培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源zjs对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)4供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.943252193247883268183266913266683260370.30
216.043275433268423271920.16
单位质量响应值RSD%判断
20454.0220398.500.20数据可信
供试品溶液-2023110921批-培哚普利-pH2.0(内含%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min175566-7556623.07544.6552.1023.0844.6552.10
2125232-12523238.24238.24
3276655-27665584.48184.48
477520-7752023.67223.67
5187631-18763157.29657.30
6134732-13473241.14341.14
10min1311425-31142595.09993.676.8095.1993.856.85
2313136-31313695.62195.77
3321768-32176898.25798.60
4265911-26591181.20181.30
5321439-32143998.15798.39
6306862-30686293.70693.87
15min1317988-31798897.10398.032.2497.5898.592.30
2317767-31776797.03697.57
3323867-32386798.89899.63
4310529-31052994.82595.24
5324740-32474099.16599.79
6331333-331333101.178101.72
20min1317887-31788797.07299.421.4697.93100.371.49
2328850-328850100.420101.34
3324921-32492199.220100.35
4323906-32390698.91099.71
5326071-32607199.571100.59
6331872-331872101.343102.29
30min1322915-32291598.60899.220.8699.86100.560.89
2324813-32481399.187100.51
3325037-32503799.256100.78
4322922-32292298.61099.80
5323604-32360498.818100.23
6330306-330306100.865102.21
45min1316966-31696696.79198.591.4498.43100.331.43
2318691-31869197.31899.04
3323021-32302198.640100.56
4326542-32654299.715101.30
5322591-32259198.509100.32
6329320-329320100.564102.32
60min1313453-31345395.71898.291.8197.75100.431.82
2317430-31743096.93399.04
3325452-32545299.382101.70
4324747-32474799.167101.15
5320908-32090897.995100.20
6329325-329325100.565102.72
极限1315132-31513296.23198.271.4298.64100.801.42
2318316-31831697.20399.70
3323240-32324098.707101.42
4325337-32533799.347101.73
5321383-32138398.140100.74
6327484-327484100.003102.56
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100257-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数5000
标示量(mg)1.25供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.696001835999946018946018325983636004530.25
212.626036845992896014860.52
单位质量响应值RSD%判断
47317.0247661.330.52数据可信
供试品溶液-2023110921批-吲达帕胺-pH2.0(内含%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min138090-380906.30111.5955.826.3011.5955.81
262760-6276010.38210.38
3141225-14122523.36323.36
439278-392786.4986.50
586127-8612714.24814.25
652814-528148.7378.74
10min1217316-21731635.95040.8120.8635.9840.8620.89
2250630-25063041.46241.50
3324812-32481253.73353.83
4182397-18239730.17430.20
5284513-28451347.06747.12
6220535-22053536.48336.52
15min1362099-36209959.90260.568.3160.0760.778.37
2364073-36407360.22860.44
3410374-41037467.88868.20
4318762-31876252.73352.88
5383999-38399963.52563.77
6357190-35719059.09059.27
20min1422823-42282369.94770.964.6370.3671.424.71
2427177-42717770.66871.12
3460430-46043076.16976.75
4399179-39917966.03666.39
5436212-43621272.16272.66
6427921-42792170.79171.21
30min1502410-50241083.11382.732.5483.8083.462.62
2504718-50471883.49584.23
3515467-51546785.27386.16
4477211-47721178.94579.57
5503391-50339183.27684.06
6497236-49723682.25782.96
45min1546708-54670890.44289.741.6691.4690.801.71
2546126-54612690.34591.41
3550420-55042091.05692.28
4535550-53555088.59689.53
5548373-54837390.71791.84
6527451-52745187.25688.29
60min1568057-56805793.97393.831.1095.3695.261.15
2567473-56747393.87795.30
3569300-56930094.17995.77
4555314-55531491.86593.16
5569349-56934994.18795.67
6573761-57376194.91796.30
极限1590728-59072897.72496.831.3999.4898.631.36
2581608-58160896.21598.02
3580495-58049596.03198.00
4576011-57601195.28996.95
5584469-58446996.68898.55
6598597-59859799.026100.78
