氨氯地平厄贝沙坦片项目信息
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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.181411781411461411481425771406231413340.52
214.241413591407231410410.32
单位质量响应值RSD%判断
9967.149904.560.45数据可信
供试品溶液-2025011811批-氨氯地平-盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min154078-5407835.28843.0014.4335.2943.0014.43
282716-8271653.97553.97
368676-6867644.81344.81
462405-6240540.72140.72
563436-6343641.39441.39
664047-6404741.79341.79
10min1127636-12763683.28790.534.8983.6891.004.92
2146146-14614695.36595.96
3137468-13746889.70290.20
4144303-14430394.16394.61
5141466-14146692.31192.77
6135371-13537188.33488.80
15min1153330-153330100.053102.331.62101.37103.811.63
2155538-155538101.494103.15
3159003-159003103.755105.25
4156838-156838102.342103.84
5160338-160338104.626106.11
6155830-155830101.684103.13
20min1157098-157098102.512103.471.43104.94106.091.38
2155058-155058101.181103.97
3160182-160182104.524107.17
4158004-158004103.103105.74
5161051-161051105.091107.74
6160023-160023104.420107.00
30min1156671-156671102.233104.982.77105.80108.752.69
2156075-156075101.844105.76
3166813-166813108.851112.66
4158469-158469103.406107.19
5162581-162581106.090109.91
6164673-164673107.455111.19
45min1157472-157472102.756104.091.97107.46109.031.91
2155230-155230101.293106.34
3164608-164608107.412112.43
4159685-159685104.200109.13
5159768-159768104.254109.25
6160344-160344104.630109.56
60min1157241-157241102.605104.561.84108.45110.651.80
2157424-157424102.724108.89
3160990-160990105.051111.26
4158777-158777103.607109.70
5164673-164673107.455113.61
6162272-162272105.888111.98
极限1160456-160456104.703103.531.90111.69110.791.75
2152761-15276199.682106.99
3158650-158650103.524110.90
4159260-159260103.922111.16
5160961-160961105.032112.38
6159880-159880104.327111.60
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100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%
110.181380045137910813751101381888138034913793000.19
210.191378405137927413788400.05
单位质量响应值RSD%判断
135491.16135313.050.10数据可信
供试品溶液-2025011811批-厄贝沙坦-盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1318018-31801821.13827.0817.7621.1427.0817.75
2534599-53459935.53435.53
3430383-43038328.60728.61
4377918-37791825.12025.12
5385251-38525125.60725.61
6398082-39808226.46026.46
10min11035673-103567368.84076.686.9469.0776.986.97
21260263-126026383.76884.16
31158617-115861777.01277.33
41214680-121468080.73881.02
51153759-115375976.68976.97
61098812-109881273.03773.33
15min11424335-142433594.67498.633.1395.6799.783.14
21498806-149880699.624100.95
31435759-143575995.43396.61
41549116-1549116102.968104.14
51493524-149352499.273100.41
61501148-150114899.779100.88
20min11531944-1531944101.826103.741.73103.88105.981.75
21562343-1562343103.847106.28
31526011-1526011101.432103.67
41594496-1594496105.984108.30
51568901-1568901104.283106.52
61580390-1580390105.046107.26
30min11557299-1557299103.512106.761.95106.69110.161.94
21588970-1588970105.617109.20
31621579-1621579107.784111.15
41617909-1617909107.540111.04
51602629-1602629106.525109.92
61648807-1648807109.594112.98
45min11581152-1581152105.097106.221.33109.43110.801.34
21583037-1583037105.222109.98
31583243-1583243105.236109.79
41634267-1634267108.628113.32
51594241-1594241105.967110.55
61612237-1612237107.163111.76
60min11578448-1578448104.917106.881.10110.42112.641.16
21616775-1616775107.465113.39
31602576-1602576106.521112.25
41617804-1617804107.533113.43
51602613-1602613106.524112.28
61629349-1629349108.301114.09
极限11623827-1623827107.934106.971.61114.60113.931.49
21574302-1574302104.642111.76
31583277-1583277105.238112.15
41636851-1636851108.799115.89
51607114-1607114106.823113.77
