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125
标示量(mg)200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%
128.075795655795395804875800835795865798520.08
228.185806185806875806520.01
单位质量响应值RSD%判断
20657.3620605.110.18数据可信
供试品溶液-2024032421批-缬沙坦钠-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1117037-1170379.90412.6018.359.9012.6018.35
2188739-18873915.97215.97
3143871-14387112.17512.18
4130787-13078711.06811.07
5138145-13814511.69111.69
6174555-17455514.77214.77
10min1330387-33038727.95930.029.0227.9830.049.02
2408889-40888934.60334.63
3366448-36644831.01131.03
4345597-34559729.24729.27
5317981-31798126.91026.93
6359313-35931330.40730.43
15min1522866-52286644.24842.733.4244.3142.803.42
2512622-51262243.38143.47
3514597-51459743.54943.62
4506993-50699342.90542.97
5473845-47384540.10040.16
6498487-49848742.18542.26
20min1586783-58678349.65748.545.9249.7948.695.91
2569820-56982048.22248.38
3585590-58559049.55649.70
4625082-62508252.89853.04
5529022-52902244.76944.90
6545512-54551246.16546.31
30min1617861-61786152.28752.303.1252.5152.523.11
2608931-60893151.53251.77
3629604-62960453.28153.51
4613545-61354551.92252.15
5590548-59054849.97650.18
6647285-64728554.77755.00
45min1635290-63529053.76252.874.2554.0753.184.24
2639392-63939254.10954.43
3632098-63209853.49253.81
4656845-65684555.58655.90
5594500-59450050.31050.60
6590237-59023749.95050.26
60min1591456-59145650.05351.622.3150.4552.012.30
2619449-61944952.42252.83
3631093-63109353.40753.81
4606214-60621451.30251.71
5610997-61099751.70752.08
6600359-60035950.80651.20
极限1622321-62232152.66552.501.0453.1452.981.03
2618632-61863252.35352.85
3628668-62866853.20253.70
4614678-61467852.01852.51
5625928-62592852.97053.43
6612134-61213451.80352.28
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125
标示量(mg)200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%
128.079907099892089914329904959888489901380.11
228.189927599904809916200.17
单位质量响应值RSD%判断
35273.8935188.790.18数据可信
供试品溶液-2024032421批-沙库巴曲缬沙坦钠-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1197859-1978599.26411.7818.749.2611.7818.75
2321729-32172915.06315.06
3242218-24221811.34111.34
4220719-22071910.33410.33
5232430-23243010.88210.88
6295235-29523513.82313.82
10min1564653-56465326.43728.459.1626.4528.489.17
2700179-70017932.78232.81
3625793-62579329.29929.32
4590788-59078827.66027.68
5542467-54246725.39825.42
6622562-62256229.14829.17
15min1903095-90309542.28340.483.9242.3440.553.92
2878148-87814841.11541.19
3878918-87891841.15141.22
4870908-87090840.77640.84
5803986-80398637.64237.70
6852686-85268639.92239.99
20min11016133-101613347.57546.105.9147.7046.245.90
2972751-97275145.54445.69
31002340-100234046.92947.07
41069141-106914150.05750.19
5902348-90234842.24842.37
6945208-94520844.25444.39
30min11072369-107236950.20849.723.1450.4249.943.13
21044478-104447848.90249.13
31084498-108449850.77650.99
41055740-105574049.42949.64
51009949-100994947.28547.48
61105313-110531351.75051.96
45min11096783-109678351.35150.474.5351.6450.764.52
21139121-113912153.33353.64
31085400-108540050.81851.12
41107057-110705751.83252.13
51023429-102342947.91748.19
61015403-101540347.54147.84
60min11016581-101658147.59649.042.3447.9749.422.33
21064219-106421949.82650.22
31084915-108491550.79551.18
41045634-104563448.95649.34
51044879-104487948.92149.27
61028944-102894448.17548.55
极限11082825-108282550.69750.211.0951.1650.671.07
21065824-106582449.90150.38
31084777-108477750.78951.26
41069269-106926950.06350.53
51077087-107708750.42950.86
61054118-105411849.35349.81
