厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源自制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500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.118572318561878568688555468555228562710.09
215.158587548591198589360.04
单位质量响应值RSD%判断
56669.1656695.450.04数据可信
供试品溶液-25120901批-厄贝沙坦-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min194234-942349.97514.6551.939.9714.6451.95
2275556-27555629.16829.17
391455-914559.6819.68
4117927-11792712.48312.48
5157860-15786016.71016.71
693163-931639.8629.86
10min1601288-60128863.64861.9610.3863.7662.1210.47
2690635-69063573.10673.43
3512897-51289754.29254.40
4591617-59161762.62562.76
5569778-56977860.31360.50
6545671-54567157.76157.87
15min1773844-77384481.91487.743.5882.7388.603.61
2845638-84563889.51390.65
3818402-81840286.63087.34
4842595-84259589.19190.03
5855819-85581990.59191.45
6837167-83716788.61789.37
20min1837629-83762988.66691.001.8090.3992.821.85
2864689-86468991.53093.66
3843289-84328989.26590.94
4865937-86593791.66293.49
5872978-87297892.40794.27
6873553-87355392.46894.20
30min1832453-83245388.11890.971.9390.8393.811.89
2848635-84863589.83192.98
3861081-86108191.14893.81
4871766-87176692.27995.12
5878021-87802192.94195.83
6864525-86452591.51394.28
45min1838780-83878088.78890.971.4992.4894.821.47
2852627-85262790.25394.40
3859036-85903690.93294.61
4864555-86455591.51695.39
5875996-87599692.72796.65
6865559-86555991.62295.40
60min1833650-83365088.24490.361.4492.9295.221.40
2843637-84363789.30294.45
3859451-85945190.97695.66
4863204-86320491.37396.26
5864186-86418691.47796.43
6857814-85781490.80295.60
90min1829273-82927387.78190.051.3793.4495.911.38
2848002-84800289.76495.90
3850286-85028690.00595.70
4858932-85893290.92196.82
5860446-86044691.08197.05
6857066-85706690.72396.53
120min1818028-81802886.59188.892.2393.2395.762.14
2825078-82507887.33794.48
3833423-83342388.22094.92
4863714-86371491.42798.34
5860711-86071191.10998.09
6837686-83768688.67295.49
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1837360-83736088.63790.651.5496.2398.501.46
2842633-84263389.19597.30
3863412-86341291.39599.07
4859745-85974591.00798.93
5869450-86945092.034100.03
6865668-86566891.63499.43
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.866301162937630326290562913629600.10
29.936285862939628980.10
单位质量响应值RSD%判断
6385.406334.140.57数据可信
供试品溶液-25120901批-非奈利酮-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13965-39655.6075.4018.555.615.4018.55
24898-48986.9266.93
33119-31194.4104.41
44326-43266.1176.12
53471-34714.9084.91
63144-31444.4464.45
10min143371-4337161.32844.3424.9861.3944.4024.95
229870-2987042.23742.31
330007-3000742.43142.48
431006-3100643.84443.91
519227-1922727.18827.24
634663-3466349.01549.06
15min153044-5304475.00667.8714.2375.7568.4214.28
247287-4728766.86667.41
350065-5006570.79471.31
449907-4990770.57071.13
534768-3476849.16349.52
652924-5292474.83675.43
20min160786-6078685.95477.0413.0687.5378.3413.12
254903-5490377.63578.92
355870-5587079.00280.31
455265-5526578.14779.49
540791-4079157.68058.58
659268-5926883.80785.23
30min165989-6598993.31186.618.6395.8488.778.79
260999-6099986.25588.41
363030-6303089.12791.31
462237-6223788.00590.21
551042-5104272.17573.72
664197-6419790.77793.13
45min168110-6811096.31092.834.0699.8895.954.35
265462-6546292.56695.68
365981-6598193.30096.47
467249-6724995.09398.28
560558-6055885.63187.98
666525-6652594.06997.43
60min167786-6778695.85294.202.22100.4998.362.47
265987-6598793.30897.45
366528-6652894.07398.28
468781-6878197.259101.50
564600-6460091.34794.64
666028-6602893.36697.78
90min166642-6664294.23494.592.1899.9499.791.90
266357-6635793.83199.01
365417-6541792.50297.76
468962-6896297.515102.84
568362-6836296.666100.98
665603-6560392.76598.21
120min165506-6550692.62892.733.6299.3898.983.19
264235-6423590.83197.05
363244-6324489.42995.71
468431-6843196.764103.17
568493-6849396.852102.24
663546-6354689.85696.34
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164793-6479391.62092.503.0099.4099.792.53
264359-6435991.00698.23
363621-6362189.96297.24
