缬沙坦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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.872458762457992460222463222462012460440.09
213.942462622460942461780.05
单位质量响应值RSD%判断
17739.2917659.830.32数据可信
长期6月-供试品溶液-BDJL7批-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%
5min193140-9314034.11334.736.6734.1134.736.67
295952-9595235.14335.14
383930-8393030.74030.74
494367-9436734.56234.56
5102546-10254637.55837.56
698976-9897636.25036.25
10min1170327-17032762.38361.403.5862.4461.453.58
2163171-16317159.76259.82
3165550-16555060.63360.68
4159935-15993558.57758.63
5170096-17009662.29862.36
6176708-17670864.72064.78
15min1207625-20762576.04474.423.7576.2074.583.75
2202829-20282974.28774.45
3200421-20042173.40573.56
4189999-18999969.58869.74
5206103-20610375.48675.65
6212148-21214877.70077.87
20min1221891-22189181.26980.222.1381.5680.512.13
2212060-21206077.66877.95
3217203-21720379.55279.83
4216173-21617379.17479.45
5222670-22267081.55481.85
6224198-22419882.11482.41
30min1228257-22825783.60085.261.9984.0285.681.98
2238356-23835687.29987.71
3233003-23300385.33885.75
4230737-23073784.50884.91
5228137-22813783.55683.98
6238200-23820087.24287.68
45min1239258-23925887.62987.943.1888.1988.503.17
2226283-22628382.87783.43
3241081-24108188.29788.85
4240040-24004087.91688.46
5245865-24586590.04990.62
6248193-24819390.90291.48
60min1248082-24808290.86190.391.6291.5791.101.61
2250957-25095791.91492.61
3244739-24473989.63790.33
4240896-24089688.22988.92
5245016-24501689.73890.46
6251043-25104391.94692.68
极限1253941-25394193.00792.713.3793.8793.573.35
2245194-24519489.80390.65
3253043-25304392.67893.52
4244613-24461389.59190.43
5253912-25391292.99693.86
6268141-26814198.20899.09
缬沙坦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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.014764933476731747722464778632478033047726920.15
216.004766073476564147658570.01
单位质量响应值RSD%判断
298106.93297866.060.06数据可信
长期6月-供试品溶液-BDJL7批-缬沙坦-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%
5min14384155-438415582.01481.863.2982.0181.863.29
24395690-439569082.22982.23
34116945-411694577.01577.01
44345790-434579081.29681.30
54486306-448630683.92483.92
64525978-452597884.66784.67
10min15103931-510393195.47895.171.8695.6195.301.86
25131745-513174595.99996.14
34964634-496463492.87293.00
45005274-500527493.63393.77
55088767-508876795.19595.33
65229788-522978897.83397.97
15min15164819-516481996.61796.631.8096.9196.921.81
25215326-521532697.56297.86
35058881-505888194.63694.92
45078966-507896695.01195.30
55160629-516062996.53996.84
65313198-531319899.39399.70
20min15173833-517383396.78696.731.8397.2497.191.83
25220080-522008097.65198.11
35061994-506199494.69495.13
45086339-508633995.14995.60
55161378-516137896.55397.01
65322661-532266199.570100.04
30min15174087-517408796.79196.721.7997.4197.341.79
25219113-521911397.63398.26
35064243-506424394.73695.33
45084785-508478595.12095.73
55164341-516434196.60897.23
65316758-531675899.460100.10
45min15166370-516637096.64696.661.8397.4397.441.83
25210897-521089797.47998.26
35061181-506118194.67995.44
45079694-507969495.02595.79
55163531-516353196.59397.37
65321209-532120999.543100.34
60min15163474-516347496.59296.872.2697.5397.812.25
25214522-521452297.54798.49
35060445-506044594.66595.58
45081071-508107195.05195.98
55165642-516564296.63397.58
65385983-5385983100.755101.72
极限15163749-516374996.59797.642.0397.7098.742.03
25239670-523967098.01799.13
35170859-517085996.73097.80
45110569-511056995.60296.69
55217762-521776297.60898.71
65415035-5415035101.298102.43
