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%
127.342780382783932771892778422772112777350.19
227.252739922750342745130.27
单位质量响应值RSD%判断
10158.5610073.870.60数据可信
长期6月-供试品溶液-2024032721批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1133251-13325121.33420.3617.2921.3320.3517.28
292313-9231314.78014.78
3113754-11375418.21218.21
4153658-15365824.60124.60
5125990-12599020.17120.17
6143876-14387623.03523.03
10min1241190-24119038.61536.836.6338.6536.866.64
2201148-20114832.20432.23
3231443-23144337.05537.08
4244111-24411139.08339.12
5230757-23075736.94536.98
6231484-23148437.06137.10
15min1307813-30781349.28247.273.6049.3847.373.60
2283897-28389745.45345.53
3301210-30121048.22448.32
4285935-28593545.77945.88
5305064-30506448.84148.94
6287613-28761346.04746.15
20min1328199-32819952.54551.342.3152.7351.512.29
2329389-32938952.73652.89
3322904-32290451.69851.87
4311240-31124049.83050.01
5317625-31762550.85251.03
6314564-31456450.36250.54
30min1331003-33100352.99452.950.9753.2653.210.96
2334942-33494253.62553.87
3326346-32634652.24952.51
4329987-32998752.83253.10
5328495-32849552.59352.85
6333710-33371053.42853.69
45min1328617-32861752.61252.961.5252.9753.311.51
2333380-33338053.37553.71
3322244-32224451.59251.94
4335143-33514353.65754.01
5330037-33003752.84053.19
6335484-33548453.71254.06
60min1331604-33160453.09153.060.9153.5453.490.91
2332203-33220353.18653.61
3326607-32660752.29152.72
4333894-33389453.45753.90
5329359-32935952.73153.17
6334680-33468053.58354.02
极限1329734-32973452.79152.981.6453.3353.501.63
2333776-33377653.43853.95
3320920-32092051.38051.90
4334477-33447753.55154.08
5330662-33066252.94053.46
6335836-33583653.76854.30
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%
127.344803444808604814854794634790614802430.21
227.254748734766724757720.27
单位质量响应值RSD%判断
17565.5817459.520.43数据可信
长期6月-供试品溶液-2024032721批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1228971-22897120.00719.0218.1620.0119.0218.16
2154503-15450313.50013.50
3193822-19382216.93516.94
4264719-26471923.13023.13
5216196-21619618.89018.89
6247742-24774221.64721.65
10min1414735-41473536.23834.556.7736.2734.586.78
2344924-34492430.13830.16
3397479-39747934.73034.76
4420820-42082036.77036.81
5397133-39713334.70034.73
6397623-39762334.74334.78
15min1530080-53008046.31644.354.1946.4144.444.19
2482956-48295642.19942.27
3517210-51721045.19245.28
4490320-49032042.84242.94
5531209-53120946.41546.50
6493552-49355243.12543.22
20min1566086-56608649.46248.212.5249.6348.382.50
2567254-56725449.56449.71
3556506-55650648.62548.79
4533508-53350846.61646.79
5547279-54727947.81947.99
6539878-53987847.17247.34
30min1570702-57070249.86649.781.0450.1250.021.03
2577834-57783450.48950.71
3562797-56279749.17549.42
4567576-56757649.59349.84
5564384-56438449.31449.56
6574987-57498750.24050.48
45min1566467-56646749.49649.851.4749.8350.181.46
2575010-57501050.24250.55
3556245-55624548.60248.93
4577077-57707750.42350.75
5569892-56989249.79550.12
6578670-57867050.56250.89
60min1570099-57009949.81349.901.0850.2350.311.08
2572121-57212149.99050.38
3560212-56021248.94949.35
4576453-57645350.36850.78
5570456-57045649.84450.26
6577426-57742650.45350.87
极限1569013-56901349.71849.901.6650.2250.391.65
2576130-57613050.34050.82
3553599-55359948.37148.86
4577594-57759450.46850.97
5570582-57058249.85550.35
6579441-57944150.62951.13
