比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203对照品来源中检院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2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.998221782304822368224882431822870.11
29.958222782329822780.09
单位质量响应值RSD%判断
8236.948269.150.28数据可信
中间条件6月-供试品溶液-2024021621批-比索洛尔-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min193047-93047101.26699.352.06101.2799.352.06
292722-92722100.912100.91
392837-92837101.037101.04
490899-9089998.92898.93
588678-8867896.51196.51
689551-8955197.46197.46
10min195235-95235103.647101.101.78103.82101.271.78
293833-93833102.121102.29
393670-93670101.944102.11
492340-92340100.496100.66
591401-9140199.47499.64
690886-9088698.91499.08
15min195083-95083103.482101.161.62103.82101.491.62
293586-93586101.852102.19
393700-93700101.977102.31
492829-92829101.029101.36
591232-9123299.29199.62
691268-9126899.33099.66
20min195216-95216103.626100.941.91104.14101.441.91
293675-93675101.949102.46
393717-93717101.995102.50
492230-92230100.377100.88
590977-9097799.01399.51
690672-9067298.68199.17
30min194889-94889103.271100.681.82103.96101.351.82
293300-93300101.541102.22
393455-93455101.710102.39
491964-91964100.087100.76
590952-9095298.98699.64
690475-9047598.46799.12
45min194870-94870103.250100.461.93104.11101.301.93
293044-93044101.263102.11
393392-93392101.641102.49
491626-9162699.719100.55
590810-9081098.83199.65
690114-9011498.07498.90
极限194408-94408102.747100.281.80103.78101.291.80
292854-92854101.056102.07
393161-93161101.390102.41
491847-9184799.960100.96
590434-9043498.42299.41
690150-9015098.11399.10
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.5499772100331999741004221002721001540.28
213.5199599100241999200.46
单位质量响应值RSD%判断
7396.907396.000.01数据可信
中间条件6月-供试品溶液-2024021621批-氨氯地平-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1108917-10891795.45995.302.7695.4695.302.76
2112008-11200898.16898.17
3108937-10893795.47695.48
4109277-10927795.77495.77
5103107-10310790.36790.37
6110166-11016696.55396.55
10min1113821-11382199.75798.681.9299.9298.841.92
2114941-114941100.738100.90
3111660-11166097.86398.02
4112611-11261198.69698.86
5108822-10882295.37595.53
6113708-11370899.65899.82
15min1113636-11363699.59598.961.5999.9299.281.59
2114486-114486100.340100.67
3112682-11268298.75899.08
4112897-11289798.94799.27
5109560-10956096.02296.33
6114193-114193100.083100.41
20min1113728-11372899.67598.841.51100.1799.331.52
2114805-114805100.619101.12
3112419-11241998.52899.01
4112160-11216098.30198.79
5109912-10991296.33196.80
6113637-11363799.595100.09
30min1114224-114224100.11098.831.45100.7799.491.46
2114210-114210100.098100.76
3112067-11206798.21998.87
4112310-11231098.43299.09
5110035-11003596.43997.07
6113760-11376099.703100.36
45min1114039-11403999.94898.601.32100.7799.421.32
2113922-11392299.845100.68
3112011-11201198.17098.99
4111878-11187898.05498.87
5110122-11012296.51597.31
6113045-11304599.07799.90
极限1112829-11282998.88798.051.3599.8899.031.36
2113723-11372399.671100.67
3111276-11127697.52698.50
4111810-11181097.99498.97
5109321-10932195.81396.76
6112293-11229398.41899.41
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203对照品来源中检院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2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.998246882446824318246082463824540.02
29.958196182169820650.18
单位质量响应值RSD%判断
8253.658247.740.06数据可信
中间条件6月-供试品溶液-2024021821批-比索洛尔-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min192087-92087100.249100.041.19100.25100.041.19
290580-9058098.60998.61
392785-92785101.009101.01
492209-92209100.382100.38
593127-93127101.381101.38
690554-9055498.58098.58
10min193113-93113101.366101.601.13101.53101.771.13
291650-9165099.77399.94
394234-94234102.586102.75
493801-93801102.115102.28
594437-94437102.807102.98
692740-92740100.960101.12
15min193092-93092101.343101.431.06101.68101.761.06
291662-9166299.787100.12
394139-94139102.483102.82
493793-93793102.106102.44
593944-93944102.271102.61
692402-92402100.592100.92
20min192969-92969101.209101.331.31101.71101.831.30
291323-9132399.41799.91
394034-94034102.369102.88
493664-93664101.966102.47
594441-94441102.812103.32
692022-92022100.178100.68
30min192476-92476100.673101.231.33101.35101.901.33
291132-9113299.21099.87
393712-93712102.018102.70
493850-93850102.168102.85
594444-94444102.815103.50
692291-92291100.471101.14
45min192360-92360100.546100.961.22101.39101.801.21
290983-9098399.04799.88
393524-93524101.814102.66
493207-93207101.468102.32
594139-94139102.483103.34
692206-92206100.379101.21
极限191987-91987100.140100.871.35101.15101.881.35
290810-9081098.85999.85
393782-93782102.094103.11
492936-92936101.173102.19
594207-94207102.557103.58
692215-92215100.389101.39
