培哚普利氨氯地平片项目信息
介质体积(ml)1000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%
110.123999640158400234005939869400210.27
210.163981539843398290.05
单位质量响应值RSD%判断
3954.643920.180.62数据可信
供试品溶液-2022081201批-培哚普利-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%
5min140352-4035297.15695.815.5997.1695.815.59
237643-3764390.63490.63
340812-4081298.26498.26
443152-43152103.898103.90
537069-3706989.25289.25
639724-3972495.64495.64
10min145494-45494109.537109.586.29110.51110.546.26
243698-43698105.213106.12
350786-50786122.278123.26
445301-45301109.072110.11
542384-42384102.049102.94
645402-45402109.315110.27
15min145774-45774110.211106.933.38112.28108.983.40
242751-42751102.932104.89
345722-45722110.086112.29
444923-44923108.162110.29
542337-42337101.936103.85
644963-44963108.258110.31
20min146243-46243111.340105.923.82114.51109.043.81
241691-41691100.380103.37
344670-44670107.553110.86
444508-44508107.163110.37
542340-42340101.943104.88
644497-44497107.136110.27
30min143867-43867105.619102.823.13109.90107.013.15
241556-41556100.055104.05
342990-42990103.508107.89
443459-43459104.637108.92
540593-4059397.737101.69
643773-43773105.393109.60
45min144473-44473107.079104.642.83112.42109.852.87
242046-42046101.235106.23
344554-44554107.274112.69
443857-43857105.595110.92
541781-41781100.597105.53
644038-44038106.031111.29
极限144930-44930108.179106.901.20114.59113.161.25
243647-43647105.090111.09
345020-45020108.396114.89
444077-44077106.125112.51
544526-44526107.206113.14
644192-44192106.402112.72
培哚普利氨氯地平片项目信息
介质体积(ml)1000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%
114.101620201623341620801623891622221622090.10
214.071621951615881618920.27
单位质量响应值RSD%判断
11504.1811506.180.02数据可信
供试品溶液-2022081201批-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%
5min189889-8988956.27556.517.1756.2756.517.17
282474-8247451.63351.63
395883-9588360.02760.03
499756-9975662.45262.45
585703-8570353.65453.65
687872-8787255.01255.01
10min1141598-14159888.64785.054.2789.2185.624.28
2129651-12965181.16881.68
3135894-13589485.07685.68
4141453-14145388.55689.18
5128165-12816580.23780.77
6138353-13835386.61687.17
15min1151346-15134694.75090.214.7696.2091.624.75
2136686-13668685.57286.90
3147423-14742392.29493.74
4147876-14787692.57794.09
5134384-13438484.13185.47
6146813-14681391.91293.33
20min1154490-15449096.71891.155.1499.1193.465.12
2135656-13565684.92787.11
3147436-14743692.30294.68
4150504-15050494.22396.66
5137377-13737786.00588.18
6148070-14807092.69995.03
30min1149981-14998193.89590.414.6397.2693.634.62
2138917-13891786.96990.00
3144025-14402590.16693.46
4149707-14970793.72497.10
5134127-13412783.97087.01
6149682-14968293.70896.97
45min1154973-15497397.02093.944.29101.3298.074.30
2143134-14313489.60993.51
3153596-15359696.158100.36
4155619-15561997.425101.74
5140779-14077988.13492.01
6152213-15221395.29399.49
极限1164873-164873103.218101.321.50108.49106.391.61
2158617-15861799.302104.10
3164108-164108102.739107.90
4161370-161370101.025106.31
5159772-159772100.025104.79
6162319-162319101.619106.77
培哚普利氨氯地平片项目信息
介质体积(ml)1000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%
110.124044140262403924034840121403130.32
210.164007040175401220.19
单位质量响应值RSD%判断
3983.503949.020.62数据可信
供试品溶液-2022081201批-培哚普利-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%
5min140204-4020496.09695.224.1496.1095.224.14
238467-3846791.94491.94
342389-42389101.319101.32
440881-4088197.71497.71
538001-3800190.83090.83
639085-3908593.42193.42
10min143677-43677104.397106.792.54105.36107.742.54
245077-45077107.743108.66
346011-46011109.976110.99
445851-45851109.593110.57
544103-44103105.415106.32
643347-43347103.608104.54
15min143498-43498103.969106.611.50105.97108.631.50
245298-45298108.272110.27
344950-44950107.440109.55
445145-45145107.906109.98
544352-44352106.011107.97
644380-44380106.077108.05
20min144007-44007105.186106.132.03108.23109.212.02
245312-45312108.305111.38
345065-45065107.715110.90
445100-45100107.798110.95
