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%
114.898598078574458590228583318586328586470.11
214.908626008625188625590.01
单位质量响应值RSD%判断
57666.0257889.870.28数据可信
供试品溶液-25121602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%
5min113147-131471.3621.1617.871.361.1617.85
213774-137741.4271.43
38747-87470.9060.91
49602-96020.9950.99
510285-102851.0661.07
611673-116731.2091.21
10min130504-305043.1603.198.413.183.218.36
235977-359773.7273.74
330500-305003.1603.17
429391-293913.0453.06
529013-290133.0063.02
629600-296003.0673.08
15min139230-392304.0654.052.224.114.102.30
240439-404394.1904.25
339653-396534.1084.15
438269-382693.9654.01
538176-381763.9554.00
638817-388174.0224.07
20min143615-436154.5194.492.474.614.582.50
245260-452604.6894.79
343398-433984.4964.59
442145-421454.3674.46
542759-427594.4304.52
642880-428804.4434.53
30min147354-473544.9064.972.495.055.122.50
249861-498615.1665.32
349004-490045.0775.22
447205-472054.8915.03
547669-476694.9395.08
646782-467824.8474.99
45min152176-521765.4065.371.915.615.572.00
253416-534165.5345.75
352163-521635.4045.60
450838-508385.2675.46
551384-513845.3245.52
650843-508435.2685.46
60min153646-536465.5585.631.935.825.891.92
255652-556525.7666.04
355755-557555.7776.03
453467-534675.5405.79
554001-540015.5955.85
653721-537215.5665.82
90min157227-572275.9296.022.356.256.342.34
259719-597196.1876.53
359969-599696.2136.53
456958-569585.9016.21
557078-570785.9146.23
657827-578275.9916.31
120min158214-582146.0316.132.766.426.522.74
261740-617406.3976.80
359905-599056.2076.60
457675-576755.9766.35
557636-576365.9716.35
659984-599846.2156.60
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159633-596336.1786.162.576.636.622.54
260915-609156.3116.79
361034-610346.3246.78
457090-570905.9156.36
558361-583616.0476.49
659926-599266.2096.66
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%
110.056427264140643996426764098642350.19
210.096423664383643100.17
单位质量响应值RSD%判断
6391.546373.640.20数据可信
供试品溶液-25121602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%
5min17149-714910.0958.6540.1610.098.6640.13
25346-53467.5497.55
32008-20082.8352.84
46504-65049.1849.18
59519-951913.44113.44
66250-62508.8258.83
10min139316-3931655.51755.812.5255.6355.902.56
240191-4019156.75256.84
338693-3869354.63754.67
438723-3872354.67954.78
541211-4121158.19258.34
639002-3900255.07355.17
15min149482-4948269.87269.770.6970.6070.490.73
249351-4935169.68770.40
348927-4892769.08869.73
449175-4917569.43870.15
549704-4970470.18570.98
649837-4983770.37371.08
20min153141-5314175.03874.261.4876.5475.751.49
253409-5340975.41776.91
351400-5140072.58073.99
451931-5193173.33074.81
552665-5266574.36675.94
652993-5299374.82976.32
30min155127-5512777.84377.931.0880.1880.251.08
256111-5611179.23281.56
354952-5495277.59679.81
454709-5470977.25279.55
555673-5567378.61481.02
654575-5457577.06379.39
45min157789-5778981.60279.931.5084.8183.111.50
257113-5711380.64783.85
355763-5576378.74181.82
455781-5578178.76681.92
557107-5710780.63983.91
656077-5607779.18482.36
60min156813-5681380.22380.771.2284.3384.841.16
257681-5768181.44985.55
357875-5787581.72385.67
455991-5599179.06383.09
557401-5740181.05485.23
657446-5744681.11785.18
90min157940-5794081.81581.931.5686.8286.901.45
257800-5780081.61786.63
359337-5933783.78788.65
456649-5664979.99284.90
557790-5779081.60386.68
658597-5859782.74387.70
120min156977-5697780.45580.721.8986.3786.601.76
257111-5711180.64486.56
357769-5776981.57387.36
455802-5580278.79684.59
556447-5644779.70785.69
658901-5890183.17289.05
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158775-5877582.99481.632.3489.8088.412.21
257381-5738181.02587.84
357581-5758181.30888.00
455743-5574378.71385.38
557656-5765681.41488.28
659728-5972884.34091.14
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%
114.898566598610138616708604358589328597420.24
214.908568938595328582120.22
单位质量响应值RSD%判断
57739.5657598.120.18数据可信
