替米沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.107636767664717665897656297641457653020.18
211.167653567682217667880.27
单位质量响应值RSD%判断
68946.1368708.600.25数据可信
中间条件6月-供试品溶液-2024070321批-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1234049-23404930.60534.907.6730.6034.907.68
2285169-28516937.28937.29
3273199-27319935.72435.72
4249716-24971632.65332.65
5282792-28279236.97936.98
6276553-27655336.16336.16
10min1437849-43784957.25461.457.4357.4261.647.43
2509138-50913866.57666.78
3480607-48060762.84563.04
4424507-42450755.51055.69
5505727-50572766.13066.34
6461876-46187660.39660.60
15min1627066-62706681.99781.218.6882.4881.758.66
2657411-65741185.96586.54
3646581-64658184.54885.10
4519702-51970267.95768.45
5666734-66673487.18487.76
6609013-60901379.63680.17
20min1707586-70758692.52688.809.0393.4789.788.99
2736237-73623796.27297.33
3671283-67128387.77988.80
4573930-57393075.04875.92
5732626-73262695.80096.86
6652702-65270285.34986.33
30min1693329-69332990.66193.063.0292.1294.543.07
2730776-73077695.55897.15
3702778-70277891.89793.40
4682724-68272489.27590.56
5729949-72994995.45097.04
6730305-73030595.49696.95
45min1724060-72406094.68095.231.2596.6497.221.13
2719630-71963094.10096.22
3729663-72966395.41297.43
4738616-73861696.58398.36
5718439-71843993.94596.06
6739014-73901496.63598.62
60min1727112-72711295.07994.281.8897.5796.801.77
2700116-70011691.54994.19
3715101-71510193.50896.05
4735761-73576196.21098.53
5733042-73304295.85498.50
6714672-71467293.45295.97
极限1700422-70042291.58995.252.8094.6098.302.69
2718450-71845093.94697.10
3750349-75034998.117101.18
4750716-75071698.165101.02
5735109-73510996.12599.30
6715275-71527593.53196.57
替米沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.107623537638097624337639727636567632450.11
211.167590437599877595150.09
单位质量响应值RSD%判断
68760.8168056.900.73数据可信
中间条件6月-供试品溶液-2024070321批-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1295420-29542038.86736.869.9438.8736.869.95
2284700-28470037.45737.46
3304958-30495840.12240.12
4285661-28566137.58337.58
5225772-22577229.70429.70
6284301-28430137.40437.40
10min1523888-52388868.92666.013.8769.1466.213.88
2511933-51193367.35367.56
3502422-50242266.10166.32
4507584-50758466.78066.99
5466551-46655161.38261.55
6497892-49789265.50565.71
15min1649201-64920185.41284.861.1586.0185.441.13
2646720-64672085.08685.67
3640475-64047584.26484.85
4632856-63285683.26283.84
5647168-64716885.14585.65
6653824-65382486.02186.59
20min1720205-72020594.75493.273.3895.8394.323.33
2664248-66424887.39288.45
3714487-71448794.00295.06
4710872-71087293.52694.57
5735574-73557496.77697.76
6708378-70837893.19894.25
30min1725088-72508895.39697.692.5897.0099.252.52
2766129-766129100.796102.34
3739895-73989597.34598.93
4740327-74032797.40198.96
5763754-763754100.484102.00
6719920-71992094.71796.28
45min1720425-72042594.78397.011.4296.9199.111.39
2742301-74230197.66199.76
3743034-74303497.75899.88
4750586-75058698.751100.85
5732495-73249596.37198.45
6735220-73522096.73098.82
60min1703555-70355592.56394.692.1095.2297.332.03
2724194-72419495.27997.92
3700581-70058192.17294.84
4737304-73730497.00499.66
5733004-73300496.43899.05
6719613-71961394.67697.31
极限1717298-71729894.37295.721.7997.5498.891.72
2735822-73582296.80999.98
3716976-71697694.32997.51
4715131-71513194.08697.28
5746739-74673998.245101.39
6733263-73326396.47299.63
