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5000
标示量(mg)10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%
110.066313762985628826311663043630330.17
210.016315763113631350.05
单位质量响应值RSD%判断
6265.716307.190.47数据可信
供试品溶液-2026051421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%
5min173069-73069104.52722.17182.07104.5322.16182.08
24518-45186.4636.46
34150-41505.9375.94
44260-42606.0946.09
53896-38965.5735.57
63075-30754.3994.40
10min17570-757010.82917.3730.0511.9917.6228.16
211499-1149916.45016.52
317896-1789625.60125.67
414732-1473221.07421.14
511079-1107915.84915.91
610076-1007614.41414.46
15min115067-1506721.55441.0747.9022.8441.5147.01
218267-1826726.13126.39
346364-4636466.32566.68
443491-4349162.21562.52
531050-3105044.41844.66
618008-1800825.76125.97
20min123147-2314733.11252.6441.0834.6353.5340.54
223925-2392534.22534.77
353406-5340676.39877.49
455115-5511578.84379.84
541053-4105358.72759.46
624121-2412134.50635.00
30min135072-3507250.17170.8726.2052.0672.3526.01
235422-3542250.67251.60
363252-6325290.48392.42
462577-6257789.51891.39
556544-5654480.88782.27
644380-4438063.48764.37
45min144871-4487164.18983.4517.4766.6485.7217.38
245955-4595565.74067.23
366878-6687895.67098.61
466015-6601594.43697.30
564935-6493592.89195.17
661359-6135987.77589.36
60min152247-5224774.74087.789.4177.9090.989.51
256184-5618480.37282.59
364816-6481692.72196.73
465844-6584494.19198.10
566005-6600594.42297.74
663078-6307890.23492.79
90min160233-6023386.16592.693.6890.1596.863.81
264927-6492792.87995.99
365043-6504393.04598.08
467231-6723196.175101.14
565673-6567393.94798.31
665659-6565993.92797.49
120min162330-6233089.16492.181.9894.1197.382.04
264604-6460492.41796.56
363993-6399391.54397.61
464452-6445292.20098.23
566187-6618794.682100.09
665053-6505393.06097.67
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166203-6620394.70593.101.11100.6499.321.25
265022-6502293.01598.19
364281-6428191.95599.04
465369-6536993.512100.56
565268-6526893.36799.83
664343-6434392.04497.68
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%
114.906637786637336621826619076631666629530.14
214.906664086660716662400.04
单位质量响应值RSD%判断
44493.4944714.090.35数据可信
供试品溶液-2026051421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%
5min1-0.00023.0959.240.0023.0959.24
2148825-14882520.02020.02
3282795-28279538.04138.04
4263303-26330335.41935.42
5188681-18868125.38125.38
6146174-14617419.66319.66
10min1347200-34720046.70567.3718.8646.7067.6319.01
2450845-45084560.64760.87
3603665-60366581.20481.63
4588311-58831179.13979.53
5516198-51619869.43869.72
6498788-49878867.09667.31
15min1634622-63462285.36889.114.4285.8990.114.63
2618510-61851083.20184.10
3688580-68858092.62793.95
4688294-68829492.58893.86
5676138-67613890.95392.01
6668266-66826689.89490.86
20min1684905-68490592.13293.871.9893.6095.862.17
2678986-67898691.33693.16
3696776-69677693.72996.08
4711966-71196695.77398.07
5712146-71214695.79797.86
6702013-70201394.43496.40
30min1726905-72690597.78296.641.35100.2799.681.20
2723849-72384997.371100.21
3705880-70588094.95498.35
4729489-72948998.130101.50
5709962-70996295.50398.63
6714412-71441296.10299.11
45min1725000-72500097.52696.670.81101.10100.780.52
2724378-72437897.442101.36
3713224-71322495.942100.39
4714385-71438596.098100.55
5712810-71281095.886100.08
6722184-72218497.147101.23
60min1728693-72869398.02394.662.30102.6899.851.89
2713636-71363695.997101.00
3686004-68600492.28097.80
4694022-69402293.35998.88
5708430-70843095.297100.55
6691537-69153793.02598.18
90min1713317-71331795.95494.531.27101.70100.761.04
2706766-70676695.073101.14
3688565-68856592.62599.17
4709170-70917095.397101.96
5699202-69920294.056100.37
6699157-69915794.050100.24
120min1687307-68730792.45692.841.2599.27100.121.14
2694790-69479093.462100.59
3679674-67967491.42999.00
4685999-68599992.28099.90
5704645-70464594.788102.15
6688409-68840992.60499.84
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1704989-70498994.83493.201.26102.68101.521.02
2693611-69361193.304101.47
3684768-68476892.114100.70
4691516-69151693.022101.67
5699874-69987494.146102.56
6682153-68215391.762100.03