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125
标示量(mg)200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%
128.075779775782705782325782705778715781240.04
228.185855535842825849180.16
单位质量响应值RSD%判断
20595.8020756.490.55数据可信
供试品溶液-2024032421批-缬沙坦钠-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1110648-1106489.34410.4117.699.3410.4117.68
2147444-14744412.45112.45
3104556-1045568.8298.83
4151219-15121912.77012.77
5124636-12463610.52510.52
6100957-1009578.5258.53
10min1350700-35070029.61429.537.0329.6329.557.04
2367060-36706030.99631.02
3341373-34137328.82728.84
4383990-38399032.42632.45
5343343-34334328.99329.01
6311918-31191826.34026.35
15min1470678-47067839.74642.299.0939.8142.369.09
2500314-50031442.24842.32
3575212-57521248.57348.64
4532862-53286244.99745.07
5461294-46129438.95339.02
6464409-46440939.21639.27
20min1538468-53846845.47047.023.8245.6047.153.83
2566144-56614447.80747.95
3567272-56727247.90348.05
4589063-58906349.74349.89
5532663-53266344.98045.11
6546992-54699246.19046.31
30min1571869-57186948.29150.052.7948.5050.272.80
2608747-60874751.40551.63
3591132-59113249.91750.14
4614891-61489151.92452.16
5579591-57959148.94349.15
6590178-59017849.83750.04
45min1582695-58269549.20550.462.1349.4950.762.13
2596720-59672050.38950.70
3593013-59301350.07650.38
4614705-61470551.90852.23
5587764-58776449.63349.92
6610623-61062351.56351.85
60min1611793-61179351.66250.283.8352.0350.663.82
2603123-60312350.93051.32
3596344-59634450.35850.75
4613831-61383151.83452.24
5551544-55154446.57446.94
6595887-59588750.31950.69
极限1612982-61298251.76351.520.8952.2251.980.89
2606811-60681151.24151.72
3602746-60274650.89851.37
4616257-61625752.03952.53
5606629-60662951.22651.67
6614983-61498351.93152.38
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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125
标示量(mg)200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%
128.079881059883819879189881749879389881030.02
228.1810000719973859987280.20
单位质量响应值RSD%判断
35201.3935441.020.48数据可信
供试品溶液-2024032421批-沙库巴曲缬沙坦钠-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1184774-1847748.6299.6518.138.639.6518.12
2247371-24737111.55211.55
3175048-1750488.1758.17
4255097-25509711.91311.91
5210330-2103309.8239.82
6167585-1675857.8267.83
10min1597668-59766827.91227.867.0827.9327.887.09
2625860-62586029.22829.25
3582194-58219427.18927.20
4656534-65653430.66130.68
5585193-58519327.32927.35
6532360-53236024.86224.87
15min1804605-80460537.57639.898.5337.6439.958.52
2855557-85555739.95540.02
3964980-96498045.06545.12
4916679-91667942.81042.88
5788231-78823136.81136.87
6795017-79501737.12837.18
20min1921340-92134043.02744.624.0943.1544.754.09
2972561-97256145.42045.55
3975404-97540445.55245.69
41014131-101413147.36147.50
5910374-91037442.51542.64
6938725-93872543.83943.96
30min1978490-97849045.69647.512.9145.8947.712.92
21040916-104091648.61248.82
31017661-101766147.52647.74
41057554-105755449.38949.61
5991322-99132246.29646.49
61017939-101793947.53947.73
45min11018204-101820447.55148.161.4247.8248.441.43
21025460-102546047.89048.18
31022030-102203047.73048.02
41056243-105624349.32849.63
51024178-102417847.83048.10
61041385-104138548.63448.90
60min11049275-104927549.00247.953.2249.3548.323.22
21032621-103262148.22448.60
31023413-102341347.79448.16
41063311-106331149.65850.04
5967020-96702045.16145.51
61025187-102518747.87748.23
极限11063859-106385949.68349.251.1750.1249.691.17
21053221-105322149.18649.64
31041987-104198748.66249.11
41064414-106441449.70950.18
51037778-103777848.46548.89
61065739-106573949.77150.20
