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%
114.181364091363571353721362751364101361650.33
214.241355771364301360040.45
单位质量响应值RSD%判断
9602.619550.840.39数据可信
供试品溶液-2025011111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%
5min169061-6906146.75429.5938.0946.7529.5938.09
223032-2303215.59315.59
347040-4704031.84631.85
454384-5438436.81836.82
537193-3719325.18025.18
631548-3154821.35821.36
10min1113658-11365876.94773.968.5477.4774.298.59
294198-9419863.77263.95
3101516-10151668.72669.08
4118670-11867080.34080.75
5113724-11372476.99177.27
6113719-11371976.98877.23
15min1130612-13061288.42592.192.7689.8093.342.55
2140781-14078195.30996.19
3135734-13573491.89293.01
4133228-13322890.19691.50
5138468-13846893.74394.88
6138239-13823993.58894.68
20min1134989-13498991.38895.643.6993.7497.823.49
2146777-14677799.368101.31
3138201-13820193.56295.70
4136876-13687692.66594.97
5144191-14419197.61899.79
6146599-14659999.248101.38
30min1139675-13967594.56097.653.3697.93100.883.18
2148363-148363100.442103.49
3142625-14262596.55799.74
4138623-13862393.84897.18
5145221-14522198.315101.58
6150888-150888102.151105.39
45min1142501-14250196.47397.112.59100.90101.442.48
2143417-14341797.094101.25
3142297-14229796.335100.59
4138655-13865593.87098.25
5143765-14376597.329101.68
6150044-150044101.580105.95
60min1141546-14154695.82797.023.66101.32102.423.50
2142223-14222396.285101.52
3142874-14287496.726102.05
4136728-13672892.56597.98
5143747-14374797.317102.75
6152763-152763103.421108.92
极限1140620-14062095.20096.854.20101.76103.323.97
2146664-14666499.292105.60
3141147-14114795.557101.95
4135449-13544991.69998.15
5141533-14153395.818102.33
6152899-152899103.513110.16
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%
110.181410743140556214046621406085140917914072460.19
210.191383738138843213860850.24
单位质量响应值RSD%判断
138236.35136024.041.15数据可信
供试品溶液-2025011111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%
5min1260795-26079517.11710.7839.6217.1210.7839.64
283549-835495.4845.48
3175233-17523311.50111.50
4213125-21312513.98913.99
5124155-1241558.1498.15
6129027-1290278.4698.47
10min1602757-60275739.56237.3810.6139.7537.5010.66
2476735-47673531.29131.35
3538746-53874635.36135.49
4644729-64472942.31742.47
5546845-54684535.89235.98
6606909-60690939.83539.93
15min1855558-85555856.15558.843.5956.7859.383.49
2933197-93319761.25161.66
3900047-90004759.07559.60
4897817-89781758.92959.55
5863705-86370556.69057.18
6928764-92876460.96061.50
20min11011833-101183366.41270.333.8567.6771.523.72
21135019-113501974.49775.59
31076130-107613070.63271.81
41060405-106040569.60070.88
51053697-105369769.16070.28
61092516-109251671.70872.92
30min11207439-120743979.25182.793.3681.2484.763.26
21336712-133671287.73689.65
31269718-126971883.33885.30
41248864-124886481.97084.02
51249679-124967982.02383.91
61255736-125573682.42184.43
45min11355458-135545888.96691.943.1991.8494.833.09
21477623-147762396.98499.88
31422651-142265193.37696.26
41385113-138511390.91293.88
51399223-139922391.83894.64
61364759-136475989.57692.50
60min11418264-141826493.08895.952.6296.9599.862.54
21519893-151989399.759103.73
31490240-149024097.812101.74
41444654-144465494.82098.79
51466619-146661996.262100.08
61431550-143155093.96097.88
极限11469370-146937096.44398.762.39101.34103.742.33
21570764-1570764103.098108.18
31517609-151760999.609104.62
41490995-149099597.862102.89
51487928-148792897.661102.55
61491390-149139097.888102.85
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%
114.181359421352601354071361181351901355830.31
214.241360991377331369160.85
