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%
111.441968431969141968881968591968701968750.02
211.521965551971811968680.23
单位质量响应值RSD%判断
17209.3517089.240.50数据可信
加速6月-供试品溶液-2024011221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%
5min110929-109295.7215.1510.875.725.1510.86
210268-102685.3755.38
38400-84004.3974.40
48618-86184.5124.51
510662-106625.5825.58
610164-101645.3215.32
10min116606-166068.6938.830.998.728.861.00
216860-168608.8268.86
316971-169718.8848.91
416862-168628.8278.85
516838-168388.8158.85
617108-171088.9568.99
15min117449-174499.1359.423.379.219.503.37
217316-173169.0659.14
318520-185209.6959.77
418028-180289.4389.51
517792-177929.3149.39
618865-188659.8769.96
20min117650-176509.2409.232.459.379.362.42
217169-171698.9889.12
317098-170988.9519.08
417893-178939.3679.49
518218-182189.5379.67
617775-177759.3059.44
30min116926-169268.8619.143.669.049.333.59
217108-171088.9569.14
317017-170178.9089.09
418641-186419.7599.94
517649-176499.2399.42
617469-174699.1459.33
45min116833-168338.8128.962.939.049.192.89
216853-168538.8239.05
316699-166998.7428.97
418019-180199.4339.67
517373-173739.0959.33
616888-168888.8419.08
60min116300-163008.5338.793.418.819.073.33
216484-164848.6298.91
316492-164928.6348.91
416781-167818.7859.07
517889-178899.3659.65
616796-167968.7939.08
极限116146-161468.4528.682.058.789.012.00
216369-163698.5698.90
316589-165898.6849.01
417073-170738.9389.27
516419-164198.5958.93
616851-168518.8219.16
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%
111.461591841594481592791590811592311592450.09
211.481597211598361597780.06
单位质量响应值RSD%判断
13895.7213917.940.12数据可信
加速6月-供试品溶液-2024011221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%
5min192099-9209954.70255.161.9954.7055.161.99
294423-9442356.08356.08
390061-9006153.49253.49
493528-9352855.55155.55
592037-9203754.66654.67
695088-9508856.47856.48
10min1132469-13246978.68079.141.2278.9879.441.22
2135609-13560980.54580.86
3131594-13159478.16178.46
4133653-13365379.38479.69
5131630-13163078.18278.49
6134457-13445779.86180.17
15min1149041-14904188.52389.822.4089.2690.562.39
2149924-14992489.04889.81
3152672-15267290.68091.41
4151075-15107589.73190.48
5147049-14704987.34088.08
6157536-15753693.56994.33
20min1156585-15658593.00492.241.5994.2493.481.57
2154913-15491392.01193.26
3150860-15086089.60490.84
4156712-15671293.08094.33
5157884-15788493.77695.00
6154836-15483691.96593.24
30min1154866-15486691.98395.053.1693.7396.813.11
2161646-16164696.01097.78
3155372-15537292.28494.02
4168509-168509100.086101.85
5161451-16145195.89497.64
6158373-15837394.06695.85
45min1162941-16294196.77996.902.0499.0499.182.00
2166536-16653698.915101.21
3161092-16109295.68197.93
4167561-16756199.523101.84
5161813-16181396.10998.39
6158910-15891094.38596.70
60min1161751-16175196.07297.402.1798.87100.222.11
2164759-16475997.859100.71
3162020-16202096.23299.01
4164158-16415897.502100.38
5170517-170517101.279104.09
6160691-16069195.44398.28
极限1162559-16255996.55297.161.8799.88100.521.81
2165217-16521798.131101.52
3166221-16622198.727102.04
4166525-16652598.908102.32
5158458-15845894.11797.49
6162531-16253196.53699.90
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%
111.441967981967631969031966701969601968190.06
211.521986611988971987790.09
单位质量响应值RSD%判断
17204.4617255.120.21数据可信
加速6月-供试品溶液-2024011221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%
5min112821-128216.6806.833.926.686.833.94
213232-132326.8946.89
312634-126346.5836.58
413349-133496.9556.96
512631-126316.5816.58
613949-139497.2687.27
10min117948-179489.3529.311.609.399.341.58
218243-182439.5059.54
317666-176669.2059.24
418128-181289.4469.48
517682-176829.2139.25
617529-175299.1339.17
15min118519-185199.6499.523.469.749.613.42
219347-1934710.08110.17
317924-179249.3399.43
417817-178179.2839.37
518363-183639.5689.66
617614-176149.1789.27
20min118007-180079.3829.281.999.539.421.96
218381-183819.5779.72
317892-178929.3239.46
417604-176049.1739.32
517437-174379.0859.23
617537-175379.1389.28
30min118302-183029.5369.033.559.739.223.50
217592-175929.1669.37
317214-172148.9699.16
416991-169918.8539.05
517365-173659.0489.24
616466-164668.5808.77
45min117652-176529.1988.833.129.459.083.10
