厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.573173431847318753208632065319210.48
213.593148931371314300.27
单位质量响应值RSD%判断
2352.322312.731.21数据可信
加速6月-供试品溶液-24032001批-左氨氯地平-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%
5min117694-1769447.89848.214.6047.9048.214.60
219223-1922352.03852.04
318084-1808448.95448.95
416771-1677145.40045.40
517658-1765847.80147.80
617416-1741647.14647.15
10min129758-2975880.55680.312.2480.8280.582.25
230667-3066783.01783.31
330186-3018681.71581.99
428946-2894678.35878.61
529320-2932079.37179.64
629131-2913178.85979.12
15min133798-3379891.49389.042.5192.2189.762.51
233209-3320989.89890.65
333591-3359190.93291.66
431627-3162785.61686.30
532265-3226587.34388.05
632861-3286188.95689.66
20min134186-3418692.54391.171.5293.7692.381.53
234233-3423392.67093.92
333842-3384291.61292.84
433484-3348490.64391.81
533439-3343990.52191.71
632892-3289289.04090.23
30min133383-3338390.36990.770.8392.1192.480.82
233246-3324689.99891.76
333927-3392791.84293.58
433256-3325690.02591.69
533727-3372791.30193.00
633643-3364391.07392.76
45min134915-3491594.51692.161.6796.7594.381.64
234525-3452593.46195.73
333485-3348590.64592.90
434034-3403492.13294.30
533633-3363391.04693.25
633678-3367891.16893.36
60min134988-3498894.71494.191.7197.4896.921.68
235076-3507694.95297.74
335020-3502094.80197.55
434334-3433492.94495.62
533850-3385091.63394.34
635493-3549396.08198.78
90min134053-3405392.18394.521.6995.4797.771.62
234711-3471193.96497.28
335271-3527195.48098.76
434501-3450193.39696.59
535571-3557196.29299.51
635382-3538295.78199.02
120min135305-3530595.57296.101.7599.3799.881.72
236602-3660299.083102.92
335463-3546396.00099.81
434710-3471093.96297.68
535342-3534295.67299.42
635582-3558296.322100.09
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135518-3551896.14994.581.26100.4898.901.23
234937-3493794.57698.96
334896-3489694.46598.81
434322-3432292.91197.15
534635-3463593.75998.04
635331-3533195.64399.94
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.152040213203996320406772040481204138820405440.03
215.202037980203759820377890.02
单位质量响应值RSD%判断
134689.37134065.070.33数据可信
加速6月-供试品溶液-24032001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%
5min1453108-45310820.23219.354.8020.2319.354.79
2445926-44592619.91119.91
3446158-44615819.92119.92
4395895-39589517.67717.68
5427229-42722919.07619.08
6431732-43173219.27719.28
10min1898578-89857840.12240.541.9940.2340.652.00
2918544-91854441.01441.12
3931526-93152641.59341.70
4878882-87888239.24339.34
5907327-90732740.51340.62
6913275-91327540.77840.89
15min11176191-117619152.51853.181.7952.8553.521.79
21202403-120240353.68854.03
31222305-122230554.57754.92
41163011-116301151.92952.25
51182945-118294552.81953.15
61199508-119950853.55953.89
20min11354195-135419560.46661.181.2961.0961.811.29
21393912-139391262.23962.88
31390841-139084162.10262.75
41358059-135805960.63861.24
51365715-136571560.98061.60
61358896-135889660.67661.31
30min11575478-157547870.34671.991.4571.3172.961.44
21626743-162674372.63573.62
31639393-163939373.20074.19
41597886-159788671.34772.29
51625837-162583772.59573.56
61608972-160897271.84272.81
45min11805019-180501980.59581.240.7781.9582.610.77
21836354-183635481.99483.38
31833359-183335981.86183.26
41824636-182463681.47182.81
51811420-181142080.88182.25
61805645-180564580.62381.99
60min11923525-192352585.88787.121.1887.6988.941.16
21956111-195611187.34289.18
31962668-196266887.63489.49
41940241-194024186.63388.42
51936665-193666586.47388.29
61987988-198798888.76590.58
90min12054825-205482591.74995.352.1794.0397.652.14
22136003-213600395.37497.70
32160828-216082896.48298.82
42112482-211248294.32496.60
52180155-218015597.34599.64
62168022-216802296.80499.11
120min12127544-212754494.99696.792.0797.7899.622.03
22110039-211003994.21597.07
32176454-217645497.180100.05
42158801-215880196.39299.19
52225258-222525899.359102.20
62208265-220826598.601101.45
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12162194-216219496.54397.791.9199.86101.161.87
22173896-217389697.066100.45
32198402-219840298.160101.57
42136036-213603695.37598.71
52218143-221814399.042102.43
62252503-2252503100.576103.97
