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%
110.727247107255187252037251517248847250930.05
210.607257757256687257220.02
单位质量响应值RSD%判断
67639.2768464.340.86数据可信
供试品溶液-2024100721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%
5min195127-9512712.58112.424.6912.5812.424.67
289679-8967911.86111.86
3101113-10111313.37313.37
490209-9020911.93111.93
591312-9131212.07712.08
696136-9613612.71512.71
10min1195265-19526525.82525.034.4425.9025.104.44
2179988-17998823.80523.87
3197736-19773626.15226.23
4177626-17762623.49223.56
5193522-19352225.59525.66
6191291-19129125.30025.37
15min1282500-28250037.36337.303.7337.5837.513.73
2275003-27500336.37136.57
3298425-29842539.46939.69
4267503-26750335.37935.58
5286708-28670837.91938.13
6282119-28211937.31237.52
20min1362333-36233347.92148.692.3648.3449.102.37
2366929-36692948.52948.93
3384996-38499650.91851.36
4362406-36240647.93148.32
5363162-36316248.03148.45
6368859-36885948.78449.20
30min1496142-49614265.61866.622.1766.3167.312.17
2502649-50264966.47967.15
3521666-52166668.99469.72
4504445-50444566.71667.38
5507659-50765967.14167.83
6489619-48961964.75665.45
45min1635938-63593884.10783.282.3085.1684.342.29
2642224-64222484.93985.98
3647166-64716685.59286.70
4621185-62118582.15683.19
5622089-62208982.27683.34
6609338-60933880.58981.64
60min1677820-67782089.64689.652.2791.1791.172.24
2705043-70504393.24794.76
3681022-68102290.07091.65
4672041-67204188.88290.37
5658562-65856287.09988.62
6672751-67275188.97690.47
极限1704684-70468493.19993.352.4095.2295.362.35
2738654-73865497.69299.72
3695503-69550391.98594.07
4702812-70281292.95294.93
5691133-69113391.40793.41
6701952-70195292.83894.83
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%
110.727260067249577232647230927230017240640.19
210.607207637201987204800.06
单位质量响应值RSD%判断
67543.2867969.810.45数据可信
供试品溶液-2024100721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%
5min194006-9400612.48712.734.6712.4912.734.68
2102206-10220613.57613.58
391313-9131312.12912.13
494839-9483912.59712.60
592148-9214812.24012.24
6100399-10039913.33613.34
10min1194236-19423625.80025.372.1825.8725.442.17
2190292-19029225.27625.35
3184767-18476724.54324.61
4188587-18858725.05025.12
5196542-19654226.10726.17
6191521-19152125.44025.51
15min1300492-30049239.91438.493.3940.1338.703.39
2297695-29769539.54339.76
3281682-28168237.41637.62
4278481-27848136.99137.20
5297639-29763939.53539.75
6282689-28268937.55037.76
20min1379796-37979650.44850.062.4650.8850.492.45
2387197-38719751.43151.87
3370655-37065549.23449.65
4362196-36219648.11048.53
5384472-38447251.06951.50
6377087-37708750.08850.51
30min1501342-50134266.59366.801.8867.3167.501.87
2501288-50128866.58667.31
3503622-50362266.89667.58
4493388-49338865.53766.22
5520558-52055869.14669.86
6496995-49699566.01666.72
45min1595921-59592179.15682.552.3980.2483.632.36
2630093-63009383.69584.79
3622371-62237182.66983.73
4613798-61379881.53182.58
5629402-62940283.60384.70
6637277-63727784.64985.72
60min1645543-64554385.74789.322.1487.2790.852.12
2680773-68077390.42791.98
3679009-67900990.19391.71
4666974-66697488.59490.09
5683605-68360590.80392.37
6678668-67866890.14791.69
极限1671763-67176389.23093.152.3791.2395.182.33
2699050-69905092.85594.91
3715373-71537395.02397.04
4696492-69649292.51594.51
5715992-71599295.10597.17
6708826-70882694.15396.19
