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%
128.272886292886332887072885492885712886180.03
228.322890512886242888380.11
单位质量响应值RSD%判断
10209.3410199.080.08数据可信
加速3月-供试品溶液-2024032721批-缬沙坦钠-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%
5min1128256-12825620.35719.109.3420.3619.109.35
2122145-12214519.38719.39
3118647-11864718.83218.83
4132419-13241921.01721.02
5120441-12044119.11619.12
699935-9993515.86215.86
10min1240557-24055738.18135.7211.4238.2135.7611.42
2234621-23462137.23937.27
3235485-23548537.37637.41
4248947-24894739.51339.55
5211745-21174533.60833.64
6179086-17908628.42428.45
15min1290153-29015346.05344.888.9646.1544.988.96
2284709-28470945.18945.28
3300253-30025347.65647.75
4306611-30661148.66548.77
5279788-27978844.40844.50
6235158-23515837.32437.40
20min1310570-31057049.29349.496.9049.4749.666.90
2313209-31320949.71249.88
3325844-32584451.71851.89
4324015-32401551.42751.61
5327112-32711251.91952.08
6270261-27026142.89643.03
30min1323582-32358251.35951.272.6851.6251.522.70
2320866-32086650.92751.18
3326347-32634751.79752.06
4323991-32399151.42351.69
5335077-33507753.18353.43
6308468-30846848.96049.17
45min1326695-32669551.85352.442.4652.1952.772.47
2323252-32325251.30651.64
3326404-32640451.80652.15
4344354-34435454.65555.01
5335967-33596753.32453.66
6325604-32560451.67951.97
60min1327119-32711951.92052.493.0252.3552.912.95
2323719-32371951.38051.80
3325188-32518851.61352.05
4323173-32317351.29451.74
5336463-33646353.40353.83
6348454-34845455.30655.68
极限1326796-32679651.86951.841.4952.3852.351.47
2323266-32326651.30851.82
3324859-32485951.56152.08
4322330-32233051.16051.69
5335815-33581553.30053.82
6326727-32672751.85852.33
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%
128.275010985011815014165010685006765010880.06
228.325019305014595016940.07
单位质量响应值RSD%判断
17725.0817715.180.04数据可信
加速3月-供试品溶液-2024032721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%
5min1220131-22013119.00917.829.9219.0117.829.94
2211571-21157118.27018.27
3203583-20358317.58017.58
4227968-22796819.68519.69
5206180-20618017.80417.80
6168888-16888814.58414.58
10min1414498-41449835.79333.4511.6935.8233.4811.69
2404366-40436634.91834.95
3406474-40647435.10035.13
4428992-42899237.04437.08
5363814-36381431.41631.45
6306282-30628226.44826.47
15min1502168-50216843.36342.169.2243.4542.249.22
2491585-49158542.44942.54
3519228-51922844.83644.92
4530275-53027545.79045.88
5482262-48226241.64441.73
6403705-40370534.86134.93
20min1535339-53533946.22746.527.0646.3946.677.07
2542556-54255646.85147.01
3564524-56452448.74848.91
4560761-56076148.42348.59
5563989-56398948.70148.85
6465144-46514440.16640.29
30min1558440-55844048.22248.182.7948.4648.422.81
2553952-55395247.83548.07
3565294-56529448.81449.06
4561085-56108548.45148.70
5578035-57803549.91450.15
6531089-53108945.86046.05
45min1563710-56371048.67749.312.4849.0049.622.49
2558557-55855748.23248.55
3565294-56529448.81449.14
4595400-59540051.41451.75
5580665-58066550.14150.46
6562568-56256848.57948.85
60min1565326-56532648.81749.412.9849.2249.812.92
2560105-56010548.36648.76
3564140-56414048.71449.12
4559502-55950248.31448.73
5581155-58115550.18450.58
6603064-60306452.07652.43
极限1565514-56551448.83348.831.5249.3249.311.50
2558645-55864548.24048.72
3562762-56276248.59549.08
4558321-55832148.21248.71
5581631-58163150.22550.71
6565819-56581948.85949.30