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源zjs对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)4供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.943250133254563251673253733249903252000.07
216.043248383243643246010.11
单位质量响应值RSD%判断
20401.5120236.970.58数据可信
供试品溶液-2023110921批-培哚普利-pH2.0(内含%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min171047-7104721.81045.0253.9821.8145.0253.98
2144938-14493844.49344.49
3208261-20826163.93263.93
4110006-11000633.77033.77
5270607-27060783.07183.07
675159-7515923.07223.07
10min1168224-16822451.64181.6523.1851.7381.8323.22
2241408-24140874.10774.29
3316211-31621197.07097.33
4300836-30083692.35192.49
5331510-331510101.767102.10
6237614-23761472.94373.04
15min1333240-333240102.298100.332.00102.59100.841.99
2330164-330164101.354101.83
3328674-328674100.896101.54
4315207-31520796.76297.27
5330119-330119101.340102.08
6323524-32352499.31599.70
20min1345370-345370106.022102.472.67106.72103.372.57
2336157-336157103.194104.07
3329064-329064101.016102.06
4319597-31959798.11099.00
5333123-333123102.262103.41
6339423-339423104.196104.98
30min1344374-344374105.716102.142.53106.84103.462.42
2334691-334691102.743104.04
3328332-328332100.791102.24
4320055-32005598.25199.53
5330695-330695101.517103.07
6338182-338182103.815105.01
45min1343240-343240105.368101.962.39106.92103.692.29
2332507-332507102.073103.78
3328044-328044100.703102.56
4320016-32001698.23999.92
5331718-331718101.831103.79
6337389-337389103.572105.19
60min1341131-341131104.720101.692.26106.69103.832.15
2335125-335125102.877104.99
3329354-329354101.105103.36
4319853-31985398.189100.26
5326994-326994100.381102.75
6335132-335132102.879104.91
极限1340357-340357104.483101.242.23106.87103.782.11
2332209-332209101.982104.50
3326526-326526100.237102.90
4319377-31937798.042100.51
5326222-326222100.144102.91
6334124-334124102.569105.01
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100257-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数5000
标示量(mg)1.25供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.696028006027386020636031396022356025950.08
212.626020996051726036360.36
单位质量响应值RSD%判断
47485.8247831.700.52数据可信
供试品溶液-2023110921批-吲达帕胺-pH2.0(内含%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min125780-257804.25011.9059.594.2511.9059.59
261884-6188410.20110.20
395631-9563115.76415.76
471558-7155811.79611.80
5143322-14332223.62523.63
634992-349925.7685.77
10min1106612-10661217.57436.7040.5417.5936.7540.56
2194091-19409131.99432.03
3284850-28485046.95547.02
4258506-25850642.61242.66
5346483-34648357.11557.21
6145458-14545823.97724.00
15min1299662-29966249.39658.6213.7649.4858.8113.86
2339102-33910255.89856.07
3386516-38651663.71463.96
4362267-36226759.71659.93
5431994-43199471.21071.53
6314039-31403951.76651.89
20min1403103-40310366.44871.067.3066.7371.487.41
2422508-42250869.64770.04
3442606-44260672.95973.47
4419893-41989369.21569.67
5488992-48899280.60681.21
6409227-40922767.45767.78
30min1502298-50229882.79983.154.3983.3583.864.46
2501947-50194782.74183.41
3504778-50477883.20884.01
4477339-47733978.68579.42
5544647-54464789.78090.71
6495432-49543281.66782.26
45min1569225-56922593.83191.483.9994.7192.523.97
2553405-55340591.22492.23
3546740-54674090.12591.26
4517046-51704685.23086.28
5581033-58103395.77897.07
6562186-56218692.67193.59
60min1597421-59742198.47995.303.9599.7496.713.90
2582338-58233895.99397.36
3567668-56766893.57595.07
4536880-53688088.50089.89
5594181-59418197.94599.62
6590279-59027997.30298.60
极限1620315-620315102.25398.773.54103.90100.563.47
2602049-60204999.242100.99
3589931-58993197.24599.11
4561439-56143992.54894.29
5607426-607426100.129102.19
6613781-613781101.176102.86
