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%
1 28.131153620115536611514501153785114967211527790.20
2 28.051152858115226611525620.04
单位质量响应值RSD%判断
40980.4141089.550.19数据可信
长期24月-供试品溶液-2024032121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%
5min1195180-1951807.70411.1832.187.7011.1832.20
2419019-41901916.53816.54
3247738-2477389.7789.78
4237232-2372329.3639.36
5224922-2249228.8778.88
6375962-37596214.83914.84
10min1521727-52172720.59226.7319.8120.6026.7419.82
2799787-79978731.56731.59
3711644-71164428.08828.10
4591437-59143723.34323.36
5580268-58026822.90322.92
6858260-85826033.87533.90
15min1814836-81483632.16137.0614.1532.2137.1314.16
21000038-100003839.47039.55
3920221-92022136.32036.38
4890437-89043735.14535.20
5834394-83439432.93332.99
61174463-117446346.35546.44
20min1973451-97345138.42143.6210.4238.5243.7410.44
21120487-112048744.22444.37
31075770-107577042.45942.58
41124710-112471044.39144.50
51027754-102775440.56440.67
61308718-130871851.65451.81
30min11116037-111603744.04949.106.4344.2149.306.46
21286364-128636450.77150.99
31210000-121000047.75747.95
41305653-130565351.53351.72
51213708-121370847.90448.08
61333032-133303252.61352.86
45min11178846-117884646.52850.304.4146.7750.584.44
21322818-132281852.21052.51
31264231-126423149.89850.17
41304608-130460851.49151.76
51249615-124961549.32149.58
61325984-132598452.33552.67
60min11225241-122524148.35950.883.0448.6751.243.09
21328636-132863652.44052.83
31277170-127717050.40850.77
41304261-130426151.47851.84
51272856-127285650.23850.58
61326307-132630752.34852.77
极限11313972-131397251.86152.050.9752.2652.501.00
21336230-133623052.73953.22
31329362-132936252.46852.91
41303845-130384551.46151.91
51307051-130705151.58852.01
61322409-132240952.19452.70
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%
1 28.131965380196666219605121963202195710819625730.20
2 28.051962624196154719620860.04
单位质量响应值RSD%判断
69767.9769949.590.19数据可信
长期24月-供试品溶液-2024032121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%
5min1320534-3205347.02110.3833.477.0210.3833.46
2708800-70880015.52515.53
3412504-4125049.0359.04
4391510-3915108.5768.58
5373320-3733208.1778.18
6636068-63606813.93213.93
10min1879066-87906619.25525.0920.0619.2725.1120.05
21355370-135537029.68829.71
31204753-120475326.38926.40
4998595-99859521.87321.89
5979558-97955821.45621.47
61455519-145551931.88131.90
15min11377092-137709230.16334.8214.2830.2134.8814.29
21692441-169244137.07137.15
31557876-155787634.12334.18
41507087-150708733.01133.06
51411882-141188230.92530.97
61992657-199265743.64743.72
20min11644521-164452136.02140.9910.5636.1241.1010.57
21896411-189641141.53841.68
31821387-182138739.89540.01
41905210-190521041.73141.84
51739285-173928538.09738.20
62220386-222038648.63548.78
30min11886665-188666541.32546.166.5741.4846.356.59
22178686-217868647.72147.93
32048607-204860744.87245.05
42214715-221471548.51048.69
52054139-205413944.99345.16
62262816-226281649.56449.79
45min11993755-199375543.67147.304.5343.8947.564.57
22239744-223974449.05949.34
32141133-214113346.89947.16
42214762-221476248.51148.77
52115182-211518246.33046.57
62251753-225175349.32249.63
60min12073553-207355345.41847.833.1445.7148.173.18
22249612-224961249.27549.64
32161230-216123047.33947.67
42212458-221245848.46148.80
52153603-215360347.17247.49
62252099-225209949.32949.72
极限12230694-223069448.86049.040.9849.2349.471.01
22268959-226895949.69950.15
32256765-225676549.43249.85
42213700-221370048.48848.91
52218827-221882748.60149.00
62245395-224539549.18249.66
