盐酸鲁拉西酮口崩片项目信息
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N877-220209对照品来源自制对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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 11.151946551952661950161947191939281947170.26
2 11.181943031955421949220.45
单位质量响应值RSD%判断
17463.4117434.880.12数据可信
供试品溶液-24122701批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1630-6300.3240.20177.820.320.20178.44
21703-17030.8760.88
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min11043-10430.5370.525.230.540.525.96
21064-10640.5470.55
3960-9600.4940.49
4999-9990.5140.51
51062-10620.5460.55
6941-9410.4840.48
15min11260-12600.6480.8763.640.650.8763.25
21280-12800.6580.66
31175-11750.6040.61
43888-38882.0002.00
51257-12570.6470.65
61292-12920.6650.67
20min11207-12070.6210.655.700.620.665.61
21313-13130.6750.68
31154-11540.5940.60
41280-12800.6580.66
51344-13440.6910.69
61310-13100.6740.68
30min11232-12320.6340.7440.570.640.7540.29
21208-12080.6210.63
31166-11660.6000.60
41218-12180.6270.63
51190-11900.6120.62
62633-26331.3551.36
45min11176-11760.6050.583.030.610.592.93
21115-11150.5740.58
31094-10940.5630.57
41113-11130.5730.58
51174-11740.6040.61
61120-11200.5760.58
60min11123-11230.5780.5711.180.580.5810.90
21068-10680.5490.56
31037-10370.5330.54
41064-10640.5470.55
51019-10190.5240.53
61352-13520.6960.70
极限11143-11430.5880.554.620.590.564.91
21081-10810.5560.56
31028-10280.5290.53
41078-10780.5550.56
51008-10080.5190.52
61108-11080.5700.58
盐酸鲁拉西酮口崩片项目信息
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N877-220209对照品来源自制对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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 11.151947621950561945091946571948011947570.11
2 11.181942171939161940660.11
单位质量响应值RSD%判断
17467.0017358.320.45数据可信
供试品溶液-24122701批-pH6.8(内含0.1%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min164291-6429133.14436.545.4233.1436.545.43
270645-7064536.41936.42
370467-7046736.32836.33
474428-7442838.37038.37
570373-7037336.27936.28
675022-7502238.67638.68
10min199492-9949251.29156.154.6451.3556.214.64
2108402-10840255.88455.94
3109927-10992756.67056.73
4111043-11104357.24657.31
5114513-11451359.03459.09
6110174-11017456.79856.86
15min1120983-12098362.37066.733.6362.5166.883.63
2129804-12980466.91767.07
3132039-13203968.07068.22
4134688-13468869.43569.59
5128136-12813666.05866.22
6130994-13099467.53167.69
20min1136799-13679970.52474.252.7070.7774.512.70
2145071-14507174.78875.05
3147309-14730975.94276.21
4146791-14679175.67575.95
5142748-14274873.59073.86
6145418-14541874.96775.24
30min1159753-15975382.35784.071.2782.7284.461.28
2163527-16352784.30384.69
3165338-16533885.23685.63
4165048-16504885.08785.49
5162330-16233083.68584.08
6162433-16243383.73984.14
45min1173711-17371189.55392.071.9690.0592.601.96
2179277-17927792.42292.95
3184082-18408294.89995.44
4180118-18011892.85693.40
5177644-17764491.58092.11
6176776-17677691.13391.67
60min1185391-18539195.57496.400.9596.2297.090.96
2188232-18823297.03997.72
3188184-18818497.01497.71
4189279-18927997.57898.28
5185799-18579995.78496.47
6185109-18510995.42996.12
极限1190610-19061098.26599.200.9799.07100.040.97
2194155-194155100.092100.94
3193515-19351599.762100.62
4194310-194310100.172101.03
5191873-19187398.91699.76
6190029-19002997.96598.81
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