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%
128.605796375792505792335793995789935793020.05
228.645841865840855841360.02
单位质量响应值RSD%判断
20255.3120395.810.49数据可信
长期3月-供试品溶液-2024032421批-缬沙坦钠-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min174648-746485.9482.25108.485.952.25108.51
259802-598024.7654.77
35997-59970.4780.48
45655-56550.4510.45
510574-105740.8430.84
612916-129161.0291.03
10min1218482-21848217.40914.4020.9517.4214.4020.99
2232385-23238518.51718.53
3131689-13168910.49310.49
4172874-17287413.77513.78
5169982-16998213.54513.55
6158640-15864012.64112.64
15min1308823-30882324.60824.039.2724.6524.069.29
2351756-35175628.02928.07
3274114-27411421.84221.86
4297570-29757023.71223.74
5299465-29946523.86323.89
6277888-27788822.14322.17
20min1377868-37786830.11030.547.4430.1930.617.45
2436369-43636934.77234.86
3355572-35557228.33328.39
4389750-38975031.05731.12
5375274-37527429.90329.97
6364962-36496229.08229.14
30min1447246-44724635.63838.048.4535.7738.168.45
2538446-53844642.90543.05
3431050-43105034.34834.45
4507899-50789940.47140.59
5457795-45779536.47936.59
6481836-48183638.39538.50
45min1488249-48824938.90641.547.3939.1041.727.40
2576077-57607745.90446.12
3477434-47743438.04438.20
4554381-55438144.17544.36
5504664-50466440.21440.39
6527010-52701041.99442.17
60min1513849-51384940.94543.486.6941.2043.736.69
2597025-59702547.57347.86
3504253-50425340.18140.40
4577509-57750946.01846.27
5530180-53018042.24742.49
6551138-55113843.91744.16
极限1591737-59173747.15247.972.6747.4748.292.69
2628126-62812650.05250.42
3592948-59294847.24847.54
4615155-61515549.01849.35
5587528-58752846.81747.13
6596494-59649447.53147.85
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%
128.601005830100613110058661005933100529110058100.04
228.641011143101145210112980.03
单位质量响应值RSD%判断
35168.1835310.680.29数据可信
长期3月-供试品溶液-2024032421批-沙库巴曲-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1120064-1200645.2131.78118.255.211.78117.98
282269-822693.5723.57
36604-66040.2870.29
47488-74880.3250.33
511654-116540.5060.51
617236-172360.7480.75
10min1298764-29876412.97310.6521.6012.9810.6621.59
2318916-31891613.84813.85
3181151-1811517.8667.87
4234438-23443810.18010.18
5228164-2281649.9079.91
6210367-2103679.1359.14
15min1423808-42380818.40317.9810.1018.4318.0010.13
2489656-48965621.26221.29
3375158-37515816.29016.30
4405992-40599217.62917.65
5411742-41174217.87917.90
6377413-37741316.38816.40
20min1528858-52885822.96423.248.1123.0323.298.13
2616133-61613326.75426.82
3494456-49445621.47021.51
4544207-54420723.63123.68
5522254-52225422.67722.72
6505140-50514021.93421.98
30min1646709-64670928.08129.949.1528.1830.029.16
2789373-78937334.27634.39
3618674-61867426.86426.94
4735570-73557031.94032.03
5659286-65928628.62828.71
6686813-68681329.82329.90
45min1735352-73535231.93134.078.3732.0834.218.37
2881212-88121238.26438.43
3709706-70970630.81730.94
4841664-84166436.54736.69
5754135-75413532.74632.88
6785668-78566834.11534.25
60min1796780-79678034.59836.797.6234.8036.997.63
2940723-94072340.84841.08
3773704-77370433.59633.77
4904768-90476839.28739.49
5818506-81850635.54135.73
6849232-84923236.87537.06
极限1950553-95055341.27542.243.8741.5342.503.90
21032895-103289544.85045.15
3944168-94416840.99841.23
41004963-100496343.63843.90
5940560-94056040.84141.09
6963939-96393941.85642.10
