盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.233880813876893878313872303875753876810.09
212.283861173861833861500.02
单位质量响应值RSD%判断
31699.1831445.440.57数据可信
供试品溶液-BXJVV61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%
5min1403871-40387196.55498.921.6396.5598.921.63
2414904-41490499.19299.19
3410632-41063298.17098.17
4412932-41293298.72098.72
5416009-41600999.45699.46
6424336-424336101.447101.45
10min1410740-41074098.196100.091.3098.36100.261.31
2420526-420526100.536100.70
3415922-41592299.43599.60
4417334-41733499.77399.94
5420506-420506100.531100.70
6426971-426971102.076102.25
15min1419019-419019100.175100.121.23100.50100.461.23
2417487-41748799.809100.14
3414168-41416899.01699.35
4416049-41604999.46599.80
5417342-41734299.774100.11
6428762-428762102.505102.84
20min1407373-40737397.39199.731.5397.88100.231.53
2416358-41635899.539100.04
3415367-41536799.30299.80
4418069-41806999.948100.44
5418679-418679100.094100.59
6427098-427098102.107102.62
30min1409276-40927697.84699.941.6398.50100.601.62
2415681-41568199.377100.04
3427353-427353102.168102.83
4414663-41466399.13499.80
5416325-41632599.531100.20
6424856-424856101.571102.25
45min1406268-40626897.12799.281.4297.94100.111.42
2416643-41664399.607100.44
3413015-41301598.74099.57
4415107-41510799.240100.07
5416164-41616499.493100.33
6424401-424401101.462102.31
60min1405422-40542296.92599.291.6097.90100.291.60
2416087-41608799.474100.47
3412653-41265398.65399.65
4414948-41494899.202100.20
5416985-41698599.689100.69
6425868-425868101.813102.83
极限1405306-40530696.89798.691.3598.0499.851.35
2413677-41367798.898100.06
3409169-40916997.82198.98
4412908-41290898.71499.87
5413751-41375198.916100.08
6421970-421970100.881102.07
盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.237801277748167730837727697734667748520.40
212.287747917741797744850.06
单位质量响应值RSD%判断
63356.6663068.810.33数据可信
供试品溶液-BXJX091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%
5min1833221-83322199.49198.921.5999.4998.921.59
2834458-83445899.63999.64
3813701-81370197.16097.16
4824463-82446398.44598.45
5815957-81595797.43097.43
6848731-848731101.343101.34
10min1842199-842199100.563100.161.54100.73100.331.54
2846810-846810101.114101.28
3825626-82562698.58498.75
4832035-83203599.35099.51
5827469-82746998.80498.97
6858959-858959102.564102.73
15min1849607-849607101.448100.311.51101.78100.641.51
2845978-845978101.014101.35
3824438-82443898.44298.77
4834509-83450999.64599.97
5829009-82900998.98899.32
6856785-856785102.305102.64
20min1838544-838544100.12799.811.58100.63100.311.58
2844988-844988100.896101.40
3823542-82354298.33598.83
4829421-82942199.03799.53
5822659-82265998.23098.72
6856085-856085102.221102.73
30min1838475-838475100.11999.651.57100.79100.311.57
2843453-843453100.713101.38
3821301-82130198.06898.72
4827553-82755398.81499.48
5822229-82222998.17998.83
6854078-854078101.982102.66
45min1839386-839386100.22799.711.66101.06100.541.66
2843676-843676100.740101.58
3819735-81973597.88198.70
4827804-82780498.84499.67
5823639-82363998.34799.17
6856184-856184102.233103.08
60min1837633-837633100.01899.541.62101.02100.541.62
2842811-842811100.636101.64
3820087-82008797.92398.90
4828015-82801598.87099.86
5819875-81987597.89898.88
6853546-853546101.918102.94
极限1834821-83482199.68299.201.58100.85100.361.58
2839144-839144100.198101.37
3816852-81685297.53798.68
4824090-82409098.40199.56
5819195-81919597.81698.96
6850689-850689101.577102.77
盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.233851053845973855533844093840813847490.16
212.283852493846783849640.11
单位质量响应值RSD%判断
31459.4431348.860.25数据可信
