替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.113813693808563809613809613812663810830.06
211.033810303811983811140.04
单位质量响应值RSD%判断
34300.9034552.490.52数据可信
供试品溶液-24041801批-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1174432-17443245.60145.525.8145.6045.525.81
2185903-18590348.60048.60
3175227-17522745.80945.81
4155610-15561040.68140.68
5179344-17934446.88646.89
6174273-17427345.56045.56
10min1292429-29242976.44974.025.8376.7074.275.83
2295798-29579877.33077.60
3291788-29178876.28276.54
4251594-25159465.77466.00
5288306-28830675.37175.63
6278834-27883472.89573.15
15min1331297-33129786.61088.373.5687.2989.043.56
2331128-33112886.56687.27
3341676-34167689.32490.00
4322250-32225084.24584.84
5355091-35509192.83193.51
6346832-34683290.67291.33
20min1357162-35716293.37296.123.2694.5397.283.26
2361534-36153494.51595.70
3373917-37391797.75398.93
4353259-35325992.35293.41
5382484-38248499.992101.19
6377758-37775898.75799.92
30min1345118-34511890.22494.332.3191.9096.022.28
2361957-36195794.62696.33
3370228-37022896.78898.51
4362631-36263194.80296.37
5361564-36156494.52396.27
6363456-36345695.01896.73
45min1357970-35797093.58493.852.3295.7696.062.29
2352017-35201792.02794.26
3367288-36728896.02098.27
4356103-35610393.09595.19
5370664-37066496.90299.18
6349970-34997091.49293.73
60min1358786-35878693.79792.034.7896.5094.764.64
2318046-31804683.14685.89
3361979-36197994.63297.42
4357955-35795593.58096.20
5360340-36034094.20397.02
6355002-35500292.80895.55
极限1354120-35412092.57793.021.3895.8096.261.30
2349429-34942991.35194.56
3354999-35499992.80796.12
4364415-36441595.26898.40
5355374-35537492.90596.24
6356549-35654993.21296.47
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.113792893787403782153779403788223786010.15
211.033786173785983786080.01
单位质量响应值RSD%判断
34077.5034325.290.52数据可信
供试品溶液-24041801批-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1164861-16486143.38343.935.2743.3843.925.28
2172504-17250445.39545.39
3180605-18060547.52647.53
4159198-15919841.89341.89
5167665-16766544.12144.12
6156734-15673441.24541.24
10min1274701-27470172.28872.033.3072.5372.283.31
2283059-28305974.48774.74
3285263-28526375.06775.33
4264600-26460069.63069.86
5263988-26398869.46969.71
6270789-27078971.25871.49
15min1328642-32864286.48287.121.5387.1287.771.53
2334973-33497388.14888.81
3332697-33269787.54988.23
4322506-32250684.86885.49
5331098-33109887.12987.76
6336548-33654888.56389.19
20min1342178-34217890.04492.685.2091.1793.805.15
2366472-36647296.43797.59
3373588-37358898.31099.48
4363703-36370395.70996.80
5340070-34007089.49090.60
6327040-32704086.06187.18
30min1351833-35183392.58595.392.9194.2197.032.87
2358882-35888294.44096.13
3372640-37264098.06099.77
4364434-36443495.90197.52
5350899-35089992.33993.95
6376177-37617798.991100.59
45min1365829-36582996.26898.351.7198.41100.521.69
2383267-383267100.857103.07
3373845-37384598.378100.64
4372585-37258598.046100.20
5368552-36855296.98599.11
6378298-37829899.549101.69
60min1368739-36873997.03495.462.1499.7198.182.05
2355224-35522493.47796.25
3361160-36116095.03997.84
4364444-36444495.90498.60
5373569-37356998.305100.97
6353499-35349993.02395.72
极限1371808-37180897.84296.272.04101.0599.521.97
2377517-37751799.344102.64
3357303-35730394.02597.36
4360990-36099094.99598.23
5364108-36410895.81599.03
6363292-36329295.60198.82
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.113794413813303812703821123833533815010.38
211.033750713749963750340.02
单位质量响应值RSD%判断
34338.5234001.270.70数据可信
供试品溶液-24041901批-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1143775-14377537.87040.345.1737.8740.345.17
2165501-16550143.59243.59
3145571-14557138.34338.34
4156901-15690141.32741.33
5153866-15386640.52840.53
6153289-15328940.37640.38
10min1248454-24845465.44269.286.7265.6569.506.71
2269016-26901670.85871.10
3235268-23526861.96962.18
4267013-26701370.33070.56
5280218-28021873.80874.03
6278129-27812973.25873.48
15min1320228-32022884.34783.413.3084.9284.023.26
2298160-29816078.53479.17
3319143-31914384.06184.62
4324879-32487985.57286.19
5311605-31160582.07682.71
6326086-32608685.89086.52
20min1356148-35614893.80893.291.2494.8594.371.23
2357523-35752394.17095.24
3351415-35141592.56193.59