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%
110.727226127221307216637217477215977219500.06
210.607234637234317234470.01
单位质量响应值RSD%判断
67346.0868249.720.95数据可信
供试品溶液-2024100821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%
5min188721-8872111.77811.493.1711.7811.493.18
290661-9066112.03612.04
384332-8433211.19511.20
483343-8334311.06411.06
586282-8628211.45411.45
685853-8585311.39711.40
10min1177492-17749223.56323.694.5523.6323.764.55
2194385-19438525.80525.87
3173717-17371723.06223.12
4173467-17346723.02823.09
5173203-17320322.99323.06
6178501-17850123.69723.76
15min1284746-28474637.80136.866.5038.0037.056.49
2310124-31012441.17041.38
3260500-26050034.58234.77
4263915-26391535.03635.23
5273693-27369336.33436.53
6272811-27281136.21736.41
20min1376917-37691750.03748.646.7050.4449.046.69
2408861-40886154.27854.72
3349624-34962446.41446.80
4339040-33904045.00945.39
5358144-35814447.54547.94
6365604-36560448.53548.93
30min1509879-50987967.68866.903.7168.3767.573.72
2536425-53642571.21271.95
3488247-48824764.81665.46
4488471-48847164.84665.48
5491985-49198565.31365.97
6508626-50862667.52268.19
45min1632662-63266283.98882.843.3985.0583.883.41
2662239-66223987.91489.05
3616269-61626981.81282.81
4605055-60505580.32381.32
5607747-60774780.68081.70
6620089-62008982.31983.36
60min1664869-66486988.26489.462.5389.7990.962.55
2705745-70574593.69095.31
3678975-67897590.13691.59
4659817-65981787.59389.03
5662766-66276687.98489.45
6671121-67112189.09490.59
极限1721555-72155595.78994.331.8497.8196.331.87
2729538-72953896.84998.99
3698918-69891892.78494.74
4704774-70477493.56195.49
5696461-69646192.45894.41
6712084-71208494.53296.52
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%
110.727159507168017167457160757165277164200.06
210.607213687210357212020.04
单位质量响应值RSD%判断
66830.2268037.921.27数据可信
供试品溶液-2024100821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%
5min183426-8342611.13511.404.9511.1411.404.94
285467-8546711.40811.41
386992-8699211.61111.61
479357-7935710.59210.59
584932-8493211.33611.34
692167-9216712.30212.30
10min1161733-16173321.58722.613.5221.6522.683.52
2170490-17049022.75622.82
3178509-17850923.82623.89
4163942-16394221.88221.94
5171299-17129922.86422.93
6170623-17062322.77422.84
15min1263350-26335035.15035.092.4735.3335.282.47
2271500-27150036.23836.43
3268550-26855035.84536.04
4254050-25405033.90934.09
5257885-25788534.42134.61
6262172-26217234.99335.19
20min1342545-34254545.72146.952.8246.1047.342.81
2367894-36789449.10449.50
3346296-34629646.22246.62
4347349-34734946.36246.73
5346498-34649846.24946.63
6360021-36002148.05448.44
30min1485390-48539064.78765.442.5565.4266.082.54
2511382-51138268.25668.92
3484498-48449864.66865.32
4474174-47417463.29063.92
5493718-49371865.89966.54
6492384-49238465.72166.38
45min1605441-60544180.81180.904.7581.8081.914.71
2643984-64398485.95587.00
3619280-61928082.65883.67
4593363-59336379.19980.18
5558521-55852174.54875.55
6615970-61597082.21683.24
60min1639742-63974285.38988.642.4186.8390.102.39
2685255-68525591.46492.98
3658812-65881287.93589.41
4659669-65966988.04989.47
5677794-67779490.46891.89
6663435-66343588.55290.03
极限1676326-67632690.27293.101.7792.1995.061.76
2712803-71280395.14197.17
3703005-70300593.83395.79
4694200-69420092.65894.57
5702808-70280893.80795.73
6696141-69614192.91794.89
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