单位质量响应值RSD%判断
9561.579614.890.40数据可信
供试品溶液-2025011211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%
5min131859-3185921.54334.1532.8121.5434.1532.81
252390-5239035.42635.43
341813-4181328.27428.27
476642-7664251.82551.82
561596-6159641.65141.65
638701-3870126.16926.17
10min1115018-11501877.77480.077.3378.0180.457.44
2115183-11518377.88678.28
3115767-11576778.28078.59
4134065-13406590.65391.23
5121645-12164582.25582.72
6108810-10881073.57673.87
15min1140113-14011394.74397.402.1095.8598.662.22
2144396-14439697.63998.90
3140893-14089395.27096.45
4147880-14788099.995101.58
5146209-14620998.865100.24
6144730-14473097.86598.97
20min1146703-14670399.199100.932.45101.36103.282.35
2149024-149024100.768103.11
3146808-14680899.270101.51
4147469-14746999.717102.41
5149232-149232100.909103.38
6156368-156368105.734107.93
30min1150576-150576101.818103.302.50105.08106.772.44
2151428-151428102.394105.86
3149345-149345100.986104.33
4153652-153652103.898107.70
5151621-151621102.525106.12
6159986-159986108.181111.55
45min1150061-150061101.470102.453.52105.86107.073.41
2143431-14343196.987101.59
3150626-150626101.852106.32
4153931-153931104.087109.04
5151269-151269102.287107.02
6159726-159726108.005112.58
60min1151651-151651102.545102.441.92108.06108.201.74
2150654-150654101.871107.55
3153170-153170103.572109.17
4149128-149128100.839106.95
5148180-148180100.198106.07
6156178-156178105.606111.38
极限1153545-153545103.826102.881.94110.48109.781.74
2152096-152096102.846109.66
3153061-153061103.498110.25
4149941-149941101.389108.62
5147911-147911100.016107.00
6156357-156357105.727112.67
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%
110.181392932138922713857601392567139196913904910.22
210.191396841139782413973320.05
单位质量响应值RSD%判断
136590.47137127.770.28数据可信
供试品溶液-2025011211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%
5min1128899-1288998.47714.0136.218.4814.0136.20
2218267-21826714.35414.35
3175773-17577311.55911.56
4344433-34443322.65022.65
5249519-24951916.40916.41
6161482-16148210.61910.62
10min1611191-61119140.19343.5813.8140.2943.7313.87
2619409-61940940.73340.89
3621863-62186340.89541.02
4843496-84349655.46955.72
5670661-67066144.10444.29
6609135-60913540.05840.18
15min1933097-93309761.36263.514.8461.9064.154.98
2955916-95591662.86263.47
3936061-93606161.55762.14
41047765-104776568.90269.77
5993150-99315065.31165.98
6928483-92848361.05861.62
20min11098040-109804072.20974.162.5373.4375.512.68
21117555-111755573.49274.80
31106184-110618472.74474.01
41171400-117140077.03378.67
51152916-115291675.81777.22
61120612-112061273.69374.93
30min11262657-126265783.03485.843.1185.0688.003.20
21279588-127958884.14786.27
31270752-127075283.56685.64
41357415-135741589.26591.75
51346790-134679088.56790.81
61314500-131450086.44388.50
45min11367641-136764189.93893.073.7792.8996.193.81
21348723-134872388.69491.76
31393935-139393591.66794.67
41475823-147582397.052100.53
51469742-146974296.65299.88
61435662-143566294.41197.43
60min11438717-143871794.61296.291.1598.56100.441.28
21466755-146675596.456100.50
31451939-145193995.48199.50
41478387-147838797.221101.78
51483790-148379097.576101.87
61465469-146546996.371100.44
极限11505175-150517598.98299.900.90103.98105.130.97
21515294-151529499.648104.77
31530136-1530136100.624105.71
41520964-1520964100.021105.66
51538423-1538423101.169106.55
61504703-150470398.951104.09
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%
114.181413361416051409421412851409131412160.21
214.241414661399691407180.76
单位质量响应值RSD%判断
9958.829881.880.55数据可信
