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2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
112.23 3880813876893878313872303875753876810.09
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%
5min1403871-40387196.96199.341.6396.9699.341.63
2414904-41490499.61099.61
3410632-41063298.58498.58
4412932-41293299.13699.14
5416009-41600999.87599.88
6424336-424336101.874101.87
10min1410740-41074098.610100.511.3098.77100.681.31
2420526-420526100.960101.13
3415922-41592299.854100.02
4417334-417334100.193100.36
5420506-420506100.955101.12
6426971-426971102.507102.68
15min1419019-419019100.598100.551.23100.92100.881.23
2417487-417487100.230100.56
3414168-41416899.43399.76
4416049-41604999.885100.22
5417342-417342100.195100.53
6428762-428762102.937103.28
20min1407373-40737397.802100.151.5398.30100.651.52
2416358-41635899.959100.46
3415367-41536799.721100.22
4418069-418069100.370100.87
5418679-418679100.516101.02
6427098-427098102.537103.05
30min1409276-40927698.259100.361.6398.92101.031.62
2415681-41568199.796100.46
3427353-427353102.599103.26
4414663-41466399.552100.22
5416325-41632599.951100.62
6424856-424856101.999102.68
45min1406268-40626897.53799.701.4298.36100.531.41
2416643-416643100.027100.86
3413015-41301599.15699.99
4415107-41510799.659100.49
5416164-41616499.912100.75
6424401-424401101.890102.74
60min1405422-40542297.33399.711.6098.32100.711.60
2416087-41608799.894100.89
3412653-41265399.069100.07
4414948-41494899.620100.62
5416985-416985100.109101.11
6425868-425868102.242103.27
极限1405306-40530697.30699.101.3598.45100.271.35
2413677-41367799.315100.48
3409169-40916998.23399.40
4412908-41290899.131100.29
5413751-41375199.333100.50
6421970-421970101.306102.50
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2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
112.23 7801277748167730837727697734667748520.40
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%
5min1833221-83322199.91199.341.5999.9199.341.59
2834458-834458100.059100.06
3813701-81370197.57097.57
4824463-82446398.86198.86
5815957-81595797.84197.84
6848731-848731101.770101.77
10min1842199-842199100.987100.591.54101.15100.751.54
2846810-846810101.540101.71
3825626-82562699.00099.16
4832035-83203599.76899.93
5827469-82746999.22199.38
6858959-858959102.997103.17
15min1849607-849607101.876100.731.51102.21101.061.51
2845978-845978101.440101.78
3824438-82443898.85899.19
4834509-834509100.065100.40
5829009-82900999.40699.73
6856785-856785102.736103.08
20min1838544-838544100.549100.231.58101.05100.731.58
2844988-844988101.322101.83
3823542-82354298.75099.24
4829421-82942199.45599.95
5822659-82265998.64499.14
6856085-856085102.652103.16
30min1838475-838475100.541100.071.57101.21100.731.57
2843453-843453101.138101.81
3821301-82130198.48199.14
4827553-82755399.23199.89
5822229-82222998.59399.25
6854078-854078102.412103.10
45min1839386-839386100.650100.131.66101.49100.971.66
2843676-843676101.164102.01
3819735-81973598.29499.11
4827804-82780499.261100.09
5823639-82363998.76299.58
6856184-856184102.664103.52
60min1837633-837633100.44099.961.62101.45100.961.61
2842811-842811101.061102.07
3820087-82008798.33699.32
4828015-82801599.286100.28
5819875-81987598.31099.30
6853546-853546102.348103.37
极限1834821-834821100.10399.621.58101.28100.791.58
2839144-839144100.621101.80
3816852-81685297.94899.10
4824090-82409098.81699.98
5819195-81919598.22999.38
6850689-850689102.005103.20
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2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
112.23 3851053845973855533844093840813847490.16
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%
5min1420645-420645101.528102.291.93101.53102.291.93
2418834-418834101.090101.09
3438840-438840105.919105.92
4418881-418881101.102101.10
5427614-427614103.210103.21
6417954-417954100.878100.88
10min1426274-426274102.886103.921.91103.06104.101.91
2436961-436961105.466105.63
3444230-444230107.220107.40
4424722-424722102.512102.68
5427640-427640103.216103.39
6423615-423615102.244102.41
15min1426091-426091102.842103.371.83103.18103.721.83
2424919-424919102.559102.90
3443849-443849107.128107.48
4424468-424468102.450102.79
5427800-427800103.255103.60
6422588-422588101.997102.34
20min1424275-424275102.404103.341.86102.92103.851.86
2429705-429705103.714104.23
3443348-443348107.007107.54
4423565-423565102.232102.74
5426428-426428102.923103.44
6421540-421540101.744102.25
30min1423661-423661102.256103.021.82102.94103.711.83
2423094-423094102.119102.81
3442257-442257106.744107.46
4424949-424949102.566103.25
5426201-426201102.869103.56
6420844-420844101.576102.25
45min1423906-423906102.315103.081.77103.17103.941.77
2423995-423995102.336103.19
3442184-442184106.726107.62
4421432-421432101.718102.57
5426073-426073102.838103.70
6424980-424980102.574103.42
60min1424955-424955102.568102.721.73103.59103.751.73
2422452-422452101.964102.99
3440258-440258106.261107.33
4421716-421716101.786102.81
5423623-423623102.246103.28
6420550-420550101.505102.52
极限1420723-420723101.546102.551.85102.74103.751.85
2420168-420168101.412102.61
3438852-438852105.922107.17
4429223-429223103.598104.79
5422308-422308101.929103.13
6418001-418001100.889102.08
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2.0对照品来源中检所对照品使用方法直接使用
对照品含量(%)90.50对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
112.23 7728197728077737997717007722297726710.11
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%
5min1830807-83080799.840100.861.1599.84100.861.15
2844420-844420101.476101.48
3848396-848396101.954101.95
4850500-850500102.207102.21
5828891-82889199.61099.61
6832600-832600100.055100.06
10min1832220-832220100.010101.981.47100.18102.151.46
2856564-856564102.935103.10
3859100-859100103.240103.41
4862503-862503103.649103.82
5839019-839019100.827100.99
6842206-842206101.210101.38
15min1833373-833373100.148102.091.61100.48102.431.61
2860880-860880103.454103.79
3862240-862240103.617103.96
4862174-862174103.609103.95
5836553-836553100.530100.86
6842124-842124101.200101.54
20min1830479-83047999.801101.631.52100.30102.141.52
2853265-853265102.539103.05
3857903-857903103.096103.61
4859800-859800103.324103.84
5834513-834513100.285100.79
6838269-838269100.737101.24
30min1830225-83022599.770101.501.41100.44102.181.41
2851221-851221102.293102.98
3856737-856737102.956103.64
4857006-857006102.988103.68
5833384-833384100.150100.82
6839091-839091100.835101.51
45min1826333-82633399.302101.231.49100.13102.081.49
2847682-847682101.868102.72
3854202-854202102.651103.51
4857291-857291103.023103.88
5832326-832326100.023100.86
6836420-836420100.514101.35
60min1824583-82458399.092101.001.47100.09102.021.47
2846464-846464101.721102.75
3852069-852069102.395103.42
4854696-854696102.711103.74
5830435-83043599.795100.80
6834765-834765100.316101.32
极限1823128-82312898.917100.841.40100.08102.021.40
2845297-845297101.581102.78
3848907-848907102.015103.21
4852960-852960102.502103.70
5830489-83048999.802100.97
6834047-834047100.229101.40
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