270389-27038978.69676.006.1979.3276.616.18
2237716-23771669.18669.77
3266254-26625477.49278.12
4275695-27569580.24080.87
5272729-27272979.37780.01
6243887-24388770.98271.55
20min1286064-28606483.25880.176.4684.3281.216.44
2246340-24634071.69672.67
3280802-28080281.72682.79
4289350-28935084.21485.29
5289235-28923584.18185.25
6261011-26101175.96676.93
30min1299793-29979387.25485.436.3688.7886.906.35
2268535-26853578.15679.52
3308871-30887189.89691.41
4305262-30526288.84590.39
5307596-30759689.52591.06
6271013-27101378.87780.26
45min1312279-31227990.88888.767.0592.9090.717.02
2275244-27524480.10981.91
3317206-31720692.32294.33
4322821-32282193.95695.99
5322029-32202993.72595.76
6280246-28024681.56583.39
60min1318238-31823892.62289.727.4395.1492.167.38
2276207-27620780.38982.64
3327077-32707795.19597.72
4322683-32268393.91696.48
5323454-32345494.14096.70
6281868-28186882.03784.31
极限1325123-32512394.62690.876.5797.6693.826.55
2278786-27878681.14083.83
3329523-32952395.90698.96
4322821-32282193.95697.04
5322269-32226993.79596.88
6294792-29479285.79888.53
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对照品来源自制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%
111.872042452043572045002046042047322044880.10
211.842045852050682048260.17
单位质量响应值RSD%判断
17227.3017299.490.30数据可信
供试品溶液-2024011621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%
5min111802-118026.1375.7615.236.145.7615.19
212085-120856.2856.28
37914-79144.1164.12
410400-104005.4085.41
512017-120176.2496.25
612236-122366.3636.36
10min116829-168298.7528.432.748.798.462.74
216504-165048.5838.62
316306-163068.4808.50
415549-155498.0868.12
516074-160748.3598.39
615990-159908.3158.35
15min116571-165718.6178.571.898.708.651.87
216797-167978.7358.82
316779-167798.7268.80
416504-165048.5838.66
516111-161118.3788.46
616099-160998.3728.45
20min116691-166918.6808.443.188.818.563.13
216749-167498.7108.84
316541-165418.6028.72
416109-161098.3778.50
515514-155148.0688.20
615761-157618.1968.32
30min116027-160278.3358.193.548.518.363.48
216101-161018.3738.55
316131-161318.3898.55
414731-147317.6617.83
516018-160188.3308.50
615441-154418.0308.20
45min115246-152467.9287.873.098.158.092.97
215426-154268.0228.25
315345-153457.9808.19
415659-156598.1438.35
514417-144177.4977.72
614740-147407.6657.88
60min114143-141437.3557.744.497.628.004.34
215148-151487.8778.15
315154-151547.8818.14
415942-159428.2908.55
514306-143067.4407.70
614593-145937.5897.85
极限114782-147827.6878.017.998.008.317.68
215046-150467.8248.14
315861-158618.2488.55
417686-176869.1979.50
514403-144037.4907.79
614608-146087.5977.90
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%
110.923088683090593091023094203095483091990.09
211.013096283102013099140.14
单位质量响应值RSD%判断
28314.9328148.410.42数据可信
供试品溶液-2024011621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%
5min1142055-14205541.56349.9612.4941.5649.9612.49
2188979-18897955.29255.29
3155810-15581045.58745.59
4178445-17844552.21052.21
5161265-16126547.18347.18
6198038-19803857.94257.94
10min1193420-19342056.59168.6413.9456.8268.9213.90
2257670-25767075.39075.70
3282676-28267682.70682.96
4221851-22185164.91065.20
5210334-21033461.54061.80
6241740-24174070.72971.05
15min1202160-20216059.14872.1214.8859.6972.7814.84
2273412-27341279.99580.72
3302443-30244388.48989.20
4229856-22985667.25267.90
5221600-22160064.83665.44
6249582-24958273.02373.74
20min1208641-20864161.04573.3914.5161.9274.4514.47
2278021-27802181.34482.51
3306125-30612589.56790.77
4231904-23190467.85168.88
5225023-22502365.83866.80
6255396-25539674.72475.84
30min1210243-21024361.51373.8014.1262.7375.2714.09
2277340-27734081.14582.77
3306187-30618789.58591.29
4230577-23057767.46368.86
5229590-22959067.17468.50
6259568-25956875.94577.48
45min1209928-20992861.42173.9714.7462.9875.8414.69