467205-6720595.030102.51
568473-6847396.823103.29
664052-6405290.57298.05
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源自制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500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.118609708614668617508609578613728613030.04
215.158639288642208640740.03
单位质量响应值RSD%判断
57002.1857034.590.05数据可信
供试品溶液-25120901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%
5min110039-100391.0560.9828.181.060.9828.29
27582-75820.7980.80
37163-71630.7540.75
414229-142291.4971.50
59040-90400.9510.95
67855-78550.8270.83
10min125935-259352.7292.7410.462.742.7610.53
223047-230472.4252.43
325754-257542.7102.72
430645-306453.2253.24
527327-273272.8762.89
623760-237602.5002.51
15min136237-362373.8133.832.623.863.882.68
235656-356563.7523.79
336757-367573.8683.91
438109-381094.0104.06
536368-363683.8273.87
635446-354463.7303.77
20min140819-408194.2954.341.714.384.421.80
240163-401634.2264.30
342144-421444.4354.52
441671-416714.3854.48
541495-414954.3664.45
641000-410004.3144.39
30min145872-458724.8274.821.194.964.951.20
245996-459964.8404.96
344803-448034.7154.85
446397-463974.8825.03
546095-460954.8514.98
645754-457544.8154.94
45min149694-496945.2295.291.175.425.481.01
250394-503945.3035.48
350355-503555.2995.48
449486-494865.2075.41
550512-505125.3155.50
651084-510845.3765.56
60min152127-521275.4855.581.235.735.821.18
252840-528405.5605.80
353403-534035.6205.86
453492-534925.6295.89
552351-523515.5095.76
653694-536945.6505.89
90min155493-554935.8395.890.846.146.200.91
255853-558535.8776.18
356025-560255.8956.20
456824-568245.9806.30
555656-556565.8576.16
656131-561315.9076.21
120min157041-570416.0026.081.196.376.451.13
257903-579036.0936.46
358075-580756.1116.48
458107-581076.1156.50
556804-568045.9776.35
658563-585636.1636.53
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158377-583776.1436.131.106.586.561.07
257791-577916.0816.51
357623-576236.0646.50
458190-581906.1236.58
557908-579086.0946.53
659389-593896.2496.69
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.866339263228632936326963123632610.16
29.936345963537634980.09
单位质量响应值RSD%判断
6415.926394.560.24数据可信
供试品溶液-25120901批-非奈利酮-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%
5min16065-60658.5157.7431.208.527.7431.22
27413-741310.40810.41
32416-24163.3923.39
45584-55847.8407.84
55049-50497.0897.09
66541-65419.1839.18
10min139116-3911654.91850.988.4655.0151.078.49
237311-3731152.38452.50
330354-3035442.61642.65
436632-3663251.43151.52
537924-3792453.24453.32
636537-3653751.29751.40
15min150327-5032770.65870.342.4071.3670.992.45
252113-5211373.16673.86
348741-4874168.43168.94
449288-4928869.19969.86
549528-4952869.53670.21
650615-5061571.06271.73
20min154234-5423476.14376.621.8477.6378.061.79
255648-5564878.12979.64
355486-5548677.90179.17
453225-5322574.72776.15
553702-5370275.39676.84
655154-5515477.43578.90
30min157946-5794681.35581.011.7783.6983.291.81
259519-5951983.56385.94
356580-5658079.43781.57
457055-5705580.10482.36
557328-5732880.48782.77
657769-5776981.10683.43
45min159403-5940383.40184.062.0386.6487.242.00
261256-6125686.00289.31
359912-5991284.11587.13
457872-5787281.25184.40
559817-5981783.98287.16
660962-6096285.58988.81
60min159931-5993184.14285.431.4488.3189.551.41
261985-6198587.02691.29
361351-6135186.13690.09
460372-6037284.76188.81
559952-5995284.17188.28
661496-6149686.33990.51
90min160488-6048884.92485.791.1890.0390.861.14
262291-6229187.45592.69
361667-6166786.57991.49
460850-6085085.43290.42
560780-6078085.33490.38
660556-6055685.01990.15
120min160410-6041084.81485.741.4990.8691.761.43
262226-6222687.36493.57
362068-6206887.14293.02
460251-6025184.59190.53
560271-6027184.61990.61
661176-6117685.89091.97
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161392-6139286.19386.571.1193.1893.541.11
262408-6240887.62094.79
361814-6181486.78693.63
460966-6096685.59592.48
560919-6091985.52992.46
662449-6244987.67794.71
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源自制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500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.118530148529118534888533978513018528220.11
