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%
110.897321187312727321177313557315887316900.06
210.957312167297427304790.15
单位质量响应值RSD%判断
67189.1666710.410.51数据可信
供试品溶液-2026031621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%
5min1104507-10450714.04913.775.0914.0513.775.09
2106159-10615914.27114.27
398804-9880413.28213.28
498251-9825113.20813.21
597001-9700113.04013.04
6109993-10999314.78614.79
10min1203508-20350827.35827.681.9927.4427.751.99
2206463-20646327.75527.83
3200609-20060926.96827.04
4208180-20818027.98628.06
5204186-20418627.44927.52
6212321-21232128.54228.62
15min1295650-29565039.74441.954.8639.9742.184.84
2307568-30756841.34741.58
3319526-31952642.95443.18
4300603-30060340.41040.64
5311253-31125341.84242.07
6337960-33796045.43245.67
20min1394949-39494953.09356.314.0053.5456.783.99
2424272-42427257.03557.50
3429258-42925857.70658.17
4416907-41690756.04556.50
5406169-40616954.60255.06
6441863-44186359.40059.89
30min1570030-57003076.63078.292.0377.3879.062.04
2592442-59244279.64280.42
3579537-57953777.90878.69
4578498-57849877.76878.53
5573093-57309377.04177.80
6600611-60061180.74181.56
45min1665432-66543289.45592.863.5690.6394.073.55
2711094-71109495.59396.82
3681526-68152691.61892.83
4687178-68717892.37893.57
5670572-67057290.14691.33
6728940-72894097.99299.26
60min1700895-70089594.22296.612.2895.8998.342.27
2729930-72993098.12599.88
3739932-73993299.470101.19
4725016-72501697.46499.17
5698602-69860293.91495.60
6717617-71761796.47098.29
极限1746787-746787100.39199.542.93102.58101.802.87
2730082-73008298.146100.44
3741003-74100399.614101.89
4774559-774559104.125106.38
5708404-70840495.23197.44
6741682-74168299.705102.06
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%
110.897328507317747316397310397305197315640.12
210.957329757346087337920.16
单位质量响应值RSD%判断
67177.5967012.970.18数据可信
供试品溶液-2026031621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%
5min197041-9704113.01713.032.9213.0213.032.94
297123-9712313.02813.03
391875-9187512.32412.32
499873-9987313.39713.40
597662-9766213.10013.10
699291-9929113.31913.32
10min1204554-20455427.43827.381.8027.5127.451.79
2200887-20088726.94727.02
3207395-20739527.82027.89
4199765-19976526.79626.87
5202943-20294327.22227.30
6209186-20918628.06028.13
15min1286000-28600038.36341.494.2238.5941.714.19
2310158-31015841.60441.83
3312397-31239741.90442.13
4313259-31325942.02042.24
5325973-32597343.72543.95
6307936-30793641.30641.54
20min1421469-42146956.53557.231.8056.9757.681.79
2432137-43213757.96658.42
3432127-43212757.96558.42
4422584-42258456.68457.14
5435363-43536358.39958.87
6416039-41603955.80756.27
30min1586442-58644278.66479.481.8979.4280.251.89
2585061-58506178.47979.25
3610631-61063181.90982.69
4591587-59158779.35480.13
5600612-60061280.56581.36
6580717-58071777.89678.67
45min1680030-68003091.21892.742.0992.4193.952.07
2700991-70099194.02995.24
3694886-69488693.21094.44
4712824-71282495.61796.83
5685763-68576391.98793.23
6673623-67362390.35891.56
60min1728506-72850697.72097.671.4699.4299.401.44
2740831-74083199.373101.11
3725215-72521597.27999.03
4738170-73817099.017100.76
5724574-72457497.19398.94
6711513-71151395.44197.14
极限1717663-71766396.26697.380.8598.5099.650.86
2734962-73496298.586100.87
3722404-72240496.90299.19
4728768-72876897.755100.05
5729170-72917097.809100.10
6722874-72287496.96599.20