4346927-34692791.37992.47
5354540-35454093.38494.48
6358611-35861194.45795.57
30min1363190-36319095.66395.441.6297.2397.031.58
2362996-36299695.61297.21
3368126-36812696.96398.50
4360537-36053794.96496.57
5351916-35191692.69394.30
6367331-36733196.75498.39
45min1352884-35288492.94894.593.0895.0496.712.99
2354794-35479493.45195.58
3376328-37632899.123101.20
4366412-36641296.51298.64
5359447-35944794.67796.80
6344884-34488490.84193.01
60min1358857-35885794.52295.122.3997.1397.772.31
2361089-36108995.10997.76
3374992-37499298.771101.40
4365308-36530896.22198.89
5357366-35736694.12996.78
6349218-34921891.98394.66
极限1356138-35613893.80595.011.4196.9498.181.38
2361653-36165395.25898.43
3366403-36640396.50999.69
4366723-36672396.59399.80
5354952-35495293.49396.67
6358309-35830994.37797.56
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.113837003837403842583847813851413843240.17
211.033942323940833941580.03
单位质量响应值RSD%判断
34592.6235735.092.30数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-24041901批-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1169135-16913543.30143.371.7843.3043.371.78
2167252-16725242.81942.82
3171443-17144343.89243.89
4167390-16739042.85442.85
5174468-17446844.66644.67
6166810-16681042.70542.71
10min1267219-26721968.41169.873.9568.6570.123.93
2292590-29259074.90775.14
3275981-27598170.65570.90
4272033-27203369.64469.88
5268186-26818668.65968.91
6261595-26159566.97267.21
15min1330076-33007684.50386.041.8985.1286.671.89
2343727-34372787.99888.65
3344240-34424088.13088.77
4331271-33127184.80985.43
5334963-33496385.75586.38
6332187-33218785.04485.65
20min1332472-33247285.11788.193.4386.2189.303.40
2344457-34445788.18589.33
3357749-35774991.58892.71
4351648-35164890.02691.12
5352283-35228390.18991.29
6328249-32824984.03685.12
30min1352627-35262790.27789.503.0491.8491.092.97
2355051-35505190.89792.53
3328402-32840284.07585.71
4357341-35734191.48493.08
5352778-35277890.31591.92
6351297-35129789.93691.48
45min1362598-36259892.83090.946.4294.8993.046.27
2350609-35060989.76091.90
3312213-31221379.93082.03
4377386-37738696.61598.72
5361471-36147192.54194.65
6367070-36707093.97496.02
60min1343960-34396088.05889.453.7990.6492.053.71
2343947-34394788.05590.69
3329039-32903984.23886.78
4366397-36639793.80296.44
5358595-35859591.80594.43
6354492-35449290.75493.32
极限1354547-35454790.76889.793.5793.8492.893.50
2355872-35587291.10894.23
3326911-32691183.69386.71
4360288-36028892.23895.40
5359222-35922291.96595.10
6347527-34752788.97192.05
替米沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.113887643887503881793876393892553885170.16
211.033779423776723778070.06
单位质量响应值RSD%判断
34970.0334252.671.47数据可信
供试品溶液-2024050921批-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1158258-15825841.15641.609.3741.1641.609.38
2173379-17337945.08945.09
3157394-15739440.93240.93
4163139-16313942.42642.43
5174460-17446045.37045.37
6133257-13325734.65534.65
10min1263159-26315968.43770.132.4168.6770.362.42
2272930-27293070.97871.23
3268428-26842869.80770.03
4280255-28025572.88373.12
5270128-27012870.24970.50
6263083-26308368.41768.61
15min1317432-31743282.55183.352.3183.1683.972.28
2318005-31800582.70083.34
3311230-31123080.93881.55
4330572-33057285.96886.61
5317498-31749882.56883.21
6328233-32823385.36085.93
20min1349545-34954590.90288.865.2091.9789.945.13
2314710-31471081.84382.95
3340845-34084588.64089.70
4364514-36451494.79595.91
5328819-32881985.51286.61
6351709-35170991.46592.51
30min1367665-36766595.61490.224.2997.1991.804.23
2349196-34919690.81192.37
3335249-33524987.18488.74
4355890-35589092.55294.20
5325686-32568684.69786.27
6347821-34782190.45492.01
45min1344002-34400289.46190.882.3591.5692.962.27
2349445-34944590.87692.94
3346454-34645490.09892.14
4341561-34156188.82690.98
5364698-36469894.84396.89
6350619-35061991.18193.24
60min1352124-35212491.57387.874.0794.1790.453.95
2352826-35282691.75594.32
3319450-31945083.07685.62
4324763-32476384.45787.11
5337607-33760787.79790.37
6340581-34058188.57191.13
极限1349348-34934890.85190.662.1993.9693.732.15
2356698-35669892.76295.84
3342318-34231889.02392.03
4358721-35872193.28896.41
5342077-34207788.96092.02
6342411-34241189.04792.10
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