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%
127.342751222762112762522764542764302760940.21
227.252738252754562746400.42
单位质量响应值RSD%判断
10098.5410078.530.15数据可信
长期6月-供试品溶液-2024032821批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1126172-12617220.25619.9315.3920.2619.9315.40
2125118-12511820.08620.09
388970-8897014.28314.28
4137077-13707722.00622.01
5144470-14447023.19323.19
6122975-12297519.74219.74
10min1219572-21957235.25035.9110.1735.2835.9410.18
2218013-21801335.00035.03
3183636-18363629.48129.50
4248140-24814039.83639.87
5234227-23422737.60337.64
6238642-23864238.31138.34
15min1283651-28365145.53745.267.4945.6345.367.50
2273357-27335743.88443.98
3245645-24564539.43639.51
4288794-28879446.36346.47
5292052-29205246.88646.99
6308125-30812549.46649.56
20min1324716-32471652.13050.555.9652.3050.725.96
2303275-30327548.68748.85
3289925-28992546.54446.68
4314738-31473850.52850.71
5311963-31196350.08250.26
6344759-34475955.34755.53
30min1327411-32741152.56252.202.7452.8252.462.76
2323844-32384451.99052.24
3314963-31496350.56450.78
4327815-32781552.62752.89
5317225-31722550.92751.19
6339848-33984854.55954.83
45min1326153-32615352.36052.342.3652.7052.682.36
2327942-32794252.64752.98
3320330-32033051.42551.73
4331053-33105353.14753.50
5314619-31461950.50950.86
6336186-33618653.97154.33
60min1325460-32546052.24952.412.1652.6852.842.17
2326505-32650552.41752.84
3323313-32331351.90452.29
4328538-32853852.74353.18
5316820-31682050.86251.29
6338298-33829854.31054.76
极限1326628-32662852.43652.472.2352.9552.982.23
2329611-32961152.91553.42
3325629-32562952.27652.75
4328359-32835952.71453.24
5314226-31422650.44550.96
6336513-33651354.02354.57
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%
127.344757284777354779724781894786914776630.24
227.254732624760764746690.42
单位质量响应值RSD%判断
17471.2117419.050.22数据可信
长期6月-供试品溶液-2024032821批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1216568-21656818.99618.5915.8019.0018.5915.80
2212674-21267418.65418.65
3150190-15019013.17413.17
4234082-23408220.53220.53
5247653-24765321.72221.72
6210680-21068018.47918.48
10min1376847-37684733.05433.6910.3533.0933.7210.35
2373490-37349032.76032.79
3314385-31438527.57627.60
4427177-42717737.46937.50
5402255-40225535.28335.32
6410398-41039835.99736.03
15min1488399-48839942.83942.537.6242.9342.627.63
2469461-46946141.17841.26
3421407-42140736.96337.03
4497062-49706243.59943.70
5502162-50216244.04644.14
6530574-53057446.53846.63
20min1559548-55954849.08047.486.3749.2447.646.37
2520968-52096845.69645.85
3493446-49344643.28243.41
4541726-54172647.51647.69
5536944-53694447.09747.27
6594903-59490352.18152.35
30min1563333-56333349.41249.172.8549.6549.402.87
2556195-55619548.78649.02
3542354-54235447.57247.77
4567148-56714849.74649.99
5547238-54723848.00048.25
6586933-58693351.48251.74
45min1562990-56299049.38249.342.5449.7049.662.55
2566129-56612949.65749.97
3550329-55032948.27148.55
4571997-57199750.17250.50
5542359-54235947.57247.90
6581512-58151251.00651.35
60min1561998-56199849.29549.452.2649.7049.852.27
2564701-56470149.53249.93
3557150-55715048.86949.23
4568390-56839049.85550.27
5545912-54591247.88448.29
6584317-58431751.25251.68
极限1563758-56375849.44949.542.3649.9450.032.35
2570234-57023450.01750.49
3565489-56548949.60150.04
4567091-56709149.74150.24
5540921-54092147.44647.93
6581519-58151951.00751.52
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%
