沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.135724855737255748375707105712965726110.30
2 28.055758055736675747360.27
单位质量响应值RSD%判断
20355.8820489.700.47数据可信
长期24月-供试品溶液-2024032421批-缬沙坦-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%
5min1230410-23041018.27316.6415.7518.2716.6415.76
2231074-23107418.32518.33
3214868-21486817.04017.04
4237792-23779218.85818.86
5150229-15022911.91411.91
6194770-19477015.44615.45
10min1391089-39108931.01529.806.5931.0529.836.60
2408343-40834332.38332.41
3367647-36764729.15629.18
4373901-37390129.65229.68
5334658-33465826.54026.56
6378989-37898930.05630.08
15min1484379-48437938.41339.135.2838.5039.215.28
2534225-53422542.36642.45
3474271-47427137.61237.69
4475595-47559537.71737.80
5474298-47429837.61437.68
6517779-51777941.06241.14
20min1538475-53847542.70344.445.2542.8544.585.25
2605469-60546948.01648.17
3540749-54074942.88443.02
4540398-54039842.85643.00
5547356-54735643.40843.53
6589529-58952946.75246.90
30min1590565-59056546.83448.434.1447.0548.644.13
2645472-64547251.18951.42
3592248-59224846.96847.18
4597471-59747147.38247.60
5597718-59771847.40247.60
6640393-64039350.78651.01
45min1621300-62130049.27250.242.2549.5750.532.26
2651595-65159551.67451.99
3615759-61575948.83249.12
4637429-63742950.55150.85
5627997-62799749.80350.08
6646719-64671951.28851.59
60min1632042-63204250.12450.791.6050.5051.171.61
2650476-65047651.58651.99
3627178-62717849.73850.11
4641724-64172450.89251.27
5637863-63786350.58550.95
6653457-65345751.82252.21
极限1640976-64097650.83251.350.8651.2951.820.87
2651531-65153151.66952.16
3642436-64243650.94851.40
4644817-64481751.13751.60
5650866-65086651.61752.06
6654621-65462151.91452.39
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 28.139748769770839781339715009728429748870.29
2 28.059791589767869779720.18
单位质量响应值RSD%判断
34656.4934865.310.43数据可信
长期24月-供试品溶液-2024032421批-沙库巴曲-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%
5min1388320-38832017.09415.5316.1517.0915.5316.14
2389432-38943217.14317.14
3360992-36099215.89115.89
4401237-40123717.66217.66
5250109-25010911.01011.01
6327099-32709914.39914.40
10min1661189-66118929.10627.956.6729.1327.976.67
2690249-69024930.38530.41
3621403-62140327.35427.38
4630819-63081927.76927.80
5564508-56450824.85024.87
6641202-64120228.22628.25
15min1820109-82010936.10136.735.4536.1836.805.45
2905038-90503839.84039.92
3801299-80129935.27335.35
4804340-80434035.40735.48
5798350-79835035.14335.20
6877267-87726738.61738.69
20min1910542-91054240.08241.795.3740.2241.925.37
21026709-102670945.19645.34
3914183-91418340.24240.37
4915230-91523040.28840.42
5928149-92814940.85740.98
61000798-100079844.05544.19
30min1999626-99962644.00445.524.2844.2145.724.28
21094819-109481948.19448.41
31000734-100073444.05244.25
41011959-101195944.54744.75
51011055-101105544.50744.69
61086574-108657447.83148.04
45min11052576-105257646.33447.252.2646.6147.532.28
21104409-110440948.61648.92
31043878-104387845.95246.22
41079919-107991947.53847.81
51063519-106351946.81647.08
61096549-109654948.27048.56
60min11071105-107110547.15047.801.6747.5048.151.68
21103956-110395648.59648.98
31062237-106223746.76047.11
41087591-108759147.87648.23
51081416-108141647.60447.94
61108409-110840948.79249.16
极限11090878-109087848.02148.480.8248.4548.920.83
21107136-110713648.73649.20
31092667-109266748.09948.53
41096930-109693048.28748.72
51106888-110688848.72549.14
61113098-111309848.99949.45
