依折麦布瑞舒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RSF-703-230318-D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(%)98.9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0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.871676391670211677951686041687511679620.43
210.931691261696751694000.23
单位质量响应值RSD%判断
15451.8915498.630.22数据可信
供试品溶液-2023122121批-瑞舒伐他汀钙-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%
5min1125533-12553369.46074.145.6969.4674.145.69
2137438-13743876.04776.05
3141770-14177078.44478.44
4124866-12486669.09169.09
5141813-14181378.46878.47
6132505-13250573.31873.32
10min1165056-16505691.32997.123.5791.7197.543.56
2177096-17709697.99198.41
3179485-17948599.31399.75
4183462-183462101.513101.90
5174281-17428196.43396.87
6173793-17379396.16396.57
15min1180346-18034699.789100.341.99100.68101.291.97
2181204-181204100.264101.23
3178989-17898999.038100.03
4188439-188439104.267105.22
5178678-17867898.86699.84
6180367-18036799.801100.74
20min1181320-181320100.328100.523.08101.78102.033.04
2184484-184484102.079103.60
3176446-17644697.63199.17
4191390-191390105.900107.43
5177112-17711298.00099.52
6179276-17927699.197100.69
30min1174018-17401896.28899.123.0498.29101.193.02
2180554-18055499.904102.00
3179515-17951599.329101.41
4188450-188450104.273106.39
5178911-17891198.995101.06
6173379-17337995.93497.98
45min1180016-18001699.607100.082.44102.15102.702.41
2179769-17976999.470102.12
3179040-17904099.067101.70
4189445-189445104.824107.52
5176681-17668197.761100.38
6180284-18028499.755102.33
60min1180051-18005199.62699.232.25102.72102.402.21
2182197-182197100.813104.01
3174015-17401596.28699.47
4185214-185214102.483105.76
5177950-17795098.463101.62
6176596-17659697.714100.85
极限1173918-17391896.23298.122.4599.88101.842.40
2173479-17347995.99099.75
3180303-18030399.765103.48
4184263-184263101.957105.80
5174150-17415096.361100.07
6177867-17786798.418102.09
依折麦布瑞舒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%
110.941858411850911859881863381866581859830.32
210.991874511880141877320.22
单位质量响应值RSD%判断
17000.2717082.070.34数据可信
供试品溶液-2023122121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%
5min113718-137187.2277.8817.457.237.8817.45
214682-146827.7357.73
316258-162588.5658.56
412489-124896.5796.58
519543-1954310.29610.30
613053-130536.8776.88
10min116856-168568.8809.776.828.929.826.76
217872-178729.4159.46
319583-1958310.31710.36
419842-1984210.45310.49
517606-176069.2759.33
619568-1956810.30910.35
15min117169-171699.0459.856.169.139.946.14
218431-184319.7109.81
320217-2021710.65110.76
419797-1979710.42910.52
517867-178679.4139.52
618656-186569.8289.92
20min117490-174909.2149.9711.069.3510.1310.92
219136-1913610.08110.23
320341-2034110.71610.88
421879-2187911.52611.68
515914-159148.3848.54
618846-188469.92810.08
30min117135-171359.0279.057.609.229.267.47
216296-162968.5858.79
317614-176149.2799.50
419142-1914210.08410.30
515303-153038.0628.27
617582-175829.2629.47
45min116614-166148.7539.378.728.999.638.60
218454-184549.7229.97
319106-1910610.06510.34
419506-1950610.27610.55
515447-154478.1388.39
617599-175999.2719.53
60min117009-170098.9619.206.559.259.516.40
218666-186669.83410.14
316486-164868.6859.02
418884-188849.94810.28
516091-160918.4778.77
617617-176179.2819.59
极限118407-184079.6979.016.3710.049.376.16
217108-171089.0139.37
317272-172729.0999.48
417212-172129.0689.45
515102-151027.9568.30
617540-175409.2409.60