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%
1 28.131153647114904311553361153203115329911529060.21
2 28.051147644115592611517850.51
单位质量响应值RSD%判断
40984.9341061.850.14数据可信
长期24月-供试品溶液-2024032221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%
5min1279641-27964111.04010.3020.9811.0410.3020.98
2187071-1870717.3867.39
3238264-2382649.4079.41
4221234-2212348.7348.73
5308941-30894112.19712.20
6329982-32998213.02813.03
10min1662294-66229426.14725.909.5726.1725.929.56
2743114-74311429.33829.35
3641322-64132225.31925.34
4553985-55398521.87121.89
5691858-69185827.31527.33
6643368-64336825.40025.42
15min1860494-86049433.97237.7610.9934.0337.8210.99
21104015-110401543.58643.65
3983409-98340938.82538.88
4810865-81086532.01332.06
5991907-99190739.16039.23
6988144-98814439.01239.08
20min11015429-101542940.08945.749.9240.2145.869.91
21278576-127857650.47850.61
31215150-121515047.97448.10
41012289-101228939.96540.07
51206572-120657247.63547.77
61223220-122322048.29348.42
30min11142659-114265945.11250.086.9545.3050.286.95
21324017-132401752.27252.49
31328692-132869252.45752.66
41168137-116813746.11846.29
51320509-132050952.13452.34
61327240-132724052.39952.61
45min11189088-118908846.94550.725.1347.2151.015.14
21341331-134133152.95653.26
31317024-131702451.99652.29
41213064-121306447.89248.14
51325668-132566852.33752.63
61322773-132277352.22352.52
60min11221070-122107048.20851.073.7548.5551.443.78
21332141-133214152.59352.99
31318500-131850052.05452.43
41242447-124244749.05249.38
51323122-132312252.23752.62
61323665-132366552.25852.64
极限11302775-130277551.43352.180.7751.8552.640.80
21330688-133068852.53553.02
31322792-132279252.22452.69
41328815-132881552.46252.87
51319412-131941252.09052.56
61326102-132610252.35452.83
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%
1 28.131963587195656119667691962691196294119625100.19
2 28.051953202196768419604430.53
单位质量响应值RSD%判断
69765.7369891.020.13数据可信
长期24月-供试品溶液-2024032221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%
5min1467327-46732710.2419.5321.9010.249.5321.91
2307587-3075876.7406.74
3396281-3962818.6848.68
4364127-3641277.9797.98
5519610-51961011.38611.39
6555016-55501612.16212.16
10min11119889-111988924.54024.309.7524.5624.329.74
21258107-125810727.56927.58
31086439-108643923.80723.82
4932179-93217920.42720.44
51170635-117063525.65225.67
61087462-108746223.83023.85
15min11457215-145721531.93235.5211.1131.9935.5811.10
21871938-187193841.02041.08
31669544-166954436.58536.64
41369753-136975330.01630.06
51681797-168179736.85436.92
61675549-167554936.71736.78
20min11718829-171882937.66543.0210.0337.7843.1410.02
22168533-216853347.52047.65
32061217-206121745.16845.28
41711688-171168837.50937.61
52047828-204782844.87545.00
62071561-207156145.39545.52
30min11934094-193409442.38247.127.0742.5647.317.08
22246235-224623549.22249.43
32252572-225257249.36149.55
41975715-197571543.29443.45
52241929-224192949.12849.33
62251524-225152449.33849.53
45min12011904-201190444.08747.745.3144.3348.005.32
22276658-227665849.88950.18
32234968-223496848.97549.25
42050670-205067044.93745.17
52250942-225094249.32549.61
62245481-224548149.20649.48
60min12065252-206525245.25648.073.9745.5748.423.99
22261548-226154849.55849.93
32239309-223930949.07049.42
42100649-210064946.03246.34
52248527-224852749.27249.63
62248003-224800349.26149.62
极限12211952-221195248.47149.190.7848.8649.620.81
22259744-225974449.51849.97
32247058-224705849.24049.68
42256545-225654549.44849.83
52241155-224115549.11149.56
62253066-225306649.37249.82
