叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
117.537833078298783627865278345783970.19
217.497799178171780810.17
单位质量响应值RSD%判断
4472.164464.320.13数据可信
供试品溶液-24091402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%
5min136548-3654841.31535.039.4041.3235.039.40
228397-2839732.10132.10
329807-2980733.69533.69
431579-3157935.69835.70
530076-3007633.99934.00
629521-2952133.37133.37
10min165684-6568474.25173.523.5074.7173.913.50
263985-6398572.33172.69
364617-6461773.04573.42
469142-6914278.16078.56
562426-6242670.56870.95
664362-6436272.75773.13
15min171066-7106680.33582.473.7481.6283.683.71
270659-7065979.87581.04
373454-7345483.03584.22
477203-7720387.27388.54
570452-7045279.64180.80
674898-7489884.66785.85
20min174795-7479584.55186.133.4086.7388.263.38
274678-7467884.41886.47
374220-7422083.90186.01
480829-8082991.37293.61
574960-7496084.73786.78
677692-7769287.82589.95
30min177098-7709887.15489.393.1990.2792.473.17
277312-7731287.39690.38
379860-7986090.27693.32
483208-8320894.06197.31
576706-7670686.71189.70
680281-8028190.75293.85
45min178533-7853388.77691.703.2692.8695.773.22
280523-8052391.02694.98
381667-8166792.31996.36
484479-8447995.49899.79
577944-7794488.11092.06
683582-8358294.48498.59
极限183954-8395494.90496.722.6099.98101.812.61
285012-8501296.100101.07
385395-8539596.533101.60
489634-89634101.325106.68
583338-8333894.20899.14
686038-8603897.260102.41
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
114.769474894273947149463294128944990.30
214.829466394741947020.06
单位质量响应值RSD%判断
6402.376390.150.14数据可信
供试品溶液-24091402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%
5min1121021-12102197.06394.142.2897.0694.142.28
2113317-11331790.88490.88
3118084-11808494.70794.71
4119125-11912595.54295.54
5116057-11605793.08193.08
6116632-11663293.54393.54
10min1123215-12321598.82295.942.1499.9096.992.13
2116062-11606293.08594.10
3120494-12049496.64097.69
4121299-12129997.28698.35
5118252-11825294.84295.88
6118426-11842694.98196.02
15min1123043-12304398.68495.972.08100.8698.082.08
2116240-11624093.22895.27
3120473-12047396.62398.75
4121444-12144497.40299.54
5117883-11788394.54696.63
6118893-11889395.35697.45
20min1123280-12328098.87496.032.06102.1599.212.07
2116301-11630193.27796.36
3120567-12056796.69999.90
4121165-12116597.178100.40
5118043-11804394.67497.81
6119062-11906295.49298.65
30min1122784-12278498.47795.872.11102.85100.122.11
2115742-11574292.82996.95
3120646-12064696.762101.04
4121241-12124197.239101.54
5118217-11821794.81499.00
6118582-11858295.10799.32
45min1122593-12259398.32495.711.92103.79101.021.93
2115904-11590492.95998.11
3120435-12043596.593101.94
4120248-12024896.443101.83
5118334-11833494.908100.15
6118474-11847495.020100.29
极限1122575-12257598.30995.841.94104.87102.221.95
2116085-11608593.10499.28
3120398-12039896.563102.99
4121053-12105397.088103.54
5118171-11817194.777101.08
6118714-11871495.212101.54
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
117.537804978070784887802778054781380.26
217.497915580032795940.78
单位质量响应值RSD%判断
4457.394550.831.47数据可信
供试品溶液-24091402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%
5min128442-2844231.89935.1910.1731.9035.1910.17
230378-3037834.07034.07
335218-3521839.49939.50
429989-2998933.63433.63
528695-2869532.18332.18
635544-3554439.86439.86
10min163251-6325170.93972.152.7271.2972.542.74
263291-6329170.98471.36
365362-6536273.30773.75
466749-6674974.86275.24
562059-6205969.60269.96
665288-6528873.22473.67
15min173552-7355282.49282.602.9783.6383.792.98
271127-7112779.77280.94
377011-7701186.37287.63
474764-7476483.85285.06
571456-7145680.14181.27
673969-7396982.96084.22
20min176546-7654685.85084.742.3487.9186.852.34
273467-7346782.39784.45
377948-7794887.42389.64
476673-7667385.99388.13
573976-7397682.96884.99
674714-7471483.79585.97