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%
128.605783015798375783895783055778005785260.14
228.645818185818055818120.01
单位质量响应值RSD%判断
20228.1820314.660.31数据可信
长期3月-供试品溶液-2024032421批-缬沙坦钠-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17087-70870.5662.8872.580.572.8872.56
244366-443663.5453.54
370281-702815.6155.62
459715-597154.7714.77
510131-101310.8090.81
625060-250602.0022.00
10min1110084-1100848.79513.3318.428.8013.3418.43
2175720-17572014.03914.05
3200834-20083416.04616.06
4182418-18241814.57414.58
5169572-16957213.54813.55
6162779-16277913.00513.01
15min1237512-23751218.97623.019.9318.9923.049.94
2312745-31274524.98725.02
3303629-30362924.25924.29
4272632-27263221.78221.81
5308442-30844224.64324.67
6293012-29301223.41123.44
20min1367462-36746229.35930.147.4229.4130.207.41
2383277-38327730.62230.69
3380529-38052930.40330.48
4327219-32721926.14426.21
5399869-39986931.94832.01
6404712-40471232.33532.40
30min1455515-45551536.39436.519.3436.4936.629.31
2451312-45131236.05836.18
3455544-45554436.39636.52
4387302-38730230.94431.06
5520102-52010241.55441.67
6471990-47199037.71037.83
45min1498992-49899239.86839.729.0140.0239.898.99
2491427-49142739.26339.45
3495240-49524039.56839.76
4422500-42250033.75633.92
5561608-56160844.87045.06
6512838-51283840.97441.15
60min1539937-53993743.13942.118.7143.3642.358.68
2520983-52098341.62541.87
3536079-53607942.83143.08
4444145-44414535.48535.71
5584284-58428446.68246.94
6536595-53659542.87243.12
极限1591378-59137847.24947.742.0247.5448.052.05
2599468-59946847.89548.21
3602265-60226548.11948.44
4576567-57656746.06546.34
5610160-61016048.74949.09
6605255-60525548.35848.68
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.601003054100517310033961003477100290710036010.10
228.641009067100874310089050.03
单位质量响应值RSD%判断
35090.9435227.130.28数据可信
长期3月-供试品溶液-2024032421批-沙库巴曲-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18824-88240.3842.0373.750.382.0373.72
257861-578612.5182.52
390391-903913.9343.93
479608-796083.4653.46
513947-139470.6070.61
629414-294141.2801.28
10min1145352-1453526.3269.6618.256.339.6618.25
2236526-23652610.29410.30
3262546-26254611.42611.43
4241774-24177410.52210.53
5228757-2287579.9569.96
6216416-2164169.4199.42
15min1327007-32700714.23217.009.6614.2417.029.67
2423814-42381418.44518.47
3403572-40357217.56417.59
4366603-36660315.95515.98
5424729-42472918.48518.50
6397393-39739317.29517.31
20min1520851-52085122.66822.758.1422.7022.808.11
2524853-52485322.84222.89
3517707-51770722.53122.59
4446862-44686219.44819.50
5559687-55968724.35824.41
6566015-56601524.63424.68
30min1658008-65800828.63728.5010.4228.7128.5810.39
2641706-64170627.92828.02
3645468-64546828.09228.18
4545239-54523923.73023.81
5755757-75575732.89232.98
6682742-68274229.71429.80
45min1750222-75022232.65132.3510.2932.7732.4910.27
2730716-73071631.80231.94
3737560-73756032.10032.24
4618511-61851126.91827.04
5856791-85679137.28937.43
6766479-76647933.35833.50
60min1835354-83535436.35635.299.9936.5335.489.97
2800125-80012534.82335.01
3821588-82158835.75735.95
4668520-66852029.09529.26
5918369-91836939.96940.17
6821742-82174235.76335.96
极限1955706-95570641.59441.822.7041.8342.072.73
2960019-96001941.78142.03
3967470-96747042.10642.36
4915813-91581339.85740.07
5994631-99463143.28843.56
6971885-97188542.29842.55