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.272934162930032925852922572922062926930.18
228.322886952887552887250.02
单位质量响应值RSD%判断
10353.4810195.091.10数据可信
加速3月-供试品溶液-2024032721批-缬沙坦钠-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%
5min1118720-11872018.71617.0123.4518.7217.0123.44
278294-7829412.34312.34
3139255-13925521.95321.95
4109053-10905317.19217.19
577312-7731212.18812.19
6124788-12478819.67219.67
10min1218041-21804134.37331.7814.9934.4031.8114.99
2161675-16167525.48725.51
3240503-24050337.91437.95
4180132-18013228.39728.43
5185790-18579029.28929.31
6223397-22339735.21835.25
15min1292675-29267546.13941.5611.3346.2341.6411.33
2221922-22192234.98535.05
3283974-28397444.76744.87
4231034-23103436.42136.50
5269547-26954742.49342.56
6282689-28268944.56544.66
20min1327841-32784151.68347.289.0451.8547.439.04
2266582-26658242.02542.15
3305282-30528248.12648.30
4267324-26732442.14242.28
5325054-32505451.24351.38
6307461-30746148.47048.64
30min1348499-34849954.93950.975.0555.1951.205.05
2309248-30924848.75248.94
3316039-31603949.82250.08
4307020-30702048.40048.61
5336688-33668853.07753.30
6322471-32247150.83651.08
45min1327645-32764551.65251.571.7951.9951.881.78
2326238-32623851.43051.70
3319236-31923650.32650.66
4325303-32530351.28351.57
5337349-33734953.18253.50
6327039-32703951.55651.89
60min1327096-32709651.56551.841.6951.9952.231.65
2330257-33025752.06452.42
3320394-32039450.50950.93
4332006-33200652.33952.71
5336720-33672053.08253.48
6326414-32641451.45851.87
极限1326970-32697051.54551.961.8652.0652.451.80
2332895-33289552.47952.92
3320541-32054150.53251.04
4334981-33498152.80853.27
5336307-33630753.01753.51
6326076-32607651.40451.91
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%
128.275081405075225073445069795066535073280.12
228.325013195012315012750.02
单位质量响应值RSD%判断
17945.8117700.390.98数据可信
加速3月-供试品溶液-2024032721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%
5min1203727-20372717.49115.8024.1417.4915.8024.15
2131663-13166311.30411.30
3237542-23754220.39520.39
4185724-18572415.94615.95
5130268-13026811.18411.18
6215351-21535118.48918.49
10min1376070-37607032.28829.7715.2232.3229.8015.23
2277114-27711423.79223.81
3414075-41407535.55135.59
4308190-30819026.46026.49
5319818-31981827.45927.48
6385055-38505533.06033.09
15min1506034-50603443.44739.0011.7343.5339.0711.73
2379941-37994132.62132.68
3489845-48984542.05742.15
4395789-39578933.98134.05
5465340-46534039.95340.02
6488261-48826141.92142.01
20min1567323-56732348.70944.449.3048.8644.589.30
2458831-45883139.39439.51
3526416-52641645.19645.36
4459376-45937639.44139.57
5562295-56229548.27748.41
6531040-53104045.59345.75
30min1604259-60425951.88048.005.3052.1248.225.31
2533001-53300145.76245.94
3545586-54558646.84247.08
4529412-52941245.45445.65
5583556-58355650.10250.31
6558641-55864147.96348.19
45min1567729-56772948.74348.581.9149.0748.881.90
2563190-56319048.35448.61
3551586-55158647.35747.67
4561921-56192148.24548.51
5584675-58467550.19850.49
6566186-56618648.61148.92
60min1566972-56697248.67848.831.7049.0849.211.67
2570312-57031248.96549.30
3553908-55390847.55747.95
4573058-57305849.20149.55
5583211-58321150.07350.45
6565298-56529848.53548.93
极限1566150-56615048.60849.011.8549.0949.471.79
2575561-57556149.41649.83
3555502-55550247.69448.17
4580443-58044349.83550.27
5582739-58273950.03250.49
6564588-56458848.47448.95