30min180156-8015689.89989.713.2492.9192.773.22
276228-7622885.49388.46
381308-8130891.19194.38
481176-8117691.04394.14
577750-7775087.20090.14
683331-8333193.46096.57
45min182752-8275292.81093.062.3596.8297.102.32
281297-8129791.17995.10
382797-8279792.86197.06
482342-8234292.35196.45
581873-8187391.82595.74
686769-8676997.316101.46
极限184343-8434394.59596.022.1399.64101.102.12
285464-8546495.852100.78
386786-8678697.335102.56
484670-8467094.962100.09
583763-8376393.94498.88
688639-8863999.413104.64
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
114.769430694380942879412694220942640.11
214.829390593778938420.10
单位质量响应值RSD%判断
6386.456332.120.61数据可信
供试品溶液-24091402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%
5min1110242-11024288.93392.443.2188.9392.443.21
2114640-11464092.48192.48
3120785-12078597.43897.44
4115270-11527092.98992.99
5111506-11150689.95389.95
6115088-11508892.84392.84
10min1113660-11366091.69194.343.0992.6895.363.09
2117113-11711394.47695.50
3123163-12316399.357100.44
4118080-11808095.25696.29
5113218-11321891.33492.33
6116407-11640793.90794.94
15min1113585-11358591.63094.382.8193.6496.452.82
2117274-11727494.60696.68
3122696-12269698.980101.17
4117724-11772494.96997.06
5113980-11398091.94993.96
6116667-11666794.11696.19
20min1113659-11365991.69094.172.8494.7197.292.84
2116730-11673094.16797.30
3122564-12256498.874102.16
4117600-11760094.86998.02
5113540-11354091.59494.63
6116285-11628593.80896.93
30min1112965-11296591.13093.992.9995.1798.162.99
2116695-11669594.13998.31
3122620-12262098.919103.30
4116895-11689594.30098.50
5113275-11327591.38095.43
6116634-11663494.09098.25
45min1113042-11304291.19294.112.9896.2599.332.98
2116969-11696994.36099.58
3122755-12275599.028104.51
4117104-11710494.46999.72
5113543-11354391.59696.67
6116576-11657694.04399.25
极限1112603-11260390.83893.802.8996.91100.062.89
2116783-11678394.210100.48
3122060-12206098.467105.05
4116775-11677594.203100.50
5113338-11333891.43197.52
6116068-11606893.63399.89
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
117.537786277905781207903178019781870.62
217.497712777182771540.06
单位质量响应值RSD%判断
4460.184411.320.78数据可信
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%
5min146079-4607952.47254.024.9552.4754.024.95
248831-4883155.60655.61
348470-4847055.19555.19
448256-4825654.95154.95
549670-4967056.56156.56
643312-4331249.32149.32
10min159377-5937767.61570.465.7168.2071.065.69
266096-6609675.26775.88
361054-6105469.52570.14
463542-6354272.35872.97
564561-6456173.51974.15
656632-5663264.48965.04
15min162731-6273171.43575.555.6572.7776.945.64
270492-7049280.27281.73
367082-6708276.38977.78
467580-6758076.95678.37
569253-6925378.86280.31
660934-6093469.38870.65
20min165760-6576074.88477.735.7077.0179.955.69
273357-7335783.53585.88
368769-6876978.31080.54
468991-6899178.56380.83
570531-7053180.31782.64
662140-6214070.76272.80
30min169061-6906178.64381.265.1181.6084.355.12
274774-7477485.14988.42
371811-7181181.77484.88
474196-7419684.49087.63
573127-7312783.27386.49
665197-6519774.24377.06
45min174711-7471185.07786.074.8888.9190.064.90
279711-7971190.77194.99
375902-7590286.43390.45
476313-7631386.90190.98
577899-7789988.70792.85
668939-6893978.50482.15
极限180802-8080292.01393.023.2196.7997.963.27
283839-8383995.471100.70
379314-7931490.31895.29
483105-8310594.63599.68
584768-8476896.529101.65
678269-7826989.12893.65
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
114.769311593091931329313392964930870.08
214.829248892635925620.12
单位质量响应值RSD%判断
6306.716245.750.69数据可信
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%
5min1116880-11688095.53694.783.8395.5494.783.83
2116105-11610594.90394.90
3120467-12046798.46898.47
4107803-10780388.11788.12
5119143-11914397.38697.39
6115306-11530694.25094.25
