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 28.131169750116726511677331164689116717011673210.16
2 28.051160631116561111631210.31
单位质量响应值RSD%判断
41497.3741465.990.06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%
5min1380529-38052914.85713.4130.3914.8613.4030.40
2502555-50255519.62219.62
3376976-37697614.71914.72
4249202-2492029.7309.73
5340453-34045313.29313.29
6210378-2103788.2148.21
10min1704438-70443827.50427.6323.6227.5327.6523.62
21011793-101179339.50439.54
3652273-65227325.46725.49
4599574-59957423.41023.43
5745375-74537529.10229.12
6531858-53185820.76620.78
15min1941521-94152136.76137.3319.9336.8337.4019.94
21325915-132591551.76951.87
3875860-87586034.19734.26
4858392-85839233.51533.57
5948276-94827637.02437.09
6787342-78734230.74130.79
20min11078391-107839142.10442.4012.8942.2442.5312.92
21352591-135259152.81053.00
31019497-101949739.80539.93
41008204-100820439.36439.48
51097879-109787942.86543.00
6958893-95889337.43937.54
30min11197728-119772846.76447.367.0446.9747.567.08
21346624-134662452.57752.85
31166524-116652445.54545.74
41135211-113521144.32344.50
51286955-128695550.24850.45
61144891-114489144.70144.86
45min11250431-125043148.82249.174.6249.1049.454.67
21344158-134415852.48152.84
31229710-122971048.01248.28
41199095-119909546.81747.07
51316610-131661051.40551.69
61216493-121649347.49647.73
60min11276785-127678549.85050.202.9950.2150.563.05
21341817-134181752.39052.84
31279599-127959949.96050.31
41237157-123715748.30348.63
51318767-131876751.49051.86
61260668-126066849.22149.54
极限11336436-133643652.17952.280.4752.6252.720.41
21335203-133520352.13152.67
31344199-134419952.48352.91
41337156-133715652.20852.62
51332177-133217752.01352.47
61348660-134866052.65753.05
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%
1 28.132004000200081919980452000107200054020007020.11
2 28.051987008198688419869460.01
单位质量响应值RSD%判断
71123.4370835.860.29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%
5min1649464-64946414.00112.5431.2314.0012.5431.19
2857458-85745818.48518.48
3640776-64077613.81413.81
4416844-4168448.9868.99
5576871-57687112.43612.44
6350008-3500087.5457.55
10min11202598-120259825.92526.0023.8925.9526.0223.90
21730071-173007137.29737.33
31109608-110960823.92123.94
41020784-102078422.00622.02
51270133-127013327.38127.40
6902059-90205919.44619.46
15min11604614-160461434.59235.1320.0834.6635.2020.08
22264595-226459548.82048.91
31489718-148971832.11532.18
41463342-146334231.54731.60
51616093-161609334.84034.91
61340120-134012028.89028.94
20min11835840-183584039.57739.8913.1139.7040.0113.14
22312997-231299749.86350.04
31733295-173329537.36637.48
41720034-172003437.08037.18
51869588-186958840.30440.43
61629759-162975935.13435.23
30min12041017-204101744.00044.607.2944.1944.797.33
22306835-230683549.73049.99
31983754-198375442.76642.94
41934959-193495941.71441.88
52197517-219751747.37447.57
61949055-194905542.01742.17
45min12129573-212957345.90946.304.8646.1746.564.92
22304505-230450549.68050.02
32093349-209334945.12845.38
42040550-204055043.99044.23
52245433-224543348.40748.68
62073076-207307644.69144.91
60min12176325-217632546.91747.303.0347.2647.643.10
22292703-229270349.42649.85
32179223-217922346.97947.30
42111161-211116145.51245.82
52251594-225159448.54048.89
62153867-215386746.43346.73
极限12288650-228865049.33849.420.4149.7649.840.37
22288027-228802749.32549.83
32300596-230059649.59650.00
42289025-228902549.34749.73
52280800-228080049.16949.60
62306213-230621349.71750.09
