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%
19.911711091709241728031729081717911719070.54
29.991707801704991706400.12
单位质量响应值RSD%判断
17346.8217081.081.10数据可信
供试品溶液-B24120811批-依折麦布-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110445-104455.4485.533.955.455.533.95
211000-110005.7375.74
310027-100275.2305.23
411182-111825.8325.83
510531-105315.4935.49
610451-104515.4515.45
10min115710-157108.1948.271.238.228.301.25
215853-158538.2688.30
316235-162358.4678.50
415836-158368.2598.29
515707-157078.1928.22
615816-158168.2498.28
15min116280-162808.4918.572.248.578.652.24
216753-167538.7388.82
315793-157938.2378.31
416766-167668.7448.82
516418-164188.5638.64
616592-165928.6548.73
20min115413-154138.0398.141.078.168.261.05
215441-154418.0538.18
315799-157998.2408.36
415673-156738.1748.30
515549-155498.1108.23
615779-157798.2308.35
30min115813-158138.2478.132.718.418.302.66
215842-158428.2628.43
315781-157818.2318.40
415455-154558.0618.23
515874-158748.2798.45
614789-147897.7137.88
45min113964-139647.2837.994.607.508.214.47
215746-157468.2128.43
315579-155798.1258.34
415461-154618.0648.28
515928-159288.3078.52
615287-152877.9738.19
60min114155-141557.3837.804.097.648.063.96
215094-150947.8728.13
315108-151087.8808.14
414615-146157.6237.88
515978-159788.3338.59
614807-148077.7237.98
极限114920-149207.7827.862.398.088.162.32
215219-152197.9388.24
315550-155508.1108.41
414668-146687.6507.95
515329-153297.9958.30
614693-146937.6637.96
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对照品来源工作对照品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%
110.963051163055763032743035153053993045760.36
210.973049713043633046670.15
单位质量响应值RSD%判断
27789.7827772.740.05数据可信
供试品溶液-B24120811批-阿托伐他汀钙-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min153735-5373515.97716.253.5515.9816.253.56
254272-5427216.13616.14
355945-5594516.63416.63
457632-5763217.13517.14
551973-5197315.45315.45
654360-5436016.16216.16
10min190961-9096127.04529.375.3227.1329.465.31
294238-9423828.01928.11
3103855-10385530.87830.97
4103809-10380930.86530.96
598886-9888629.40129.49
6101017-10101730.03530.12
15min1120830-12083035.92638.184.4636.1638.434.46
2123147-12314736.61436.86
3128304-12830438.14838.41
4136428-13642840.56340.83
5131910-13191039.22039.47
6129870-12987038.61338.87
20min1128534-12853438.21640.314.0238.6540.784.02
2129054-12905438.37138.82
3140489-14048941.77142.25
4139185-13918541.38341.87
5139818-13981841.57142.04
6136397-13639740.55441.03
30min1146285-14628543.49445.624.4344.1446.304.39
2153248-15324845.56446.23
3160822-16082247.81648.52
4152781-15278145.42546.15
5161590-16159048.04448.74
6145803-14580343.35144.05
45min1131430-13143039.07744.837.4839.9745.787.38
2152605-15260545.37346.29
3151966-15196645.18346.16
4151065-15106544.91545.89
5166796-16679649.59250.56
6150812-15081244.84045.78
60min1132328-13232839.34444.397.2840.4545.587.18
2149024-14902444.30845.48
3155182-15518246.13947.36
4145260-14526043.18944.41
5165133-16513349.09850.34
6148792-14879244.23945.43
极限1153430-15343045.61847.133.4146.9548.563.41
2158024-15802446.98448.40
3161138-16113847.91049.39
4154677-15467745.98947.45
5168017-16801749.95551.47
6155714-15571446.29747.73
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%
19.911707711703961704581706841706211705860.10
29.991706001702801704400.14
单位质量响应值RSD%判断
17213.5217061.060.63数据可信
供试品溶液-B24120811批-依折麦布-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110672-106725.5915.462.645.595.462.59
210733-107335.6235.62
310349-103495.4225.42
410534-105345.5185.52
510032-100325.2555.26
610205-102055.3465.35
10min115738-157388.2458.071.818.288.101.84
215743-157438.2478.28
315289-152898.0098.04
415401-154018.0688.10
515126-151267.9247.95
615141-151417.9327.96
15min116649-166498.7228.512.018.808.591.99
216488-164888.6388.71
315908-159088.3348.41
415945-159458.3538.43