215.158548978541478545220.07
单位质量响应值RSD%判断
56440.9056404.090.05数据可信
供试品溶液-25120901批-厄贝沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min197484-9748410.36710.4432.7010.3710.4432.68
2104160-10416011.07611.08
3146892-14689215.62115.62
492042-920429.7889.79
546336-463364.9274.93
6102147-10214710.86210.86
10min1353196-35319637.55935.0913.9237.6735.2013.97
2341317-34131736.29636.42
3387241-38724141.17941.35
4332191-33219135.32535.43
5250066-25006626.59226.65
6315854-31585433.58833.71
15min1508657-50865754.09154.334.6454.6254.834.75
2518365-51836555.12355.65
3551485-55148558.64559.28
4501304-50130453.30953.81
5479711-47971151.01351.36
6505806-50580653.78854.28
20min1596201-59620163.40062.882.5764.5363.992.70
2600975-60097563.90865.05
3614016-61401665.29566.58
4580801-58080161.76362.86
5572844-57284460.91761.83
6583207-58320762.01963.11
30min1693021-69302173.69673.711.5775.5375.521.67
2697807-69780774.20576.05
3712034-71203475.71877.73
4681110-68111072.43074.21
5687300-68730073.08874.68
6687808-68780873.14274.92
45min1740926-74092678.79080.041.4081.4582.671.49
2759563-75956380.77283.45
3769664-76966481.84784.70
4747219-74721979.46082.04
5745837-74583779.31381.72
6752945-75294580.06982.66
60min1784596-78459683.43483.221.3986.9786.741.47
2787571-78757183.75187.32
3793139-79313984.34388.10
4768527-76852781.72685.19
5769894-76989481.87185.16
6791919-79191984.21387.70
90min1817854-81785486.97186.591.6191.4391.041.59
2821682-82168287.37891.88
3825009-82500987.73292.43
4789736-78973683.98188.36
5821528-82152887.36291.56
6810011-81001186.13790.56
120min1823155-82315587.53587.271.5092.9692.681.53
2820563-82056387.25992.73
3836781-83678188.98494.65
4799088-79908884.97590.28
5819989-81998987.19892.37
6824608-82460887.68993.07
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1813921-81392186.55386.651.0492.9593.031.06
2824662-82466287.69594.14
3814906-81490686.65893.32
4801249-80124985.20591.46
5811543-81154386.30092.44
6822822-82282287.49993.85
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.866283662606628846287462668627740.21
29.936286862835628520.04
单位质量响应值RSD%判断
6366.536329.510.42数据可信
供试品溶液-25120901批-非奈利酮-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16815-68159.6547.9022.719.657.9022.71
27239-723910.25510.26
34855-48556.8786.88
44410-44106.2476.25
54257-42576.0316.03
65891-58918.3458.35
10min132450-3245045.97043.614.9646.0843.704.99
232692-3269246.31346.43
330375-3037543.03143.11
430628-3062843.38943.46
528799-2879940.79840.86
629753-2975342.14942.24
15min141694-4169459.06659.341.2259.6859.911.25
242539-4253960.26360.89
342368-4236860.02060.57
441764-4176459.16559.72
541121-4112158.25458.77
641852-4185259.28959.85
20min146742-4674266.21765.760.5967.4967.000.62
246677-4667766.12567.42
346346-4634665.65666.88
446488-4648865.85767.07
546260-4626065.53466.70
646022-4602265.19766.42
30min152587-5258774.49774.400.4576.5176.360.40
252133-5213373.85475.89
352546-5254674.43976.39
452824-5282474.83376.77
552630-5263074.55876.45
652383-5238374.20876.15
45min154712-5471277.50778.951.1080.3581.741.04
255691-5569178.89481.75
356138-5613879.52882.31
456535-5653580.09082.86
555611-5561178.78181.51
655694-5569478.89981.67
60min157961-5796182.11082.080.9985.8185.740.95
257463-5746381.40585.13
357959-5795982.10785.77
458321-5832182.62086.28
557175-5717580.99784.60
658756-5875683.23686.88
90min160982-6098286.39085.930.7691.0090.510.69
260178-6017885.25189.89
360577-6057785.81690.39
460505-6050585.71490.29
561404-6140486.98891.49
660293-6029385.41489.98
120min161699-6169987.40587.360.8592.9892.890.77
260670-6067085.94891.53
361840-6184087.60593.13
461728-6172887.44792.98
561860-6186087.63493.10
662198-6219888.11293.63
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161329-6132986.88186.980.8693.4293.480.80
261069-6106986.51393.05
360700-6070085.99092.49
461938-6193887.74494.25
561256-6125686.77893.22
662081-6208187.94794.44
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