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 28.131159498115986911605221160557116158211604060.07
2 28.051166505116657611665400.01
单位质量响应值RSD%判断
41251.5541587.880.58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%
5min1286886-28688611.21810.7934.8711.2210.7934.86
2209215-2092158.1818.18
3452997-45299717.71317.71
4288726-28872611.29011.29
5185047-1850477.2367.24
6232175-2321759.0799.08
10min1766112-76611229.95726.1219.4729.9826.1419.48
2572743-57274322.39622.41
3773875-77387530.26130.29
4811718-81171831.74031.76
5508945-50894519.90119.91
6574821-57482122.47722.49
15min11074764-107476442.02637.8315.3042.0937.8915.31
2877908-87790834.32934.38
31063293-106329341.57841.66
41154310-115431045.13745.21
5799665-79966531.26931.31
6834563-83456332.63432.69
20min11288918-128891850.40045.7212.3150.5445.8512.33
21098179-109817942.94243.05
31278765-127876550.00350.15
41322184-132218451.70151.85
5998554-99855439.04639.14
61029213-102921340.24540.35
30min11342141-134214152.48150.475.4752.7050.675.50
21297866-129786650.75050.93
31351402-135140252.84453.08
41346397-134639752.64852.88
51195323-119532346.74046.90
61211507-121150747.37347.55
45min11340496-134049652.41751.902.1652.7352.182.21
21344454-134445452.57252.84
31347364-134736452.68653.01
41349802-134980252.78153.10
51294167-129416750.60650.85
61286887-128688750.32150.57
60min11340190-134019052.40552.141.3052.8052.511.35
21346300-134630052.64453.00
31348764-134876452.74053.15
41341945-134194552.47452.88
51312098-131209851.30751.63
61310823-131082351.25751.59
极限11337288-133728852.29252.520.5852.7852.980.57
21355093-135509352.98853.43
31346413-134641352.64953.14
41339152-133915252.36552.86
51347024-134702452.67253.08
61334239-133423952.17252.59
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 28.131989848198844019900661989586198797619891830.05
2 28.052001066199821919996420.11
单位质量响应值RSD%判断
70713.9471288.480.58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%
5min1484453-48445310.4419.9936.1310.449.9836.15
2345350-3453507.4437.44
3771061-77106116.61816.62
4485506-48550610.46310.46
5305426-3054266.5826.58
6388587-3885878.3758.37
10min11307546-130754628.18024.5219.7228.2024.5319.73
2973433-97343320.97920.99
31320129-132012928.45128.48
41384361-138436129.83529.85
5861335-86133518.56318.57
6978704-97870421.09321.11
15min11841387-184138739.68535.5515.5539.7535.6115.55
21490212-149021232.11632.16
31814410-181441039.10339.18
41970378-197037842.46542.53
51360161-136016129.31429.36
61420162-142016230.60730.66
20min12201126-220112647.43843.0112.5247.5743.1312.54
21870698-187069840.31740.42
32187646-218764647.14747.29
42261925-226192548.74848.89
51700419-170041936.64736.74
61752255-175225537.76437.86
30min12295364-229536449.46947.525.5449.6847.715.58
22216099-221609947.76047.93
32304260-230426049.66049.88
42306717-230671749.71349.93
52041491-204149143.99744.15
62065842-206584244.52244.69
45min12294919-229491949.45948.842.3149.7549.112.35
22296573-229657349.49549.74
32304769-230476949.67149.97
42302935-230293549.63249.93
52204287-220428747.50647.73
62193931-219393147.28347.52
60min12287789-228778949.30549.091.4549.6849.441.50
22301241-230124149.59549.93
32306668-230666849.71250.10
42299453-229945349.55749.94
52234987-223498748.16848.47
62237440-223744048.22048.54
极限12284226-228422649.22949.490.5549.6949.920.55
22313990-231399049.87050.28
32301040-230104049.59150.06
42297910-229791049.52449.99
52300247-230024749.57449.96
62279323-227932349.12349.52
