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100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.914766247668475714766847512476160.15
211.994767947792477360.17
单位质量响应值RSD%判断
3997.983981.320.30数据可信
长期3月-供试品溶液-24051501批-左氨氯地平-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%
5min141050-4105083.15483.763.1583.1583.763.15
240259-4025981.55181.55
342638-4263886.37086.37
442820-4282086.73986.74
541761-4176184.59484.59
639572-3957280.16080.16
10min147745-4774596.71596.054.6497.1896.524.63
245829-4582992.83493.29
350586-50586102.470102.95
449400-49400100.068100.55
545586-4558692.34292.81
645367-4536791.89892.34
15min147871-4787196.97197.194.4297.9798.194.41
246361-4636193.91294.88
351238-51238103.791104.84
449669-49669100.613101.65
545599-4559992.36893.35
647147-4714795.50496.46
20min148538-4853898.32297.323.8099.8698.863.80
246683-4668394.56496.05
350222-50222101.733103.36
449986-49986101.255102.85
545827-4582792.83094.33
646997-4699795.20096.69
30min149106-4910699.47297.124.18101.5699.204.17
245451-4545192.06894.08
350447-50447102.189104.38
449470-49470100.210102.37
546257-4625793.70195.71
646950-4695095.10597.12
45min148444-4844498.13197.044.00100.7799.664.00
245910-4591092.99895.53
350616-50616102.531105.29
449497-49497100.264102.98
546193-4619393.57296.10
646777-4677794.75597.30
60min149136-4913699.53396.924.25102.72100.084.23
245879-4587992.93595.98
350633-50633102.565105.89
449021-4902199.300102.57
545666-4566692.50495.56
646752-4675294.70497.77
极限150263-50263101.816101.252.91105.55104.942.93
247954-4795497.139100.70
352136-52136105.610109.51
450621-50621102.541106.37
548854-4885498.962102.53
650062-50062101.409105.01
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%
111.353931973930383930473933873934483932230.05
211.363939063937273938160.04
单位质量响应值RSD%判断
34645.2034666.900.05数据可信
长期3月-供试品溶液-24051501批-阿齐沙坦-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%
5min1104377-10437727.02529.526.8927.0229.526.89
2108890-10889028.19328.19
3118620-11862030.71330.71
4120434-12043431.18231.18
5108147-10814728.00128.00
6123605-12360532.00332.00
10min1272929-27292970.66672.464.3370.8272.624.33
2269761-26976169.84570.00
3298925-29892577.39677.57
4291156-29115675.38575.56
5272109-27210970.45370.61
6274193-27419370.99371.17
15min1310038-31003880.27480.153.4880.8280.713.47
2291280-29128075.41775.96
3324908-32490884.12484.72
4309904-30990480.23980.83
5312212-31221280.83781.38
6308920-30892079.98480.56
20min1312766-31276680.98081.572.8081.9782.582.80
2299055-29905577.43078.39
3322412-32241283.47884.55
4320482-32048282.97884.02
5321497-32149783.24184.24
6313977-31397781.29482.31
30min1324499-32449984.01883.703.3985.4685.163.38
2302323-30232378.27679.67
3329202-32920285.23686.77
4322173-32217383.41684.91
5333303-33330386.29787.76
6328051-32805184.93886.41
45min1329159-32915985.22485.393.0287.1387.323.01
2311732-31173280.71282.54
3334103-33410386.50588.51
4329183-32918385.23187.19
5341579-34157988.44090.38
6332965-33296586.21088.15
60min1339744-33974487.96586.622.9690.3489.022.94
2316255-31625581.88384.16
3337775-33777587.45589.94
4331253-33125385.76788.20
5344283-34428389.14091.57
6337899-33789987.48789.91
极限1376333-37633397.43997.991.75100.31100.881.77
2367630-36763095.18597.92
3381163-38116398.689101.66
4383343-38334399.254102.17
5386149-38614999.980102.90
6376194-37619497.403100.31
