厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.679467594895945679474794687947140.13
212.609570495989958460.22
单位质量响应值RSD%判断
7475.457606.831.24数据可信
长期24月-供试品溶液-2023061421批-氢氯噻嗪-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137779-3777939.96145.178.3339.9645.178.33
245785-4578548.42948.43
341768-4176844.18044.18
441400-4140043.79143.79
541692-4169244.10044.10
647783-4778350.54250.54
10min181871-8187186.59985.292.5686.8085.522.55
281380-8138086.07986.32
381274-8127485.96786.19
482624-8262487.39587.61
576888-7688881.32881.55
679783-7978384.39084.64
15min185997-8599790.96389.372.3991.6090.032.37
284822-8482289.72090.39
387251-8725192.28992.94
484443-8444389.31989.98
582238-8223886.98787.61
682221-8222186.96987.64
20min190478-9047895.70391.143.4196.7992.243.37
287547-8754792.60293.72
387898-8789892.97494.09
483961-8396188.80989.91
582840-8284087.62488.69
684287-8428789.15490.26
30min189241-8924194.39491.362.5795.9692.912.55
287829-8782992.90194.48
387724-8772492.79094.37
485519-8551990.45792.00
584017-8401788.86990.37
683904-8390488.74990.30
45min188162-8816293.25392.782.6295.2994.792.59
291864-9186497.16999.22
387892-8789292.96795.01
486539-8653991.53693.54
586608-8660891.60993.55
685233-8523390.15592.15
60min190067-9006795.26894.661.8897.7797.141.87
290348-9034895.56598.10
390698-9069895.93598.44
489744-8974494.92697.38
586129-8612991.10393.51
689974-8997495.17097.62
极限189028-8902894.16994.761.8897.1597.701.87
291835-9183597.138100.15
391505-9150596.78999.77
488074-8807493.16096.09
587993-8799393.07495.93
689069-8906994.21297.14
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.712584772581262588032587742584432585250.11
214.802624852624142624500.02
单位质量响应值RSD%判断
17574.7817733.110.64数据可信
长期24月-供试品溶液-2023061421批-厄贝沙坦-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min182336-8233631.09335.439.7031.0935.439.71
2101318-10131838.26238.26
391933-9193334.71734.72
487949-8794933.21333.21
591967-9196734.73034.73
6107395-10739540.55640.56
10min1205736-20573677.69478.782.0877.8578.962.09
2209666-20966679.17879.37
3207344-20734478.30178.47
4213956-21395680.79880.96
5202414-20241476.43976.61
6212636-21263680.29980.50
15min1234898-23489888.70688.501.1189.2589.071.10
2234227-23422788.45389.04
3238486-23848690.06190.63
4234922-23492288.71589.29
5230740-23074087.13687.69
6232766-23276687.90188.51
20min1253181-25318195.61191.862.5596.6092.872.52
2245140-24514092.57493.60
3246049-24604992.91793.93
4237958-23795889.86290.88
5236271-23627189.22590.22
6240883-24088390.96792.01
30min1250994-25099494.78592.301.8196.2593.771.78
2246643-24664393.14294.63
3246508-24650893.09194.57
4242398-24239891.53993.00
5240410-24041090.78892.23
6239480-23948090.43791.94
45min1248856-24885693.97793.362.0795.9295.302.04
2256397-25639796.82598.78
3246809-24680993.20495.15
4244677-24467792.39994.32
5245077-24507792.55094.44
6241517-24151791.20693.16
60min1253446-25344695.71194.691.5398.1297.091.51
2251412-25141294.94397.38
3253178-25317895.61098.02
4251525-25152594.98597.37
5243160-24316091.82694.18
6251700-25170095.05197.46
极限1248711-24871193.92394.551.7896.8197.421.75
2256270-25627096.77799.69
3255699-25569996.56299.45
4246779-24677993.19396.05
5246348-24634893.03095.84
6248461-24846193.82896.71