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.54100441100174100254997721005601002400.31
213.519979199863998270.06
单位质量响应值RSD%判断
7403.257389.120.14数据可信
中间条件6月-供试品溶液-2024021821批-氨氯地平-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1109082-10908295.60796.231.4795.6196.231.47
2112775-11277598.84498.84
3108727-10872795.29695.30
4110435-11043596.79396.79
5108534-10853495.12795.13
6109175-10917595.68895.69
10min1111931-11193198.10499.951.6398.26100.111.63
2116141-116141101.794101.96
3111807-11180797.99598.15
4115141-115141100.917101.08
5113744-11374499.69399.85
6115440-115440101.179101.34
15min1112093-11209398.24699.791.9998.57100.121.99
2116150-116150101.802102.14
3110812-11081297.12397.45
4115256-115256101.018101.35
5112780-11278098.84899.17
6116051-116051101.715102.04
20min1112342-11234298.46499.771.3198.95100.271.31
2115374-115374101.122101.63
3111978-11197898.14598.63
4114058-11405899.968100.47
5113701-11370199.655100.14
6115563-115563101.287101.78
30min1109927-10992796.34799.882.2497.00100.542.23
2114859-114859100.670101.34
3111951-11195198.12198.77
4115817-115817101.510102.17
5114487-114487100.344101.00
6116713-116713102.295102.96
45min1111289-11128997.54199.731.8698.35100.551.86
2115082-115082100.866101.71
3111427-11142797.66298.47
4115001-115001100.795101.63
5113431-11343199.419100.24
6116465-116465102.078102.91
极限1110431-11043196.78999.091.9897.76100.081.98
2114081-11408199.988101.00
3110352-11035296.72097.69
4114168-114168100.065101.07
5113330-11333099.330100.32
6115944-115944101.621102.63
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203对照品来源中检院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2000
标示量(mg)5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.998235082294822228230982250822850.07
29.958227782242822600.04
单位质量响应值RSD%判断
8236.748267.340.27数据可信
中间条件6月-供试品溶液-2024022021批-比索洛尔-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min194594-94594102.962101.002.51102.96101.002.51
289560-8956097.48397.48
394819-94819103.207103.21
494293-94293102.634102.63
593273-93273101.524101.52
690195-9019598.17498.17
10min195797-95797104.271102.082.51104.44102.252.51
290728-9072898.75498.92
396084-96084104.584104.76
494986-94986103.389103.56
594030-94030102.348102.52
691073-9107399.13099.29
15min195540-95540103.992101.912.68104.34102.252.68
290315-9031598.30498.63
396301-96301104.820105.17
495037-95037103.444103.79
593687-93687101.975102.31
690874-9087498.91399.24
20min195368-95368103.804101.872.39104.32102.382.39
291059-9105999.11499.61
395952-95952104.440104.96
494622-94622102.992103.51
593890-93890102.196102.71
690654-9065498.67399.17
30min195434-95434103.876101.612.53104.57102.282.53
290275-9027598.26198.92
395571-95571104.025104.72
494627-94627102.998103.69
593555-93555101.831102.51
690626-9062698.64399.30
45min195063-95063103.472101.252.63104.34102.102.63
289642-8964297.57298.39
395450-95450103.894104.76
494358-94358102.705103.56
593139-93139101.378102.23
690471-9047198.47499.30
极限194891-94891103.285101.062.59104.32102.082.59
289705-8970597.64198.62
395086-95086103.498104.54
494219-94219102.554103.58
593124-93124101.362102.38
690075-9007598.04399.03
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.5410018299810999381002691000671000530.19
213.5110003399738998860.21
单位质量响应值RSD%判断
7389.447393.490.04数据可信
中间条件6月-供试品溶液-2024022021批-氨氯地平-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1109272-10927295.83495.743.0695.8395.743.06
2114846-114846100.723100.72
3104958-10495892.05192.05
4107415-10741594.20694.21
5110404-11040496.82796.83
6108110-10811094.81594.82
10min1111718-11171897.98097.682.9098.1497.842.90
2116893-116893102.518102.69
3107818-10781894.55994.71
4109344-10934495.89896.05
5112761-11276198.89499.06
6109737-10973796.24296.40
15min1111306-11130697.61897.342.7797.9497.662.77
2116420-116420102.103102.44
3107567-10756794.33994.65
4109570-10957096.09696.41
5111842-11184298.08898.41
6109255-10925595.82096.14
20min1110874-11087497.23997.213.1497.7397.703.14
2116830-116830102.463102.97
3107456-10745694.24294.71
4108342-10834295.01995.50
5112614-11261498.76699.26
6108933-10893395.53796.02
30min1110470-11047096.88596.622.9897.5397.262.98
2115299-115299101.120101.80
3105661-10566192.66893.29
4108383-10838395.05595.69
5111901-11190198.14098.79
6109283-10928395.84496.48
45min1110968-11096897.32296.613.1198.1397.423.10
2116127-116127101.847102.69
3106297-10629793.22594.01
4108723-10872395.35396.15
5110842-11084297.21198.03
6108003-10800394.72295.52
极限1109346-10934695.89996.273.0996.8797.243.09
2115758-115758101.523102.54
3106281-10628193.21194.15
4107707-10770794.46295.41
5111353-11135397.66098.64
6108198-10819894.89395.85
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