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%
128.605789745790195794825796485798075793860.07
228.645818905821675820280.04
单位质量响应值RSD%判断
20258.2520322.210.23数据可信
长期3月-供试品溶液-2024032521批-缬沙坦钠-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133768-337682.6952.7265.082.702.7265.01
236082-360822.8802.88
358609-586094.6784.68
46232-62320.4970.50
511782-117820.9400.94
658308-583084.6544.65
10min1162528-16252812.97311.1534.5312.9811.1534.54
2104407-1044078.3348.34
3161363-16136312.88012.89
4118211-1182119.4369.44
579212-792126.3236.32
6212291-21229116.94516.95
15min1293752-29375223.44820.9818.7823.4721.0118.79
2199535-19953515.92715.95
3285963-28596322.82622.86
4270593-27059321.59921.62
5206209-20620916.46016.47
6321327-32132725.64925.68
20min1393481-39348131.40828.1615.3931.4728.2215.39
2270803-27080321.61621.66
3352309-35230928.12228.19
4408064-40806432.57232.62
5306063-30606324.43124.47
6386277-38627730.83330.91
30min1468851-46885137.42535.297.4737.5435.407.49
2425933-42593333.99934.08
3419320-41932033.47133.59
4486453-48645338.83038.94
5398915-39891531.84231.92
6453269-45326936.18136.31
45min1501697-50169740.04638.845.8640.2339.005.86
2497195-49719539.68739.82
3461659-46165936.85037.02
4521994-52199441.66741.84
5444168-44416835.45435.59
6492467-49246739.31039.50
60min1531394-53139442.41740.875.7342.6641.105.73
2524170-52417041.84042.04
3487935-48793538.94839.18
4541436-54143643.21843.46
5464883-46488337.10837.30
6522124-52212441.67741.93
极限1587300-58730046.87946.591.5447.2046.891.59
2575215-57521545.91546.19
3578231-57823146.15546.45
4595543-59554347.53747.85
5574332-57433245.84446.10
6591474-59147447.21347.54
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%
128.601004106100422510050021005423100543410048380.07
228.641010716101078910107520.01
单位质量响应值RSD%判断
35134.2035291.620.32数据可信
长期3月-供试品溶液-2024032521批-沙库巴曲-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141717-417171.8131.8763.971.811.8763.96
243191-431911.8771.88
373802-738023.2073.21
49173-91730.3990.40
516084-160840.6990.70
674076-740763.2193.22
10min1209168-2091689.0897.8236.349.097.8236.32
2130990-1309905.6925.70
3209059-2090599.0859.09
4151899-1518996.6016.60
598817-988174.2944.30
6279418-27941812.14212.15
15min1394603-39460317.14715.3220.2417.1715.3320.25
2260400-26040011.31611.33
3387619-38761916.84416.86
4365739-36573915.89315.90
5270221-27022111.74211.75
6436115-43611518.95118.98
20min1541831-54183123.54521.1116.5923.5921.1616.59
2365364-36536415.87715.91
3490524-49052421.31621.36
4569200-56920024.73424.77
5412635-41263517.93117.96
6535772-53577223.28223.34
30min1673189-67318929.25327.558.5029.3427.638.52
2602604-60260426.18626.24
3606133-60613326.33926.42
4707548-70754830.74630.83
5560632-56063224.36224.42
6654065-65406528.42228.52
45min1750238-75023832.60131.566.6532.7431.696.66
2734352-73435231.91132.01
3691618-69161830.05430.18
4790828-79082834.36534.50
5652217-65221728.34228.44
6738887-73888732.10832.25
60min1802648-80264834.87934.026.4635.0734.206.47
2799740-79974034.75334.91
3747160-74716032.46832.65
4842247-84224736.60036.79
5700438-70043830.43730.58
6804759-80475934.97135.17
极限1914071-91407139.72140.472.1739.9740.702.20
2921366-92136640.03840.25
3929665-92966540.39840.63
4964451-96445141.91042.16
5912751-91275139.66339.86
6945149-94514941.07141.33