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.679288592908931259330193055930550.19
212.609417794055941160.10
单位质量响应值RSD%判断
7344.517469.521.20数据可信
长期24月-供试品溶液-2023061421批-氢氯噻嗪
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141234-4123444.40545.725.0644.4045.725.06
242748-4274846.03546.04
339529-3952942.56942.57
441458-4145844.64644.65
544570-4457047.99748.00
645177-4517748.65148.65
10min179706-7970685.83585.770.7286.0686.000.72
280724-8072486.93187.16
379462-7946285.57285.78
479585-7958585.70585.93
579117-7911785.20185.44
679270-7927085.36585.61
15min184514-8451491.01389.021.8391.6689.681.81
283927-8392790.38091.05
383437-8343789.85390.49
480691-8069186.89687.55
581514-8151487.78288.45
681899-8189988.19688.87
20min185008-8500891.54590.772.0692.6591.872.04
286187-8618792.81493.93
385495-8549592.06993.16
482055-8205588.36489.45
582236-8223688.55989.66
684736-8473691.25292.36
30min188463-8846395.26593.482.7396.8395.032.70
288834-8883495.66597.25
389204-8920496.06397.61
484260-8426090.73992.27
583909-8390990.36191.91
686134-8613492.75794.32
45min187801-8780194.55293.481.3496.5995.501.33
288590-8859095.40297.46
386111-8611192.73294.76
485892-8589292.49794.48
585710-8571092.30194.30
686725-8672593.39495.42
60min187835-8783594.58993.861.1697.1096.351.16
288279-8827995.06797.60
386145-8614592.76995.26
485720-8572092.31194.76
587330-8733094.04596.51
687652-8765294.39296.89
极限190559-9055997.52295.052.16100.5198.012.13
289312-8931296.17999.19
388611-8861195.42598.38
486069-8606992.68795.59
585826-8582692.42595.36
689186-8918696.04499.01
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.712544272543342540262542212545382543090.08
214.802571452572562572000.04
单位质量响应值RSD%判断
17288.1717378.380.37数据可信
长期24月-供试品溶液-2023061421批-厄贝沙坦
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min189749-8974934.51935.546.1634.5235.546.16
293854-9385436.09836.10
383955-8395532.29132.29
490021-9002134.62434.62
597033-9703337.32137.32
699741-9974138.36238.36
10min1203757-20375778.36979.340.9378.5479.520.93
2205386-20538678.99579.18
3205418-20541879.00879.17
4208130-20813080.05180.22
5206165-20616579.29579.48
6208913-20891380.35280.54
15min1232028-23202889.24288.490.9089.8189.060.89
2230046-23004688.48089.06
3231669-23166989.10489.66
4226272-22627287.02987.60
5229811-22981188.39088.97
6230541-23054188.67189.26
20min1238133-23813391.59191.731.5392.6092.751.52
2241371-24137192.83693.85
3241108-24110892.73593.74
4233633-23363389.86090.87
5234698-23469890.26991.29
6242062-24206293.10294.14
30min1247638-24763895.24694.582.1796.7196.052.13
2249939-24993996.13197.61
3252584-25258497.14998.61
4240793-24079392.61494.07
5238742-23874291.82593.30
6245735-24573594.51496.02
45min1246035-24603594.63094.110.9896.5796.060.97
2248315-24831595.50797.47
3241938-24193893.05495.01
4243290-24329093.57495.49
5242867-24286793.41195.35
6245626-24562694.47296.45
60min1245210-24521094.31293.831.0796.7396.241.06
2245863-24586394.56497.00
3241219-24121992.77795.19
4240317-24031792.43194.82
5244339-24433993.97796.38
6246743-24674394.90297.35
极限1252327-25232797.05094.781.9999.9497.671.95
2248681-24868195.64898.56
3247425-24742595.16498.05
4240517-24051792.50795.36
5240385-24038592.45795.33
6249186-24918695.84298.76
