沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.51 1167479116754411685331168079116882911680930.06
228.631174212117454111743760.02
单位质量响应值RSD%判断
40971.3441019.070.09数据可信
供试品溶液-2024032121批-缬沙坦钠-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1181481-1814817.3025.9821.097.305.9821.08
2128610-1286105.1755.17
3194670-1946707.8337.83
4130148-1301485.2375.24
5136054-1360545.4745.47
6120237-1202374.8384.84
10min1563954-56395422.69221.738.0322.7121.748.03
2506704-50670420.38820.40
3609813-60981324.53724.55
4488948-48894819.67419.69
5545508-54550821.94921.96
6525615-52561521.14921.16
15min1870402-87040235.02233.813.7835.0933.873.78
2831497-83149733.45733.51
3846064-84606434.04334.11
4781508-78150831.44531.50
5851722-85172234.27134.33
6860677-86067734.63134.69
20min11117513-111751344.96542.605.3845.1142.735.37
21027587-102758741.34741.48
31009180-100918040.60640.75
4991312-99131239.88740.01
51083493-108349343.59643.73
61123069-112306945.18945.32
30min11284167-128416751.67149.274.5851.9249.504.57
21171151-117115147.12347.35
31176992-117699247.35847.60
41175241-117524147.28847.50
51253257-125325750.42750.66
61285628-128562851.73051.96
45min11299412-129941252.28450.802.3652.6451.142.37
21247327-124732750.18850.52
31234280-123428049.66350.01
41232333-123233349.58549.90
51265680-126568050.92751.27
61295751-129575152.13752.49
60min11293466-129346652.04550.812.1652.5251.262.17
21251199-125119950.34450.78
31235419-123541949.70950.16
41235432-123543249.71050.14
51264642-126464250.88551.34
61296431-129643152.16452.63
极限11298773-129877352.25851.600.9852.8552.170.99
21284801-128480151.69652.25
31263786-126378650.85151.41
41275821-127582151.33551.87
51278817-127881751.45552.03
61292447-129244752.00452.59
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.51 2017054201586420173612016097201715420167060.04
228.632023950202750020257250.13
单位质量响应值RSD%判断
70736.7970755.330.02数据可信
供试品溶液-2024032121批-沙库巴曲-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1312077-3120777.7026.3422.007.706.3421.97
2221474-2214745.4665.47
3343787-3437878.4848.48
4223954-2239545.5275.53
5233926-2339265.7735.77
6206734-2067345.1025.10
10min1984023-98402324.28523.307.9924.3023.327.98
2892833-89283322.03422.05
31065506-106550626.29626.31
4851056-85105621.00321.02
5953441-95344123.53023.54
6917936-91793622.65422.67
15min11526766-152676637.67936.234.0837.7536.294.08
21454290-145429035.89035.95
31468662-146866236.24536.32
41357699-135769933.50733.57
51496382-149638236.92936.99
61503893-150389337.11537.18
20min11954388-195438848.23245.555.6448.3945.695.64
21789814-178981444.17144.31
31752674-175267443.25443.41
41722152-172215242.50142.63
51894731-189473146.76046.91
61959283-195928348.35348.50
30min12248000-224800055.47852.804.6955.7453.054.68
22040224-204022450.35150.59
32054352-205435250.69950.95
42056744-205674450.75850.99
52189553-218955354.03654.29
62248930-224893055.50155.75
45min12261501-226150155.81254.152.4956.2054.522.50
22166884-216688453.47753.83
32141159-214115952.84253.21
42139477-213947752.80053.14
52201324-220132454.32754.70
62255022-225502255.65256.03
60min12254846-225484655.64754.112.4556.1654.592.46
22167382-216738253.48953.96
32138165-213816552.76853.25
42140718-214071852.83153.29
52195208-219520854.17654.67
62257836-225783655.72156.22
极限12258621-225862155.74155.160.9956.3755.771.00
22241650-224165055.32255.91
32196564-219656454.20954.81
42225374-222537454.92055.50
52237691-223769155.22455.84
62250884-225088455.55056.17
