培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
19.74198461991990819906198931595055.21
29.781996819975199720.03
单位质量响应值RSD%判断
1637.582042.1315.55数据不可信!(响应值差异过大,请重新称样测定!)
长期18月-供试品溶液-2022081601批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123416-23416109.916108.783.14109.92108.783.14
224549-24549115.235115.23
322945-22945107.705107.71
422666-22666106.396106.40
522709-22709106.598106.60
622760-22760106.837106.84
10min123659-23659111.057110.771.55112.28111.981.55
224062-24062112.949114.23
323415-23415109.912111.11
422990-22990107.917109.10
523782-23782111.634112.82
623677-23677111.141112.33
15min123501-23501110.315109.841.69112.77112.281.69
223986-23986112.592115.13
322972-22972107.832110.25
422967-22967107.809110.19
523622-23622110.883113.31
623347-23347109.592112.01
20min123146-23146108.649108.632.47112.33112.292.43
223936-23936112.357116.14
323606-23606110.808114.42
422438-22438105.325108.90
522607-22607106.119109.78
623120-23120108.527112.17
30min122864-22864107.325106.112.37112.21110.982.34
223508-23508110.348115.38
322682-22682106.471111.32
422056-22056103.532108.28
522293-22293104.645109.48
622233-22233104.363109.21
45min122101-22101103.744106.282.47109.82112.322.41
223593-23593110.747117.01
322267-22267104.523110.55
422430-22430105.288111.19
523016-23016108.039114.04
622441-22441105.340111.34
极限122031-22031103.415105.392.24110.65112.612.19
223088-23088108.377115.87
322262-22262104.499111.69
421938-21938102.978110.05
523057-23057108.231115.43
622330-22330104.819111.99
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.1716608516651016685716702416661957.74
214.181666001655161660580.47
单位质量响应值RSD%判断
11758.5711710.720.29数据可信
长期18月-供试品溶液-2022081601批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1176699-17669997.61396.912.7397.6196.912.73
2184057-184057101.678101.68
3175784-17578497.10897.11
4170773-17077394.34094.34
5173193-17319395.67795.68
6172009-17200995.02295.02
10min1181121-181121100.05699.631.61101.14100.711.62
2184450-184450101.895103.02
3181033-181033100.008101.09
4176087-17608797.27598.32
5178142-17814298.41099.47
6181288-181288100.148101.20
15min1178355-17835598.52898.941.66100.72101.121.67
2184586-184586101.970104.23
3178290-17829098.492100.68
4176273-17627397.37899.51
5177093-17709397.83199.99
6180012-18001299.444101.61
20min1177316-17731697.95498.582.64101.25101.872.60
2183763-183763101.516104.91
3184703-184703102.035105.32
4173344-17334495.76098.97
5174954-17495496.64999.89
6176643-17664397.582100.86
30min1173903-17390396.06995.862.19100.45100.242.18
2179530-17953099.177103.70
3175445-17544596.921101.34
4168329-16832992.99097.26
5172366-17236695.22099.54
6171536-17153694.76199.12
45min1170822-17082294.36794.732.8299.81100.172.77
2179510-17951099.166104.79
3173162-17316295.659101.15
4166698-16669892.08997.40
5166441-16644191.94797.32
6172214-17221495.136100.55
极限1168608-16860893.14493.592.3399.64100.082.30
2176233-17623397.356104.08
3169016-16901693.36999.93
4165466-16546691.40897.74
5166019-16601991.71398.11
6171135-17113594.540101.01
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
19.742016120059201432011220133201220.20
29.781986919882198760.05
单位质量响应值RSD%判断
2065.912032.311.16数据可信
长期18月-供试品溶液-2022081901批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123280-2328096.93993.802.8596.9493.802.85
222951-2295195.56995.57
323040-2304095.93995.94
421963-2196391.45591.45
521750-2175090.56890.57
622178-2217892.35092.35
10min123590-2359098.23097.362.1599.3198.402.14
223334-2333497.16498.23
323320-2332097.10598.17
423110-2311096.23197.25
522714-2271494.58295.59
624214-24214100.828101.85
15min123222-2322296.69795.791.1198.8797.921.12
223091-2309196.15298.29
322921-2292195.44497.59
423140-2314096.35698.44
522526-2252693.79995.86
623125-2312596.29398.44
20min123425-2342597.54394.681.88100.7997.871.86
222991-2299195.73598.95
322814-2281494.99898.20
422435-2243593.42096.58
522294-2229492.83395.93
622463-2246393.53796.75
30min123698-2369898.67993.762.84103.0198.002.78
222440-2244093.44197.71
322526-2252693.79998.06
422187-2218792.38796.58
521794-2179490.75194.88
622459-2245993.52097.78
45min122337-2233793.01291.671.8898.4496.951.78
222108-2210892.05897.37
322181-2218192.36297.67
421766-2176690.63495.85
522388-2238893.22498.36
621303-2130388.70694.00
极限122216-2221692.50890.661.4898.9696.961.48
221884-2188491.12697.46
321909-2190991.23097.56
421642-2164290.11896.35