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.679350593684937329345993775936310.16
212.609347193371934210.08
单位质量响应值RSD%判断
7389.987414.370.24数据可信
长期24月-供试品溶液-2023061521批-氢氯噻嗪
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134534-3453437.21147.0012.2837.2147.0012.28
251315-5131555.29355.29
343142-4314246.48746.49
444558-4455848.01248.01
544238-4423847.66847.67
643950-4395047.35747.36
10min174982-7498280.79586.594.6680.9886.824.67
280023-8002386.22786.50
377127-7712783.10683.34
482118-8211888.48488.72
583023-8302389.45989.70
684879-8487991.45991.70
15min183651-8365190.13692.903.1890.7393.563.18
283659-8365990.14590.85
385172-8517291.77592.42
487748-8774894.55195.23
586261-8626192.94893.63
690792-9079297.83198.52
20min186795-8679593.52495.063.8294.5696.203.80
284809-8480991.38492.54
384863-8486391.44292.55
489302-8930296.22597.38
590202-9020297.19598.35
693365-93365100.603101.79
30min188556-8855695.42194.691.5596.9396.301.55
286978-8697893.72195.34
386169-8616992.84994.41
487791-8779194.59796.23
587681-8768194.47896.11
690117-9011797.10398.79
45min189952-8995296.92696.802.0598.9198.892.05
288169-8816995.00497.09
388247-8824795.08897.12
490248-9024897.24499.35
589262-8926296.18298.29
693163-93163100.385102.56
60min190361-9036197.36696.731.6199.8499.301.57
287619-8761994.41296.97
390655-9065597.683100.19
488541-8854195.40598.00
589966-8996696.94199.53
691506-9150698.600101.27
极限191904-9190499.02997.451.69101.99100.501.65
289047-8904795.95098.98
391128-9112898.193101.18
489667-8966796.61899.69
588638-8863895.51098.58
692247-9224799.398102.57
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.712558392563562559542558082561622560240.10
214.802545882551592548740.16
单位质量响应值RSD%判断
17404.7617221.220.75数据可信
长期24月-供试品溶液-2023061521批-厄贝沙坦
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min165623-6562325.27033.0413.4625.2733.0413.46
2101097-10109738.93038.93
383758-8375832.25332.25
489694-8969434.53934.54
588064-8806433.91233.91
686610-8661033.35233.35
10min1173782-17378266.92074.166.0267.0574.326.02
2194297-19429774.82075.01
3184278-18427870.96171.12
4196626-19662675.71675.89
5203604-20360478.40378.57
6202920-20292078.14078.31
15min1216755-21675583.46887.623.5083.9388.163.51
2224107-22410786.29986.87
3223856-22385686.20286.72
4229786-22978688.48689.04
5230518-23051888.76789.33
6240201-24020192.49693.05
20min1234312-23431290.22893.053.7991.1194.023.78
2234236-23423690.19991.20
3233205-23320589.80290.75
4243721-24372193.85294.85
5249739-24973996.16997.17
6254587-25458798.03699.06
30min1244893-24489394.30394.721.3495.6396.161.36
2246207-24620794.80996.26
3241554-24155493.01794.41
4244979-24497994.33695.80
5246573-24657394.95096.44
6251590-25159096.88298.39
45min1249775-24977596.18396.791.9597.9898.701.97
2248140-24814095.55397.48
3246694-24669494.99696.86
4251489-25148996.84398.78
5251383-25138396.80298.76
6260599-260599100.351102.35
60min1250776-25077696.56896.551.3598.8598.951.33
2246818-24681895.04497.45
3253187-25318797.49799.83
4246648-24664894.97997.40
5252237-25223797.13199.58
6254760-25476098.103100.60
极限1254973-25497398.18596.811.61100.9599.701.55
2248103-24810395.53998.42
3253972-25397297.799100.62
4248716-24871695.77598.67
5246672-24667294.98897.92
6256056-25605698.602101.59
