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%
1111.95499515501375513665512945495555504610.15
2112.95575325573985574650.02
单位质量响应值RSD%判断
4919.224937.690.27数据可信
供试品溶液-49G03N批-shui(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%
5min1203086-20308636.49337.2716.9736.4937.2816.97
2164770-16477029.60829.61
3206160-20616037.04537.05
4247796-24779644.52744.53
5248069-24806944.57644.58
6174707-17470731.39331.39
10min1269024-26902448.34147.375.5748.4047.435.58
2253279-25327945.51245.56
3249316-24931644.80044.86
4288678-28867851.87351.95
5267461-26746148.06148.13
6254041-25404145.64945.70
15min1333359-33335959.90256.318.3260.0456.458.31
2266615-26661547.90948.03
3318757-31875757.27857.41
4306164-30616455.01555.18
5315055-31505556.61356.77
6340391-34039161.16561.29
20min1348225-34822562.57361.668.6162.8161.908.59
2316099-31609956.80057.01
3331143-33114359.50459.74
4326516-32651658.67258.92
5337647-33764760.67260.92
6399321-39932171.75571.99
30min1402407-40240772.30967.0312.1272.6567.3712.07
2348286-34828662.58462.88
3336258-33625860.42360.75
4325343-32534358.46158.81
5382131-38213168.66669.02
6443885-44388579.76380.11
45min1378224-37822467.96467.318.3568.4367.768.33
2341655-34165561.39361.80
3346883-34688362.33262.76
4358644-35864464.44564.89
5404112-40411272.61673.08
6418068-41806875.12375.61
60min1406054-40605472.96570.505.1873.5471.065.19
2358512-35851264.42264.93
3386288-38628869.41369.95
4386228-38622869.40269.96
5400035-40003571.88372.47
6416753-41675374.88775.50
90min1435299-43529978.22076.583.3378.9277.263.35
2397923-39792371.50472.12
3426993-42699376.72777.38
4430564-43056477.36978.04
5431119-43111977.46978.17
6435118-43511878.18778.92
120min1421819-42181975.79777.962.4976.6378.762.50
2419059-41905975.30176.03
3435436-43543678.24479.02
4441707-44170779.37180.17
5443739-44373979.73680.57
6441217-44121779.28380.15
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1417796-41779675.07575.902.7476.0376.832.75
2416029-41602974.75775.62
3407923-40792373.30074.21
4432301-43230177.68178.61
5420572-42057275.57376.54
6439621-43962178.99679.99
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%
1111.95502425499295503785498035496995500100.06
2112.95615925624045619980.11
单位质量响应值RSD%判断
4915.194977.840.90数据可信
供试品溶液-49G03N批-pH4.0(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%
5min1359119-35911964.29763.461.8664.3063.461.86
2349855-34985562.63962.64
3355435-35543563.63863.64
4347362-34736262.19262.19
5350316-35031662.72162.72
6364735-36473565.30365.30
10min1393814-39381470.50969.741.5670.6269.851.56
2382537-38253768.49068.59
3391448-39144870.08670.19
4381678-38167868.33768.44
5391306-39130670.06070.16
6396433-39643370.97871.09
15min1416440-41644074.56073.701.8074.7973.921.79
2404304-40430472.38872.61
3411299-41129973.64073.86
4401242-40124271.83972.06
5418774-41877474.97875.20
6417619-41761974.77175.00
20min1428767-42876776.76776.391.8377.1276.741.83
2418919-41891975.00475.34
3427447-42744776.53176.88
4416426-41642674.55874.90
5437352-43735278.30578.65
6431165-43116577.19777.55
30min1451949-45194980.91880.151.9681.3980.621.95
2443522-44352279.40979.87
3439295-43929578.65279.13
4437498-43749878.33178.79
5458461-45846182.08482.56
6455157-45515781.49281.97
45min1470897-47089784.31084.161.9784.9284.761.96
2465068-46506883.26783.86
3465694-46569483.37983.98
4457744-45774481.95682.55
5482897-48289786.45987.07
6478071-47807185.59586.21
60min1482045-48204586.30686.562.0187.0687.302.01
2477566-47756685.50586.24
3477870-47787085.55986.30
4472764-47276484.64585.37
5493078-49307888.28289.04
6497435-49743589.06289.82
90min1495121-49512188.64889.501.4689.5490.381.46
2493412-49341288.34289.22
3501385-50138589.76990.65
4492977-49297788.26489.13
5510757-51075791.44792.35
6505536-50553690.51291.42
120min1505494-50549490.50591.111.4291.5592.151.41
2505968-50596890.59091.61
3511863-51186391.64592.68
4500099-50009989.53990.56
5521201-52120193.31794.37
6508642-50864291.06892.13
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1513507-51350791.93992.291.0993.1393.481.09
2513976-51397692.02393.20
3516000-51600092.38693.57
4508531-50853191.04992.21
5525565-52556594.09895.31
6515371-51537192.27393.48
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%
1111.95519095500875505565495015504525505010.17
2112.95575575570745573160.07
单位质量响应值RSD%判断
4919.584936.370.25数据可信
供试品溶液-1批-pH4.0(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%
5min1449480-44948080.77681.181.3780.7881.181.37
2451715-45171581.17781.18
3441807-44180779.39779.40
4451377-45137781.11781.12
5460177-46017782.69882.70
6455661-45566181.88681.89
10min1468652-46865284.22184.791.0184.3684.921.00
2471942-47194284.81284.95
3468829-46882984.25384.39
4477366-47736685.78785.92
5477563-47756385.82285.96
6466414-46641483.81983.96
15min1476858-47685885.69686.470.8485.9786.740.84
2478355-47835585.96586.24
3477582-47758285.82686.10
4484365-48436587.04587.32
5486356-48635687.40387.68
6483335-48333586.86087.14
20min1483143-48314386.82587.160.9187.2487.580.92
2481238-48123886.48386.90
3479429-47942986.15886.57
4487093-48709387.53587.96
5488501-48850187.78888.21
6490660-49066088.17688.60
30min1483073-48307386.81387.270.9787.3887.840.97
2480158-48015886.28986.85
3481165-48116586.47087.03
4488830-48883087.84788.42
5490770-49077088.19688.77
6489620-48962087.98988.56
45min1484211-48421187.01787.570.8987.7288.280.89
2483308-48330886.85587.56
3483076-48307686.81387.52
4488750-48875087.83388.55
5492230-49223088.45889.18
6492183-49218388.45089.16
60min1485607-48560787.26887.450.7088.1288.300.70
2483028-48302886.80587.66
3482830-48283086.76987.62
4489367-48936787.94488.81
5491195-49119588.27289.14
6487570-48757087.62188.48
90min1484237-48423787.02287.350.8788.0288.360.86
2479988-47998886.25887.26
3483207-48320786.83787.83
4489236-48923687.92088.93
5490102-49010288.07689.09
6489707-48970788.00589.01
120min1483407-48340786.87387.270.5288.0288.420.52
2483464-48346486.88388.02
3483712-48371286.92888.07
4488895-48889587.85989.01
5486176-48617687.37088.53
6488195-48819587.73388.89
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1481856-48185686.59487.050.9087.8888.340.89
2479996-47999686.26087.55
3479729-47972986.21287.49
4487553-48755387.61888.92
5488249-48824987.74389.05
6488970-48897087.87289.17
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