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源zjs对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)4供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.943261373262873257703252703253033257530.15
216.043252753262243257500.21
单位质量响应值RSD%判断
20436.2020308.600.45数据可信
供试品溶液-2023111021批-培哚普利-pH2.0(内含%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1148090-14809045.34230.9628.0545.3430.9628.05
2119789-11978936.67736.68
380865-8086524.75924.76
478315-7831523.97823.98
577993-7799323.88023.88
6101632-10163231.11731.12
10min1312444-31244495.66388.409.2195.8488.529.21
2282918-28291886.62386.77
3247768-24776875.86175.96
4280234-28023485.80185.90
5323020-32302098.90199.00
6285961-28596187.55587.68
15min1319423-31942397.800101.302.3098.36101.772.25
2328728-328728100.649101.14
3339836-339836104.050104.45
4329133-329133100.773101.21
5328934-328934100.712101.20
6339001-339001103.794104.27
20min1319501-31950197.824101.292.3498.78102.172.28
2326396-32639699.935100.83
3339280-339280103.880104.70
4330798-330798101.283102.12
5329369-329369100.845101.74
6339586-339586103.973104.86
30min1319366-31936697.783101.042.4199.13102.332.35
2323132-32313298.936100.23
3338435-338435103.621104.86
4332284-332284101.738102.99
5328191-328191100.485101.78
6338652-338652103.687104.99
45min1316847-31684797.011100.292.1098.75101.982.03
2324797-32479799.445101.14
3337919-337919103.463105.11
4329082-329082100.757102.41
5329109-329109100.766102.46
6327555-327555100.290102.01
60min1315463-31546396.588100.632.4198.71102.722.35
2325245-32524599.583101.67
3336857-336857103.138105.20
4328666-328666100.630102.69
5329533-329533100.895103.00
6336282-336282102.962105.08
极限1316067-31606796.772100.472.1899.28102.962.13
2327525-327525100.281102.77
3334197-334197102.323104.80
4327652-327652100.320102.78
5326892-326892100.087102.59
6336537-336537103.040105.57
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100257-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数5000
标示量(mg)1.25供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.696034286018506019056025946017116022980.12
212.626006376025446015900.23
单位质量响应值RSD%判断
47462.4147669.570.31数据可信
供试品溶液-2023111021批-吲达帕胺-pH2.0(内含%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min165592-6559210.8338.4520.7010.838.4520.69
251819-518198.5588.56
334269-342695.6605.66
449170-491708.1218.12
547787-477877.8937.89
658319-583199.6329.63
10min1211625-21162534.95233.2814.8835.0033.3214.89
2183742-18374230.34730.38
3150092-15009224.78924.81
4210160-21016034.71034.74
5233315-23331538.53438.57
6220091-22009136.35036.39
15min1352117-35211758.15660.235.4258.3460.395.43
2347882-34788257.45657.61
3344504-34450456.89957.02
4367228-36722860.65260.82
5387718-38771864.03664.22
6388472-38847264.16064.34
20min1424900-42490070.17773.313.9370.5973.723.94
2429429-42942970.92571.31
3434435-43443571.75272.10
4446201-44620173.69574.11
5460105-46010575.99176.43
6468216-46821677.33177.77
30min1502697-50269783.02685.205.8283.7285.905.81
2464082-46408276.64877.32
3521337-52133786.10486.74
4521592-52159286.14786.86
5534143-53414388.21988.97
6551219-55121991.04091.79
45min1560489-56048992.57194.881.4993.6095.921.50
2568376-56837693.87394.85
3580829-58082995.93096.91
4574811-57481194.93695.99
5582129-58212996.14597.24
6580186-58018695.82496.94
60min1587417-58741797.01899.472.1898.42100.902.18
2593830-59383098.07799.43
3610070-610070100.760102.12
4596001-59600198.43699.87
5602597-60259799.525101.01
6623835-623835103.033104.53
极限1604598-60459899.856102.161.90101.64103.981.91
2615338-615338101.630103.37
3618873-618873102.214103.98
4613514-613514101.328103.16
5619021-619021102.238104.12
6639869-639869105.681107.59
