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%
110.021723181722231722561721331722871722430.05
210.111732321733561732940.06
单位质量响应值RSD%判断
17189.9217140.850.21数据可信
供试品溶液-U039846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%
5min17487-74873.9164.0612.273.924.0612.26
28658-86584.5284.53
37585-75853.9673.97
47467-74673.9053.91
56365-63653.3293.33
69022-90224.7194.72
10min115110-151107.9037.991.907.928.021.94
215692-156928.2078.23
315459-154598.0858.11
415299-152998.0018.02
514845-148457.7647.78
615298-152988.0018.03
15min116079-160798.4098.241.888.478.301.90
215995-159958.3658.44
315891-158918.3118.38
415735-157358.2298.30
515414-154148.0628.12
615378-153788.0438.11
20min115791-157918.2598.053.308.378.173.27
215374-153748.0418.16
316181-161818.4638.58
415194-151947.9468.06
515078-150787.8867.99
614788-147887.7347.85
30min114576-145767.6237.801.627.787.951.57
215206-152067.9538.11
315034-150347.8638.02
415061-150617.8778.03
514891-148917.7887.94
614686-146867.6817.84
45min115145-151457.9217.911.088.128.111.08
215118-151187.9078.11
315381-153818.0448.25
415042-150427.8678.07
515162-151627.9308.12
614882-148827.7837.98
60min115002-150027.8467.800.948.098.040.91
215073-150737.8838.13
314950-149507.8198.07
414864-148647.7748.02
514886-148867.7858.02
614670-146707.6727.92
极限114754-147547.7167.771.768.008.061.75
215022-150227.8578.15
315264-152647.9838.28
414819-148197.7508.04
514769-147697.7248.01
614502-145027.5857.87
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%
110.993104923104883104243102243105063104270.04
211.093122663122123122390.02
单位质量响应值RSD%判断
28246.3128155.000.23数据可信
供试品溶液-U039846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%
5min1107941-10794131.61626.0617.1631.6226.0617.16
294431-9443127.65927.66
3102999-10299930.16930.17
468583-6858320.08820.09
580678-8067823.63123.63
679278-7927823.22123.22
10min1303283-30328388.83284.545.8789.0184.685.89
2300584-30058488.04288.20
3307693-30769390.12490.29
4273363-27336380.06980.18
5270703-27070379.28979.42
6276089-27608980.86781.00
15min1329002-32900296.36593.114.6197.0393.724.62
2329094-32909496.39297.03
3327631-32763195.96496.63
4312651-31265191.57692.13
5317521-31752193.00293.57
6291437-29143785.36285.94
20min1327220-32722095.84392.635.5297.0593.765.52
2325862-32586295.44696.62
3332243-33224397.31598.52
4311833-31183391.33692.40
5316186-31618692.61193.70
6284110-28411083.21684.27
30min1310029-31002990.80891.334.9992.5592.984.98
2326337-32633795.58597.29
3323446-32344694.73896.48
4310651-31065190.99092.56
5317399-31739992.96794.57
6283050-28305082.90684.42
45min1324096-32409694.92892.594.5197.1794.744.52
2324557-32455795.06397.30
3323268-32326894.68696.95
4314327-31432792.06794.15
5322372-32237294.42396.54
6288050-28805084.37086.35
60min1324036-32403694.91192.664.3297.6895.334.33
2327284-32728495.86298.63
3322659-32265994.50797.30
4313319-31331991.77294.36
5320632-32063293.91496.56
6290145-29014584.98487.43
极限1337134-33713498.747100.351.57102.04103.531.46
2337596-33759698.882102.18
3342897-342897100.435103.75
4341335-34133599.978103.08
5351648-351648102.998106.16
6344938-344938101.033103.95
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%
110.021720581720401721681722711723191721710.08
210.111737191752831745010.64
单位质量响应值RSD%判断
17182.7317260.240.32数据可信
供试品溶液-U039846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%
5min17749-77494.0403.9214.614.043.9214.54
26935-69353.6153.62
39516-95164.9614.96
47377-73773.8463.85
57225-72253.7663.77
66283-62833.2753.28
10min115627-156278.1467.961.428.177.991.45
215328-153287.9908.01
315382-153828.0198.05
415215-152157.9327.95
515081-150817.8627.88
615037-150377.8397.86
15min116194-161948.4428.271.588.518.341.60
215785-157858.2298.29
316073-160738.3798.45
415976-159768.3288.39
515604-156048.1348.20
615593-155938.1298.19
20min115693-156938.1818.171.298.308.281.27
215412-154128.0348.14
315496-154968.0788.20
415934-159348.3068.42
515855-158558.2658.37
615642-156428.1548.26
30min115592-155928.1288.011.838.298.171.83
215149-151497.8978.05
315258-152587.9548.12
415523-155238.0928.25
515695-156958.1828.34
614977-149777.8077.96
45min115394-153948.0257.921.048.238.121.04
214965-149657.8018.00