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.605869475871535871145869575863735869090.06
228.645829545829135829340.01
单位质量响应值RSD%判断
20521.2920353.840.58数据可信
长期3月-供试品溶液-2024032521批-缬沙坦钠-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111773-117730.9333.9966.420.933.9966.48
271463-714635.6635.66
35848-58480.4630.46
487299-872996.9186.92
563987-639875.0715.07
662029-620294.9164.92
10min1171019-17101913.55315.3515.9513.5515.3615.96
2201577-20157715.97415.98
3142016-14201611.25411.26
4220483-22048317.47317.48
5215665-21566517.09117.10
6211747-21174716.78016.79
15min1312699-31269924.78124.506.6024.8024.536.62
2311301-31130124.67024.71
3269819-26981921.38221.40
4325867-32586725.82425.86
5324311-32431125.70125.74
6310756-31075624.62724.66
20min1419550-41955033.24831.995.2433.3132.065.24
2413866-41386632.79832.88
3372417-37241729.51329.57
4426097-42609733.76733.85
5406057-40605732.17932.26
6383984-38398430.43030.51
30min1483314-48331438.30138.353.9038.4238.473.90
2519188-51918841.14441.28
3480035-48003538.04238.15
4485181-48518138.44938.59
5468248-46824837.10837.24
6467356-46735637.03737.16
45min1524365-52436541.55541.713.4641.7441.903.45
2554658-55465843.95544.16
3538965-53896542.71242.88
4523536-52353641.48941.69
5505217-50521740.03740.23
6511104-51110440.50440.69
60min1549397-54939743.53843.583.2043.7943.843.18
2575299-57529945.59145.86
3565226-56522644.79345.03
4546143-54614343.28043.55
5532258-53225842.18042.44
6531572-53157242.12642.38
极限1609958-60995848.33847.611.1548.6647.941.14
2607780-60778048.16548.51
3601001-60100147.62847.94
4593007-59300746.99447.34
5598697-59869747.44547.78
6594448-59444847.10947.44
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%
128.601016074101582810164461016298101617710161650.03
228.641010989101100010109940.01
单位质量响应值RSD%判断
35530.2435300.070.46数据可信
长期3月-供试品溶液-2024032521批-沙库巴曲-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min119857-198570.8582.8363.150.862.8363.06
293025-930254.0194.02
38700-87000.3760.38
4110498-1104984.7744.77
582549-825493.5673.57
678079-780793.3743.37
10min1222833-2228339.62811.0116.479.6311.0116.49
2265658-26565811.47811.48
3185231-1852318.0038.00
4289193-28919312.49512.50
5287626-28762612.42712.43
6278576-27857612.03612.04
15min1424420-42442018.33818.117.1218.3618.137.12
2421869-42186918.22818.25
3361787-36178715.63215.65
4439312-43931218.98119.01
5445658-44565819.25619.28
6421389-42138918.20718.23
20min1585488-58548825.29724.305.6025.3524.355.61
2578298-57829824.98625.04
3513354-51335422.18022.22
4592211-59221125.58825.65
5570609-57060924.65424.71
6534139-53413923.07923.13
30min1704570-70457030.44230.404.1230.5330.504.11
2758072-75807232.75432.85
3689776-68977629.80329.88
4706938-70693830.54530.65
5685954-68595429.63829.74
6676776-67677629.24129.34
45min1792457-79245734.24034.493.4734.3834.643.45
2844298-84429836.48036.63
3814342-81434235.18535.31
4795154-79515434.35634.51
5770234-77023433.27933.43
6773502-77350233.42133.56
60min1858024-85802437.07337.143.3737.2737.343.35
2900616-90061638.91339.13
3884071-88407138.19838.38
4856689-85668937.01537.23
5829393-82939335.83636.04
6828475-82847535.79635.99
极限1989911-98991142.77142.141.3243.0342.401.31
2992014-99201442.86243.14
3972936-97293642.03842.29
4963823-96382341.64441.92
5970711-97071141.94142.21
6962390-96239041.58241.84
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%
