替米沙坦片项目信息
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对照品来源中检所对照品使用方法干燥2小时
对照品含量(%)100.00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%
111.375050495054845056915051875048625052550.07
211.375055745047055051400.13
单位质量响应值RSD%判断
44437.5544427.440.02数据可信
供试品溶液-1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%
5min143678-436788.84712.7019.808.8512.7019.80
259504-5950412.05312.05
369492-6949214.07614.08
476263-7626315.44715.45
554506-5450611.04011.04
672739-7273914.73414.73
10min197509-9750919.75124.1515.3019.8024.2215.32
2106032-10603221.47721.54
3130754-13075426.48526.56
4140584-14058428.47628.56
5105617-10561721.39321.45
6134814-13481427.30727.39
15min1152397-15239730.86934.7011.3031.0334.9111.33
2160036-16003632.41632.60
3192264-19226438.94439.17
4188228-18822838.12638.37
5149727-14972730.32830.51
6185364-18536437.54637.78
20min1185265-18526537.52642.5510.8037.8642.9510.83
2197537-19753740.01240.38
3227710-22771046.12446.57
4236503-23650347.90548.36
5187150-18715037.90838.26
6226347-22634745.84846.29
30min1238365-23836548.28255.8011.2348.8256.4311.24
2249912-24991250.62151.21
3290326-29032658.80759.50
4316125-31612564.03364.75
5258403-25840352.34152.90
6299684-29968460.70261.40
45min1293693-29369359.48969.389.8960.3070.329.89
2315167-31516763.83864.71
3359497-35949772.81873.84
4389856-38985678.96780.04
5348470-34847070.58471.43
6348520-34852070.59471.63
60min1328417-32841766.52276.337.7167.6677.667.75
2360362-36036272.99374.22
3387345-38734578.45879.89
4413221-41322183.70085.22
5387259-38725978.44179.68
6384477-38447777.87879.30
90min1369966-36996674.93884.085.8776.4585.835.90
2418452-41845284.75986.39
3413784-41378483.81485.68
4442321-44232189.59491.58
5427761-42776186.64588.32
6418285-41828584.72586.58
120min1388463-38846378.68588.785.7980.6191.005.83
2441711-44171189.47191.57
3446560-44656090.45392.78
4461099-46109993.39895.88
5448224-44822490.79092.95
6443892-44389289.91292.24
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1435314-43531488.17590.802.4090.5493.522.51
2447221-44722190.58793.18
3439477-43947789.01891.85
4465903-46590394.37197.37
5452829-45282991.72394.39
6448920-44892090.93193.76
替米沙坦片项目信息
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对照品来源中检所对照品使用方法干燥2小时
对照品含量(%)100.00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%
111.375046765046475040365046785052105046490.09
211.375053215053805053500.01
单位质量响应值RSD%判断
44384.2644445.910.10数据可信
供试品溶液-2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%
5min187794-8779417.79018.9517.0617.7918.9617.06
284173-8417317.05617.06
3122079-12207924.73724.74
491425-9142518.52618.53
599447-9944720.15120.15
676290-7629015.45915.46
10min1156436-15643631.69932.7715.7431.8032.8715.75
2141089-14108928.58928.68
3205404-20540441.62241.76
4162977-16297733.02533.13
5170793-17079334.60834.72
6133578-13357827.06727.15
15min1215143-21514343.59544.3414.3343.8744.6214.33
2199380-19938040.40140.65
3259615-25961552.60752.98
4223347-22334745.25845.54
5243590-24359049.36049.66
6171708-17170834.79435.03
20min1257133-25713352.10453.0012.9752.6253.5312.98
2245331-24533149.71250.19
3295729-29572959.92560.59
4275191-27519155.76356.30
5291121-29112158.99159.57
6204678-20467841.47541.90
30min1314189-31418963.66565.3311.8164.4766.1511.80
2332202-33220267.31568.07
