叶酸左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)1.5
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5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%
117.377469674759746317446574565746230.16
217.277451274183743480.32
单位质量响应值RSD%判断
4296.094305.040.15数据可信
长期3月-供试品溶液-2024092121批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122143-2214326.00726.708.7826.0126.708.77
226133-2613330.69330.69
322068-2206825.91925.92
423749-2374927.89327.89
520271-2027123.80823.81
622054-2205425.90325.90
10min154127-5412763.57365.554.3063.6265.594.30
259489-5948969.87069.92
353939-5393963.35263.39
456861-5686166.78466.83
553339-5333962.64762.69
657103-5710367.06867.11
15min163381-6338174.44179.054.0474.5979.204.05
271252-7125283.68683.85
366415-6641578.00578.15
468632-6863280.60980.77
565778-6577877.25777.40
668348-6834880.27580.43
20min171357-7135783.80986.494.3584.0886.784.34
279520-7952093.39793.70
372526-7252685.18285.46
470705-7070583.04483.34
574691-7469187.72588.00
673033-7303385.77886.07
30min176270-7627089.58092.073.6889.9992.503.68
283615-8361598.20698.67
376280-7628089.59190.01
477368-7736890.86991.30
579863-7986393.80094.22
676954-7695490.38390.81
45min178475-7847592.17094.133.3792.7394.713.37
285327-85327100.217100.84
378118-7811891.75092.32
480135-8013594.11994.70
578513-7851392.21492.79
680293-8029394.30594.89
极限180390-8039094.41997.324.2395.1398.064.22
289245-89245104.819105.61
379171-7917192.98793.71
482145-8214596.48097.22
583410-8341097.96698.69
682803-8280397.25397.99
叶酸左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)1.5
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8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%
115.269393693637937419405593876938490.18
215.389412494115941200.01
单位质量响应值RSD%判断
6150.006119.640.35数据可信
长期3月-供试品溶液-2024092121批-叶酸-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1114289-11428995.57097.012.8495.5797.022.84
2119610-119610100.020100.02
3120494-120494100.759100.76
4112344-11234493.94493.94
5115407-11540796.50596.51
6113951-11395195.28895.29
10min1117389-11738998.16399.942.6098.32100.102.60
2122826-122826102.709102.88
3123825-123825103.544103.71
4116167-11616797.14197.30
5118950-11895099.46899.63
6117911-11791198.59998.76
15min1118121-11812198.775100.762.5099.10101.092.50
2123003-123003102.857103.19
3124235-124235103.887104.23
4116898-11689897.75298.07
5122148-122148102.142102.47
6118572-11857299.15299.47
20min1118105-11810598.761100.532.5399.25101.022.53
2123190-123190103.013103.52
3124434-124434104.054104.57
4116812-11681297.68098.16
5120341-120341100.631101.13
6118425-11842599.02999.52
30min1119043-11904399.546100.902.43100.20101.562.43
2123466-123466103.244103.93
3124903-124903104.446105.13
4117366-11736698.14398.79
5120352-120352100.640101.30
6118837-11883799.373100.03
45min1118070-11807098.732100.922.5599.55101.752.55
2123230-123230103.047103.90
3124494-124494104.104104.96
4116785-11678597.65798.47
5122193-122193102.180103.01
6119337-11933799.791100.61
极限1118349-11834998.965100.842.7099.95101.842.70
2124440-124440104.059105.08
3124650-124650104.234105.27
4116962-11696297.80598.78
5120378-120378100.662101.66
6118755-11875599.305100.29
叶酸左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)1.5
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5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%
117.377448374428745277446974274744360.14
217.277269472650726720.05
单位质量响应值RSD%判断
4285.324207.991.29数据可信
长期3月-供试品溶液-2024092121批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117171-1717120.42526.3212.8020.4326.3212.80
222708-2270827.01127.01
321533-2153325.61425.61
425881-2588130.78630.79
522833-2283327.16027.16
622624-2262426.91226.91
10min153594-5359463.75166.074.0763.7866.114.07
256649-5664967.38567.43
353773-5377363.96464.01
457534-5753468.43868.49
558413-5841369.48369.53
653280-5328063.37763.42
15min169685-6968582.89181.442.6383.0381.592.63
268820-6882081.86282.02
365546-6554677.96878.12
470500-7050083.86184.03
569022-6902282.10382.26
667215-6721579.95380.10
20min175851-7585190.22687.513.2990.5087.803.28
272822-7282286.62386.92
369052-6905282.13882.42
474691-7469188.84689.15
574709-7470988.86789.17
674259-7425988.33288.62
30min175386-7538689.67390.852.3690.1091.282.36
274359-7435988.45188.89
374785-7478588.95889.37
478442-7844293.30893.76
576890-7689091.46291.91
678381-7838193.23593.67
45min176730-7673091.27192.522.5791.8593.102.57
277905-7790592.66993.25
375024-7502489.24289.81
481096-8109696.46597.07
577678-7767892.39993.00
678234-7823493.06093.65
极限183902-8390299.80395.954.06100.5396.704.04
278653-7865393.55994.30
375088-7508889.31890.03
483074-8307498.81899.59
581379-8137996.80197.55
681907-8190797.43098.17
叶酸左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)1.5
