厄贝沙坦片项目信息
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800
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%
112.167200387200497198827197087198017198960.03
212.167169867175757172800.06
单位质量响应值RSD%判断
59201.9758986.840.26数据可信
长期36月-供试品溶液-20210227批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min155968-559687.8928.8832.817.898.8732.83
265260-652609.2039.20
331717-317174.4734.47
463856-638569.0059.00
596096-9609613.55113.55
664743-647439.1309.13
10min1198016-19801627.92431.6012.8127.9631.6412.83
2225227-22522731.76131.81
3206942-20694229.18229.20
4198806-19880628.03528.08
5268627-26862737.88137.95
6246896-24689634.81734.86
15min1332379-33237946.87147.663.2047.0547.863.25
2344168-34416848.53448.74
3334983-33498347.23947.41
4322931-32293145.53945.72
5354677-35467750.01650.27
6338716-33871647.76547.98
20min1409138-40913857.69657.852.9058.1158.292.93
2415176-41517658.54758.99
3410494-41049457.88758.29
4390661-39066155.09055.50
5427309-42730960.25860.77
6408510-40851057.60758.07
30min1459768-45976864.83569.594.1565.5470.324.09
2507204-50720471.52572.26
3496567-49656770.02570.72
4509115-50911571.79472.48
5478205-47820567.43568.24
6510073-51007371.92972.68
45min1557391-55739178.60279.812.4579.6380.892.41
2573894-57389480.92982.03
3582697-58269782.17183.21
4550814-55081477.67578.72
5553038-55303877.98879.13
6577910-57791081.49682.60
60min1592451-59245183.54685.832.4984.9787.302.47
2628129-62812988.57790.08
3618055-61805587.15788.61
4594151-59415183.78685.22
5599449-59944984.53386.07
6619542-61954287.36688.88
极限1625067-62506788.14690.722.8189.9892.632.78
2666778-66677894.02895.97
3645459-64545991.02192.91
4638521-63852190.04391.90
5623265-62326587.89189.85
6660964-66096493.20895.16
厄贝沙坦片项目信息
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800
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%
112.167187907191257192467192737195347191940.04
212.167175587187287181430.12
单位质量响应值RSD%判断
59144.2459057.810.11数据可信
长期36月-供试品溶液-20210301批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min142672-426726.0176.3153.236.026.3153.24
216686-166862.3532.35
373526-7352610.36710.37
435089-350894.9484.95
573349-7334910.34210.34
627232-272323.8403.84
10min1209874-20987429.59325.5620.6229.6225.6020.65
2128189-12818918.07518.09
3223786-22378631.55431.61
4155238-15523821.88921.91
5205723-20572329.00729.06
6164934-16493423.25623.28
15min1345653-34565348.73845.497.4848.9245.657.55
2286309-28630940.37040.47
3344791-34479148.61648.83
4317085-31708544.70944.84
5337361-33736147.56847.77
6304637-30463742.95443.09
20min1423497-42349759.71458.364.7360.1458.754.80
2390403-39040355.04755.35
3429041-42904160.49560.95
4408494-40849457.59857.96
5438344-43834461.80762.24
6393541-39354155.49055.84
30min1495194-49519469.82371.504.0170.5472.184.02
2484063-48406368.25468.83
3529336-52933674.63775.39
4531774-53177474.98175.63
5511326-51132672.09872.84
6490798-49079869.20369.83
45min1533911-53391175.28280.393.2276.3581.433.18
2573646-57364680.88581.81
3584680-58468082.44183.57
4573218-57321880.82581.85
5580904-58090481.90883.01
6574650-57465081.02782.00
60min1601945-60194584.87586.821.7686.3288.261.75
2622116-62211687.71989.04
3617164-61716487.02188.56
4624525-62452588.05989.48
5625962-62596288.26289.78
6602819-60281984.99886.38
极限1648786-64878691.48091.481.7693.3593.351.75
2654620-65462092.30294.07
3644669-64466990.89992.87
4651790-65179091.90393.77
5663425-66342593.54495.50
6629470-62947088.75690.56
厄贝沙坦片项目信息