217444-174449.0899.34
316651-166518.6768.92
417088-170888.9049.15
516478-164788.5868.83
616379-163798.5348.77
60min117485-174859.1108.683.049.418.973.02
217056-170568.8879.19
316374-163748.5328.82
416494-164948.5948.89
516304-163048.4958.78
616204-162048.4438.73
极限117050-170508.8848.613.259.238.953.18
217026-170268.8719.22
316343-163438.5158.85
416515-165158.6058.95
516630-166308.6659.00
615593-155938.1258.46
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%
111.461589271589521590231589091590111589640.04
211.481610271605201607740.23
单位质量响应值RSD%判断
13871.2014004.700.68数据可信
加速6月-供试品溶液-2024011221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%
5min196541-9654157.21456.941.8157.2156.941.81
294826-9482656.19856.20
395557-9555756.63156.63
496813-9681357.37557.38
593873-9387355.63355.63
698826-9882658.56858.57
10min1137637-13763781.56979.892.1481.8980.202.14
2132371-13237178.44878.76
3132450-13245078.49578.81
4138977-13897782.36382.68
5132647-13264778.61278.92
6134698-13469879.82780.15
15min1152458-15245890.35388.761.8891.1289.511.86
2146904-14690487.06187.81
3145842-14584286.43287.18
4150544-15054489.21889.99
5152502-15250290.37991.12
6150335-15033589.09589.86
20min1157639-15763993.42392.062.0594.7093.312.04
2151980-15198090.06991.30
3150908-15090889.43490.67
4156011-15601192.45893.73
5158841-15884194.13695.38
6156625-15662592.82294.09
30min1165180-16518097.89294.443.5099.6896.203.46
2151251-15125189.63791.37
3155350-15535092.06793.79
4161028-16102895.43297.22
5165287-16528797.95699.73
6157989-15798993.63195.41
45min1167584-16758499.31796.462.69101.6598.742.68
2157792-15779293.51495.74
3156880-15688092.97395.21
4165630-16563098.159100.47
5164566-16456697.52899.84
6164082-16408297.24299.54
60min1167535-16753599.28896.812.11102.1899.632.10
2159968-15996894.80397.55
3158563-15856393.97196.73
4163952-16395297.165100.03
5164316-16431697.380100.24
6165752-16575298.231101.07
极限1168061-16806199.60096.952.57103.04100.322.55
2158257-15825793.78997.07
3158994-15899494.22697.50
4164769-16476997.649101.05
5167720-16772099.398102.80
6163778-16377897.061100.45
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%
111.441981651981571981151980601979931980980.04
211.521972011971731971870.02
单位质量响应值RSD%判断
17316.2617116.930.82数据可信
加速6月-供试品溶液-2024011222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%
5min113038-130386.7996.159.796.806.169.79
211243-112435.8635.86
310339-103395.3915.39
413290-132906.9306.93
511785-117856.1456.15
611118-111185.7985.80
10min117958-179589.3649.241.159.409.281.13
217838-178389.3029.33
317677-176779.2189.25
417774-177749.2689.31
517358-173589.0529.09
617755-177559.2599.29
15min117749-177499.2559.321.509.359.411.46
218013-180139.3939.48
318190-181909.4859.57
417674-176749.2169.31
517532-175329.1429.23
618131-181319.4559.54
20min117698-176989.2299.422.369.379.562.29
218075-180759.4259.56
318484-184849.6399.77
417518-175189.1359.28
517974-179749.3739.51
618600-186009.6999.84
30min116898-168988.8129.141.989.009.331.94
217413-174139.0809.27
317799-177999.2829.47
417643-176439.2009.39
517618-176189.1879.37
617838-178389.3029.49
45min116872-168728.7989.031.309.049.261.26
217432-174329.0909.33
317328-173289.0369.27
417320-173209.0329.27
517380-173809.0639.30
617512-175129.1329.37
60min116484-164848.5968.821.948.899.111.88
217291-172919.0179.31
317200-172008.9699.26
416703-167038.7109.00
516691-166918.7048.99
617088-170888.9119.20
极限116030-160308.3598.531.778.708.871.71
216741-167418.7309.07
316386-163868.5458.88
416134-161348.4138.75
516221-162218.4598.80
616663-166638.6899.03
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%
111.461600171601241598121598491597251599050.11
211.481595451591721593580.17
单位质量响应值RSD%判断
13953.3213881.360.37数据可信
加速6月-供试品溶液-2024011222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%
5min188500-8850052.52553.492.0152.5353.492.01
291017-9101754.01954.02
389467-8946753.09953.10
493390-9339055.42855.43
589217-8921752.95152.95
689122-8912252.89552.89
10min1128873-12887376.48776.961.2776.7877.261.27
2129116-12911676.63176.93
3130888-13088877.68377.98
4131777-13177778.21178.52
5127146-12714675.46275.76
6130218-13021877.28577.58
15min1140653-14065383.47984.220.6384.2084.950.63
