替米沙坦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%
110.727366737368177362777369207362167365810.05
210.607381577391457386510.10
单位质量响应值RSD%判断
68710.9169684.061.00数据可信
供试品溶液-2024100721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%
5min1315297-31529741.01040.177.1241.0140.177.12
2329552-32955242.86442.86
3275445-27544535.82735.83
4288193-28819337.48537.48
5317819-31781941.33841.34
6326828-32682842.51042.51
10min1547649-54764971.23271.115.2671.4671.335.26
2578035-57803575.18475.42
3493394-49339464.17564.37
4543715-54371570.72070.93
5557786-55778672.55172.78
6559744-55974472.80573.04
15min1675943-67594387.91988.093.4888.5488.703.49
2704182-70418291.59292.25
3636428-63642882.78083.34
4682651-68265188.79289.39
5694406-69440690.32190.95
6669736-66973687.11287.75
20min1726041-72604194.43594.462.4995.5595.572.51
2745353-74535396.94798.11
3700564-70056491.12292.14
4708840-70884092.19893.29
5736504-73650495.79696.93
6740216-74021696.27997.40
30min1735991-73599195.73096.181.5197.3797.821.51
2748731-74873197.38799.09
3741270-74127096.41697.94
4718695-71869593.48095.09
5746613-74661397.11198.78
6745500-74550096.96698.63
45min1730300-73030094.98995.672.0297.1697.842.03
2749919-74991997.54199.79
3725347-72534794.34596.40
4722276-72227693.94696.07
5758222-75822298.621100.83
6726990-72699094.55996.76
60min1727705-72770594.65295.721.8097.3598.421.79
2747697-74769797.252100.04
3735971-73597195.72798.31
4718871-71887193.50396.15
5754483-75448398.135100.89
6730693-73069395.04097.76
极限1721636-72163693.86294.311.5397.0897.541.55
2733997-73399795.47098.80
3717242-71724293.29196.40
4709735-70973592.31495.48
5739625-73962596.20299.50
6728183-72818394.71497.97
替米沙坦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%
110.727374417360257361727365327366387365620.08
210.607364957368167366560.04
单位质量响应值RSD%判断
68709.1469495.850.81数据可信
供试品溶液-2024100721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%
5min1301665-30166539.29139.224.6339.2939.234.63
2293283-29328338.19938.20
3297710-29771038.77538.78
4281293-28129336.63736.64
5320363-32036341.72641.73
6312610-31261040.71640.72
10min1530441-53044169.08868.793.2069.3169.013.20
2505457-50545765.83466.05
3509822-50982266.40266.62
4537912-53791270.06170.26
5537280-53728069.97870.21
6547961-54796171.36971.60
15min1660876-66087686.07686.242.5886.6886.842.57
2641847-64184783.59884.18
3646291-64629184.17784.76
4688338-68833889.65390.25
5663466-66346686.41387.03
6671997-67199787.52588.15
20min1759781-75978198.95895.453.44100.0496.533.42
2705627-70562791.90592.95
3709784-70978492.44693.50
4748944-74894497.54798.64
5715383-71538393.17594.28
6757410-75741098.64999.76
30min1757432-75743298.65296.962.25100.2898.572.25
2723311-72331194.20895.76
3731553-73155395.28296.85
4747496-74749697.35898.99
5738632-73863296.20497.82
6768263-768263100.063101.72
45min1716486-71648693.31995.993.0795.5098.143.03
2718174-71817493.53995.62
3727763-72776394.78896.88
4769050-769050100.165102.34
5728922-72892294.93997.09
6761416-76141699.171101.38
60min1738872-73887296.23595.492.0298.9398.172.02
2714270-71427093.03095.63
3725362-72536294.47597.10
4743915-74391596.89299.62
5722816-72281694.14496.82
6753611-75361198.154100.92
极限1742358-74235896.68995.282.2899.9298.492.27
2711658-71165892.69095.80
3729250-72925094.98298.13
4737440-73744096.04899.32
5714007-71400792.99696.20
6754517-75451798.272101.58