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%
110.897114577125167107387097587093447107630.19
210.957103467110047106750.07
单位质量响应值RSD%判断
65267.4964901.830.40数据可信
供试品溶液-2026031721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%
5min190649-9064912.53513.274.6412.5413.274.64
295161-9516113.15913.16
3103612-10361214.32814.33
492865-9286512.84212.84
597395-9739513.46813.47
696048-9604813.28213.28
10min1179858-17985824.87127.307.0824.9427.387.07
2205806-20580628.45928.53
3215465-21546529.79529.87
4193035-19303526.69326.76
5206292-20629228.52728.60
6184255-18425525.47925.55
15min1282613-28261339.08042.614.9739.2942.834.97
2315902-31590243.68443.91
3326605-32660545.16445.41
4301557-30155741.70041.92
5316335-31633543.74443.98
6305684-30568442.27142.49
20min1374865-37486551.83756.033.8152.2656.493.82
2416562-41656257.60358.08
3412517-41251757.04457.54
4404719-40471955.96656.42
5413701-41370157.20857.68
6408716-40871656.51856.97
30min1528340-52834073.06076.792.9673.7777.562.98
2571288-57128878.99979.79
3569194-56919478.71079.52
4561843-56184377.69378.46
5557285-55728577.06377.86
6543973-54397375.22275.99
45min1663979-66397991.81792.211.2192.9493.421.19
2656619-65661990.79992.03
3669109-66910992.52693.78
4676739-67673993.58194.78
5659950-65995091.26092.48
6674731-67473193.30494.49
60min1687187-68718795.02696.151.4396.6597.861.42
2681952-68195294.30296.04
3705130-70513097.50799.27
4706526-70652697.70099.41
5698729-69872996.62298.35
6692181-69218195.71797.42
极限1674797-67479793.31395.331.9895.4797.581.96
2671851-67185192.90595.17
3693429-69342995.88998.20
4706103-70610397.64299.90
5690121-69012195.43297.70
6699967-69996796.79399.03
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%
110.897151327151017142557140547169727151030.17
210.957142137145987144060.04
单位质量响应值RSD%判断
65666.0265242.560.46数据可信
供试品溶液-2026031721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%
5min1108330-10833014.89613.816.7214.9013.816.74
296302-9630213.24213.24
3105175-10517514.46214.46
4104621-10462114.38614.39
597903-9790313.46213.46
690358-9035812.42412.42
10min1197218-19721827.11827.603.1927.2027.683.18
2191168-19116826.28626.36
3203534-20353427.98628.07
4204491-20449128.11828.20
5209363-20936328.78828.86
6198764-19876427.33027.40
15min1295903-29590340.68742.504.2440.9242.734.22
2293934-29393440.41740.64
3328694-32869445.19645.43
4309859-30985942.60642.84
5317244-31724443.62243.86
6308868-30886842.47042.69
20min1406909-40690955.95156.551.2856.4157.021.29
2407696-40769656.05956.50
3409251-40925156.27356.76
4417087-41708757.35057.82
5418824-41882457.58958.07
6408018-40801856.10356.56
30min1550504-55050475.69576.761.9776.4777.541.96
2544285-54428574.84075.60
3567886-56788678.08578.88
4550470-55047075.69176.48
5568724-56872478.20179.00
6567459-56745978.02778.80
45min1658843-65884390.59291.251.5291.7892.451.51
2658419-65841990.53491.71
3681871-68187193.75994.99
4662341-66234191.07392.29
5653126-65312689.80691.04
6666975-66697591.71092.91
60min1685653-68565394.27994.801.6095.9796.521.58
2682177-68217793.80195.48
3699929-69992996.24298.00
4685171-68517194.21295.93
5677818-67781893.20194.93
6705954-70595497.07098.78
极限1698885-69888596.09894.971.9598.3297.221.91
2686047-68604794.33396.53
3695453-69545395.62697.92
4678511-67851193.29795.54
5674883-67488392.79895.05
6710438-71043897.68799.94
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%
