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%
111.914602046218462104608546113461290.19
211.994651746313464150.32
单位质量响应值RSD%判断
3873.133871.140.04数据可信
加速3月-供试品溶液-24051503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%
5min140262-4026284.03283.605.1584.0383.605.15
240491-4049184.51084.51
339454-3945482.34682.35
436932-3693277.08277.08
539830-3983083.13083.13
643347-4334790.47190.47
10min145745-4574595.47692.985.2695.9493.445.26
245979-4597995.96496.43
344773-4477393.44793.90
440349-4034984.21484.64
543591-4359190.98091.44
646858-4685897.79998.30
15min145992-4599295.99192.995.5996.9993.985.58
245263-4526394.47095.47
344697-4469793.28994.27
440127-4012783.75084.65
543831-4383191.48192.45
647428-4742898.988100.03
20min145545-4554595.05892.845.2096.5994.345.20
245887-4588795.77297.30
344935-4493593.78595.28
440764-4076485.08086.44
542726-4272689.17590.65
647038-4703898.17599.77
30min145223-4522394.38692.804.6296.4594.814.63
245543-4554395.05497.11
344892-4489293.69695.71
440914-4091485.39387.23
543401-4340190.58492.55
646792-4679297.66199.80
45min145275-4527594.49592.815.4897.0895.345.47
244455-4445592.78395.37
344848-4484893.60496.14
440151-4015183.80086.11
544424-4442492.71995.19
647666-4766699.485102.17
60min144285-4428592.42991.804.8395.5494.854.83
244487-4448792.85095.95
344482-4448292.84095.90
440351-4035184.21886.99
543430-4343090.64493.63
646879-4687997.843101.08
极限149226-49226102.741101.432.92106.36104.982.98
249007-49007102.284105.90
347608-4760899.364102.94
446894-4689497.874101.12
547965-47965100.109103.60
650881-50881106.195109.98
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%
111.353978393964703978063977973973483974520.15
211.363990504007983999240.31
单位质量响应值RSD%判断
35017.8035204.580.38数据可信
加速3月-供试品溶液-24051503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%
5min1120926-12092630.90427.7715.8430.9027.7715.84
2100455-10045525.67225.67
377211-7721119.73219.73
4119443-11944330.52530.53
5114046-11404629.14629.15
6119983-11998330.66330.66
10min1271335-27133569.34366.884.7869.5167.034.80
2262531-26253167.09367.24
3237145-23714560.60560.71
4266873-26687368.20268.37
5263198-26319867.26367.43
6269086-26908668.76868.94
15min1294754-29475475.32874.081.5075.8874.601.53
2288165-28816573.64474.16
3284295-28429572.65573.10
4286039-28603973.10173.65
5294133-29413375.16975.70
6291758-29175874.56275.11
20min1298667-29866776.32876.270.4677.3077.210.48
2298691-29869176.33477.26
3297582-29758276.05076.90
4296550-29655075.78776.74
5300657-30065776.83677.79
6298509-29850976.28777.25
30min1305621-30562178.10579.661.6279.5081.021.60
2311027-31102779.48680.84
3310163-31016379.26680.54
4312315-31231579.81681.19
5320912-32091282.01383.39
6310137-31013779.25980.65
45min1317863-31786381.23482.652.3783.0784.452.32
2314712-31471280.42882.22
3325628-32562883.21884.93
4321525-32152582.16983.99
5336701-33670186.04887.88
6323892-32389282.77484.61
60min1318091-31809181.29283.402.2883.5885.662.24
2320553-32055381.92184.16
3326335-32633583.39985.57
4328322-32832283.90686.18
5339370-33937086.73089.04
6325414-32541483.16385.45
极限1391427-391427100.034101.021.37102.77103.751.34
2393440-393440100.548103.24
3393456-393456100.552103.19
4405253-405253103.567106.31
5390743-39074399.859102.65
6397414-397414101.564104.32