供试品溶液-2024072521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%
5min1420645-420645101.101101.861.93101.10101.861.93
2418834-418834100.666100.67
3438840-438840105.474105.47
4418881-418881100.677100.68
5427614-427614102.776102.78
6417954-417954100.455100.45
10min1426274-426274102.454103.491.91102.62103.661.91
2436961-436961105.023105.19
3444230-444230106.770106.95
4424722-424722102.081102.25
5427640-427640102.783102.95
6423615-423615101.815101.98
15min1426091-426091102.410102.941.83102.75103.281.83
2424919-424919102.129102.47
3443849-443849106.678107.03
4424468-424468102.020102.36
5427800-427800102.821103.16
6422588-422588101.568101.91
20min1424275-424275101.974102.901.86102.48103.421.86
2429705-429705103.279103.79
3443348-443348106.558107.09
4423565-423565101.803102.31
5426428-426428102.491103.01
6421540-421540101.316101.82
30min1423661-423661101.826102.591.83102.51103.271.82
2423094-423094101.690102.38
3442257-442257106.296107.00
4424949-424949102.136102.81
5426201-426201102.437103.12
6420844-420844101.149101.82
45min1423906-423906101.885102.651.77102.73103.511.77
2423995-423995101.906102.76
3442184-442184106.278107.16
4421432-421432101.290102.14
5426073-426073102.406103.26
6424980-424980102.143102.99
60min1424955-424955102.137102.291.73103.16103.321.73
2422452-422452101.536102.56
3440258-440258105.815106.88
4421716-421716101.359102.38
5423623-423623101.817102.84
6420550-420550101.078102.09
极限1420723-420723101.120102.121.85102.31103.321.85
2420168-420168100.987102.18
3438852-438852105.477106.72
4429223-429223103.163104.35
5422308-422308101.501102.70
6418001-418001100.466101.65
盐酸伐地那非片项目信息
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D23106010771对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.12对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.9306
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.237728197728077737997717007722297726710.11
212.287735747729677732700.06
单位质量响应值RSD%判断
63178.3362969.870.24数据可信
供试品溶液-2024073021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%
5min1830807-83080799.421100.431.1599.42100.441.15
2844420-844420101.050101.05
3848396-848396101.526101.53
4850500-850500101.777101.78
5828891-82889199.19199.19
6832600-83260099.63599.64
10min1832220-83222099.590101.551.4799.76101.721.46
2856564-856564102.503102.67
3859100-859100102.807102.98
4862503-862503103.214103.38
5839019-839019100.403100.57
6842206-842206100.785100.95
15min1833373-83337399.728101.661.61100.06102.001.61
2860880-860880103.020103.36
3862240-862240103.182103.52
4862174-862174103.174103.52
5836553-836553100.108100.44
6842124-842124100.775101.11
20min1830479-83047999.381101.201.5299.88101.711.52
2853265-853265102.108102.62
3857903-857903102.663103.18
4859800-859800102.890103.40
5834513-83451399.864100.36
6838269-838269100.314100.82
30min1830225-83022599.351101.071.41100.01101.751.41
2851221-851221101.864102.54
3856737-856737102.524103.21
4857006-857006102.556103.24
5833384-83338499.729100.40
6839091-839091100.412101.08
45min1826333-82633398.885100.801.4999.71101.651.49
2847682-847682101.440102.29
3854202-854202102.220103.07
4857291-857291102.590103.45
5832326-83232699.603100.43
6836420-836420100.092100.93
60min1824583-82458398.676100.581.4799.67101.591.47
2846464-846464101.294102.31
3852069-852069101.965102.99
4854696-854696102.279103.31
5830435-83043599.376100.37
6834765-83476599.894100.90
极限1823128-82312898.502100.421.4099.66101.601.40
2845297-845297101.155102.34
3848907-848907101.587102.78
4852960-852960102.072103.27
5830489-83048999.383100.55
6834047-83404799.808100.98
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