依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-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(%)100.00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%
110.131746501748901748561743831744131746380.14
210.251754391761521757960.29
单位质量响应值RSD%判断
17239.6817150.830.37数据可信
供试品溶液-2024012921批-依折麦布-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min191981-9198148.14349.6118.8548.1449.6118.85
2109593-10959357.36157.36
378599-7859941.13941.14
472362-7236237.87537.87
5119258-11925862.42062.42
696908-9690850.72250.72
10min1158860-15886083.14879.129.0683.4279.399.09
2153611-15361180.40180.72
3137044-13704471.72971.96
4132297-13229769.24569.46
5167866-16786687.86288.21
6157258-15725882.30982.59
15min1175140-17514091.66991.264.1792.4091.984.23
2177161-17716192.72793.49
3166531-16653187.16387.79
4166277-16627787.03087.63
5185643-18564397.16698.00
6175383-17538391.79692.54
20min1182105-18210595.31496.273.0196.5597.493.03
2181754-18175495.13196.41
3180462-18046294.45495.57
4185244-18524496.95798.04
5194490-194490101.797103.17
6179538-17953893.97195.22
30min1181563-18156395.03198.662.7196.80100.422.66
2184827-18482796.73998.55
3188849-18884998.844100.48
4194611-194611101.860103.48
5193906-193906101.491103.43
6187277-18727798.02199.79
45min1187067-18706797.91299.501.93100.21101.801.96
2187912-18791298.354100.70
3188541-18854198.683100.87
4190389-19038999.650101.83
5197161-197161103.195105.70
6189544-18954499.208101.52
60min1189729-18972999.30599.771.36102.14102.631.31
2188531-18853198.678101.57
3193935-193935101.506104.24
4191498-191498100.231102.97
5192790-192790100.907103.98
6187219-18721997.991100.86
极限1187088-18708897.923100.091.91101.31103.501.88
2186937-18693797.844101.28
3190860-19086099.897103.19
4194716-194716101.915105.21
5195386-195386102.266105.90
6192332-192332100.667104.08
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100601-201906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(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.954226294208534209844220274210754215140.19
211.054247514249604248560.04
单位质量响应值RSD%判断
38494.4338448.510.09数据可信
供试品溶液-2024012921批-辛伐他汀-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1233394-23339454.32755.9417.9854.3355.9417.98
2275195-27519564.05764.06
3202696-20269647.18247.18
4183814-18381442.78642.79
5298574-29857469.49969.50
6248270-24827057.79057.79
10min1377560-37756087.88583.768.4688.1984.078.49
2364409-36440984.82385.18
3329492-32949276.69676.96
4317087-31708773.80874.05
5396484-39648492.29092.68
6373961-37396187.04787.37
15min1405737-40573794.44394.303.4295.2395.083.49
2413169-41316996.17397.00
3387359-38735990.16690.85
4392024-39202491.25191.90
5425171-42517198.96799.87
6407289-40728994.80595.61
20min1415725-41572596.76897.722.5698.0899.012.58
2414266-41426696.42997.79
3413842-41384296.33097.52
4423161-42316198.49999.65
5440139-440139102.451103.90
6411619-41161995.81397.14
30min1407517-40751794.85898.662.4896.71100.502.42
2416754-41675497.00898.90
3426426-42642699.259100.98
4435464-435464101.363103.06
5433356-433356100.872102.89
6423683-42368398.621100.48
45min1416007-41600796.83498.361.7499.21100.751.79
2419638-41963897.679100.12
3418960-41896097.52199.80
4420960-42096097.987100.25
5436784-436784101.670104.25
6422976-42297698.456100.87
60min1422369-42236998.31599.031.08101.23101.971.07
2420986-42098697.993100.97
3428122-42812299.654102.47
4428991-42899199.856102.67
5431354-431354100.406103.55
6420872-42087297.966100.92
极限1416374-41637496.91998.271.42100.38101.761.40
2415193-41519396.644100.17
3419350-41935097.612100.98
4428815-42881599.815103.18
5428194-42819499.671103.37
6425136-42513698.959102.46