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%
1 28.131147961115122111514631151026114999511503330.13
2 28.051152290115260811524490.02
单位质量响应值RSD%判断
40893.4641085.530.34数据可信
长期24月-供试品溶液-2024032321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%
5min1300678-30067811.88112.8517.2711.8812.8517.27
2397926-39792615.72315.72
3372599-37259914.72214.72
4305015-30501512.05212.05
5334783-33478313.22813.23
6240691-2406919.5109.51
10min1686342-68634227.11925.354.9427.1425.374.94
2649666-64966625.67025.70
3649703-64970325.67225.70
4653441-65344125.81925.84
5608339-60833924.03724.06
6601252-60125223.75723.77
15min1985646-98564638.94635.915.5939.0135.985.59
2892392-89239235.26135.33
3861093-86109334.02434.09
4958281-95828137.86437.93
5870401-87040134.39234.45
6885719-88571934.99735.05
20min11206432-120643247.66943.297.6247.8043.427.61
21071036-107103642.32042.45
3996082-99608239.35839.48
41176680-117668046.49446.62
51021872-102187240.37740.50
61101727-110172743.53243.65
30min11295790-129579051.20048.106.5351.4148.296.51
21197999-119799947.33647.53
31119293-111929344.22644.42
41298181-129818151.29551.50
51133205-113320544.77644.96
61259044-125904449.74849.93
45min11293841-129384151.12349.673.5451.4249.943.54
21259669-125966949.77350.05
31225566-122556648.42648.69
41293513-129351351.11051.40
51183867-118386746.77847.04
61285743-128574350.80351.07
60min11284586-128458650.75850.141.9851.1450.501.98
21264794-126479449.97650.34
31276761-127676150.44850.79
41285096-128509650.77851.15
51220404-122040448.22248.56
61282726-128272650.68451.04
极限11280430-128043050.59350.580.6951.0651.020.69
21274178-127417850.34650.79
31291236-129123651.02051.45
41284142-128414250.74051.20
51266414-126641450.04050.46
61284295-128429550.74651.18
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 28.131953785195790919592091957983195635619570480.11
2 28.051961157196232019617380.05
单位质量响应值RSD%判断
69571.5669937.180.38数据可信
长期24月-供试品溶液-2024032321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%
5min1505671-50567111.09312.0117.7411.0912.0117.73
2672733-67273314.75714.76
3629494-62949413.80913.81
4512293-51229311.23811.24
5564441-56444112.38212.38
6400954-4009548.7968.80
10min11164027-116402725.53523.815.0425.5523.835.04
21098384-109838424.09524.12
31099207-109920724.11324.14
41105822-110582224.25824.28
51028889-102888922.57022.59
61016126-101612622.29022.31
15min11669099-166909936.61433.785.5936.6833.845.58
21512108-151210833.17133.24
31458822-145882232.00232.06
41624666-162466635.64035.70
51475994-147599432.37832.44
61499346-149934632.89132.94
20min12048514-204851444.93740.767.7545.0640.887.74
21816855-181685539.85639.98
31686367-168636736.99337.11
41998024-199802443.83043.95
51729887-172988737.94838.06
61868290-186829040.98441.09
30min12202060-220206048.30645.306.6448.5045.486.63
22031323-203132344.56044.75
31896222-189622241.59741.77
42203889-220388948.34648.54
51920277-192027742.12442.30
62137053-213705346.88047.05
45min12199379-219937948.24746.803.6748.5247.063.66
22135794-213579446.85247.11
32077887-207788745.58245.83
42198600-219860048.23048.50
52005378-200537843.99144.24
62182637-218263747.88048.13
60min12183302-218330247.89447.242.0748.2547.582.09
22144582-214458247.04547.38
32165455-216545547.50347.83
42183706-218370647.90348.26
52067586-206758645.35645.67
62176035-217603547.73548.07
极限12175994-217599447.73447.720.6848.1748.140.68
22165653-216565347.50747.92
32194154-219415448.13248.53
42183222-218322247.89248.32
52152343-215234347.21547.61
62181709-218170947.85948.27
