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%
110.181670851666631663881666581661231665830.22
210.131684241680501682370.16
单位质量响应值RSD%判断
16363.7516607.801.05数据可信
0天-供试品溶液-2023120821批-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%
5min19918-99185.4045.2317.595.405.2217.57
28025-80254.3734.37
312652-126526.8946.89
48111-81114.4194.42
59260-92605.0455.05
69587-95875.2245.22
10min116537-165379.0108.723.289.048.753.32
215906-159068.6678.69
316702-167029.1009.14
415313-153138.3438.37
515695-156958.5528.58
615864-158648.6448.67
15min116850-168509.1819.015.849.269.095.87
215437-154378.4118.48
317995-179959.8059.89
415550-155508.4738.54
516388-163888.9299.00
617011-170119.2699.35
20min117704-177049.6469.681.649.789.811.60
217568-175689.5729.69
317453-174539.5099.65
417883-178839.7449.86
517759-177599.6769.80
618285-182859.96310.09
30min112288-122886.6957.337.656.887.517.56
212756-127566.9507.12
315164-151648.2628.46
412933-129337.0477.22
513871-138717.5587.74
613722-137227.4777.66
45min116008-160088.7229.1011.818.949.3211.65
215134-151348.2468.46
320004-2000410.89911.14
415323-153238.3498.56
515533-155338.4638.68
618226-182269.93110.16
60min116538-165389.0119.5018.449.289.7718.07
214589-145897.9498.21
322135-2213512.06112.36
414887-148878.1118.37
515675-156758.5418.81
620758-2075811.31011.59
极限121329-2132911.62110.7215.7911.9411.0415.52
216273-162738.8679.17
322785-2278512.41512.78
416465-164658.9719.27
518123-181239.87510.19
623069-2306912.56912.91
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USP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%
111.003082503082813075133074963068263076730.20
211.153104343101723103030.06
单位质量响应值RSD%判断
27970.2727829.870.36数据可信
0天-供试品溶液-2023120821批-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%
5min1113322-11332213.42011.4820.4813.4211.4820.47
269219-692198.1978.20
3109516-10951612.96912.97
473873-738738.7488.75
5105732-10573212.52112.52
6109763-10976312.99913.00
10min1153100-15310018.13117.147.0318.2117.207.09
2128583-12858315.22715.27
3151610-15161017.95418.03
4135510-13551016.04816.10
5151244-15124417.91117.98
6148115-14811517.54017.61
15min1153011-15301118.12017.707.0518.3017.867.10
2133455-13345515.80415.93
3158825-15882518.80918.98
4139104-13910416.47316.61
5155079-15507918.36518.53
6157126-15712618.60718.78
20min1156197-15619718.49718.792.7718.7719.042.84
2152102-15210218.01218.23
3163764-16376419.39319.67
4157343-15734318.63318.86
5159478-15947818.88619.16
6162991-16299119.30219.57
30min1153508-15350818.17919.162.9018.5619.522.85
2159339-15933918.86919.19
3165905-16590519.64720.03
4164701-16470119.50419.84
5162378-16237819.22919.61
6164788-16478819.51519.90
45min1161756-16175619.15619.311.5619.6419.781.57
2161424-16142419.11619.54
3167495-16749519.83520.33
4164208-16420819.44619.89
5160483-16048319.00519.49
6163154-16315419.32119.81
60min1156161-15616118.49319.312.6219.0819.882.56
2160712-16071219.03219.56
3167966-16796619.89120.49
4166619-16661919.73220.28
5162870-16287019.28819.88
6163867-16386719.40620.00
极限1158303-15830318.74719.192.6319.4419.882.57
2161048-16104819.07219.71
3169612-16961220.08620.80
4164221-16422119.44820.11
5160384-16038418.99319.69
6158767-15876718.80219.51
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%
110.181681361684651683041682441684251683150.08
210.131668081675001671540.30
单位质量响应值RSD%判断
16533.8916500.890.15数据可信
0天-供试品溶液-第1批-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%
5min18199-81994.4595.2712.404.465.2712.39
29044-90444.9184.92
310995-109955.9795.98
48783-87834.7764.78
511084-110846.0276.03
69999-99995.4375.44
10min113054-130547.0996.921.837.126.951.81
212474-124746.7836.81
312905-129057.0187.05
412488-124886.7916.82
512802-128026.9627.00
612667-126676.8886.92
15min115895-158958.6448.284.528.718.354.46
214924-149248.1168.18
314042-140427.6367.71
415199-151998.2658.33
515819-158198.6028.67
615500-155008.4298.50
20min116732-167329.0998.862.609.218.972.54
216822-168229.1489.26
315707-157078.5418.66
416036-160368.7208.83
516208-162088.8148.93
616248-162488.8368.95
30min115112-151128.2187.068.048.387.227.86
212429-124296.7596.92
312521-125216.8096.97
412604-126046.8547.01
512634-126346.8707.04
612624-126246.8657.03
45min119481-1948110.5948.5911.8710.808.7911.60
214960-149608.1358.33
316032-160328.7188.92