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.135725355729045732535749125743605735930.18
2 28.055739745753475746600.17
单位质量响应值RSD%判断
20390.7920486.990.34数据可信
长期24月-供试品溶液-2024032521批-缬沙坦-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%
5min1180121-18012114.27315.0819.5914.2715.0819.57
2234476-23447618.58018.58
3155076-15507612.28812.29
4240061-24006119.02319.02
5164151-16415113.00813.01
6168186-16818613.32713.33
10min1366627-36662729.05229.026.7329.0829.056.74
2400097-40009731.70431.74
3338620-33862026.83326.85
4389789-38978930.88730.92
5343585-34358527.22627.25
6358874-35887428.43828.46
15min1519003-51900341.12739.393.0041.2039.463.00
2505146-50514640.02940.11
3476872-47687237.78837.85
4486932-48693238.58538.67
5492241-49224139.00639.07
6502222-50222239.79739.87
20min1583660-58366046.25044.693.1146.3944.833.09
2567788-56778844.99245.14
3558929-55892944.29044.42
4532415-53241542.18942.34
5567854-56785444.99845.13
6573482-57348245.44445.58
30min1628318-62831849.78948.773.1950.0148.983.16
2612662-61266248.54848.77
3632359-63235950.10950.31
4579610-57961045.92946.15
5611739-61173948.47548.68
6628107-62810749.77249.98
45min1638361-63836150.58550.052.1150.8950.342.10
2632498-63249850.12050.43
3639029-63902950.63850.92
4604948-60494847.93748.23
5635207-63520750.33550.62
6639293-63929350.65950.95
60min1641470-64147050.83150.561.0651.2250.941.05
2635975-63597550.39650.79
3641663-64166350.84651.22
4625108-62510849.53549.91
5642421-64242150.90651.28
6641282-64128250.81651.20
极限1647890-64789051.34051.361.1751.8151.831.14
2641523-64152350.83551.31
3641859-64185950.86251.32
4651445-65144551.62252.08
5661483-66148352.41752.87
6644884-64488451.10251.57
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 28.139750889758509754929785799775369765090.16
2 28.059771679801509786580.22
单位质量响应值RSD%判断
34714.1534889.770.36数据可信
长期24月-供试品溶液-2024032521批-沙库巴曲-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%
5min1301831-30183113.27114.0420.1613.2714.0420.18
2395404-39540417.38517.39
3257958-25795811.34211.34
4405183-40518317.81517.82
5274347-27434712.06212.06
6281147-28114712.36112.36
10min1619702-61970227.24727.206.7727.2727.226.78
2675355-67535529.69429.72
3571220-57122025.11525.13
4659011-65901128.97529.01
5580057-58005725.50425.52
6606041-60604126.64626.67
15min1878600-87860038.63036.963.0038.7037.033.00
2852434-85243437.48037.56
3806718-80671835.47035.53
4823972-82397236.22836.31
5831928-83192836.57836.64
6849764-84976437.36237.43
20min1987416-98741643.41541.973.1143.5542.103.09
2960373-96037342.22642.37
3945784-94578441.58441.70
4900879-90087939.61039.75
5961696-96169642.28442.41
6970572-97057242.67442.80
30min11064277-106427746.79445.823.2347.0046.023.21
21036932-103693245.59245.80
31072392-107239247.15147.34
4980861-98086143.12743.33
51036269-103626945.56345.76
61062527-106252746.71746.92
45min11082696-108269647.60447.062.1647.8947.342.14
21071196-107119647.09847.39
31084301-108430147.67547.94
41024396-102439645.04145.32
51075569-107556947.29147.56
61083583-108358347.64347.92
60min11087249-108724947.80447.541.0548.1747.891.05
21076782-107678247.34447.71
31088189-108818947.84648.19
41059844-105984446.59946.95
51087274-108727447.80548.15
61087857-108785747.83148.19
极限11102194-110219448.46148.461.1348.9048.891.11
21090816-109081647.96148.41
31091116-109111647.97448.40
41107231-110723148.68349.11
51123849-112384949.41349.84
61097169-109716948.24048.68
