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%
128.032872092861572862322861042862822863970.17
227.972874062871042872550.08
单位质量响应值RSD%判断
10217.5210270.110.37数据可信
加速6月-供试品溶液-SDR926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%
5min1102869-10286916.26415.217.8416.2615.217.83
292545-9254514.63214.63
3101796-10179616.09516.09
494764-9476414.98314.98
5101775-10177516.09116.09
683469-8346913.19713.20
10min1216571-21657134.24132.125.8034.2732.145.80
2193479-19347930.59030.61
3208971-20897133.04033.07
4206734-20673432.68632.71
5208422-20842232.95332.98
6184591-18459129.18529.21
15min1250919-25091939.67240.707.9439.7640.787.93
2232619-23261936.77936.85
3289737-28973745.80945.89
4273034-27303443.16843.25
5249009-24900939.37039.45
6249093-24909339.38339.45
20min1276997-27699743.79544.668.5243.9544.818.51
2262327-26232741.47641.61
3322511-32251150.99151.15
4300461-30046147.50547.66
5265226-26522641.93442.08
6267270-26727042.25742.39
30min1306156-30615648.40549.183.6848.6349.403.68
2301379-30137947.65047.86
3325201-32520151.41651.66
4325504-32550451.46451.69
5300249-30024947.47147.69
6307889-30788948.67948.89
45min1320567-32056750.68450.442.0750.9950.752.09
2312444-31244449.39949.68
3326764-32676451.66351.99
4326574-32657451.63351.95
5315179-31517949.83250.13
6312804-31280449.45649.74
60min1329606-32960652.11350.942.0452.5051.322.05
2317855-31785550.25550.62
3327424-32742451.76852.18
4326521-32652151.62552.03
5318357-31835750.33450.71
6313292-31329249.53349.90
极限1325854-32585451.52051.111.6051.9951.581.61
2324197-32419751.25851.71
3327749-32774951.81952.32
4326459-32645951.61552.10
5321458-32145850.82551.29
6313682-31368249.59550.05
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.034948704937204934074934244940134938870.13
227.974956924951664954290.08
单位质量响应值RSD%判断
17619.9417712.870.38数据可信
加速6月-供试品溶液-SDR926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%
5min1171747-17174714.87613.888.1414.8813.888.14
2153914-15391413.33113.33
3169539-16953914.68514.68
4157884-15788413.67513.68
5170155-17015514.73814.74
6138200-13820011.97011.97
10min1366971-36697131.78529.785.9331.8129.805.93
2327457-32745728.36328.38
3354148-35414830.67430.70
4350143-35014330.32830.35
5352454-35245430.52830.55
6311463-31146326.97727.00
15min1426093-42609336.90637.878.3136.9837.948.30
2392777-39277734.02034.09
3494290-49429042.81342.89
4465493-46549340.31940.39
5421909-42190936.54436.62
6422764-42276436.61836.68
20min1472467-47246740.92341.709.1141.0641.839.10
2443467-44346738.41138.54
3554273-55427348.00848.16
4513862-51386244.50844.65
5449862-44986238.96539.10
6454459-45445939.36339.49
30min1521452-52145245.16646.144.1045.3746.344.10
2515019-51501944.60844.80
3559228-55922848.43748.66
4560479-56047948.54648.76
5511743-51174344.32544.53
6528042-52804245.73645.93
45min1549378-54937847.58447.432.1947.8747.712.21
2534437-53443746.29046.55
3561677-56167748.65048.96
4561611-56161148.64448.94
5539643-53964346.74147.02
6538693-53869346.65946.93
60min1565129-56512948.94947.902.1449.3148.262.15
2542510-54251046.98947.33
3562463-56246348.71849.11
4563069-56306948.77049.15
5545505-54550547.24947.60
6539169-53916946.70047.05
极限1560931-56093148.58548.261.5549.0348.701.56
2559209-55920948.43648.86
3564701-56470148.91249.38
4562749-56274948.74249.20
5554118-55411847.99548.43
6541204-54120446.87647.30
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%
128.032863942861132867932869012865752865550.12
