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)5
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%
112.609346893665934889349793521935280.09
212.679357193456935140.09
单位质量响应值RSD%判断
7422.867380.740.41数据可信
供试品溶液-GA5217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%
5min123944-2394425.80229.3412.8125.8029.3412.81
231590-3159034.04134.04
323219-2321925.02025.02
428796-2879631.03031.03
525496-2549627.47427.47
630298-3029832.64932.65
10min173081-7308178.75178.761.7078.8878.901.71
272641-7264178.27778.45
372102-7210277.69677.82
475058-7505880.88181.04
571698-7169877.26177.40
673930-7393079.66679.83
15min182602-8260289.01188.521.5189.5389.061.50
281234-8123487.53788.10
380941-8094187.22187.73
484245-8424590.78191.34
582482-8248288.88189.41
681367-8136787.68088.24
20min184164-8416490.69491.102.3191.6692.082.29
282019-8201988.38289.38
383254-8325489.71390.66
486128-8612892.81093.82
587415-8741594.19795.17
684240-8424090.77691.78
30min187757-8775794.56693.870.8395.9995.310.83
287181-8718193.94595.39
386320-8632093.01794.42
488076-8807694.90996.39
586975-8697593.72395.16
686354-8635493.05494.51
45min190056-9005697.04394.481.6198.9496.391.57
287192-8719293.95795.87
387044-8704493.79795.66
488159-8815994.99996.95
587755-8775594.56396.47
685857-8585792.51894.44
60min190167-9016797.16394.711.7399.5497.101.69
287165-8716593.92896.31
387829-8782994.64396.98
489236-8923696.15998.59
586554-8655493.26995.65
686421-8642193.12695.51
极限190416-9041697.43195.131.45100.3097.981.41
286936-8693693.68196.53
387972-8797294.79797.60
487770-8777094.58097.49
587461-8746194.24797.09
689115-8911596.02998.88
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)5
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%
1 14.682339752343332345832337982338032340980.15
2 14.772338992330242334620.27
单位质量响应值RSD%判断
15946.7315806.500.63数据可信
供试品溶液-GA5217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%
5min12328-23280.9781.1415.040.981.1415.27
23204-32041.3451.35
32344-23440.9840.98
42692-26921.1301.13
52500-25001.0501.05
63227-32271.3551.36
10min17326-73263.0763.335.603.083.335.59
28307-83073.4883.49
37857-78573.2993.30
48341-83413.5023.51
57485-74853.1433.15
68254-82543.4663.47
15min110131-101314.2544.301.934.274.321.97
210463-104634.3944.42
310026-100264.2104.23
410343-103434.3434.37
510072-100724.2294.25
610456-104564.3914.41
20min111206-112064.7064.882.464.754.932.46
212013-120135.0445.09
311403-114034.7884.83
411623-116234.8814.93
511736-117364.9284.97
611764-117644.9404.99
30min112907-129075.4205.602.185.485.672.20
213603-136035.7125.78
313300-133005.5855.65
413721-137215.7625.83
513281-132815.5775.64
613219-132195.5515.62
45min115059-150596.3236.292.816.426.392.76
215178-151786.3736.47
314760-147606.1986.29
414598-145986.1306.23
514638-146386.1476.24
615707-157076.5966.69
60min115853-158536.6576.561.996.786.681.96
215793-157936.6326.76
315362-153626.4516.58
415336-153366.4406.57
515332-153326.4386.56
616028-160286.7306.86
极限116135-161356.7756.722.406.936.882.37
216278-162786.8357.00
315804-158046.6366.79
415804-158046.6366.80
515483-154836.5026.66
616547-165476.9487.11
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)5
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%
112.609316493360934859330392970932560.22
212.679352893397934620.10
单位质量响应值RSD%判断
7401.277376.640.24数据可信
供试品溶液-GA5217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%
5min125977-2597728.04130.4513.4928.0430.4513.49
225395-2539527.41327.41
326369-2636928.46428.46
434315-3431537.04137.04
531641-3164134.15534.15
625555-2555527.58527.59
10min176736-7673682.83381.032.9582.9781.182.94
277342-7734283.48783.62
373459-7345979.29579.44
473415-7341579.24879.43
577050-7705083.17283.34
672371-7237178.12178.26
15min186007-8600792.84089.862.7993.3990.422.78
281783-8178388.28188.84
385385-8538592.16992.71
482856-8285689.43990.02
583688-8368890.33790.92
679759-7975986.09686.62
20min190573-9057397.76992.852.9198.7993.862.89
284210-8421090.90191.90
386705-8670593.59494.59
485617-8561792.41993.45
585467-8546792.25893.30
683505-8350590.14091.10
30min191255-9125598.50595.772.67100.0197.242.66
289098-8909896.17797.63
390619-9061997.81999.29
487018-8701893.93295.42
589396-8939696.49998.00
684916-8491691.66393.07
45min191266-9126698.51796.291.39100.5298.241.38
289354-8935496.45398.38
389717-8971796.84598.80
487686-8768694.65396.61
588486-8848695.51697.50
688713-8871395.76197.63
60min190982-9098298.21195.802.07100.7098.242.06
289482-8948296.59299.01
389514-8951496.62699.07
488974-8897496.04398.48
587992-8799294.98397.44
685573-8557392.37294.72
极限189977-8997797.12694.252.12100.1197.162.12
286851-8685193.75196.65
388088-8808895.08798.01
487206-8720694.13597.05