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125
标示量(mg)200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%
128.075803065800535803545804075797565801750.05
228.185821335821745821540.01
单位质量响应值RSD%判断
20668.8620658.410.04数据可信
供试品溶液-2024032521批-缬沙坦钠-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1129881-12988110.97410.4318.9910.9710.4218.97
2148825-14882512.57512.57
3111046-1110469.3839.38
498555-985558.3278.33
5151280-15128012.78212.78
6100831-1008318.5208.52
10min1358587-35858730.29829.136.8430.3229.146.84
2353622-35362229.87929.90
3349864-34986429.56129.58
4321382-32138227.15527.17
5373396-37339631.55031.57
6311427-31142726.31426.33
15min1522102-52210244.11441.934.8544.1842.004.86
2486946-48694641.14441.21
3511027-51102743.17943.24
4476724-47672440.28040.34
5517491-51749143.72543.80
6463281-46328139.14439.20
20min1579017-57901748.92347.982.7349.0748.122.73
2555331-55533146.92247.06
3585303-58530349.45449.59
4576072-57607248.67448.80
5566707-56670747.88348.03
6544589-54458946.01446.14
30min1601015-60101550.78250.791.6751.0151.011.66
2603872-60387251.02351.24
3607369-60736951.31951.54
4614727-61472751.94152.15
5591885-59188550.01050.24
6587678-58767849.65549.86
45min1605483-60548351.15951.052.1951.4751.352.18
2589719-58971949.82750.13
3621379-62137952.50352.81
4618200-61820052.23452.53
5595798-59579850.34150.65
6594335-59433550.21850.50
60min1602572-60257250.91351.381.5451.3151.761.54
2622322-62232252.58252.97
3605498-60549851.16151.55
4614061-61406151.88452.27
5608439-60843951.40951.80
6595355-59535550.30450.67
极限1599730-59973050.67351.941.5851.1552.411.57
2622309-62230952.58153.05
3619007-61900752.30252.78
4623613-62361352.69153.16
5617524-61752452.17752.66
6605841-60584151.19051.64
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125
标示量(mg)200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%
128.079906139905569909419907649897739905290.05
228.189931209935909933550.04
单位质量响应值RSD%判断
35287.8235250.350.08数据可信
供试品溶液-2024032521批-沙库巴曲缬沙坦钠-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1218851-21885110.2369.7119.6210.249.7019.65
2251282-25128211.75211.75
3186287-1862878.7138.71
4165160-1651607.7247.72
5256320-25632011.98811.99
6167309-1673097.8257.82
10min1611867-61186728.61727.486.8928.6327.506.90
2601510-60151028.13228.15
3598300-59830027.98228.00
4546944-54694425.58025.59
5636432-63643229.76629.79
6530653-53065324.81824.83
15min1895638-89563841.88839.725.0441.9539.785.05
2828242-82824238.73638.80
3877826-87782641.05541.12
4815173-81517338.12538.18
5885860-88586041.43141.50
6792288-79228837.05537.11
20min1993172-99317246.45045.552.8046.5845.682.80
2948013-94801344.33844.47
31004708-100470846.99047.12
4986569-98656946.14146.26
5976756-97675645.68245.82
6934498-93449843.70643.82
30min11028800-102880048.11648.361.8848.3348.561.88
21042170-104217048.74248.95
31052228-105222849.21249.42
41056461-105646149.41049.61
51012194-101219447.34047.55
61012091-101209147.33547.52
45min11036719-103671948.48748.702.0348.7848.982.02
21034272-103427248.37248.66
31070606-107060650.07250.36
41063649-106364949.74650.02
51021856-102185647.79248.09
61020652-102065247.73548.00
60min11033588-103358848.34048.881.6048.7149.251.60
21064288-106428849.77650.14
31054183-105418349.30449.68
41056426-105642649.40849.77
51043561-104356148.80749.18
61019021-101902147.65948.01
极限11043117-104311748.78649.761.3849.2450.211.37
21076798-107679850.36150.81
31077335-107733550.38650.84
41072566-107256650.16350.61
51064465-106446549.78450.24
61049189-104918949.07049.50
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125
