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%
127.345546395540905552545548985551705548100.09
227.255548325546545547430.03
单位质量响应值RSD%判断
20292.9820357.540.23数据可信
加速6月-供试品溶液-2024032421批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1219057-21905717.45516.128.3317.4616.128.35
2204741-20474116.31516.31
3192062-19206215.30415.30
4178375-17837514.21414.21
5196543-19654315.66115.66
6222852-22285217.75817.76
10min1386431-38643130.79231.465.3330.8231.485.34
2410998-41099832.75032.78
3396903-39690331.62731.65
4357399-35739928.47928.50
5401159-40115931.96631.99
6415599-41559933.11733.15
15min1488604-48860438.93440.646.3839.0140.726.38
2537043-53704342.79442.88
3485307-48530738.67138.75
4471648-47164837.58337.65
5552047-55204743.98944.07
6525529-52552941.87641.96
20min1541124-54112443.11944.996.0643.2645.136.06
2577674-57767446.03246.18
3532948-53294842.46842.61
4534869-53486942.62142.75
5618762-61876249.30649.46
6582048-58204846.38046.53
30min1606630-60663048.33949.173.4148.5649.403.41
2604710-60471048.18648.42
3603014-60301448.05148.26
4600321-60032147.83648.04
5641227-64122751.09651.33
6646791-64679151.53951.77
45min1644717-64471751.37451.181.4451.6751.481.45
2635547-63554750.64350.95
3630180-63018050.21550.51
4640327-64032751.02451.31
5656547-65654752.31652.64
6646453-64645351.51251.83
60min1643323-64332351.26351.720.9151.6552.110.91
2647123-64712351.56651.96
3644078-64407851.32351.70
4655741-65574152.25252.62
5656969-65696952.35052.76
6646829-64682951.54251.95
极限1656819-65681952.33851.921.0352.8152.401.01
2648546-64854651.67952.16
3644364-64436451.34651.81
4660577-66057752.63853.09
5654482-65448252.15252.65
6644740-64474051.37651.87
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%
127.349584349580789572839580359587759581210.06
227.259573349573939573640.01
单位质量响应值RSD%判断
35044.6635132.620.18数据可信
加速6月-供试品溶液-2024032421批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1377172-37717216.44815.089.3916.4515.089.40
2353102-35310215.39815.40
3329786-32978614.38214.38
4299531-29953113.06213.06
5329341-32934114.36214.36
6385260-38526016.80116.80
10min1664985-66498528.99929.585.3929.0329.615.39
2704084-70408430.70430.73
3681100-68110029.70229.73
4613244-61324426.74326.76
5690585-69058530.11530.14
6716275-71627531.23631.26
15min1838992-83899236.58738.206.4636.6638.276.45
2921548-92154840.18740.26
3832790-83279036.31736.39
4809002-80900235.27935.35
5949513-94951341.40741.48
6903492-90349239.40039.48
20min1930860-93086040.59342.336.1840.7342.476.17
2992650-99265043.28843.43
3915462-91546239.92240.06
4917510-91751040.01140.14
51065702-106570246.47446.62
61001717-100171743.68343.83
30min11039158-103915845.31646.043.8145.5246.253.81
21037863-103786345.26045.48
31013270-101327044.18744.39
41031886-103188644.99945.19
51101782-110178248.04748.27
61110336-111033648.42048.64
45min11110743-111074348.43848.191.6648.7248.481.67
21090282-109028247.54647.84
31080649-108064947.12647.40
41101696-110169648.04348.31
51131993-113199349.36549.67
61114666-111466648.60948.91
60min11109474-110947448.38348.700.8648.7449.060.87
21113651-111365148.56548.94
31107122-110712248.28048.63
41124443-112444349.03549.38
51131994-113199449.36549.75
61113622-111362248.56348.94
极限11139871-113987149.70849.041.1550.1549.491.13
21116618-111661848.69449.15
31111758-111175848.48248.92
41138394-113839449.64450.07
51128893-112889349.22949.69
61111945-111194548.49048.95
