非奈利酮厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号80324110503对照品来源自制对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%) 0.33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%
114.888364428352588376198358468374088365150.13
214.968347118348978348040.02
单位质量响应值RSD%判断
56217.4155802.410.53数据可信
供试品溶液-25111201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%
5min19115-91150.9741.0823.800.971.0723.96
210004-100041.0691.07
313652-136521.4591.46
46299-62990.6730.67
510679-106791.1411.14
610611-106111.1341.13
10min131155-311553.3303.207.373.343.227.39
231487-314873.3653.38
331925-319253.4123.43
425907-259072.7692.78
529451-294513.1483.16
629791-297913.1843.20
15min141077-410774.3904.311.924.444.352.02
240918-409184.3734.42
340983-409834.3804.43
439446-394464.2164.25
539829-398294.2574.30
639539-395394.2264.27
20min148223-482235.1544.843.395.254.943.35
245887-458874.9045.00
344491-444914.7554.86
444602-446024.7674.85
544395-443954.7454.84
644348-443484.7404.83
30min150854-508545.4356.3332.125.596.4831.42
297646-9764610.43610.59
350395-503955.3865.54
449409-494095.2815.42
550194-501945.3655.51
656747-567476.0656.21
45min155627-556275.9455.791.616.166.011.77
254728-547285.8496.12
353317-533175.6985.91
453679-536795.7375.93
554089-540895.7815.99
653573-535735.7265.94
60min158625-586256.2666.042.296.556.322.39
257357-573576.1306.46
355967-559675.9826.26
456105-561055.9966.26
555905-559055.9756.25
654981-549815.8766.15
极限160664-606646.4846.252.206.836.602.16
258648-586486.2686.67
357575-575756.1546.50
458409-584096.2436.57
558560-585606.2596.60
656866-568666.0786.42
非奈利酮厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号240901对照品来源自制对照品使用方法直接使用
对照品含量(%)100.2对照品水分(%)0.06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%
110.061259071240121256901248081256621252160.64
210.151247311240611243960.39
单位质量响应值RSD%判断
12446.9212255.761.10数据可信
供试品溶液-25111201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%
5min19278-92786.77011.0230.886.7711.0230.89
213480-134809.8379.84
321865-2186515.95615.96
411254-112548.2128.21
516581-1658112.10012.10
618171-1817113.26013.26
10min159091-5909143.12050.4311.7043.2050.5511.74
267502-6750249.25849.37
375346-7534654.98255.16
460080-6008043.84243.93
576313-7631355.68855.82
676281-7628155.66455.81
15min188103-8810364.29166.452.8764.8567.132.91
288262-8826264.40765.06
390902-9090266.33467.12
492659-9265967.61668.19
594898-9489869.25070.00
691558-9155866.81367.58
20min198922-9892272.18671.973.0673.4573.393.00
295486-9548669.67971.05
395008-9500869.33070.86
4100728-10072873.50474.83
5102852-10285275.05476.58
698783-9878372.08573.59
30min1106763-10676377.90878.382.8779.9880.602.85
2104607-10460776.33578.48
3103928-10392875.83978.13
4108741-10874179.35181.50
5112389-11238982.01384.37
6108011-10801178.81981.13
45min1112435-11243582.04781.543.0984.9884.623.04
2107157-10715778.19681.19
3108158-10815878.92682.06
4113900-11390083.11686.14
5116169-11616984.77288.04
6112583-11258382.15585.34
60min1115133-11513384.01683.033.0587.8687.032.95
2110698-11069880.78084.64
3109746-10974680.08584.10
4117574-11757485.79789.75
5117601-11760185.81790.03
6111955-11195581.69785.79
极限1121004-12100488.30085.274.1093.0890.193.94
2111767-11176781.56086.32
3111641-11164181.46886.37
4120428-12042887.88092.78
5121882-12188288.94194.10
6114375-11437583.46388.47
非奈利酮厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号80324110503对照品来源自制对照品使用方法直接使用