标示量(mg)200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%
128.075815395809495808525806245808625809650.06
228.185794205804175799180.13
单位质量响应值RSD%判断
20697.0120579.060.41数据可信
供试品溶液-2024032521批-缬沙坦钠-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1132620-13262011.22011.7327.4711.2211.7327.46
2163880-16388013.86413.86
3150934-15093412.76912.77
473025-730256.1786.18
5128002-12800210.82910.83
6183448-18344815.52015.52
10min1332677-33267728.14429.569.6628.1629.589.67
2347563-34756329.40429.43
3383483-38348332.44232.46
4309757-30975726.20526.22
5326991-32699127.66327.68
6396066-39606633.50733.53
15min1473352-47335240.04542.656.5440.1142.726.55
2521372-52137244.10844.18
3529631-52963144.80644.88
4484579-48457940.99541.05
5468352-46835239.62239.69
6547379-54737946.30846.39
20min1541309-54130945.79448.043.4345.9348.183.44
2567474-56747448.00848.15
3569248-56924848.15848.31
4574361-57436148.59048.71
5555451-55545146.99147.12
6599260-59926050.69750.86
30min1579539-57953949.02851.613.5049.2451.833.49
2600809-60080950.82851.05
3599236-59923650.69550.93
4635011-63501153.72153.92
5613002-61300251.85952.07
6632608-63260853.51853.76
45min1583848-58384849.39351.382.8249.6851.682.82
2603667-60366751.07051.38
3601834-60183450.91551.23
4626355-62635552.98953.28
5599741-59974150.73851.03
6628367-62836753.15953.49
60min1588670-58867049.80151.362.7550.1751.752.75
2601266-60126650.86751.26
3593653-59365350.22350.62
4626838-62683853.03053.41
5604038-60403851.10151.48
6627949-62794953.12453.55
极限1618768-61876852.34751.773.2952.8052.243.23
2622070-62207052.62753.11
3615836-61583652.09952.58
4621167-62116752.55053.02
5622582-62258252.67053.13
6571203-57120348.32348.83
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125
标示量(mg)200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%
128.079915089912239904729909429911689910630.04
228.189909589905539907560.03
单位质量响应值RSD%判断
35306.8435158.130.30数据可信
供试品溶液-2024032521批-沙库巴曲缬沙坦钠-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1222627-22262710.42310.9627.9410.4210.9627.95
2277743-27774313.00313.00
3253830-25383011.88411.88
4121157-1211575.6725.67
5218153-21815310.21410.21
6311256-31125614.57214.57
10min1565686-56568626.48427.849.8726.5027.869.88
2589966-58996627.62127.64
3654590-65459030.64730.67
4527139-52713924.68024.69
5554724-55472425.97125.99
6675942-67594231.64631.67
15min1806552-80655237.76140.376.9737.8240.436.97
2892845-89284541.80141.87
3905102-90510242.37542.45
4826740-82674038.70638.76
5797726-79772637.34837.41
6944154-94415444.20444.28
20min1925205-92520543.31645.553.7543.4445.683.76
2970891-97089145.45545.59
3973672-97367245.58645.73
4985584-98558446.14346.26
5949099-94909944.43544.56
61033161-103316148.37148.52
30min1989944-98994446.34748.963.7646.5449.163.75
21029865-102986548.21648.43
31024505-102450547.96548.18
41094058-109405851.22251.41
51050933-105093349.20349.40
61084743-108474350.78651.02
45min1997714-99771446.71148.863.0746.9949.153.07
21032333-103233348.33248.63
31030244-103024448.23448.53
41080898-108089850.60650.88
51040909-104090948.73349.01
61079960-107996050.56250.88
60min11005603-100560347.08148.802.9647.4349.172.96
21027937-102793748.12648.50
31019903-101990347.75048.13
41080301-108030150.57850.94
51042492-104249248.80849.17
61077797-107779750.46150.86
极限11063279-106327949.78149.621.8050.2150.071.76
21067952-106795250.00050.45
31054124-105412449.35249.81
41080029-108002950.56551.01
51068772-106877250.03850.48
61024971-102497147.98748.47
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125