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%
127.345570335563595566615566055567185566750.05
227.255555495552085553780.05
单位质量响应值RSD%判断
20361.1920380.840.07数据可信
加速6月-供试品溶液-2024032521批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1251263-25126319.97718.3910.6519.9818.3910.67
2266222-26622221.16621.17
3237157-23715718.85518.86
4212103-21210316.86316.86
5218576-21857617.37817.38
6202162-20216216.07316.07
10min1438253-43825334.84333.654.5934.8833.694.59
2425383-42538333.82033.86
3447974-44797435.61635.65
4418749-41874933.29333.32
5417577-41757733.20033.23
6391814-39181431.15131.18
15min1527799-52779941.96342.943.2942.0543.033.28
2519335-51933541.29041.38
3562413-56241344.71544.81
4547198-54719843.50543.59
5527183-52718341.91442.00
6556689-55668944.26044.34
20min1567742-56774245.13847.234.1645.3047.394.15
2563585-56358544.80844.97
3602866-60286647.93148.10
4618268-61826849.15549.31
5590371-59037146.93847.09
6621536-62153649.41549.57
30min1604831-60483148.08750.423.3048.3250.663.28
2614729-61472948.87449.11
3649123-64912351.60951.85
4630844-63084450.15550.39
5650990-65099051.75751.99
6654791-65479152.05952.29
45min1634720-63472050.46351.941.5450.7852.261.53
2658914-65891452.38752.70
3659432-65943252.42852.76
4648837-64883751.58651.91
5658623-65862352.36452.68
6659406-65940652.42652.75
60min1647002-64700251.44052.061.0251.8452.471.02
2664383-66438352.82253.23
3656801-65680152.21952.64
4647385-64738551.47051.88
5657582-65758252.28152.69
6655871-65587152.14552.55
极限1656134-65613452.16652.120.8552.6552.610.84
2662340-66234052.65953.15
3655701-65570152.13252.64
4645443-64544351.31651.81
5655463-65546352.11352.61
6657947-65794752.31052.81
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%
127.349594709589639602379598879596889596490.05
227.259578469582439580440.03
单位质量响应值RSD%判断
35100.5535157.580.12数据可信
加速6月-供试品溶液-2024032521批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1431751-43175118.80617.3010.8618.8117.3010.88
2458421-45842119.96819.97
3407850-40785017.76517.77
4363353-36335315.82715.83
5375700-37570016.36516.36
6345853-34585315.06515.06
10min1752143-75214332.76231.704.6132.7931.734.61
2731968-73196831.88331.92
3771297-77129733.59633.63
4719874-71987431.35731.38
5717738-71773831.26331.29
6673579-67357929.34029.37
15min1905524-90552439.44340.443.5339.5340.523.52
2888715-88871538.71138.80
3968072-96807242.16842.25
4943745-94374541.10841.19
5905305-90530539.43439.51
6958841-95884141.76641.84
20min1974501-97450142.44844.494.3142.6044.644.30
2966842-96684242.11442.26
31037002-103700245.17045.33
41065319-106531946.40446.55
51014870-101487044.20644.35
61069271-106927146.57646.72
30min11038265-103826545.22547.513.3745.4547.743.35
21058117-105811746.09046.31
31117026-111702648.65648.89
41084622-108462247.24447.47
51118528-111852848.72148.94
61128324-112832449.14849.37
45min11092696-109269647.59649.041.5947.8949.341.59
21134425-113442549.41449.71
31135746-113574649.47149.78
41117853-111785348.69249.00
51137489-113748949.54749.85
61136945-113694549.52349.83
60min11112876-111287648.47549.151.0748.8549.531.07
21145381-114538149.89150.27
31131640-113164049.29249.69
41115968-111596848.61048.99
51133564-113356449.37649.76
61130148-113014849.22749.61
极限11126489-112648949.06849.210.9549.5349.670.94
21144244-114424449.84150.30
31131730-113173049.29649.77
41111783-111178348.42748.89
51129155-112915549.18449.65
61134573-113457349.42049.89
