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%
110.266127561060611886117261053611500.16
210.296130361029611660.32
单位质量响应值RSD%判断
5960.045944.220.19数据可信
供试品溶液-5122601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%
5min13358-33585.0739.2764.535.079.2764.52
212744-1274419.25419.25
39306-930614.06014.06
43454-34545.2195.22
53568-35685.3915.39
64372-43726.6056.61
10min140534-4053461.24165.859.1161.3065.959.19
249041-4904174.09474.31
346633-4663370.45670.61
439044-3904458.99059.05
540955-4095561.87761.94
645281-4528168.41368.49
15min154938-5493883.00385.881.9783.7486.712.06
257647-5764787.09688.13
358001-5800187.63188.57
456948-5694886.04086.75
556215-5621584.93385.68
657299-5729986.57187.40
20min159313-5931389.61390.901.9491.2792.691.92
259792-5979290.33792.34
360422-6042291.28993.20
461844-6184493.43795.11
558625-5862588.57490.27
660988-6098892.14493.94
30min159763-5976390.29390.940.6892.9593.740.74
260597-6059791.55394.56
360485-6048591.38494.31
460096-6009690.79693.50
560530-6053091.45294.13
659686-5968690.17793.00
45min160780-6078091.83092.440.7195.4996.240.72
260718-6071891.73695.76
361681-6168193.19197.13
461326-6132692.65596.37
560929-6092992.05595.75
661654-6165493.15096.97
60min161692-6169293.20892.681.6797.8997.511.59
260668-6066891.66196.71
361431-6143192.81397.79
462096-6209693.81898.56
559679-5967990.16694.88
662472-6247294.38699.24
90min160045-6004590.71991.241.0096.4397.100.97
259935-5993590.55396.62
360611-6061191.57597.58
461323-6132392.65098.44
559709-5970990.21295.93
660713-6071391.72997.63
120min159475-5947589.85891.612.0996.5898.492.01
260172-6017290.91197.98
360753-6075391.78998.82
461578-6157893.03699.85
559277-5927789.55996.28
662556-6255694.513101.44
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159830-5983090.39592.352.2398.12100.252.11
259747-5974790.26998.35
361958-6195893.610101.66
462396-6239694.271102.12
560142-6014290.86698.58
662671-6267194.687102.66
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%
115.226329586323836321196338436336926329990.13
215.286334176316796325480.20
单位质量响应值RSD%判断
41589.9541397.120.33数据可信
供试品溶液-5122601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%
5min15993-59930.8671.2529.580.871.2529.40
29784-97841.4151.41
38246-82461.1921.19
48825-88251.2761.28
56061-60610.8760.88
612799-127991.8511.85
10min123305-233053.3703.536.283.383.546.37
225425-254253.6763.69
323932-239323.4613.47
423989-239893.4693.48
522806-228063.2983.31
626961-269613.8993.92
15min131517-315174.5574.711.994.604.772.13
232863-328634.7524.81
332672-326724.7244.78
433078-330784.7834.84
532227-322274.6604.71
633288-332884.8134.88
20min135334-353345.1095.242.105.215.352.07
236292-362925.2485.36
336198-361985.2345.34
437610-376105.4385.54
535819-358195.1795.28
636301-363015.2495.37
30min137629-376295.4415.602.525.605.762.37
239327-393275.6875.85
339356-393565.6915.85
439254-392545.6765.84
539391-393915.6965.85
637295-372955.3935.57
45min140486-404865.8546.011.696.076.231.65
241459-414595.9956.23
342355-423556.1256.35
442083-420836.0856.31
541798-417986.0446.26
640994-409945.9286.16
60min142364-423646.1266.271.576.416.561.57
243387-433876.2746.57
343736-437366.3246.62
444399-443996.4206.72
543169-431696.2426.53
643133-431336.2376.54
90min142104-421046.0886.493.326.446.853.20
244837-448376.4846.85
345444-454446.5716.94
446348-463486.7027.07
545763-457636.6176.97
644595-445956.4496.82
120min143404-434046.2766.733.576.697.163.48
246187-461876.6797.12
347378-473786.8517.29
448071-480716.9517.39
546693-466936.7527.18
647379-473796.8517.29
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143956-439566.3566.763.086.847.273.04
246839-468396.7737.29
347590-475906.8827.39
447990-479906.9397.46
547029-470296.8007.30
647226-472266.8297.35