128.605772355773545778145782125776125776450.07
228.645810095810855810470.01
单位质量响应值RSD%判断
20197.3820287.950.32数据可信
长期3月-供试品溶液-2024032621批-缬沙坦钠-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min149682-496823.9754.8351.613.984.8351.54
254700-547004.3774.38
392495-924957.4007.40
48703-87030.6960.70
564703-647035.1775.18
691635-916357.3327.33
10min1201550-20155016.12616.6915.7916.1316.7015.81
2214899-21489917.19417.20
3223104-22310417.85017.86
4145955-14595511.67811.68
5233695-23369518.69818.71
6232420-23242018.59618.61
15min1319805-31980525.58726.4010.2425.6226.4410.25
2359154-35915428.73628.77
3336743-33674326.94326.98
4267703-26770321.41921.44
5339303-33930327.14827.19
6357105-35710528.57228.62
20min1378237-37823730.26332.609.7430.3432.689.74
2432967-43296734.64234.73
3398912-39891231.91732.00
4347576-34757627.80927.87
5436374-43637434.91435.00
6450577-45057736.05036.14
30min1435821-43582134.87038.279.7535.0038.409.75
2480344-48034438.43238.57
3452596-45259636.21236.35
4432487-43248734.60334.71
5537719-53771943.02343.17
6530784-53078442.46842.62
45min1474283-47428337.94741.378.6338.1341.568.64
2516424-51642441.31941.52
3492655-49265539.41739.62
4476995-47699538.16438.32
5578149-57814946.25746.47
6563799-56379945.10945.33
60min1498813-49881339.91043.348.0140.1643.608.01
2540832-54083243.27243.55
3516244-51624441.30441.57
4505890-50589040.47640.70
5602914-60291448.23948.53
6585051-58505146.81047.11
极限1598118-59811847.85548.672.2048.1749.012.24
2601987-60198748.16548.51
3600555-60055548.05048.39
4598945-59894547.92148.21
5629241-62924150.34550.72
6621035-62103549.68950.06
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%
128.601001565100152810028531002885100229710022260.07
228.641008295100813710082160.02
单位质量响应值RSD%判断
35042.8735203.070.33数据可信
长期3月-供试品溶液-2024032621批-沙库巴曲-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min164695-646952.8193.4552.172.823.4552.14
269461-694613.0263.03
3122257-1222575.3265.33
411648-116480.5070.51
585671-856713.7323.73
6121131-1211315.2775.28
10min1265451-26545111.56511.9516.4511.5711.9616.47
2278763-27876312.14512.15
3292698-29269812.75212.76
4189341-1893418.2498.25
5310423-31042313.52413.53
6309129-30912913.46813.48
15min1433846-43384618.90119.4910.8918.9219.5210.91
2486354-48635421.18921.21
3456316-45631619.88019.91
4357352-35735215.56815.58
5460664-46066420.06920.10
6489761-48976121.33721.37
20min1524574-52457422.85424.7110.5522.9124.7710.56
2604351-60435126.32926.39
3556181-55618124.23124.29
4475777-47577720.72820.77
5607915-60791526.48426.55
6634742-63474227.65327.72
30min1628235-62823527.37030.1210.4727.4630.2210.47
2695046-69504630.28030.38
3652369-65236928.42128.52
4616789-61678926.87126.95
5780601-78060134.00834.11
6775768-77576833.79733.91
45min1713183-71318331.07133.919.3031.2134.069.30
2775240-77524033.77433.93
3736012-73601232.06532.22
4712437-71243731.03831.16
5877882-87788238.24638.41
6854959-85495937.24737.42
60min1775795-77579533.79836.618.6233.9936.828.62
2832937-83293736.28836.50
3794246-79424634.60234.81
4780947-78094734.02334.19
5946001-94600141.21441.44
6912096-91209639.73639.97
极限1964590-96459042.02342.863.2042.2743.123.24
2969113-96911342.22042.49
3961279-96127941.87942.14
4960343-96034341.83842.07
51031885-103188544.95545.25
61015373-101537344.23644.53
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%