227.972905852905692905770.01
单位质量响应值RSD%判断
10223.1510388.881.14数据可信
长期6月-供试品溶液-SDR926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%
5min194609-9460914.86914.7715.0914.8714.7715.08
293727-9372714.73014.73
3121104-12110419.03319.03
484464-8446413.27413.27
587740-8774013.78913.79
682183-8218312.91612.92
10min1201647-20164731.69130.4211.0831.7230.4411.09
2198201-19820131.14931.17
3229086-22908636.00336.04
4181575-18157528.53728.56
5183833-18383328.89128.91
6166918-16691826.23326.25
15min1251889-25188939.58741.797.2739.6641.877.28
2274775-27477543.18443.26
3301518-30151847.38747.48
4258939-25893940.69540.76
5254500-25450039.99740.07
6253909-25390939.90539.97
20min1286466-28646645.02147.484.7245.1647.634.73
2316439-31643949.73249.88
3315851-31585149.63949.81
4290103-29010345.59345.73
5312741-31274149.15149.29
6291241-29124145.77245.90
30min1324670-32467051.02550.921.2851.2451.151.25
2326939-32693951.38251.61
3316338-31633849.71649.97
4328221-32822151.58451.80
5323690-32369050.87151.09
6324261-32426150.96151.17
45min1326246-32624651.27351.101.4851.5851.411.45
2326411-32641151.29951.62
3316087-31608749.67750.01
4330281-33028151.90752.21
5324863-32486351.05651.36
6326910-32691051.37851.67
60min1325566-32556651.16651.061.4651.5651.461.42
2326008-32600851.23651.64
3315703-31570349.61650.04
4329269-32926951.74852.13
5325453-32545351.14951.54
6327494-32749451.46951.85
极限1325123-32512351.09750.971.4551.5751.451.41
2325332-32533251.13051.62
3315504-31550449.58550.09
4328455-32845551.62052.09
5323565-32356550.85251.33
6327927-32792751.53752.00
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%
128.034944104940504950434954884939974945980.14
227.975003295005385004340.03
单位质量响应值RSD%判断
17645.3117891.810.99数据可信
长期6月-供试品溶液-SDR926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%
5min1158246-15824613.62813.5016.2513.6313.5116.26
2155840-15584013.42113.42
3205596-20559617.70617.71
4139136-13913611.98211.98
5146140-14614012.58612.59
6135941-13594111.70711.71
10min1341551-34155129.41528.1711.8129.4428.1911.81
2335610-33561028.90328.93
3391277-39127733.69733.73
4305149-30514926.28026.30
5309098-30909826.62026.64
6279736-27973624.09124.11
15min1427726-42772636.83639.017.7236.9139.087.72
2468230-46823040.32440.39
3517694-51769444.58444.67
4440367-44036737.92537.99
5433012-43301237.29137.36
6430924-43092437.11137.17
20min1488611-48861142.07944.615.2042.2144.745.21
2545367-54536746.96747.11
3543928-54392846.84347.00
4495422-49542242.66642.79
5537513-53751346.29146.42
6496826-49682642.78742.91
30min1558871-55887148.13048.031.3148.3348.241.28
2564476-56447648.61348.83
3544348-54434846.88047.12
4564029-56402948.57448.77
5557731-55773148.03248.24
6557121-55712147.98048.17
45min1562304-56230448.42648.241.4248.7148.531.39
2562705-56270548.46048.76
3545466-54546646.97647.29
4569356-56935649.03349.31
5559054-55905448.14648.43
6561953-56195348.39648.67
60min1560998-56099848.31348.191.4748.6848.561.44
2562457-56245748.43948.82
3543958-54395846.84647.24
4567780-56778048.89749.26
5559179-55917948.15748.52
6563312-56331248.51348.87
极限1560217-56021748.24648.191.5048.6948.641.46
2561654-56165448.37048.83
3544045-54404546.85347.33
4567426-56742648.86749.31
5557892-55789248.04648.49
6565882-56588248.73449.17
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%
128.035757445743235751775750385734165747400.16
227.975792365783135787740.12
单位质量响应值RSD%判断
20504.4620692.670.65数据可信