414802-148028.0498.25
514708-147087.9988.21
614774-147748.0348.24
60min117987-179879.7818.2710.6810.058.5210.46
214271-142717.7608.00
316392-163928.9149.16
414450-144507.8588.10
513866-138667.5407.79
614305-143057.7798.03
极限121781-2178111.84410.3910.4512.1710.6810.23
219306-1930610.49810.79
319358-1935810.52710.82
419434-1943410.56810.85
515565-155658.4648.76
619165-1916510.42210.71
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USP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%
111.003097033099733100053098453104683099990.10
211.153074373088603081480.33
单位质量响应值RSD%判断
28181.7327636.591.39数据可信
0天-供试品溶液-第1批-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%
5min1102931-10293112.18711.5624.6812.1911.5624.69
270623-706238.3618.36
371573-715738.4748.47
494380-9438011.17411.17
5131884-13188415.61415.61
6114409-11440913.54513.55
10min1145631-14563117.24217.092.0417.3117.152.09
2145324-14532417.20617.25
3139419-13941916.50716.55
4142289-14228916.84616.91
5147522-14752217.46617.55
6145692-14569217.24917.32
15min1154239-15423918.26117.913.6918.4218.073.75
2148645-14864517.59917.74
3142083-14208316.82216.96
4150237-15023717.78717.94
5157637-15763718.66318.85
6155011-15501118.35318.52
20min1147771-14777117.49517.912.9917.7618.172.97
2158305-15830518.74318.98
3145362-14536217.21017.44
4150784-15078417.85218.11
5153413-15341318.16318.45
6151882-15188217.98218.26
30min1155265-15526518.38319.463.1718.7419.823.15
2169458-16945820.06320.41
3161553-16155319.12719.45
4165537-16553719.59919.95
5167938-16793819.88320.27
6166491-16649119.71220.08
45min1161050-16105019.06819.562.0819.5320.032.06
2171144-17114420.26320.72
3163433-16343319.35019.78
4163866-16386619.40119.86
5165382-16538219.58020.08
6166447-16644719.70720.19
60min1155966-15596618.46619.382.6419.0419.962.60
2168208-16820819.91520.48
3163302-16330219.33419.88
4163001-16300119.29919.87
5167135-16713519.78820.40
6164618-16461819.49020.08
极限1160671-16067119.02319.692.8119.7020.372.71
2171660-17166020.32421.00
3164423-16442319.46720.12
4172063-17206320.37121.05
5166034-16603419.65820.38
6162876-16287619.28419.98
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%
110.181676131673181673861673241672521673790.09
210.131664041664331664180.02
单位质量响应值RSD%判断
16441.9416428.230.06数据可信
0天-供试品溶液-2023120821批-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%
5min112412-124126.7835.9714.296.785.9714.31
210326-103265.6435.64
310959-109595.9895.99
412375-123756.7636.76
58206-82064.4854.48
611263-112636.1556.16
10min115933-159338.7088.552.588.758.592.62
215774-157748.6218.65
315474-154748.4578.49
415697-156978.5798.62
514948-149488.1698.19
616082-160828.7898.82
15min117068-170689.3289.272.219.419.352.24
217254-172549.4309.51
317083-170839.3369.42
416899-168999.2369.32
516245-162458.8788.95
617228-172289.4159.50
20min118309-1830910.00610.011.2310.1410.141.24
218083-180839.88310.01
318746-1874610.24510.38
418222-182229.95910.10
518244-182449.97110.09
618321-1832110.01310.15
30min110317-103175.6385.832.145.836.022.05
210492-104925.7345.92
310848-108485.9296.12
410861-108615.9366.13
510842-108425.9256.10
610610-106105.7995.99
45min112983-129837.0957.151.807.327.361.78
212723-127236.9537.17
313386-133867.3167.54
413028-130287.1207.34
513056-130567.1357.34
613279-132797.2577.48
60min115925-159258.7038.690.738.978.950.75
215810-158108.6408.90
315981-159818.7349.00
416062-160628.7789.04
515752-157528.6098.86
615841-158418.6578.92
极限118813-1881310.28210.051.3010.5910.361.29
218316-1831610.01010.31
318389-1838910.05010.36
418453-1845310.08510.40
518173-181739.93210.23
618168-181689.92910.24
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USP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%
111.003080383085303081573080483077623081070.10
211.153066473067833067150.04
单位质量响应值RSD%判断
28009.7327508.071.28数据可信
0天-供试品溶液-2023120821批-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%
5min1136935-13693516.30013.8025.2316.3013.8025.24
2127280-12728015.15115.15
3103902-10390212.36812.37
4125502-12550214.93914.94
562105-621057.3937.39
6139894-13989416.65216.65
10min1159036-15903618.93118.608.8419.0218.688.91
2164745-16474519.61019.69
3160134-16013419.06119.13
4160562-16056219.11219.20
5128546-12854615.30115.34
6164776-16477619.61419.71
15min1164770-16477019.61319.425.2619.8119.605.35