516495-164958.6418.71
616032-160328.3998.47
20min115639-156398.1938.200.598.328.320.59
215822-158228.2898.41
315609-156098.1778.30
415597-155978.1718.29
515580-155808.1628.28
615711-157118.2308.35
30min115468-154688.1038.271.948.278.441.91
215784-157848.2698.44
315418-154188.0778.24
415858-158588.3078.47
516170-161708.4718.64
616069-160698.4188.58
45min114905-149057.8088.172.998.028.392.94
215769-157698.2618.48
315161-151617.9428.15
415783-157838.2688.48
516116-161168.4438.66
615874-158748.3168.53
60min114818-148187.7637.991.868.028.241.80
215243-152437.9858.25
315071-150717.8958.15
415411-154118.0738.33
515641-156418.1948.45
615291-152918.0108.27
极限114593-145937.6458.083.307.958.383.20
215490-154908.1158.42
315156-151567.9408.24
415511-155118.1268.43
516117-161178.4438.75
615627-156278.1868.49
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对照品来源工作对照品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%
110.963050463047543046303047983048423048140.05
210.973041063041593041320.02
单位质量响应值RSD%判断
27811.5027723.970.23数据可信
供试品溶液-B24120811批-阿托伐他汀钙-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min154555-5455516.22815.852.1216.2315.852.13
253018-5301815.77115.77
354420-5442016.18816.19
453621-5362115.95115.95
551680-5168015.37315.37
652447-5244715.60115.60
10min197138-9713828.89528.152.7228.9928.242.71
297485-9748528.99929.09
391900-9190027.33727.43
491349-9134927.17327.26
595049-9504928.27428.36
694825-9482528.20728.29
15min1129252-12925238.44837.153.4138.7037.393.40
2126810-12681037.72237.97
3120836-12083635.94536.19
4118975-11897535.39135.63
5128906-12890638.34538.59
6124466-12446637.02537.27
20min1133026-13302639.57140.272.1740.0440.722.15
2138050-13805041.06641.52
3133924-13392439.83840.28
4131429-13142939.09639.53
5137798-13779840.99141.45
6137939-13793941.03241.48
30min1148010-14801044.02846.034.4944.7146.704.44
2158974-15897447.29047.98
3146447-14644743.56344.23
4151874-15187445.17845.83
5163450-16345048.62149.30
6159700-15970047.50648.18
45min1147039-14703943.73946.166.0244.6747.095.94
2163307-16330748.57949.53
3142529-14252942.39843.30
4152672-15267245.41546.32
5166138-16613849.42150.37
6159294-15929447.38548.33
60min1142107-14210742.27244.975.2943.4446.165.23
2155414-15541446.23147.45
3144028-14402842.84443.98
4147237-14723743.79844.96
5162712-16271248.40249.63
6155565-15556546.27647.48
极限1152782-15278245.44848.484.4946.8549.914.45
2167509-16750949.82951.30
3158363-15836347.10848.49
4159340-15934047.39948.80
5172367-17236751.27452.77
6167451-16745149.81151.27
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%
19.911699481703021700531698041701751700560.12
29.991702341700341701340.09
单位质量响应值RSD%判断
17160.0417030.430.54数据可信
供试品溶液-B24120812批-依折麦布-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110476-104765.5025.645.815.505.645.80
210560-105605.5465.55
310209-102095.3615.36
410693-106935.6155.62
511960-119606.2816.28
610488-104885.5085.51
10min114949-149497.8518.174.867.888.204.86
214720-147207.7307.76
315679-156798.2348.26
415393-153938.0848.11
516863-168638.8568.89
615744-157448.2688.30
15min116195-161958.5058.593.778.588.663.77
217033-170338.9459.02
315765-157658.2798.35
415978-159788.3918.47
517205-172059.0359.12
615913-159138.3578.43
20min115305-153058.0377.986.128.168.105.99
215482-154828.1308.25
315678-156788.2338.35
415697-156978.2438.37
513330-133307.0007.13
615706-157068.2488.37
30min115373-153738.0738.181.298.248.351.25
215420-154208.0988.27
315743-157438.2678.43
415460-154608.1198.29
515880-158808.3398.51
615621-156218.2038.37
45min115055-150557.9068.153.548.128.363.44
215364-153648.0688.28
315339-153398.0558.27
415008-150087.8828.10
516404-164048.6158.83
615955-159558.3798.59
60min114837-148377.7928.003.108.058.263.06
215266-152668.0178.28
314863-148637.8058.06
414857-148577.8028.06
515922-159228.3618.63
615682-156828.2358.50