供试品溶液-2025011111批-氨氯地平-0.05molhcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min155811-5581136.47641.9314.2436.4841.9314.25
276606-7660650.06650.07
362801-6280141.04441.04
470476-7047646.06046.06
552210-5221034.12234.12
666999-6699943.78843.79
10min1127019-12701983.01487.773.5683.4288.243.59
2135044-13504488.25988.82
3139365-13936591.08391.54
4136909-13690989.47889.99
5130047-13004784.99385.37
6137397-13739789.79790.28
15min1156143-156143102.048103.461.46103.38104.901.46
2155881-155881101.877103.41
3162239-162239106.032107.50
4158696-158696103.717105.22
5158017-158017103.273104.60
6158814-158814103.794105.28
20min1156888-156888102.535102.091.06105.00104.681.03
2155647-155647101.724104.39
3157231-157231102.759105.41
4153699-153699100.451103.11
5155391-155391101.557104.03
6158381-158381103.511106.15
30min1157327-157327102.822103.312.08106.42107.032.06
2155722-155722101.773105.57
3161129-161129105.307109.09
4156987-156987102.600106.37
5154357-154357100.881104.48
6162907-162907106.469110.26
45min1157319-157319102.817101.951.75107.56106.821.70
2155930-155930101.909106.84
3160141-160141104.661109.62
4152534-15253499.690104.60
5153574-153574100.369105.09
6156437-156437102.240107.21
60min1153595-153595100.383102.011.55106.27108.021.53
2154208-154208100.784106.85
3156353-156353102.186108.31
4156216-156216102.096108.12
5155650-155650101.726107.56
6160461-160461104.870110.98
极限1156802-156802102.479100.971.65109.48108.111.59
2154475-154475100.958108.14
3157192-157192102.734109.99
4152136-15213699.429106.59
5150893-15089398.617105.58
6155475-155475101.612108.88
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%
110.181369860137882713718751380107137660613754550.33
210.191369384137769613735400.43
单位质量响应值RSD%判断
135113.46134792.930.17数据可信
供试品溶液-2025011111批-厄贝沙坦-0.05molhcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1297452-29745219.83723.4317.7519.8423.4317.75
2435912-43591229.07129.07
3332440-33244022.17022.17
4396788-39678826.46226.46
5271143-27114318.08218.08
6374041-37404124.94524.94
10min1982854-98285465.54669.664.8365.7769.924.87
21093048-109304872.89573.22
31048591-104859169.93070.18
41083895-108389572.28572.58
5981964-98196465.48765.69
61076723-107672371.80772.08
15min11409969-140996994.03196.151.3494.9897.181.40
21458868-145886897.29298.42
31446080-144608096.43997.46
41456662-145666297.14598.24
51427355-142735595.19096.12
61451753-145175396.81797.89
20min11509567-1509567100.673100.721.20102.67102.821.21
21536660-1536660102.480104.69
31486755-148675599.152101.25
41495236-149523699.717101.89
51510673-1510673100.747102.73
61522733-1522733101.551103.70
30min11566722-1566722104.485104.641.85107.60107.861.86
21578263-1578263105.254108.61
31549544-1549544103.339106.54
41578240-1578240105.253108.54
51528107-1528107101.909105.01
61613475-1613475107.602110.88
45min11566035-1566035104.439103.740.93108.71108.130.94
21578427-1578427105.265109.79
31549968-1549968103.367107.71
41554712-1554712103.684108.14
51539213-1539213102.650106.89
61545383-1545383103.061107.54
60min11568791-1568791104.622104.651.77110.06110.191.75
21586537-1586537105.806111.50
31523189-1523189101.581107.07
41591269-1591269106.122111.73
51551919-1551919103.497108.88
61593921-1593921106.298111.92
极限11583241-1583241105.586103.901.95112.18110.601.90
21603410-1603410106.931113.80
31521705-1521705101.482108.10
41553814-1553814103.624110.41
51535550-1535550102.406108.93
61550099-1550099103.376110.18
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%
114.181394371408141399841403511397251400620.39
214.241429821425981427900.20
单位质量响应值RSD%判断
9877.4310027.391.07数据可信