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%
127.345557525558335550865549385548525552920.09
227.255602745600035601380.04
单位质量响应值RSD%判断
20310.6120555.520.85数据可信
加速6月-供试品溶液-2024032621批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1169446-16944613.43116.4715.0713.4316.4715.08
2175237-17523713.89013.89
3228152-22815218.08518.08
4201510-20151015.97315.97
5223880-22388017.74617.75
6248474-24847419.69619.70
10min1390517-39051730.95532.777.2330.9832.807.24
2438406-43840634.75134.77
3402590-40259031.91231.94
4382466-38246630.31730.34
5406517-40651732.22332.25
6460274-46027436.48436.52
15min1542469-54246943.00042.453.3143.0742.533.30
2547184-54718443.37343.45
3532398-53239842.20142.28
4508391-50839140.29840.38
5524639-52463941.58641.67
6558178-55817844.24544.34
20min1621508-62150849.26547.412.6349.4147.562.62
2603791-60379147.86048.01
3588389-58838946.64046.79
4590815-59081546.83246.98
5577439-57743945.77245.92
6606877-60687748.10548.27
30min1658077-65807752.16351.292.4452.3951.522.44
2655360-65536051.94852.18
3630770-63077049.99950.23
4652224-65222451.70051.92
5623767-62376749.44449.67
6661812-66181252.46052.71
45min1658887-65888752.22852.450.9652.5452.770.95
2659105-65910552.24552.56
3654008-65400851.84152.16
4665620-66562052.76153.07
5672094-67209453.27553.59
6660748-66074852.37552.71
60min1659862-65986252.30552.530.9052.7152.930.89
2659245-65924552.25652.66
3657387-65738752.10952.51
4665137-66513752.72353.12
5673574-67357453.39253.79
6660895-66089552.38752.81
极限1657036-65703652.08152.370.9752.5752.860.96
2656506-65650652.03952.53
3656462-65646252.03552.52
4663091-66309152.56153.05
5672726-67272653.32553.81
6658558-65855852.20252.71
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%
127.349574619593609575879578289573629579200.09
227.259648399659749654060.09
单位质量响应值RSD%判断
35037.3135427.740.79数据可信
加速6月-供试品溶液-2024032621批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1287550-28755012.48915.4115.5712.4915.4115.57
2297017-29701712.90012.90
3391446-39144617.00117.00
4343793-34379314.93214.93
5383042-38304216.63616.64
6426515-42651518.52418.52
10min1671563-67156329.16730.837.3029.1930.867.29
2752164-75216432.66832.69
3691462-69146230.03130.06
4654905-65490528.44428.47
5697969-69796930.31430.34
6791429-79142934.37334.40
15min1931985-93198540.47839.953.3440.5540.033.35
2939587-93958740.80840.88
3913153-91315339.66039.74
4872870-87287037.91037.98
5901776-90177639.16639.24
6959824-95982441.68741.78
20min11068399-106839946.40244.642.7046.5444.792.70
21036918-103691845.03545.18
31011203-101120343.91844.06
41014841-101484144.07644.21
5990903-99090343.03743.18
61045344-104534445.40145.56
30min11133252-113325249.21948.302.5549.4348.522.55
21127808-112780848.98349.20
31083122-108312247.04247.26
41118911-111891148.59648.81
51070821-107082146.50846.72
61139224-113922449.47949.71
45min11136637-113663749.36649.530.9749.6649.830.96
21136509-113650949.36149.66
31125045-112504548.86349.16
41148617-114861749.88650.18
51156896-115689650.24650.54
61139318-113931849.48349.80
60min11138690-113869049.45549.600.9549.8349.980.94
21136297-113629749.35149.73
31129388-112938849.05149.43
41146818-114681849.80850.18
51160776-116077650.41550.79
61140338-114033849.52749.93
极限11133527-113352749.23149.460.9949.6949.920.98
21129439-112943949.05449.52
31132083-113208349.16849.63
41143469-114346949.66350.12
51159617-115961750.36450.82
61134446-113444649.27149.75
