培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.231621961626431618541614701618641620050.28
216.251627551626361626960.06
单位质量响应值RSD%判断
9981.8210012.060.22数据可信
长期9月-供试品溶液-2023110721批-培哚普利-pH2.0(内含0.19%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1156961-15696197.93590.548.5497.9390.548.54
2132932-13293282.94282.94
3128868-12886880.40680.41
4141631-14163188.37088.37
5156279-15627997.50997.51
6153939-15393996.04996.05
10min1161629-161629100.84799.051.39101.2499.411.40
2155956-15595697.30897.64
3158394-15839498.82999.15
4158763-15876399.05999.41
5160868-160868100.372100.76
6156894-15689497.89398.28
15min1161458-161458100.74098.881.43101.5499.631.43
2157039-15703997.98398.70
3158372-15837298.81599.53
4159026-15902699.22399.97
5159914-15991499.777100.57
6155001-15500196.71297.49
20min1160635-160635100.22798.361.70101.4399.521.70
2156236-15623697.48298.60
3156939-15693997.92199.03
4158577-15857798.943100.09
5160054-16005499.864101.06
6153462-15346295.75196.91
30min1160116-16011699.90398.201.50101.5099.741.50
2156414-15641497.59399.10
3158392-15839298.827100.33
4157644-15764498.36199.90
5158486-15848698.886100.48
6153247-15324795.61797.16
45min1160407-160407100.08598.491.15102.08100.441.16
2157141-15714198.04799.94
3157846-15784698.487100.39
4158319-15831998.782100.72
5158531-15853198.914100.90
6154899-15489996.64898.58
60min1159536-15953699.54198.071.04101.94100.411.06
2156275-15627597.50799.79
3156819-15681997.846100.14
4157369-15736998.189100.52
5158282-15828298.759101.14
6154828-15482896.60498.92
极限1159761-15976199.68298.001.34102.48100.721.34
2155566-15556697.06499.74
3157621-15762198.346101.03
4157077-15707798.007100.73
5158454-15845498.866101.64
6153885-15388596.01598.72
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.253016343027203021823023733027223023260.15
212.293033143034133033640.03
单位质量响应值RSD%判断
24679.6724683.810.02数据可信
长期9月-供试品溶液-2023110721批-吲达帕胺-pH2.0(内含0.19%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min191389-9138929.08827.489.4429.0927.489.45
287441-8744127.83227.83
369915-6991522.25322.25
490282-9028228.73628.74
589795-8979528.58128.58
689107-8910728.36228.36
10min1173145-17314555.11153.443.0955.2353.543.11
2164765-16476552.44352.55
3158888-15888850.57350.66
4170556-17055654.28754.40
5170062-17006254.12954.24
6169894-16989454.07654.19
15min1211500-21150067.31965.931.6467.6666.261.66
2203709-20370964.83965.16
3202975-20297564.60564.90
4210088-21008866.86967.20
5207920-20792066.17966.51
6206655-20665565.77766.11
20min1237147-23714775.48273.092.6276.0973.682.63
2226755-22675572.17472.75
3219752-21975269.94570.50
4232204-23220473.90974.51
5232981-23298174.15674.75
6228928-22892872.86673.46
30min1264750-26475084.26881.931.8285.1882.811.82
2252134-25213480.25281.12
3256075-25607581.50782.34
4258815-25881582.37983.27
5259555-25955582.61483.51
6253009-25300980.53181.42
45min1285059-28505990.73287.971.8891.9889.181.88
2272217-27221786.64487.83
3276238-27623887.92489.08
4275977-27597787.84189.07
5278463-27846388.63389.86
6270308-27030886.03787.24
60min1295381-29538194.01790.952.0995.6392.512.08
2282404-28240489.88791.42
3286520-28652091.19792.70
4285493-28549390.87092.45
5287379-28737991.47093.05
6277334-27733488.27389.82
极限1302073-30207396.14793.022.0898.1394.942.07
2290180-29018092.36294.26
3291248-29124892.70294.57
4290432-29043292.44294.38
5295559-29555994.07496.02
6283964-28396490.38392.29