标示量(mg)200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%
128.075811785810265803495806185798485806040.10
228.185809195803705806440.07
单位质量响应值RSD%判断
20684.1520604.830.28数据可信
供试品溶液-2024032621批-缬沙坦钠-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1118400-11840010.01311.0718.3610.0111.0718.38
2150794-15079412.75312.75
3116702-1167029.8709.87
4140077-14007711.84711.85
5161837-16183713.68713.69
697832-978328.2748.27
10min1339457-33945728.70929.212.5228.7329.222.53
2352476-35247629.81029.83
3339090-33909028.67828.69
4359376-35937630.39330.41
5343620-34362029.06129.08
6338039-33803928.58928.60
15min1461832-46183239.05841.273.6239.1241.343.62
2483453-48345340.88740.96
3513744-51374443.44943.51
4493985-49398541.77741.85
5496104-49610441.95742.03
6478577-47857740.47440.54
20min1528829-52882944.72447.545.0744.8547.685.07
2547058-54705846.26646.41
3600750-60075050.80750.94
4566969-56696947.95048.09
5589019-58901949.81549.96
6540085-54008545.67645.81
30min1592882-59288250.14150.633.7050.3550.853.69
2598411-59841150.60950.83
3616792-61679252.16452.38
4592754-59275450.13150.35
5627518-62751853.07153.29
6563822-56382247.68447.89
45min1604547-60454751.12850.615.6351.4250.915.61
2602970-60297050.99551.30
3619173-61917352.36552.67
4599168-59916850.67350.98
5630530-63053053.32553.64
6534002-53400245.16245.45
60min1609148-60914851.51751.492.0851.8951.882.09
2606602-60660251.30251.69
3620070-62007052.44152.84
4594039-59403950.23950.63
5626286-62628652.96653.37
6596726-59672650.46650.83
极限1620809-62080952.50352.480.8852.9652.950.89
2617869-61786952.25552.73
3621747-62174752.58353.07
4615132-61513252.02352.49
5630452-63045253.31953.81
6617215-61721552.19952.64
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125
标示量(mg)200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%
128.079921429913599908419904839912409912130.07
228.189912779914089913420.01
单位质量响应值RSD%判断
35312.1835178.920.27数据可信
供试品溶液-2024032621批-沙库巴曲缬沙坦钠-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1199566-1995669.34010.3418.859.3410.3418.85
2255110-25511011.93911.94
3195766-1957669.1629.16
4237868-23786811.13211.13
5273636-27363612.80612.81
6163149-1631497.6367.64
10min1576070-57607026.96127.472.5326.9827.492.54
2598489-59848928.01028.03
3577154-57715427.01127.03
4611269-61126928.60828.63
5584645-58464527.36227.38
6574534-57453426.88926.90
15min1784167-78416736.70038.953.9036.7639.013.90
2822891-82289138.51238.58
3879231-87923141.14941.21
4846144-84614439.60039.67
5845510-84551039.57139.64
6815501-81550138.16638.22
20min1899830-89983042.11345.055.5042.2345.185.50
2936583-93658343.83343.96
31034145-103414548.39948.53
4970753-97075345.43245.56
51012933-101293347.40647.54
6921823-92182343.14243.26
30min11018016-101801647.64448.113.9047.8448.313.89
21024461-102446147.94648.15
31064992-106499249.84250.05
41011758-101175847.35147.56
51079921-107992150.54150.75
6968221-96822145.31445.51
45min11038173-103817348.58748.334.6948.8648.614.68
21038925-103892548.62348.91
31066769-106676949.92650.22
41020875-102087547.77848.06
51085391-108539150.79751.09
6945829-94582944.26644.53
60min11044728-104472848.89448.892.3549.2549.252.35
21042038-104203848.76849.13
31064914-106491449.83950.21
41013398-101339847.42847.79
51078912-107891250.49450.87
61024058-102405847.92748.27
极限11067264-106726449.94949.981.2750.3850.431.28
21062236-106223649.71350.16
31068645-106864550.01350.47
41053452-105345249.30249.75
51093390-109339051.17251.64
61062699-106269949.73550.16
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125
标示量(mg)200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%