61630760-1630760108.395115.39
氨氯地平厄贝沙坦片项目信息
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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.181405681414211410231406441420561411420.44
214.241416881416171416520.04
单位质量响应值RSD%判断
9953.609947.470.05数据可信
供试品溶液-2025011811批-氨氯地平-盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min158928-5892838.39542.4210.3138.4042.4210.31
257413-5741337.40837.41
364274-6427441.87941.88
465259-6525942.52042.52
569053-6905344.99244.99
675669-7566949.30349.30
10min1133784-13378487.16989.922.1687.6090.392.18
2135469-13546988.26788.68
3141563-14156392.23792.70
4137639-13763989.68190.15
5139243-13924390.72691.23
6140353-14035391.44992.00
15min1152455-15245599.334100.100.91100.73101.570.92
2153512-153512100.023101.42
3153770-153770100.191101.68
4155591-155591101.378102.85
5151793-15179398.903100.41
6154633-154633100.753102.32
20min1164473-164473107.165101.783.02109.66104.362.89
2156276-156276101.824104.33
3155829-155829101.533104.14
4157150-157150102.393104.99
5152677-15267799.479102.09
6150805-15080598.259100.94
30min1155454-155454101.288101.340.77104.98105.050.72
2156147-156147101.740105.38
3155238-155238101.148104.88
4156004-156004101.647105.38
5156931-156931102.251105.96
6153419-15341999.962103.74
45min1156829-156829102.184101.420.54107.00106.260.52
2155266-155266101.166105.94
3154378-154378100.587105.44
4156227-156227101.792106.65
5155570-155570101.364106.21
6155686-155686101.439106.33
60min1156445-156445101.934100.941.84107.88106.901.75
2152325-15232599.249105.14
3152020-15202099.051105.02
4159647-159647104.020110.01
5154949-154949100.959106.93
6154142-154142100.433106.45
极限1154054-154054100.376100.700.58107.46107.800.57
2153526-153526100.032107.03
3155936-155936101.602108.68
4154935-154935100.950108.10
5153911-153911100.283107.38
6154991-154991100.987108.12
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100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%
110.181371851137209913738391371263137486913727840.11
210.191384256138833213862940.21
单位质量响应值RSD%判断
134851.08136044.550.63数据可信
供试品溶液-2025011811批-厄贝沙坦-盐酸溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1360993-36099323.98727.0011.8123.9927.0111.81
2353218-35321823.47023.47
3398311-39831126.46726.47
4407512-40751227.07827.08
5437152-43715229.04829.05
6481287-48128731.98031.98
10min11091419-109141972.52276.163.1772.7976.463.20
21116762-111676274.20674.47
31185917-118591778.80179.10
41144114-114411476.02476.32
51162728-116272877.26077.58
61175833-117583378.13178.49
15min11474900-147490098.00397.361.1499.0898.501.15
21456074-145607496.75397.84
31458359-145835996.90498.07
41450670-145067096.39397.54
51456351-145635196.77197.95
61494656-149465699.316100.54
20min11572936-1572936104.518101.871.54106.68104.101.46
21544224-1544224102.610104.77
31537080-1537080102.135104.38
41514886-1514886100.660102.88
51518651-1518651100.911103.17
61510482-1510482100.368102.69
30min11567850-1567850104.180103.650.71107.50107.000.67
21572971-1572971104.520107.82
31552691-1552691103.173106.55
41544143-1544143102.605105.94
51566412-1566412104.084107.46
61554764-1554764103.310106.75
45min11597137-1597137106.126104.591.03110.61109.100.99
21579812-1579812104.975109.44
31566586-1566586104.096108.62
41548212-1548212102.875107.35
51575909-1575909104.715109.25
61576487-1576487104.754109.34
60min11592319-1592319105.806104.421.24111.46110.091.18
21546922-1546922102.789108.42
31548231-1548231102.876108.56
41586913-1586913105.446111.06
51575296-1575296104.675110.37
61578958-1578958104.918110.67
极限11576807-1576807104.775104.840.79111.61111.680.78
21570462-1570462104.353111.12
31583822-1583822105.241112.07
41557569-1557569103.497110.29
51586905-1586905105.446112.31
