拉莫三嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
111.055862305861465864885867735864955864260.05
211.145855495850495852990.07
单位质量响应值RSD%判断
53070.2352540.310.71数据可信
长期24月-供试品溶液-2022101711批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1562369-56236995.56496.331.7095.5696.331.70
2561763-56176395.46195.46
3566457-56645796.25896.26
4556987-55698794.64994.65
5569223-56922396.72896.73
6584512-58451299.32699.33
10min1578183-57818398.25198.301.2198.4198.461.22
2573928-57392897.52897.69
3582420-58242098.97199.13
4573237-57323797.41097.57
5572431-57243197.27397.43
6590490-590490100.342100.51
15min1578937-57893798.37998.341.0998.7098.661.09
2575317-57531797.76498.09
3582733-58273399.02499.35
4574641-57464197.64997.97
5571604-57160497.13397.46
6588850-588850100.064100.40
20min1577936-57793698.20998.181.1798.7098.661.17
2573452-57345297.44797.93
3581896-58189698.88299.37
4574115-57411597.56098.04
5570245-57024596.90297.39
6588849-588849100.063100.56
30min1576661-57666197.99298.051.1898.6498.701.18
2572716-57271697.32297.97
3580970-58097098.72599.38
4575156-57515697.73798.38
5568491-56849196.60497.25
6587971-58797199.914100.58
45min1573877-57387797.51997.791.1498.3398.611.14
2571986-57198697.19898.01
3578647-57864798.33099.15
4574417-57441797.61198.42
5567483-56748396.43397.24
6586577-58657799.677100.51
60min1574001-57400197.54097.551.3698.5298.531.36
2570774-57077496.99297.96
3577203-57720398.08499.07
4574311-57431197.59398.56
5562163-56216395.52996.50
6585905-58590599.563100.56
极限1573232-57323297.41097.441.1298.5598.581.12
2567986-56798696.51897.65
3576282-57628297.92899.08
4574184-57418497.57198.71
5565419-56541996.08297.21
6583469-58346999.149100.31
拉莫三嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
111.055861845865045869635859725860845863410.07
211.145862145859025860580.04
单位质量响应值RSD%判断
53062.5352608.440.61数据可信
长期24月-供试品溶液-2022101811批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1569293-56929396.68497.501.5196.6897.501.51
2577955-57795598.15598.16
3565799-56579996.09196.09
4581096-58109698.68998.69
5564815-56481595.92495.92
6585572-58557299.44999.45
10min1571838-57183897.11697.981.4797.2898.141.47
2578877-57887798.31298.48
3571050-57105096.98397.14
4584107-58410799.20099.36
5566846-56684696.26996.43
6588785-58878599.995100.16
15min1569393-56939396.70197.701.4397.0298.031.44
2578033-57803398.16998.50
3570356-57035696.86597.19
4580587-58058798.60298.93
5565700-56570096.07496.39
6587597-58759799.793100.13
20min1568963-56896396.62897.691.4597.1198.171.45
2578826-57882698.30398.79
3569601-56960196.73797.22
4582106-58210698.86099.35
5565524-56552496.04496.52
6586201-58620199.556100.05
30min1567712-56771296.41697.451.4697.0698.101.46
2576009-57600997.82598.48
3568478-56847896.54697.19
4581408-58140898.74299.40
5564163-56416395.81396.45
6585132-58513299.374100.04
45min1565705-56570596.07597.211.4196.8898.021.41
2575092-57509297.66998.49
3567633-56763396.40297.21
4578377-57837798.22799.05
5563451-56345195.69296.49
6583980-58398099.179100.01
60min1567212-56721296.33197.331.4097.3098.301.40
2575216-57521697.69098.67
3567878-56787896.44497.41
4580588-58058898.60399.59
5563849-56384995.76096.72
6583744-58374499.139100.13
极限1565170-56517095.98497.231.4797.1198.371.47
2574380-57438097.54898.69
3567491-56749196.37897.51
4579784-57978498.46699.62
5563877-56387795.76496.88
6584340-58434099.240100.40
拉莫三嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
111.055861805863195852305858695853525857900.09
211.145835275841455838360.08
单位质量响应值RSD%判断
