替米沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所对照品使用方法干燥2小时
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.125010745006005010215006245017815010200.10
211.205009025012325010670.05
单位质量响应值RSD%判断
45055.7644738.120.51数据可信
供试品溶液-F95000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%
5min170102-7010214.05311.4120.9014.0511.4120.91
262252-6225212.47912.48
339480-394807.9147.91
452996-5299610.62410.62
567865-6786513.60413.60
648812-488129.7859.78
10min1129979-12997926.05623.0311.1526.1323.1011.17
2115197-11519723.09323.16
395804-9580419.20519.25
4106020-10602021.25321.31
5127088-12708825.47625.55
6115355-11535523.12423.18
15min1182554-18255436.59532.5211.8636.8232.7111.86
2163877-16387732.85133.05
3137066-13706627.47627.63
4140952-14095228.25528.43
5179360-17936035.95536.17
6169479-16947933.97434.16
20min1219247-21924743.95140.307.7144.3840.677.75
2206031-20603141.30141.68
3173253-17325334.73135.03
4196353-19635339.36139.70
5207270-20727041.55041.97
6204085-20408540.91141.28
30min1257184-25718451.55650.486.4552.2351.086.48
2266059-26605953.33553.94
3222740-22274044.65145.15
4252004-25200450.51751.07
5266416-26641653.40654.05
6246491-24649149.41250.01
45min1339146-33914667.98662.968.0568.9463.848.01
2341397-34139768.43769.34
3277298-27729855.58856.33
4323293-32329364.80865.64
5295638-29563859.26460.21
6307779-30777961.69862.57
60min1369453-36945374.06172.814.0075.4074.043.99
2379107-37910775.99677.28
3353030-35303070.76971.82
4376996-37699675.57376.77
5358599-35859971.88573.16
6342141-34214168.58669.80
90min1422118-42211884.61885.213.4186.3686.843.39
2442695-44269588.74390.45
3419499-41949984.09385.54
4430999-43099986.39988.01
5434068-43406887.01488.69
6401016-40101680.38881.99
120min1412026-41202682.59588.844.8584.8190.944.69
2469807-46980794.17896.38
3462470-46247092.70794.62
4447251-44725189.65791.75
5439048-43904888.01290.17
6428496-42849685.89787.94
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1461854-46185492.58491.624.4995.2694.224.39
2476970-47697095.61498.34
3475204-47520495.26097.69
4435737-43573787.34989.94
5464425-46442593.09995.74
6428075-42807585.81388.33
替米沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所对照品使用方法干燥2小时
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.124994555001995005224995754990954997690.12
211.205030555032135031340.03
单位质量响应值RSD%判断
44943.2644922.680.04数据可信
供试品溶液-F95000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%
5min166852-6685213.39011.6112.0713.3911.6112.05
251502-5150210.31610.32
356742-5674211.36511.37
460509-6050912.12012.12
548712-487129.7579.76
663463-6346312.71212.71
10min1120737-12073724.18322.086.3524.2622.146.37
2102303-10230320.49120.55
3109978-10997822.02822.09
4112469-11246922.52722.59
5102640-10264020.55920.61
6113226-11322622.67922.75
15min1174927-17492735.03831.196.6635.2531.386.67
2153194-15319430.68530.86
3153028-15302830.65130.84
4153985-15398530.84331.04
5143418-14341828.72628.89
6155878-15587831.22231.42
20min1211594-21159442.38239.066.8942.7939.426.88
2198487-19848739.75740.10
3197059-19705939.47139.83
4186451-18645137.34637.71
5173280-17328034.70835.04
6203098-20309840.68041.05
30min1289505-28950557.98751.459.2258.6352.039.18
2264058-26405852.89053.45
3265272-26527253.13453.71
4252154-25215450.50651.08
5217173-21717343.49944.02
6252969-25296950.66951.27
45min1347740-34774069.65265.833.9970.6166.703.98
2332549-33254966.60967.47
3314182-31418262.93063.80
4336966-33696667.49468.35
5325736-32573665.24466.01
6314791-31479163.05263.93
60min1366374-36637473.38470.193.2174.7371.423.18
2334328-33432866.96568.19
3347009-34700969.50570.73
4352555-35255570.61671.84
5358244-35824471.75672.88
6344179-34417968.93870.17
90min1442113-44211388.55584.192.8790.3185.812.88
2415775-41577583.27984.88
3414697-41469783.06384.67
4424746-42474685.07686.70
5417386-41738683.60285.13
6407310-40731081.58483.19
120min1458830-45883091.90388.661.9594.1590.741.98
2443605-44360588.85390.91
3434603-43460387.05089.12
4439343-43934388.00090.09
5442231-44223188.57890.57
6437112-43711287.55389.62
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1446995-44699589.53288.862.6392.2991.442.56
2431600-43160086.44989.00
3428369-42836985.80288.35
4443815-44381588.89591.48
5454010-45401090.93793.42
6457108-45710891.55894.11
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