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.51 1177079117740911773441176015117585111767400.07
228.631172563117273911726510.02
单位质量响应值RSD%判断
41274.6440958.820.55数据可信
供试品溶液-2024032121批-缬沙坦钠-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min187085-870853.4944.9233.183.494.9233.23
2163193-1631936.5476.55
3119700-1197004.8024.80
494726-947263.8003.80
5181878-1818787.2977.30
689748-897483.6013.60
10min1464101-46410118.61920.5212.0218.6320.5312.02
2564584-56458422.65022.66
3513475-51347520.60020.61
4482806-48280619.36919.38
5601882-60188224.14724.16
6442029-44202917.73417.74
15min1789278-78927831.66532.697.5831.7132.747.59
2786968-78696831.57231.64
3834580-83458033.48233.54
4792219-79221931.78331.83
5929769-92976937.30137.37
6755579-75557930.31330.36
20min11022165-102216541.00841.627.5441.1341.757.54
2954223-95422338.28238.42
31067314-106731442.81942.95
41015146-101514640.72640.85
51177370-117737047.23447.39
6988201-98820139.64539.76
30min11241369-124136949.80248.596.3250.0148.816.31
21066894-106689442.80243.02
31245134-124513449.95350.18
41198858-119885848.09648.31
51288770-128877051.70351.96
61226104-122610449.18949.39
45min11281733-128173351.42149.975.3551.7450.305.34
21114129-111412944.69745.01
31276485-127648551.21151.55
41245765-124576549.97850.30
51294558-129455851.93652.31
61260926-126092650.58650.90
60min11295643-129564351.97950.044.8852.4150.484.87
21130311-113031145.34645.76
31264307-126430750.72251.17
41245593-124559349.97150.40
51293612-129361251.89852.39
61254203-125420350.31750.74
极限11305576-130557652.37851.670.9352.9352.220.96
21273347-127334751.08551.60
31295886-129588651.98952.55
41279109-127910951.31651.86
51291496-129149651.81352.42
61281800-128180051.42451.96
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.51 2033478203531020345402033006203008620332840.10
228.632018277201673120175040.06
单位质量响应值RSD%判断
71318.2770468.180.85数据可信
供试品溶液-2024032121批-沙库巴曲-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1152554-1525543.7575.2533.733.765.2533.74
2282595-2825956.9606.96
3204563-2045635.0385.04
4163367-1633674.0244.02
5320392-3203927.8917.89
6155654-1556543.8343.83
10min1810966-81096619.97322.0012.0019.9822.0212.02
2984337-98433724.24324.26
3893320-89332022.00122.01
4844682-84468220.80320.81
51053592-105359225.94925.97
6773638-77363819.05419.06
15min11379357-137935733.97234.987.7334.0235.047.74
21365584-136558433.63333.70
31448380-144838035.67235.73
41382314-138231434.04534.10
51627506-162750640.08340.16
61318559-131855932.47432.53
20min11779557-177955743.82844.507.6843.9644.647.68
21656457-165645740.79640.94
31850966-185096645.58745.73
41768876-176887643.56543.70
52057601-205760150.67650.84
61726414-172641442.51942.64
30min12190864-219086453.95852.096.6254.1852.326.60
21851477-185147745.59945.83
32164999-216499953.32153.56
42087935-208793551.42351.65
52251606-225160655.45455.73
62142072-214207252.75652.97
45min12238388-223838855.12953.365.6355.4753.715.62
21926493-192649347.44747.78
32211857-221185754.47554.83
42166726-216672653.36453.71
52259146-225914655.64056.04
62197248-219724854.11554.45
60min12252386-225238655.47353.435.1055.9453.915.09
21954945-195494548.14848.59
32201035-220103554.20954.69
42167735-216773553.38853.85
52252032-225203255.46555.99
62189469-218946953.92454.38
极限12269786-226978655.90255.250.7056.4955.840.72
22230086-223008654.92455.47
32250073-225007355.41656.02
42229808-222980854.91755.50
52247280-224728055.34855.99
62232877-223287754.99355.57
