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%
111.237664187663527652747648807641307654110.13
211.327665247659857662540.05
单位质量响应值RSD%判断
68157.7067690.280.49数据可信
供试品溶液-2024070421批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min186219-8621911.4249.7516.1411.429.7516.13
252675-526756.9806.98
373868-738689.7889.79
476304-7630410.11010.11
582772-8277210.96810.97
669560-695609.2179.22
10min1141353-14135318.73019.0314.8018.7919.0814.81
2106006-10600614.04614.08
3155844-15584420.65020.70
4150130-15013019.89319.95
5168709-16870922.35422.42
6139657-13965718.50518.56
15min1198942-19894226.36028.1916.6726.5328.3516.65
2153384-15338420.32420.44
3217797-21779728.85929.03
4231963-23196330.73630.90
5259289-25928934.35634.54
6214957-21495728.48228.64
20min1239542-23954231.74036.1819.3732.0536.5019.33
2191599-19159925.38725.62
3273418-27341836.22936.56
4292847-29284738.80339.14
5346360-34636045.89446.27
6294464-29446439.01739.33
30min1332831-33283144.10147.0719.9244.5947.5919.87
2249993-24999333.12533.50
3365526-36552648.43348.96
4411625-41162554.54155.09
5450206-45020659.65360.28
6321265-32126542.56843.10
45min1468195-46819562.03762.7612.4262.7763.5412.17
2472965-47296562.66963.22
3504902-50490266.90167.70
4463153-46315361.36962.22
5376788-37678849.92550.89
6555990-55599073.67074.44
60min1506598-50659867.12671.5911.2968.2172.7211.04
2590917-59091778.29879.20
3576000-57600076.32277.49
4509429-50942967.50168.70
5450556-45055659.70060.94
6608245-60824580.59481.77
极限1548666-54866672.70077.8812.9374.1579.4012.68
2638649-63864984.62385.96
3661794-66179487.68989.28
4538284-53828471.32472.90
5479680-47968063.55965.13
6659382-65938287.37088.99
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%
111.237657997668687660247648997642017655580.14
211.327661887661967661920.01
单位质量响应值RSD%判断
68170.7967684.810.51数据可信
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%
5min1171103-17110322.67022.189.0622.6722.189.05
2151213-15121320.03520.04
3163827-16382721.70621.71
4163552-16355221.67021.67
5195359-19535925.88425.88
6159436-15943621.12521.12
10min1331236-33123643.88739.658.8844.0139.778.87
2265606-26560635.19235.30
3275790-27579036.54136.66
4323327-32332742.83942.96
5310678-31067841.16341.31
6288763-28876338.26038.38
15min1444682-44468258.91852.589.8359.2952.939.81
2366245-36624548.52648.83
3368679-36867948.84849.17
4448662-44866259.44659.80
5382749-38274950.71251.08
6370267-37026749.05949.39
20min1531171-53117170.37861.6710.0271.0762.309.99
2427767-42776756.67757.25
3433250-43325057.40458.00
4519032-51903268.76969.46
5439405-43940558.21958.87
6442141-44214158.58259.18
30min1605059-60505980.16772.377.6981.2673.357.69
2512780-51278067.94168.83
3521615-52161569.11270.03
4595039-59503978.84079.91
5519976-51997668.89469.87
6522879-52287969.27970.21
45min1670162-67016288.79383.075.6590.3384.455.68
2599243-59924379.39780.67
3605199-60519980.18681.48
4674630-67463089.38590.89
5603646-60364679.98081.34
6608750-60875080.65781.97
60min1692876-69287691.80388.752.8793.8390.592.94
2646391-64639185.64487.35
3670963-67096388.89990.64
4690638-69063891.50693.51
5652271-65227186.42388.23
6665952-66595288.23690.00
极限1699578-69957892.69195.391.4995.2397.721.34
2720702-72070295.49097.68
3728407-72840796.51198.75
4720168-72016895.41997.93
5722067-72206795.67097.96
6728693-72869396.54898.80
