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R075K0对照品来源USP对照品使用方法直接使用
对照品含量(%)99.8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%
110.181685711684201680411678901682951682430.17
210.131683531685861684700.10
单位质量响应值RSD%判断
16526.8216630.800.45数据可信
0天-供试品溶液-2023121421批-10mg/20mg-依折麦布-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111275-112756.1095.7010.376.115.7010.37
210676-106765.7845.78
39017-90174.8854.89
411679-116796.3276.33
511167-111676.0506.05
69364-93645.0735.07
10min120693-2069311.21110.794.9811.2510.835.00
219830-1983010.74410.78
320164-2016410.92410.95
420754-2075411.24411.28
520051-2005110.86310.90
618042-180429.7759.80
15min121845-2184511.83511.472.1511.9311.562.16
221634-2163411.72111.81
321016-2101611.38611.47
421013-2101311.38411.48
520847-2084711.29511.39
620707-2070711.21911.30
20min122412-2241212.14211.921.5512.3012.071.52
222045-2204511.94412.10
322358-2235812.11312.26
421572-2157211.68711.85
521739-2173911.77811.93
621835-2183511.83011.97
30min115292-152928.2858.241.488.518.461.38
214996-149968.1258.35
315404-154048.3468.56
415047-150478.1528.38
514972-149728.1128.33
615493-154938.3948.60
45min117935-179359.7179.913.289.9910.183.15
217460-174609.4609.73
318002-180029.75310.02
418654-1865410.10610.38
518631-1863110.09410.36
619096-1909610.34610.60
60min115793-157938.5569.4410.558.899.7610.15
216301-163018.8329.15
316885-168859.1489.47
416151-161518.7509.08
519186-1918610.39510.72
620242-2024210.96711.28
极限118614-1861410.08511.5912.0910.4611.9611.74
219852-1985210.75511.13
318873-1887310.22510.59
424356-2435613.19613.57
523942-2394212.97113.35
622690-2269012.29312.67
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1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.003131253128773120333118213124533124620.18
211.153127703127963127830.01
单位质量响应值RSD%判断
28405.6428052.290.89数据可信
0天-供试品溶液-2023121421批-10mg/20mg-阿托伐他汀钙-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1147702-14770217.28820.5828.7417.2920.5828.73
2218922-21892225.62425.62
3161572-16157218.91218.91
4242981-24298128.44028.44
5181501-18150121.24421.24
6102489-10248911.99612.00
10min1288375-28837533.75434.586.7633.8534.696.83
2312701-31270136.60136.74
3300450-30045035.16735.27
4320584-32058437.52437.68
5284176-28417633.26233.38
6266091-26609131.14531.21
15min1309560-30956036.23336.932.7236.5237.232.79
2329226-32922638.53538.88
3310037-31003736.28936.59
4323232-32323237.83438.20
5310604-31060436.35536.66
6310169-31016936.30536.54
20min1318372-31837237.26538.021.2037.7538.541.26
2330369-33036938.66939.23
3324105-32410537.93638.44
4326483-32648338.21438.79
5324777-32477738.01438.52
6325004-32500438.04138.48
30min1317699-31769937.18637.881.3237.8838.611.25
2322297-32229737.72438.50
3322999-32299937.80638.52
4323359-32335937.84838.64
5324736-32473638.01038.73
6330862-33086238.72739.38
45min1324668-32466838.00238.321.2938.9039.261.28
2323709-32370937.88938.87
3324984-32498438.03938.96
4333434-33343439.02840.03
5325633-32563338.11539.04
6332137-33213738.87639.74
60min1314985-31498536.86838.622.9037.9839.772.78
2329277-32927738.54139.74
3334411-33441139.14240.28
4323077-32307737.81539.03
5338148-33814839.57940.72
6339768-33976839.76940.85
极限1333476-33347639.03338.700.9240.3540.060.79
2329128-32912838.52439.93
3333501-33350139.03540.39
4326161-32616138.17639.60
5328963-32896338.50439.86
6332768-33276838.95040.25