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.345590835597595594975584915590625591780.09
227.255556395583945570160.35
单位质量响应值RSD%判断
20452.7420440.950.05数据可信
长期6月-供试品溶液-2024032421批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1227443-22744318.01616.6115.9018.0216.6115.90
2208444-20844416.51116.51
3249157-24915719.73619.74
4182397-18239714.44814.45
5230804-23080418.28218.28
6159796-15979612.65712.66
10min1438746-43874634.75331.688.2334.7831.718.23
2399542-39954231.64831.68
3439019-43901934.77534.81
4361776-36177628.65628.68
5389224-38922430.83130.86
6371531-37153129.42929.45
15min1518349-51834941.05940.775.3241.1540.855.32
2498243-49824339.46639.55
3563580-56358044.64144.73
4488505-48850538.69538.77
5496792-49679239.35139.43
6522591-52259141.39541.46
20min1573072-57307245.39345.375.2445.5545.525.23
2547282-54728243.35043.50
3621619-62161949.23949.40
4548170-54817043.42143.56
5552568-55256843.76943.92
6593849-59384947.03947.18
30min1622336-62233649.29549.074.1549.5349.304.15
2597330-59733047.31547.53
3658196-65819652.13652.38
4601207-60120747.62247.83
5597100-59710047.29647.52
6640956-64095650.77050.99
45min1641275-64127550.79651.101.7651.1151.401.77
2643966-64396651.00951.31
3662554-66255452.48152.82
4637689-63768950.51250.80
5631327-63132750.00850.31
6653682-65368251.77852.08
60min1644382-64438251.04250.982.9351.4451.372.92
2607362-60736248.10948.49
3660686-66068652.33352.75
4654716-65471651.86052.23
5644539-64453951.05451.44
6650026-65002651.48951.88
极限1643797-64379750.99551.720.9651.4852.190.95
2653637-65363751.77552.24
3659958-65995852.27552.78
4659410-65941052.23252.69
5651527-65152751.60852.08
6648970-64897051.40551.88
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%
127.349640269630129635049631809643329636110.06
227.259588139650859619490.47
单位质量响应值RSD%判断
35245.4635300.880.12数据可信
长期6月-供试品溶液-2024032421批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1390383-39038316.93515.5516.3716.9315.5516.37
2356939-35693915.48415.48
3427163-42716318.53118.53
4310318-31031813.46213.46
5395798-39579817.17017.17
6270418-27041811.73111.73
10min1754586-75458632.73429.788.4332.7629.808.43
2686412-68641229.77729.80
3754602-75460232.73532.77
4618971-61897126.85126.87
5667335-66733528.94928.98
6636370-63637027.60627.63
15min1916443-91644339.75638.545.6139.8438.625.62
2855397-85539737.10737.18
3969853-96985342.07342.16
4837652-83765236.33836.40
5853425-85342537.02237.10
6897982-89798238.95539.02
20min1984254-98425442.69742.725.3842.8542.865.38
2940271-94027140.78940.93
31070343-107034346.43246.59
4940378-94037840.79440.92
5949584-94958441.19341.33
61023410-102341044.39644.53
30min11069311-106931146.38746.224.1846.6146.434.18
21027129-102712944.55744.76
31132526-113252649.12949.36
41033359-103335944.82845.02
51027155-102715544.55844.77
61102917-110291747.84548.05
45min11104308-110430847.90548.151.7448.2048.441.76
21107553-110755348.04648.33
31138708-113870849.39849.71
41096413-109641347.56347.83
51086562-108656247.13647.42
61126348-112634848.86149.15
60min11109948-110994848.15048.411.5148.5348.781.52
21090896-109089647.32447.68
31139429-113942949.42949.83
41126722-112672248.87849.23
51108202-110820248.07448.43
61120827-112082748.62248.99
极限11111093-111109348.20048.870.9748.6649.320.96
21129120-112912048.98249.42
31138871-113887149.40549.88
41137803-113780349.35849.79
51123399-112339948.73449.17
61118941-111894148.54048.99
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%