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.573174731504315463152231390315420.42
213.593139231477314340.20
单位质量响应值RSD%判断
2324.392313.020.35数据可信
加速6月-供试品溶液-24032501批-左氨氯地平-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%
5min123540-2354064.09960.455.7564.1060.455.75
223824-2382464.87364.87
321440-2144058.38158.38
420489-2048955.79155.79
522127-2212760.25260.25
621776-2177659.29659.30
10min131638-3163886.15085.572.7086.5185.902.72
233007-3300789.87890.24
330808-3080883.89084.21
430743-3074383.71384.02
531373-3137385.42985.76
630977-3097784.35084.68
15min133650-3365091.62991.362.4192.4692.162.41
235113-3511395.61396.47
332954-3295489.73490.52
433273-3327390.60291.38
533006-3300689.87590.68
633301-3330190.67991.48
20min134183-3418393.08093.033.6394.4294.343.62
236503-3650399.398100.79
333115-3311590.17291.46
434112-3411292.88794.17
533929-3392992.38993.70
633136-3313690.22991.53
30min134587-3458794.18094.401.8296.0496.241.83
235787-3578797.44899.39
334528-3452894.02095.81
434566-3456694.12395.92
534708-3470894.51096.33
633841-3384192.14993.95
45min133135-3313590.22693.382.2392.6195.742.21
235504-3550496.67799.16
334364-3436493.57395.89
434202-3420293.13295.45
534058-3405892.74095.09
634494-3449493.92796.24
60min135944-3594497.87596.721.93100.7699.601.92
236439-3643999.223102.24
335545-3554596.78999.62
435733-3573397.301100.14
534805-3480594.77497.64
634657-3465794.37197.21
90min134441-3444193.78396.233.7997.2199.653.73
237787-37787102.894106.47
335761-3576197.377100.75
435368-3536896.30799.68
534391-3439193.64797.04
634299-3429993.39696.76
120min134953-3495395.17793.871.8299.1397.821.82
235220-3522095.904100.05
334154-3415493.00196.91
434850-3485094.89698.81
533601-3360191.49595.40
634057-3405792.73796.62
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134289-3428993.36995.933.4397.85100.403.36
237320-37320101.622106.30
336028-3602898.104102.53
434868-3486894.94599.38
534427-3442793.74598.16
634446-3444693.79698.19
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.152046090204673020465982046388204612620463860.02
215.202038819203979920393090.04
单位质量响应值RSD%判断
135074.98134165.070.48数据可信
加速6月-供试品溶液-24032501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%
5min1507436-50743622.61720.667.4822.6220.667.48
2478563-47856321.33021.33
3435018-43501819.38919.39
4411667-41166718.34818.35
5481786-48178621.47321.47
6466383-46638320.78720.79
10min1965177-96517743.01841.902.2543.1442.012.26
2951939-95193942.42842.55
3915709-91570940.81440.92
4912578-91257840.67440.78
5948272-94827242.26542.38
6946799-94679942.19942.31
15min11249770-124977055.70354.271.6156.0754.621.62
21218070-121807054.29054.64
31200604-120060453.51153.85
41194095-119409553.22153.55
51222243-122224354.47654.83
61220551-122055154.40054.75
20min11446820-144682064.48562.531.8665.1663.181.87
21399593-139959362.38063.04
31365533-136553360.86261.49
41408004-140800462.75563.38
51396803-139680362.25662.91
61401589-140158962.46963.12
30min11667777-166777774.33372.941.5875.3773.941.57
21592739-159273970.98971.99
31625880-162588072.46673.44
41638071-163807173.00973.98
51653406-165340673.69374.70
61641407-164140773.15874.16
45min11816439-181643980.95981.111.3482.4082.511.32
21785203-178520379.56780.96
31806020-180602080.49581.87
41823422-182342281.27182.65
51830235-183023581.57482.99
61857648-185764882.79684.20
60min12023092-202309290.17088.031.5892.0789.881.57
21928251-192825185.94387.78
31960315-196031587.37289.19
41986884-198688488.55690.39
51977535-197753588.14090.00
61974405-197440588.00089.87
90min12109441-210944194.01992.301.2096.4194.641.20
22066468-206646892.10394.42
32035613-203561390.72893.03
42079328-207932892.67695.00
52078195-207819592.62694.98
62056812-205681291.67394.03
120min12106989-210698993.90993.151.5996.8396.011.56
22040441-204044190.94393.77
32075364-207536492.50095.31
42133487-213348795.09097.93
52073710-207371092.42695.30
62109830-210983094.03696.90
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12143332-214333295.52994.530.9798.9797.900.96
22087858-208785893.05796.39
32117269-211726994.36897.69
42133763-213376395.10398.47
52109354-210935494.01597.40
62133882-213388295.10898.49