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源zjs对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)4供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.943253023260593259743258333274603261260.25
216.043233063235243234150.05
单位质量响应值RSD%判断
20459.6020163.031.04数据可信
供试品溶液-2023111021批-培哚普利-pH2.0(内含%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1158717-15871748.74435.3234.4748.7435.3234.47
2153019-15301946.99446.99
3140195-14019543.05543.06
473185-7318522.47622.48
583561-8356125.66325.66
681411-8141125.00225.00
10min1317429-31742997.48687.778.5497.6887.918.57
2301190-30119092.49992.69
3284298-28429887.31187.48
4247234-24723475.92876.02
5271665-27166583.43183.53
6292884-29288489.94890.05
15min1322485-32248599.03997.452.3899.6297.942.44
2324810-32481099.753100.31
3324844-32484499.763100.28
4308188-30818894.64895.04
5311356-31135695.62196.06
6312240-31224095.89296.35
20min1321379-32137998.69997.721.7799.6898.601.83
2323537-32353799.362100.32
3324339-32433999.608100.53
4312169-31216995.87196.64
5315664-31566496.94497.76
6311967-31196795.80996.65
30min1320024-32002498.28397.902.0299.6699.172.07
2325842-325842100.070101.42
3326342-326342100.223101.54
4311525-31152595.67396.83
5316604-31660497.23398.44
6312357-31235795.92897.15
45min1320369-32036998.38997.471.64100.1699.131.69
2320874-32087498.544100.30
3323858-32385899.460101.18
4311217-31121795.57897.12
5316125-31612597.08698.68
6311788-31178895.75497.36
60min1321270-32127098.66697.281.90100.8399.331.95
2320538-32053898.441100.59
3323840-32384099.455101.57
4309035-30903594.90896.83
5314611-31461196.62198.60
6311222-31122295.58097.57
极限1317901-31790197.63196.741.80100.1999.191.86
2320130-32013098.316100.86
3320900-32090098.552101.07
4307736-30773694.50996.81
5314500-31450096.58698.96
6308881-30888194.86197.24
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100257-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数5000
标示量(mg)1.25供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.696052836026716017596037396001616027230.33
212.625985225977265981240.10
单位质量响应值RSD%判断
47495.9047394.930.16数据可信
供试品溶液-2023111021批-吲达帕胺-pH2.0(内含%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min171935-7193511.9118.9223.6311.918.9223.61
263611-6361110.53310.53
343117-431177.1397.14
439295-392956.5066.51
558005-580059.6049.60
647270-472707.8277.83
10min1219651-21965136.37033.9312.6936.4233.9712.68
2195775-19577532.41632.46
3162867-16286726.96827.00
4194057-19405732.13232.16
5234523-23452338.83238.87
6222603-22260336.85936.89
15min1358173-35817359.30657.684.3059.5057.854.31
2339014-33901456.13456.31
3323797-32379753.61453.75
4350763-35076358.07958.23
5352210-35221058.31958.51
6366021-36602160.60660.78
20min1430770-43077071.32770.643.0471.7671.053.06
2420287-42028769.59169.99
3403504-40350466.81267.16
4431090-43109071.38071.77
5435082-43508272.04172.47
6439145-43914572.71473.13
30min1509242-50924284.32083.661.7885.0484.341.80
2504018-50401883.45584.13
3490814-49081481.26981.89
4512989-51298984.94185.61
5499813-49981382.75983.47
6514626-51462685.21285.92
45min1562771-56277193.18492.301.1994.2493.321.20
2554935-55493591.88692.89
3549271-54927190.94891.89
4566481-56648193.79894.81
5551839-55183991.37392.42
6559295-55929592.60893.66
60min1591951-59195198.01596.571.5599.4497.961.54
2581456-58145696.27797.65
3577079-57707995.55396.86
4591497-59149797.94099.33
5569209-56920994.25095.66
6588053-58805397.37098.79
极限1608016-608016100.67599.481.00102.49101.251.01
2602025-60202599.683101.44
3593745-59374598.312100.00
4605134-605134100.198101.98
5593452-59345298.264100.05
6602401-60240199.746101.56
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