替普瑞酮颗粒项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
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%
1 111.45379195366395403845385665361625379340.32
2 110.25377825397395387600.26
单位质量响应值RSD%判断
4828.854888.930.88数据可信
供试品溶液-1批-pH6.8(内含2%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1430173-43017378.40884.974.3778.4184.974.37
2465606-46560684.86684.87
3465383-46538384.82684.83
4476284-47628486.81386.81
5467417-46741785.19685.20
6492027-49202789.68289.68
10min1484670-48467088.34189.721.7188.4789.861.71
2493384-49338489.93090.07
3500543-50054391.23491.38
4489175-48917589.16289.31
5482512-48251287.94888.09
6503221-50322191.72391.87
15min1493191-49319189.89490.651.6190.1790.941.61
2498211-49821190.80991.10
3505726-50572692.17992.47
4491550-49155089.59589.89
5487693-48769388.89289.18
6507572-50757292.51692.82
20min1495211-49521190.26391.121.5890.6991.561.58
2501951-50195191.49191.93
3507791-50779192.55593.00
4495268-49526890.27390.72
5489595-48959589.23989.68
6509685-50968592.90193.36
30min1498580-49858090.87791.541.4991.4592.141.49
2502178-50217891.53292.13
3510112-51011292.97993.58
4498459-49845990.85591.45
5492326-49232689.73790.32
6511697-51169793.26793.88
45min1501227-50122791.35991.881.6692.0992.631.66
2504241-50424191.90892.66
3512749-51274993.45994.22
4499417-49941791.02991.77
5492444-49244489.75890.49
6514436-51443693.76794.53
60min1502258-50225891.54791.931.7192.4392.831.71
2504965-50496592.04092.94
3512575-51257593.42794.34
4499710-49971091.08391.98
5491603-49160389.60590.49
6514974-51497493.86594.79
极限1502959-50295991.67592.081.7492.7193.141.74
2506630-50663092.34493.40
3512999-51299993.50594.57
4499346-49934691.01692.06
5492810-49281089.82590.86
6516504-51650494.14495.22
替普瑞酮颗粒项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
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%
1 111.45389855402555397875401395399925398320.10
2 110.25432945428045430490.07
单位质量响应值RSD%判断
4845.894927.851.19数据可信
供试品溶液-25062401批-pH6.8(内含2%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1496522-49652289.98690.101.1289.9990.101.12
2493538-49353889.44589.45
3501619-50161990.91090.91
4505920-50592091.68991.69
5491486-49148689.07489.07
6493890-49389089.50989.51
10min1507741-50774192.01992.601.1292.1792.761.12
2510218-51021892.46892.62
3517455-51745593.78093.93
4518214-51821493.91894.07
5508149-50814992.09392.24
6504043-50404391.34991.50
15min1508274-50827492.11692.951.2892.4293.261.28
2515202-51520293.37293.67
3519345-51934594.12294.43
4520546-52054694.34094.65
5509806-50980692.39492.70
6504147-50414791.36891.67
20min1508351-50835192.13092.871.1892.5993.331.18
2513578-51357893.07793.54
3517657-51765793.81794.28
4520644-52064494.35894.82
5509712-50971292.37792.83
6504592-50459291.44991.90
30min1509570-50957092.35193.011.1592.9693.631.15
2513394-51339493.04493.66
3517943-51794393.86894.49
4521303-52130394.47795.10
5512198-51219892.82793.44
6504886-50488691.50292.11
45min1508382-50838292.13693.181.2492.9093.951.24
2512220-51222092.83193.60
3519241-51924194.10494.88
4520427-52042794.31995.10
5519199-51919994.09694.86
6505531-50553191.61992.38
60min1507931-50793192.05492.811.2892.9793.731.28
2511484-51148492.69893.62
3518073-51807393.89294.83
4521042-52104294.43095.37
5510788-51078892.57293.49
6503191-50319191.19592.11
极限1508111-50811192.08792.731.2793.1693.801.27
2511436-51143692.68993.77
3517750-51775093.83394.92
4520046-52004694.25095.35
5510077-51007792.44393.52
6502388-50238891.04992.11
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