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%
110.764469044555445624453744584445860.14
210.834464544635446400.02
单位质量响应值RSD%判断
4143.684121.880.38数据可信
供试品溶液-2022081101批-培哚普利-醋酸盐缓冲液(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%
5min136789-3678975.95068.817.0075.9568.807.00
230230-3023062.40962.41
334970-3497072.19572.19
433628-3362869.42469.42
532451-3245166.99566.99
631905-3190565.86765.87
10min141458-4145885.58983.233.4286.4384.003.44
238208-3820878.88079.57
341170-4117084.99585.80
441725-4172586.14186.91
539967-3996782.51183.26
639373-3937381.28582.02
15min141873-4187386.44686.861.3488.2488.551.38
241134-4113484.92086.49
342572-4257287.88989.64
442683-4268388.11889.85
542233-4223387.18988.85
641943-4194386.59188.23
20min142613-4261387.97488.271.2190.7390.921.24
242386-4238687.50590.02
343372-4337289.54192.26
443208-4320889.20291.91
542939-4293988.64791.28
642013-4201386.73589.33
30min143001-4300188.77589.591.0592.5193.221.03
243089-4308988.95792.44
343656-4365690.12793.85
443237-4323789.26292.96
544200-4420091.25094.87
643178-4317889.14092.70
45min143372-4337289.54190.571.1894.2695.201.17
243524-4352489.85594.33
344616-4461692.10996.83
443820-4382090.46695.16
544383-4438391.62896.26
643494-4349489.79394.34
极限145836-4583694.62895.101.39100.34100.741.33
246552-4655296.106101.58
346328-4632895.643101.39
446071-4607195.113100.81
546677-4667796.364102.01
644922-4492292.74198.29
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%
113.981637451633651634871633561633071634520.11
213.981632271632751632510.03
单位质量响应值RSD%判断
11691.8511677.470.09数据可信
供试品溶液-2022081101批-氨氯地平-醋酸盐缓冲液(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%
5min1108414-10841460.14754.985.3760.1554.985.37
292752-9275251.45851.46
3100994-10099456.03056.03
498742-9874254.78154.78
597324-9732453.99453.99
696401-9640153.48253.48
10min1138530-13853076.85574.612.9877.5275.222.99
2129785-12978572.00372.57
3138018-13801876.57177.19
4137524-13752476.29776.91
5132564-13256473.54574.14
6130489-13048972.39472.99
15min1141101-14110178.28178.410.8479.8079.840.87
2139477-13947777.38078.75
3142573-14257379.09880.57
4142569-14256979.09680.55
5141554-14155478.53379.95
6140693-14069378.05579.45
20min1143407-14340779.56179.651.1281.9581.961.13
2142475-14247579.04381.28
3145958-14595880.97683.33
4144306-14430680.05982.39
5143934-14393479.85382.14
6141311-14131178.39880.66
30min1144767-14476780.31580.910.9083.5984.110.86
2145045-14504580.46983.58
3146602-14660281.33384.59
4144847-14484780.35983.58
5148106-14810682.16885.34
6145698-14569880.83283.97
45min1146287-14628781.15882.151.0385.3386.251.00
2147198-14719881.66485.67
3150607-15060783.55587.71
4147510-14751081.83785.95
5148968-14896882.64686.74
6147904-14790482.05586.09
极限1169072-16907293.79994.021.6198.8799.021.55
2171360-17136095.06999.98
3170832-17083294.77699.86
4170114-17011494.37799.40
5171217-17121794.989100.00
6164172-16417291.08196.03
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%
110.764470044504445354449844584445640.19
210.834462144629446250.02
单位质量响应值RSD%判断
4141.644120.500.37数据可信
供试品溶液-2022081101批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130995-3099564.01571.147.7464.0271.157.75
231488-3148865.03365.03
335432-3543273.17973.18
434724-3472471.71771.72
537551-3755177.55677.56
636493-3649375.37075.37
10min138392-3839279.29383.894.1880.0084.684.19
240085-4008582.78983.51
342231-4223187.22188.03
439658-3965881.90782.70
542972-4297288.75289.61
640382-4038283.40384.24
15min140626-4062683.90686.882.6985.5088.612.72
242460-4246087.69489.34
343004-4300488.81890.60
440990-4099084.65886.37
543506-4350689.85591.70
641820-4182086.37288.14
20min141608-4160885.93588.232.3588.4690.922.37
243249-4324989.32491.94
344051-4405190.98093.75
441683-4168386.09088.74
543428-4342889.69492.54
642303-4230387.37090.09