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100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.914757147761476804747247590476150.24
211.994782847856478420.05
单位质量响应值RSD%判断
3997.903990.160.14数据可信
长期3月-供试品溶液-24051501批-左氨氯地平-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%
5min139312-3931279.54580.3010.9479.5580.3010.95
231127-3112762.98462.98
341402-4140283.77483.77
442658-4265886.31686.32
541679-4167984.33584.33
641946-4194684.87584.88
10min145645-4564592.36094.281.8392.8094.731.82
247104-4710495.31295.66
346627-4662794.34794.81
447662-4766296.44196.92
547010-4701095.12295.59
645528-4552892.12392.59
15min146761-4676194.61895.461.3195.5796.441.30
247449-4744996.01096.89
346480-4648094.04995.04
447865-4786596.85297.87
547835-4783596.79197.79
646684-4668494.46295.45
20min147023-4702395.14895.621.3396.6397.121.32
247318-4731895.74597.16
347666-4766696.44997.96
447769-4776996.65898.21
547639-4763996.39597.93
646108-4610893.29794.80
30min147370-4737095.85095.151.9597.8697.181.92
247424-4742495.95997.90
346311-4631193.70795.76
448008-4800897.14199.23
547494-4749496.10198.17
645540-4554092.14794.17
45min146955-4695595.01094.901.0997.5597.461.09
247082-4708295.26797.75
346767-4676794.63097.20
447670-4767096.45799.09
546838-4683894.77497.38
646090-4609093.26095.80
60min147494-4749496.10194.421.2499.1797.511.21
246659-4665994.41297.42
346654-4665494.40197.50
446645-4664594.38397.55
546832-4683294.76297.89
645697-4569792.46595.52
极限149617-49617100.39799.272.22104.00102.892.18
248548-4854898.234101.77
349019-4901999.187102.81
450466-50466102.115105.81
549447-49447100.053103.71
647277-4727795.66299.23
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%
111.353930763925563931643931963927743929530.08
211.363953833956723955280.06
单位质量响应值RSD%判断
34621.4134817.610.40数据可信
长期3月-供试品溶液-24051501批-阿齐沙坦-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%
5min1107022-10702227.65929.3612.8427.6629.3612.84
2102367-10236726.45626.46
3138767-13876735.86435.86
4109973-10997328.42228.42
5100797-10079726.05026.05
6122727-12272731.71831.72
10min1269510-26951069.65372.835.0369.8173.005.05
2281767-28176772.82172.97
3303014-30301478.31278.51
4271202-27120270.09170.25
5270678-27067869.95570.10
6294742-29474276.17476.35
15min1307320-30732079.42580.642.6479.9781.202.65
2306843-30684379.30279.85
3319292-31929282.51983.15
4301698-30169877.97278.52
5313674-31367481.06781.60
6323234-32323483.53884.14
20min1313446-31344681.00882.182.4381.9983.192.46
2316827-31682781.88282.87
3329682-32968285.20586.30
4307487-30748779.46880.45
5317064-31706481.94482.93
6323304-32330483.55684.62
30min1324063-32406383.75283.631.9885.1885.112.01
2316837-31683781.88583.33
3331805-33180585.75387.32
4315439-31543981.52482.95
5325094-32509484.01985.46
6328392-32839284.87186.40
45min1332400-33240085.90785.522.3687.8087.462.37
2319253-31925382.50984.41
3337594-33759487.24989.29
4323411-32341183.58485.46
5334938-33493886.56388.47
6337937-33793787.33889.34
60min1339894-33989487.84486.832.6890.2289.242.68
2325144-32514484.03286.39
3350284-35028490.52993.06
4328250-32825084.83487.17
5334406-33440686.42588.81
6337760-33776087.29289.78
极限1374255-37425596.72498.212.3599.59101.102.34
2365329-36532994.41797.24
3389189-389189100.584103.61
4381098-38109898.493101.30
5382788-38278898.930101.80
6387362-387362100.112103.08
