富马酸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)1.5
对照品批号10071-202203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%
110.098285282937828978289482926829010.04
210.128248482514824990.03
单位质量响应值RSD%判断
8216.158152.080.56数据可信
长期18月-供试品溶液-2022110211批-富马酸比索洛尔-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%
5min188702-8870297.35197.742.6497.3597.742.64
288904-8890497.57397.57
387513-8751396.04696.05
493693-93693102.829102.83
588020-8802096.60396.60
687499-8749996.03196.03
10min189896-8989698.66299.422.6498.8299.582.64
290335-9033599.14399.31
388619-8861997.26097.42
494791-94791104.034104.21
591621-91621100.555100.72
688261-8826196.86797.03
15min189696-8969698.44299.322.6898.7799.642.68
290292-9029299.09699.42
388614-8861497.25597.58
494765-94765104.005104.35
591508-91508100.431100.76
688084-8808496.67396.99
20min189684-8968498.42999.172.6498.9299.662.64
289927-8992798.69699.19
388549-8854997.18397.67
494580-94580103.802104.32
591387-91387100.298100.79
688014-8801496.59697.08
30min189489-8948998.21598.962.6098.8799.622.60
289764-8976498.51799.17
388402-8840297.02297.67
494316-94316103.513104.20
591203-91203100.096100.76
687844-8784496.41097.05
45min190099-9009998.88498.872.5499.7099.702.55
289682-8968298.42799.25
388181-8818196.77997.59
494033-94033103.202104.07
590907-9090799.771100.60
687611-8761196.15496.96
极限189042-8904297.72498.542.7198.7199.532.71
289524-8952498.25399.24
387849-8784996.41597.38
494101-94101103.277104.31
590777-9077799.629100.62
687439-8743995.96596.93
富马酸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)1.5
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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.941045771045351046181045551045011045570.05
213.961041921041721041820.02
单位质量响应值RSD%判断
7500.507462.890.36数据可信
长期18月-供试品溶液-2022110211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%
5min1110520-11052095.77496.253.6995.7796.253.68
2118091-118091102.335102.33
3105759-10575991.64891.65
4111763-11176396.85196.85
5108803-10880394.28694.29
6111474-11147496.60196.60
10min1114471-11447199.198100.293.1499.36100.463.14
2122516-122516106.169106.34
3111653-11165396.75696.91
4114850-11485099.52699.69
5116064-116064100.578100.74
6114853-11485399.52999.69
15min1114911-11491199.579100.292.9799.90100.622.97
2122256-122256105.944106.29
3112166-11216697.20097.51
4115196-11519699.826100.15
5115795-115795100.345100.67
6114083-11408398.86199.19
20min1113875-11387598.68199.942.8399.17100.432.83
2121472-121472105.265105.79
3111866-11186696.94097.42
4114765-11476599.45299.95
5115519-115519100.106100.60
6114434-11443499.16699.66
30min1114251-11425199.007100.012.8199.66100.672.81
2121532-121532105.317106.02
3111951-11195197.01497.65
4114333-11433399.07899.74
5115541-115541100.125100.78
6114822-11482299.502100.16
45min1108664-10866494.16598.983.6694.9999.813.65
2121116-121116104.956105.83
3111497-11149796.62097.42
4114483-11448399.208100.03
5115279-11527999.898100.72
6114308-11430899.05699.88
极限1113836-11383698.64799.412.8899.62100.402.88
2120887-120887104.758105.81
3111019-11101996.20697.17
4114118-11411898.89299.88
5114879-11487999.551100.54
6113531-11353198.38399.37
富马酸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)1.5
对照品批号10071-202203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%
110.098277582779827268291682794827980.09
210.128306383037830500.03
单位质量响应值RSD%判断
8205.958206.520.01数据可信
长期18月-供试品溶液-2022110311批-富马酸比索洛尔-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%
5min190010-9001098.51998.622.6798.5298.632.67
291514-91514100.165100.17
391289-9128999.91999.92
491523-91523100.175100.18
585347-8534793.41593.42
690957-9095799.55699.56
10min190523-9052399.08099.332.6999.2499.502.69
292403-92403101.138101.31
391755-91755100.429100.60
492161-92161100.873101.04
585964-8596494.09094.25
691728-91728100.399100.57
15min190182-9018298.70799.122.8099.0499.452.80
292420-92420101.157101.49
391649-91649100.313100.65
491911-91911100.600100.93
585616-8561693.71094.02
691566-91566100.222100.56
20min190081-9008198.59798.882.7999.0999.372.79
292211-92211100.928101.43
391213-9121399.836100.34
491614-91614100.275100.78
585409-8540993.48393.95
691489-91489100.138100.64
30min189913-8991398.41398.752.7399.0799.412.74
291763-91763100.438101.11
391427-91427100.070100.74
491679-91679100.346101.02
585385-8538593.45794.08
691158-9115899.776100.44
45min189757-8975798.24298.542.7499.0699.362.74
291865-91865100.549101.39
390918-9091899.513100.35
491562-91562100.218101.05
585226-8522693.28394.06
690840-9084099.427100.26
极限189480-8948097.93998.342.6898.9299.322.68
291556-91556100.211101.22
391047-9104799.654100.65
491159-9115999.777100.78
585163-8516393.21494.15
690648-9064899.217100.22
富马酸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)1.5
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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.941045561045441045251045681044241045230.06
213.961045461046931046200.10
单位质量响应值RSD%判断
7498.067494.270.04数据可信
长期18月-供试品溶液-2022110311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%
5min1112280-11228097.11198.293.0997.1198.293.09
2109017-10901794.28894.29
3116060-116060100.380100.38
4118529-118529102.515102.52
5114963-11496399.43199.43
6111017-11101796.01896.02
10min1113338-11333898.02699.202.8798.1999.372.87
2111183-11118396.16296.32
3116403-116403100.677100.84
4119765-119765103.584103.76
5115937-115937100.274100.44
6111578-11157896.50396.66
15min1113052-11305297.77899.182.7498.1099.512.74
2111312-11131296.27396.59
3116710-116710100.942101.28
4119336-119336103.213103.56
5115787-115787100.144100.48
6111825-11182596.71797.04
20min1112920-11292097.66498.782.5998.1599.272.59
2110890-11089095.90896.39
3115722-115722100.088100.59
4118735-118735102.694103.21
5115371-11537199.784100.28
6111608-11160896.52997.01
30min1112699-11269997.47398.783.0198.1299.443.01
2110392-11039295.47896.12
3116267-116267100.559101.23
4119566-119566103.412104.10
5115026-11502699.486100.15
6111294-11129496.25896.90
45min1112700-11270097.47498.862.8198.2999.682.81
2111098-11109896.08896.89
3116153-116153100.460101.30
4119289-119289103.173104.03
5115311-11531199.732100.56
6111268-11126896.23597.04
极限1112420-11242097.23298.672.7698.2199.662.75
2110683-11068395.72996.69
3116296-116296100.584101.59
4118523-118523102.510103.54
5115407-11540799.815100.81
6111160-11116096.14297.11
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