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%
110.266122960836607796084960971609330.30
210.296085961244610520.45
单位质量响应值RSD%判断
5938.895933.140.07数据可信
供试品溶液-5122901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%
5min111767-1176717.8268.2068.9017.838.2068.91
22602-26023.9423.94
32458-24583.7243.72
42347-23473.5563.56
56853-685310.38210.38
66461-64619.7889.79
10min147097-4709771.35058.0118.1571.5558.1018.22
237447-3744756.73156.77
328532-2853243.22543.27
432246-3224648.85148.89
542722-4272264.72264.84
641707-4170763.18463.29
15min156878-5687886.16884.152.2587.1684.892.42
254379-5437982.38283.06
354332-5433282.31182.83
454653-5465382.79783.38
557013-5701386.37287.21
656030-5603084.88385.69
20min160273-6027391.31191.242.7193.2692.902.61
259629-5962990.33591.92
361431-6143193.06594.50
461154-6115492.64694.15
561584-6158493.29795.09
657269-5726986.76088.51
30min160737-6073792.01492.371.1894.9895.061.16
260126-6012691.08893.68
361918-6191893.80396.27
460305-6030591.35993.89
561609-6160993.33596.17
661145-6114592.63295.35
45min162500-6250094.68593.902.3798.6797.612.33
259733-5973390.49394.10
362877-6287795.25698.77
462547-6254794.75698.30
563574-6357496.312100.18
660668-6066891.90995.66
60min163537-6353796.25695.482.59101.29100.242.52
260745-6074592.02696.64
364991-6499198.459103.03
462825-6282595.17799.78
564426-6442697.603102.54
661636-6163693.37698.14
90min161394-6139493.00993.082.5199.1298.902.37
259030-5903089.42895.06
363185-6318595.723101.39
462960-6296095.382101.04
561461-6146193.11199.13
660609-6060991.82097.63
120min159913-5991390.76692.272.1397.9199.122.00
259280-5928089.80796.43
362273-6227394.341101.07
461836-6183693.679100.40
562058-6205894.015101.07
660066-6006690.99797.82
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161822-6182293.65894.711.31101.81102.581.16
261691-6169193.459101.08
363048-6304895.515103.29
463826-6382696.694104.45
562100-6210094.079102.18
662606-6260694.845102.68
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%
115.226333496316136319836329676322256324270.12
215.286333516330976332240.03
单位质量响应值RSD%判断
41552.3741441.360.19数据可信
供试品溶液-5122901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%
5min19643-96431.3940.9833.261.390.9833.02
27280-72801.0531.05
34395-43950.6350.64
43873-38730.5600.56
58468-84681.2241.22
67128-71281.0311.03
10min123509-235093.3993.0310.483.413.0410.52
223301-233013.3693.38
318655-186552.6972.70
418547-185472.6822.69
521697-216973.1373.15
620225-202252.9242.94
15min130430-304304.4004.333.764.454.373.80
231633-316334.5744.62
329007-290074.1944.23
428633-286334.1404.18
530449-304494.4034.45
629350-293504.2444.29
20min134291-342914.9584.943.715.065.033.71
235630-356305.1525.25
334348-343484.9665.05
433340-333404.8214.90
535166-351665.0855.18
632136-321364.6474.74
30min137151-371515.3725.342.805.535.492.86
238149-381495.5165.67
336443-364435.2695.41
435390-353905.1175.25
537974-379745.4915.64
636618-366185.2955.44
45min140462-404625.8505.792.226.076.002.30
240244-402445.8196.04
339624-396245.7295.93
439413-394135.6995.89
541520-415206.0036.22
639059-390595.6485.85
60min143199-431996.2466.152.366.536.422.37
242551-425516.1526.44
343101-431016.2326.49
441237-412375.9626.22
543723-437236.3226.60
641452-414525.9946.26
90min143343-433436.2676.361.376.626.701.25
243695-436956.3186.67
344871-448716.4886.82
444019-440196.3656.69
544415-444156.4226.77
643416-434166.2776.61
120min144631-446316.4536.531.226.876.941.22
245246-452466.5426.96
345366-453666.5596.96
445225-452256.5396.93
546054-460546.6597.08
644544-445446.4416.84
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146189-461896.6786.690.947.177.170.99
246929-469296.7857.28
345894-458946.6367.11
445756-457566.6167.08
546177-461776.6777.17
646561-465616.7327.20
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%