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.231626471622011623081617351618571621500.23
216.251629881636961633420.31
单位质量响应值RSD%判断
9990.7610051.820.44数据可信
长期9月-供试品溶液-2023110821批-培哚普利-pH2.0(内含0.19%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1100192-10019262.36370.5329.7762.3670.5329.77
2152884-15288495.16095.16
3108127-10812767.30267.30
491003-9100356.64356.64
5155234-15523496.62296.62
672451-7245145.09645.10
10min1163240-163240101.60699.472.21101.8699.752.14
2156600-15660097.47397.85
3162377-162377101.068101.34
4162028-162028100.851101.08
5154498-15449896.16496.55
6160107-16010799.65699.84
15min1163267-163267101.62299.111.83102.2899.791.77
2156713-15671397.54398.31
3161105-161105100.277100.95
4159844-15984499.492100.12
5155240-15524096.62697.40
6159213-15921399.09999.68
20min1162410-162410101.08999.122.10102.15100.192.04
2155555-15555596.82297.98
3162721-162721101.283102.36
4160249-16024999.744100.77
5154887-15488796.40697.56
6159628-15962899.357100.33
30min1161942-161942100.79898.891.92102.26100.371.85
2156505-15650597.41498.96
3161510-161510100.529102.01
4159824-15982499.479100.91
5154085-15408595.90797.45
6159433-15943399.236100.61
45min1161577-161577100.57198.601.90102.44100.471.84
2156216-15621697.23499.17
3161741-161741100.673102.55
4157898-15789898.281100.11
5154101-15410195.91797.84
6158977-15897798.952100.72
60min1161116-161116100.28498.191.77102.56100.451.71
2155289-15528996.65798.98
3160406-16040699.842102.13
4157816-15781698.230100.45
5153973-15397395.83898.15
6157881-15788198.270100.44
极限1167765-167765104.42298.793.25107.10101.453.17
2155186-15518696.59399.31
3161176-161176100.321103.00
4157161-15716197.822100.43
5153323-15332395.43398.13
6157714-15771498.166100.72
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.253041023037783035493035353030943036120.13
212.293040173052573046370.29
单位质量响应值RSD%判断
24784.6524787.390.01数据可信
长期9月-供试品溶液-2023110821批-吲达帕胺-pH2.0(内含0.19%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min156841-5684118.01620.5432.8618.0220.5432.87
275948-7594824.07224.07
367058-6705821.25421.25
446059-4605914.59914.60
5100002-10000231.69631.70
642823-4282313.57313.57
10min1155835-15583549.39250.496.7049.4650.576.74
2165053-16505352.31452.41
3161732-16173251.26151.35
4151123-15112347.89947.96
5175942-17594255.76555.89
6146123-14612346.31446.37
15min1202361-20236164.13964.383.7864.4164.663.82
2206462-20646265.43965.74
3208067-20806765.94766.24
4194078-19407861.51461.76
5213230-21323067.58467.93
6194507-19450761.65061.89
20min1226699-22669971.85371.992.7072.3872.542.75
2228134-22813472.30872.88
3233323-23332373.95274.51
4219799-21979969.66670.16
5234320-23432074.26874.89
6220568-22056869.91070.40
30min1254970-25497080.81381.002.1781.6381.832.22
2257279-25727981.54582.40
3261684-26168482.94183.79
4248046-24804678.61979.39
5260996-26099682.72383.64
6250377-25037779.35880.12
45min1276678-27667887.69487.721.6488.8388.881.68
2277672-27767288.00989.19
3282211-28221189.44890.63
4269602-26960285.45186.54
5280447-28044788.88890.14
6274008-27400886.84887.93
60min1283634-28363489.89990.531.8791.3992.041.90
2286428-28642890.78492.32
3293149-29314992.91494.45
4278757-27875788.35389.78
5290016-29001691.92193.53
6281855-28185589.33590.77
极限1292617-29261792.74693.171.6494.5995.041.66
2294355-29435593.29795.19
3300822-30082295.34697.26
4286326-28632690.75292.54
5296573-29657394.00095.97
6293102-29310292.90094.69