依折麦布瑞舒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RSF-703-230318-D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(%)98.9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0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.871704451701761703051708211707911705080.17
210.931723671722231722950.06
单位质量响应值RSD%判断
15686.1115763.490.35数据可信
供试品溶液-2023122121批-瑞舒伐他汀钙-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%
5min1118035-11803564.27568.784.9564.2868.784.95
2130713-13071371.17971.18
3129299-12929970.40970.41
4134440-13444073.20873.21
5124305-12430567.68967.69
6121028-12102865.90565.90
10min1169510-16951092.30592.582.2392.6692.962.22
2166469-16646990.64991.04
3174935-17493595.25995.65
4167370-16737091.14091.55
5174507-17450795.02695.40
6167320-16732091.11391.48
15min1176374-17637496.04396.061.3296.9196.961.31
2174055-17405594.78095.68
3177256-17725696.52397.44
4174184-17418494.85095.76
5180391-18039198.23099.13
6176217-17621795.95896.83
20min1179283-17928397.62796.902.2899.0398.322.26
2181332-18133298.743100.17
3178292-17829297.08798.54
4175634-17563495.64097.08
5182012-18201299.113100.56
6171095-17109593.16894.57
30min1179220-17922097.59395.992.0199.5497.961.99
2178512-17851297.20799.18
3179513-17951397.75299.75
4171636-17163693.46395.43
5176640-17664096.18898.19
6172167-17216793.75295.68
45min1176418-17641896.06795.761.9798.5698.261.94
2170692-17069292.94995.46
3180596-18059698.342100.88
4175019-17501995.30597.80
5178349-17834997.11999.65
6174068-17406894.78797.23
60min1177133-17713396.45696.112.4099.4899.152.36
2176872-17687296.31499.34
3184194-184194100.301103.39
4173397-17339794.42297.44
5175170-17517095.38798.46
6172261-17226193.80396.77
极限1169970-16997092.55694.851.6696.1198.421.64
2175549-17554995.59499.16
3176996-17699696.382100.02
4172943-17294394.17597.72
5177240-17724096.515100.12
6172412-17241293.88697.38
依折麦布瑞舒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%
110.941869581884181905181887431896651888600.72
210.991896051911681903860.59
单位质量响应值RSD%判断
17263.2517323.570.25数据可信
供试品溶液-2023122121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%
5min113926-139267.2297.6612.307.237.6612.33
213510-135107.0137.01
314407-144077.4797.48
415358-153587.9737.97
513235-132356.8716.87
618138-181389.4169.42
10min119317-1931710.02810.147.6310.0710.187.61
218602-186029.6579.70
317971-179719.3299.37
418616-186169.6649.71
520810-2081010.80310.84
621827-2182711.33111.38
15min118532-185329.62110.4511.069.7210.5510.96
220299-2029910.53810.63
316987-169878.8188.91
421773-2177311.30311.40
523222-2322212.05512.15
619950-1995010.35710.47
20min117387-173879.0269.908.799.1810.068.72
217004-170048.8278.98
319103-191039.91710.06
421180-2118010.99511.16
519055-190559.89210.06
620645-2064510.71710.89
30min117248-172488.9548.723.459.158.933.32
217638-176389.1569.36
316075-160758.3458.54
416879-168798.7628.98
516618-166188.6278.85
616344-163448.4858.72
45min117283-172838.9729.303.949.229.563.86
217291-172918.9769.23
318760-187609.7399.98
417438-174389.0539.32
517960-179609.3249.59
618786-187869.75210.03
60min117692-176929.1849.263.309.489.573.20
218314-183149.5079.81
318008-180089.3489.65
416746-167468.6939.01
517927-179279.3069.63
618333-183339.5179.85
极限116252-162528.4378.743.558.799.103.53
216551-165518.5928.95
316334-163348.4798.83
417710-177109.1949.56
516741-167418.6919.06
617412-174129.0399.43