587460-8746094.40997.34
684290-8429090.98793.80
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)5
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%
1 14.682335282328762332412341762329032333450.23
2 14.772338772333052335910.18
单位质量响应值RSD%判断
15895.4415815.230.36数据可信
供试品溶液-GA5217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%
5min12367-23670.9951.1816.461.001.1816.38
23283-32831.3801.38
32390-23901.0051.00
43293-32931.3851.38
53127-31271.3151.31
62432-24321.0231.02
10min18027-80273.3753.433.553.383.433.58
28050-80503.3853.39
37870-78703.3093.31
48601-86013.6163.62
58420-84203.5403.55
67953-79533.3443.35
15min110698-106984.4984.313.394.524.343.39
210171-101714.2774.30
310182-101824.2814.30
410481-104814.4074.43
510350-103504.3524.38
69674-96744.0684.09
20min111957-119575.0284.823.755.074.873.74
211001-110014.6264.67
311551-115514.8574.90
411791-117914.9585.00
511635-116354.8924.94
610898-108984.5824.62
30min113648-136485.7395.592.655.815.662.64
213240-132405.5675.64
313226-132265.5615.63
413181-131815.5425.61
513711-137115.7655.84
612750-127505.3615.43
45min114883-148836.2586.252.886.366.352.82
214711-147116.1866.28
314637-146376.1546.25
414638-146386.1556.25
514596-145966.1376.24
615710-157106.6066.70
60min115705-157056.6036.511.596.736.641.55
215650-156506.5806.71
315528-155286.5296.65
415578-155786.5506.68
515378-153786.4666.60
615034-150346.3216.45
极限116205-162056.8146.702.316.986.862.24
216033-160336.7416.90
316448-164486.9167.07
415518-155186.5256.69
515923-159236.6956.86
615538-155386.5336.69
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)5
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%
112.609337993774936909362993753936450.17
212.679349693586935410.07
单位质量响应值RSD%判断
7432.147382.870.48数据可信
供试品溶液-HA0117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%
5min130850-3085033.21831.9611.2733.2231.9611.28
224863-2486326.77126.77
331625-3162534.05234.05
426618-2661828.66128.66
533913-3391336.51636.52
630208-3020832.52732.53
10min171888-7188877.40677.192.0577.5777.352.05
271636-7163677.13577.27
372371-7237177.92678.10
470831-7083176.26876.41
573872-7387279.54279.72
669520-6952074.85675.02
15min179288-7928885.37486.351.1985.9386.901.20
278944-7894485.00485.52
381158-8115887.38787.95
480047-8004786.19186.72
581219-8121987.45388.03
680530-8053086.71187.25
20min181951-8195188.24189.201.5789.2290.181.58
282059-8205988.35889.30
382806-8280689.16290.16
481896-8189688.18289.14
585306-8530691.85492.87
683044-8304489.41890.39
30min183921-8392190.36391.400.9591.7892.820.95
284217-8421790.68192.07
384670-8467091.16992.61
485683-8568392.26093.66
585952-8595292.54994.03
684846-8484691.35992.78
45min185234-8523491.77692.641.1993.6594.521.20
285343-8534391.89493.73
386550-8655093.19395.09
484839-8483991.35193.21
587303-8730394.00495.94
686922-8692293.59495.47
60min184987-8498791.51094.061.5593.8496.411.53
287535-8753594.25496.55
387951-8795194.70297.07
486756-8675693.41595.73
588059-8805994.81897.23
688862-8886295.68398.03
极限186262-8626292.88394.311.7495.6797.121.71
288254-8825495.02897.80
386099-8609992.70895.55
486360-8636092.98995.77
589075-8907595.91298.80
689449-8944996.31599.14
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)5
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%
1 14.682347292341442339982340932340812342090.13
2 14.772332922338682335800.18
单位质量响应值RSD%判断
15954.2915814.490.63数据可信
供试品溶液-HA0117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%
5min13124-31241.3111.349.701.311.349.77
22618-26181.0991.10
33539-35391.4851.49
43306-33061.3881.39
53277-32771.3751.38
63252-32521.3651.36
10min17876-78763.3063.459.713.313.459.76
27619-76193.1983.20
38427-84273.5373.54
48405-84053.5283.53
59599-95994.0294.04
67370-73703.0933.10
15min19842-98424.1314.120.484.154.150.45
29839-98394.1304.15
39816-98164.1204.14
49792-97924.1104.13
59767-97674.0994.13
69902-99024.1564.18
20min111016-110164.6234.672.344.674.722.30
210740-107404.5084.55
311218-112184.7084.75
411528-115284.8384.88
511079-110794.6504.70
611201-112014.7014.74
30min112488-124885.2415.351.145.315.421.13
212749-127495.3515.42
312896-128965.4135.48
412788-127885.3675.44
512861-128615.3985.47
612722-127225.3405.41
45min113954-139545.8575.911.135.956.011.11
214027-140275.8875.98
314361-143616.0276.12
413942-139425.8525.95
514186-141865.9546.05
614078-140785.9096.00
60min115395-153956.4616.363.056.586.482.95
214742-147426.1876.31
315287-152876.4166.54
414744-147446.1886.31
514841-148416.2296.36
615896-158966.6726.79
极限115144-151446.3566.442.036.516.601.96
215904-159046.6756.83
315371-153716.4516.61
415384-153846.4576.61
515223-152236.3896.55
615014-150146.3016.46
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