128.605801305802475802495805895804945803420.04
228.645890065889265889660.01
单位质量响应值RSD%判断
20291.6820564.460.95数据可信
长期3月-供试品溶液-2024032621批-缬沙坦钠-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min158886-588864.6692.4076.464.672.4076.53
210247-102470.8120.81
356641-566414.4914.49
432963-329632.6142.61
57604-76040.6030.60
614990-149901.1891.19
10min1188744-18874414.96512.1135.9214.9712.1235.92
2136396-13639610.81410.82
3233832-23383218.54018.55
4167327-16732713.26713.27
589997-899977.1367.14
6100233-1002337.9477.95
15min1294548-29454823.35422.0311.4323.3922.0511.47
2261995-26199520.77320.79
3323791-32379125.67225.71
4295092-29509223.39723.42
5241876-24187619.17819.19
6249453-24945319.77819.79
20min1378564-37856430.01529.276.6630.0929.336.68
2363323-36332328.80728.86
3380499-38049930.16830.25
4406539-40653932.23332.30
5344490-34449027.31327.36
6341567-34156727.08227.13
30min1466669-46666937.00135.455.4237.1235.565.42
2436735-43673534.62734.73
3437377-43737734.67834.81
4482506-48250638.25638.38
5445583-44558335.32935.42
6414101-41410132.83332.93
45min1506630-50663040.16939.035.1040.3539.205.10
2481301-48130138.16138.32
3485428-48542838.48838.68
4528627-52862741.91342.10
5496865-49686539.39539.54
6454531-45453136.03836.19
60min1529989-52998942.02141.583.5242.2741.813.53
2515727-51572740.89041.11
3519341-51934141.17741.43
4553254-55325443.86644.12
5530066-53006642.02742.24
6497930-49793039.47939.69
极限1596853-59685347.32247.461.2947.6447.761.29
2600902-60090247.64347.93
3601655-60165547.70348.03
4596380-59638047.28547.61
5609436-60943648.32048.61
6586178-58617846.47646.75
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%
128.601006545100653510064521007272100723910068090.05
228.641025085102513310251090.01
单位质量响应值RSD%判断
35203.1135792.911.18数据可信
长期3月-供试品溶液-2024032621批-沙库巴曲-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min181368-813683.5081.7871.293.511.7971.15
216375-163750.7060.71
372555-725553.1283.13
442958-429581.8521.85
514501-145010.6250.63
620607-206070.8880.89
10min1245761-24576110.5948.5837.5410.608.5937.53
2176243-1762437.5987.60
3313156-31315613.50013.50
4215567-2155679.2939.30
5116823-1168235.0365.04
6127135-1271355.4815.48
15min1392213-39221316.90816.0812.8016.9316.1012.84
2348140-34814015.00815.02
3446885-44688519.26519.29
4397307-39730717.12717.15
5321163-32116313.84513.85
6332145-33214514.31814.33
20min1516406-51640622.26221.947.5422.3121.987.56
2493914-49391421.29221.33
3537757-53775723.18223.24
4565698-56569824.38624.43
5471999-47199920.34720.38
6468260-46826020.18620.22
30min1665953-66595328.70827.725.8528.8027.805.86
2618144-61814426.64726.72
3640884-64088427.62827.73
4701763-70176330.25230.34
5637845-63784527.49727.56
6593759-59375925.59625.66
45min1755790-75579032.58131.745.7332.7231.865.74
2710990-71099030.65030.77
3736593-73659331.75331.90
4800177-80017734.49534.63
5738767-73876731.84731.96
6674860-67486029.09229.20
60min1814906-81490635.12934.774.4535.3234.944.46
2785422-78542233.85834.03
3810899-81089934.95735.15
4862286-86228637.17237.37
5811140-81114034.96735.13
6754125-75412532.50932.67
极限1961730-96173041.45941.551.5741.7141.791.58
2963708-96370841.54441.77
3975095-97509542.03542.29
4966349-96634941.65841.92
5979752-97975242.23642.46
6936521-93652140.37240.59
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