543889-43889104.904107.93
643032-43032102.855105.89
30min142788-42788102.272103.541.02106.37107.691.03
243995-43995105.157109.32
343480-43480103.926108.19
443507-43507103.991108.22
543212-43212103.286107.36
642936-42936102.626106.69
45min143165-43165103.173104.841.08108.29110.021.10
243783-43783104.650109.86
344589-44589106.577111.88
444074-44074105.346110.62
543920-43920104.978110.08
643638-43638104.304109.39
极限143682-43682104.409105.471.64110.56111.701.60
243394-43394103.721109.98
344931-44931107.394113.76
444731-44731106.916113.24
544657-44657106.740112.89
643372-43372103.668109.80
培哚普利氨氯地平片项目信息
介质体积(ml)1000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%
114.101618081619681623301618901620311620050.13
214.071613691622541618120.39
单位质量响应值RSD%判断
11489.7211500.500.07数据可信
供试品溶液-2022081201批-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%
5min135727-3572722.38623.188.7922.3923.188.80
232000-3200020.05120.05
341216-4121625.82625.83
439016-3901624.44724.45
538497-3849724.12224.12
635544-3554422.27222.27
10min186307-8630754.08054.913.4954.3055.143.50
284233-8423352.78052.98
391564-9156457.37457.63
491088-9108857.07557.32
587336-8733654.72454.97
685243-8524353.41353.64
15min1108047-10804767.70269.291.9068.4770.071.90
2111792-11179270.04870.78
3111749-11174970.02270.85
4113507-11350771.12371.94
5109468-10946868.59269.38
6108911-10891168.24369.00
20min1121467-12146776.11176.553.0577.5578.033.03
2124602-12460278.07579.50
3124051-12405177.73079.26
4126446-12644679.23180.76
5120479-12047975.49276.97
6115995-11599572.68274.12
30min1128789-12878980.69981.692.1382.9083.942.12
2133879-13387983.88886.10
3130802-13080281.96084.27
4133017-13301783.34885.67
5129332-12933281.03983.27
6126453-12645379.23581.40
45min1135810-13581085.09886.702.1588.1189.762.13
2142165-14216589.08092.13
3140312-14031287.91991.05
4140347-14034787.94191.09
5134734-13473484.42487.46
6136849-13684985.74988.71
极限1153710-15371096.31496.731.35100.17100.651.35
2151862-15186295.15699.10
3157270-15727098.545102.55
4155821-15582197.637101.67
5155142-15514297.211101.10
6152430-15243095.51299.33
培哚普利氨氯地平片项目信息
介质体积(ml)1000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%
110.124007839581401424009139940399660.58
210.163998739702398440.51
单位质量响应值RSD%判断
3949.213921.650.50数据可信
供试品溶液-2022081201批-培哚普利-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%
5min136213-3621387.23484.315.7087.2384.315.70
233022-3302279.54779.55
337545-3754590.44390.44
435480-3548085.46885.47
532254-3225477.69777.70
635485-3548585.48085.48
10min139581-3958195.34792.572.6396.2293.422.64
238186-3818691.98792.78
338532-3853292.82093.72
439209-3920994.45195.31
536675-3667588.34789.12
638394-3839492.48893.34
15min139375-3937594.85192.901.7196.6894.671.73
238114-3811491.81393.53
338547-3854792.85694.69
439250-3925094.55096.35
537667-3766790.73792.40
638446-3844692.61394.39
20min139505-3950595.16492.982.5097.9495.672.51
238279-3827992.21194.84
338694-3869493.21195.97
439565-3956595.30998.05
536936-3693688.97691.54
638604-3860492.99495.70
30min138916-3891693.74592.512.1197.4796.142.13
238108-3810891.79995.35
338419-3841992.54896.24
439552-3955295.27798.98
537140-3714089.46792.92
638283-3828392.22095.86
45min138815-3881593.50293.031.9098.1797.581.90
238531-3853192.81897.29
338185-3818591.98496.60
439753-3975395.762100.41
537573-3757390.51094.86
638866-3886693.62598.18
极限140584-4058497.76396.802.32103.36102.282.21
240587-4058797.771103.17
338351-3835192.38497.92
440938-4093898.616104.22
540152-4015296.723101.98
640481-4048197.515103.01
培哚普利氨氯地平片项目信息
介质体积(ml)1000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%
114.101624071622771620031624131623301622860.11
214.071622971621991622480.05
单位质量响应值RSD%判断
11509.6511531.490.14数据可信
供试品溶液-2022081201批-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%
5min192270-9227057.68854.388.3257.6954.388.33
278220-7822048.90448.90
395309-9530959.58859.59
484024-8402452.53352.53
579814-7981449.90149.90