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.231616781623511623041621881619831621010.18
216.251634441639601637020.23
单位质量响应值RSD%判断
9987.7410073.970.61数据可信
长期9月-供试品溶液-2023110822批-培哚普利-pH2.0(内含0.19%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1155077-15507796.43491.698.5496.4391.698.54
2127416-12741679.23379.23
3151023-15102393.91393.91
4158610-15861098.63198.63
5136449-13644984.85084.85
6156104-15610497.07297.07
10min1157787-15778798.11999.241.2898.5099.601.26
2159743-15974399.33599.65
3157862-15786298.16598.54
4162147-162147100.830101.22
5161926-161926100.693101.03
6158060-15806098.28898.68
15min1157436-15743697.90099.041.4598.6899.811.44
2159170-15917098.97999.69
3157612-15761298.01098.78
4162393-162393100.983101.78
5161820-161820100.627101.37
6157212-15721297.76198.54
20min1157170-15717097.73598.841.4098.90100.001.39
2158920-15892098.82399.93
3157078-15707897.67898.84
4162030-162030100.757101.96
5161289-161289100.296101.44
6157206-15720697.75798.93
30min1156432-15643297.27698.521.5398.84100.081.51
2158683-15868398.676100.18
3156132-15613297.09098.64
4161933-161933100.697102.30
5160634-16063499.889101.43
6156796-15679697.50299.07
45min1156136-15613697.09298.691.5799.04100.641.55
2158982-15898298.862100.76
3156577-15657797.36699.31
4161935-161935100.698102.71
5161326-161326100.319102.26
6157238-15723897.77799.73
60min1156068-15606897.05098.211.5799.39100.551.56
2158313-15831398.446100.74
3155790-15579096.87799.21
4161610-161610100.496102.91
5160002-16000299.496101.84
6155784-15578496.87399.22
极限1155763-15576396.86098.011.5499.59100.751.53
2157463-15746397.917100.61
3155749-15574996.85199.57
4161317-161317100.314103.13
5159802-15980299.372102.12
6155618-15561896.77099.50
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.253038463042453045053049213046273044290.14
212.293059643069243064440.23
单位质量响应值RSD%判断
24851.3524934.420.24数据可信
长期9月-供试品溶液-2023110822批-吲达帕胺-pH2.0(内含0.19%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min193402-9340229.47725.8116.1429.4825.8116.15
266806-6680621.08421.08
377659-7765924.50924.51
4100064-10006431.58031.58
569240-6924021.85221.85
683489-8348926.34926.35
10min1169708-16970853.55951.374.5253.6851.474.54
2158517-15851750.02750.11
3154084-15408448.62848.73
4173358-17335854.71154.84
5158869-15886950.13850.23
6162013-16201351.13051.24
15min1205407-20540764.82563.713.3265.1664.023.33
2202005-20200563.75164.04
3191636-19163660.47960.77
4211906-21190666.87667.22
5200499-20049963.27663.56
6199885-19988563.08263.39
20min1228456-22845672.09971.192.7172.6971.752.73
2227165-22716571.69272.23
3216045-21604568.18268.72
4234114-23411473.88574.50
5225507-22550771.16871.71
6222123-22212370.10070.66
30min1254182-25418280.21879.712.5781.1080.562.57
2258279-25827981.51182.34
3242117-24211776.41077.22
4258772-25877281.66782.57
5254382-25438280.28181.11
6247686-24768678.16879.01
45min1272919-27291986.13186.082.9687.3387.242.94
2280463-28046388.51289.66
3262277-26227782.77383.89
4281181-28118188.73989.97
5275605-27560586.97988.13
6264071-26407183.33984.49
60min1282911-28291189.28589.342.8990.8390.852.88
2292660-29266092.36193.87
3273240-27324086.23387.68
4290002-29000291.52393.11
5285983-28598390.25491.75
6273663-27366386.36687.85
极限1289880-28988091.48491.563.0493.3993.433.02
2300525-30052594.84496.72
3284343-28434389.73791.53
4296772-29677293.65995.62
5293028-29302892.47894.33
6276184-27618487.16289.00
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