对照品含量(%)100.1对照品水分(%) 0.33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%
114.888181218214938213838207898216318206830.18
214.968258648221428240030.32
单位质量响应值RSD%判断
55153.4355080.410.10数据可信
供试品溶液-25111201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%
5min167121-671217.2907.4827.577.297.4827.56
252693-526935.7235.72
388342-883429.5959.59
449622-496225.3895.39
559877-598776.5036.50
695426-9542610.36410.36
10min1379459-37945941.21339.966.4841.2940.046.50
2369198-36919840.09840.16
3394605-39460542.85842.96
4343484-34348437.30537.37
5335024-33502436.38736.46
6385586-38558641.87841.99
15min1529975-52997557.56057.401.8758.1057.931.90
2528180-52818057.36557.87
3545205-54520559.21459.80
4515001-51500155.93456.41
5528591-52859157.41057.89
6523990-52399056.91057.49
20min1619247-61924767.25666.680.9868.4367.840.97
2604979-60497965.70666.85
3618065-61806567.12768.37
4613014-61301466.57967.67
5619208-61920867.25168.37
6609066-60906666.15067.36
30min1725137-72513778.75677.351.9680.6879.251.90
2701105-70110576.14678.02
3710139-71013977.12779.11
4708564-70856476.95678.79
5732193-73219379.52381.38
6695992-69599275.59177.54
45min1787027-78702785.47884.681.8888.2887.441.83
2775698-77569884.24886.97
3783026-78302685.04487.89
4767316-76731683.33786.03
5802634-80263487.17389.92
6762124-76212482.77385.56
60min1813205-81320588.32188.511.7592.0792.211.69
2797193-79719386.58290.24
3815038-81503888.52092.31
4824985-82498589.60193.22
5836135-83613590.81294.53
6802937-80293787.20690.91
极限1816499-81649988.67989.362.3193.4194.042.23
2800244-80024486.91491.53
3829983-82998390.14394.92
4828748-82874890.00994.62
5853341-85334192.68097.40
6807615-80761587.71492.39
非奈利酮厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号240901对照品来源自制对照品使用方法直接使用
对照品含量(%)100.2对照品水分(%)0.06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%
110.061207701211761218111215561210361212700.35
210.151216101214801215450.08
单位质量响应值RSD%判断
12054.6711974.880.47数据可信
供试品溶液-25111201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%
5min110199-101997.6517.3430.717.657.3430.72
213128-131289.8489.85
35576-55764.1834.18
413076-130769.8099.81
57571-75715.6795.68
69183-91836.8886.89
10min148162-4816236.12835.375.2336.2135.465.28
250025-5002537.52537.63
344756-4475633.57333.62
448818-4881836.62036.73
543634-4363432.73132.79
647553-4755335.67135.75
15min162633-6263346.98347.922.0347.4748.392.02
265182-6518248.89549.42
364232-6423248.18348.60
464744-6474448.56749.08
564534-6453448.40948.84
661936-6193646.46046.93
20min170925-7092553.20353.811.7454.2154.811.73
271763-7176353.83254.90
371545-7154553.66854.62
473456-7345655.10256.16
572704-7270454.53855.50
669973-6997352.48953.48
30min181039-8103960.79060.832.0362.3962.441.99
281490-8149061.12862.80
380937-8093760.71462.26
481453-8145361.10162.77
583384-8338462.54964.12
678271-7827158.71460.29
45min187678-8767865.77066.072.0368.0568.361.97
288827-8882766.63268.98
389118-8911866.85069.08
487036-8703665.28967.64
590462-9046267.85970.12
685366-8536664.03666.26
60min190915-9091568.19869.651.9871.2072.661.94
292685-9268569.52672.61
393424-9342470.08173.05
494393-9439370.80773.88
595105-9510571.34174.36
690546-9054667.92270.86
极限192334-9233469.26370.852.5073.0374.642.41
293349-9334970.02473.88
396030-9603072.03575.78
495157-9515771.38075.24
597959-9795973.48277.29
691850-9185068.90072.59
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