110.897353017336807336177331007337787338950.12
210.957319667311937315800.08
单位质量响应值RSD%判断
67391.6466810.960.62数据可信
供试品溶液-2026031821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%
5min190794-9079412.17813.236.3812.1813.246.37
299601-9960113.35913.36
3107510-10751014.42014.42
4101643-10164313.63313.63
5100475-10047513.47713.48
691994-9199412.33912.34
10min1187092-18709225.09426.715.1325.1626.795.14
2198240-19824026.59026.66
3211687-21168728.39328.47
4204727-20472727.46027.54
5205953-20595327.62427.70
6187310-18731025.12425.19
15min1279765-27976537.52441.966.7337.7342.186.72
2317244-31724442.55142.77
3336551-33655145.14145.38
4320996-32099643.05543.28
5326453-32645343.78744.01
6296041-29604139.70739.92
20min1395069-39506952.99056.655.7353.4157.105.73
2430949-43094957.80258.26
3455378-45537861.07961.57
4429323-42932357.58458.05
5430941-43094157.80158.27
6392445-39244552.63853.07
30min1548351-54835173.54977.623.5474.2678.393.56
2581889-58188978.04878.83
3595315-59531579.84880.68
4587005-58700578.73479.52
5600106-60010680.49181.28
6559693-55969375.07175.79
45min1677314-67731490.84792.201.8591.9793.401.85
2691203-69120392.71093.92
3675442-67544290.59691.87
4687878-68787892.26493.49
5710257-71025795.26596.51
6682377-68237791.52692.66
60min1727597-72759797.59197.131.1099.2198.851.11
2727008-72700897.51299.24
3723153-72315396.99598.77
4721689-72168996.79998.54
5734779-73477998.554100.32
6710938-71093895.35797.00
极限1724777-72477797.21397.361.6699.3899.611.66
2714222-71422295.79798.07
3739528-73952899.191101.51
4724712-72471297.20499.48
5739994-73999499.254101.57
6711924-71192495.48997.67
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%
110.897305387329217317937294817311487311760.18
210.957373647335037354340.38
单位质量响应值RSD%判断
67141.9767162.920.03数据可信
供试品溶液-2026031821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%
5min190531-9053112.13313.617.8812.1313.617.87
2102314-10231413.71213.71
3106344-10634414.25314.25
496680-9668012.95712.96
5113712-11371215.24015.24
699872-9987213.38513.39
10min1200875-20087526.92227.515.6626.9927.595.67
2204456-20445627.40227.48
3209480-20948028.07528.15
4198344-19834426.58326.65
5225947-22594730.28230.37
6192565-19256525.80825.88
15min1333564-33356444.70542.545.9344.9242.765.91
2326486-32648643.75743.99
3320399-32039942.94143.18
4300179-30017940.23140.45
5334796-33479644.87145.12
6288850-28885038.71338.93
20min1439341-43934158.88256.613.8059.3557.083.80
2436491-43649158.50058.97
3425678-42567857.05157.52
4398119-39811953.35753.80
5426050-42605057.10157.60
6408702-40870254.77655.21
30min1580195-58019577.76076.692.0378.5577.472.03
2583794-58379478.24279.04
3560397-56039775.10675.90
4555228-55522874.41475.15
5575427-57542777.12177.94
6578259-57825977.50078.24
45min1677179-67717990.75891.771.6191.9892.971.58
2694234-69423493.04494.27
3673126-67312690.21591.42
4678891-67889190.98792.14
5683373-68337391.58892.84
6701567-70156794.02695.19
60min1697437-69743793.47394.111.7095.2095.831.66
2698514-69851493.61795.37
3685565-68556591.88293.59
4708653-70865394.97696.63
5701969-70196994.08095.84
6721037-72103796.63698.33
极限1705423-70542394.54394.872.2596.7997.112.20
2705477-70547794.55096.82
3685890-68589091.92594.14
4707287-70728794.79396.98
5707417-70741794.81097.09
6735634-73563498.592100.82
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