521254-2125488.50294.68
621731-2173190.48996.77
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.178354983220833798316083190833000.20
214.188342683511834680.08
单位质量响应值RSD%判断
5878.625886.320.10数据可信
长期18月-供试品溶液-2022081901批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min187378-8737896.29192.253.3496.2992.253.34
285553-8555394.28094.28
385512-8551294.23594.23
481017-8101789.28189.28
580693-8069388.92488.92
682104-8210490.47990.48
10min189964-8996499.14196.732.13100.2197.762.14
288823-8882397.88398.93
388541-8854197.57398.62
485067-8506793.74494.74
585959-8595994.72795.72
688328-8832897.33898.34
15min188362-8836297.37595.631.4099.5597.731.42
287419-8741996.33698.47
386753-8675395.60297.73
486256-8625695.05597.09
584762-8476293.40895.45
687107-8710795.99298.08
20min188748-8874897.80194.822.17101.0597.982.16
287337-8733796.24699.45
386815-8681595.67198.86
484449-8444993.06396.15
584215-8421592.80595.88
684684-8468493.32296.48
30min186776-8677695.62893.191.8699.9797.411.88
285365-8536594.07398.35
385036-8503693.71097.97
482653-8265391.08495.21
582853-8285391.30495.41
684713-8471393.35497.54
45min185193-8519393.88391.881.6499.2997.131.66
284051-8405192.62597.94
383816-8381692.36697.66
481304-8130489.59794.73
582375-8237590.77895.90
683509-8350992.02797.26
极限184165-8416592.75090.611.7299.2096.881.74
282802-8280291.24897.60
382711-8271191.14897.47
480772-8077289.01195.14
580373-8037388.57294.70
682495-8249590.91097.16
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
19.744034640291403954075740875405330.66
29.783992039883399020.07
单位质量响应值RSD%判断
4161.504079.961.40数据可信
长期18月-供试品溶液-2022081001批-培哚普利-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%
5min143993-4399391.09791.861.3991.1091.861.39
244739-4473992.64192.64
345165-4516593.52493.52
444740-4474092.64492.64
543997-4399791.10591.11
643527-4352790.13290.13
10min146198-4619895.66395.480.8496.6796.500.82
245965-4596595.18096.21
345523-4552394.26595.30
446650-4665096.59997.63
546337-4633795.95096.96
645984-4598495.22096.22
15min145771-4577194.77894.410.8596.8596.500.83
245358-4535893.92396.01
344912-4491293.00095.09
445931-4593195.11097.21
545797-4579794.83296.91
645801-4580194.84196.90
20min145043-4504393.27193.020.5996.4096.150.58
244584-4458492.32195.45
345201-4520193.59896.72
445205-4520593.60696.77
544767-4476792.69995.83
644721-4472192.60495.72
30min144267-4426791.66492.211.2495.8396.381.20
244563-4456392.27796.43
345442-4544294.09798.26
444762-4476292.68996.89
544350-4435091.83696.00
643804-4380490.70594.85
45min144413-4441391.96691.031.2297.1596.221.16
244000-4400091.11196.29
343204-4320489.46394.67
444387-4438791.91397.14
544353-4435391.84297.02
643403-4340389.87595.03
极限143598-4359890.27989.570.7096.4895.770.67
243279-4327989.61895.81
342848-4284888.72694.93
443579-4357990.23996.49
543001-4300189.04395.25
643234-4323489.52595.67
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.171655031657901657011668221665441660720.35
214.181675221672571673900.12
单位质量响应值RSD%判断
11719.9711804.650.51数据可信
长期18月-供试品溶液-2022081001批-氨氯地平-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%
5min1152095-15209583.82586.802.0683.8286.802.06
2159631-15963187.97887.98
3161002-16100288.73388.73
4159470-15947087.88987.89
5156329-15632986.15886.16
6156456-15645686.22886.23
10min1173168-17316895.43994.800.9396.3795.760.91
2172072-17207294.83595.81
3169306-16930693.31094.30
4173142-17314295.42496.40
5171012-17101294.25095.21
6173325-17332595.52596.48
15min1173703-17370395.73394.321.2497.7396.341.21
2170324-17032493.87195.90
3168302-16830292.75794.78
4171476-17147694.50696.54
5169734-16973493.54695.55
6173336-17333695.53197.55
20min1170318-17031893.86893.030.7396.9296.090.71
2167591-16759192.36595.44
3169327-16932793.32296.37
4168298-16829892.75595.84
5167353-16735392.23495.28
6169862-16986293.61696.70
30min1167817-16781792.48991.710.7496.5995.820.73
2167484-16748492.30696.41
3164961-16496190.91595.01
4166560-16656091.79795.91
5164920-16492090.89394.96
6166727-16672791.88996.01
45min1166187-16618791.59190.720.9996.7295.840.96
2165217-16521791.05696.18
3161758-16175889.15094.25
4165806-16580691.38196.52
5163782-16378290.26695.34
6164878-16487890.87096.01
极限1164372-16437290.59189.381.1796.7395.501.12
2162092-16209289.33495.47
3159603-15960387.96294.05
4162681-16268189.65995.81
5160392-16039288.39794.48
6163884-16388490.32296.47
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