2141708-14170884.10584.83
3142855-14285584.78685.51
4142979-14297984.85985.60
5141421-14142183.93584.65
6141826-14182684.17584.90
20min1146875-14687587.17289.201.7088.3590.391.68
2149279-14927988.59889.79
3151455-15145589.89091.09
4149150-14915088.52289.74
5154439-15443991.66192.84
6150544-15054489.34990.54
30min1148381-14838188.06591.942.4289.7393.632.39
2152837-15283790.71092.40
3157281-15728193.34895.04
4158049-15804993.80395.51
5157585-15758593.52895.22
6155342-15534292.19793.88
45min1155410-15541092.23794.561.7994.3996.761.78
2157850-15785093.68595.87
3159574-15957494.70996.92
4163992-16399297.33199.56
5160329-16032995.15797.37
6158835-15883594.27096.47
60min1154110-15411091.46693.591.6294.1396.311.60
2160264-16026495.11897.83
3160072-16007295.00497.75
4159056-15905694.40197.17
5157210-15721093.30596.04
6155399-15539992.23194.95
极限1148506-14850688.14091.282.1991.3194.522.16
2154718-15471891.82695.06
3156264-15626492.74496.01
4156742-15674293.02896.32
5155784-15578492.45995.71
6150782-15078289.49092.73
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%
111.441976241976261977471974921977251976430.06
211.522002812011422007120.31
单位质量响应值RSD%判断
17276.4917422.920.60数据可信
加速6月-供试品溶液-2024011222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%
5min19782-97825.0626.089.365.066.089.37
211292-112925.8435.84
311891-118916.1536.15
412337-123376.3846.38
512320-123206.3756.38
612878-128786.6646.66
10min117450-174509.0309.604.719.069.634.68
218730-187309.6929.72
318164-181649.3999.43
419862-1986210.27810.31
519131-191319.8999.93
617950-179509.2889.33
15min117617-176179.1169.382.179.199.462.23
218155-181559.3949.48
317775-177759.1989.28
418446-184469.5459.64
518659-186599.6559.75
618092-180929.3629.45
20min117732-177329.1759.394.119.309.534.09
218102-181029.3679.51
317169-171698.8849.02
418956-189569.8099.95
519106-191069.88610.03
617869-178699.2469.39
30min116675-166758.6299.053.388.819.243.39
217485-174859.0489.24
317223-172238.9129.10
417713-177139.1669.37
518455-184559.5509.75
617334-173348.9709.16
45min116843-168438.7158.782.868.949.022.82
217516-175169.0649.30
316482-164828.5298.77
417459-174599.0349.29
517099-170998.8489.10
616365-163658.4688.71
60min116338-163388.4548.612.178.738.902.22
216828-168288.7089.00
316213-162138.3898.67
417036-170368.8159.12
517026-170268.8109.11
616447-164478.5118.80
极限115562-155628.0538.373.638.388.713.57
216951-169518.7719.11
315500-155008.0218.35
416133-161338.3488.70
516714-167148.6499.00
616183-161838.3748.71
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%
111.461589711592351593261589881591731591390.10
211.481622791626361624580.16
单位质量响应值RSD%判断
13886.4714151.391.34数据可信
加速6月-供试品溶液-2024011222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%
5min190814-9081453.51353.933.9953.5153.934.00
288887-8888752.37752.38
386827-8682751.16351.16
496286-9628656.73756.74
591000-9100053.62253.62
695288-9528856.14956.15
10min1129423-12942376.26378.423.7476.5678.723.73
2131862-13186277.70077.99
3129533-12953376.32876.61
4142685-14268584.07884.39
5133704-13370478.78679.08
6131268-13126877.35077.66
15min1143678-14367884.66384.732.0685.3885.472.06
2141322-14132283.27584.00
3139416-13941682.15282.86
4145072-14507285.48586.27
5147187-14718786.73187.47
6146112-14611286.09786.84
20min1150168-15016888.48788.603.2089.6889.803.19
2149527-14952788.11089.29
3141897-14189783.61484.78
4155867-15586791.84693.10
5153907-15390790.69191.91
6150742-15074288.82690.05
30min1149683-14968388.20290.932.3589.8892.622.35
2151707-15170789.39491.07
3152093-15209389.62291.25
4158528-15852893.41495.18
5157594-15759492.86394.58
6156255-15625592.07493.79
45min1156566-15656692.25792.051.8694.4394.251.87
2156311-15631192.10794.28
3151898-15189889.50791.63
4160933-16093394.83197.12
5156301-15630192.10194.34
6155248-15524891.48193.71
60min1155488-15548891.62292.412.2994.3195.122.29
2154231-15423190.88293.56
3152032-15203289.58692.21
4160867-16086794.79297.61
5160803-16080394.75497.50
6157518-15751892.81895.55
极限1150279-15027988.55390.742.4991.7593.962.45
2157245-15724592.65895.85
3148556-14855687.53790.66
4153925-15392590.70194.04
5157863-15786393.02296.30
6156025-15602591.93995.19
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