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5000
标示量(mg)10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%
110.066319963200631146313563244631780.09
210.016354963406634780.16
单位质量响应值RSD%判断
6280.126341.460.69数据可信
供试品溶液-2026051421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%
5min16542-65429.3226.9820.099.326.9820.08
24564-45646.5046.50
35280-52807.5247.52
43712-37125.2905.29
54230-42306.0286.03
65053-50537.2017.20
10min128282-2828240.30226.8330.5340.4126.9130.49
223464-2346433.43733.51
315463-1546322.03522.12
413702-1370219.52619.58
515317-1531721.82721.89
616741-1674123.85623.94
15min139889-3988956.84347.4225.2857.3947.8025.18
240892-4089258.27258.72
321065-2106530.01830.35
436551-3655152.08652.36
536876-3687652.54952.86
624384-2438434.74835.09
20min147619-4761967.85861.9226.9669.0462.8226.80
251855-5185573.89574.99
325165-2516535.86136.52
454551-5455177.73678.59
548689-4868969.38370.28
632835-3283546.79147.52
30min155660-5566079.31774.4622.3481.2576.0522.28
258075-5807582.75884.67
332060-3206045.68646.75
464477-6447791.88193.60
557836-5783682.41884.08
645390-4539064.68265.93
45min162356-6235688.85985.2012.7691.6887.6212.97
262695-6269589.34292.17
345916-4591665.43167.00
467206-6720695.77098.51
564019-6401991.22893.81
656541-5654180.57282.54
60min167212-6721295.77988.888.0499.5892.248.15
265220-6522092.94096.76
354231-5423177.28079.58
458458-5845883.30487.11
563313-6331390.22293.82
665781-6578193.73996.60
90min165698-6569893.62193.480.4598.4997.840.71
265581-6558193.45498.31
365563-6556393.42996.58
465422-6542293.22897.96
565244-6524492.97497.57
666100-6610094.19498.10
120min163962-6396291.14792.681.2097.0698.081.12
264371-6437191.73097.63
365316-6531693.07797.27
465325-6532593.09098.85
566165-6616594.28799.92
665104-6510492.77597.73
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163783-6378390.89291.571.5897.8197.981.21
263161-6316190.00696.92
365633-6563393.52898.75
465392-6539293.18599.98
563640-6364090.68897.37
663926-6392691.09697.08
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%
114.906637586641026645186655066652656646300.12
214.906707246687956697600.21
单位质量响应值RSD%判断
44606.0444950.340.55数据可信
供试品溶液-2026051421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%
5min1201834-20183427.04529.9019.8827.0429.9019.89
2291041-29104138.99839.00
3201125-20112526.95026.95
4189635-18963525.41025.41
5267027-26702735.78035.78
6187982-18798225.18925.19
10min1566495-56649575.90876.256.7776.2176.586.82
2628871-62887184.26684.70
3564033-56403375.57875.88
4546940-54694073.28873.57
5591657-59165779.28079.68
6516206-51620669.16969.45
15min1691127-69112792.60891.972.5393.7593.142.61
2703580-70358094.27795.65
3679055-67905590.99192.13
4689141-68914192.34293.44
5699509-69950993.73195.01
6655588-65558887.84688.89
20min1716401-71640195.99595.461.8998.1797.661.95
2723876-72387696.99699.41
3696405-69640593.31595.47
4721563-72156396.68698.81
5721894-72189496.73199.05
6694497-69449793.06095.08
30min1706866-70686694.71796.201.7097.9699.461.72
2730057-73005797.825101.32
3705570-70557094.54397.73
4734672-73467298.443101.64
5718229-71822996.24099.63
6712000-71200095.40598.46
45min1698754-69875493.63096.031.5097.92100.361.51
2720509-72050996.545101.13
3712984-71298495.53799.77
4726801-72680197.388101.68
5727184-72718497.440101.90
6713619-71361995.62299.74
60min1716084-71608495.95294.911.24101.28100.311.22
2720485-72048596.542102.20
3701180-70118093.95599.25
4703852-70385294.31399.69
5698258-69825893.56499.11
6710137-71013795.155100.34
90min1695637-69563793.21293.890.5099.61100.340.59
2705441-70544194.526101.25
3697885-69788593.51499.86
4700641-70064193.883100.30
5702561-70256194.140100.73
6701853-70185394.045100.28
120min1675936-67593690.57392.901.6198.01100.401.58
2694191-69419193.019100.80
3690421-69042192.51499.90
4698963-69896393.658101.12
5709820-70982095.113102.75
6690653-69065392.54599.83
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1674783-67478390.41892.071.5298.86100.601.39
2680218-68021891.14699.96
3696599-69659993.341101.75
4701220-70122093.961102.47
5689496-68949692.390101.08
6680455-68045591.17899.49