极限115250-152508.0098.212.468.318.522.42
215643-156438.2158.52
315277-152778.0238.32
415977-159778.3908.69
516201-162018.5088.82
615473-154738.1268.43
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对照品来源工作对照品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%
110.963041613045103036093036413037633039370.13
210.973018483015473016980.08
单位质量响应值RSD%判断
27731.4827502.100.59数据可信
供试品溶液-B24120812批-阿托伐他汀钙-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min151715-5171515.46816.085.2415.4716.085.24
252038-5203815.56415.56
351854-5185415.50915.51
454108-5410816.18416.18
559114-5911417.68117.68
653744-5374416.07516.07
10min188972-8897226.61127.836.6026.7027.926.59
286601-8660125.90225.99
395788-9578828.65028.74
489919-8991926.89526.98
5103653-10365331.00231.10
693339-9333927.91828.01
15min1122933-12293336.76937.104.4237.0037.344.43
2121271-12127136.27236.50
3121610-12161036.37336.62
4121531-12153136.35036.59
5135167-13516740.42840.70
6121767-12176736.42036.66
20min1132068-13206839.50138.575.7139.9439.025.62
2119682-11968235.79736.23
3131388-13138839.29839.75
4133441-13344139.91240.35
5119923-11992335.86936.36
6137157-13715741.02341.47
30min1148277-14827744.34944.147.3645.0144.807.29
2129694-12969438.79139.42
3144565-14456543.23943.90
4145864-14586443.62844.29
5161314-16131448.24948.94
6155780-15578046.59447.27
45min1145750-14575043.59444.359.8544.5045.269.73
2129837-12983738.83439.68
3141724-14172442.38943.30
4143405-14340542.89243.80
5172433-17243351.57452.54
6156549-15654946.82447.76
60min1145549-14554943.53443.889.4844.6845.049.37
2130119-13011938.91839.98
3138387-13838741.39142.53
4141304-14130442.26443.41
5169349-16934950.65251.90
6155535-15553546.52047.71
极限1158127-15812747.29647.875.5848.6849.275.59
2148042-14804244.27945.56
3155655-15565546.55647.93
4158359-15835947.36548.74
5173767-17376751.97353.50
6166419-16641949.77651.23
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%
19.911701821703541699091698741699101700460.13
29.991720191717721718960.11
单位质量响应值RSD%判断
17159.0317206.810.20数据可信
供试品溶液-B24120812批-依折麦布-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110453-104535.4615.503.595.465.503.62
211247-112475.8765.88
310479-104795.4755.47
410123-101235.2895.29
510396-103965.4325.43
610459-104595.4645.46
10min115604-156048.1538.293.768.188.323.74
216943-169438.8528.88
315820-158208.2658.30
415731-157318.2198.25
515908-159088.3118.34
615143-151437.9127.94
15min116169-161698.4488.542.688.528.622.69
217022-170228.8938.98
315795-157958.2528.33
416506-165068.6248.70
516043-160438.3828.46
616571-165718.6588.73
20min115665-156658.1847.948.238.318.068.11
216496-164968.6198.75
314623-146237.6407.76
412962-129626.7726.90
515874-158748.2948.42
615517-155178.1078.23
30min115387-153878.0398.241.558.218.401.53
216126-161268.4258.60
315693-156938.1998.36
415766-157668.2378.40
515734-157348.2218.39
615894-158948.3048.47
45min115317-153178.0038.082.958.228.292.87
215715-157158.2118.44
315606-156068.1548.36
415565-155658.1328.34
515936-159368.3268.54
614626-146267.6427.86
60min115531-155318.1147.962.348.378.222.32
215536-155368.1178.39
314729-147297.6957.95
414888-148887.7788.03
515194-151947.9388.20
615512-155128.1058.36
极限115820-158208.2658.242.898.578.542.87
216516-165168.6298.95
315504-155048.1008.40
415163-151637.9228.22
515660-156608.1828.49
615927-159278.3218.62
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对照品来源工作对照品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%
110.963036863033893032263033103031613033540.07
210.973061553061583061560.01
单位质量响应值RSD%判断
27678.2827908.480.59数据可信
供试品溶液-B24120812批-阿托伐他汀钙-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min152593-5259315.63115.603.6615.6315.603.66
256061-5606116.66116.66
351336-5133615.25715.26
450415-5041514.98314.98
552317-5231715.54915.55
652318-5231815.54915.55