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.51 1180300118154411806061180712117727711800880.14
228.631184789118571211852500.06
单位质量响应值RSD%判断
41392.0741398.880.02数据可信
供试品溶液-2024032221批-缬沙坦钠-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1228209-2282099.0948.1213.239.098.1213.22
2179542-1795427.1547.15
3244681-2446819.7509.75
4200839-2008398.0038.00
5186126-1861267.4177.42
6182624-1826247.2777.28
10min1715058-71505828.49323.6213.2128.5123.6413.20
2597058-59705823.79123.81
3607605-60760524.21224.23
4622506-62250624.80524.82
5507973-50797320.24220.26
6506880-50688020.19820.21
15min11045331-104533141.65433.7913.0041.7433.8613.00
2852015-85201533.95134.02
3842893-84289333.58733.66
4858824-85882434.22234.30
5732096-73209629.17229.23
6757404-75740430.18130.24
20min11238034-123803449.33340.2811.7049.5140.4211.70
2993991-99399139.60839.75
3997280-99728039.73939.89
4995251-99525139.65839.81
5896733-89673335.73335.86
6943622-94362237.60137.73
30min11277254-127725450.89644.937.6351.1845.177.65
21112078-111207844.31444.55
31153545-115354545.96646.20
41119822-111982244.62244.86
51020040-102004040.64640.85
61082800-108280043.14743.36
45min11274700-127470050.79446.536.4951.1946.866.51
21150239-115023945.83446.17
31233156-123315649.13849.48
41162521-116252146.32446.66
51067120-106712042.52242.82
61117879-111787944.54544.85
60min11281331-128133151.05847.196.0751.5747.636.10
21183005-118300547.14047.57
31236204-123620449.26049.71
41196031-119603147.65948.10
51084258-108425843.20543.60
61124565-112456544.81145.22
极限11274268-127426850.77750.311.2251.4050.851.27
21255797-125579750.04150.58
31270723-127072350.63551.19
41281976-128197651.08451.63
51244494-124449449.59050.08
61247767-124776749.72150.23
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.51 2024867202651620255442026907202292620253520.08
228.632035057203643420357460.05
单位质量响应值RSD%判断
71040.0671105.340.07数据可信
供试品溶液-2024032221批-沙库巴曲-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1396920-3969209.7518.6613.559.758.6613.56
2310618-3106187.6317.63
3425250-42525010.44710.45
4346174-3461748.5048.50
5320259-3202597.8677.87
6316461-3164617.7747.77
10min11248223-124822330.66325.3813.4630.6925.4013.46
21043483-104348325.63425.65
31060151-106015126.04326.07
41086623-108662326.69426.71
5880444-88044421.62921.65
6880202-88020221.62321.64
15min11819766-181976644.70436.1513.1744.7936.2313.16
21481873-148187336.40336.48
31459386-145938635.85135.93
41486548-148654836.51836.60
51270595-127059531.21331.28
61311709-131170932.22332.29
20min12159574-215957453.05143.1111.9753.2443.2611.98
21722259-172225942.30842.46
31723981-172398142.35142.51
41732626-173262642.56342.72
51555591-155559138.21438.35
61634161-163416140.14440.28
30min12223312-222331254.61748.057.8154.9248.307.83
21928566-192856647.37647.63
32000661-200066149.14749.40
41942645-194264547.72247.98
51768352-176835243.44143.66
61872604-187260446.00246.23
45min12219302-221930254.51949.676.7554.9550.036.78
21989288-198928848.86849.22
32136779-213677952.49152.86
42010749-201074949.39549.76
51846392-184639245.35845.67
61928449-192844947.37447.70
60min12224509-222450954.64650.406.2555.2050.876.29
22051290-205129050.39150.85
32144359-214435952.67853.16
42072251-207225150.90651.38
51873146-187314646.01546.43
61944803-194480347.77548.21
极限12214693-221469354.40554.081.0055.0854.661.06
22201530-220153054.08254.66
32208692-220869254.25854.86
42231394-223139454.81655.40
52175734-217573453.44853.97
62176337-217633753.46354.00