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%
128.272891452889142891402890482890022890500.04
228.322886412884782885600.04
单位质量响应值RSD%判断
10224.6210189.270.25数据可信
加速3月-供试品溶液-2024032821批-缬沙坦钠-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%
5min1106234-10623416.85716.8817.8316.8616.8817.83
2100135-10013515.88915.89
3114926-11492618.23618.24
493795-9379514.88314.88
584453-8445313.40113.40
6138732-13873222.01422.01
10min1210315-21031533.37231.7012.9033.4031.7212.90
2194523-19452330.86630.89
3184220-18422029.23129.26
4205095-20509532.54432.57
5164129-16412926.04326.07
6240275-24027538.12638.16
15min1287051-28705145.54842.4011.0045.6342.4811.00
2261148-26114841.43841.52
3241781-24178138.36538.44
4293842-29384246.62646.70
5224971-22497135.69835.76
6294511-29451146.73246.83
20min1311290-31129049.39447.528.6849.5547.678.68
2302285-30228547.96648.11
3273195-27319543.35043.49
4333826-33382652.97053.13
5264706-26470642.00342.13
6311661-31166149.45349.63
30min1322500-32250051.17350.694.2051.4250.924.22
2326767-32676751.85052.08
3301199-30119947.79348.01
4335320-33532053.20853.45
5305002-30500248.39748.59
6325994-32599451.72851.99
45min1329962-32996252.35751.972.1052.6852.282.13
2330538-33053852.44952.76
3315610-31561050.08050.37
4334991-33499153.15553.49
5323607-32360751.34951.62
6330418-33041852.43052.78
60min1330780-33078052.48752.251.6552.9052.661.66
2330928-33092852.51152.91
3318768-31876850.58150.96
4334419-33441953.06553.49
5331292-33129252.56852.93
6329697-32969752.31552.75
极限1329838-32983852.33852.341.6652.8452.831.65
2330130-33013052.38452.87
3320007-32000750.77851.24
4333687-33368752.94853.46
5335890-33589053.29853.75
6329454-32945452.27752.80
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%
128.275017625015345017365017785017605017140.03
228.325011715010145010920.03
单位质量响应值RSD%判断
17747.2217693.930.22数据可信
加速3月-供试品溶液-2024032821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%
5min1180403-18040315.57815.6218.5815.5815.6218.57
2169703-16970314.65414.65
3196559-19655916.97316.97
4158354-15835413.67413.67
5142325-14232512.29012.29
6238148-23814820.56420.56
10min1361132-36113231.18429.5913.1731.2129.6213.17
2333574-33357428.80428.83
3315221-31522127.21927.25
4352145-35214530.40830.43
5280375-28037524.21024.23
6413592-41359235.71435.75
15min1494841-49484142.72939.7411.1742.8139.8211.17
2449467-44946738.81138.88
3415785-41578535.90335.98
4506737-50673743.75743.83
5386454-38645433.37033.43
6508344-50834443.89543.99
20min1536062-53606246.28944.598.8346.4444.748.84
2521652-52165245.04545.18
3470107-47010740.59440.73
4576837-57683749.81049.96
5455559-45555939.33739.45
6538273-53827346.48046.65
30min1555981-55598148.00947.644.3248.2447.864.33
2564240-56424048.72248.93
3519792-51979244.88445.09
4580567-58056750.13250.36
5525928-52592845.41445.60
6563788-56378848.68348.93
45min1568319-56831949.07448.882.2049.3849.182.23
2571787-57178749.37449.67
3545049-54504947.06547.34
4580382-58038250.11650.43
5558759-55875948.24948.51
6572039-57203949.39549.72
60min1572106-57210649.40149.191.6749.7949.561.69
2572495-57249549.43549.81
3551093-55109347.58747.94
4578893-57889349.98750.38
5572161-57216149.40649.74
6571119-57111949.31649.72
极限1570450-57045049.25849.321.6049.7349.781.59
2571403-57140349.34149.80
3555061-55506147.92948.36
4577713-57771349.88550.37
5581725-58172550.23250.65
6570697-57069749.28049.77