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%
111.914628246135461184633146090461910.24
211.994609046128461090.06
单位质量响应值RSD%判断
3878.343845.620.60数据可信
加速3月-供试品溶液-24051503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%
5min142686-4268689.32787.121.7889.3387.121.78
241527-4152786.90286.90
341524-4152486.89686.90
440844-4084485.47385.47
540910-4091085.61185.61
642306-4230688.53288.53
10min146223-4622396.72991.803.5597.2392.293.54
244276-4427692.65593.14
344477-4447793.07593.56
442442-4244288.81789.29
541871-4187187.62288.10
643924-4392491.91892.41
15min145642-4564295.51391.742.8496.5592.732.84
244594-4459493.32094.32
344283-4428392.66993.67
442716-4271689.39090.36
542317-4231788.55589.52
643473-4347390.97491.98
20min146663-4666397.65092.683.7099.2194.183.68
245424-4542495.05796.57
344627-4462793.38994.90
443314-4331490.64192.11
542048-4204887.99289.45
643647-4364791.33892.85
30min145359-4535994.92191.902.4997.0393.912.50
244481-4448193.08495.13
344298-4429892.70194.73
442456-4245688.84690.81
542792-4279289.54991.49
644093-4409392.27294.29
45min143943-4394391.95889.931.6494.5992.461.67
242913-4291389.80292.36
343354-4335490.72593.27
442383-4238388.69391.16
541994-4199487.87990.32
643246-4324690.49993.03
60min145085-4508594.34890.123.0197.4993.153.00
243559-4355991.15494.21
343689-4368991.42694.48
441649-4164987.15790.11
541898-4189887.67890.61
642505-4250588.94891.98
极限147384-4738499.15999.182.00102.83102.711.94
246855-4685598.052101.62
348882-48882102.293105.85
446935-4693598.219101.66
548068-48068100.590104.01
646245-4624596.775100.30
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%
111.353973093968903973533976443971503972690.07
211.363965193969603967400.08
单位质量响应值RSD%判断
35001.6734924.300.16数据可信
加速3月-供试品溶液-24051503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%
5min1132308-13230833.95628.0117.5833.9628.0117.58
2116571-11657129.91729.92
380055-8005520.54620.55
4108213-10821327.77227.77
594637-9463724.28824.29
6122944-12294431.55331.55
10min1273235-27323570.12465.537.2970.3165.697.32
2267899-26789968.75468.92
3227939-22793958.49958.61
4252618-25261864.83364.99
5239444-23944461.45261.59
6270908-27090869.52769.70
15min1293433-29343375.30873.073.4075.8973.593.44
2292329-29232975.02475.57
3280145-28014571.89772.34
4279003-27900371.60472.12
5270258-27025869.36069.84
6293166-29316675.23975.80
20min1304585-30458578.17075.803.3479.1776.723.36
2303334-30333477.84978.81
3294765-29476575.64976.49
4294287-29428775.52776.44
5277244-27724471.15372.01
6297898-29789876.45377.43
30min1311943-31194380.05878.792.3981.4980.132.43
2309720-30972079.48880.88
3304568-30456878.16579.42
4306713-30671378.71680.05
5294056-29405675.46776.72
6314910-31491080.81982.22
45min1319621-31962182.02980.421.5883.9082.201.60
2311056-31105679.83081.67
3315711-31571181.02582.72
4314210-31421080.64082.41
5305011-30501178.27979.96
6314468-31446880.70682.56
60min1324391-32439183.25381.961.6185.5884.201.62
2318781-31878181.81384.10
3323582-32358283.04585.19
4319636-31963682.03284.25
5310042-31004279.57081.68
6319792-31979282.07284.37
极限1387962-38796299.568100.070.80102.36102.760.82
2395064-395064101.390104.13
3390829-390829100.304102.91
4387235-38723599.381102.05
5387132-38713299.355101.91
6391346-391346100.436103.19