供试品溶液-25121602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%
5min167486-674867.0059.2036.567.019.2036.55
2132049-13204913.70713.71
3111694-11169411.59411.59
452617-526175.4625.46
561139-611396.3466.35
6106951-10695111.10211.10
10min1348458-34845836.17138.557.9536.2538.658.02
2401877-40187741.71641.87
3403496-40349641.88442.01
4348354-34835436.16036.22
5338588-33858835.14635.22
6387557-38755740.23040.35
15min1528303-52830354.83956.593.7155.3257.123.79
2576166-57616659.80860.42
3549571-54957157.04757.64
4530309-53030955.04855.51
5526799-52679954.68355.14
6559916-55991658.12158.69
20min1610520-61052063.37465.212.0464.4666.372.08
2644348-64434866.88568.17
3638522-63852266.28067.51
4629139-62913965.30666.38
5629958-62995865.39166.46
6616700-61670064.01565.23
30min1706203-70620373.30675.111.7275.1076.991.78
2736081-73608176.40778.43
3738820-73882076.69278.66
4725221-72522175.28077.08
5717541-71754174.48376.28
6717483-71748374.47776.40
45min1794701-79470182.49283.090.8085.1085.810.75
2796352-79635282.66485.54
3805091-80509183.57186.39
4805833-80583383.64886.28
5807592-80759283.83086.45
6793236-79323682.34085.10
60min1821568-82156885.28185.971.0088.8189.620.91
2821975-82197585.32389.11
3827534-82753485.90089.65
4834907-83490786.66690.23
5841455-84145587.34590.90
6822011-82201185.32789.00
90min1852989-85298988.54389.341.2093.0193.941.12
2862322-86232289.51194.25
3850449-85044988.27992.98
4861051-86105189.38093.91
5879484-87948491.29395.82
6857805-85780589.04393.66
120min1854463-85446388.69690.631.2194.1596.221.22
2881982-88198291.55297.29
3880151-88015191.36297.04
4881060-88106091.45796.98
5872079-87207990.52496.06
6868968-86896890.20195.81
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1842587-84258787.46389.671.2593.9096.261.24
2866251-86625189.91996.67
3867728-86772890.07396.77
4873672-87367290.69097.23
5865476-86547689.83996.38
6867120-86712090.01096.62
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%
110.056383664000641566387464015639760.20
210.096354663764636550.25
单位质量响应值RSD%判断
6365.776308.720.64数据可信
供试品溶液-25121602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%
5min14502-45026.4036.1564.046.406.1464.06
29070-907012.89912.90
34142-41425.8915.89
41738-17382.4722.47
51413-14132.0102.01
65063-50637.2017.20
10min130709-3070943.67443.575.6443.7543.645.71
232293-3229345.92746.07
332634-3263446.41246.48
428708-2870840.82840.86
528544-2854440.59540.62
630931-3093143.99044.07
15min141272-4127258.69758.781.8259.2559.341.91
242604-4260460.59161.24
341484-4148458.99859.58
440466-4046657.55058.03
540707-4070757.89358.37
641463-4146358.96859.54
20min145293-4529364.41565.141.9265.6266.341.88
246236-4623665.75667.08
346461-4646166.07667.31
446013-4601365.43966.56
546546-4654666.19767.31
644261-4426162.94864.17
30min150360-5036071.62272.311.7173.5574.241.69
251285-5128572.93774.99
351869-5186973.76875.74
450979-5097972.50274.35
551193-5119372.80674.66
649385-4938570.23572.16
45min155019-5501978.24878.181.8680.9780.921.77
254431-5443177.41180.28
355273-5527378.60981.40
455367-5536778.74281.40
556395-5639580.20482.87
653348-5334875.87178.57
60min156356-5635680.14980.092.1183.7483.692.00
255548-5554879.00082.73
356256-5625680.00783.67
457009-5700981.07884.61
558085-5808582.60886.16
654629-5462977.69381.24
90min158317-5831782.93883.092.1587.4287.582.05
258248-5824882.84087.45
357856-5785682.28286.84
458628-5862883.38087.81
560648-6064886.25390.72
656835-5683580.83085.24
120min158426-5842683.09384.531.8588.4989.941.78
259784-5978485.02490.55
360024-6002485.36690.83
460374-6037485.86391.22
560278-6027885.72791.16
657726-5772682.09787.41
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157663-5766382.00883.531.5088.3389.881.44
258667-5866783.43689.91
359035-5903583.95990.37
459717-5971784.92991.24
559565-5956584.71391.09
657755-5775582.13988.36
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%
114.898668978623488688688675928675428666490.29
214.908663508640288651890.19
单位质量响应值RSD%判断