61591227-1591227105.733112.65
氨氯地平厄贝沙坦片项目信息
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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.181347651348421362651351661361391354350.53
214.241343181345301344240.12
单位质量响应值RSD%判断
9551.139439.890.83数据可信
供试品溶液-2025011811批-氨氯地平-pH4.5(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145912-4591231.34933.6743.6231.3533.6743.62
221692-2169214.81214.81
325889-2588917.67717.68
468370-6837046.68446.68
566080-6608045.12045.12
667891-6789146.35746.36
10min1117852-11785280.47178.787.2780.8279.167.42
2100386-10038668.54568.71
3110990-11099075.78575.98
4119382-11938281.51582.03
5122725-12272583.79884.30
6120953-12095382.58883.10
15min1144827-14482798.88998.887.53100.13100.127.62
2123411-12341184.26685.19
3146568-146568100.078101.12
4152951-152951104.437105.86
5150037-150037102.447103.88
6151051-151051103.139104.57
20min1146486-146486100.022102.286.34102.36104.626.45
2132473-13247390.45492.32
3150945-150945103.067105.22
4159010-159010108.574111.16
5155503-155503106.179108.75
6154308-154308105.363107.94
30min1148161-148161101.166103.736.16104.62107.226.28
2135439-13543992.47995.35
3150981-150981103.091106.39
4158384-158384108.146111.94
5159197-159197108.701112.45
6159370-159370108.820112.57
45min1151769-151769103.629104.625.92108.21109.266.06
2136525-13652593.22197.12
3152193-152193103.919108.36
4161044-161044109.963114.96
5160254-160254109.423114.38
6157513-157513107.552112.51
60min1152080-152080103.842106.603.98109.57112.404.19
2147869-147869100.967105.90
3152448-152448104.093109.69
4161754-161754110.447116.66
5163511-163511111.647117.82
6159028-159028108.586114.74
极限1152055-152055103.825107.633.33110.71114.623.47
2155376-155376106.092112.15
3152212-152212103.932110.68
4164602-164602112.392119.83
5162116-162116110.695118.11
6159448-159448108.873116.23
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100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%
110.181391679139293413909791393255139157713920850.07
210.191393571139678013951760.17
单位质量响应值RSD%判断
136747.05136916.190.09数据可信
供试品溶液-2025011811批-厄贝沙坦-pH4.5(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1207712-20771213.66214.3643.8213.6614.3643.82
295566-955666.2866.29
3111749-1117497.3507.35
4300687-30068719.77719.78
5296143-29614319.47919.48
6298252-29825219.61719.62
10min1699635-69963546.01844.469.0946.1744.629.20
2562286-56228636.98437.05
3649852-64985242.74442.83
4711103-71110346.77246.99
5725985-72598547.75147.97
6707239-70723946.51846.74
15min11057166-105716669.53467.787.1670.2068.447.22
2883410-88341058.10658.59
31047315-104731568.88669.44
41044081-104408168.67469.41
51087608-108760871.53772.28
61063715-106371569.96570.70
20min11214195-121419579.86379.405.2681.3080.805.34
21080006-108000671.03772.16
31237580-123758081.40182.72
41230400-123040080.92982.43
51250527-125052782.25383.79
61229960-122996080.90082.41
30min11368278-136827889.99891.734.8692.3294.024.93
21267837-126783783.39185.31
31425819-142581993.78296.01
41423447-142344793.62696.03
51439710-143971094.69697.15
61442395-144239594.87397.28
45min11502674-150267498.83799.745.31102.16103.045.36
21362630-136263089.62692.47
31555711-1555711102.326105.59
41538728-1538728101.209104.65
51590566-1590566104.618108.13
61547648-1547648101.795105.26
60min11567897-1567897103.127104.653.13107.55109.063.26
21502133-150213398.802102.64
31624813-1624813106.871111.28
41597049-1597049105.045109.61
51636576-1636576107.645112.32
61617578-1617578106.395110.99
极限11604904-1604904105.561107.621.60111.13113.201.77
21600841-1600841105.294110.23
31654890-1654890108.849114.44
41646666-1646666108.308114.04
51659501-1659501109.153115.02
61650055-1650055108.531114.31