依折麦布瑞舒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RSF-703-230318-D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(%)98.9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0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.871700711704641710741713161719621709770.44
210.931672591669871671230.12
单位质量响应值RSD%判断
15729.2515290.302.01数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2023122221批-瑞舒伐他汀钙-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%
5min1116712-11671264.44862.407.3264.4562.407.32
2105881-10588158.46758.47
3118839-11883965.62365.62
4124878-12487868.95768.96
5105564-10556458.29258.29
6106193-10619358.64058.64
10min1159610-15961088.13688.333.7288.4988.683.73
2161779-16177989.33489.66
3167094-16709492.26992.63
4164662-16466290.92691.31
5150887-15088783.32083.64
6155742-15574286.00186.33
15min1170867-17086794.35394.702.1095.2095.542.11
2172564-17256495.29096.11
3171431-17143194.66495.54
4177843-17784398.20599.09
5168092-16809292.82093.61
6168155-16815592.85593.66
20min1173543-17354395.83096.312.0997.2097.672.10
2176823-17682397.64198.99
3173528-17352895.82297.22
4180439-18043999.638101.07
5171321-17132194.60395.91
6170811-17081194.32295.64
30min1176245-17624597.32296.921.2199.2398.821.21
2177200-17720097.85099.74
3172993-17299395.52697.46
4177851-17785198.209100.20
5175897-17589797.13098.96
6172865-17286595.45697.30
45min1175468-17546896.89397.542.0499.3499.972.03
2182029-182029100.516102.95
3176122-17612297.25499.72
4179805-17980599.288101.82
5173255-17325595.67198.04
6173112-17311295.59297.97
60min1173133-17313395.60496.751.0798.5999.731.00
2177115-17711597.803100.80
3174006-17400696.08699.09
4173472-17347295.79198.88
5177169-17716997.832100.73
6176355-17635597.383100.29
极限1171276-17127694.57895.571.8698.0999.091.85
2171551-17155194.73098.27
3175051-17505196.663100.20
4178471-17847198.551102.17
5169507-16950793.60297.04
6172613-17261395.31798.76
依折麦布瑞舒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%
110.941892431887471907291915281915541903600.69
210.991849341865081857210.60
单位质量响应值RSD%判断
17400.3716899.092.07数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2023122221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%
5min113852-138527.2537.217.947.257.217.95
212907-129076.7586.76
314518-145187.6017.60
413897-138977.2767.28
512208-122086.3926.39
615254-152547.9877.99
10min119005-190059.9519.845.129.999.885.09
218497-184979.6859.72
318383-183839.6259.67
418066-180669.4599.50
520626-2062610.80010.84
618140-181409.4989.54
15min118724-187249.8049.542.929.909.642.88
218286-182869.5749.67
317500-175009.1639.26
418799-187999.8439.94
518322-183229.5939.69
617686-176869.2609.36
20min117341-173419.0809.131.899.239.271.85
217537-175379.1829.33
317144-171448.9769.12
417852-178529.3479.49
517008-170088.9059.05
617716-177169.2769.42
30min117686-176869.2609.234.929.469.434.82
217098-170988.9529.15
316722-167228.7558.95
418896-188969.89410.09
516979-169798.8909.09
618411-184119.6409.84
45min116832-168328.8139.134.659.069.384.57
217745-177459.2919.54
316989-169898.8959.14
418893-188939.89210.15
516733-167338.7619.01
617426-174269.1249.38
60min117393-173939.1079.374.849.419.674.66
217818-178189.3299.63
319533-1953310.22710.52
418013-180139.4319.74
517084-170848.9459.24
617537-175379.1829.49
极限118142-181429.4999.353.069.859.702.95
217870-178709.3579.71
318729-187299.80610.16
417695-176959.2659.63
517558-175589.1939.54
617128-171288.9689.32