128.075804855807935808615805715804395806300.04
228.185819435819905819660.01
单位质量响应值RSD%判断
20685.0720651.740.12数据可信
供试品溶液-2024032621批-缬沙坦钠-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1149672-14967212.64310.5522.5912.6410.5522.59
2100544-1005448.4938.49
3133116-13311611.24511.24
480736-807366.8206.82
5135006-13500611.40511.40
6150488-15048812.71212.71
10min1349313-34931329.50829.326.1229.5329.346.13
2316049-31604926.69826.71
3350062-35006229.57129.59
4334378-33437828.24628.26
5352874-35287429.80929.83
6379962-37996232.09732.12
15min1497602-49760242.03541.462.6942.1041.532.70
2487892-48789241.21441.27
3498778-49877842.13442.20
4470344-47034439.73239.79
5483086-48308640.80840.88
6507296-50729642.85342.93
20min1560399-56039947.33947.752.6747.4847.882.67
2576082-57608248.66448.79
3564933-56493347.72247.86
4549604-54960446.42746.55
5551494-55149446.58746.72
6588923-58892349.74949.89
30min1584286-58428649.35750.231.6149.5850.451.60
2600576-60057650.73350.94
3600989-60098950.76850.99
4587083-58708349.59349.80
5587651-58765149.64149.86
6607435-60743551.31351.54
45min1586089-58608949.50951.112.2949.8151.412.28
2617314-61731452.14752.44
3614745-61474551.93052.23
4595460-59546050.30150.59
5597570-59757050.47950.78
6619197-61919752.30652.62
60min1590932-59093249.91851.232.1350.3051.622.13
2613629-61362951.83652.22
3613852-61385251.85552.24
4598075-59807550.52250.89
5597769-59776950.49650.88
6624764-62476452.77653.18
极限1606550-60655051.23852.101.0951.7052.571.10
2616081-61608152.04352.51
3624515-62451552.75553.23
4616761-61676152.10052.55
5613178-61317851.79852.26
6623639-62363952.68153.17
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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125
标示量(mg)200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%
128.079914819915489902149913499911759911530.06
228.189946519946619946560.01
单位质量响应值RSD%判断
35310.0535296.520.03数据可信
供试品溶液-2024032621批-沙库巴曲缬沙坦钠-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1252312-25231211.7899.8422.9711.799.8422.96
2168383-1683837.8687.87
3223994-22399410.46610.47
4134792-1347926.2986.30
5229605-22960510.72810.73
6253905-25390511.86311.86
10min1593862-59386227.74827.606.2327.7727.616.24
2538178-53817825.14625.16
3595124-59512427.80727.82
4567504-56750426.51626.53
5600494-60049428.05828.08
6648387-64838730.29530.32
15min1850049-85004939.71839.152.8439.7839.212.84
2836880-83688039.10239.16
3849693-84969339.70139.76
4800556-80055637.40537.46
5822415-82241538.42738.49
6867737-86773740.54440.61
20min1962483-96248344.97145.202.9245.1045.332.92
2985862-98586246.06446.18
3966803-96680345.17345.30
4937389-93738943.79943.92
5940372-94037243.93844.07
61011956-101195647.28347.42
30min1998543-99854346.65647.662.1746.8647.872.18
21034788-103478848.35048.55
31027078-102707847.98948.19
41002741-100274146.85247.04
51003658-100365846.89547.10
61053867-105386749.24149.46
45min11000247-100024746.73648.372.4347.0248.652.43
21055900-105590049.33649.61
31054105-105410549.25249.54
41017232-101723247.52947.80
51022885-102288547.79348.07
61061135-106113549.58149.88
60min11009292-100929247.15848.532.1147.5248.892.11
21051179-105117949.11549.48
31053352-105335249.21749.58
41023760-102376047.83448.18
51027203-102720347.99548.35
61067108-106710849.86050.24
极限11043510-104351048.75749.580.9749.2050.020.98
21060553-106055349.55350.00
31072251-107225150.10050.55
41061186-106118649.58350.01
51058774-105877449.47049.91
61070412-107041250.01450.48
点击查看处理图标(自动生成)
 
原始图谱下载图谱(谢鑫慧 于 2024-05-03 17:05:09 完成)
生成报告数据部分(等待生成报告)
Current page cost:719 ms