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8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%
115.269421594178941329404994027941200.09
215.389382893748937880.07
单位质量响应值RSD%判断
6167.766098.050.81数据可信
长期3月-供试品溶液-2024092121批-叶酸-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1120763-120763101.01896.274.33101.0296.284.33
2115729-11572996.80796.81
3120108-120108100.470100.47
4114451-11445195.73895.74
5111850-11185093.56293.56
6107650-10765090.04990.05
10min1126685-126685105.972100.264.14106.14100.424.14
2120813-120813101.060101.22
3123393-123393103.218103.39
4118541-11854199.15999.32
5117187-11718798.02798.18
6112516-11251694.11994.27
15min1127544-127544106.690101.233.99107.04101.563.99
2121373-121373101.528101.86
3124855-124855104.441104.78
4119664-119664100.099100.42
5118888-11888899.45099.77
6113774-11377495.17295.48
20min1127819-127819106.920101.424.00107.44101.923.99
2121918-121918101.984102.48
3124818-124818104.410104.92
4120082-120082100.448100.94
5118964-11896499.513100.00
6113892-11389295.27095.74
30min1127833-127833106.932101.393.97107.63102.063.97
2121727-121727101.824102.49
3124440-124440104.094104.78
4119574-119574100.023100.68
5120023-120023100.399101.05
6113669-11366995.08495.71
45min1128838-128838107.773101.964.21108.65102.804.21
2121495-121495101.630102.47
3126010-126010105.407106.27
4120015-120015100.392101.22
5120959-120959101.182102.00
6114039-11403995.39396.18
极限1128498-128498107.488101.504.02108.55102.504.02
2121559-121559101.684102.69
3124694-124694104.306105.34
4119860-119860100.263101.26
5119014-11901499.555100.54
6114382-11438295.68096.62
叶酸左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)1.5
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5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%
117.377275572779725207260572354726030.25
217.277117971216711980.04
单位质量响应值RSD%判断
4179.794122.640.98数据可信
中间条件3月-供试品溶液-2024092121批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141088-4108849.99747.665.6550.0047.665.65
240428-4042849.19449.19
339995-3999548.66748.67
440581-4058149.38049.38
535505-3550543.20343.20
637423-3742345.53745.54
10min161134-6113474.38972.582.5674.4772.662.57
260411-6041173.50973.59
359344-5934472.21172.29
461180-6118074.44574.53
558295-5829570.93471.01
657508-5750869.97770.05
15min173051-7305188.89085.052.9289.1085.252.92
267715-6771582.39782.60
370737-7073786.07486.28
470158-7015885.37085.58
570089-7008985.28685.48
667604-6760482.26282.45
20min177356-7735694.12892.751.8394.4893.091.83
274863-7486391.09591.44
376724-7672493.35993.70
477976-7797694.88395.23
574450-7445090.59290.92
675963-7596392.43392.76
30min180817-8081798.34097.101.5998.8597.601.58
281026-8102698.59499.09
378532-7853295.55996.06
479329-7932996.52997.04
580854-8085498.38598.87
678216-7821695.17595.66
45min181920-8192099.68299.831.54100.36100.491.53
282577-82577100.481101.14
380409-8040997.84398.50
483607-83607101.735102.40
582974-82974100.964101.61
680754-8075498.26398.91
极限182506-82506100.395101.481.88101.24102.311.87
283454-83454101.548102.37
382120-8212099.925100.75
486004-86004104.651105.49
584361-84361102.652103.47
681948-8194899.716100.52
叶酸左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)1.5
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8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%
115.269400593996939239401594021939920.05
215.389414894328942380.14
单位质量响应值RSD%判断
6159.376127.310.37数据可信
中间条件3月-供试品溶液-2024092121批-叶酸-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1117097-11709797.78395.162.5797.7895.162.57
2110193-11019392.01792.02
3117201-11720197.86997.87
4114641-11464195.73295.73
5111230-11123092.88392.88
6113374-11337494.67494.67
10min1120937-120937100.98997.862.66101.1598.022.66
2113886-11388695.10195.25
3120040-120040100.240100.40
4118027-11802798.55998.72
5113392-11339294.68994.84
6116889-11688997.60997.77
15min1121463-121463101.42898.762.48101.7699.082.48
2115214-11521496.21096.52
3120835-120835100.904101.23
4120022-120022100.225100.55
5114681-11468195.76596.08
6117387-11738798.02598.35
20min1121757-121757101.67499.082.88102.1799.572.88
2114857-11485795.91296.38
3122595-122595102.374102.87
4119458-11945899.754100.25
5114433-11443395.55896.03
6118824-11882499.22599.71
30min1124234-124234103.74299.003.35104.4199.663.34
2114780-11478095.84896.48
3120946-120946100.997101.67
4120251-120251100.416101.07
5113892-11389295.10695.74
6117259-11725997.91898.57
45min1121151-121151101.16898.382.50102.0199.192.50
2114691-11469195.77396.57
3120279-120279100.440101.28
4119167-11916799.511100.34
5114026-11402695.21896.01
6117528-11752898.14398.95
极限1121122-121122101.14498.122.43102.1699.102.44
2114890-11489095.94096.89
3119917-119917100.137101.14
4118592-11859299.031100.02
5113904-11390495.11696.06
6116596-11659697.36498.34
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