加速6月-供试品溶液-TAWW4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%
5min1175004-17500413.76015.166.5513.7615.166.56
2207175-20717516.29016.29
3179594-17959414.12114.12
4196205-19620515.42715.43
5199335-19933515.67315.67
6199509-19950915.68715.69
10min1353343-35334327.78330.975.6227.8130.995.61
2415829-41582932.69632.72
3385497-38549730.31130.33
4400305-40030531.47531.50
5404271-40427131.78731.81
6403912-40391231.75931.79
15min1472368-47236837.14242.406.3437.2142.486.34
2564956-56495644.42244.50
3543917-54391742.76742.84
4538811-53881142.36642.44
5556762-55676243.77743.86
6558806-55880643.93844.02
20min1584467-58446745.95648.823.1746.0948.963.17
2621477-62147748.86649.02
3634733-63473349.90850.05
4640420-64042050.35550.50
5618018-61801848.59448.75
6626114-62611449.23049.38
30min1644140-64414050.64850.022.1050.8650.262.08
2626858-62685849.28949.53
3642763-64276350.53950.77
4655022-65502251.50351.74
5618956-61895648.66848.90
6629586-62958649.50349.74
45min1644081-64408150.64349.852.2950.9450.162.27
2619543-61954348.71449.03
3641025-64102550.40350.72
4653596-65359651.39151.71
5617783-61778348.57548.89
6627812-62781249.36449.68
60min1630902-63090249.60749.582.2149.9849.972.19
2618109-61810948.60149.00
3638476-63847650.20250.60
4653515-65351551.38551.79
5616621-61662148.48448.88
6625659-62565949.19549.59
极限1634112-63411249.85949.532.1950.3250.012.18
2616553-61655348.47948.96
3637805-63780550.15050.63
4650774-65077451.16951.66
5614431-61443148.31248.79
6626001-62600149.22249.70
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%
128.039923719904629895569924869887209907190.17
227.979937799947259942520.07
单位质量响应值RSD%判断
35344.9535547.090.41数据可信
加速6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%
5min1295995-29599512.77814.197.0312.7814.197.03
2354312-35431215.29515.30
3304173-30417313.13113.13
4336136-33613614.51114.51
5340394-34039414.69514.69
6340731-34073114.70914.71
10min1604059-60405926.07729.175.7226.1029.205.72
2713561-71356130.80430.83
3663414-66341428.63928.66
4687683-68768329.68729.71
5693741-69374129.94829.97
6692304-69230429.88629.91
15min1810303-81030334.98040.056.4835.0440.126.48
2973248-97324842.01442.09
3937213-93721340.45940.53
4926146-92614639.98140.05
5958145-95814541.36241.44
6961553-96155341.50941.58
20min11001965-100196543.25446.103.3143.3846.243.32
21068681-106868146.13446.28
31091562-109156247.12247.26
41102544-110254447.59647.74
51064015-106401545.93346.08
61079035-107903546.58146.72
30min11106397-110639747.76247.252.1747.9647.472.16
21079139-107913946.58646.81
31106520-110652047.76847.98
41129552-112955248.76248.98
51064395-106439545.94946.17
61081798-108179846.70046.92
45min11109736-110973647.90647.152.3248.1847.442.30
21067152-106715246.06846.37
31105767-110576747.73548.03
41125861-112586148.60348.90
51063387-106338745.90646.20
61081409-108140946.68446.98
60min11086585-108658546.90746.872.1347.2647.242.12
21065391-106539145.99246.37
31100560-110056047.51047.89
41123238-112323848.48948.87
51062577-106257745.87146.24
61076350-107635046.46546.84
极限11093379-109337947.20046.862.2247.6347.312.20
21062950-106295045.88746.34
31098566-109856647.42447.88
41122113-112211348.44148.90
51058206-105820645.68246.13
61077670-107767046.52246.98
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%
128.035786455766875768105768085759665769830.18
227.975745305738455741880.09
单位质量响应值RSD%判断
20584.4820528.710.20数据可信