供试品溶液-2025011111批-氨氯地平-0.05molhcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min162384-6238440.64242.6215.8440.6442.6215.84
251186-5118633.34733.35
375414-7541449.13149.13
478476-7847651.12551.13
558191-5819137.91037.91
666911-6691143.59143.59
10min1134333-13433387.51588.964.3787.9789.434.41
2125559-12555981.79982.17
3137781-13778189.76190.31
4141144-14114491.95292.52
5141328-14132892.07292.49
6139154-13915490.65691.14
15min1158922-158922103.534102.711.97104.96104.171.98
2153666-153666100.110101.39
3154341-154341100.550102.09
4158332-158332103.150104.74
5161876-161876105.459106.90
6158821-158821103.468104.96
20min1160374-160374104.480102.592.69107.05105.202.67
2151741-15174198.856101.25
3153549-153549100.034102.69
4156818-156818102.164104.90
5162745-162745106.025108.64
6159632-159632103.997106.64
30min1162874-162874106.109103.331.95109.84107.071.95
2154523-154523100.668104.16
3156167-156167101.739105.51
4159475-159475103.894107.77
5160921-160921104.837108.63
6157688-157688102.730106.53
45min1159279-159279103.767102.132.74108.68107.022.69
2151493-15149398.694103.30
3153224-15322499.822104.72
4154337-154337100.547105.57
5161800-161800105.409110.37
6160475-160475104.546109.48
60min1161974-161974105.523102.713.25111.59108.743.16
2152598-15259899.414105.12
3151580-15158098.751104.76
4155297-155297101.173107.32
5163270-163270106.367112.50
6161209-161209105.024111.12
极限1158772-158772103.436102.062.27110.68109.232.29
2150739-15073998.203105.01
3154789-154789100.842107.95
4156405-156405101.894109.16
5160705-160705104.696112.01
6158534-158534103.281110.55
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%
110.181367592135806213589891366364136540013632810.33
210.191385569139059813880840.26
单位质量响应值RSD%判断
133917.58136220.221.21数据可信
供试品溶液-2025011111批-厄贝沙坦-0.05molhcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1341652-34165222.76723.9520.7922.7723.9520.79
2268022-26802217.86017.86
3433524-43352428.88928.89
4448443-44844329.88329.88
5285724-28572419.04019.04
6378694-37869425.23525.24
10min11025735-102573568.35270.736.2268.6171.006.27
2964425-96442564.26764.47
31110421-111042173.99674.32
41141994-114199476.10076.43
51029939-102993968.63368.84
61096097-109609773.04173.32
15min11406137-140613793.70195.082.0094.7196.132.08
21398217-139821793.17494.09
31447313-144731396.44597.59
41469707-146970797.93899.12
51404961-140496193.62394.60
61434544-143454495.59496.69
20min11499933-149993399.952100.510.85102.01102.620.94
21502180-1502180100.102102.05
31512234-1512234100.771102.99
41532196-1532196102.102104.37
51497408-149740899.784101.80
61505649-1505649100.333102.49
30min11560748-1560748104.004104.052.00107.17107.282.00
21570749-1570749104.671107.73
31603286-1603286106.839110.17
41581100-1581100105.361108.76
51517213-1517213101.103104.23
61535509-1535509102.322105.59
45min11559566-1559566103.926103.921.29108.25108.301.31
21567573-1567573104.459108.68
31577626-1577626105.129109.65
41562617-1562617104.129108.70
51520643-1520643101.332105.58
61569137-1569137104.563108.97
60min11563340-1563340104.177104.500.89109.65110.040.91
21573522-1573522104.856110.24
31569995-1569995104.621110.31
41571759-1571759104.738110.47
51544518-1544518102.923108.30
61586249-1586249105.704111.27
极限11546494-1546494103.054104.021.69109.69110.721.71
21555402-1555402103.648110.20
31602798-1602798106.806113.66
41578906-1578906105.214112.11
51527694-1527694101.802108.32
61554664-1554664103.599110.34
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%
114.181422251416181417621414931419801418160.21
214.241419811419541419680.02