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%
1 28.131161795116313211619071161362116219911620790.06
2 28.051167082116654611668140.04
单位质量响应值RSD%判断
41311.0241597.650.49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%
5min1392123-39212315.32011.1419.9515.3211.1419.95
2296356-29635611.57911.58
3271585-27158510.61110.61
4269922-26992210.54610.55
5229673-2296738.9738.97
6251772-2517729.8379.84
10min1651114-65111425.43925.1010.3325.4625.1210.33
2592664-59266423.15523.17
3633724-63372424.76024.78
4770218-77021830.09230.11
5602308-60230823.53223.55
6604384-60438423.61323.63
15min1895457-89545734.98536.649.1435.0536.709.14
2869689-86968933.97934.04
3894905-89490534.96435.02
41085517-108551742.41142.48
5883237-88323734.50834.56
6998275-99827539.00339.06
20min11040168-104016840.63943.399.4340.7743.529.42
21028018-102801840.16540.28
31027208-102720840.13340.25
41260766-126076649.25849.40
51084026-108402642.35342.46
61223644-122364447.80847.93
30min11152930-115293045.04547.535.5545.2447.735.55
21171545-117154545.77245.95
31154360-115436045.10145.28
41293862-129386250.55150.77
51228732-122873248.00748.19
61298523-129852350.73350.93
45min11201086-120108646.92648.833.4247.2049.103.42
21244803-124480348.63448.89
31199276-119927646.85647.11
41287924-128792450.31950.62
51267782-126778249.53249.79
61298397-129839750.72851.01
60min11233307-123330748.18549.372.3548.5349.722.36
21268426-126842649.55749.90
31222768-122276847.77448.11
41287828-128782850.31550.70
51272828-127282849.72950.07
61296875-129687550.66951.04
极限11302067-130206750.87250.620.7451.3051.050.71
21299785-129978550.78351.20
31307192-130719251.07251.49
41283615-128361550.15150.62
51284762-128476250.19650.62
61296132-129613250.64051.09
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 28.131995147199214619883561990107199038219912280.13
2 28.051996467199730919968880.03
单位质量响应值RSD%判断
70786.6371190.300.41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%
5min1667294-66729414.38410.3720.6114.3810.3720.60
2500476-50047610.78810.79
3457981-4579819.8729.87
4454766-4547669.8039.80
5382794-3827948.2518.25
6424406-4244069.1489.15
10min11110078-111007823.92823.5810.5623.9523.6010.56
21007462-100746221.71621.73
31080465-108046523.29023.31
41315785-131578528.36228.38
51020800-102080022.00422.02
61029006-102900622.18122.20
15min11524984-152498432.87134.479.2032.9434.539.19
21484782-148478232.00532.06
31526209-152620932.89832.95
41850717-185071739.89339.96
51502476-150247632.38632.44
61706661-170666136.78836.84
20min11772858-177285838.21440.849.5438.3340.969.53
21755128-175512837.83237.94
31748933-174893337.69937.81
42153542-215354246.42046.55
51847226-184722639.81739.92
62090731-209073145.06645.18
30min11969639-196963942.45644.785.7242.6444.975.72
21994676-199467642.99643.17
31967256-196725642.40542.58
42212310-221231047.68747.89
52098508-209850845.23445.40
62223555-222355547.92948.12
45min12044739-204473944.07545.963.6944.3346.223.69
22119279-211927945.68245.92
32039240-203924043.95644.20
42204658-220465847.52247.81
52161640-216164046.59546.84
62223113-222311347.92048.19
60min12103711-210371145.34646.502.4645.6746.832.48
22163728-216372846.64046.96
32085315-208531544.95045.27
42199488-219948847.41147.78
52169784-216978446.77047.09
62220782-222078247.87048.22
极限12219320-221932047.83847.760.7748.2448.170.74
22228323-222832348.03248.43
32237757-223775748.23548.63
42193043-219304347.27247.72
52199097-219909747.40247.80
62215861-221586147.76348.19