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%
111.914599046280460284608746102460970.25
211.994615145799459750.55
单位质量响应值RSD%判断
3870.453834.450.67数据可信
加速3月-供试品溶液-2024052421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%
5min140195-4019584.32382.0012.0084.3282.0012.00
229620-2962062.13862.14
340576-4057685.12285.12
442131-4213188.38488.38
541326-4132686.69686.70
640689-4068985.35985.36
10min146091-4609196.69294.023.6797.1694.473.71
241562-4156287.19187.54
345726-4572695.92696.40
445045-4504594.49794.99
545078-4507894.56795.05
645393-4539395.22895.70
15min145253-4525394.93493.683.4595.9494.663.48
241547-4154787.15987.99
345254-4525494.93695.94
445465-4546595.37996.39
544912-4491294.21895.23
645495-4549595.44296.44
20min144889-4488994.17092.853.1695.7094.353.19
241874-4187487.84589.16
345780-4578096.03997.57
445028-4502894.46296.01
544542-4454293.44294.97
643452-4345291.15692.69
30min144060-4406092.43193.503.4094.4995.523.42
241826-4182687.74589.55
345228-4522894.88196.95
444900-4490094.19396.26
546219-4621996.96099.01
645191-4519194.80496.84
45min143627-4362791.52392.084.1194.0994.624.12
240441-4044184.83987.13
344399-4439993.14295.74
444434-4443493.21695.81
545496-4549695.44498.03
644970-4497094.34096.91
60min143833-4383391.95592.072.7995.0395.112.84
241464-4146486.98589.75
344602-4460293.56896.68
444642-4464293.65296.76
544339-4433993.01696.13
644440-4444093.22896.32
极限146519-4651997.59099.051.07101.18102.601.03
247349-4734999.331102.57
347090-4709098.788102.42
446860-4686098.305101.94
547934-47934100.558104.19
647531-4753199.713103.32
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%
111.353966203961333966613965693962063964380.07
211.363950193941713945950.16
单位质量响应值RSD%判断
34928.4634735.480.40数据可信
加速3月-供试品溶液-2024052421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%
5min1108176-10817627.86726.1712.3527.8726.1712.35
281916-8191621.10221.10
3115097-11509729.65029.65
4109616-10961628.23828.24
591336-9133623.52923.53
6103447-10344726.64926.65
10min1280399-28039972.23468.523.6972.3968.663.70
2253840-25384065.39265.51
3274427-27442770.69570.86
4264295-26429568.08568.24
5259262-25926266.78966.92
6263565-26356567.89768.05
15min1311523-31152380.25175.433.6780.8175.953.68
2280859-28085972.35272.83
3295581-29558176.14576.70
4289893-28989374.67975.21
5284688-28468873.33973.84
6294230-29423075.79776.32
20min1317463-31746381.78277.143.5582.7878.083.56
2288477-28847774.31575.20
3303229-30322978.11579.10
4293859-29385975.70176.65
5291371-29137175.06075.97
6302240-30224077.86078.81
30min1326574-32657484.12979.633.0785.5981.003.08
2305613-30561378.72980.02
3310469-31046979.98081.39
4299516-29951677.15878.53
5302916-30291678.03479.36
6309586-30958679.75381.13
45min1331195-33119585.31980.783.0387.2482.603.04
2307196-30719679.13780.87
3314751-31475181.08382.94
4306003-30600378.82980.63
5307432-30743279.19880.96
6314893-31489381.12082.94
60min1332667-33266785.69881.912.4288.1084.182.43
2316704-31670481.58683.76
3315097-31509781.17283.48
4312802-31280280.58182.82
5311581-31158180.26682.47
6318911-31891182.15584.43
极限1388010-38801099.95598.241.40102.83100.961.41
2380961-38096198.139100.77
3375532-37553296.74199.50
4374830-37483096.56099.24
5382996-38299698.664101.31
6385698-38569899.360102.09
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%