2170241-17024120.26520.46
3167003-16700319.87920.05
4164935-16493519.63319.82
5146147-14614717.39717.52
6166013-16601319.76119.96
20min1165675-16567519.72119.702.2720.0319.992.35
2167592-16759219.94920.25
3169676-16967620.19720.48
4166433-16643319.81120.11
5158638-15863818.88319.11
6164964-16496419.63619.95
30min1159697-15969719.00919.782.1219.4220.182.02
2166843-16684319.86020.28
3169197-16919720.14020.54
4168292-16829220.03320.44
5168159-16815920.01720.34
6164956-16495619.63520.06
45min1166362-16636219.80319.890.8220.3220.400.79
2165958-16595819.75520.28
3169425-16942520.16720.68
4165863-16586319.74320.26
5167302-16730219.91520.35
6167712-16771219.96420.49
60min1164666-16466619.60119.690.7320.2320.310.68
2166810-16681019.85620.49
3166276-16627619.79320.41
4165388-16538819.68720.32
5165926-16592619.75120.30
6163515-16351519.46420.10
极限1165620-16562019.71519.730.6820.4520.460.65
2165191-16519119.66320.41
3167596-16759619.95020.68
4166236-16623619.78820.53
5165659-16565919.71920.38
6164238-16423819.55020.30
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%
110.181666321663751664041663131659721663390.15
210.131680091684461682280.19
单位质量响应值RSD%判断
16339.7816606.911.15数据可信
0天-供试品溶液-第1批-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%
5min19561-95615.2135.359.485.215.359.51
210175-101755.5485.55
38518-85184.6454.64
411058-110586.0306.03
59117-91174.9714.97
610462-104625.7055.70
10min114169-141697.7267.840.747.767.870.73
214447-144477.8787.91
314358-143587.8297.85
414425-144257.8667.90
514424-144247.8657.89
614422-144227.8647.90
15min115275-152758.3298.511.168.408.591.16
215557-155578.4838.56
315658-156588.5388.61
415725-157258.5758.65
515704-157048.5638.63
615761-157618.5948.67
20min116775-167759.1479.170.699.279.290.67
216836-168369.1809.30
316972-169729.2549.37
416633-166339.0709.19
516887-168879.2089.33
616768-167689.1439.27
30min110576-105765.7675.801.955.945.971.93
210788-107885.8826.06
310481-104815.7155.88
410317-103175.6265.80
510820-108205.9006.07
610804-108045.8916.07
45min111054-110546.0286.958.326.237.168.11
212409-124096.7666.97
312609-126096.8757.08
412732-127326.9437.15
514200-142007.7437.95
613463-134637.3417.55
60min115557-155578.4839.086.108.729.335.96
216694-166949.1039.35
317989-179899.80910.05
415652-156528.5358.78
517696-176969.6499.90
616364-163648.9239.17
极限116388-163888.93610.379.939.2210.669.69
220063-2006310.94011.23
320871-2087111.38111.67
417386-173869.4809.77
520882-2088211.38711.69
618546-1854610.11310.41
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USP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%
111.003064873061763061423056623066023062140.12
211.153096383100063098220.09
单位质量响应值RSD%判断
27837.6427786.730.13数据可信
0天-供试品溶液-第1批-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%
5min1124368-12436814.77514.703.7814.7714.703.79
2120099-12009914.26714.27
3125084-12508414.86014.86
4129864-12986415.42715.43
5116705-11670513.86413.86
6126343-12634315.00915.01
10min1163357-16335719.40619.181.5119.4919.261.52
2158002-15800218.77018.85
3160108-16010819.02019.10
4164483-16448319.54019.63
5160136-16013619.02419.10
6162501-16250119.30519.39
15min1167498-16749819.89819.780.8220.0919.960.84
2165815-16581519.69819.88
3164810-16481019.57919.77
4168134-16813419.97420.17
5165258-16525819.63219.81
6167375-16737519.88420.07
20min1168989-16898920.07519.830.6820.3820.130.70
2165911-16591119.71020.00
3166222-16622219.74720.04
4167323-16732319.87720.18
5166249-16624919.75020.04
6166921-16692119.83020.13
30min1168753-16875320.04719.961.3020.4620.371.27
2165782-16578219.69420.10
3165149-16514919.61920.03
4167970-16797019.95420.37
5169840-16984020.17620.58
6170570-17057020.26320.67
45min1149495-14949517.76019.494.4918.2820.014.38
2165851-16585119.70320.21
3164260-16426019.51420.03
4168780-16878020.05120.58
5167276-16727619.87220.39
6168817-16881720.05520.58
60min1170906-17090620.30319.901.6020.9320.521.56
2165136-16513619.61820.24
3163584-16358419.43320.06
4168572-16857220.02620.66
5168850-16885020.05920.68
6167879-16787919.94420.58
极限1160804-16080419.10319.380.8519.8420.120.81
2164090-16409019.49320.22
3162571-16257119.31320.05
4163079-16307919.37320.12
5164727-16472719.56920.30
6163681-16368119.44520.19
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