缬沙坦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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.872481672481812482652482342483472482390.03
213.942523352524082523720.03
单位质量响应值RSD%判断
17897.5518104.160.82数据可信
长期6月-供试品溶液-BDJL7批-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%
5min191649-9164933.00635.795.0633.0135.795.06
2103569-10356937.29937.30
396192-9619234.64234.64
4103360-10336037.22337.22
5103840-10384037.39637.40
697689-9768935.18135.18
10min1168864-16886460.81462.263.0860.8762.323.07
2177580-17758063.95364.01
3168327-16832760.62060.68
4174160-17416062.72162.78
5180399-18039964.96865.03
6167984-16798460.49760.56
15min1205622-20562274.05273.902.7374.2174.072.73
2208470-20847075.07775.25
3196251-19625170.67770.84
4203403-20340373.25273.42
5213053-21305376.72876.90
6204478-20447873.64073.80
20min1221944-22194479.93080.002.9380.2180.282.93
2225016-22501681.03681.33
3216052-21605277.80878.08
4221902-22190279.91580.20
5232845-23284583.85584.15
6215002-21500277.43077.71
30min1229478-22947882.64383.862.0183.0684.282.01
2231199-23119983.26383.69
3231023-23102383.19983.61
4233582-23358284.12184.54
5241909-24190987.12087.56
6229870-22987082.78483.20
45min1240333-24033386.55287.251.9487.1087.811.95
2244840-24484088.17588.74
3240755-24075586.70487.25
4242652-24265287.38787.95
5249509-24950989.85790.44
6235554-23555484.83185.38
60min1245399-24539988.37787.922.5489.0788.622.53
2246750-24675088.86389.58
3238038-23803885.72686.42
4241934-24193487.12987.84
5254408-25440891.62192.35
6238231-23823185.79586.49
极限1256546-25654692.39190.493.0293.2391.343.01
2257987-25798792.91093.77
3241238-24123886.87887.71
4246810-24681088.88589.74
5259254-25925493.36694.25
6245757-24575788.50689.34
缬沙坦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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.014750718475178947546414756739475839247544560.07
216.004824174482936748267700.08
单位质量响应值RSD%判断
296967.90301673.121.12数据可信
长期6月-供试品溶液-BDJL7批-缬沙坦-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%
5min14300485-430048580.09582.242.6180.0982.242.61
24498143-449814383.77683.78
34353729-435372981.08681.09
44466686-446668683.19083.19
54575968-457596885.22585.23
64297518-429751880.03980.04
10min15028404-502840493.65294.062.3293.7994.202.32
25106650-510665095.10995.25
34970072-497007292.56692.70
45023230-502323093.55693.69
55253196-525319697.83997.98
64921403-492140391.65991.79
15min15130741-513074195.55895.492.2995.8595.782.29
25176346-517634696.40796.71
35048159-504815994.02094.31
45082980-508298094.66894.96
55328649-532864999.24499.55
64995398-499539893.03793.32
20min15134727-513472795.63295.512.3096.0895.962.30
25179039-517903996.45796.92
35053844-505384494.12694.57
45081217-508121794.63695.09
55328885-532888599.24899.72
64991176-499117692.95993.40
30min15137216-513721695.67995.482.3496.2996.102.34
25176650-517665096.41397.03
35050204-505020494.05894.66
45076357-507635794.54595.16
55331472-533147299.29699.93
64988893-498889392.91693.51
45min15146688-514668895.85595.572.3796.6296.342.37
25180580-518058096.48697.27
35050534-505053494.06494.82
45075409-507540994.52795.30
55338468-533846899.427100.23
64995929-499592993.04793.80
60min15159537-515953796.09495.592.3197.0296.522.31
25182468-518246896.52197.46
35050064-505006494.05594.97
45074639-507463994.51395.44
55329673-532967399.263100.23
64998637-499863793.09894.00
极限15232148-523214897.44796.532.3398.5397.622.32
25260908-526090897.98299.08
35112120-511212095.21196.28
45088992-508899294.78095.86
55359081-535908199.811100.94
65045291-504529193.96695.03
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