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100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.914752147520476724759747812476240.26
211.994764447592476180.08
单位质量响应值RSD%判断
3998.663971.480.49数据可信
长期3月-供试品溶液-24051502批-左氨氯地平-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%
5min143992-4399289.21688.012.2489.2288.012.25
243013-4301387.23187.23
342804-4280486.80786.81
443777-4377788.78088.78
544762-4476290.77890.78
642033-4203385.24385.24
10min150474-50474102.36299.812.02102.86100.302.01
248395-4839598.14698.63
349133-4913399.642100.12
450358-50358102.127102.62
548786-4878698.93899.44
648145-4814597.63998.11
15min151017-51017103.463100.501.99104.53101.541.98
248485-4848598.32899.36
349274-4927499.928100.96
450364-50364102.139103.20
549538-49538100.464101.52
648654-4865498.67199.69
20min150613-50613102.64499.752.71104.28101.352.70
248135-4813597.61899.19
348922-4892299.214100.81
450914-50914103.254104.88
548970-4897099.312100.92
647567-4756796.46698.03
30min150094-50094101.591100.152.10103.80102.312.09
248137-4813797.62299.74
348927-4892799.224101.37
451063-51063103.556105.76
548874-4887499.117101.28
649220-4922099.819101.92
45min149588-49588100.56599.452.33103.34102.162.31
247967-4796797.27899.94
349030-4903099.433102.13
451003-51003103.435106.21
548026-4802697.397100.11
648610-4861098.582101.24
60min150521-50521102.45799.362.35105.79102.622.33
248127-4812797.602100.80
348307-4830797.967101.21
450303-50303102.015105.37
548850-4885099.068102.32
647858-4785897.056100.26
极限150835-50835103.094101.593.00107.00105.402.95
248151-4815197.651101.39
348729-4872998.823102.61
452294-52294106.053109.97
550528-50528102.471106.28
650019-50019101.439105.18
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%
111.353923693924273924683928313929023925990.07
211.363934623933943934280.02
单位质量响应值RSD%判断
34590.2234632.750.09数据可信
长期3月-供试品溶液-24051502批-阿齐沙坦-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%
5min1120713-12071331.29534.368.0131.2934.368.01
2128384-12838433.28333.28
3142308-14230836.89336.89
4123273-12327331.95831.96
5133097-13309734.50534.51
6147494-14749438.23838.24
10min1295575-29557576.62877.654.3176.8077.844.30
2304667-30466778.98579.17
3322050-32205083.49183.70
4284043-28404373.63873.82
5297212-29721277.05277.24
6293590-29359076.11376.33
15min1317126-31712682.21582.184.7182.8182.804.70
2326993-32699384.77385.40
3340543-34054388.28688.95
4299166-29916677.55978.15
5311345-31134580.71681.34
6306659-30665979.50180.14
20min1318056-31805682.45682.784.5583.5183.864.54
2331403-33140385.91687.01
3341899-34189988.63789.80
4305574-30557479.22080.24
5312024-31202480.89281.96
6306888-30688879.56180.64
30min1322959-32295983.72784.444.3385.2485.984.33
2339587-33958788.03889.61
3346447-34644789.81691.47
4311583-31158380.77882.24
5314945-31494581.64983.17
6318814-31881482.65284.17
45min1331774-33177486.01286.956.3087.9988.956.24
2370952-37095296.16998.23
3349992-34999290.73592.89
4317096-31709682.20784.11
5322534-32253483.61785.59
6319899-31989982.93484.91
60min1336513-33651387.24187.756.0989.7090.246.02
2374510-37451097.09199.69
3349204-34920490.53193.19
4320054-32005482.97485.34
5327965-32796585.02587.46
6322629-32262983.64186.08
极限1387373-387373100.42699.391.61103.37102.371.61
2393979-393979102.139105.27
3377369-37736997.833100.99
4381067-38106798.791101.62
5380860-38086098.738101.65
6379602-37960298.412101.32