长期6月-供试品溶液-TAWW4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%
5min1164771-16477112.98213.0510.1912.9813.0510.20
2183087-18308714.42514.42
3153242-15324212.07412.07
4139422-13942210.98510.98
5172906-17290613.62313.62
6180618-18061814.23014.23
10min1377266-37726629.72428.156.9729.7528.176.97
2394385-39438531.07331.10
3331234-33123426.09726.12
4348012-34801227.41927.44
5333814-33381426.30026.32
6359014-35901428.28628.31
15min1533103-53310342.00240.394.0142.0740.464.01
2529555-52955541.72241.80
3492624-49262438.81338.88
4515594-51559440.62240.69
5482667-48266738.02838.09
6522462-52246241.16341.23
20min1605785-60578547.72847.433.8247.8747.573.81
2609477-60947748.01948.16
3604129-60412947.59847.73
4631928-63192849.78849.92
5561302-56130244.22444.35
6599480-59948047.23247.37
30min1643120-64312050.67050.362.2550.8950.572.24
2613918-61391848.36948.59
3632051-63205149.79850.01
4654726-65472651.58451.80
5647395-64739551.00751.21
6643534-64353450.70250.92
45min1641641-64164150.55350.442.2950.8650.732.27
2615336-61533648.48148.79
3631603-63160349.76250.05
4653935-65393551.52251.82
5652560-65256051.41451.70
6645767-64576750.87851.18
60min1640498-64049850.46350.342.4650.8550.732.44
2611498-61149848.17848.57
3630778-63077849.69750.07
4652330-65233051.39551.78
5651668-65166851.34351.72
6647060-64706050.98051.37
极限1638878-63887850.33650.212.2650.8150.682.24
2612437-61243748.25248.72
3629510-62951049.59850.05
4649379-64937951.16351.64
5650379-65037951.24251.70
6643216-64321650.67751.15
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%
128.039939189933479929019932729919199930710.08
227.979923299906169914720.13
单位质量响应值RSD%判断
35428.8635447.690.04数据可信
长期6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%
5min1278944-27894412.04412.1210.4512.0412.1210.46
2309394-30939413.35913.36
3259400-25940011.20011.20
4234923-23492310.14410.14
5294021-29402112.69512.70
6307985-30798513.29813.30
10min1645965-64596527.89226.427.1127.9126.447.11
2676950-67695029.23029.25
3566303-56630324.45224.47
4596255-59625525.74525.76
5570365-57036524.62724.65
6615616-61561626.58126.60
15min1917129-91712939.60038.074.0939.6738.144.09
2911221-91122139.34539.42
3846778-84677836.56236.62
4887022-88702238.30038.36
5828855-82885535.78935.85
6899174-89917438.82538.89
20min11043517-104351745.05744.733.9845.1944.863.98
21049341-104934145.30945.45
31039149-103914944.86944.99
41088776-108877647.01147.14
5962293-96229341.55041.67
61032517-103251744.58244.71
30min11106414-110641447.77347.512.3147.9847.712.29
21056714-105671445.62745.84
31088594-108859447.00447.20
41130786-113078648.82549.03
51113451-111345148.07748.27
61105677-110567747.74147.95
45min11105286-110528647.72447.602.3048.0147.882.28
21058877-105887745.72046.01
31089005-108900547.02147.29
41126567-112656748.64348.93
51123935-112393548.53048.80
61111136-111113647.97748.26
60min11104171-110417147.67647.542.4148.0447.902.40
21054930-105493045.55045.91
31086656-108665646.92047.27
41125287-112528748.58848.95
51121995-112199548.44648.80
61112835-111283548.05048.42
极限11101912-110191247.57947.392.3248.0247.832.30
21053100-105310045.47145.91
31083985-108398546.80547.23
41118591-111859148.29948.74
51120049-112004948.36248.79
61107858-110785847.83548.28
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%
128.031162788116049411617071161478115959411612120.11
227.971147415114740311474090.01
单位质量响应值RSD%判断
41427.4741022.850.70数据可信
加速6月-供试品溶液-TYN28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%