依折麦布瑞舒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RSF-703-230318-D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(%)98.9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0.962
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.871698411728801728741725281732851722820.81
210.931728641735281731960.28
单位质量响应值RSD%判断
15849.3115845.930.02数据可信
供试品溶液-2023122221批-瑞舒伐他汀钙-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%
5min1117764-11776463.63059.494.0663.6359.494.06
2112470-11247060.77060.77
3108187-10818758.45558.46
4108418-10841858.58058.58
5108862-10886258.82058.82
6104867-10486756.66256.66
10min1160085-16008586.49785.793.4886.8586.123.48
2166974-16697490.21990.56
3160099-16009986.50486.83
4159822-15982286.35586.68
5155057-15505783.78084.11
6150601-15060181.37381.69
15min1170507-17050792.12890.944.0692.9691.744.04
2176774-17677495.51496.35
3168381-16838190.97991.78
4173514-17351493.75394.56
5159411-15941186.13386.92
6161260-16126087.13287.90
20min1171929-17192992.89693.952.7794.2495.262.77
2181158-18115897.88399.25
3177080-17708095.68096.99
4175013-17501394.56395.89
5168754-16875491.18192.45
6169304-16930491.47892.73
30min1171985-17198592.92794.243.4694.7996.073.44
2182261-18226198.479100.39
3177710-17771096.02097.86
4178291-17829196.33498.19
5166053-16605389.72291.50
6170166-17016691.94493.70
45min1171169-17116992.48691.443.5694.8693.793.52
2173203-17320393.58596.05
3162875-16287588.00490.38
4177856-17785696.09998.49
5167658-16765890.58992.86
6162584-16258487.84790.12
60min1169588-16958891.63292.962.7794.5295.822.77
2178977-17897796.70599.68
3172504-17250493.20796.07
4176162-17616295.18498.10
5166757-16675790.10292.88
6168318-16831890.94593.70
极限1168460-16846091.02291.932.0894.4295.312.09
2174351-17435194.20597.72
3173458-17345893.72397.11
4171465-17146592.64696.09
5167721-16772190.62393.90
6165350-16535089.34292.60
依折麦布瑞舒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%
110.941884661898201901581910941919351902950.70
210.991913721917131915420.13
单位质量响应值RSD%判断
17394.4217428.750.14数据可信
供试品溶液-2023122221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%
5min118439-184399.5077.3517.209.517.3517.19
212287-122876.3356.34
312910-129106.6566.66
416060-160608.2818.28
512869-128696.6356.64
612962-129626.6836.68
10min117753-177539.1549.122.319.219.172.26
217639-176399.0959.13
317727-177279.1409.18
417224-172248.8818.93
517415-174158.9799.02
618419-184199.4979.53
15min116723-167238.6229.034.468.739.124.44
216793-167938.6598.74
318090-180909.3279.42
418468-184689.5229.62
516908-169088.7188.80
618047-180479.3059.40
20min118408-184089.4919.344.459.649.484.40
217643-176439.0979.23
319051-190519.8239.96
418318-183189.4459.59
516760-167608.6428.78
618547-185479.5639.70
30min118234-182349.4029.705.219.619.895.09
218618-186189.6009.78
320482-2048210.56110.75
418387-183879.4809.68
517751-177519.1539.34
619385-193859.99510.19
45min118807-188079.6979.266.709.959.516.54
217269-172698.9049.14
315936-159368.2178.47
419276-192769.93910.19
518121-181219.3439.58
618405-184059.4909.74
60min117423-174238.9839.044.399.299.344.30
218209-182099.3899.68
317453-174538.9999.30
418566-185669.5739.88
516421-164218.4678.75
617114-171148.8249.13
极限117761-177619.1589.302.289.529.652.19
217759-177599.1579.50
318784-187849.68510.03
418203-182039.3869.75
517964-179649.2629.60
617727-177279.1409.49
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