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100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.914761947734475494751147588476000.18
211.994771647752477340.06
单位质量响应值RSD%判断
3996.643981.150.28数据可信
长期3月-供试品溶液-24051502批-左氨氯地平-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%
5min143631-4363188.39880.3723.7788.4080.3723.77
220450-2045041.43341.43
342767-4276786.64886.65
443674-4367488.48688.49
544154-4415489.45889.46
643336-4333687.80187.80
10min149694-49694100.68296.712.64101.1797.162.69
246406-4640694.02194.25
347451-4745196.13896.62
447760-4776096.76497.26
548594-4859498.45498.95
646505-4650594.22194.71
15min150176-50176101.65997.822.16102.7198.802.19
247667-4766796.57697.33
347659-4765996.55997.57
448243-4824397.74398.77
548621-4862198.50899.55
647309-4730995.85096.86
20min149817-49817100.93297.411.90102.5598.931.93
247603-4760396.44697.73
347379-4737995.99297.54
447832-4783296.91098.48
548295-4829597.84899.44
647539-4753996.31697.86
30min149332-4933299.94997.581.82102.1299.651.83
247924-4792497.09698.92
347804-4780496.85398.94
448143-4814397.54099.65
548911-4891199.096101.23
646859-4685994.93997.02
45min149828-49828100.95497.891.75103.69100.501.81
247414-4741496.06398.43
348041-4804197.33399.96
448348-4834897.955100.61
548528-4852898.320101.01
647738-4773896.71999.33
60min150472-50472102.25997.442.68105.55100.602.71
246721-4672194.65997.56
347357-4735795.94899.11
448084-4808497.420100.62
548276-4827697.809101.04
647661-4766196.56399.71
极限150716-50716102.753100.341.47106.61104.041.54
248588-4858898.442101.87
349724-49724100.743104.44
448974-4897499.224102.96
549627-49627100.547104.32
649528-49528100.346104.03
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%
111.353936203934413934163926873935303933390.10
211.363937893937973937930.01
单位质量响应值RSD%判断
34655.4234664.880.02数据可信
长期3月-供试品溶液-24051502批-阿齐沙坦-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%
5min1104905-10490527.15830.1318.0427.1630.1318.05
284604-8460421.90321.90
3117994-11799430.54730.55
4148078-14807838.33538.34
5119663-11966330.97930.98
6123007-12300731.84531.84
10min1282864-28286473.22973.751.2173.3873.921.22
2286960-28696074.29074.41
3283466-28346673.38573.55
4290931-29093175.31875.53
5281884-28188472.97673.15
6283182-28318273.31273.49
15min1308415-30841579.84479.582.2080.4080.152.15
2318824-31882482.53983.07
3308771-30877179.93680.51
4301051-30105177.93878.57
5300097-30009777.69178.27
6307127-30712779.51180.09
20min1319001-31900182.58581.062.5083.5982.082.45
2324102-32410283.90584.90
3313409-31340981.13782.16
4306432-30643279.33180.40
5302826-30282678.39779.41
6312876-31287680.99982.02
30min1313121-31312181.06282.542.8082.5284.012.75
2331441-33144185.80587.26
3325891-32589184.36885.84
4310522-31052280.39081.89
5310033-31003380.26381.71
6321941-32194183.34684.82
45min1331013-33101385.69485.243.0687.6087.173.00
2336362-33636287.07989.01
3335649-33564986.89588.84
4317111-31711182.09584.05
5316298-31629881.88583.78
6339124-33912487.79489.73
60min1340774-34077488.22188.193.1390.6190.593.05
2336720-33672087.17289.59
3351026-35102690.87593.30
4322751-32275183.55585.96
5340933-34093388.26390.61
6351715-35171591.05493.48
极限1378878-37887898.08699.241.46100.96102.131.45
2386995-386995100.187103.09
3389624-389624100.868103.80
4379700-37970098.299101.17
5376553-37655397.484100.32
6388161-388161100.489103.42
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