53012.6752408.980.81数据可信
长期24月-供试品溶液-2022101911批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1572409-57240997.44598.050.9197.4498.050.91
2583106-58310699.26699.27
3576501-57650198.14198.14
4581212-58121298.94398.94
5571999-57199997.37597.37
6570723-57072397.15897.16
10min1572159-57215997.40298.801.1297.5698.961.12
2586456-58645699.836100.00
3583759-58375999.37799.54
4587411-58741199.999100.16
5578359-57835998.45898.62
6574106-57410697.73497.90
15min1570412-57041297.10598.791.1297.4399.121.12
2586030-58603099.764100.10
3583393-58339399.31599.64
4586623-58662399.865100.20
5580376-58037698.80199.13
6574907-57490797.87098.19
20min1569468-56946896.94498.541.1597.4399.041.15
2585118-58511899.608100.11
3582881-58288199.22799.72
4585271-58527199.634100.13
5577300-57730098.27798.77
6573117-57311797.56598.05
30min1568921-56892196.85198.411.1397.5099.071.12
2584507-58450799.504100.17
3581425-58142598.98099.64
4584719-58471999.540100.20
5575928-57592898.04498.70
6573103-57310397.56398.21
45min1565994-56599496.35398.101.1997.1698.921.19
2582506-58250699.16499.99
3578904-57890498.55099.38
4583366-58336699.310100.14
5575844-57584498.03098.85
6570831-57083197.17697.99
60min1566436-56643696.42897.891.1197.4098.881.11
2580443-58044398.81299.81
3577842-57784298.37099.36
4582020-58202099.081100.08
5574897-57489797.86898.85
6568557-56855796.78997.76
极限1564459-56445996.09197.671.1197.2298.821.11
2578515-57851598.48499.64
3576323-57632398.11199.26
4581378-58137898.972100.13
5573281-57328197.59398.74
6568427-56842796.76797.90
拉莫三嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
111.051167308116769611685271167100116709011675440.06
211.141162134116381811629760.11
单位质量响应值RSD%判断
105660.09104396.410.86数据可信
长期24月-供试品溶液-2022102011批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11169708-116970899.93799.530.6399.9499.530.63
21169962-116996299.95899.96
31168834-116883499.86299.86
41169663-116966399.93399.93
51153474-115347498.55098.55
61158263-115826398.95998.96
10min11190103-1190103101.679100.640.90101.85100.810.90
21187024-1187024101.416101.58
31178970-1178970100.728100.89
41178418-1178418100.681100.85
51160674-116067499.16599.33
61172478-1172478100.173100.34
15min11188833-1188833101.571100.560.93101.91100.900.93
21187670-1187670101.471101.81
31178341-1178341100.674101.01
41177406-1177406100.594100.93
51160279-116027999.13199.46
61169689-116968999.935100.27
20min11186622-1186622101.382100.450.93101.89100.950.93
21187185-1187185101.430101.93
31176256-1176256100.496101.00
41174117-1174117100.313100.82
51157646-115764698.90699.40
61172455-1172455100.171100.67
30min11185080-1185080101.250100.180.95101.92100.850.95
21183951-1183951101.154101.83
31172307-1172307100.159100.83
41170468-1170468100.002100.67
51154921-115492198.67399.33
61168934-116893499.871100.54
45min11185019-1185019101.245100.040.97102.09100.880.97
21181788-1181788100.969101.81
31170346-117034699.991100.83
41170302-117030299.987100.82
51154633-115463398.64999.47
61163494-116349499.406100.24
60min11178240-1178240100.66699.690.81101.68100.700.81
21175893-1175893100.465101.48
31167273-116727399.729100.73
41165187-116518799.550100.55
51152885-115288598.49999.49
61161713-116171399.254100.25
极限11173338-1173338100.24799.420.91101.43100.590.91
21175260-1175260100.411101.59
31161844-116184499.265100.43
41162977-116297799.362100.53
51145631-114563197.88099.03
61163090-116309099.371100.53
拉莫三嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
111.051169311116986011691541170212117000311697080.04
211.141169858117230711710820.15