111.914577645986459144605345910459280.23
211.994600145953459770.08
单位质量响应值RSD%判断
3856.263834.610.40数据可信
加速3月-供试品溶液-2024052421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%
5min140828-4082885.80686.051.9085.8186.051.90
242343-4234388.99088.99
340510-4051085.13885.14
440964-4096486.09286.09
541011-4101186.19086.19
640016-4001684.09984.10
10min143741-4374191.92893.551.7992.4094.031.79
244862-4486294.28494.78
344504-4450493.53194.00
445582-4558295.79796.28
544932-4493294.43194.91
643459-4345991.33591.80
15min144516-4451693.55794.901.0394.5495.891.03
245808-4580896.27297.29
344749-4474994.04695.04
445136-4513694.86095.87
545345-4534595.29996.30
645365-4536595.34196.32
20min144847-4484794.25295.811.2095.7697.341.19
246184-4618497.06298.62
345346-4534695.30196.82
445708-4570896.06297.60
545240-4524095.07896.61
646207-4620797.11198.61
30min145505-4550595.63595.890.9597.6797.950.94
246366-4636697.44599.54
345347-4534795.30397.35
445531-4553195.69097.76
545155-4515594.90096.96
645848-4584896.35698.40
45min144401-4440193.31594.250.9995.8896.840.98
245695-4569596.03598.67
344709-4470993.96296.54
444717-4471793.97996.58
544749-4474994.04696.63
644804-4480494.16296.74
60min144109-4410992.70194.011.0395.7897.121.02
245409-4540995.43398.60
344721-4472193.98897.08
444603-4460393.74096.86
544465-4446593.45096.56
645072-4507294.72597.83
极限147614-47614100.068100.511.08103.66104.141.03
247463-4746399.750103.45
348705-48705102.360105.98
447280-4728099.366103.01
548110-48110101.110104.74
647773-47773100.402104.03
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%
111.353947903950113950413949843951623949980.04
211.363957063952733954900.08
单位质量响应值RSD%判断
34801.5934814.260.03数据可信
加速3月-供试品溶液-2024052421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%
5min1111617-11161728.77326.617.6928.7726.617.69
292831-9283123.93123.93
396358-9635824.84024.84
4107597-10759727.73727.74
5110935-11093528.59828.60
6100027-10002725.78625.79
10min1264633-26463368.21966.612.6668.3866.762.67
2250517-25051764.58064.71
3251789-25178964.90865.05
4263172-26317267.84268.00
5265644-26564468.47968.64
6254563-25456365.62365.77
15min1293101-29310175.55775.140.9576.1075.660.95
2292748-29274875.46675.96
3290162-29016274.80075.30
4287248-28724874.04974.58
5295105-29510576.07476.61
6290467-29046774.87875.39
20min1299166-29916677.12177.381.8478.0878.321.81
2306459-30645979.00179.91
3297860-29786076.78477.70
4290957-29095775.00575.95
5303647-30364778.27679.24
6303030-30303078.11779.04
30min1306316-30631678.96480.301.9180.3581.661.87
2321151-32115182.78884.14
3313008-31300880.68982.03
4304405-30440578.47179.83
5313103-31310380.71482.11
6310917-31091780.15081.51
45min1307183-30718379.18881.092.6381.0182.902.58
2326396-32639684.14085.95
3317390-31739081.81983.61
4304166-30416678.41080.20
5319651-31965182.40284.25
6312556-31255680.57382.38
60min1312920-31292080.66682.722.5482.9384.982.49
2330755-33075585.26487.54
3326726-32672684.22586.47
4309546-30954679.79782.03
5323508-32350883.39685.70
6321905-32190582.98385.23
极限1386954-38695499.75198.901.85102.47101.621.79
2375785-37578596.87299.62
3396065-396065102.100104.81
4380570-38057098.106100.78
5380523-38052398.094100.86
6381893-38189398.447101.16
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