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%
128.272876942878162876592877622876692877200.03
228.322920882921842921360.03
单位质量响应值RSD%判断
10177.5710315.540.96数据可信
加速3月-供试品溶液-2024032821批-缬沙坦钠-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%
5min1121937-12193719.27516.2228.2819.2716.2228.28
286609-8660913.69013.69
379019-7901912.49112.49
4147483-14748323.31323.31
5109036-10903617.23517.24
671509-7150911.30311.30
10min1203029-20302932.09331.1611.7832.1231.1911.79
2186593-18659329.49529.52
3175339-17533927.71627.74
4228095-22809536.05536.09
5218384-21838434.52034.55
6171403-17140327.09427.11
15min1259848-25984841.07441.428.2941.1641.508.31
2268768-26876842.48442.56
3250059-25005939.52739.59
4280369-28036944.31844.42
5286230-28623045.24445.33
6226802-22680235.85135.91
20min1304547-30454748.14047.876.3548.2948.026.36
2321540-32154050.82650.97
3294338-29433846.52646.66
4312078-31207849.33049.50
5315770-31577049.91450.08
6268636-26863642.46342.59
30min1326998-32699851.68951.472.2251.9251.702.23
2330895-33089552.30552.53
3327806-32780651.81652.03
4325007-32500751.37451.63
5331385-33138552.38252.63
6311778-31177849.28349.48
45min1327306-32730651.73751.951.1552.0652.261.16
2330708-33070852.27552.59
3333245-33324552.67652.97
4327203-32720351.72152.06
5330870-33087052.30152.63
6322568-32256850.98851.26
60min1326663-32666351.63652.010.9552.0452.410.94
2329949-32994952.15552.56
3334335-33433552.84853.23
4327294-32729451.73552.16
5330142-33014252.18652.60
6325958-32595851.52451.89
极限1325675-32567551.47951.921.1651.9752.411.15
2329302-32930252.05352.54
3335361-33536153.01153.48
4326456-32645651.60352.12
5328990-32899052.00352.51
6325070-32507051.38451.83
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%
128.274994614996244996454994294996444995610.03
228.325063015071605067300.12
单位质量响应值RSD%判断
17671.0617893.010.89数据可信
加速3月-供试品溶液-2024032821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%
5min1208782-20878217.96715.0329.2717.9715.0329.29
2147053-14705312.65512.65
3132992-13299211.44511.44
4253737-25373721.83521.84
5185662-18566215.97715.98
6119670-11967010.29810.30
10min1348555-34855529.99529.1412.1630.0229.1612.18
2320200-32020027.55527.58
3299523-29952325.77525.79
4393495-39349533.86233.90
5376550-37655032.40432.43
6293254-29325425.23625.25
15min1447337-44733738.49538.868.4338.5838.938.44
2463265-46326539.86639.93
3429667-42966736.97537.04
4483370-48337041.59641.69
5494900-49490042.58842.67
6390652-39065233.61733.68
20min1524943-52494345.17444.986.5445.3245.116.55
2556383-55638347.87948.01
3507262-50726243.65243.78
4538625-53862546.35146.51
5546307-54630747.01247.16
6462323-46232339.78539.90
30min1565492-56549248.66348.452.3048.8848.662.32
2572238-57223849.24449.46
3566515-56651548.75148.95
4561454-56145448.31648.56
5574067-57406749.40149.63
6538345-53834546.32746.51
45min1566173-56617348.72248.921.1549.0249.211.16
2572460-57246049.26349.56
3575275-57527549.50549.78
4566071-56607148.71349.03
5572935-57293549.30449.62
6557622-55762247.98648.24
60min1565093-56509348.62948.990.9049.0149.370.90
2571725-57172549.19949.58
3577259-57725949.67650.04
4566475-56647548.74849.15
5571692-57169249.19749.59
6563824-56382448.52048.86
极限1563476-56347648.49048.941.1748.9549.401.16
2570262-57026249.07449.53
3580526-58052649.95750.40
4565810-56581048.69049.17
5569689-56968949.02449.50
6562388-56238848.39648.82
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%