127.345554215548455551665558825554985553620.07
227.255543995544015544000.01
单位质量响应值RSD%判断
20313.1720344.950.12数据可信
长期6月-供试品溶液-2024032521批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1174703-17470313.91815.7411.9713.9215.7411.96
2198172-19817215.78815.79
3231485-23148518.44218.44
4217762-21776217.34917.35
5171473-17147313.66113.66
6192027-19202715.29915.30
10min1352782-35278228.10630.586.0728.1330.616.07
2401440-40144031.98232.01
3396182-39618231.56431.59
4407935-40793532.50032.53
5357630-35763028.49228.51
6387330-38733030.85830.88
15min1465348-46534837.07439.814.7437.1439.884.75
2501164-50116439.92740.01
3518056-51805641.27341.36
4530402-53040242.25742.34
5481312-48131238.34638.42
6501640-50164039.96540.04
20min1531845-53184542.37244.444.0942.5044.594.10
2548857-54885743.72743.87
3570417-57041745.44545.60
4595763-59576347.46447.62
5542304-54230443.20543.34
6557985-55798544.45444.60
30min1607170-60717048.37348.462.6148.5848.682.62
2592206-59220647.18147.40
3630737-63073750.25050.48
4623065-62306549.63949.87
5592425-59242547.19847.40
6603728-60372848.09948.32
45min1638632-63863250.87950.982.0551.1651.282.04
2628901-62890150.10450.40
3664981-66498152.97953.29
4631341-63134150.29850.61
5634645-63464550.56250.85
6640706-64070651.04551.34
60min1648175-64817551.64051.681.3852.0152.071.37
2646025-64602551.46851.85
3663403-66340352.85353.25
4635614-63561450.63951.04
5649494-64949451.74552.11
6649637-64963751.75652.14
极限1654598-65459852.15152.151.5852.6152.621.56
2660560-66056052.62653.09
3663001-66300152.82153.31
4636721-63672150.72751.21
5663368-66336852.85053.31
6649477-64947751.74352.21
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%
127.349570759587329575109575789578089577410.07
227.259570939572759571840.02
单位质量响应值RSD%判断
35030.7635126.020.20数据可信
长期6月-供试品溶液-2024032521批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1295889-29588912.90714.6511.9812.9114.6611.97
2338301-33830114.75714.76
3390704-39070417.04317.04
4372845-37284516.26416.26
5290682-29068212.68012.68
6327314-32731414.27814.28
10min1603941-60394126.34528.716.2126.3728.736.21
2688516-68851630.03430.06
3679479-67947929.64029.67
4701273-70127330.59030.62
5612029-61202926.69826.72
6663233-66323328.93128.95
15min1798860-79886034.84737.454.8534.9137.524.86
2860605-86060537.54137.62
3890057-89005738.82538.90
4913532-91353239.84939.93
5826131-82613136.03736.10
6861523-86152337.58137.65
20min1912673-91267339.81241.804.1739.9441.944.17
2943565-94356541.16041.30
3979206-97920642.71442.86
41025143-102514344.71844.86
5930917-93091740.60840.73
6957898-95789841.78541.92
30min11045178-104517845.59245.612.6645.7845.812.67
21016373-101637344.33644.54
31084858-108485847.32347.54
41070605-107060546.70146.92
51017401-101740144.38044.57
61038577-103857745.30445.51
45min11099022-109902247.94148.042.1248.2148.322.11
21080586-108058647.13747.42
31146271-114627150.00250.29
41087582-108758247.44247.74
51092531-109253147.65847.93
61102242-110224248.08148.36
60min11116875-111687548.72048.781.3949.0749.151.38
21114829-111482948.63048.99
31144214-114421449.91250.29
41095585-109558547.79148.17
51118475-111847548.78949.14
61120167-112016748.86349.22
极限11128651-112865149.23349.251.5549.6649.691.53
21138353-113835349.65650.10
31144628-114462849.93050.39
41098726-109872647.92848.38
51143071-114307149.86250.29
61120470-112047048.87649.32
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%