5min1272552-27255210.70811.1622.0710.7111.1622.06
2340280-34028013.36913.37
3347124-34712413.63813.64
4219043-2190438.6068.61
5202619-2026197.9607.96
6323050-32305012.69212.69
10min1657170-65717025.81925.1014.4725.8425.1214.49
2671461-67146126.38026.40
3755816-75581629.69429.72
4536038-53603821.06021.07
5519796-51979620.42220.43
6692494-69249427.20627.23
15min1907259-90725935.64435.209.9435.7035.269.96
2925911-92591136.37736.44
3990974-99097438.93339.01
4808168-80816831.75131.80
5769872-76987230.24630.29
6973094-97309438.23138.30
20min11129026-112902644.35741.718.9844.4841.838.99
21094334-109433442.99443.12
31074942-107494242.23242.37
4975028-97502838.30738.41
5922234-92223436.23236.33
61174201-117420146.13246.26
30min11284768-128476850.47547.447.8350.6747.637.83
21292929-129292950.79650.99
31201383-120138347.19947.41
41120001-112000144.00244.17
51069781-106978142.02942.19
61275935-127593550.12850.34
45min11284040-128404050.44749.383.0950.7349.653.13
21294145-129414550.84451.13
31271799-127179949.96650.25
41201453-120145347.20247.44
51214995-121499547.73447.96
61275402-127540250.10850.40
60min11282257-128225750.37749.831.4150.7450.181.45
21289989-128998950.68151.05
31273345-127334550.02750.40
41248141-124814149.03749.35
51246266-124626648.96349.27
61269291-126929149.86750.24
极限11279052-127905250.25150.150.9350.7050.590.94
21289349-128934950.65551.11
31275582-127558250.11550.57
41288928-128892850.63951.04
51259914-125991449.49949.89
61266504-126650449.75850.22
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%
128.032003231199654319996211998159199614719987400.15
227.971979390198193019806600.10
单位质量响应值RSD%判断
71307.1770813.730.50数据可信
加速6月-供试品溶液-TYN28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%
5min1463818-4638189.98810.4123.039.9910.4123.06
2583078-58307812.55612.56
3594872-59487212.81012.81
4368000-3680007.9247.92
5338309-3383097.2857.28
6553310-55331011.91511.91
10min11127564-112756424.28023.5414.7724.3023.5614.78
21148483-114848324.73124.75
31296010-129601027.90827.93
4912920-91292019.65819.67
5885461-88546119.06719.08
61189107-118910725.60625.63
15min11558254-155825433.55533.1010.2233.6133.1610.23
21589939-158993934.23734.30
31702680-170268036.66536.73
41378825-137882529.69129.74
51317526-131752628.37128.41
61675808-167580836.08636.15
20min11941196-194119641.80139.229.1641.9139.349.16
21881592-188159240.51740.64
31840050-184005039.62339.75
41668392-166839235.92636.02
51579714-157971434.01734.11
62018271-201827143.46043.58
30min12210535-221053547.60144.648.0747.7844.828.08
22226498-222649847.94448.13
32061511-206151144.39244.59
41916764-191676441.27541.43
51830773-183077339.42339.57
62191916-219191647.20047.39
45min12210824-221082447.60746.513.2747.8746.763.30
22226086-222608647.93548.20
32184487-218448747.04047.31
42057080-205708044.29644.52
52085898-208589844.91745.13
62193997-219399747.24447.52
60min12206682-220668247.51846.961.5247.8647.291.57
22219234-221923447.78848.13
32190506-219050647.16947.52
42141455-214145546.11346.41
52139914-213991446.08046.37
62186317-218631747.07947.43
极限12208185-220818547.55047.350.9347.9747.760.94
22220594-222059447.81748.24
32194981-219498147.26647.69
42217535-221753547.75148.13
52169307-216930746.71347.08
62182807-218280747.00447.43
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%
128.031145422114497811457851143786114470311449350.07
227.971166551116384211651960.17