单位质量响应值RSD%判断
10001.139969.660.23数据可信
供试品溶液-2025011211批-氨氯地平-0.05molhcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min189186-8918657.90847.6321.4457.9147.6321.44
243144-4314428.01328.01
373123-7312347.47847.48
479264-7926451.46551.47
577924-7792450.59550.60
677498-7749850.31950.32
10min1149205-14920596.87793.422.7397.5293.952.83
2137678-13767889.39389.70
3146030-14603094.81695.34
4145031-14503194.16794.74
5141827-14182792.08792.65
6143491-14349193.16793.73
15min1158041-158041102.615101.190.98104.33102.761.03
2155346-155346100.865102.17
3155840-155840101.185102.77
4157160-157160102.043103.66
5154078-154078100.041101.63
6154590-154590100.374101.97
20min1157886-157886102.514101.500.84105.37104.190.85
2156707-156707101.748104.17
3156473-156473101.596104.30
4157264-157264102.110104.86
5154366-154366100.228102.93
6155228-155228100.788103.50
30min1151665-15166598.475100.381.73102.47104.201.66
2154998-154998100.639104.19
3154172-154172100.102103.94
4159573-159573103.609107.50
5153518-15351899.678103.49
6153678-15367899.782103.61
45min1157990-157990102.581101.001.05107.67105.931.02
2156687-156687101.735106.41
3154188-154188100.113105.06
4155593-155593101.025106.06
5153563-15356399.707104.63
6155272-155272100.817105.75
60min1155285-155285100.825100.681.54107.06106.741.48
2156094-156094101.350107.15
3153198-15319899.470105.53
4158963-158963103.213109.37
5152131-15213198.777104.80
6154732-154732100.466106.52
极限1152727-15272799.164100.012.12106.52107.181.87
2160622-160622104.290111.22
3153101-15310199.407106.57
4152782-15278299.200106.51
5151914-15191498.636105.76
6153006-15300699.345106.52
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%
110.181382145138181913819601380894136940813792450.41
210.191374084137179913729420.12
单位质量响应值RSD%判断
135485.76134734.250.40数据可信
供试品溶液-2025011211批-厄贝沙坦-0.05molhcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1560158-56015837.31429.5025.2837.3129.5025.28
2231933-23193315.45015.45
3433862-43386228.90128.90
4494945-49494532.97032.97
5455032-45503230.31130.31
6481122-48112232.04932.05
10min11263067-126306784.13779.395.7884.5579.725.86
21060488-106048870.64270.81
31203872-120387280.19380.51
41222377-122237781.42681.79
51193086-119308679.47579.81
61208186-120818680.48180.84
15min11447190-144719096.40297.372.3297.7598.582.40
21399195-139919593.20494.16
31474402-147440298.21499.43
41489490-148949099.219100.49
51478277-147827798.47299.69
61481965-148196598.71899.97
20min11502842-1502842100.109101.831.22102.53104.131.26
21507277-1507277100.404102.40
31540300-1540300102.604104.91
41545144-1545144102.927105.30
51541271-1541271102.669104.98
61535588-1535588102.290104.64
30min11482928-148292898.782102.111.74102.32105.531.68
21528349-1528349101.808104.92
31532723-1532723102.099105.54
41551191-1551191103.329106.85
51555376-1555376103.608107.06
61546510-1546510103.018106.50
45min11542542-1542542102.753103.540.47107.38108.090.49
21553388-1553388103.476107.71
31549742-1549742103.233107.81
41561533-1561533104.018108.68
51558206-1558206103.797108.40
61560339-1560339103.939108.57
60min11492556-149255699.423102.441.50105.20108.151.40
21543867-1543867102.841108.23
31542618-1542618102.758108.48
41542105-1542105102.724108.55
51547977-1547977103.115108.87
61557814-1557814103.771109.55
极限11484429-148442998.882102.262.03105.76109.111.84
21573214-1573214104.796111.33
31526873-1526873101.709108.58
41524102-1524102101.525108.49
51543922-1543922102.845109.75
61558571-1558571103.821110.76
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%
114.181415651417521424481425571414641419570.36