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R075K0对照品来源USP对照品使用方法直接使用
对照品含量(%)99.8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%
110.181683761680631679031679561678541680300.13
210.131683331680381681860.13
单位质量响应值RSD%判断
16505.8916602.760.42数据可信
0天-供试品溶液-2023121421批-10mg/20mg-依折麦布-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111688-116886.3427.269.836.347.269.85
212878-128786.9876.99
312646-126466.8616.86
414852-148528.0588.06
515055-150558.1698.17
613213-132137.1697.17
10min121274-2127411.54312.092.8411.5812.132.85
222102-2210211.99212.03
322262-2226212.07912.12
423217-2321712.59712.64
522272-2227212.08412.13
622562-2256212.24212.28
15min125062-2506213.59813.751.3613.7013.851.38
225285-2528513.71913.82
325505-2550513.83913.94
425938-2593814.07314.19
525219-2521913.68313.80
625004-2500413.56713.67
20min120615-2061511.18511.121.0711.3611.301.02
220243-2024310.98311.17
320573-2057311.16311.34
420459-2045911.10111.29
520253-2025310.98911.18
620803-2080311.28711.47
30min123404-2340412.69912.921.5312.9413.161.53
224032-2403213.03913.28
324312-2431213.19113.44
423937-2393712.98813.24
523801-2380112.91413.16
623384-2338412.68812.93
45min113870-138707.5267.691.307.838.011.32
214342-143427.7828.10
314072-140727.6357.95
414354-143547.7888.11
514250-142507.7328.05
614155-141557.6808.00
60min117651-176519.5779.450.949.939.810.88
217331-173319.4039.76
317527-175279.5109.87
417251-172519.3609.73
517481-174819.4859.85
617256-172569.3639.72
极限120772-2077211.27110.981.8611.6711.391.75
220187-2018710.95311.36
320437-2043711.08911.50
419963-1996310.83211.25
520312-2031211.02111.44
619695-1969510.68611.10
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1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.003119053119633113933113223112723115710.11
211.153123603117513120560.14
单位质量响应值RSD%判断
28324.6427987.090.85数据可信
0天-供试品溶液-2023121421批-10mg/20mg-阿托伐他汀钙-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1129479-12947915.19421.1532.5815.1921.1532.58
2121830-12183014.29714.30
3134914-13491415.83215.83
4257524-25752430.22130.22
5208067-20806724.41724.42
6229706-22970626.95626.96
10min1249574-24957429.28833.148.9629.3733.269.04
2268746-26874631.53831.62
3263286-26328630.89730.98
4308270-30827036.17636.34
5294689-29468934.58234.72
6309721-30972136.34636.50
15min1292164-29216434.28636.814.2534.5337.104.34
2312636-31263636.68836.94
3306730-30673035.99536.25
4329796-32979638.70239.07
5316682-31668237.16337.49
6323838-32383838.00338.35
20min1313944-31394436.84238.132.2537.2838.642.37
2320166-32016637.57238.03
3323783-32378337.99638.46
4332886-33288639.06539.65
5326684-32668438.33738.87
6332312-33231238.99739.56
30min1315253-31525336.99538.842.4137.6439.562.45
2336461-33646139.48440.15
3334796-33479639.28939.96
4335193-33519339.33540.14
5330408-33040838.77439.52
6333615-33361539.15039.93
45min1314050-31405036.85438.652.4137.7039.592.49
2333161-33316139.09739.98
3328149-32814938.50939.40
4334126-33412639.21040.23
5331281-33128138.87639.84
6335490-33549039.37040.37
60min1329956-32995638.72139.020.7139.7740.170.82
2333037-33303739.08240.19
3332152-33215238.97840.08
4334057-33405739.20240.44
5330012-33001238.72739.91
6335979-33597939.42740.64
极限1326366-32636638.29938.840.8539.5740.200.92
2334723-33472339.28040.60
3330119-33011938.74040.06
4332654-33265439.03740.49
5330371-33037138.76940.16
6331435-33143538.89440.33
