氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304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125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.221500144150345414950851496666150695315004600.33
211.151506372149918915027800.34
单位质量响应值RSD%判断
133730.84134778.480.56数据可信
供试品溶液-2024041821批-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%
60min178833-788335.4246.9712.315.426.9712.33
2104867-1048677.2157.21
3102664-1026647.0637.06
4114059-1140597.8477.85
597363-973636.6996.70
6110213-1102137.5837.58
120min1168092-16809211.56514.3811.3911.5714.3911.41
2207082-20708214.24714.26
3201198-20119813.84313.85
4227991-22799115.68615.70
5214400-21440014.75114.76
6235562-23556216.20716.22
240min1327282-32728222.51727.469.9222.5427.499.93
2404097-40409727.80227.83
3384412-38441226.44826.48
4420205-42020528.91028.95
5420103-42010328.90328.94
6438428-43842830.16430.20
360min1477182-47718232.83140.359.8132.8940.429.81
2616598-61659842.42242.50
3582083-58208340.04840.12
4586404-58640440.34540.42
5620043-62004342.65942.73
6636810-63681043.81343.89
480min1631941-63194143.47852.379.0243.5952.519.01
2808037-80803755.59455.73
3766710-76671052.75052.88
4745787-74578751.31151.45
5801398-80139855.13755.28
6813496-81349655.96956.12
600min1799393-79939354.99963.827.4155.1764.037.42
2971720-97172066.85567.08
3935993-93599364.39764.61
4906229-90622962.34962.57
5978286-97828667.30767.53
6973834-97383467.00167.23
720min1985891-98589167.83074.795.4468.0975.105.44
21136742-113674278.20978.53
31098434-109843475.57375.88
41051535-105153572.34672.66
51140012-114001278.43478.76
61110053-111005376.37376.70
840min11166318-116631880.24485.574.5080.6085.994.51
21305019-130501989.78690.22
31255552-125555286.38386.80
41193180-119318082.09282.51
51300206-130020689.45589.90
61242020-124202085.45285.90
960min11357076-135707693.36899.154.7293.8599.704.73
21534647-1534647105.585106.16
31461595-1461595100.559101.11
41367054-136705494.05494.60
51477771-1477771101.672102.25
61448836-144883699.681100.25
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1080min11520908-1520908104.640103.500.59105.26104.200.55
21506019-1506019103.615104.35
31501524-1501524103.306104.01
41498745-1498745103.115103.80
51496078-1496078102.931103.66
61503071-1503071103.413104.14
1200min11513571-1513571104.135103.370.51104.91104.220.48
21502573-1502573103.378104.27
31499740-1499740103.183104.04
41493671-1493671102.766103.60
51496379-1496379102.952103.83
61508632-1508632103.795104.67
1320min11517354-1517354104.395103.340.62105.33104.340.59
21498053-1498053103.067104.11
31497267-1497267103.013104.02
41491702-1491702102.630103.62
51499520-1499520103.168104.20
61508003-1508003103.752104.79
1440min11508646-1508646103.796102.950.60104.88104.110.57
21485654-1485654102.214103.41
31503990-1503990103.476104.64
41490624-1490624102.556103.70
51490120-1490120102.521103.71
61498912-1498912103.126104.32
极限11499879-1499879103.193102.610.51104.44103.930.50
21484838-1484838102.158103.51
31488711-1488711102.425103.74
41482953-1482953102.028103.33
51490918-1490918102.576103.92
61501079-1501079103.275104.62
氟伐他汀钠缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100800-202304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125
标示量(mg)80供试品稀释倍数1系数0.9493
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.221503895150581914967841494777149265614987860.39
211.151501267150061515009410.04
单位质量响应值RSD%判断
133581.64134613.540.55数据可信
供试品溶液-2024041821批-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%
60min1109464-1094647.5407.337.797.547.337.81
297418-974186.7106.71
3108088-1080887.4457.45
494996-949966.5436.54
5113255-1132557.8017.80
6114919-1149197.9167.92
120min1227102-22710215.64315.455.5815.6515.465.57
2209174-20917414.40814.42
3229638-22963815.81815.83
4209288-20928814.41614.43
5240262-24026216.55016.56
6230332-23033215.86615.88
240min1452800-45280031.18930.503.2431.2230.533.24
2427924-42792429.47629.51
3433446-43344629.85629.89
4447227-44722730.80630.84
5464252-46425231.97832.01
6430987-43098729.68729.72
360min1680938-68093846.90445.134.5846.9945.204.57
2621361-62136142.80042.88
3630676-63067643.44243.52
4668281-66828146.03246.11
5694091-69409147.81047.89
6635354-63535443.76443.84
480min1883630-88363060.86659.133.8261.0259.283.82
2845797-84579758.26058.40
3815056-81505656.14256.29
4888807-88880761.22261.37
5888286-88828661.18661.34
6828930-82893057.09857.24
600min11061551-106155173.12171.503.7673.3671.743.76
21040823-104082371.69371.92
3974363-97436367.11567.34
41071446-107144673.80374.04
51070627-107062773.74673.99
61009557-100955769.54069.77
720min11225535-122553584.41782.283.5684.7782.623.55
21197794-119779482.50682.84
31116576-111657676.91177.24
41220416-122041684.06484.41
51227050-122705084.52184.88
61179868-117986881.27181.61
840min11388727-138872795.65792.643.3596.1493.113.35
21356047-135604793.40693.87
31266046-126604687.20787.65
41360117-136011793.68794.16
51377812-137781294.90695.39
61321139-132113991.00291.46
960min11490818-1490818102.690101.482.14103.31102.082.15
21471419-1471419101.353101.95
31410986-141098697.19197.77
41484759-1484759102.272102.89
51494576-1494576102.948103.58
61486898-1486898102.420103.01
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
1080min11489562-1489562102.603102.760.41103.38103.520.42
21498627-1498627103.227103.98
31490999-1490999102.702103.42
41487870-1487870102.487103.26
51499801-1499801103.308104.09
61484448-1484448102.251103.00
1200min11487232-1487232102.443102.800.57103.37103.710.57
21503689-1503689103.576104.48
31487118-1487118102.435103.31
41484204-1484204102.234103.16
51502490-1502490103.494104.43
61489791-1489791102.619103.52
1320min11494638-1494638102.953103.050.60104.04104.120.60
21504586-1504586103.638104.70
31496018-1496018103.048104.08
41486444-1486444102.388103.46
51507901-1507901103.866104.96
61486564-1486564102.397103.45
1440min11485164-1485164102.300102.380.39103.54103.600.39
21497787-1497787103.170104.39
31485825-1485825102.346103.53
41482698-1482698102.130103.36
51482756-1482756102.134103.38
61483638-1483638102.195103.40
极限11480293-1480293101.965102.220.96103.36103.600.95
21507863-1507863103.864105.24
31477274-1477274101.757103.09
41468323-1468323101.140102.52
51493081-1493081102.845104.25
61477516-1477516101.773103.14
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