盐酸氟西汀胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100513-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8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0.8946
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.125112355110055106655110545107345109390.05
212.125105135105805105460.01
单位质量响应值RSD%判断
42156.6842124.260.06数据可信
供试品溶液-22011003-1批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1405604-40560477.34074.289.2777.3474.289.27
2417516-41751679.61179.61
3323364-32336461.65961.66
4372203-37220370.97170.97
5411664-41166478.49678.50
6407027-40702777.61177.61
10min1505853-50585396.45596.392.6097.3197.212.64
2504357-50435796.17097.05
3487188-48718892.89693.58
4497148-49714894.79695.58
5525283-525283100.160101.03
6513236-51323697.86398.73
15min1510925-51092597.42396.362.4799.3598.262.51
2502311-50231195.78097.73
3487021-48702192.86594.58
4496388-49638894.65196.49
5515825-51582598.357100.34
6519735-51973599.102101.05
20min1493748-49374894.14794.652.8797.1697.622.89
2497347-49734794.83497.85
3476029-47602990.76993.52
4487850-48785093.02395.92
5507066-50706696.68799.76
6516392-51639298.465101.52
30min1495531-49553194.48794.111.9898.5598.132.03
2488264-48826493.10297.17
3482704-48270492.04195.80
4485294-48529492.53596.46
5504126-50412696.126100.28
6505525-50552596.393100.54
极限1487767-48776793.00793.292.1798.1298.362.21
2489391-48939193.31798.42
3478500-47850091.24096.02
4477466-47746691.04396.00
5503938-50393896.090101.31
6498545-49854595.062100.28
盐酸氟西汀胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100513-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8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0.8946
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.125152455155765157685153125146535153110.09
212.125222475214165218320.12
单位质量响应值RSD%判断
42517.4143055.450.89数据可信
供试品溶液-22011003-1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%
5min1304798-30479857.24366.1412.1157.2466.1412.11
2385965-38596572.48772.49
3300536-30053656.44356.44
4383195-38319571.96771.97
5341924-34192464.21664.22
6396508-39650874.46774.47
10min1453870-45387085.24091.226.6285.8891.966.58
2516700-51670097.04097.85
3490407-49040792.10292.73
4515473-51547396.81097.61
5498203-49820393.56694.28
6439681-43968182.57583.40
15min1539756-539756101.37097.003.63102.9598.753.59
2529520-52952099.448101.33
3487581-48758191.57193.22
4525005-52500598.600100.48
5507113-50711395.24096.99
6509886-50988695.76097.51
20min1551367-551367103.55197.643.80106.26100.463.70
2509099-50909995.61398.60
3492787-49278792.54995.22
4529790-52979099.499102.47
5516963-51696397.09099.90
6519250-51925097.519100.33
30min1546266-546266102.59397.042.93106.45100.952.82
2509280-50928095.64799.70
3503486-50348694.55898.25
4516163-51616396.939101.02
5511296-51129696.02599.92
6513762-51376296.488100.38
极限1532190-53219099.94996.621.98104.95101.611.89
2501913-50191394.26399.38
3508256-50825695.454100.20
4515579-51557996.830101.98
5512935-51293596.333101.29
6515887-51588796.887101.85
盐酸氟西汀胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100513-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8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0.8946
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.125166425168425166495167185172225168150.05
212.125129265133025131140.06
单位质量响应值RSD%判断
42641.5042336.140.51数据可信
供试品溶液-22011003-1批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1471830-47183089.23276.959.0589.2376.959.05
2405922-40592276.76776.77
3424747-42474780.32780.33
4381211-38121172.09472.09
5378742-37874271.62771.63
6378911-37891171.65971.66
10min1497077-49707794.00693.400.8895.0094.260.90
2490722-49072292.80493.66
3494145-49414593.45294.34
4497563-49756394.09894.90
5486786-48678692.06092.86
6497038-49703893.99994.80
15min1497527-49752794.09193.521.2496.1395.421.21
2484664-48466491.65993.54
3491959-49195993.03894.97
4502921-50292195.11196.96
5495904-49590493.78495.60
6494174-49417493.45795.30
20min1493692-49369293.36693.070.4796.4596.000.50
2492636-49263693.16696.07
3492176-49217693.07996.04
4495220-49522093.65596.56
5489444-48944492.56395.42
6489529-48952992.57995.46
30min1490786-49078692.81692.920.4296.9496.890.42
2489776-48977692.62596.56
3491584-49158492.96796.97
4495328-49532893.67597.62
5489992-48999292.66696.56
6490587-49058792.77996.69
极限1478148-47814890.42691.681.0195.5896.680.89
2484112-48411291.55496.52
3480432-48043290.85895.89
4491044-49104492.86597.85
5486597-48659792.02496.94
6488384-48838492.36297.30
盐酸氟西汀胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100513-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8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0.8946
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.125211405213375211995212585215615212990.04
212.125200695224665212680.33
单位质量响应值RSD%判断
43011.4743008.910.01数据可信
供试品溶液-22011003-1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%
5min1395044-39504473.80370.326.5273.8070.326.52
2375206-37520670.09770.10
3385753-38575372.06872.07
4371754-37175469.45269.45
5331390-33139061.91161.91
6399268-39926874.59274.59
10min1531520-53152099.30093.714.79100.1294.494.78
2520830-52083097.30398.08
3507239-50723994.76495.56
4503190-50319094.00894.78
5473165-47316588.39889.09
6473720-47372088.50289.33
15min1539217-539217100.73897.863.55102.6699.693.55
2538440-538440100.593102.45
3536774-536774100.282102.14
4527327-52732798.517100.33
5503529-50352994.07195.74
6497709-49770992.98494.80
20min1532317-53231799.44998.303.27102.49101.213.28
2537821-537821100.477103.46
3542431-542431101.339104.31
4535506-535506100.045102.96
5502378-50237893.85696.57
6506507-50650794.62797.47
30min1508638-50863895.02597.743.1199.17101.743.06
2531392-53139299.276103.37
3547038-547038102.199106.29
4532944-53294499.566103.59
5510583-51058395.38999.15
6508541-50854195.00798.90
极限1499601-49960193.33797.302.4998.54102.392.32
2514428-51442896.107101.30
3528090-52809098.659103.89
4529088-52908898.846103.97
5518250-51825096.821101.64
6535497-535497100.043105.00
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