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R075K0对照品来源USP对照品使用方法直接使用
对照品含量(%)99.8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%
110.181684431680191679031679441678031680220.15
210.131680081682181681130.09
单位质量响应值RSD%判断
16505.1116595.560.39数据可信
0天-供试品溶液-2023121421批-10mg/20mg-依折麦布-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110159-101595.5134.7420.875.514.7420.84
29803-98035.3205.32
35245-52452.8472.85
49501-95015.1565.16
59445-94455.1265.13
68292-82924.5004.50
10min118555-1855510.0709.976.3110.1010.006.32
219423-1942310.54110.57
316897-168979.1709.19
419343-1934310.49810.53
519044-1904410.33510.36
616959-169599.2049.23
15min122056-2205611.97011.662.7512.0611.742.72
221974-2197411.92612.01
321734-2173411.79511.86
421572-2157211.70711.79
521026-2102611.41111.50
620544-2054411.14911.23
20min123640-2364012.83012.691.7512.9812.841.76
224045-2404513.05013.20
323300-2330012.64512.78
423376-2337612.68612.84
523063-2306312.51712.67
622912-2291212.43512.57
30min111153-111536.0535.931.136.286.151.15
210883-108835.9066.13
310973-109735.9556.16
410880-108805.9056.13
510820-108205.8726.09
610841-108415.8846.09
45min112904-129047.0036.990.937.267.240.87
212958-129587.0327.29
313062-130627.0897.32
412759-127596.9247.18
512853-128536.9757.23
612757-127576.9237.16
60min115956-159568.6608.651.088.968.941.11
215996-159968.6818.98
315848-158488.6018.88
416175-161758.7789.07
515999-159998.6838.97
615664-156648.5018.78
极限118045-180459.79310.022.3810.1410.362.28
218608-1860810.09910.45
319226-1922610.43410.76
418540-1854010.06210.40
518325-183259.94510.28
618063-180639.80310.13
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1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.003113303111973108853109793108413110460.07
211.153116333117173116750.02
单位质量响应值RSD%判断
28276.9127952.910.82数据可信
0天-供试品溶液-2023121421批-10mg/20mg-阿托伐他汀钙-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1203720-20372023.94217.9332.6423.9417.9232.65
2153229-15322918.00818.01
383073-830739.7639.76
4195410-19541022.96522.96
5177203-17720320.82520.83
6102571-10257112.05412.05
10min1286197-28619733.63433.787.1433.7733.887.19
2301172-30117235.39435.49
3269733-26973331.69931.75
4305455-30545535.89836.03
5305428-30542835.89436.01
6256644-25664430.16130.23
15min1326775-32677538.40337.582.7138.7237.872.79
2328263-32826338.57838.87
3310423-31042336.48136.71
4324728-32472838.16338.49
5320723-32072337.69238.01
6307957-30795736.19236.43
20min1330486-33048638.83938.571.8539.3739.061.93
2334286-33428639.28639.80
3317023-31702337.25737.69
4331613-33161338.97239.51
5329413-32941338.71339.24
6326229-32622938.33938.77
30min1327466-32746638.48438.941.2439.2339.651.21
2329287-32928738.69839.43
3328791-32879138.64039.28
4336367-33636739.53040.29
5329475-32947538.72039.46
6336686-33668639.56840.22
45min1327028-32702838.43339.121.4039.4040.051.29
2328842-32884238.64639.59
3333995-33399539.25240.11
4331922-33192239.00839.98
5335886-33588639.47440.43
6339618-33961839.91240.78
60min1332324-33232439.05539.140.8640.2340.280.92
2334298-33429839.28740.45
3327557-32755738.49539.57
4335263-33526339.40140.59
5334262-33426239.28340.46
6334356-33435639.29440.38
极限1327944-32794438.54138.791.2439.9340.151.25
2326124-32612438.32739.70
3325304-32530438.23039.52
4334152-33415239.27040.68
5333517-33351739.19540.59
6333522-33352239.19640.50
