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%
1114.05731775726515695765705145738955719630.33
2113.55801955810255806100.11
单位质量响应值RSD%判断
5017.225115.511.38数据可信
供试品溶液-25072102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%
5min1455701-45570179.66481.051.9679.6681.051.95
2462345-46234580.82580.83
3451217-45121778.88078.88
4473141-47314182.71382.71
5473255-47325582.73382.73
6466280-46628081.51381.51
10min1489951-48995185.65185.151.5085.7885.281.50
2493671-49367186.30286.44
3472947-47294782.67982.81
4487496-48749685.22285.36
5490537-49053785.75485.89
6487728-48772885.26385.40
15min1496247-49624786.75286.291.9787.0386.571.97
2497200-49720086.91987.20
3473924-47392482.85083.12
4497881-49788187.03887.32
5498879-49887987.21287.49
6497545-49754586.97987.26
20min1497627-49762786.99386.681.8187.4187.101.81
2499921-49992187.39487.82
3477802-47780283.52883.93
4497917-49791787.04487.47
5501788-50178887.72188.15
6499847-49984787.38187.80
30min1502014-50201487.76087.141.8188.3387.711.81
2502524-50252487.84988.42
3480219-48021983.95084.50
4500339-50033987.46788.04
5502941-50294187.92288.49
6502916-50291687.91888.49
45min1506422-50642288.53188.061.5689.2488.771.56
2505489-50548988.36889.08
3488021-48802185.31486.00
4506787-50678788.59589.31
5509623-50962389.09089.81
6506039-50603988.46489.18
60min1504962-50496288.27688.211.4589.1389.071.45
2508161-50816188.83589.70
3490360-49036085.72386.55
4506791-50679188.59589.46
5510999-51099989.33190.20
6506392-50639288.52689.39
极限1507750-50775088.76388.631.7689.7789.631.76
2513662-51366289.79790.81
3489961-48996185.65386.62
4510374-51037489.22290.23
5513874-51387489.83490.85
6506218-50621888.49589.51
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%
1114.05841655843765806575800155796485817720.40
2113.55928685889975909320.47
单位质量响应值RSD%判断
5103.265206.451.42数据可信
供试品溶液-25072301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%
5min1460109-46010979.05479.511.9479.0579.521.94
2462355-46235579.44079.44
3479641-47964182.41082.41
4462157-46215779.40679.41
5452745-45274577.78977.79
6459712-45971278.98678.99
10min1475906-47590681.76883.351.7081.9083.481.70
2482686-48268682.93383.07
3499609-49960985.84185.98
4488698-48869883.96684.10
5480263-48026382.51782.65
6483455-48345583.06583.20
15min1484053-48405383.16884.571.5483.4484.841.54
2490506-49050684.27784.55
3505357-50535786.82987.11
4496106-49610685.23985.51
5487939-48793983.83684.10
6489281-48928184.06684.34
20min1483462-48346283.06784.971.8483.4785.381.84
2490798-49079884.32784.74
3509992-50999287.62588.05
4499324-49932485.79286.21
5491230-49123084.40184.81
6492437-49243784.60985.02
30min1488396-48839683.91486.101.8184.4686.651.80
2499310-49931085.79086.34
3514579-51457988.41388.98
4504613-50461386.70187.26
5495072-49507285.06185.61
6504600-50460086.69987.25
45min1496346-49634685.28087.511.8485.9788.211.83
2501790-50179086.21686.91
3522010-52201089.69090.41
4515169-51516988.51489.22
5507799-50779987.24887.94
6512901-51290188.12588.82
60min1500638-50063886.01888.321.7686.8489.161.76
2507389-50738987.17888.02
3524519-52451990.12190.99
4521706-52170689.63890.49
5512235-51223588.01088.85
6517619-51761988.93589.78
极限1511825-51182587.94089.491.3988.9190.481.39
2519381-51938189.23890.22
3531161-53116191.26292.28
4526961-52696190.54191.54
5515099-51509988.50289.48
6520498-52049889.43090.42
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