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800
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%
112.167189017193257196927192267193227192930.04
212.167237157236767236960.01
单位质量响应值RSD%判断
59152.3859514.470.44数据可信
长期36月-供试品溶液-20210302批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min131454-314544.4187.0144.724.427.0144.72
223261-232613.2673.27
341399-413995.8155.81
483350-8335011.70711.71
555131-551317.7437.74
664699-646999.0879.09
10min1183787-18378725.81328.6517.0325.8428.6817.07
2170613-17061323.96323.98
3170179-17017923.90223.93
4256458-25645836.02036.08
5219358-21935830.80930.85
6223425-22342531.38031.43
15min1295826-29582641.54944.827.7841.7045.007.83
2290229-29022940.76340.90
3306281-30628143.01743.17
4346970-34697048.73248.97
5331766-33176646.59746.79
6343538-34353848.25048.45
20min1370524-37052452.04055.455.7852.4055.855.83
2377375-37737553.00353.34
3377361-37736153.00153.36
4418428-41842858.76859.25
5402242-40224256.49556.92
6422820-42282059.38559.83
30min1462785-46278564.99864.795.8565.6265.475.76
2483623-48362367.92568.53
3463410-46341065.08665.71
4449530-44953063.13763.91
5416281-41628158.46759.18
6492334-49233469.14969.89
45min1540967-54096775.97978.532.5276.9279.532.56
2554375-55437577.86278.81
3545793-54579376.65777.61
4569083-56908379.92881.02
5574944-57494480.75181.75
6569643-56964380.00781.09
60min1568013-56801379.77884.813.1981.1086.213.17
2602590-60259084.63485.97
3620158-62015887.10288.44
4600821-60082184.38685.88
5617637-61763786.74788.15
6613879-61387986.22087.71
极限1624446-62444687.70489.061.4289.4390.881.39
2632412-63241288.82390.58
3645156-64515690.61292.39
4630600-63060088.56890.48
5644994-64499490.59092.43
6626850-62685088.04189.96
厄贝沙坦片项目信息
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800
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%
112.167231427227597226967230247227257228690.03
212.167158827160157159480.02
单位质量响应值RSD%判断
59446.4658877.300.69数据可信
长期36月-供试品溶液-AA366批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min193139-9313913.12011.8715.3013.1211.8715.28
288588-8858812.47812.48
394712-9471213.34113.34
485417-8541712.03212.03
584571-8457111.91311.91
659316-593168.3558.36
10min1269837-26983738.00940.785.2638.0740.845.24
2302211-30221142.56942.63
3271196-27119638.20138.27
4301956-30195642.53342.59
5300186-30018642.28442.34
6291667-29166741.08441.13
15min1368167-36816751.86052.642.3752.1252.912.37
2388103-38810354.66854.94
3364549-36454951.35051.61
4380697-38069753.62553.90
5370048-37004852.12552.40
6370844-37084452.23752.48
20min1423326-42332659.63060.502.5860.1461.022.57
2444814-44481462.65663.20
3438547-43854761.77462.29
4431577-43157760.79261.33
5414556-41455658.39458.93
6424076-42407659.73560.24
30min1458221-45822164.54568.843.3865.3669.673.36
2501215-50121570.60171.46
3494989-49498969.72470.55
4503844-50384470.97171.82
5487454-48745468.66369.49
6486523-48652368.53169.34
45min1536108-53610875.51677.342.3076.6578.512.28
2557860-55786078.58079.79
3546669-54666977.00478.18
4553894-55389478.02179.22
5533741-53374175.18376.35
6566027-56602779.73080.88
60min1564556-56455679.52381.361.5381.0482.921.52
2576721-57672181.23782.84
3588120-58812082.84284.40
4582790-58279082.09283.68
5570323-57032380.33681.88
6582964-58296482.11683.66
极限1592006-59200683.39085.451.7585.3087.421.74
2610001-61000185.92587.94
3596459-59645984.01785.99
4620455-62045587.39789.40
5608045-60804585.64987.59
6612773-61277386.31588.27
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