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R075K0对照品来源USP对照品使用方法直接使用
对照品含量(%)99.8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%
110.181688171686791687441688691688491687920.05
210.131676661690341683500.58
单位质量响应值RSD%判断
16580.7516618.950.17数据可信
0天-供试品溶液-2023121421批-10mg/20mg-依折麦布-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18697-86974.7064.8710.204.714.8710.17
27763-77634.2004.20
310020-100205.4225.42
49714-97145.2565.26
58181-81814.4274.43
69599-95995.1945.19
10min117772-177729.6169.803.829.649.833.81
218415-184159.9649.99
319223-1922310.40110.43
417898-178989.6849.71
518200-182009.8489.87
617165-171659.2889.32
15min120855-2085511.28411.121.9211.3611.201.91
220127-2012710.89110.97
320761-2076111.23411.32
420482-2048211.08311.17
521024-2102411.37611.46
620074-2007410.86210.94
20min121898-2189811.84911.921.2211.9912.071.22
222103-2210311.96012.10
322424-2242412.13312.28
422228-2222812.02712.17
521672-2167211.72711.87
621905-2190511.85311.99
30min110846-108465.8695.761.876.085.971.86
210459-104595.6595.86
310909-109095.9036.12
410474-104745.6675.88
510499-104995.6815.89
610681-106815.7795.99
45min112622-126226.8306.922.447.077.162.39
212413-124136.7176.95
312785-127856.9187.17
413307-133077.2007.44
512945-129457.0047.24
612633-126336.8367.07
60min115429-154298.3488.673.378.638.953.30
215512-155128.3938.67
316808-168089.0959.38
416328-163288.8359.12
515773-157738.5358.81
616286-162868.8129.09
极限118812-1881210.17910.232.0310.5010.562.00
219023-1902310.29310.61
319398-1939810.49610.84
418868-1886810.20910.54
518245-182459.87210.20
619075-1907510.32110.65
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)10供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.003126603125853125883127833127183126670.03
211.153112963133883123420.48
单位质量响应值RSD%判断
28424.2728012.741.04数据可信
0天-供试品溶液-2023121421批-10mg/20mg-阿托伐他汀钙-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1210406-21040624.63721.5524.0624.6421.5524.07
2120095-12009514.06214.06
3212144-21214424.84024.84
4213360-21336024.98324.98
5213858-21385825.04125.04
6134284-13428415.72415.72
10min1303215-30321535.50434.477.0235.6434.587.07
2274694-27469432.16532.24
3313261-31326136.68136.82
4301658-30165835.32235.46
5310421-31042136.34836.49
6262791-26279130.77130.86
15min1328723-32872338.49138.042.4438.8338.352.52
2313746-31374636.73736.99
3330521-33052138.70239.04
4330867-33086738.74239.08
5329657-32965738.60038.94
6315799-31579936.97837.24
20min1331856-33185638.85838.961.4339.4139.481.49
2325130-32513038.07038.53
3338068-33806839.58540.14
4337510-33751039.52040.07
5332095-33209538.88639.44
6331567-33156738.82439.29
30min1331146-33114638.77539.311.5539.5440.041.56
2332720-33272038.95939.63
3344721-34472140.36441.14
4331218-33121838.78339.55
5337249-33724939.48940.26
6337085-33708539.47040.15
45min1341629-34162940.00239.841.1940.9840.801.23
2336174-33617439.36340.25
3344907-34490740.38641.39
4334751-33475139.19740.18
5343620-34362040.23541.23
6340437-34043739.86340.76
60min1339397-33939739.74139.751.0640.9440.931.05
2336738-33673839.43040.54
3343007-34300740.16441.39
4333774-33377439.08240.29
5341531-34153139.99141.21
6342239-34223940.07441.19
极限1338881-33888139.68039.091.4141.1040.491.40
2334140-33414039.12540.45
3336944-33694439.45440.90
4325572-32557238.12239.54
5335642-33564239.30140.74
6331973-33197338.87240.21
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