127.342744122742992757692775652761762756440.50
227.252778782780202779490.04
单位质量响应值RSD%判断
10082.0810199.960.83数据可信
长期6月-供试品溶液-2024032921批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min186876-8687613.87519.4616.6013.8819.4616.59
2137822-13782222.01222.01
3112584-11258417.98117.98
4140016-14001622.36222.36
5119698-11969819.11719.12
6133913-13391321.38821.39
10min1214892-21489234.32138.027.7134.3438.057.72
2242887-24288738.79238.83
3224886-22488635.91735.95
4258079-25807941.21941.26
5228203-22820336.44736.48
6259324-25932441.41741.45
15min1291020-29102046.48047.642.8046.5647.742.80
2304825-30482548.68548.79
3306605-30660548.96949.06
4290162-29016246.34346.45
5290862-29086246.45446.55
6306145-30614548.89549.00
20min1307026-30702649.03650.683.7049.1950.853.70
2325084-32508451.92052.10
3331394-33139452.92853.10
4303631-30363148.49448.68
5310176-31017649.53949.71
6326536-32653652.15252.34
30min1321129-32112951.28952.341.2151.5352.601.22
2325751-32575152.02752.30
3329503-32950352.62652.89
4329296-32929652.59352.86
5327830-32783052.35952.61
6332760-33276053.14653.42
45min1326623-32662352.16652.142.3252.4952.492.30
2328231-32823152.42352.78
3329411-32941152.61152.96
4311642-31164249.77350.13
5330119-33011952.72453.06
6332883-33288353.16653.53
60min1328034-32803452.39152.851.0252.8053.281.01
2326458-32645852.14052.58
3329781-32978152.67053.11
4334459-33445953.41853.85
5334407-33440753.40953.84
6332206-33220653.05853.51
极限1333166-33316653.21152.551.1953.7153.071.17
2325732-32573252.02452.55
3328006-32800652.38752.91
4331895-33189553.00853.53
5323528-32352851.67252.19
6331853-33185353.00153.54
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%
127.344754234758104778314806954781504775820.45
227.254805174808204806680.05
单位质量响应值RSD%判断
17468.2517639.190.69数据可信
长期6月-供试品溶液-2024032921批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1146265-14626512.75018.1217.0712.7518.1217.07
2236467-23646720.61320.61
3192060-19206016.74216.74
4238718-23871820.81020.81
5204240-20424017.80417.80
6229429-22942920.00020.00
10min1369605-36960532.21935.707.7632.2435.737.77
2417824-41782436.42336.46
3386092-38609233.65733.68
4444455-44445538.74438.78
5393046-39304634.26334.29
6446168-44616838.89438.93
15min1501374-50137443.70644.772.8443.7844.862.85
2525095-52509545.77445.87
3528886-52888646.10446.19
4498904-49890443.49143.59
5500565-50056543.63543.72
6526321-52632145.88145.98
20min1529008-52900846.11547.663.7246.2647.823.72
2561271-56127148.92749.10
3570817-57081749.75949.92
4523073-52307345.59845.77
5533897-53389746.54146.70
6562040-56204048.99449.17
30min1554097-55409748.30249.291.1848.5349.541.18
2562246-56224649.01249.27
3568844-56884449.58749.83
4567809-56780949.49749.75
5566512-56651249.38449.62
6573319-57331949.97850.23
45min1564817-56481749.23649.440.9349.5449.770.93
2565697-56569749.31349.65
3569047-56904749.60549.93
4559016-55901648.73149.06
5570287-57028749.71350.03
6574203-57420350.05550.39
60min1566663-56666349.39749.750.9049.7850.160.90
2563495-56349549.12149.54
3569582-56958249.65250.06
4577231-57723150.31950.73
5573892-57389250.02850.43
6573604-57360450.00250.43
极限1569914-56991449.68149.600.7450.1550.090.73
2562356-56235649.02249.52
3566770-56677049.40749.90
4573041-57304149.95350.45
5568292-56829249.53950.02
6573553-57355349.99850.50
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