692238-9223857.66857.67
10min1119820-11982074.91371.424.4175.4971.964.44
2111068-11106869.44169.93
3120219-12021975.16275.76
4111924-11192469.97670.50
5107602-10760267.27467.77
6114790-11479071.76872.34
15min1123807-12380777.40674.823.1278.7376.083.16
2116498-11649872.83674.02
3123601-12360177.27778.62
4117014-11701473.15974.38
5115638-11563872.29873.47
6121511-12151175.97077.26
20min1126085-12608578.83076.014.2280.9378.014.22
2119556-11955674.74876.66
3125847-12584778.68180.80
4122088-12208876.33178.29
5112371-11237170.25672.15
6123455-12345577.18679.24
30min1127412-12741279.66077.632.8482.5580.402.90
2121732-12173276.10878.77
3126948-12694879.36982.28
4124656-12465677.93680.66
5118306-11830673.96676.56
6125964-12596478.75481.58
45min1129159-12915980.75279.762.3984.4483.302.45
2126954-12695479.37382.79
3129389-12938980.89684.60
4127676-12767679.82583.32
5121896-12189676.21179.55
6130387-13038781.52085.13
极限1144713-14471390.47690.241.7194.9794.581.57
2145084-14508490.70894.92
3139454-13945487.18891.70
4145706-14570691.09795.39
5144792-14479290.52694.62
6146295-14629591.46595.89
培哚普利氨氯地平片项目信息
介质体积(ml)1000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%
110.124003140208402734002540283401640.32
210.164012739857399920.48
单位质量响应值RSD%判断
3968.773936.220.59数据可信
供试品溶液-2022081201批-培哚普利-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%
5min134362-3436282.41883.884.0982.4283.884.09
234137-3413781.87881.88
336396-3639687.29787.30
432854-3285478.80178.80
535646-3564685.49885.50
636440-3644087.40287.40
10min137365-3736589.62192.431.9190.4593.271.92
238674-3867492.76193.58
338618-3861892.62693.50
438115-3811591.42092.21
538910-3891093.32794.18
639531-3953194.81695.69
15min138053-3805391.27193.122.9192.9994.882.88
237548-3754890.06091.81
338317-3831791.90493.70
438817-3881793.10494.81
539558-3955894.88196.67
640651-4065197.50299.32
20min137589-3758990.15892.682.0492.7995.382.04
238159-3815991.52594.17
338440-3844092.19994.92
438534-3853492.42595.06
539627-3962795.04697.78
639495-3949594.73097.53
30min138160-3816091.52892.881.9095.0696.501.91
238084-3808491.34594.91
338432-3843292.18095.82
438360-3836092.00795.56
539657-3965795.11898.81
639655-3965595.11398.86
45min138938-3893893.39494.661.4397.8499.211.45
238966-3896693.46197.94
339134-3913493.86498.43
439474-3947494.67999.16
540240-4024096.517101.16
640044-4004496.046100.74
极限139002-3900293.54795.461.1998.93100.961.17
240148-4014896.296101.71
339510-3951094.766100.27
440139-4013996.274101.70
539814-3981495.495101.10
640192-4019296.401102.06
培哚普利氨氯地平片项目信息
介质体积(ml)1000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%
114.101621261620551619701621601625501621720.14
214.071623521622571623040.05
单位质量响应值RSD%判断
11501.5611535.470.21数据可信
供试品溶液-2022081201批-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%
5min155187-5518734.51033.3910.0034.5133.3810.00
249028-4902830.65830.66
360838-6083838.04338.04
445903-4590328.70428.70
553092-5309233.20033.20
656297-5629735.20435.20
10min186974-8697454.38753.774.9954.7354.105.02
282121-8212151.35251.66
392385-9238557.77158.15
480599-8059950.40150.69
585455-8545553.43753.77
688398-8839855.27755.63
15min1101712-10171263.60362.865.4164.4963.745.42
291893-9189357.46358.28
3103757-10375764.88265.84
496653-9665360.43961.23
5101977-10197763.76964.64
6107182-10718267.02467.93
20min1108291-10829167.71767.264.0169.2468.764.04
2100313-10031362.72864.12
3110286-11028668.96570.57
4104522-10452265.36066.76
5110962-11096269.38770.89
6110958-11095869.38570.96
30min1116820-11682073.05072.514.3375.2574.684.34
2107448-10744867.19069.21
3118248-11824873.94376.24
4112766-11276670.51572.56
5120997-12099775.66277.86
6119415-11941574.67376.94
45min1122421-12242176.55376.744.1279.4979.644.12
2114576-11457671.64774.34
3124636-12463677.93880.97
4119770-11977074.89577.65
5128860-12886080.57983.53
6126049-12604978.82181.84
极限1133924-13392483.74686.602.1487.4490.262.07
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