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-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1601288-60128863.64861.9610.3863.6561.9610.39
2690635-69063573.10673.11
3512897-51289754.29254.29
4591617-59161762.62562.62
5569778-56977860.31360.31
6545671-54567157.76157.76
15min1773844-77384481.91487.743.5882.6288.433.57
2845638-84563889.51390.33
3818402-81840286.63087.23
4842595-84259589.19189.89
5855819-85581990.59191.26
6837167-83716788.61789.26
20min1837629-83762988.66691.001.8090.2892.661.81
2864689-86468991.53093.34
3843289-84328989.26590.83
4865937-86593791.66293.35
5872978-87297892.40794.08
6873553-87355392.46894.09
30min1832453-83245388.11890.971.9390.7293.641.89
2848635-84863589.83192.65
3861081-86108191.14893.71
4871766-87176692.27994.98
5878021-87802192.94195.64
6864525-86452591.51394.17
45min1838780-83878088.78890.971.4992.3794.661.47
2852627-85262790.25394.08
3859036-85903690.93294.50
4864555-86455591.51695.25
5875996-87599692.72796.46
6865559-86555991.62295.29
60min1833650-83365088.24490.361.4492.8195.061.41
2843637-84363789.30294.13
3859451-85945190.97695.56
4863204-86320491.37396.12
5864186-86418691.47796.24
6857814-85781490.80295.49
90min1829273-82927387.78190.051.3793.3395.741.36
2848002-84800289.76495.58
3850286-85028690.00595.60
4858932-85893290.92196.68
5860446-86044691.08196.86
6857066-85706690.72396.42
120min1818028-81802886.59188.892.2393.1195.592.15
2825078-82507887.33794.15
3833423-83342388.22094.81
4863714-86371491.42798.20
5860711-86071191.10997.90
6837686-83768688.67295.38
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1837360-83736088.63790.651.5496.1298.341.49
2842633-84263389.19596.98
3863412-86341291.39598.97
4859745-85974591.00798.80
5869450-86945092.03499.84
6865668-86566891.63499.32
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-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%
5min110039-100391.0560.8557.241.060.8657.23
27582-75820.7980.80
3-0.0000.00
414229-142291.4971.50
59040-90400.9510.95
67855-78550.8270.83
10min125935-259352.7292.7410.462.742.7510.55
223047-230472.4252.43
325754-257542.7102.71
430645-306453.2253.24
527327-273272.8762.89
623760-237602.5002.51
15min136237-362373.8133.832.623.863.882.67
235656-356563.7523.79
336757-367573.8683.90
438109-381094.0104.06
536368-363683.8273.87
635446-354463.7303.77
20min140819-408194.2954.341.714.384.421.74
240163-401634.2264.30
342144-421444.4354.51
441671-416714.3854.48
541495-414954.3664.45
641000-410004.3144.39
30min145872-458724.8274.821.194.964.951.27
245996-459964.8404.96
344803-448034.7154.84
446397-463974.8825.03
546095-460954.8514.98
645754-457544.8154.94
45min149694-496945.2295.291.175.425.471.01
250394-503945.3035.48
350355-503555.2995.47
449486-494865.2075.41
550512-505125.3155.50
651084-510845.3765.56
60min152127-521275.4855.581.235.735.821.17
252840-528405.5605.80
353403-534035.6205.85
453492-534925.6295.89
552351-523515.5095.76
653694-536945.6505.89
90min155493-554935.8395.890.846.146.200.91
255853-558535.8776.18
356025-560255.8956.19
456824-568245.9806.30
555656-556565.8576.16
656131-561315.9076.21
120min157041-570416.0026.081.196.376.451.12
257903-579036.0936.46
358075-580756.1116.47
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158377-583776.1436.131.106.586.561.10
257791-577916.0816.51
357623-576236.0646.49
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-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%
5min197484-9748410.3675.38109.6310.375.38109.63
2104160-10416011.07611.08
3-0.0000.00
4-0.0000.00
5-0.0000.00
6102147-10214710.86210.86
10min1353196-35319637.55935.0913.9237.6735.1513.93
2341317-34131736.29636.42
3387241-38724141.17941.18
4332191-33219135.32535.33
5250066-25006626.59226.59
6315854-31585433.58833.71
15min1508657-50865754.09154.334.6454.6254.784.69
2518365-51836555.12355.65
3551485-55148558.64559.10
4501304-50130453.30953.70
5479711-47971151.01351.31
6505806-50580653.78854.28
20min1596201-59620163.40062.882.5764.5363.942.66
2600975-60097563.90865.05
3614016-61401665.29566.40
4580801-58080161.76362.75
5572844-57284460.91761.78
6583207-58320762.01963.11
30min1693021-69302173.69673.711.5775.5375.461.63
2697807-69780774.20576.05
3712034-71203475.71877.55
4681110-68111072.43074.10
5687300-68730073.08874.63
6687808-68780873.14274.92
45min1740926-74092678.79080.041.4081.4582.611.44
2759563-75956380.77283.45
3769664-76966481.84784.52
4747219-74721979.46081.94
5745837-74583779.31381.66
6752945-75294580.06982.66
60min1784596-78459683.43483.221.3986.9786.681.48
2787571-78757183.75187.32
3793139-79313984.34387.93
4768527-76852781.72685.08
5769894-76989481.87185.10
6791919-79191984.21387.70
90min1817854-81785486.97186.591.6191.4390.981.60
2821682-82168287.37891.88
3825009-82500987.73292.25
4789736-78973683.98188.25
5821528-82152887.36291.50
6810011-81001186.13790.56
120min1823155-82315587.53587.271.5092.9692.621.52
2820563-82056387.25992.73
3836781-83678188.98494.48
4799088-79908884.97590.18
5819989-81998987.19892.31
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1813921-81392186.55386.651.0492.9592.971.10
2824662-82466287.69594.14
3814906-81490686.65893.14
4801249-80124985.20591.35
5811543-81154386.30092.38
6822822-82282287.49993.85
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