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5000
标示量(mg)10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%
110.066285462796628816279362813628270.07
210.016335263494634230.16
单位质量响应值RSD%判断
6245.236335.961.02数据可信
供试品溶液-2026051421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%
5min19046-904612.93211.6212.3312.9311.6212.32
28514-851412.17212.17
38231-823111.76711.77
48124-812411.61411.61
56195-61958.8578.86
68657-865712.37612.38
10min130645-3064543.81143.197.6743.9543.327.68
233023-3302347.21147.35
329454-2945442.10942.24
429581-2958142.29042.42
526454-2645437.82037.92
632113-3211345.91046.05
15min147403-4740367.76966.205.6068.4066.805.62
248565-4856569.43070.09
346602-4660266.62467.22
446787-4678766.88867.49
541204-4120458.90759.43
647254-4725467.55668.20
20min153749-5374976.84276.192.9578.2377.543.01
254248-5424877.55578.99
353249-5324976.12777.47
453905-5390577.06578.41
550201-5020171.76972.94
654414-5441477.79279.19
30min158339-5833983.40483.552.0885.6485.742.13
260533-6053386.54088.83
358099-5809983.06085.25
458790-5879084.04886.25
556830-5683081.24683.22
658058-5805883.00285.26
45min161145-6114587.41588.021.0990.5891.141.16
262796-6279689.77593.03
361541-6154187.98191.09
461125-6112587.38790.52
561013-6101387.22690.10
661786-6178688.33291.52
60min162114-6211488.80090.331.1292.9494.421.07
263968-6396891.45195.70
363600-6360090.92595.01
463417-6341790.66394.77
563465-6346590.73294.57
662532-6253289.39893.56
90min162355-6235589.14591.281.4394.2796.381.32
263856-6385691.29196.56
365071-6507193.02898.12
463498-6349890.77995.89
564398-6439892.06696.92
663900-6390091.35496.51
120min162032-6203288.68391.581.6994.8097.701.58
264229-6422991.82498.11
364188-6418891.76697.89
465278-6527893.32499.44
564461-6446192.15698.03
664173-6417391.74497.92
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164556-6455692.29292.801.1199.3999.931.01
264396-6439692.06399.37
364437-6443792.12299.27
466282-6628294.759101.92
565072-6507293.02999.93
664709-6470992.51099.70
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%
114.906575506574096576616580306569286575160.07
214.906649956649066649500.01
单位质量响应值RSD%判断
44128.5944627.520.80数据可信
供试品溶液-2026051421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%
5min1176440-17644023.85620.8623.4023.8620.8623.40
2176728-17672823.89523.89
3163497-16349722.10622.11
4156626-15662621.17721.18
582337-8233711.13211.13
6170157-17015723.00623.01
10min1370621-37062150.11047.6613.4950.3847.8913.53
2383755-38375551.88652.15
3369542-36954249.96450.21
4359929-35992948.66548.90
5256777-25677734.71834.84
6374373-37437350.61850.87
15min1474909-47490964.21161.637.9465.0362.398.04
2477597-47759764.57465.42
3467636-46763663.22764.03
4464214-46421462.76563.54
5382726-38272651.74752.26
6467806-46780663.25064.07
20min1531890-53189071.91570.365.0673.4571.815.21
2531117-53111771.81073.37
3525694-52569471.07772.58
4530343-53034371.70673.18
5467116-46711663.15764.24
6536346-53634672.51774.04
30min1590406-59040679.82778.853.2482.1681.083.40
2603617-60361781.61383.97
3584295-58429579.00081.29
4588175-58817579.52581.80
5547454-54745474.01975.81
6585025-58502579.09981.43
45min1632735-63273585.55084.952.0688.7788.052.26
2639353-63935386.44589.71
3630141-63014185.19988.37
4624238-62423884.40187.55
5604527-60452781.73684.34
6638601-63860186.34389.55
60min1650827-65082787.99688.411.0692.1792.461.26
2661100-66110089.38593.61
3659490-65949089.16793.28
4656680-65668088.78792.88
5642178-64217886.82690.34
6653169-65316988.31392.48
90min1663089-66308989.65490.611.3194.8095.641.42
2671713-67171390.82096.04
3681939-68193992.20297.31
4665631-66563189.99795.08
5660220-66022089.26693.75
6678558-67855891.74596.89
120min1663484-66348489.70791.471.5395.8597.501.60
2678987-67898791.80398.03
3676375-67637591.45097.58
4686721-68672192.84998.93
5665561-66556189.98895.46
6687975-68797593.01999.18
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1687697-68769792.98192.991.31100.12100.041.36
2682839-68283992.32499.57
3679584-67958491.88499.03
4700595-70059594.725101.83
5679409-67940991.86098.33
6696502-69650294.171101.37
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5000