10min192322-9232227.43827.724.6327.5227.804.63
2100805-10080529.95930.05
388743-8874326.37426.46
491116-9111627.08027.16
595574-9557428.40428.49
691016-9101627.05027.14
15min1123930-12393036.83236.453.4837.0736.693.48
2128467-12846738.18038.44
3116240-11624034.54634.78
4119363-11936335.47435.71
5123537-12353736.71536.96
6124335-12433536.95237.19
20min1135228-13522840.19038.489.3740.6338.939.30
2138890-13889041.27841.75
3125396-12539637.26737.69
4106635-10663531.69232.12
5137037-13703740.72741.18
6133767-13376739.75540.20
30min1150697-15069744.78744.203.8345.4544.863.81
2144264-14426442.87543.58
3147397-14739743.80644.44
4140664-14066441.80542.41
5155389-15538946.18146.86
6153940-15394045.75146.41
45min1150649-15064944.77344.333.7045.6945.233.68
2146267-14626743.47044.41
3149244-14924444.35545.23
4142718-14271842.41643.25
5158946-15894647.23848.17
6147086-14708643.71444.63
60min1153099-15309945.50144.194.7946.6745.344.76
2152778-15277845.40546.59
3142901-14290142.47043.59
4136894-13689440.68541.76
5152170-15217045.22546.42
6154332-15433245.86747.03
极限1168048-16804849.94448.444.6851.3649.844.66
2167445-16744549.76451.20
3157294-15729446.74748.10
4150154-15015444.62545.93
5165579-16557949.21050.65
6169423-16942350.35251.77
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%
19.911706491704811704221706981706531705810.08
29.991705361705031705200.02
单位质量响应值RSD%判断
17213.0217069.070.60数据可信
供试品溶液-B24120911批-依折麦布-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110010-100105.2435.072.925.245.072.90
29928-99285.2005.20
39788-97885.1265.13
49609-96095.0335.03
59502-95024.9774.98
69257-92574.8484.85
10min116004-160048.3828.452.958.418.482.97
216473-164738.6288.66
315229-152297.9768.00
416420-164208.6008.63
516441-164418.6118.64
616195-161958.4828.51
15min116999-169998.9038.870.838.988.940.81
216940-169408.8728.95
316995-169958.9018.97
416733-167338.7648.84
517105-171058.9599.03
616797-167978.7978.87
20min116561-165618.6748.761.528.808.881.50
216826-168268.8138.94
317098-170988.9559.08
416866-168668.8348.96
516610-166108.7008.82
616389-163898.5848.71
30min116080-160808.4228.251.478.608.421.46
215624-156248.1838.36
315878-158788.3168.49
415531-155318.1348.31
515873-158738.3148.49
615499-154998.1188.29
45min116368-163688.5738.605.088.798.824.96
215724-157248.2358.46
316569-165698.6788.90
417985-179859.4209.64
516054-160548.4088.63
615807-158078.2798.49
60min115914-159148.3358.421.488.608.681.44
216208-162088.4898.76
316309-163098.5428.81
416269-162698.5218.79
515695-156958.2208.49
616038-160388.4008.66
极限114950-149507.8307.957.048.148.266.78
215296-152968.0118.32
313188-131886.9077.22
415998-159988.3798.70
516096-160968.4308.74
615577-155778.1588.47
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100590-202005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(%)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%
110.963039263037573041613041013039803039850.06
210.973042793043203043000.01
单位质量响应值RSD%判断
27735.8627739.290.01数据可信
供试品溶液-B24120911批-阿托伐他汀钙-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146801-4680113.93714.305.8013.9414.305.80
247371-4737114.10714.11
345931-4593113.67813.68
450348-5034814.99314.99
552413-5241315.60815.61
645239-4523913.47213.47
10min197675-9767529.08727.889.3229.1627.969.31
291964-9196427.38627.46
388719-8871926.42026.50
498887-9888729.44829.53
5104632-10463231.15831.25
679915-7991523.79823.87
15min1125659-12565937.42035.968.4737.6636.208.46
2118391-11839135.25635.49
3112376-11237633.46533.69
4123744-12374436.85037.10
5136520-13652040.65440.91
6107911-10791132.13532.34
20min1140290-14029041.77740.677.0542.2241.107.06
2131958-13195839.29639.72
3130917-13091738.98639.39
4139753-13975341.61742.07
5152078-15207845.28745.77
6124508-12450837.07737.46
30min1141236-14123642.05940.287.9542.7440.947.93
2126720-12672037.73638.38
3129797-12979738.65239.28