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.51 1160765116310811621291162973116319911624350.09
228.631161579115780611596920.24
单位质量响应值RSD%判断
40772.8940506.180.47数据可信
供试品溶液-2024032221批-缬沙坦钠-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1128731-1287315.2257.3132.345.237.3132.33
2199611-1996118.1028.10
3139964-1399645.6815.68
4130090-1300905.2805.28
5206131-2061318.3678.37
6275663-27566311.18911.19
10min1524554-52455421.29123.4715.2721.3023.4915.29
2606187-60618724.60524.62
3533196-53319621.64221.65
4467412-46741218.97218.98
5622429-62242925.26425.28
6716333-71633329.07529.10
15min1837656-83765634.00035.9311.4534.0636.0011.47
2950634-95063438.58638.66
3834720-83472033.88133.94
4742945-74294530.15630.21
5914157-91415737.10537.18
61030731-103073141.83741.93
20min11017385-101738541.29543.579.3141.4343.729.32
21205705-120570548.93949.10
31056957-105695742.90143.04
4935872-93587237.98638.11
51053503-105350342.76142.92
61171780-117178047.56247.74
30min11143855-114385546.42848.707.0046.6548.947.01
21292603-129260352.46652.73
31259919-125991951.13951.37
41076435-107643543.69243.90
51166357-116635747.34247.59
61259391-125939151.11851.41
45min11205200-120520048.91849.994.7349.2550.344.76
21294037-129403752.52452.91
31283800-128380052.10952.45
41139683-113968346.25946.56
51209122-120912249.07749.43
61257561-125756151.04451.45
60min11208739-120873949.06250.323.7949.5050.783.81
21290281-129028152.37252.87
31285604-128560452.18252.64
41173061-117306147.61448.02
51218840-121884049.47249.94
61261885-126188551.21951.73
极限11269608-126960851.53351.681.1652.0852.251.14
21291811-129181152.43453.05
31285953-128595352.19652.77
41274432-127443251.72852.24
51266546-126654651.40851.98
61250370-125037050.75251.38
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.51 2004897200817220070662006866200884020071680.08
228.632003617199719920004080.23
单位质量响应值RSD%判断
70402.2469871.040.54数据可信
供试品溶液-2024032221批-沙库巴曲-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1218452-2184525.4387.7433.585.447.7433.58
2344341-3443418.5728.57
3241521-2415216.0126.01
4220713-2207135.4945.49
5356658-3566588.8798.88
6483382-48338212.03312.03
10min1916711-91671122.82025.1315.6222.8325.1415.64
21061186-106118626.41726.44
3928753-92875323.12023.13
4809941-80994120.16320.17
51083219-108321926.96526.99
61256760-125676031.28631.31
15min11455351-145535136.22938.3211.7636.2938.4011.78
21657077-165707741.25141.33
31447946-144794636.04536.11
41287818-128781832.05932.12
51586472-158647239.49339.57
61802273-180227344.86544.96
20min11769072-176907244.03946.6410.0044.1846.8010.02
22098875-209887552.24952.42
31834982-183498245.68045.82
41622247-162224740.38440.51
51826031-182603145.45745.62
62089852-208985252.02452.22
30min12000440-200044049.79952.027.1350.0452.287.15
22252943-225294356.08456.37
32193873-219387354.61454.86
41866940-186694046.47546.69
52025714-202571450.42850.70
62198243-219824354.72355.03
45min12089989-208998952.02853.264.9452.3853.644.96
22253083-225308356.08856.50
32232544-223254455.57755.94
41974582-197458249.15549.48
52096070-209607052.17952.56
62189874-218987454.51454.95
60min12094219-209421952.13353.573.9752.6054.064.00
22244421-224442155.87256.41
32231273-223127355.54556.04
42031558-203155850.57351.00
52111643-211164352.56753.06
62197736-219773654.71055.26
极限12213711-221371155.10855.141.0855.6955.761.05
22243398-224339855.84756.51
32233024-223302455.58956.20
42219412-221941255.25055.79
52205622-220562254.90655.52
62175411-217541154.15454.83