110.266092361204610896137361094611370.28
210.296120461172611880.04
单位质量响应值RSD%判断
5958.775946.360.15数据可信
供试品溶液-5123001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%
5min110349-1034915.6359.5259.6515.639.5259.63
29554-955414.43414.43
32433-24333.6763.68
49068-906813.69913.70
52264-22643.4203.42
64130-41306.2396.24
10min146576-4657670.36460.3816.4070.5460.4816.48
245267-4526768.38768.55
332805-3280549.56049.60
443811-4381166.18766.34
531197-3119747.13147.17
640129-4012960.62560.69
15min155867-5586784.40184.352.6185.3685.132.76
257976-5797687.58788.51
354511-5451182.35282.94
457081-5708186.23587.12
554299-5429982.03282.59
655282-5528283.51784.26
20min159439-5943989.79789.771.7391.6991.491.74
259377-5937789.70491.60
360799-6079991.85293.36
460330-6033091.14392.99
558321-5832188.10889.58
658267-5826788.02789.70
30min161849-6184993.43893.821.8496.3396.541.77
261713-6171393.23396.12
363888-6388896.51999.05
462842-6284294.93897.80
561807-6180793.37595.83
660531-6053191.44794.10
45min162452-6245294.34995.391.9198.2899.151.77
261923-6192393.55097.48
365325-6532598.689102.29
463641-6364196.145100.06
562819-6281994.90498.39
662704-6270494.73098.39
60min163682-6368296.20796.052.03101.18100.861.96
262150-6215093.89398.86
365307-6530798.662103.36
464906-6490698.056103.04
562807-6280794.88599.43
662622-6262294.60699.32
90min160130-6013090.84192.651.9696.8998.531.82
261638-6163893.11999.13
363569-6356996.037101.83
460992-6099292.14398.21
560835-6083591.90697.50
660794-6079491.84497.61
120min159931-5993190.54092.652.2397.6099.562.13
262659-6265994.662101.71
362217-6221793.994100.85
462239-6223994.027101.12
561569-6156993.01599.63
659343-5934389.65296.44
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161095-6109592.29994.521.36100.36102.461.24
262636-6263694.627102.72
363630-6363096.129104.03
462809-6280994.888103.03
562288-6228894.101101.75
662943-6294395.091102.88
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%
115.226318216337206318426332616330586327400.14
215.286342756348496345620.07
单位质量响应值RSD%判断
41572.9341528.930.08数据可信
供试品溶液-5123001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%
5min18978-89781.2960.9423.631.300.9423.58
27511-75111.0851.08
35447-54470.7870.79
45317-53170.7680.77
55046-50460.7290.73
66938-69381.0021.00
10min122285-222853.2182.977.943.232.987.88
220591-205912.9732.99
321157-211573.0553.06
418258-182582.6362.65
518981-189812.7412.75
622026-220263.1813.19
15min129637-296374.2804.272.994.334.313.01
230508-305084.4054.45
329831-298314.3084.35
428812-288124.1604.20
528246-282464.0794.12
630360-303604.3844.43
20min133364-333644.8184.782.584.924.872.59
233139-331394.7854.88
334192-341924.9375.03
432736-327364.7274.81
531659-316594.5724.66
633507-335074.8384.93
30min136946-369465.3355.362.215.495.502.21
237283-372835.3845.53
338384-383845.5435.69
437018-370185.3455.48
535830-358305.1745.31
637230-372305.3765.52
45min139521-395215.7075.773.155.925.973.12
239949-399495.7695.98
341440-414405.9846.19
440077-400775.7875.98
537802-378025.4595.65
640874-408745.9026.11
60min141689-416896.0206.032.206.296.302.26
241875-418756.0476.32
342120-421206.0826.36
442270-422706.1046.36
539971-399715.7726.02
642531-425316.1426.42
90min141436-414365.9836.092.886.326.422.87
243541-435416.2876.63
342659-426596.1606.50
441639-416396.0136.34
540375-403755.8306.15
643269-432696.2486.59
120min143156-431566.2326.273.076.646.682.98
245830-458306.6187.03
342498-424986.1376.55
443848-438486.3326.73
542041-420416.0716.45
643220-432206.2416.65
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143551-435516.2896.372.616.776.852.54
244764-447646.4646.95
343761-437616.3196.80
443772-437726.3216.79
542873-428736.1916.64
646144-461446.6637.14
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