单位质量响应值RSD%判断
40846.7741658.781.40数据可信
长期6月-供试品溶液-TYN28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%
5min1406029-40602915.94211.7824.7315.9411.7824.73
2184608-1846087.2487.25
3286245-28624511.23911.24
4318858-31885812.52012.52
5267719-26771910.51210.51
6337332-33733213.24513.25
10min1715633-71563328.09924.7911.8828.1324.8111.89
2500953-50095319.67019.68
3592174-59217423.25123.27
4661484-66148425.97325.99
5662795-66279526.02426.04
6655174-65517425.72525.75
15min1901084-90108435.38033.507.0835.4533.567.10
2759968-75996829.84029.88
3820718-82071832.22532.28
4886454-88645434.80634.87
5829891-82989132.58532.65
6920456-92045636.14136.21
20min11074589-107458942.19341.605.3042.3341.725.31
2976069-97606938.32538.42
31014927-101492739.85039.96
41101831-110183143.26343.38
51060877-106087741.65441.77
61128712-112871244.31844.44
30min11173970-117397046.09547.973.5346.3048.163.50
21249829-124982949.07449.23
31234126-123412648.45748.63
41282102-128210250.34150.53
51172721-117272146.04646.23
61217738-121773847.81448.01
45min11279839-127983950.25249.482.3050.5349.752.29
21253409-125340949.21449.45
31286726-128672650.52250.78
41286654-128665450.51950.80
51237032-123703248.57148.83
61217671-121767147.81148.09
60min11295277-129527750.85849.692.3951.2250.042.37
21250760-125076049.11049.43
31287744-128774450.56250.90
41283661-128366150.40250.76
51261010-126101049.51349.85
61214562-121456247.68948.05
极限11296973-129697350.92549.692.3951.3750.122.38
21249640-124964049.06649.47
31284636-128463650.44050.87
41283352-128335250.39050.84
51264989-126498949.66950.09
61214128-121412847.67248.11
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%
128.031973952197019919734781971047197133119720010.09
227.972008660200720520079320.06
单位质量响应值RSD%判断
70353.2371788.771.43数据可信
长期6月-供试品溶液-TYN28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%
5min1696863-69686315.00511.0225.4815.0111.0225.48
2308631-3086316.6466.65
3487892-48789210.50510.51
4547245-54724511.78311.78
5453369-4533699.7629.76
6577131-57713112.42712.43
10min11226101-122610126.40123.2912.0426.4323.3112.05
2854547-85454718.40018.41
31014143-101414321.83721.85
41133609-113360924.40924.43
51139567-113956724.53724.55
61122361-112236124.16724.19
15min11543590-154359033.23731.497.0833.3131.557.09
21302966-130296628.05628.10
31406577-140657730.28730.34
41520115-152011532.73232.79
51423164-142316430.64430.70
61578535-157853533.98934.05
20min11842233-184223339.66739.215.4139.7939.325.42
21676232-167623236.09336.18
31744409-174440937.56137.67
41893378-189337840.76940.88
51822011-182201139.23239.34
61947290-194729041.93042.05
30min12014508-201450843.37745.243.6543.5745.423.62
22152235-215223546.34246.49
32121046-212104645.67145.84
42206644-220664447.51447.70
52013333-201333343.35243.53
62099015-209901545.19745.38
45min12202126-220212647.41746.692.3647.6846.942.35
22157228-215722846.45046.68
32217313-221731347.74447.99
42214021-221402147.67347.93
52125969-212596945.77746.02
62094388-209438845.09745.36
60min12230846-223084648.03546.902.3848.3847.232.37
22152219-215221946.34246.65
32217198-221719847.74148.06
42207788-220778847.53947.88
52169286-216928646.71047.03
62091749-209174945.04045.38
极限12232223-223222348.06546.962.4448.4947.362.43
22150224-215022446.29946.68
32215894-221589447.71348.12
42212939-221293947.65048.07
52182933-218293347.00347.40
62090172-209017245.00645.42
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