127.345549575545485542335553885546965547640.08
227.255540865555325548090.19
单位质量响应值RSD%判断
20291.2920359.960.24数据可信
长期6月-供试品溶液-2024032621批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1213314-21331416.99716.9812.2717.0016.9812.28
2184755-18475514.72214.72
3244948-24494819.51819.52
4210126-21012616.74316.74
5184436-18443614.69614.70
6240829-24082919.19019.19
10min1385742-38574230.73731.355.6530.7731.375.64
2358207-35820728.54328.57
3419054-41905433.39133.42
4405036-40503632.27432.30
5382753-38275330.49930.52
6409465-40946532.62732.66
15min1509344-50934440.58640.324.2340.6740.404.23
2467684-46768437.26637.34
3506640-50664040.37140.46
4501098-50109839.92940.01
5527701-52770142.04942.12
6523694-52369441.72941.82
20min1582236-58223646.39445.263.8746.5445.403.86
2531537-53153742.35442.49
3554818-55481844.20944.36
4566169-56616945.11445.26
5584903-58490346.60746.75
6588220-58822046.87147.03
30min1649779-64977951.77649.603.9852.0049.823.97
2582666-58266646.42946.63
3605307-60530748.23348.46
4639796-63979650.98151.20
5633911-63391150.51250.73
6623000-62300049.64249.88
45min1658707-65870752.48851.752.1852.8052.062.19
2621829-62182949.54949.83
3648164-64816451.64851.96
4656869-65686952.34152.65
5658205-65820552.44852.75
6653195-65319552.04852.37
60min1661058-66105852.67552.601.2753.0752.991.29
2643911-64391151.30951.67
3666249-66624953.08953.48
4659808-65980852.57552.97
5665032-66503252.99253.39
6664819-66481952.97553.38
极限1659078-65907852.51752.850.6653.0053.330.67
2658616-65861652.48052.93
3666769-66676953.13053.61
4660605-66060552.63953.12
5668415-66841553.26153.74
6666251-66625153.08953.58
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%
127.349565679572339558679572449579469569710.09
227.259569939572859571390.03
单位质量响应值RSD%判断
35002.6035124.370.25数据可信
长期6月-供试品溶液-2024032621批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1364665-36466515.91415.9012.7515.9115.9012.73
2314103-31410313.70713.71
3420991-42099118.37218.37
4358445-35844515.64315.64
5313624-31362413.68713.69
6413615-41361518.05018.05
10min1660897-66089728.84229.425.7828.8729.455.78
2612385-61238526.72426.75
3720290-72029031.43331.46
4693980-69398030.28530.31
5656463-65646328.64828.67
6701581-70158130.61730.65
15min1874778-87477838.17537.884.3138.2537.964.31
2800594-80059434.93835.01
3869795-86979537.95838.04
4859592-85959237.51337.59
5905700-90570039.52539.60
6898126-89812639.19439.28
20min1998921-99892143.59342.573.9143.7342.713.91
2912196-91219639.80839.93
3953329-95332941.60341.75
4971234-97123442.38542.52
51006169-100616943.90944.05
61010743-101074344.10944.26
30min11117441-111744148.76546.654.0348.9846.864.02
2999639-99963943.62443.82
31040151-104015145.39245.61
41098533-109853347.94048.15
51088515-108851547.50347.71
61070202-107020246.70446.92
45min11135734-113573449.56348.772.2749.8649.062.27
21068136-106813646.61346.88
31115153-111515348.66548.96
41129706-112970649.30049.59
51132474-113247449.42149.71
61124030-112403049.05349.35
60min11137883-113788349.65749.601.3650.0349.971.38
21106523-110652348.28948.63
31147670-114767050.08450.46
41136753-113675349.60849.98
51144061-114406149.92750.30
61146928-114692850.05250.43
极限11136750-113675049.60849.910.6150.0750.360.62
21135929-113592949.57249.99
31150673-115067350.21550.67
41140083-114008349.75350.21
51151209-115120950.23950.69
61147539-114753950.07950.54
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