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.51 1168501117308711725611171185117079711712260.16
228.631160605116342611620160.18
单位质量响应值RSD%判断
41081.2340587.360.86数据可信
供试品溶液-2024032321批-缬沙坦钠-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1114781-1147814.6376.0636.304.646.0636.26
296115-961153.8833.88
3174760-1747607.0607.06
497914-979143.9553.96
5225355-2253559.1049.10
6190693-1906937.7037.70
10min1449056-44905618.14021.7312.9218.1521.7412.94
2469218-46921818.95518.96
3551768-55176822.29022.31
4564313-56431322.79622.81
5639982-63998225.85325.87
6552887-55288722.33522.35
15min1718147-71814729.01133.9110.6729.0633.9710.68
2790763-79076331.94432.00
3838302-83830233.86533.93
4884528-88452835.73235.79
5982973-98297339.70939.79
6821455-82145533.18433.25
20min1932860-93286037.68542.949.0837.8043.079.09
21045365-104536542.22942.35
31060046-106004642.82242.96
41102886-110288644.55344.69
51222034-122203449.36649.53
61014272-101427240.97341.11
30min11155259-115525946.66949.595.5046.8749.825.53
21156503-115650346.71946.93
31258119-125811950.82451.06
41245878-124587850.32950.57
51332987-133298753.84854.12
61216677-121667749.15049.38
45min11218175-121817549.21051.123.2949.5151.463.33
21232337-123233749.78250.10
31250347-125034750.51050.86
41279311-127931151.68052.03
51334037-133403753.89154.29
61278063-127806351.63051.97
60min11228021-122802149.60851.472.5050.0251.932.54
21253565-125356550.64051.07
31282401-128240151.80552.27
41273140-127314051.43151.90
51322330-132233053.41853.93
61285085-128508551.91352.37
极限11264673-126467351.08952.101.7951.6152.661.84
21282565-128256551.81252.35
31278400-127840051.64352.22
41286769-128676951.98152.56
51332554-133255453.83154.46
61292567-129256752.21652.79
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.51 2021116202800920273202025653202439020252980.14
228.632000819200650120036600.21
单位质量响应值RSD%判断
71038.1669984.631.06数据可信
供试品溶液-2024032321批-沙库巴曲-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1194624-1946244.8196.3936.954.826.3936.95
2164474-1644744.0734.07
3302123-3021237.4817.48
4167560-1675604.1494.15
5390630-3906309.6739.67
6328221-3282218.1288.13
10min1780968-78096819.33923.3012.9419.3523.3212.95
2824010-82401020.40520.41
3962438-96243823.83223.85
4999004-99900424.73824.75
51115258-111525827.61727.64
6964716-96471623.88923.91
15min11248800-124880030.92336.2610.6830.9836.3210.69
21382529-138252934.23534.29
31464775-146477536.27236.34
41544550-154455038.24738.31
51712652-171265242.41042.49
61432362-143236235.46935.54
20min11625160-162516040.24345.968.9440.3746.118.94
21824412-182441245.17745.31
31848705-184870545.77945.93
41926271-192627147.69947.85
52126816-212681652.66552.84
61786046-178604644.22744.38
30min12018723-201872349.98953.185.1850.2053.435.21
22039838-203983850.51250.74
32198949-219894954.45254.70
42173842-217384253.83054.09
52321216-232121657.47957.77
62133943-213394352.84253.09
45min12119221-211922152.47754.573.2652.8054.933.29
22139095-213909552.96953.31
32196141-219614154.38254.75
42224376-222437655.08155.46
52319745-231974557.44357.86
62223485-222348555.05955.42
60min12131488-213148852.78154.812.6053.2255.302.64
22173099-217309953.81154.27
32225350-222535055.10555.60
42219790-221979054.96855.46
52300898-230089856.97657.53
62230631-223063155.23655.72
极限12206019-220601954.62755.681.6455.1856.291.69
22244892-224489255.58956.17
32230449-223044955.23255.85
42241321-224132155.50156.12
52315882-231588257.34758.02
62253058-225305855.79156.40