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 28.131165600116725111632771162219116457911645850.17
2 28.051165388116634511658660.06
单位质量响应值RSD%判断
41400.1141563.850.28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%
5min1316847-31684712.37112.6315.1912.3712.6315.19
2267344-26734410.43810.44
3400041-40004115.61915.62
4279033-27903310.89410.89
5322029-32202912.57312.57
6355551-35555113.88213.88
10min1646346-64634625.23626.204.6525.2626.224.65
2635458-63545824.81124.83
3684468-68446826.72426.75
4655744-65574425.60325.62
5684819-68481926.73826.76
6719795-71979528.10328.13
15min1968385-96838537.80936.416.0737.8736.476.06
2842179-84217932.88232.94
3894420-89442034.92134.99
4956423-95642337.34237.40
5934300-93430036.47836.54
6999743-99974339.03439.10
20min11180649-118064946.09745.593.4846.2245.723.48
21103810-110381043.09743.21
31168030-116803045.60445.73
41205492-120549247.06747.19
51139046-113904644.47244.60
61209355-120935547.21847.35
30min11271429-127142949.64150.693.2949.8450.893.29
21280268-128026849.98650.17
31334045-133404552.08652.29
41323183-132318351.66251.86
51235398-123539848.23448.43
61345210-134521052.52252.74
45min11271331-127133149.63750.683.2749.9250.973.27
21284014-128401450.13350.40
31333330-133333052.05852.35
41319770-131977051.52951.82
51234159-123415948.18648.47
61345773-134577352.54452.85
60min11269320-126932049.55950.603.3349.9350.973.32
21280180-128018049.98350.34
31332089-133208952.01052.39
41318741-131874151.48851.86
51231239-123123948.07248.43
61343791-134379152.46652.86
极限11264513-126451349.37150.453.3349.8250.913.33
21276834-127683449.85250.29
31326409-132640951.78852.25
41315367-131536751.35751.82
51228337-122833747.95948.40
61341758-134175852.38752.86
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 28.131992850199361819899231992276199404519925420.09
2 28.051996268200064019984540.16
单位质量响应值RSD%判断
70833.3571246.130.42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%
5min1536853-53685311.56411.8015.6911.5611.8015.67
2449794-4497949.6889.69
3680342-68034214.65414.65
4468807-46880710.09810.10
5544915-54491511.73711.74
6605915-60591513.05113.05
10min11097908-109790823.64924.604.7923.6724.624.79
21079814-107981423.25923.28
31162585-116258525.04225.07
41116136-111613624.04124.06
51168809-116880925.17625.20
61227436-122743626.43926.46
15min11649477-164947735.52934.226.1435.5934.286.14
21432021-143202130.84530.90
31521905-152190532.78132.85
41631193-163119335.13535.19
51594074-159407434.33634.40
61702454-170245436.67036.74
20min12012579-201257943.35042.933.4743.4743.053.46
21884861-188486140.59940.71
31993394-199339442.93743.06
42057985-205798544.32844.44
51944969-194496941.89442.01
62064910-206491044.47844.60
30min12175251-217525146.85447.773.2947.0447.963.28
22188144-218814447.13247.31
32277308-227730849.05349.24
42257720-225772048.63148.82
52108543-210854345.41745.61
62300403-230040349.55049.75
45min12175879-217587946.86847.793.2147.1448.063.21
22194286-219428647.26447.52
32274348-227434848.98949.26
42257109-225710948.61848.89
52110331-211033145.45645.72
62299755-229975549.53649.82
60min12168710-216871046.71347.743.3547.0648.093.34
22190394-219039447.18047.51
32273404-227340448.96949.32
42257563-225756348.62748.98
52105776-210577645.35845.70
62301848-230184849.58149.95
极限12164835-216483546.63047.613.2747.0548.043.27
22182462-218246247.01047.42
32268028-226802848.85349.29
42252158-225215848.51148.94
52103305-210330545.30545.72
62292282-229228249.37549.82
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