厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)0
对照品批号100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5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%
119665696812970909724296892969380.24
219696797436972020.35
单位质量响应值RSD%判断
96938.0097202.000.20数据可信
供试品溶液-FA4456批-氢氯噻嗪-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%
5min134651-346512.8472.5311.122.852.5311.17
225660-256602.1082.11
330833-308332.5332.53
432382-323822.6612.66
527797-277972.2842.28
633168-331682.7252.73
10min180181-801816.5886.352.336.606.362.34
278600-786006.4586.47
376315-763156.2716.28
476785-767856.3096.32
575229-752296.1816.19
676533-765336.2896.30
15min188533-885337.2757.122.157.327.162.15
287963-879637.2287.27
384496-844966.9436.99
488314-883147.2577.30
585211-852117.0027.04
685042-850426.9887.03
20min188075-880757.2377.232.157.327.312.12
287495-874957.1897.27
385393-853937.0177.10
490977-909777.4757.56
588793-887937.2967.37
686865-868657.1377.22
30min188603-886037.2807.421.507.407.541.44
291929-919297.5547.67
390462-904627.4337.55
490491-904917.4357.55
591629-916297.5297.64
688991-889917.3127.43
45min191172-911727.4917.371.397.657.531.39
289214-892147.3317.48
389762-897627.3767.53
488813-888137.2987.45
591235-912357.4977.65
688224-882247.2497.40
60min191337-913377.5057.382.037.707.581.98
291245-912457.4977.69
386867-868677.1387.33
490191-901917.4117.60
591034-910347.4807.67
688449-884497.2687.46
极限192089-920897.5677.531.197.807.761.19
292690-926907.6167.84
391812-918127.5447.77
491474-914747.5167.75
592120-921207.5697.80
689558-895587.3597.58
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)0
对照品批号100607-202305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1000
标示量(mg)150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%
112650852656222660912652852654652655100.15
212660732665632663180.14
单位质量响应值RSD%判断
265510.00266318.000.22数据可信
供试品溶液-FA4456批-厄贝沙坦-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%
5min13603-36030.0900.0816.300.090.0816.40
22353-23530.0590.06
33267-32670.0820.08
43625-36250.0910.09
53092-30920.0780.08
63855-38550.0970.10
10min19381-93810.2350.235.050.240.235.74
29043-90430.2270.23
38982-89820.2250.23
49907-99070.2480.25
58508-85080.2130.21
69143-91430.2290.23
15min112605-126050.3160.303.870.320.304.72
211822-118220.2960.30
311945-119450.2990.30
412275-122750.3080.31
511309-113090.2840.28
611590-115900.2910.29
20min113107-131070.3290.342.200.330.342.23
213589-135890.3410.34
313458-134580.3370.34
413925-139250.3490.35
513478-134780.3380.34
613151-131510.3300.33
30min115170-151700.3800.391.530.390.391.32
215507-155070.3890.39
315538-155380.3900.39
415859-158590.3980.40
515426-154260.3870.39
615622-156220.3920.40
45min116295-162950.4090.422.810.420.432.84
216347-163470.4100.42
317260-172600.4330.44
416898-168980.4240.43
517245-172450.4320.44
616262-162620.4080.41
60min117520-175200.4390.453.140.450.463.37
217580-175800.4410.45
318163-181630.4550.46
419015-190150.4770.49
518190-181900.4560.46
617717-177170.4440.45
极限118113-181130.4540.472.280.470.481.87
218620-186200.4670.48
319179-191790.4810.49
418514-185140.4640.48
519110-191100.4790.49
618359-183590.4600.47
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)0
对照品批号100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5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%
119696197249970809680896963970120.17
219694797188970680.18
单位质量响应值RSD%判断
97012.0097068.000.05数据可信
供试品溶液-FA4456批-氢氯噻嗪-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%
5min136463-364632.9972.4916.153.002.4916.22
233712-337122.7712.77
323343-233431.9191.92
426579-265792.1852.18
529016-290162.3852.38
632845-328452.7002.70
10min177119-771196.3396.263.096.356.273.06
278576-785766.4586.47
375180-751806.1796.19
476440-764406.2836.29
577562-775626.3756.39
671944-719445.9135.93
15min183574-835746.8697.042.506.927.082.46
288242-882427.2537.30
383424-834246.8576.90
487503-875037.1927.23
586817-868177.1367.18
684251-842516.9256.97
20min185173-851737.0017.293.017.087.362.98
290760-907607.4607.54
389531-895317.3597.43
492254-922547.5837.66
587747-877477.2127.29
686582-865827.1167.19
30min185821-858217.0547.333.037.177.442.98
288572-885727.2807.40
389145-891457.3277.44
494090-940907.7347.85
588750-887507.2957.41
688521-885217.2767.39
45min185164-851647.0007.313.187.157.463.13
291592-915927.5287.68
387866-878667.2227.37
492693-926937.6197.77
589334-893347.3437.49
687130-871307.1617.31
60min188055-880557.2377.403.647.427.583.57
290735-907357.4587.65
388365-883657.2637.45
495997-959977.8908.08
589976-899767.3957.58
686767-867677.1327.32
极限187643-876437.2047.472.457.437.702.40
291227-912277.4987.73
392585-925857.6107.83
493992-939927.7257.96
589805-898057.3817.61
690271-902717.4207.64
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)0
对照品批号100607-202305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1000
标示量(mg)150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%
112672012665962664912658762663872665100.18
212656672652082654380.13
单位质量响应值RSD%判断
266510.00265438.000.29数据可信
供试品溶液-FA4456批-厄贝沙坦-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%
5min13546-35460.0890.0817.910.090.0816.97
23719-37190.0930.09
32358-23580.0590.06
42619-26190.0660.07
52871-28710.0720.07
63467-34670.0870.09
10min18568-85680.2150.225.050.220.224.63
29573-95730.2400.24
38317-83170.2080.21
49021-90210.2260.23
58924-89240.2240.22
68624-86240.2160.22
15min111370-113700.2850.293.360.290.303.49
212036-120360.3020.30
311257-112570.2820.28
411802-118020.2960.30
512280-122800.3080.31
611813-118130.2960.30
20min112982-129820.3250.344.780.330.344.93
214357-143570.3600.36
314162-141620.3550.36
413405-134050.3360.34
513180-131800.3300.33
612794-127940.3210.32
30min115043-150430.3770.381.860.380.382.13
215206-152060.3810.39
315091-150910.3780.38
415409-154090.3860.39
515563-155630.3900.39
614769-147690.3700.37
45min116474-164740.4130.422.890.420.422.87
217295-172950.4340.44
315905-159050.3990.41
416757-167570.4200.43
516759-167590.4200.43
616266-162660.4080.41
60min116997-169970.4260.442.810.430.453.29
217509-175090.4390.45
317333-173330.4340.44
418247-182470.4570.47
517372-173720.4350.44
618148-181480.4550.46
极限117400-174000.4360.462.560.450.472.22
218714-187140.4690.48
318320-183200.4590.47
418439-184390.4620.47
518222-182220.4570.47
617865-178650.4480.46
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