单位质量响应值RSD%判断
105855.93105124.060.50数据可信
长期24月-供试品溶液-2022102111批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11157194-115719498.43298.721.0098.4398.721.00
21175008-117500899.94899.95
31168161-116816199.36599.37
41144701-114470197.37097.37
51150819-115081997.89097.89
61167220-116722099.28599.29
10min11189016-1189016101.13999.751.11101.3099.921.11
21181818-1181818100.527100.69
31178054-1178054100.207100.37
41153568-115356898.12498.29
51163012-116301298.92799.09
61170966-117096699.60499.77
15min11188861-1188861101.12699.681.21101.46100.011.21
21184446-1184446100.750101.08
31177806-1177806100.186100.52
41153099-115309998.08498.41
51160015-116001598.67299.00
61166812-116681299.25099.58
20min11187521-1187521101.01299.501.13101.51100.001.13
21178396-1178396100.236100.74
31175219-117521999.966100.47
41152413-115241398.02698.51
51157695-115769598.47598.97
61167372-116737299.29899.79
30min11184695-1184695100.77299.321.12101.4499.981.11
21175062-117506299.952100.62
31174197-117419799.879100.54
41149905-114990597.81298.47
51155864-115586498.31998.98
61166088-116608899.18999.85
45min11185193-1185193100.81499.091.28101.6599.921.28
21175174-117517499.962100.80
31171906-117190699.684100.52
41147036-114703697.56898.38
51151753-115175397.97098.79
61158410-115841098.53699.36
60min11182011-1182011100.54398.951.18101.5599.941.18
21172846-117284699.764100.77
31167321-116732199.294100.29
41145128-114512897.40698.38
51151673-115167397.96398.95
61160680-116068098.72999.72
极限11180230-1180230100.39298.751.19101.5699.911.19
21169210-116921099.454100.62
31166914-116691499.259100.42
41142612-114261297.19298.33
51149752-114975297.79998.95
61156974-115697498.41499.57
拉莫三嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
111.051170339117054011700341169141117079911701710.06
211.141168061117020311691320.13
单位质量响应值RSD%判断
105897.83104949.010.64数据可信
长期24月-供试品溶液-2022102211批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11132294-113229496.37697.841.1696.3897.851.16
21142865-114286597.27697.28
31153331-115333198.16798.17
41161701-116170198.87998.88
51140395-114039597.06597.07
61166590-116659099.29599.30
10min11148730-114873097.77598.760.8097.9498.920.80
21151259-115125997.99098.15
31165309-116530999.18699.35
41168099-116809999.42399.59
51157251-115725198.50098.66
61171098-117109899.67999.84
15min11148987-114898797.79798.700.8698.1299.020.86
21147370-114737097.65997.98
31164416-116441699.11099.44
41166502-116650299.28899.62
51157757-115775798.54398.87
61172209-117220999.773100.10
20min11142187-114218797.21898.511.0097.7099.001.00
21144760-114476097.43797.93
31163932-116393299.06999.56
41165535-116553599.20599.70
51157810-115781098.54899.04
61170130-117013099.596100.09
30min11146125-114612597.55398.260.8398.2098.920.84
21141880-114188097.19297.84
31160155-116015598.74799.41
41158977-115897798.64799.31
51152099-115209998.06298.72
61167581-116758199.379100.04
45min11143978-114397897.37098.180.8598.1899.000.85
21140848-114084897.10497.92
31157429-115742998.51599.34
41159826-115982698.71999.55
51152558-115255898.10198.92
61166460-116646099.284100.11
60min11147708-114770897.68898.370.8298.6699.350.82
21142755-114275597.26698.24
31163635-116363599.044100.03
41160176-116017698.74999.74
51153078-115307898.14599.13
61166989-116698999.329100.32
极限11142914-114291497.28098.080.7598.4299.230.75
21141479-114147997.15898.29
31155709-115570998.36999.52
41157237-115723798.49999.65
51152903-115290398.13099.28
61163611-116361199.041100.20
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