10min1119018-11901897.28495.583.8098.3596.633.80
2117847-11784796.32797.38
3119304-11930497.51898.61
4108350-10835088.56489.54
5120657-12065798.62499.71
6116387-11638795.13396.18
15min1120116-12011698.18295.564.40100.3297.674.38
2117770-11777096.26498.39
3122182-12218299.870102.05
4107968-10796888.25290.21
5119264-11926497.48599.66
6114139-11413993.29695.40
20min1118491-11849196.85395.814.12100.0998.984.11
2117966-11796696.42499.62
3122117-12211799.817103.10
4108597-10859788.76691.71
5120746-12074698.696101.96
6115360-11536094.29497.43
30min1118454-11845496.82395.563.81101.1399.803.81
2117291-11729195.872100.14
3121499-12149999.312103.71
4109069-10906989.15293.08
5120091-12009198.161102.52
6115028-11502894.02398.21
45min1118750-11875097.06595.293.80102.45100.593.80
2117047-11704795.673101.00
3119899-11989998.004103.50
4108153-10815388.40393.32
5119765-11976597.895103.34
6115864-11586494.70699.94
极限1118364-11836496.74995.463.71103.21101.823.73
2117065-11706595.688102.08
3120937-12093798.853105.44
4108680-10868088.83494.74
5119592-11959297.753104.29
6116092-11609294.892101.18
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
117.537730977295779157684877184773100.50
217.497796477506777350.42
单位质量响应值RSD%判断
4410.154444.540.55数据可信
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%
5min148798-4879855.67354.902.6255.6754.902.61
249027-4902755.93455.93
349453-4945356.42056.42
447788-4778854.52154.52
545988-4598852.46752.47
647695-4769554.41554.41
10min165584-6558474.82471.662.7775.4472.272.76
264306-6430673.36673.99
362383-6238371.17271.80
461514-6151470.18170.79
561810-6181070.51871.10
661281-6128169.91570.52
15min170343-7034380.25476.943.4681.7078.353.43
268568-6856878.22979.67
366851-6685176.27077.69
466063-6606375.37176.76
563859-6385972.85674.22
668969-6896978.68680.07
20min173521-7352183.87979.303.7486.2281.563.70
269621-6962179.43081.74
368904-6890478.61280.88
467925-6792577.49579.72
566008-6600875.30877.48
671084-7108481.09983.35
30min178970-7897090.09683.524.6293.3786.664.55
272216-7221682.39085.58
373968-7396884.38987.53
471351-7135181.40484.49
568899-6889978.60681.62
673812-7381284.21187.37
45min185364-8536497.39187.578.05101.6791.647.83
280087-8008791.37095.47
375694-7569486.35890.43
474382-7438284.86288.85
566921-6692176.34980.24
678079-7807989.08093.17
极限184066-8406695.91092.113.95101.2797.163.86
282803-8280394.46999.59
383444-8344495.200100.24
479145-7914590.29695.23
578914-7891490.03294.77
676035-7603586.74891.83
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
114.769262792754927349282492647927170.09
214.829244192632925360.15
单位质量响应值RSD%判断
6281.646243.990.43数据可信
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%
5min1117845-11784596.53095.791.2596.5395.791.25
2118534-11853497.09497.09
3115261-11526194.41394.41
4115484-11548494.59694.60
5118280-11828096.88696.89
6116276-11627695.24595.24
10min1119232-11923297.66697.181.1898.7498.241.18
2120020-12002098.31299.39
3117154-11715495.96497.01
4116970-11697095.81396.86
5120178-12017898.44199.52
6118269-11826996.87797.94
15min1120164-12016498.43097.471.32100.5999.621.32
2120685-12068598.856101.03
3117469-11746996.22298.34
4116974-11697495.81797.93
5120187-12018798.448100.62
6118505-11850597.07199.21
20min1120261-12026198.50997.111.37101.76100.341.36
2119929-11992998.237101.51
3117096-11709695.91799.10
4116739-11673995.62498.80
5119835-11983598.160101.42
6117477-11747796.22999.44
30min1119487-11948797.87597.191.30102.22101.491.30
2120341-12034198.575102.94
3116808-11680895.68199.93
4116692-11669295.58699.83
5119662-11966298.018102.37
6118891-11889197.387101.67
45min1119141-11914197.59297.161.67103.03102.551.64
2119704-11970498.053103.51
3117299-11729996.083101.40
4115810-11581094.863100.17
5121485-12148599.512104.96
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