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.573124331213314263132831300313020.27
213.593155631451315040.24
单位质量响应值RSD%判断
2306.712318.180.36数据可信
加速6月-供试品溶液-24032502批-左氨氯地平-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%
5min119481-1948153.19057.203.9153.1957.203.91
221567-2156758.88658.89
321798-2179859.51759.52
420798-2079856.78656.79
521190-2119057.85757.86
620866-2086656.97256.97
10min129079-2907979.39782.001.7679.6982.311.77
230503-3050383.28583.61
329898-2989881.63381.96
430266-3026682.63882.95
530464-3046483.17883.50
629974-2997481.84082.16
15min132236-3223688.01690.432.0188.7591.202.00
232918-3291889.87990.67
333486-3348691.42992.21
433698-3369892.00892.78
532521-3252188.79589.58
633865-3386592.46493.24
20min132258-3225888.07791.522.0289.3092.802.02
233588-3358891.70893.00
333730-3373092.09693.39
433375-3337591.12692.41
534047-3404792.96194.24
634113-3411393.14194.43
30min131917-3191787.14589.711.8988.8691.501.88
232347-3234788.32090.12
332853-3285389.70191.50
433228-3322890.72592.52
533233-3323390.73992.53
633563-3356391.64093.44
45min133357-3335791.07793.622.8793.2895.902.82
234249-3424993.51395.80
334292-3429293.63095.93
433814-3381492.32594.62
533845-3384592.41094.71
636168-3616898.752101.06
60min133301-3330190.92494.272.1993.6397.082.16
234354-3435493.79996.61
334622-3462294.53197.35
435368-3536896.56899.38
535255-3525596.25999.07
634269-3426993.56796.43
90min132169-3216987.83491.051.8091.0494.381.80
233759-3375992.17595.50
333600-3360091.74195.09
433384-3338491.15194.50
533417-3341791.24194.59
633758-3375892.17295.55
120min132609-3260989.03592.121.7992.7395.961.79
234030-3403092.91596.76
333959-3395992.72196.58
433576-3357691.67595.53
533938-3393892.66496.52
634324-3432493.71797.61
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133351-3335191.06192.441.3295.2596.781.31
234551-3455194.33798.70
333411-3341191.22595.60
433800-3380092.28796.65
534082-3408293.05797.42
633942-3394292.67497.09
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.152038011203647320358482037230203581320366750.05
215.202036368203984620381070.13
单位质量响应值RSD%判断
134433.99134085.990.19数据可信
加速6月-供试品溶液-24032502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%
5min1461359-46135920.61821.994.3820.6221.994.39
2498997-49899722.30022.30
3520631-52063123.26723.27
4487700-48770021.79521.80
5507632-50763222.68622.69
6476249-47624921.28321.28
10min1904465-90446540.42041.882.2440.5342.002.25
2964354-96435443.09643.22
3952450-95245042.56542.69
4925117-92511741.34341.46
5939862-93986242.00242.13
6936920-93692041.87041.99
15min11190752-119075253.21453.981.1653.5554.341.17
21215792-121579254.33354.70
31228908-122890854.91955.29
41208753-120875354.01954.37
51194730-119473053.39253.75
61208810-120881054.02154.37
20min11365426-136542661.02061.840.8361.6562.490.84
21393341-139334162.26862.93
31396802-139680262.42263.09
41377898-137789861.57862.23
51381091-138109161.72062.38
61387412-138741262.00362.65
30min11573053-157305370.29970.920.9871.2771.920.99
21605235-160523571.73772.75
31606290-160629071.78472.80
41586531-158653170.90171.89
51579721-157972170.59771.60
61571112-157111270.21271.21
45min11778331-177833179.47381.402.0480.8482.792.02
21843411-184341182.38183.79
31854073-185407382.85884.27
41788352-178835279.92181.31
51799375-179937580.41381.80
61864854-186485483.33984.72
60min11922720-192272085.92586.251.5287.7388.091.50
21957900-195790087.49889.36
31953279-195327987.29189.17
41950119-195011987.15088.98
51883550-188355084.17586.01
61912214-191221485.45687.30
90min12004895-200489589.59891.151.7391.8893.471.71
22105551-210555194.09696.45
32048163-204816391.53193.89
42028088-202808890.63492.95
52029991-202999190.71993.02
62020650-202065090.30292.63
120min12058829-205882992.00893.321.2094.7996.151.20
22132675-213267595.30898.18
32088818-208881893.34896.22
42080739-208073992.98795.81
52073919-207391992.68295.49
62094063-209406393.58396.41
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12092617-209261793.51893.811.0096.8197.160.99
22140916-214091695.67699.08
32083642-208364293.11796.51
42095390-209539093.64296.98
52087565-208756593.29296.62
62094924-209492493.62196.97