替米沙坦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%
110.727366727355387363297353657339537355710.15
210.607345267340367342810.05
单位质量响应值RSD%判断
68616.7069271.790.68数据可信
供试品溶液-2024100821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%
5min1329467-32946743.01045.553.5643.0145.553.56
2347704-34770445.39045.39
3353345-35334546.12746.13
4365294-36529447.68747.69
5341674-34167444.60344.60
6356011-35601146.47546.47
10min1571546-57154674.61176.992.6274.8577.242.62
2584927-58492776.35876.61
3594738-59473877.63977.90
4616401-61640180.46780.73
5579826-57982675.69275.94
6591270-59127077.18677.44
15min1685471-68547189.48492.762.5090.1493.452.50
2713107-71310793.09193.77
3714162-71416293.22993.92
4736239-73623996.11196.82
5696337-69633790.90291.57
6718326-71832693.77394.46
20min1713362-71336293.12595.391.9594.2896.581.94
2754274-75427498.46599.66
3737375-73737596.25997.46
4727166-72716694.92796.17
5720949-72094994.11595.29
6730958-73095895.42296.63
30min1707842-70784292.40494.771.7494.0796.501.75
2728031-72803195.04096.78
3735000-73500095.94997.69
4741138-74113896.75198.52
5714270-71427093.24394.94
6729538-72953895.23696.97
45min1713673-71367393.16594.502.3295.3596.762.29
2741458-74145896.79299.06
3741610-74161096.81299.09
4720508-72050894.05796.37
5698472-69847291.18193.39
6727887-72788795.02197.29
60min1706916-70691692.28394.121.3794.9896.901.39
2723676-72367694.47197.28
3717818-71781893.70696.52
4734031-73403195.82398.66
5714733-71473393.30496.02
6728886-72888695.15197.95
极限1695008-69500890.72993.522.0393.9496.822.02
2731164-73116495.44898.78
3711829-71182992.92496.26
4725156-72515694.66498.03
5705812-70581292.13995.38
6729383-72938395.21698.54
替米沙坦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%
110.727346547348757343517335017335437341850.09
210.607377207365647371420.12
单位质量响应值RSD%判断
68487.4169541.701.09数据可信
供试品溶液-2024100821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%
5min1313755-31375540.91843.053.0140.9243.053.01
2337553-33755344.02244.02
3337267-33726743.98543.98
4330933-33093343.15943.16
5322932-32293242.11542.12
6338299-33829944.11944.12
10min1557732-55773272.73773.372.7272.9673.602.72
2574409-57440974.91175.16
3584610-58461076.24276.49
4543585-54358570.89271.13
5550168-55016871.75071.98
6564827-56482773.66273.91
15min1689810-68981089.96188.971.8690.5989.621.85
2694977-69497790.63591.30
3684418-68441889.25889.93
4682187-68218788.96789.60
5658345-65834585.85886.49
6683581-68358189.14989.80
20min1714431-71443193.17293.482.9094.3094.622.86
2742041-74204196.77397.94
3678926-67892688.54289.71
4721255-72125594.06295.19
5722546-72254694.23195.34
6721416-72141694.08395.23
30min1710724-71072492.68993.461.6694.3495.121.64
2729079-72907995.08396.78
3695963-69596390.76492.42
4722512-72251294.22695.88
5717707-71770793.60095.23
6723746-72374694.38796.06
45min1715763-71576393.34693.621.3295.5195.801.30
2730394-73039495.25497.48
3702829-70282991.65993.82
4721773-72177394.13096.30
5722795-72279594.26396.42
6713791-71379193.08995.29
60min1731997-73199795.46394.621.6298.1597.321.57
2716042-71604293.38396.14
3709263-70926392.49895.17
4723067-72306794.29997.00
5731768-73176895.43398.11
6741078-74107896.64899.36
极限1695850-69585090.74992.782.5293.9696.002.46
2744332-74433297.072100.35
3705046-70504691.94895.13
4717328-71732893.55096.77
5708258-70825892.36795.57
6697609-69760990.97994.23
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