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-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(%)100.00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%
110.131753241760881758791755931755871756940.17
210.251751401755551753480.17
单位质量响应值RSD%判断
17343.9317107.120.98数据可信
供试品溶液-2024012921批-依折麦布-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min166025-6602534.49851.1522.2834.5051.1522.28
281439-8143942.55242.55
3117840-11784061.57261.57
4110240-11024057.60157.60
591554-9155447.83747.84
6120263-12026362.83862.84
10min1146305-14630576.44580.695.7876.6480.985.81
2153991-15399180.46180.70
3165571-16557186.51286.85
4149918-14991878.33378.65
5145785-14578576.17376.44
6165021-16502186.22486.57
15min1174497-17449791.17691.262.3391.7992.002.31
2175275-17527591.58292.27
3181493-18149394.83195.65
4170753-17075389.21989.97
5175649-17564991.77892.47
6170315-17031588.99089.82
20min1177526-17752692.75893.420.9593.8894.660.97
2178362-17836293.19594.39
3179976-17997694.03895.39
4176750-17675092.35393.60
5181437-18143794.80296.00
6178711-17871193.37794.70
30min1183136-18313695.68995.491.6397.3397.251.59
2179721-17972193.90595.62
3184421-18442196.36198.23
4183085-18308595.66397.43
5187048-18704897.73499.46
6179082-17908293.57195.41
45min1182762-18276295.49495.022.5497.6697.312.49
2174803-17480391.33593.57
3184311-18431196.30398.71
4179413-17941393.74496.04
5188424-18842498.453100.72
6181457-18145794.81297.17
60min1181841-18184195.01394.730.9297.7197.540.88
2179312-17931293.69196.43
3179852-17985293.97496.92
4181836-18183695.01097.83
5183942-18394296.11198.93
6180965-18096594.55597.44
极限1185934-18593497.15196.211.64100.3899.561.58
2180460-18046094.29197.55
3184046-18404696.16599.63
4184901-18490196.61299.96
5188444-18844498.463101.81
6181060-18106094.60598.02
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100601-201906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(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.954249884242224257134249734244144248620.14
211.054237924234714236320.06
单位质量响应值RSD%判断
38800.1838337.740.85数据可信
供试品溶液-2024012921批-辛伐他汀-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1164199-16419938.12555.5521.8838.1355.5521.87
2200055-20005546.45146.45
3290526-29052667.45767.46
4262747-26274761.00761.01
5223119-22311951.80651.81
6294712-29471268.42968.43
10min1340540-34054079.07082.695.5579.2882.995.58
2359241-35924183.41283.67
3379748-37974888.17488.55
4341721-34172179.34479.68
5336201-33620178.06278.35
6379226-37922688.05288.43
15min1397448-39744892.28391.782.2692.9392.552.24
2400678-40067893.03393.75
3407616-40761694.64495.51
4383305-38330589.00089.78
5395656-39565691.86792.59
6387021-38702189.86290.73
20min1400402-40040292.96992.631.4794.1393.901.48
2396505-39650592.06493.30
3407755-40775594.67796.07
4390451-39045190.65991.93
5401729-40172993.27794.51
6396714-39671492.11393.48
30min1403451-40345193.67793.131.6595.3694.921.61
2393769-39376991.42993.18
3406872-40687294.47296.39
4400519-40051992.99694.77
5408814-40881494.92296.67
6393079-39307991.26993.15
45min1399220-39922092.69591.362.5194.9093.682.44
2380888-38088888.43890.70
3393794-39379491.43593.88
4384787-38478789.34491.64
5408233-40823394.78897.06
6393986-39398691.48093.87
60min1394003-39400391.48491.090.6094.2093.900.51
2392956-39295691.24093.99
3389494-38949490.43793.39
4391706-39170690.95093.74
5395540-39554091.84094.64
6390034-39003490.56293.46
极限1402519-40251993.46192.731.3896.6896.051.35
2394792-39479291.66794.92
3404834-40483493.99897.45
4396299-39629992.01795.31
5405283-40528394.10397.42
6392548-39254891.14694.54