58203.4358066.380.17数据可信
供试品溶液-25121602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%
5min1154367-15436715.89522.9124.2815.9022.9124.27
2234910-23491024.18924.19
3155877-15587716.05116.05
4261641-26164126.94126.94
5250260-25026025.76925.77
6277689-27768928.59428.59
10min1613233-61323363.14573.2512.7063.3273.5112.74
2785404-78540480.87481.14
3588208-58820860.56860.75
4784052-78405280.73481.03
5713777-71377773.49873.78
6783711-78371180.69981.02
15min1861771-86177188.73790.481.7089.6291.551.85
2888103-88810391.44992.62
3862032-86203288.76489.62
4896653-89665392.32993.53
5874440-87444090.04291.14
6889290-88929091.57192.79
20min1912085-91208593.91893.831.7295.7895.911.67
2930578-93057895.82298.01
3920375-92037594.77296.61
4918023-91802394.52996.75
5887187-88718791.35493.46
6899400-89940092.61294.84
30min1902798-90279892.96293.280.9395.8796.400.98
2913655-91365594.08097.33
3907323-90732393.42896.32
4910713-91071393.77797.05
5890549-89054991.70094.82
6910110-91011093.71596.98
45min1898315-89831592.50092.381.3396.4496.531.33
2908739-90873993.57397.87
3896660-89666092.33096.26
4908701-90870193.57097.88
5876663-87666390.27194.41
6893626-89362692.01796.32
60min1888398-88839891.47992.041.2396.4597.221.28
2905706-90570693.26198.59
3893345-89334591.98896.94
4905745-90574593.26598.62
5876893-87689390.29495.43
6892906-89290691.94397.27
90min1879069-87906990.51892.172.1896.5098.372.05
2898825-89882592.55398.92
3924824-92482495.230101.21
4906806-90680693.37499.76
5871306-87130689.71995.86
6889699-88969991.61397.96
120min1877336-87733690.34091.211.1197.3398.441.11
2884368-88436891.06498.46
3877191-87719190.32597.36
4893259-89325991.97999.41
5901814-90181492.860100.00
6880969-88096990.71498.08
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1894771-89477192.13591.161.25100.1399.401.24
2889181-88918191.56099.97
3874414-87441490.03998.08
4892638-89263891.916100.37
5868463-86846389.42697.60
6892455-89245591.897100.27
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%
110.056508264730654216502465298651110.41
210.096530064785650420.56
单位质量响应值RSD%判断
6478.716446.180.36数据可信
供试品溶液-25121602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%
5min12727-27273.8038.8598.213.808.8598.23
218565-1856525.89125.89
32972-29724.1454.14
43295-32954.5954.60
53150-31504.3934.39
67385-738510.29910.30
10min117206-1720623.99643.8331.1924.0443.9331.29
245350-4535063.24663.53
326032-2603236.30536.35
428095-2809539.18239.23
537199-3719951.87851.93
634699-3469948.39248.51
15min135340-3534049.28662.4816.3949.5963.0716.57
254823-5482376.45777.45
344602-4460262.20362.65
438037-3803753.04753.53
550559-5055970.51171.14
645453-4545363.39064.04
20min144189-4418961.62771.4112.6062.4872.6912.81
260921-6092184.96286.80
352281-5228172.91274.05
444494-4449462.05263.13
555291-5529177.11078.52
650056-5005669.80971.17
30min152586-5258673.33779.607.3474.8881.677.63
262368-6236886.98089.76
357741-5774180.52782.48
452432-5243273.12374.89
561145-6114585.27487.54
656185-5618578.35780.49
45min160210-6021083.97084.903.0786.3387.863.37
262664-6266487.39291.14
361829-6182986.22889.07
458438-5843881.49984.08
562916-6291687.74490.96
659214-5921482.58185.58
60min162545-6254587.22687.292.1690.5291.192.34
262840-6284087.63892.36
363849-6384989.04592.85
460696-6069684.64888.13
564182-6418289.50993.70
661436-6143685.68089.60
90min163595-6359588.69188.242.7092.9593.122.53
261977-6197786.43492.13
366395-6639592.59697.39
461764-6176486.13790.56
563492-6349288.54793.73
662426-6242687.06091.93
120min163732-6373288.88287.363.0794.1393.222.87
260598-6059884.51191.17
363384-6338488.39794.22
460619-6061984.54089.92
565474-6547491.31197.48
662053-6205386.54092.38
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163636-6363688.74885.852.4994.9892.672.11
259688-5968883.24290.84
362655-6265587.38094.18
459948-5994883.60589.92
561835-6183586.23693.42
661578-6157885.87892.68
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