2273025-27302579.88281.96
3312808-31280891.52293.72
4234556-23455668.62770.40
5226289-22628966.20867.91
6260219-26021976.13578.09
60min1205498-20549860.12574.0514.8962.0276.3414.83
2274616-27461680.34882.86
3312924-31292491.55694.26
4229735-22973567.21669.37
5238208-23820869.69571.77
6257574-25757475.36177.74
极限1310602-31060290.87695.423.2393.1198.123.49
2328285-32828596.05099.01
3343135-343135100.395103.61
4326129-32612995.41997.95
5321861-32186194.17196.63
6326746-32674695.60098.40
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对照品来源自制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%
111.872042532044652044032044132044212043910.04
211.842068822066122067470.10
单位质量响应值RSD%判断
17219.1217461.740.99数据可信
供试品溶液-2024011621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%
5min19280-92804.8055.6312.824.805.6312.84
29377-93774.8554.85
310429-104295.4005.40
412040-120406.2346.23
511606-116066.0096.01
612562-125626.5046.50
10min116197-161978.3868.594.128.418.624.13
215783-157838.1728.20
316190-161908.3828.41
417190-171908.9008.93
516576-165768.5828.62
617592-175929.1089.14
15min116300-163008.4398.542.748.518.622.79
216101-161018.3368.41
316024-160248.2968.37
416839-168398.7188.80
516530-165308.5588.64
617190-171908.9008.99
20min115770-157708.1658.452.398.298.582.40
215994-159948.2818.40
316335-163358.4578.58
416705-167058.6498.78
516400-164008.4918.62
616759-167598.6778.81
30min115934-159348.2508.261.478.428.441.50
215925-159258.2458.41
315665-156658.1108.28
416071-160718.3218.50
515819-158198.1908.37
616348-163488.4648.65
45min115533-155338.0427.972.708.258.192.68
215181-151817.8608.07
314889-148897.7097.92
416112-161128.3428.57
515435-154357.9918.21
615231-152317.8868.12
60min115021-150217.7777.952.708.038.212.73
215002-150027.7678.02
315231-152317.8868.14
416134-161348.3538.63
515366-153667.9568.22
615357-153577.9518.23
极限114442-144427.4777.733.737.788.033.60
214893-148937.7118.01
315067-150677.8018.10
415689-156898.1238.44
515274-152747.9088.22
614163-141637.3337.65
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%
110.923085663090803087573088633088313088190.07
211.013124703117363121030.17
单位质量响应值RSD%判断
28280.1328347.230.17数据可信
供试品溶液-2024011621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%
5min1133927-13392739.07145.2619.9139.0745.2619.91
2164751-16475148.06348.06
3102069-10206929.77729.78
4175175-17517551.10451.10
5175168-17516851.10251.10
6179840-17984052.46552.47
10min1266723-26672377.81273.667.3878.0373.917.40
2257521-25752175.12775.39
3215438-21543862.85063.02
4256226-25622674.74975.03
5256347-25634774.78575.07
6262717-26271776.64376.93
15min1282862-28286282.52077.198.1983.1777.868.20
2269782-26978278.70479.39
3221916-22191664.74065.25
4266717-26671777.81078.51
5270959-27095979.04779.75
6275385-27538580.33981.06
20min1286406-28640683.55478.557.8984.6679.647.91
2276769-27676980.74281.86
3226891-22689166.19167.07
4273584-27358479.81380.94
5275246-27524680.29881.44
6276614-27661480.69781.86
30min1293057-29305785.49479.408.5387.0780.938.54
2281119-28111982.01183.58
3227024-22702466.23067.47
4271313-27131379.15180.73
5278300-27830081.18982.77
6282264-28226482.34683.96
45min1296303-29630386.44180.168.3088.4982.138.30
2280864-28086481.93783.96
3230200-23020067.15768.77
4282753-28275382.48884.50
5280565-28056581.85083.89
6278003-27800381.10283.17
60min1295779-29577986.28881.286.7088.8283.706.76
2281635-28163582.16284.64
3242009-24200970.60272.58
4283760-28376082.78285.25
5286230-28623083.50385.99
6282347-28234782.37084.89
极限1316779-31677992.41595.733.1795.4298.603.10
2334753-33475397.658100.60
3325621-32562194.99497.37
4341281-34128199.563102.50
5334508-33450897.587100.54
6315975-31597592.18095.16
点击查看处理图标(自动生成)
 
原始图谱下载图谱(谢超君 于 2024-07-25 18:52:08 完成)
生成报告数据部分下载报告(谢超君 于 2024-07-25 18:52:42 完成)
Current page cost:811 ms