214.241413191424711418950.58
单位质量响应值RSD%判断
10011.079964.540.33数据可信
供试品溶液-2025011211批-氨氯地平-0.05molhcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min166472-6647243.14947.4712.5443.1547.4612.54
274672-7467248.47248.47
376600-7660049.72449.72
476128-7612849.41749.42
559175-5917538.41338.41
685689-8568955.62455.62
10min1144435-14443593.75894.353.1794.2494.873.21
2143250-14325092.98993.53
3141911-14191192.12092.67
4145871-14587194.69095.24
5142307-14230792.37792.80
6154265-154265100.139100.76
15min1156673-156673101.702101.520.84103.22103.090.87
2155730-155730101.090102.66
3154192-154192100.092101.67
4157194-157194102.040103.64
5156545-156545101.619103.07
6157981-157981102.551104.28
20min1159113-159113103.286102.541.57105.94105.251.53
2158714-158714103.027105.72
3153048-15304899.349102.04
4158257-158257102.730105.47
5159966-159966103.840106.42
6158715-158715103.028105.90
30min1158051-158051102.597101.770.97106.40105.610.97
2157088-157088101.972105.81
3153847-15384799.868103.66
4156737-156737101.744105.62
5157087-157087101.971105.71
6157828-157828102.452106.47
45min1158069-158069102.608101.621.35107.55106.601.31
2155439-155439100.901105.87
3154398-154398100.225105.13
4154213-154213100.105105.11
5158402-158402102.824107.69
6158774-158774103.066108.22
60min1159629-159629103.621101.321.36109.70107.421.26
2157453-157453102.208108.30
3154135-154135100.055106.07
4154960-154960100.590106.71
5155885-155885101.191107.20
6154400-154400100.227106.53
极限1155809-155809101.141100.061.20108.37107.291.17
2152881-15288199.241106.47
3151839-15183998.564105.69
4152908-15290899.258106.49
5155153-155153100.715107.85
6156289-156289101.453108.86
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%
110.181373199137552013755111381267137365113758300.24
210.191380075137223413761540.41
单位质量响应值RSD%判断
135150.29135049.460.06数据可信
供试品溶液-2025011211批-厄贝沙坦-0.05molhcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1394415-39441526.27529.5617.3526.2729.5617.36
2469436-46943631.27331.27
3479765-47976531.96131.96
4460670-46067030.68930.69
5318459-31845921.21521.21
6539981-53998135.97235.97
10min11153978-115397876.87580.184.8277.1780.504.86
21206474-120647480.37280.72
31199646-119964679.91780.27
41226688-122668881.71982.06
51135308-113530875.63175.87
61298999-129899986.53686.94
15min11446372-144637296.35498.421.7197.5099.641.78
21485661-148566198.971100.21
31488923-148892399.188100.43
41502012-1502012100.060101.31
51445007-144500796.26397.34
61496482-149648299.692101.05
20min11522999-1522999101.458102.721.18103.67105.041.19
21567696-1567696104.436106.78
31526557-1526557101.695104.04
41560316-1560316103.944106.30
51539402-1539402102.551104.70
61535044-1535044102.261104.73
30min11540293-1540293102.610104.031.01105.95107.481.01
21570232-1570232104.605108.11
31578338-1578338105.145108.62
41575443-1575443104.952108.47
51558474-1558474103.821107.11
61546700-1546700103.037106.64
45min11551380-1551380103.349104.230.79107.83108.840.72
21562278-1562278104.075108.74
31569940-1569940104.585109.23
41558631-1558631103.832108.51
51586529-1586529105.690110.13
61558586-1558586103.829108.58
60min11556808-1556808103.710103.721.01109.34109.490.95
21569703-1569703104.570110.39
31564961-1564961104.254110.06
41568850-1568850104.513110.35
51553743-1553743103.506109.12
61527684-1527684101.770107.67
极限11540729-1540729102.639102.930.55109.42109.850.49
21554125-1554125103.532110.51
31540709-1540709102.638109.60
41546849-1546849103.047110.04
51554924-1554924103.585110.35
61533356-1533356102.148109.18
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