315251-152517.9508.16
415304-153047.9788.18
515069-150697.8558.06
615178-151787.9128.11
60min115175-151757.9117.761.378.168.011.35
214568-145687.5947.84
314950-149507.7938.05
414905-149057.7708.02
514967-149677.8028.05
614789-147897.7097.95
极限114688-146887.6577.671.177.957.961.16
214850-148507.7418.03
314895-148957.7658.06
414762-147627.6957.99
514650-146507.6377.93
614417-144177.5167.80
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%
110.993098113098273100213102573101713100170.07
211.093136013160633148320.56
单位质量响应值RSD%判断
28209.0128388.820.45数据可信
供试品溶液-U039846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%
5min192632-9263227.03826.0721.9727.0426.0721.96
274847-7484721.84721.85
3122076-12207635.63235.63
487767-8776725.61825.62
593846-9384627.39227.39
664677-6467718.87818.88
10min1297511-29751186.84083.9211.2786.9984.0611.29
2260292-26029275.97676.10
3321444-32144493.82594.02
4294963-29496386.09686.24
5313484-31348491.50291.65
6237255-23725569.25269.36
15min1321925-32192593.96695.292.9694.6095.903.00
2327667-32766795.64296.19
3341414-34141499.654100.37
4315442-31544292.07392.69
5333173-33317397.24997.91
6319065-31906593.13193.62
20min1321574-32157493.86395.832.3095.0296.972.31
2331595-33159596.78897.86
3334260-33426097.56698.84
4318428-31842892.94594.08
5337770-33777098.59199.79
6326299-32629995.24296.25
30min1319569-31956993.27894.922.6694.9596.602.68
2328395-32839595.85497.47
3333696-33369697.40299.22
4312374-31237491.17892.83
5334610-33461097.66899.42
6322587-32258794.15995.70
45min1317880-31788092.78594.962.6094.9897.162.58
2328205-32820595.79997.94
3334123-33412397.52699.88
4312173-31217391.11993.27
5328658-32865895.93198.22
6331025-33102596.62298.68
60min1317742-31774292.74594.632.6095.4597.352.59
2327146-32714695.49098.17
3334536-33453697.647100.54
4310959-31095990.76593.43
5327913-32791395.71498.54
6326820-32682095.39597.99
极限1338970-33897098.941100.480.88102.17103.740.89
2347512-347512101.434104.64
3345741-345741100.917104.36
4343396-343396100.233103.40
5346100-346100101.022104.38
6343786-343786100.347103.47
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%
110.021733671736191735311735981733721734970.07
210.111734641743161738900.35
单位质量响应值RSD%判断
17315.0717199.800.48数据可信
供试品溶液-X013993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%
5min18329-83294.3334.8512.154.334.8512.16
210830-108305.6345.63
310288-102885.3525.35
49751-97515.0735.07
58693-86934.5224.52
68043-80434.1844.18
10min115140-151407.8768.122.297.908.142.30
215483-154838.0558.09
316015-160158.3318.36
415894-158948.2688.30
515811-158118.2258.25
615275-152757.9467.97
15min115470-154708.0488.272.178.128.342.18
215741-157418.1898.26
316394-163948.5288.60
416075-160758.3628.44
516081-160818.3668.44
615623-156238.1278.19
20min115473-154738.0498.222.918.168.342.88
215241-152417.9298.05
316013-160138.3308.45
416178-161788.4168.54
516406-164068.5358.65
615522-155228.0758.19
30min115284-152847.9518.112.128.118.282.13
215286-152867.9528.12
315895-158958.2698.44
415861-158618.2518.42
515938-159388.2918.46
615324-153247.9728.13
45min114916-149167.7608.032.427.968.242.42
215080-150807.8458.05
315780-157808.2098.42
415772-157728.2058.42
515680-156808.1578.37
615363-153637.9928.19
60min114795-147957.6977.993.197.948.243.15
214707-147077.6517.90
315533-155338.0818.34
415883-158838.2638.52
515672-156728.1538.41
615592-155928.1118.36
极限114823-148237.7117.703.058.008.002.97
214151-141517.3627.66
315372-153727.9978.30
414811-148117.7058.01
515200-152007.9078.21
614474-144747.5307.82
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%
110.993113433117533116133115653113163115180.06
211.093118103131843124970.32
单位质量响应值RSD%判断
28345.5928178.270.42数据可信
供试品溶液-X013993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%
5min187679-8767925.62634.8228.2525.6334.8228.25
2134677-13467739.36239.36
3142157-14215741.54841.55
4151561-15156144.29744.30
5131568-13156838.45338.45
667212-6721219.64419.64
10min1304688-30468889.05192.182.9089.1992.372.95
2316035-31603592.36792.59
3322932-32293294.38394.61
4318921-31892193.21193.46
5325603-32560395.16495.38
6304084-30408488.87488.98
15min1330528-33052896.60397.841.4997.2498.551.50
2334496-33449697.76398.49