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.679443094188941549393694369942150.21
212.609358193661936210.07
单位质量响应值RSD%判断
7436.077430.240.06数据可信
长期24月-供试品溶液-2023061521批-氢氯噻嗪
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141383-4138344.40546.433.5144.4146.433.51
241799-4179944.85244.85
344403-4440347.64647.65
445357-4535748.66948.67
543591-4359146.77446.77
643068-4306846.21346.21
10min176708-7670882.31086.733.1082.5386.963.09
280353-8035386.22186.45
380693-8069386.58686.82
480939-8093986.85087.09
581868-8186887.84788.08
684418-8441890.58390.81
15min183049-8304989.11492.342.0989.7593.002.09
287773-8777394.18394.84
385149-8514991.36792.04
486025-8602592.30792.99
586512-8651292.83093.50
687809-8780994.22294.91
20min188399-8839994.85593.382.0895.9394.502.05
284641-8464190.82291.95
386665-8666592.99494.12
485283-8528391.51192.65
587982-8798294.40795.54
689171-8917195.68396.84
30min187170-8717093.53696.253.0495.0997.843.01
287553-8755393.94795.53
388135-8813594.57296.16
493763-93763100.611102.21
589231-8923195.74897.36
692343-9234399.087100.72
45min187636-8763694.03695.172.1396.0697.242.12
287224-8722493.59495.64
386708-8670893.04095.11
488826-8882695.31397.41
590182-9018296.76898.86
691576-9157698.264100.39
60min192661-9266199.42897.941.80101.92100.491.73
289962-8996296.53299.05
393346-93346100.163102.69
488953-8895395.44998.03
591511-9151198.194100.77
691222-9122297.884100.50
极限190609-9060997.22696.201.35100.2199.241.31
289598-8959896.14199.14
388552-8855295.01998.05
488225-8822594.66897.72
589553-8955396.09399.16
691397-9139798.072101.18
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.712582982578872584052581942586092582790.11
214.802563832565952564890.06
单位质量响应值RSD%判断
17558.0617330.340.93数据可信
长期24月-供试品溶液-2023061521批-厄贝沙坦
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min180091-8009130.61032.614.9530.6132.614.95
280422-8042230.73630.74
389219-8921934.09834.10
489923-8992334.36734.37
586314-8631432.98832.99
685925-8592532.83932.84
10min1179271-17927168.51573.944.1468.6774.104.14
2191204-19120473.07673.23
3193446-19344673.93374.10
4197506-19750675.48475.66
5196482-19648275.09375.26
6202816-20281677.51477.68
15min1215407-21540782.32686.772.8082.8287.302.80
2231254-23125488.38288.90
3224485-22448585.79586.34
4228923-22892387.49188.04
5229260-22926087.62088.16
6232847-23284788.99189.54
20min1239739-23973991.62591.021.9392.5391.991.91
2231837-23183788.60589.57
3236832-23683290.51491.48
4234677-23467789.69190.68
5241748-24174892.39393.37
6244138-24413893.30694.30
30min1241383-24138392.25495.703.6693.6297.123.64
2244988-24498893.63195.04
3245116-24511693.68095.10
4265504-265504101.472102.91
5248086-24808694.81596.26
6257320-25732098.34499.81
45min1243694-24369493.13794.622.1994.9696.522.19
2243952-24395293.23595.11
3241851-24185192.43294.32
4247958-24795894.76696.71
5252551-25255196.52298.44
6255373-25537397.60099.56
60min1256613-25661398.07497.171.56100.3799.551.51
2250605-25060595.77898.12
3259573-25957399.206101.56
4248799-24879995.08897.50
5255109-25510997.49999.90
6254826-25482697.39199.83
极限1251679-25167996.18995.131.3198.9797.981.28
2248913-24891395.13197.95
3246204-24620494.09696.94
4245881-24588193.97396.86
5246854-24685494.34497.23
6253875-25387597.02899.96
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