替米沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.107630347600627591087616707583427604430.26
211.167593247609587601410.16
单位质量响应值RSD%判断
68508.3868112.990.41数据可信
中间条件6月-供试品溶液-2024070421批-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1312299-31229941.14639.813.8041.1539.813.80
2311605-31160541.05541.05
3282657-28265737.24137.24
4302858-30285839.90239.90
5308223-30822340.60940.61
6295347-29534738.91338.91
10min1541208-54120871.30569.625.4571.5369.845.44
2534567-53456770.43070.66
3523180-52318068.93069.14
4517189-51718968.14168.36
5570583-57058375.17675.40
6483563-48356363.71063.93
15min1667601-66760187.95884.783.4688.5885.383.46
2658299-65829986.73287.35
3624004-62400482.21482.80
4660404-66040487.01087.61
5638276-63827684.09484.74
6612154-61215480.65381.22
20min1714807-71480794.17790.647.1795.2991.727.10
2693662-69366291.39192.49
3589272-58927277.63878.68
4711088-71108893.68794.77
5718922-71892294.71995.83
6700212-70021292.25493.27
30min1703811-70381192.72995.712.0394.3797.292.00
2720517-72051794.93096.54
3718186-71818694.62396.10
4734869-73486996.82198.42
5741213-74121397.65699.29
6739909-73990997.48599.02
45min1727679-72767995.87393.971.8598.0296.081.84
2695532-69553291.63893.77
3701222-70122292.38794.39
4726863-72686395.76697.91
5716005-71600594.33596.51
6712068-71206893.81695.89
60min1694457-69445791.49692.842.2694.1895.472.19
2712804-71280493.91396.56
3700288-70028892.26494.78
4680242-68024289.62392.30
5718898-71889894.71697.42
6721104-72110495.00797.60
极限1717500-71750094.53293.141.2997.7296.301.24
2694044-69404491.44294.61
3706992-70699293.14896.18
4708380-70838093.33196.50
5699231-69923192.12595.35
6715643-71564394.28797.41
替米沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.107628877621817615387625707607527619860.12
211.167550927538807544860.12
单位质量响应值RSD%判断
68647.3967606.271.09数据可信
中间条件6月-供试品溶液-2024070421批-pH7.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1302431-30243139.95540.442.4239.9640.442.42
2297941-29794139.36239.36
3309954-30995440.94940.95
4306228-30622840.45740.46
5318674-31867442.10142.10
6301584-30158439.84439.84
10min1503812-50381266.56168.172.2566.7868.402.25
2502099-50209966.33466.55
3518779-51877968.53868.77
4514201-51420167.93368.16
5528791-52879169.86170.09
6528478-52847869.81970.04
15min1664481-66448187.78785.363.8488.3885.963.82
2605848-60584880.04180.63
3675790-67579089.28189.89
4631774-63177483.46684.07
5649348-64934885.78886.41
6649424-64942485.79886.41
20min1706695-70669593.36489.746.3094.4490.816.22
2696010-69601091.95392.98
3695672-69567291.90893.01
4681198-68119889.99691.06
5702017-70201792.74693.85
6593771-59377178.44679.53
30min1725895-72589595.90194.781.9697.5096.361.96
2713348-71334894.24395.79
3731113-73111396.59098.21
4728843-72884396.29197.86
5711178-71117893.95795.57
6694254-69425491.72193.24
45min1714524-71452494.39994.052.1796.5396.152.09
2724965-72496595.77897.84
3683662-68366290.32192.47
4724239-72423995.68297.78
5706520-70652093.34195.48
6717489-71748994.79196.82
60min1704294-70429493.04791.713.0995.7094.343.01
2675369-67536989.22691.82
3723266-72326695.55498.21
4707356-70735693.45296.08
5666267-66626788.02390.68
6688539-68853990.96693.52
极限1718335-71833594.90293.501.2398.0796.641.21
2708778-70877893.64096.73
3704333-70433393.05296.24
4717408-71740894.78097.93
5698523-69852392.28595.43
6699174-69917492.37195.43
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