3333842-33384297.57298.33
4330528-33052896.60397.37
5344113-344113100.573101.32
6335135-33513597.94998.55
20min1334373-33437397.72798.041.8798.9099.291.83
2328959-32895996.14497.42
3332088-33208897.05998.36
4331279-33127996.82298.12
5345058-345058100.850102.15
6340972-34097299.655100.80
30min1337275-33727598.57598.361.15100.29100.161.13
2334463-33446397.75399.56
3335881-33588198.167100.00
4331093-33109396.76898.61
5342650-342650100.146102.01
6337916-33791698.762100.46
45min1333025-33302597.33397.891.2599.60100.221.21
2332127-33212797.07099.42
3334851-33485197.866100.25
4329786-32978696.38698.76
5339866-33986699.332101.75
6339840-33984099.325101.57
60min1337076-33707698.51798.531.83101.32101.421.77
2328519-32851996.01698.91
3333235-33323597.394100.32
4335686-33568698.110101.02
5344188-344188100.595103.56
6344091-344091100.567103.37
极限1342467-342467100.09298.751.44103.44102.181.39
2331512-33151296.891100.32
3337888-33788898.754102.22
4333117-33311797.360100.82
5343547-343547100.408103.94
6338614-33861498.966102.33
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%
110.021725591724751727551728741728901727110.11
210.111736391749881743140.55
单位质量响应值RSD%判断
17236.6317241.740.03数据可信
供试品溶液-X013993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%
5min19475-94754.9344.846.604.934.846.62
28916-89164.6434.64
38293-82934.3194.32
49830-98305.1195.12
59300-93004.8434.84
69938-99385.1755.18
10min115337-153377.9878.102.068.018.132.05
215436-154368.0388.06
315214-152147.9237.95
415849-158498.2548.28
515490-154908.0678.09
616045-160458.3568.38
15min115501-155018.0728.282.168.148.362.17
216013-160138.3398.41
315475-154758.0598.13
416196-161968.4348.51
515997-159978.3318.40
616274-162748.4758.55
20min115281-152817.9588.151.328.078.261.34
215664-156648.1578.27
315668-156688.1598.27
415767-157678.2118.33
515617-156178.1338.25
615896-158968.2788.40
30min115078-150787.8527.991.358.018.151.35
215138-151387.8838.05
315308-153087.9728.13
415621-156218.1358.30
515460-154608.0518.21
615440-154408.0418.21
45min115227-152277.9308.041.298.138.241.31
215228-152287.9308.14
315406-154068.0238.23
415404-154048.0228.23
515617-156178.1338.34
615712-157128.1828.40
60min115154-151547.8927.841.908.148.101.88
215120-151207.8748.12
314485-144857.5437.79
415169-151697.8998.16
515178-151787.9048.16
615258-152587.9468.20
极限114344-143447.4707.551.167.767.851.09
214527-145277.5657.86
314770-147707.6927.98
414306-143067.4507.75
514565-145657.5857.88
614513-145137.5587.86
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%
110.993091063092913095853098713099033095510.12
211.093123333140743132040.40
单位质量响应值RSD%判断
28166.6128242.020.19数据可信
供试品溶液-X013993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%
5min165107-6510719.06723.3830.9119.0723.3830.91
264292-6429218.82918.83
368240-6824019.98519.99
4125614-12561436.78836.79
591053-9105326.66626.67
664695-6469518.94718.95
10min1284748-28474883.39282.656.9583.5082.786.97
2251502-25150273.65673.76
3290205-29020584.99085.10
4302970-30297088.72988.93
5297338-29733887.07987.23
6266523-26652378.05578.16
15min1317442-31744292.96793.024.6793.5493.614.65
2327043-32704395.77996.29
3331774-33177497.16597.75
4315582-31558292.42293.12
5323996-32399694.88795.52
6289967-28996784.92185.46
20min1322007-32200794.30493.285.2795.3994.395.24
2330704-33070496.85197.90
3336122-33612298.43899.56
4312714-31271491.58392.79
5320996-32099694.00895.17
6288572-28857284.51285.52
30min1319743-31974393.64193.365.2295.2594.985.21
2320579-32057993.88695.47
3335289-33528998.19499.86
4321220-32122094.07495.79
5328763-32876396.28397.96
6287179-28717984.10485.58
45min1325875-32587595.43794.594.1397.5796.744.11
2326740-32674095.69097.80
3340721-34072199.785102.00
4313352-31335291.76994.01
5328834-32883496.30498.52
6302447-30244788.57690.52
60min1325237-32523795.25094.083.6897.9196.753.69
2330489-33048996.78899.43
3329596-32959696.52799.30
4318941-31894193.40696.16
5324530-32453095.04397.79
6298635-29863587.45989.90
极限1336937-33693798.67798.520.82101.87101.710.89
2339137-33913799.321102.50
3338910-33891099.254102.56
4334745-33474598.035101.31
5336739-33673998.619101.90
6331882-33188297.196100.12
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