3344263-34426369.75970.75
4352238-35223871.37572.22
5341973-34197369.29570.20
6249434-24943450.54451.20
45min1370593-37059375.09576.3912.3176.2677.5812.29
2392856-39285679.60680.73
3392740-39274079.58280.96
4416388-41638884.37485.62
5402142-40214281.48882.78
6287331-28733158.22359.16
60min1397410-39741080.52982.4311.7482.1184.0411.72
2435066-43506688.15989.73
3420401-42040185.18887.01
4436916-43691688.53490.25
5436389-43638988.42790.17
6314430-31443063.71464.98
90min1417775-41777584.65586.865.9186.6888.946.01
2439355-43935589.02891.09
3430782-43078287.29189.59
4437955-43795588.74590.95
5460574-46057493.32895.56
6385520-38552078.11979.74
120min1422990-42299085.71285.875.3188.2188.425.40
2428057-42805786.73989.29
3412581-41258183.60386.38
4444087-44408789.98792.68
5448181-44818190.81793.57
6386700-38670078.35980.41
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1429653-42965387.06289.093.2290.0392.133.06
2443461-44346189.86092.90
3440491-44049189.25892.50
4459288-45928893.06796.27
5418475-41847584.79788.06
6446691-44669190.51593.00
替米沙坦片项目信息
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对照品来源中检所对照品使用方法干燥2小时
对照品含量(%)100.00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%
111.375060235052695058915055215052355055880.08
211.375053015054275053640.02
单位质量响应值RSD%判断
44466.8444447.140.04数据可信
供试品溶液-3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%
5min1120357-12035724.36522.1813.3424.3722.1813.34
2117803-11780323.84823.85
3125966-12596625.50125.50
4100884-10088420.42320.42
586683-8668317.54817.55
6105637-10563721.38521.39
10min1188875-18887538.23636.0513.5538.3736.1813.55
2189432-18943238.34938.48
3211818-21181842.88143.02
4169732-16973234.36134.47
5141472-14147228.64028.74
6167246-16724633.85833.98
15min1238856-23885648.35547.2714.7248.7047.6014.70
2252823-25282351.18251.53
3281665-28166557.02157.40
4239089-23908948.40248.71
5187995-18799538.05838.31
6200692-20069240.62940.94
20min1283181-28318157.32855.1714.1457.9455.7614.13
2300510-30051060.83661.47
3317293-31729364.23464.93
4280091-28009156.70257.28
5214332-21433243.39043.86
6239728-23972848.53149.06
30min1329636-32963666.73265.6912.4967.6766.5812.50
2349879-34987970.83171.80
3374105-37410575.73576.79
4337846-33784668.39569.28
5261619-26161952.96353.67
6293825-29382559.48360.29
45min1397445-39744580.46077.0113.1381.7778.2613.12
2409761-40976182.95384.31
3429624-42962486.97488.45
4409723-40972382.94584.21
5307482-30748262.24863.25
6328347-32834766.47267.60
60min1421937-42193785.41881.8112.3387.1783.5012.33
2421855-42185585.40287.22
3456868-45686892.49094.45
4439397-43939788.95390.68
5334999-33499967.81869.17
6349711-34971170.79672.30
90min1435153-43515388.09485.2211.1290.3287.3611.13
2430429-43042987.13789.43
3461265-46126593.38095.85
4471113-47111395.37397.60
5364562-36456273.80375.53
6363265-36326573.54075.44
120min1434185-43418587.89885.819.7890.6188.439.81
2422511-42251185.53488.32
3455358-45535892.18495.17
4478359-47835996.84099.59
5373410-37341075.59477.73
6379537-37953776.83579.14
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1445122-44512290.11289.754.0993.3292.844.28
2443215-44321589.72692.98
3452564-45256491.61895.12
4471506-47150695.45398.74
5424356-42435685.90888.46
6423303-42330385.69588.43
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