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%
11185352805339335317165355565337675340500.29
2117.85338845343065340950.06
单位质量响应值RSD%判断
4525.854533.910.13数据可信
供试品溶液-25072901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%
5min1415498-41549881.23178.972.3481.2378.962.34
2403008-40300878.78978.79
3388372-38837275.92875.93
4405360-40536079.24979.25
5400122-40012278.22578.22
6411093-41109380.37080.37
10min1446142-44614287.22285.341.6587.3685.471.66
2435491-43549185.13985.27
3425771-42577183.23983.37
4439040-43904085.83385.97
5431614-43161484.38184.51
6440929-44092986.20386.34
15min1457401-45740189.42387.471.7189.7087.741.71
2447076-44707687.40487.68
3436929-43692985.42085.69
4446192-44619287.23187.51
5442184-44218486.44886.72
6454646-45464688.88489.16
20min1461262-46126290.17888.441.7090.6188.861.70
2451996-45199688.36688.79
3441772-44177286.36786.77
4451894-45189488.34688.77
5446649-44664987.32187.74
6460680-46068090.06490.49
30min1469645-46964591.81789.921.4992.4090.481.49
2459221-45922189.77990.34
3452303-45230388.42688.98
4460614-46061490.05190.62
5452656-45265688.49589.06
6465101-46510190.92891.50
45min1477511-47751193.35491.331.4394.0992.051.43
2464652-46465290.84091.56
3458535-45853589.64590.34
4469561-46956191.80092.52
5462732-46273290.46591.17
6469989-46998991.88492.61
60min1481474-48147494.12991.732.2195.0292.602.20
2472585-47258592.39193.26
3463249-46324990.56691.41
4476351-47635193.12894.00
5452339-45233988.43389.29
6469226-46922691.73592.62
极限1481274-48127494.09092.821.3095.1493.851.31
2472593-47259392.39393.41
3464938-46493890.89691.90
4478889-47888993.62494.65
5471778-47177892.23493.24
6479331-47933193.71094.74
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%
11185376305370625372955375075335915366170.32
2117.85375925343315359620.44
单位质量响应值RSD%判断
4547.604549.760.04数据可信
供试品溶液-25073101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%
5min1436876-43687685.05784.611.3185.0684.601.32
2425358-42535882.81582.81
3430476-43047683.81183.81
4440235-44023585.71185.71
5439318-43931885.53285.53
6435117-43511784.71584.71
10min1463956-46395690.32990.081.4690.4790.221.46
2454285-45428588.44688.58
3459314-45931489.42689.57
4473193-47319392.12892.27
5466700-46670090.86491.01
6458664-45866489.29989.44
15min1473661-47366192.21991.361.7192.5191.651.70
2461918-46191889.93390.22
3465035-46503590.53990.83
4482282-48228293.89794.19
5470755-47075591.65391.95
6461815-46181589.91390.20
20min1477053-47705392.87992.081.2393.3392.531.23
2465946-46594690.71791.15
3471157-47115791.73192.17
4481961-48196193.83594.29
5472938-47293892.07892.52
6468731-46873191.25991.70
30min1479364-47936493.32992.651.1893.9393.241.18
2468457-46845791.20691.79
3475083-47508392.49693.09
4484364-48436494.30394.91
5476109-47610992.69593.30
6471740-47174091.84592.44
45min1481663-48166393.77793.141.2494.5393.891.24
2469387-46938791.38792.13
3475926-47592692.66093.41
4486476-48647694.71495.48
5480905-48090593.62994.38
6475869-47586992.64993.39
60min1481976-48197693.83893.331.0694.7594.231.06
2472264-47226491.94792.84
3479926-47992693.43994.34
4487167-48716794.84895.77
5477956-47795693.05593.97
6476815-47681592.83393.73
极限1484679-48467994.36493.391.0795.4394.451.07
2471361-47136191.77192.82
3480561-48056193.56294.62
4485135-48513594.45395.54
5478538-47853893.16894.23
6477687-47768793.00394.06
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