氨氯地平厄贝沙坦片项目信息
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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.181356881346131344501350871349291349530.36
214.241364501360561362530.21
单位质量响应值RSD%判断
9517.149568.330.38数据可信
供试品溶液-2025011811批-氨氯地平-pH4.5(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134176-3417623.22031.3726.3823.2231.3726.38
246309-4630931.46331.46
363634-6363443.23443.23
440359-4035927.42027.42
534905-3490523.71523.71
657664-5766439.17839.18
10min1106843-10684372.59177.224.8772.8577.564.95
2113214-11321476.91977.27
3117337-11733779.72080.20
4115743-11574378.63778.94
5107776-10777673.22473.49
6121001-12100182.21082.64
15min1131215-13121589.14996.824.7690.2198.034.81
2145578-14557898.908100.11
3144286-14428698.03099.40
4142648-14264896.91798.10
5139733-13973394.93696.01
6151568-151568102.977104.33
20min1133415-13341590.644101.366.0992.70103.646.09
2152862-152862103.856106.16
3153848-153848104.526106.98
4157629-157629107.095109.35
5143373-14337397.40999.54
6153967-153967104.607107.10
30min1141657-14165796.244103.334.0599.31106.744.12
2157551-157551107.042110.50
3155158-155158105.416109.03
4152649-152649103.712107.16
5148271-148271100.737103.95
6157219-157219106.817110.47
45min1146415-14641599.476104.963.40103.61109.523.49
2156324-156324106.209110.86
3155565-155565105.693110.48
4157768-157768107.190111.79
5150152-150152102.015106.35
6160663-160663109.157114.00
60min1147996-147996100.550104.953.14105.79110.673.23
2154409-154409104.907110.73
3155503-155503105.651111.61
4158289-158289107.544113.33
5149903-149903101.846107.31
6160688-160688109.174115.23
极限1152921-152921103.897106.821.60110.25113.701.74
2158324-158324107.567114.56
3155899-155899105.920113.06
4158891-158891107.953114.94
5157378-157378106.925113.52
6159894-159894108.634115.90
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100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%
110.181393572139221413918631390170139083913917320.10
210.191387231138749813873640.02
单位质量响应值RSD%判断
136712.38136149.560.30数据可信
供试品溶液-2025011811批-厄贝沙坦-pH4.5(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1162456-16245610.71713.8025.7010.7213.8025.70
2215001-21500114.18314.18
3292441-29244119.29219.29
4179039-17903911.81111.81
5156607-15660710.33110.33
6249511-24951116.46016.46
10min1629813-62981341.54743.576.0841.6743.726.13
2668498-66849844.09944.26
3699942-69994246.17446.39
4667620-66762044.04144.17
5597619-59761939.42439.54
6698911-69891146.10646.29
15min1952627-95262762.84365.833.8863.4266.473.94
21013746-101374666.87567.52
31021043-102104367.35668.08
4990024-99002465.31065.93
5957772-95777263.18263.73
61052346-105234669.42170.12
20min11111646-111164673.33378.374.9474.6179.744.95
21215408-121540880.17881.57
31233934-123393481.40082.88
41247607-124760782.30283.65
51118673-111867373.79675.05
61200720-120072079.20980.68
30min11321574-132157487.18190.733.5689.2792.973.59
21433044-143304494.53596.82
31406048-140604892.75495.13
41399247-139924792.30594.57
51310652-131065286.46188.54
61381349-138134991.12493.47
45min11443634-144363495.23399.453.6098.30102.703.63
21535783-1535783101.312104.64
31526197-1526197100.680104.09
41559065-1559065102.848106.13
51434638-143463894.64097.68
61546366-1546366102.010105.37
60min11541224-1541224101.671104.002.83105.79108.352.87
21607822-1607822106.064110.52
31598383-1598383105.442109.97
41623291-1623291107.085111.51
51506112-150611299.355103.44
61582543-1582543104.397108.89
极限11618197-1618197106.749107.711.52112.00113.221.53
21656421-1656421109.270114.91
31620169-1620169106.879112.58
41671275-1671275110.250115.87
51617981-1617981106.734111.93
61612568-1612568106.377112.03
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