阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.08 3872633872583873313871633873723872770.03
211.03 3874933875573875250.02
单位质量响应值RSD%判断
34952.8035133.730.37数据可信
供试品溶液-540383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%
5min187463-8746322.39520.3712.4822.4020.3812.48
268130-6813017.44517.45
382856-8285621.21621.22
476487-7648719.58519.59
569507-6950717.79817.80
692891-9289123.78523.79
10min1253552-25355264.92462.737.6365.0562.847.63
2249678-24967863.93264.03
3263336-26333667.42967.55
4220246-22024656.39556.50
5223165-22316557.14357.24
6259963-25996366.56566.70
15min1371464-37146495.11693.931.8995.6094.391.92
2368867-36886794.45194.90
3375379-37537996.11896.61
4359298-35929892.00192.42
5357782-35778291.61292.03
6368222-36822294.28694.79
20min1383108-38310898.09799.361.9499.11100.341.89
2382636-38263697.97698.95
3387685-38768599.269100.30
4400864-400864102.644103.58
5392516-392516100.506101.43
6381379-38137997.65598.68
30min1379209-37920997.09998.551.6898.66100.081.63
2378806-37880696.99698.52
3387320-38732099.176100.75
4393568-393568100.776102.28
5390454-39045499.978101.46
6379876-37987697.27098.84
45min1374256-37425695.83198.121.4597.93100.211.42
2379560-37956097.18999.25
3382995-38299598.068100.20
4386447-38644798.952101.02
5386745-38674599.029101.07
6389294-38929499.681101.79
60min1372797-37279795.45797.831.7998.09100.451.74
2377519-37751996.66699.27
3386110-38611098.866101.54
4392102-392102100.400103.01
5384068-38406898.343100.93
6379689-37968997.22299.88
极限1359858-35985892.14496.802.8895.3099.972.80
2375757-37575796.21599.35
3389379-38937999.703102.93
4388474-38847499.471102.64
5380128-38012897.334100.47
6374634-37463495.92899.13
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.08 3899063897703899793897653902513899340.06
211.03 3872493874103873300.03
单位质量响应值RSD%判断
35192.6035116.050.16数据可信
供试品溶液-540383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%
5min179729-7972920.35120.5811.6120.3520.5811.62
297272-9727224.82824.83
374278-7427818.95918.96
474133-7413318.92218.92
585253-8525321.76121.76
673124-7312418.66518.66
10min1237732-23773260.68061.313.2160.7961.423.22
2249588-24958863.70663.84
3241222-24122261.57161.68
4234037-23403759.73759.84
5248310-24831063.38063.50
6230351-23035158.79658.90
15min1369508-36950894.31692.981.3694.7793.431.37
2366862-36686293.64094.13
3364074-36407492.92993.38
4357057-35705791.13791.57
5368275-36827594.00194.47
6359796-35979691.83792.27
20min1401445-401445102.467100.361.63103.44101.331.62
2385748-38574898.46199.47
3392594-392594100.208101.17
4390156-39015699.586100.53
5400412-400412102.204103.20
6388849-38884999.252100.19
30min1399254-399254101.908100.221.63103.45101.751.61
2384391-38439198.11499.67
3393014-393014100.315101.84
4393623-393623100.471101.97
5399503-399503101.972103.53
6386100-38610098.551100.04
45min1394360-394360100.65999.561.37102.77101.641.35
2380722-38072297.17899.28
3390027-39002799.553101.63
4389463-38946399.409101.46
5396011-396011101.080103.21
6389707-38970799.471101.51
60min1394093-394093100.59199.221.38103.26101.861.37
2382766-38276697.700100.34
3389963-38996399.537102.17
4385665-38566598.440101.05
5395580-395580100.970103.66
6384270-38427098.083100.68
极限1390315-39031599.62698.121.30102.85101.301.30
2379232-37923296.79899.98
3384854-38485498.233101.42
4383940-38394097.999101.15
5389631-38963199.452102.70
6378449-37844996.59899.73
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