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-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(%)100.00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%
110.131763221769331766421761061759061763820.24
210.251761821764771763300.12
单位质量响应值RSD%判断
17411.8517202.930.86数据可信
供试品溶液-2024012921批-依折麦布-jf50z(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min180280-8028041.74840.0012.0441.7540.0012.04
289007-8900746.28646.29
370906-7090636.87336.87
470321-7032136.56936.57
585191-8519144.30244.30
665818-6581834.22734.23
10min1129274-12927467.22670.775.9767.4670.995.95
2136055-13605570.75271.01
3126575-12657565.82366.03
4134051-13405169.71069.91
5148374-14837477.15977.40
6142190-14219073.94374.13
15min1154068-15406880.12087.715.6780.7388.335.66
2170319-17031988.57189.22
3162844-16284484.68385.25
4168238-16823887.48888.08
5181646-18164694.46195.14
6174866-17486690.93591.54
20min1181679-18167994.47894.402.1595.5395.502.15
2176496-17649691.78392.93
3180369-18036993.79794.84
4178577-17857792.86593.94
5186502-18650296.98698.19
6185499-18549996.46597.57
30min1183700-18370095.52997.261.6497.1098.891.65
2185426-18542696.42798.08
3190114-19011498.865100.43
4183999-18399995.68597.28
5190611-19061199.123100.86
6188360-18836097.95299.59
45min1191190-19119099.42498.302.06101.53100.462.01
2187932-18793297.73099.92
3194729-194729101.265103.38
4183279-18327995.31097.43
5189797-18979798.700100.99
6187216-18721697.35899.54
60min1192888-192888100.30798.991.74102.97101.711.71
2187042-18704297.267100.00
3193615-193615100.685103.36
4186064-18606496.75999.41
5193066-193066100.400103.24
6189497-18949798.544101.27
极限1191428-19142899.54898.091.60102.76101.351.56
2187333-18733397.418100.69
3191219-19121999.439102.67
4183348-18334895.34698.54
5188796-18879698.179101.57
6189578-18957898.586101.86
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100601-201906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(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.954254494271324265154251904256984259970.19
211.054261424259934260680.03
单位质量响应值RSD%判断
38903.8438558.190.64数据可信
供试品溶液-2024012921批-辛伐他汀-jf50z(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1204541-20454147.29345.9011.2347.2945.9011.23
2227236-22723652.54052.54
3183139-18313942.34442.34
4184105-18410542.56842.57
5220172-22017250.90750.91
6171911-17191139.74839.75
10min1308562-30856271.34475.476.1771.6175.726.15
2325357-32535775.22775.52
3302926-30292670.04170.28
4322749-32274974.62474.86
5355829-35582982.27382.56
6342917-34291779.28779.51
15min1359002-35900283.00790.865.6383.6791.535.62
2394980-39498091.32592.03
3378489-37848987.51288.14
4395234-39523491.38492.03
5422107-42210797.59798.34
6407895-40789594.31194.97
20min1418834-41883496.84196.161.9797.9697.341.97
2404950-40495093.63094.85
3412210-41221095.30996.42
4409976-40997694.79295.95
5425428-42542898.36599.65
6424031-42403198.04299.23
30min1414481-41448195.83497.171.3897.4998.891.38
2416499-41649996.30198.04
3426141-42614198.530100.17
4414507-41450795.84097.53
5426873-42687398.699100.53
6423121-42312197.83299.56
45min1425402-42540298.35997.261.91100.5599.511.85
2417997-41799796.64798.92
3432695-432695100.045102.23
4409340-40934094.64596.86
5421843-42184397.53699.91
6416542-41654296.31198.58
60min1427263-42726398.78997.601.58101.53100.391.55
2415296-41529696.02398.83
3428630-42863099.106101.85
4413649-41364995.64298.39
5427676-42767698.885101.80
6420082-42008297.12999.94
极限1423373-42337397.89096.391.54101.1899.731.50
2413698-41369895.65399.00
3422158-42215897.609100.90
4405935-40593593.85897.13
5417162-41716296.45499.92
6419009-41900996.881100.23
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