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.135727225729155762875730625720175734010.29
2 28.055736895736555736720.01
单位质量响应值RSD%判断
20383.9720451.760.24数据可信
长期24月-供试品溶液-2024032621批-缬沙坦-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%
5min1170954-17095413.56115.8718.0613.5615.8718.06
2212491-21249116.85516.86
3243900-24390019.34719.35
4180576-18057614.32414.32
5236177-23617718.73418.73
6156265-15626512.39512.40
10min1379048-37904830.06730.989.8630.0931.009.87
2390689-39068930.99131.02
3456281-45628136.19436.23
4350917-35091727.83627.86
5408313-40831332.38932.42
6357818-35781828.38328.40
15min1512425-51242540.64740.477.1440.7240.547.13
2508421-50842140.32940.41
3548704-54870443.52543.62
4457160-45716036.26336.33
5483833-48383338.37938.46
6550468-55046843.66543.73
20min1582420-58242046.19945.208.2946.3445.358.28
2563936-56393644.73344.88
3606224-60622448.08748.25
4509954-50995440.45140.58
5524039-52403941.56841.72
6632670-63267050.18550.33
30min1634387-63438750.32148.776.5350.5449.006.53
2605985-60598548.06848.29
3646076-64607651.24951.49
4564466-56446644.77544.97
5574196-57419645.54745.77
6664184-66418452.68552.91
45min1647958-64795851.39850.174.0751.7050.484.07
2627499-62749949.77550.08
3649900-64990051.55251.88
4601653-60165347.72548.00
5604148-60414847.92348.22
6663846-66384652.65852.97
60min1647691-64769151.37751.052.4951.7651.432.51
2642686-64268650.98051.36
3655091-65509151.96452.38
4625143-62514349.58849.94
5625479-62547949.61549.99
6665085-66508552.75653.16
极限1653851-65385151.86552.020.6652.3452.490.66
2654522-65452251.91952.39
3651920-65192051.71252.22
4652560-65256051.76352.20
5658764-65876452.25552.71
6663137-66313752.60253.09
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 28.139756639754999806079751539744209762680.26
2 28.059763689757409760540.05
单位质量响应值RSD%判断
34705.5834796.930.19数据可信
长期24月-供试品溶液-2024032621批-沙库巴曲-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%
5min1284582-28458212.53114.7918.8112.5314.7818.81
2357891-35789115.75915.76
3412686-41268618.17118.17
4301246-30124613.26413.26
5398623-39862317.55217.55
6259849-25984911.44211.44
10min1639771-63977128.17029.0510.0228.1929.0810.02
2660024-66002429.06229.09
3773148-77314834.04334.07
4591265-59126526.03526.06
5689564-68956430.36330.39
6605022-60502226.64026.66
15min1866101-86610138.13638.017.3138.2038.087.31
2859427-85942737.84237.92
3929185-92918540.91441.00
4771859-77185933.98634.05
5817682-81768236.00436.08
6934602-93460241.15241.22
20min1986063-98606343.41842.468.4943.5542.608.47
2954396-95439642.02442.16
31026933-102693345.21845.37
4860380-86038037.88438.01
5884782-88478238.95939.10
61073268-107326847.25847.39
30min11074256-107425647.30245.856.7747.5146.066.76
21026148-102614845.18345.39
31097157-109715748.31048.54
4952623-95262341.94642.13
5970213-97021342.72042.93
61127624-112762449.65249.86
45min11096634-109663448.28747.204.2648.5747.484.26
21063773-106377346.84047.12
31103652-110365248.59648.91
41016347-101634744.75245.01
51022797-102279745.03645.31
61128481-112848149.68949.98
60min11096837-109683748.29648.022.6648.6648.382.68
21087785-108778547.89748.26
31112279-111227948.97649.37
41058039-105803946.58846.92
51058277-105827746.59846.95
61130329-113032949.77150.15
极限11111973-111197348.96249.080.6449.4149.530.65
21111105-111110548.92449.37
31108970-110897048.83049.30
41109727-110972748.86349.27
51119913-111991349.31249.74
61126877-112687749.61950.08