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.51 1199795119730411942911197196119648211970140.17
228.631187586118682711872060.05
单位质量响应值RSD%判断
41985.7641467.200.88数据可信
供试品溶液-2024032321批-缬沙坦钠-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1184486-1844867.2936.8713.547.296.8713.54
2161145-1611456.3716.37
3146650-1466505.7985.80
4152050-1520506.0116.01
5200541-2005417.9287.93
6197621-1976217.8137.81
10min1500011-50001119.76721.0110.0619.7821.0310.06
2566055-56605522.37822.39
3535622-53562221.17521.19
4441550-44155017.45617.47
5556488-55648822.00022.02
6589571-58957123.30823.32
15min1761297-76129730.09631.757.6330.1631.817.62
2799944-79994431.62431.69
3859864-85986433.99334.05
4703589-70358927.81527.87
5850400-85040033.61933.69
6843394-84339433.34233.41
20min1946459-94645937.41639.668.8537.5439.798.85
2974314-97431438.51838.65
31025581-102558140.54440.68
4875984-87598434.63034.74
51083650-108365042.84042.98
61113431-111343144.01744.16
30min11110722-111072243.91045.516.9344.1245.736.94
21110278-111027843.89344.11
31128962-112896244.63144.86
41057919-105791941.82342.01
51252295-125229549.50749.74
61246525-124652549.27949.52
45min11197588-119758847.34447.722.9347.6548.042.94
21206706-120670647.70548.02
31171204-117120446.30146.63
41171567-117156746.31646.60
51258624-125862449.75750.10
61237409-123740948.91949.27
60min11216547-121654748.09447.982.2448.5148.402.27
21210742-121074247.86448.29
31186215-118621546.89547.32
41184254-118425446.81747.20
51257176-125717649.70050.16
61226347-122634748.48148.94
极限11279034-127903450.56449.900.9151.0850.430.87
21251787-125178749.48750.02
31271517-127151750.26750.80
41264512-126451249.99050.48
51254818-125481849.60750.17
61251512-125151249.47650.04
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.51 2061430205799320555092060627206224020595600.14
228.632042737204351720431270.03
单位质量响应值RSD%判断
72239.9271363.150.87数据可信
供试品溶液-2024032321批-沙库巴曲-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1318065-3180657.7347.3014.367.737.3014.35
2278084-2780846.7626.76
3250905-2509056.1016.10
4259947-2599476.3216.32
5348927-3489278.4858.48
6345424-3454248.4008.40
10min1870402-87040221.16622.5310.2821.1822.5510.29
2988039-98803924.02624.04
3935607-93560722.75122.76
4765634-76563418.61818.63
5970762-97076223.60623.63
61028772-102877225.01725.04
15min11323441-132344132.18234.038.0632.2534.108.06
21388458-138845833.76333.83
31501330-150133036.50836.57
41217749-121774929.61229.67
51496721-149672136.39636.47
61469007-146900735.72235.80
20min11641803-164180339.92442.459.1040.0642.599.10
21688553-168855341.06141.20
31779949-177994943.28343.43
41524160-152416037.06337.18
51893937-189393746.05546.21
61944984-194498447.29747.45
30min11931783-193178346.97548.747.3147.2048.987.32
21937069-193706947.10447.34
31960482-196048247.67347.91
41828975-182897544.47544.68
52191455-219145553.29053.54
62177096-217709652.94153.20
45min12082641-208264150.64451.043.3250.9751.383.34
22093581-209358150.91051.25
32029476-202947649.35149.70
42026098-202609849.26949.57
52195192-219519253.38153.75
62166300-216630052.67853.05
60min12116036-211603651.45651.322.6651.9051.782.69
22098239-209823951.02351.48
32054664-205466449.96450.42
42046826-204682649.77350.18
52186946-218694653.18053.67
62161100-216110052.55253.05
极限12232584-223258454.29053.491.0354.8554.060.99
22175454-217545452.90153.47
32217010-221701053.91154.48
42205453-220545353.63054.15
52189350-218935053.23953.85
62178505-217850552.97553.59
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