30min142398-4239887.56689.501.7891.0593.171.82
244009-4400990.89494.50
343995-4399590.86594.64
442719-4271988.22991.83
544080-4408091.04094.88
642817-4281788.43292.13
45min142508-4250887.79389.941.6992.2594.601.73
243921-4392190.71295.33
344489-4448991.88596.67
442884-4288488.57093.15
543918-4391890.70695.56
643558-4355889.96294.64
极限143939-4393990.74992.861.3096.1898.521.35
245455-4545593.88099.51
344772-4477292.46998.28
444977-4497792.89398.46
545573-4557394.12499.99
645053-4505393.05098.73
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%
113.981636631631301630771630771631171632130.16
213.981630171629981630080.01
单位质量响应值RSD%判断
11674.7511660.090.09数据可信
供试品溶液-2022081101批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min196248-9624853.47659.306.8153.4859.306.80
299492-9949255.27955.28
3110327-11032761.29961.30
4107970-10797059.98959.99
5111850-11185062.14562.14
6114514-11451463.62563.62
10min1131018-13101872.79575.943.9173.3976.603.91
2133972-13397274.43675.05
3143007-14300779.45680.14
4133308-13330874.06774.73
5143672-14367279.82580.52
6135104-13510475.06575.77
15min1138949-13894977.20179.302.7478.6080.802.75
2143652-14365279.81481.26
3146538-14653881.41882.98
4137520-13752076.40777.90
5147131-14713181.74783.32
6142523-14252379.18780.73
20min1141572-14157278.65980.532.8980.9282.922.89
2146016-14601681.12883.46
3150210-15021083.45885.93
4138920-13892077.18579.52
5148255-14825582.37284.86
6144682-14468280.38782.81
30min1143397-14339779.67381.912.4982.8185.192.50
2149264-14926482.93286.16
3150950-15095083.86987.26
4143017-14301779.46182.66
5151276-15127684.05087.45
6146618-14661881.46284.78
45min1144478-14447880.27382.782.5684.2986.972.57
2149937-14993783.30687.46
3153555-15355585.31689.64
4144396-14439680.22884.31
5151934-15193484.41688.75
6149621-14962183.13187.35
极限1161392-16139289.67192.311.6294.5897.421.65
2167498-16749893.06398.14
3165449-16544991.92597.20
4165715-16571592.07397.04
5169076-16907693.94099.21
6167705-16770593.17898.32
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%
110.764462744618445924463344582446100.05
210.834461944648446340.05
单位质量响应值RSD%判断
4145.914121.330.43数据可信
供试品溶液-2022081201批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137739-3773977.89680.8110.9877.9080.8110.98
232855-3285567.81567.81
340785-4078584.18384.18
437150-3715076.68076.68
545575-4557594.07094.07
640800-4080084.21484.21
10min142206-4220687.11691.197.6587.9892.097.68
239199-3919980.90981.66
345677-4567794.28095.22
442755-4275588.24989.10
548080-4808099.240100.29
647158-4715897.33798.27
15min142617-4261787.96491.996.2589.8093.906.31
240741-4074184.09285.74
345721-4572194.37196.35
443339-4333989.45591.29
547942-4794298.956101.10
647033-4703397.07999.10
20min142528-4252887.78192.205.9090.5995.135.97
241512-4151285.68488.27
345489-4548993.89296.92
443313-4331389.40192.23
548168-4816899.422102.67
646993-4699396.997100.09
30min142709-4270988.15492.484.8091.9496.444.90
242443-4244387.60591.14
345270-4527093.44097.52
443951-4395190.71894.54
547669-4766998.392102.74
646787-4678796.572100.75
45min143171-4317189.10892.743.8993.8797.734.03
243163-4316389.09193.60
345643-4564394.21099.32
443947-4394790.71095.54
547203-4720397.430102.88
646465-4646595.907101.15
极限145303-4530393.50895.282.0699.26101.292.24
246066-4606695.083100.59
345807-4580794.549100.71
445233-4523393.36499.20
547659-4765998.371104.90
646893-4689396.790103.10
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%
113.981631561632311632171631911629281631450.08
213.981631701634461633080.12
单位质量响应值RSD%判断
11669.8911681.550.08数据可信
供试品溶液-2022081201批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1110274-11027461.22668.1113.5061.2368.1213.50
2102664-10266457.00057.00
3127882-12788271.00271.00
4116168-11616864.49864.50
5148954-14895482.70182.70
6130152-13015272.26272.26