128.272906762903492904022904292902752904260.06
228.322889832892342891080.07
单位质量响应值RSD%判断
10273.2910208.620.45数据可信
加速3月-供试品溶液-2024032921批-缬沙坦钠-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%
5min1138680-13868021.93218.3921.0921.9318.3921.08
2137203-13720321.69921.70
374778-7477811.82611.83
4122211-12221119.32819.33
5100610-10061015.91215.91
6124163-12416319.63619.64
10min1238685-23868537.74836.2213.0137.7836.2413.01
2235270-23527037.20837.24
3177919-17791928.13828.16
4241555-24155538.20238.23
5214973-21497333.99834.02
6265581-26558142.00242.03
15min1291881-29188146.16146.296.3446.2646.386.35
2297250-29725047.01047.11
3256476-25647640.56240.63
4303018-30301847.92348.02
5307834-30783448.68448.77
6299700-29970047.39847.50
20min1309390-30939048.93050.782.9849.1150.952.94
2315234-31523449.85550.03
3334118-33411852.84152.98
4324012-32401251.24351.42
5329094-32909452.04752.21
6314660-31466049.76449.95
30min1321539-32153950.85252.241.4351.1152.491.40
2329052-32905252.04052.30
3334824-33482452.95353.17
4331126-33112652.36852.63
5332593-33259352.60052.85
6332612-33261252.60352.87
45min1327736-32773651.83252.450.7852.1752.790.77
2329827-32982752.16252.51
3335077-33507752.99353.30
4332044-33204452.51352.86
5331959-33195952.50052.84
6333316-33331652.71453.07
60min1327862-32786251.85252.370.7152.2852.800.68
2329264-32926452.07352.51
3334327-33432752.87453.27
4331564-33156452.43752.87
5331232-33123252.38552.81
6332669-33266952.61253.05
极限1327183-32718351.74452.280.7452.2652.800.72
2328332-32833251.92652.45
3333726-33372652.77953.27
4331121-33112152.36752.89
5330962-33096252.34252.86
6332211-33221152.53953.07
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%
128.275043475039505041505043615037285041070.06
228.325014045018835016440.07
单位质量响应值RSD%判断
17831.8717713.420.48数据可信
加速3月-供试品溶液-2024032921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%
5min1237617-23761720.45817.0821.7720.4617.0821.77
2234849-23484920.22020.22
3125098-12509810.77110.77
4209005-20900517.99517.99
5170852-17085214.71014.71
6212882-21288218.32918.33
10min1410626-41062635.35433.9013.2035.3933.9313.20
2404160-40416034.79734.83
3304986-30498626.25926.28
4415760-41576035.79635.83
5369049-36904931.77431.80
6458069-45806939.43939.47
15min1502891-50289143.29843.456.3443.3943.536.35
2512355-51235544.11244.20
3442058-44205838.06038.12
4523862-52386245.10345.19
5529194-52919445.56245.64
6517403-51740344.54744.64
20min1533524-53352445.93547.753.1046.1047.913.07
2543861-54386146.82546.99
3578144-57814449.77749.90
4560313-56031348.24248.41
5568744-56874448.96749.12
6543142-54314246.76346.93
30min1554603-55460347.75049.171.5447.9949.411.52
2568953-56895348.98549.23
3579234-57923449.87150.08
4573033-57303349.33749.58
5575396-57539649.54049.78
6575357-57535749.53749.79
45min1566654-56665448.78849.410.8249.1149.730.80
2571058-57105849.16749.49
3580137-58013749.94850.24
4574581-57458149.47049.80
5574204-57420449.43849.76
6576845-57684549.66550.00
60min1566605-56660548.78349.360.7549.1949.760.73
2570489-57048949.11849.52
3578755-57875549.82950.20
4574304-57430449.44649.86
5573733-57373349.39749.80
6576029-57602949.59550.01
极限1566458-56645848.77149.300.7649.2549.780.75
2568558-56855848.95149.44
3578010-57801049.76550.22
4573867-57386749.40949.90
5573029-57302949.33649.82
6575514-57551449.55050.05
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%