标示量(mg)10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%
110.066220562135620656218462274621730.13
210.016200562197621010.22
单位质量响应值RSD%判断
6180.226203.900.28数据可信
供试品溶液-2026051421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%
5min18364-836412.14711.5637.6312.1511.5637.64
212928-1292818.77618.78
34082-40825.9285.93
48472-847212.30412.30
58109-810911.77711.78
65800-58008.4238.42
10min129137-2913742.31639.2421.4442.4539.3721.46
234008-3400849.39049.60
326634-2663438.68138.75
429183-2918342.38342.52
526608-2660838.64338.77
616558-1655824.04724.14
15min144983-4498365.33059.0418.3865.9359.6118.39
244405-4440564.49065.25
341561-4156160.36060.86
447025-4702568.29568.90
539567-3956757.46458.02
626387-2638738.32238.68
20min151404-5140474.65570.9513.5975.9972.1713.67
252880-5288076.79978.27
350782-5078273.75274.92
454813-5481379.60680.97
546812-4681267.98669.18
636440-3644052.92253.71
30min158398-5839884.81281.447.5086.9783.457.71
258518-5851884.98787.31
357882-5788284.06386.05
459465-5946586.36288.61
553635-5363577.89579.85
648568-4856870.53671.91
45min162521-6252190.80087.664.8993.9090.585.14
261085-6108588.71591.99
362101-6210190.19093.11
462805-6280591.21394.42
558305-5830584.67787.50
655353-5535380.39082.55
60min163627-6362792.40790.424.2396.5294.304.48
263525-6352592.25896.52
364373-6437393.49097.41
464110-6411093.10897.33
559744-5974486.76790.53
658157-5815784.46287.51
90min161763-6176389.69991.021.9294.8495.912.20
263769-6376992.61397.90
363858-6385892.74297.70
463641-6364192.42797.69
561594-6159489.45494.18
661391-6139189.15993.15
120min163184-6318491.76392.430.9497.9098.331.09
264021-6402192.97999.29
364141-6414193.15399.14
464028-6402892.98999.27
562655-6265590.99596.71
663810-6381092.67297.65
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163202-6320291.78993.551.4898.94100.481.51
265451-6545195.056102.40
364235-6423593.290100.32
465284-6528494.813102.13
563436-6343692.12998.86
664882-6488294.229100.24
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%
114.906512606510126516936512496509736512370.05
214.906660976638126649540.25
单位质量响应值RSD%判断
43707.1844627.791.48数据可信
供试品溶液-2026051421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%
5min1154286-15428620.96113.6543.2520.9613.6443.25
2113367-11336715.40215.40
341026-410265.5745.57
4140383-14038319.07319.07
569028-690289.3789.38
684537-8453711.48511.49
10min1353506-35350648.02839.4019.7448.2639.5519.83
2283876-28387638.56838.74
3207214-20721428.15228.21
4356895-35689548.48848.70
5276665-27666537.58837.69
6261681-26168135.55235.68
15min1456497-45649762.02056.5111.0862.7957.1011.22
2412490-41249056.04156.64
3340824-34082446.30546.68
4471108-47110864.00564.76
5414654-41465456.33556.86
6399878-39987854.32854.85
20min1512700-51270069.65667.216.4971.1168.436.68
2502240-50224068.23569.46
3440052-44005259.78660.68
4536015-53601572.82474.29
5487590-48759066.24567.39
6489621-48962166.52167.65
30min1594367-59436780.75178.313.4382.9880.283.65
2575707-57570778.21680.20
3543450-54345073.83475.39
4595369-59536980.88883.16
5565408-56540876.81778.70
6584236-58423679.37581.24
45min1650410-65041088.36685.552.2591.4988.392.47
2618699-61869984.05786.91
3614066-61406683.42885.80
4642118-64211887.23990.41
5622696-62269684.60087.34
6630236-63023685.62588.37
60min1671670-67167091.25489.091.6695.3692.871.84
2655237-65523789.02192.80
3652064-65206488.59091.89
4664175-66417590.23694.37
5640998-64099887.08790.76
6650168-65016888.33392.03
90min1659700-65970089.62890.611.1394.7595.391.15
2673968-67396891.56696.34
3658259-65825989.43293.72
4667288-66728890.65995.80
5665385-66538590.40095.05
6677038-67703891.98396.66
120min1677364-67736492.02892.281.6398.1598.061.53
2675226-67522691.73797.53
3674402-67440291.62596.90
4672173-67217391.32297.47
5674598-67459891.65297.30
6701467-70146795.302101.00
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1676326-67632691.88793.041.2099.0399.851.17
2689129-68912993.626100.44
3680773-68077392.49198.79
4686755-68675593.303100.47
5678035-67803592.11998.79
6698065-69806594.840101.60
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