10min1134450-13445074.64883.449.9075.3384.209.93
2133388-13338874.05974.69
3156382-15638286.82587.61
4145771-14577180.93481.65
5169511-16951194.11595.03
6162230-16223090.07290.88
15min1136479-13647975.77584.939.0777.2886.619.12
2138692-13869277.00478.46
3158444-15844487.97089.72
4149441-14944182.97284.59
5171197-17119795.05197.02
6163529-16352990.79392.60
20min1136798-13679875.95285.308.9478.3087.928.98
2141148-14114878.36780.68
3158210-15821087.84090.57
4149269-14926982.87685.41
5172609-17260995.83598.86
6163720-16372090.90093.71
30min1138289-13828976.78085.828.1379.9889.408.20
2142917-14291779.34982.53
3158464-15846487.98191.69
4152387-15238784.60788.07
5171076-17107694.98499.07
6164320-16432091.23395.06
45min1141211-14121178.40286.407.1682.4590.937.28
2145087-14508780.55484.62
3160720-16072089.23493.92
4153022-15302284.96089.36
5169740-16974094.24299.38
6163953-16395391.02995.87
极限1167222-16722292.84494.082.3797.7699.572.57
2169852-16985294.30499.26
3164826-16482691.51497.19
4167190-16719092.82698.17
5176127-17612797.788103.98
6171510-17151095.225101.07
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%
110.764453544510445474452544535445300.04
210.834448344609445460.21
单位质量响应值RSD%判断
4138.484113.200.44数据可信
供试品溶液-2022081201批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137918-3791878.41379.982.8578.4179.982.85
239786-3978682.27682.28
337410-3741077.36277.36
440225-4022583.18483.18
538471-3847179.55779.56
638236-3823679.07179.07
10min141317-4131785.44289.653.8386.3190.543.81
244644-4464492.32293.24
342444-4244487.77388.63
444967-4496792.99093.91
544862-4486292.77393.66
641868-4186886.58187.46
15min141905-4190586.65889.942.7988.4891.822.79
243975-4397590.93992.88
342861-4286188.63590.47
444766-4476692.57494.53
544825-4482592.69694.61
642609-4260988.11489.95
20min142332-4233287.54190.352.6890.3293.232.69
244284-4428491.57894.53
342886-4288688.68791.51
444784-4478492.61295.60
545085-4508593.23496.18
642765-4276588.43691.26
30min142659-4265988.21790.632.1391.9794.522.15
244081-4408191.15895.13
343824-4382490.62694.43
444520-4452092.06696.08
545033-4503393.12797.11
642832-4283288.57592.38
45min142952-4295288.82391.502.4093.5696.402.41
245135-4513593.33798.32
343666-4366690.30095.11
444996-4499693.05098.09
545419-4541993.92598.94
643316-4331689.57694.36
极限145061-4506193.18494.191.3998.91100.101.42
245835-4583594.785100.80
345404-4540493.89499.71
445335-4533593.75199.82
546674-4667496.520102.58
644977-4497793.01198.79
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%
113.981631801628281628291631101631391630170.11
213.981628681630641629660.09
单位质量响应值RSD%判断
11660.7311657.080.03数据可信
供试品溶液-2022081201批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1118815-11881566.06367.153.3666.0667.153.36
2121846-12184667.74867.75
3117495-11749565.32965.33
4127955-12795571.14571.14
5121491-12149167.55167.55
6117004-11700465.05665.06
10min1137090-13709076.22481.055.6176.9681.805.58
2148264-14826482.43783.19
3142562-14256279.26679.99
4154836-15483686.09186.88
5154871-15487186.11086.86
6137004-13700476.17676.90
15min1139538-13953877.58582.435.1079.1784.085.08
2148138-14813882.36784.04
3146450-14645081.42883.03
4157190-15719087.40089.15
5156991-15699187.28989.00
6141191-14119178.50480.07
20min1139182-13918277.38782.825.3879.8385.395.35
2149570-14957083.16385.75
3146801-14680181.62384.13
4158040-15804087.87290.59
5158294-15829488.01490.69
6141881-14188178.88881.33
30min1142669-14266979.32683.524.4682.6387.004.46
2149947-14994783.37386.88
3150089-15008983.45286.87
4157584-15758487.61991.31
5157984-15798487.84191.50
6143013-14301379.51782.84
45min1144656-14465680.43184.864.4784.6189.274.48
2154808-15480886.07590.51
3150703-15070383.79388.14
4160073-16007389.00393.67
5159983-15998388.95393.58
6145495-14549580.89785.10
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