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%
1 28.131156150115680011489061157051115870411555220.34
2 28.051152278115521811537480.19
单位质量响应值RSD%判断
41077.9241131.840.10数据可信
长期24月-供试品溶液-TYN28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%
5min1333845-33384513.15410.4321.6613.1510.4321.66
2252308-2523089.9419.94
3191457-1914577.5447.54
4218511-2185118.6108.61
5264115-26411510.40710.41
6327920-32792012.92112.92
10min1664582-66458226.18623.1911.6926.2123.2011.70
2578060-57806022.77722.79
3496081-49608119.54619.56
4529751-52975120.87320.89
5598778-59877823.59323.61
6663730-66373026.15226.17
15min1956881-95688137.70334.029.3637.7734.089.36
2783639-78363930.87730.93
3860682-86068233.91233.96
4757238-75723829.83629.89
5882839-88283934.78534.84
6939975-93997537.03737.10
20min11170298-117029846.11241.557.4046.2441.667.40
21029044-102904440.54640.65
31073237-107323742.28742.39
4951581-95158137.49437.59
5999794-99979439.39439.51
61103426-110342643.47743.60
30min11277374-127737450.33147.867.3950.5448.047.38
21278491-127849150.37550.55
31304379-130437951.39551.57
41098993-109899343.30243.46
51110779-111077943.76743.95
61218100-121810047.99548.19
45min11276202-127620250.28449.174.1350.5749.434.12
21289456-128945650.80751.06
31299728-129972851.21151.47
41184795-118479546.68346.92
51184635-118463546.67746.93
61252759-125275949.36149.64
60min11272507-127250750.13949.582.9950.5149.923.00
21286240-128624050.68051.02
31298017-129801751.14451.49
41217328-121732847.96548.28
51206309-120630947.53147.86
61269571-126957150.02350.38
极限11259069-125906949.60949.831.7250.0750.261.72
21284383-128438350.60751.03
31289564-128956450.81151.24
41257399-125739949.54449.93
51229334-122933448.43848.85
61268634-126863449.98650.43
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 28.131965959196828719547431967753197062619654740.32
2 28.051961350196549319634220.15
单位质量响应值RSD%判断
69871.1069997.220.13数据可信
长期24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%
5min1564394-56439412.3499.6722.4912.359.6722.47
2419338-4193389.1759.18
3315654-3156546.9076.91
4361528-3615287.9107.91
5442003-4420039.6719.67
6549013-54901312.01212.01
10min11123997-112399724.59321.7211.9824.6121.7311.99
2974577-97457721.32421.34
3833219-83321918.23118.24
4890685-89068519.48819.50
51009913-100991322.09722.11
61122729-112272924.56524.59
15min11622900-162290035.50931.999.5935.5732.049.59
21322508-132250828.93728.99
31459794-145979431.94031.98
41277487-127748727.95228.00
51493177-149317732.67132.72
61595744-159574434.91534.98
20min11985459-198545943.44239.107.5143.5639.207.52
21744411-174441138.16838.27
31819446-181944639.81039.90
41608892-160889235.20335.29
51692454-169245437.03137.14
61871168-187116840.94141.06
30min12168374-216837447.44445.037.5947.6445.207.58
22170640-217064047.49447.66
32212876-221287648.41848.58
41856891-185689140.62940.78
51877585-187758541.08241.25
62062591-206259145.13045.32
45min12166231-216623147.39746.304.3047.6746.544.30
22188159-218815947.87748.12
32208506-220850648.32248.56
42002624-200262443.81844.04
52005941-200594143.89044.13
62124073-212407346.47546.74
60min12159173-215917347.24346.713.1147.5947.033.12
22185847-218584747.82748.15
32204468-220446848.23448.56
42060188-206018845.07745.37
52045330-204533044.75245.06
62153415-215341547.11747.46
极限12140998-214099846.84547.001.7247.2847.411.73
22179161-217916147.68048.08
32191601-219160147.95248.36
42134339-213433946.70047.07
52087593-208759345.67746.06
62156106-215610647.17647.59
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