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%
111.237605677595237598547598777594087598460.06
211.327637907668137653020.28
单位质量响应值RSD%判断
67662.1567606.180.06数据可信
供试品溶液-2024070421批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1186122-18612224.76727.119.3424.7727.119.34
2187081-18708124.89524.89
3186774-18677424.85424.85
4223293-22329329.71329.71
5224404-22440429.86129.86
6214847-21484728.58928.59
10min1310717-31071741.34748.0111.3541.4848.1611.34
2318893-31889342.43542.57
3357564-35756447.58147.72
4414346-41434655.13755.30
5395162-39516252.58452.75
6368074-36807448.97949.14
15min1396429-39642952.75261.8912.7353.1262.3112.66
2536760-53676071.42671.80
3400823-40082353.33753.74
4446718-44671859.44459.92
5507738-50773867.56468.02
6502135-50213566.81967.25
20min1474043-47404363.08067.8410.3463.7468.6010.30
2466700-46670062.10362.87
3464147-46414761.76462.46
4509217-50921767.76168.56
5551890-55189073.43974.27
6592869-59286978.89279.69
30min1542824-54282472.23378.966.8173.2480.106.82
2554154-55415473.74174.86
3592880-59288078.89479.94
4600684-60068479.93281.11
5651733-65173386.72587.97
6617905-61790582.22483.46
45min1590400-59040078.56485.345.6179.9886.925.64
2623860-62386083.01684.54
3634075-63407584.37685.86
4636016-63601684.63486.26
5692372-69237292.13393.86
6671025-67102589.29390.99
60min1631587-63158784.04587.923.6185.8989.983.68
2641835-64183585.40887.40
3659695-65969587.78589.73
4658122-65812287.57689.67
5698456-69845692.94395.18
6674703-67470389.78291.98
极限1672263-67226389.45789.211.7991.7791.751.81
2665640-66564088.57691.04
3669310-66931089.06491.50
4656189-65618987.31889.90
5692176-69217692.10794.86
6666878-66687888.74191.43
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%
111.237621987621287620887622787627627622910.04
211.327597237605207601220.08
单位质量响应值RSD%判断
67879.8867148.590.77数据可信
供试品溶液-2024070421批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min142019-420195.6024.3017.525.604.3017.48
228405-284053.7873.79
332031-320314.2704.27
430676-306764.0894.09
534466-344664.5954.59
625795-257953.4393.44
10min1106547-10654714.20411.8813.7514.2311.9013.74
287700-8770011.69111.71
390293-9029312.03712.06
483651-8365111.15111.17
596352-9635212.84512.87
670125-701259.3489.37
15min1146104-14610419.47717.519.3119.5917.609.34
2138271-13827118.43318.52
3132047-13204717.60317.69
4123505-12350516.46416.55
5136640-13664018.21518.31
6111550-11155014.87114.94
20min1168125-16812522.41320.717.1622.6320.907.20
2160207-16020721.35721.55
3154533-15453320.60120.79
4152434-15243420.32120.50
5161311-16131121.50421.70
6135704-13570418.09118.24
30min1180590-18059024.07423.212.5424.4223.522.63
2172324-17232422.97223.28
3172564-17256423.00423.31
4173143-17314323.08223.37
5177921-17792123.71824.04
6168218-16821822.42522.68
45min1177267-17726723.63123.551.5924.1123.981.59
2173420-17342023.11823.55
3173374-17337423.11223.54
4179192-17919223.88824.31
5180001-18000123.99624.45
6176757-17675723.56323.94
60min1178842-17884223.84123.901.0124.4524.460.94
2180915-18091524.11824.68
3180386-18038624.04724.61
4178608-17860823.81024.36
5176141-17614123.48124.06
6180688-18068824.08724.60
极限1177877-17787723.71323.591.2524.4524.281.24
2179110-17911023.87724.57
3177756-17775623.69624.39
4172744-17274423.02823.71
5176650-17665023.54924.26
6177562-17756223.67124.31
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