128.272883982884682881542882902882152883050.05
228.322896832893832895330.08
单位质量响应值RSD%判断
10198.2710223.620.18数据可信
加速3月-供试品溶液-2024032921批-缬沙坦钠-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%
5min1111645-11164517.70919.0913.4917.7119.0913.49
2103411-10341116.40216.40
3103959-10395916.48916.49
4136408-13640821.63621.64
5126723-12672320.10020.10
6140036-14003622.21222.21
10min1225810-22581035.81735.955.3935.8535.995.39
2212339-21233933.68033.71
3217325-21732534.47134.50
4241829-24182938.35838.39
5240789-24078938.19338.23
6221981-22198135.20935.25
15min1300560-30056047.67345.792.6147.7645.882.59
2290490-29049046.07646.16
3290943-29094346.14846.23
4288195-28819545.71245.81
5283383-28338344.94945.05
6278456-27845644.16744.26
20min1331569-33156952.59249.982.9352.7650.152.91
2319407-31940750.66350.82
3314170-31417049.83249.99
4310039-31003949.17749.35
5308515-30851548.93549.11
6307041-30704148.70148.87
30min1331914-33191452.64652.711.0352.9052.961.03
2327088-32708851.88152.13
3330440-33044052.41352.66
4336763-33676353.41553.67
5334953-33495353.12853.38
6332603-33260352.75653.01
45min1330933-33093352.49152.480.9052.8352.820.90
2327902-32790252.01052.34
3330093-33009352.35752.69
4327957-32795752.01952.37
5335598-33559853.23153.57
6332842-33284252.79453.13
60min1331219-33121952.53652.641.2152.9753.071.20
2327592-32759251.96152.38
3337506-33750653.53353.95
4327432-32743251.93552.37
5334864-33486453.11453.55
6332716-33271652.77453.20
极限1330701-33070152.45452.360.8252.9752.870.82
2327557-32755751.95552.46
3328992-32899252.18352.69
4327318-32731851.91752.44
5334264-33426453.01953.54
6331805-33180552.62953.14
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%
128.275007005004305002115003174999875003290.06
228.325027495022525025000.07
单位质量响应值RSD%判断
17698.2317743.640.19数据可信
加速3月-供试品溶液-2024032921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%
5min1190853-19085316.48017.7913.8716.4817.7913.87
2176217-17621715.21615.22
3176955-17695515.28015.28
4233921-23392120.19920.20
5217578-21757818.78718.79
6240769-24076920.79020.79
10min1388048-38804833.50733.695.6033.5333.725.60
2364710-36471031.49231.52
3373642-37364232.26332.29
4417207-41720736.02536.06
5415666-41566635.89235.92
6381552-38155232.94632.98
15min1519428-51942844.85243.012.7144.9343.102.69
2501894-50189443.33843.42
3502062-50206243.35243.43
4496966-49696642.91243.01
5488695-48869542.19842.29
6479829-47982941.43241.52
20min1574030-57403049.56647.003.0649.7247.163.05
2552222-55222247.68347.83
3542178-54217846.81646.97
4535244-53524446.21746.38
5532832-53283246.00946.17
6529406-52940645.71345.87
30min1574900-57490049.64149.651.0049.8849.891.00
2566288-56628848.89849.13
3571652-57165249.36149.59
4582472-58247250.29550.54
5579428-57942850.03250.27
6575447-57544749.68949.92
45min1572514-57251449.43549.451.0049.7649.760.99
2567144-56714448.97249.28
3570861-57086149.29349.60
4566927-56692748.95349.28
5581325-58132550.19650.52
6577049-57704949.82750.14
60min1573755-57375549.54349.661.2649.9550.061.25
2567473-56747349.00049.39
3585732-58573250.57750.97
4567143-56714348.97249.38
5579915-57991550.07450.48
6576580-57658049.78650.19
极限1572831-57283149.46349.370.8549.9549.850.85
2567171-56717148.97449.45
3569891-56989149.20949.69
4566530-56653048.91949.41
5579123-57912350.00650.49
6574921-57492149.64350.13
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