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.135730395752495748245749105708695737780.33
2 28.055763495740405751940.29
单位质量响应值RSD%判断
20397.3720506.020.38数据可信
长期24月-供试品溶液-TAWW4批-缬沙坦-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%
5min1194715-19471515.42013.489.3415.4213.489.34
2148576-14857611.76611.77
3165725-16572513.12413.12
4175178-17517813.87313.87
5160174-16017412.68512.68
6177229-17722914.03514.04
10min1384282-38428230.43229.235.7330.4629.255.73
2343114-34311427.17227.19
3370450-37045029.33729.36
4389194-38919430.82130.84
5342964-34296427.16027.18
6384606-38460630.45830.48
15min1557657-55765744.16243.192.1844.2443.262.18
2551274-55127443.65743.72
3527763-52776341.79541.87
4541410-54141042.87542.95
5537320-53732042.55142.62
6556745-55674544.09044.16
20min1626138-62613849.58549.801.3749.7449.941.37
2639426-63942650.63750.78
3631723-63172350.02750.17
4615943-61594348.77848.92
5623761-62376149.39749.53
6636008-63600850.36750.51
30min1627367-62736749.68250.291.7749.9250.521.75
2646219-64621951.17551.40
3645518-64551851.12051.34
4617896-61789648.93249.16
5632710-63271050.10650.33
6640715-64071550.74050.97
45min1627102-62710249.66150.231.9849.9850.541.97
2647074-64707451.24351.55
3644997-64499751.07951.39
4613823-61382348.61048.92
5632587-63258750.09650.40
6640230-64023050.70151.02
60min1626247-62624749.59450.161.7749.9950.551.76
2644455-64445551.03651.43
3642504-64250450.88151.28
4615301-61530148.72749.12
5632072-63207250.05550.44
6639515-63951550.64451.05
极限1625005-62500549.49550.081.8849.9850.561.87
2644893-64489351.07051.55
3642414-64241450.87451.35
4613985-61398548.62349.09
5629018-62901849.81350.28
6638976-63897650.60251.09
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 28.139758079790929781579787679721099767860.30
2 28.059814199777299795740.27
单位质量响应值RSD%判断
34724.0034922.420.41数据可信
长期24月-供试品溶液-TAWW4批-沙库巴曲-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%
5min1327160-32716014.37612.499.7514.3812.499.76
2246725-24672510.84110.84
3276533-27653312.15112.15
4293277-29327712.88712.89
5266408-26640811.70611.71
6295594-29559412.98912.99
10min1649357-64935728.53427.385.8528.5627.405.86
2577815-57781525.39025.41
3624917-62491727.46027.48
4658023-65802328.91428.94
5578539-57853925.42225.44
6649303-64930328.53128.55
15min1946733-94673341.60140.652.2241.6740.722.21
2935252-93525241.09641.16
3895067-89506739.33039.40
4917966-91796640.33740.41
5911317-91131740.04440.11
6944697-94469741.51141.58
20min11063923-106392346.75046.921.3646.8947.061.35
21085693-108569347.70747.84
31071867-107186747.09947.23
41045968-104596845.96146.10
51059516-105951646.55646.69
61079905-107990547.45247.59
30min11065142-106514246.80447.381.7747.0247.601.76
21096984-109698448.20348.41
31096356-109635648.17548.39
41049402-104940246.11246.33
51073337-107333747.16447.37
61088485-108848547.82948.05
45min11065553-106555346.82247.331.9947.1247.621.97
21099283-109928348.30448.59
31095170-109517048.12348.41
41042373-104237345.80346.09
51072600-107260047.13147.42
61087245-108724547.77548.07
60min11062382-106238246.68247.271.8047.0647.641.79
21095230-109523048.12648.50
31092082-109208247.98748.36
41045376-104537645.93546.30
51072898-107289847.14547.51
61086326-108632647.73548.11
极限11061281-106128146.63447.221.8947.0947.661.88
21096472-109647248.18048.63
31091262-109126247.95148.40
41043538-104353845.85446.30
51068992-106899246.97347.41
61085660-108566047.70548.16
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