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.573097630960311343086530908309690.34
213.593165231565316080.20
单位质量响应值RSD%判断
2282.172325.831.34数据可信
加速6月-供试品溶液-2024042411批-左氨氯地平-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%
5min116928-1692846.39348.4612.4046.3948.4612.40
216279-1627944.61444.61
320494-2049456.16656.17
419543-1954353.56053.56
514563-1456339.91239.91
618291-1829150.12950.13
10min130282-3028282.99184.302.3083.2584.572.32
230714-3071484.17584.42
330519-3051983.64183.95
431974-3197487.62887.93
529973-2997382.14482.37
631103-3110385.24185.52
15min132034-3203487.79390.962.5688.5191.702.56
233968-3396893.09393.81
332821-3282189.95090.73
434307-3430794.02294.81
532697-3269789.61090.29
633318-3331891.31292.06
20min133618-3361892.13492.502.1193.3493.752.11
232885-3288590.12591.36
333461-3346191.70492.98
434669-3466995.01496.32
533333-3333391.35392.53
634554-3455494.69995.96
30min134596-3459694.81494.971.3896.5396.731.38
234076-3407693.38995.12
334306-3430694.01995.81
435464-3546497.19399.03
534792-3479295.35197.03
634684-3468495.05596.84
45min133099-3309990.71292.381.6392.9694.661.62
233152-3315290.85793.11
333403-3340391.54593.85
434253-3425393.87496.25
534090-3409093.42795.64
634244-3424493.85096.16
60min133779-3377992.57593.632.1695.3296.432.12
233805-3380592.64695.40
333347-3334791.39194.21
434319-3431994.05596.95
534253-3425393.87496.61
635480-3548097.237100.07
90min133889-3388992.87793.801.7096.1497.121.68
234367-3436794.18797.46
333280-3328091.20894.53
434926-3492695.71999.14
534262-3426293.89997.15
634632-3463294.91398.29
120min134151-3415193.59593.161.4797.3797.001.40
234684-3468495.05598.85
333186-3318690.95094.78
434192-3419293.70797.66
533956-3395693.06096.84
633790-3379092.60596.51
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134851-3485195.51393.861.8299.8198.211.76
234149-3414993.58997.91
333181-3318190.93695.27
434890-3489095.620100.09
534198-3419893.72398.02
634214-3421493.76798.18
厄贝沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.152032526203323420325952033046203225720327320.02
215.202033753203614020349460.09
单位质量响应值RSD%判断
134173.73133878.030.16数据可信
加速6月-供试品溶液-2024042411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%
5min1367877-36787716.46916.188.8216.4716.188.82
2344790-34479015.43515.44
3390729-39072917.49217.49
4381325-38132517.07117.07
5304969-30496913.65313.65
6379113-37911316.97216.97
10min1895735-89573540.10041.312.8940.1941.402.90
2923379-92337941.33741.42
3948999-94899942.48442.58
4923241-92324141.33141.43
5889893-88989339.83839.91
6955134-95513442.75942.85
15min11201187-120118753.77455.012.8854.0955.332.89
21248412-124841255.88856.20
31269282-126928256.82357.16
41240657-124065755.54155.87
51172368-117236852.48452.78
61240489-124048955.53455.87
20min11425650-142565063.82364.181.8664.4464.801.87
21401361-140136162.73563.36
31469625-146962565.79166.44
41436200-143620064.29564.93
51410273-141027363.13463.72
61458115-145811565.27665.92
30min11668225-166822574.68275.081.3075.6576.061.31
21656967-165696774.17875.15
31710907-171090776.59377.61
41659565-165956574.29575.28
51670362-167036274.77875.72
61696876-169687675.96576.97
45min11842330-184233082.47783.872.2183.8685.272.20
21853883-185388382.99484.38
31948535-194853587.23188.67
41842019-184201982.46383.87
51860240-186024083.27884.63
61893921-189392184.78686.21
60min11969972-196997288.19188.731.4390.0390.601.44
21983503-198350388.79790.64
32024841-202484190.64792.57
41951744-195174487.37589.24
51957837-195783787.64889.47
62004545-200454589.73991.63
90min12072947-207294792.80193.220.8995.1395.580.91
22070141-207014192.67595.02
32115956-211595694.72697.15
42084463-208446393.31695.66
52064283-206428392.41394.72
62086508-208650893.40895.80
120min12117451-211745194.79395.391.7497.6498.271.73
22164058-216405896.88099.74
32186148-218614897.868100.82
42117749-211774994.80697.67
52085098-208509893.34596.16
62114627-211462794.66797.58
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12169192-216919297.10996.151.23100.4899.551.22
22136256-213625695.63599.03
32186249-218624997.873101.37
42124389-212438995.10498.50
52119339-211933994.87898.21
62150649-215064996.27999.72
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