4132257-13225739.38540.07
5154367-15436745.96946.71
6127213-12721337.88338.47
45min1150549-15054944.83243.937.8945.7444.817.86
2134037-13403739.91540.77
3142933-14293342.56443.40
4145251-14525143.25444.16
5168617-16861750.21351.21
6143729-14372942.80143.60
60min1149395-14939544.48844.606.2545.6545.736.23
2139566-13956641.56242.64
3145724-14572443.39544.47
4145063-14506343.19844.34
5166799-16679949.67150.94
6152064-15206445.28346.32
极限1149953-14995344.65545.579.3646.0646.949.25
2148114-14811444.10745.41
3131993-13199339.30640.62
4155041-15504146.17047.55
5176026-17602652.41953.97
6157011-15701146.75648.05
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%
19.911707691705951706531700951704791705180.16
29.991702931704301703620.06
单位质量响应值RSD%判断
17206.6617053.250.64数据可信
供试品溶液-B24120911批-依折麦布-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19414-94144.9344.961.854.934.961.81
29734-97345.1025.10
39460-94604.9584.96
49536-95364.9985.00
59400-94004.9264.93
69207-92074.8254.83
10min116115-161158.4468.451.588.478.471.58
216475-164758.6348.66
316028-160288.4008.43
416306-163068.5468.57
516054-160548.4148.44
615736-157368.2478.27
15min116927-169278.8718.791.038.958.871.04
217000-170008.9108.99
316624-166248.7138.79
416846-168468.8298.90
516574-165748.6868.76
616707-167078.7568.83
20min116648-166488.7258.641.358.858.761.36
216822-168228.8168.94
316503-165038.6498.77
416373-163738.5818.71
516299-162998.5428.66
616242-162428.5128.63
30min116447-164478.6208.7811.598.798.9511.37
216163-161638.4718.65
315919-159198.3438.51
415746-157468.2528.42
520664-2066410.83011.00
615575-155758.1638.33
45min116017-160178.3948.321.998.618.541.94
216359-163598.5748.80
316013-160138.3928.61
415592-155928.1728.39
515517-155178.1328.36
615762-157628.2618.47
60min116156-161568.4678.411.378.738.671.36
216122-161228.4498.72
316282-162828.5338.80
415643-156438.1988.46
516055-160558.4148.69
615973-159738.3718.63
极限115740-157408.2498.310.908.568.620.89
215881-158818.3238.64
316117-161178.4478.76
415747-157478.2538.56
515831-158318.2978.62
615780-157808.2708.58
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对照品来源工作对照品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%
110.963046813043363039853030203033263038700.23
210.973033363026633030000.16
单位质量响应值RSD%判断
27725.3627620.780.27数据可信
供试品溶液-B24120911批-阿托伐他汀钙-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146496-4649613.87813.983.0713.8813.983.08
249653-4965314.82114.82
345865-4586513.69013.69
446214-4621413.79413.79
546957-4695714.01614.02
645881-4588113.69513.69
10min187960-8796026.25527.655.4926.3327.735.49
299323-9932329.64729.73
395715-9571528.57028.65
493651-9365127.95428.03
593681-9368127.96228.04
685489-8548925.51725.59
15min1116961-11696134.91135.754.6035.1335.984.60
2129622-12962238.69038.94
3120747-12074736.04136.28
4119228-11922835.58835.82
5119013-11901335.52435.76
6113082-11308233.75333.97
20min1132513-13251339.55340.453.4539.9740.883.47
2143274-14327442.76543.23
3137379-13737941.00641.44
4133317-13331739.79340.22
5136587-13658740.76941.20
6129985-12998538.79939.20
30min1140531-14053141.94741.223.3242.5841.883.29
2141145-14114542.13042.83
3136537-13653740.75441.42
4131464-13146439.24039.89
5143903-14390342.95343.61
6135024-13502440.30340.92
45min1147383-14738343.99243.893.8844.8644.783.84
2154648-15464846.16047.09
3145195-14519543.33944.23
4137355-13735540.99941.87
5149487-14948744.62045.52
6148193-14819344.23445.08
60min1153346-15334645.77245.444.2646.8946.574.18
2154405-15440546.08847.28
3148611-14861144.35845.49
4141251-14125142.16143.26
5159501-15950147.60948.75
6156362-15636246.67247.76
极限1158543-15854347.32347.892.5448.6949.272.54
2165442-16544249.38250.83
3159007-15900747.46148.84
4154135-15413546.00747.34
5163515-16351548.80750.22
6162041-16204148.36749.72
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