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%
128.011127980112835811277531127485112722911277610.04
228.021141664114101011413370.05
单位质量响应值RSD%判断
40262.8040732.940.83数据可信
裸放高温-供试品溶液-2024022221批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min160401-604012.4601.4947.012.461.4847.13
233994-339941.3851.38
321188-211880.8630.86
455005-550052.2402.24
521471-214710.8750.87
626908-269081.0961.10
10min1165408-1654086.7377.7539.516.747.7639.50
2208846-2088468.5078.51
3206193-2061938.3998.40
4319845-31984513.02813.03
5139428-1394285.6795.68
6102538-1025384.1774.18
15min1384164-38416415.64818.4518.4315.6718.4718.44
2489529-48952919.94019.96
3421521-42152117.17017.19
4604869-60486924.63824.67
5428841-42884117.46817.48
6388890-38889015.84015.85
20min1558079-55807922.73225.0012.8022.7925.0612.83
2658765-65876526.83326.90
3613003-61300324.96925.03
4747585-74758530.45130.54
5565611-56561123.03923.09
6539622-53962221.98022.03
30min1769303-76930331.33534.0314.1831.4434.1514.19
2961027-96102739.14539.27
3861087-86108735.07435.19
4983384-98338440.05540.21
5733085-73308529.86029.96
6705084-70508428.72028.82
45min1913114-91311437.19338.1911.8237.3738.3811.84
21050729-105072942.79943.01
3954832-95483238.89239.08
41070740-107074043.61443.86
5845098-84509834.42334.59
6791488-79148832.23932.40
60min1974422-97442239.69040.1810.7839.9540.4610.80
21096236-109623644.65244.96
31003059-100305940.85741.14
41107973-110797345.13045.47
5896652-89665236.52336.77
6841000-84100034.25634.49
极限11154425-115442547.02247.582.0247.3747.952.10
21185460-118546048.28648.69
31171588-117158847.72148.09
41195612-119561248.70049.14
51172409-117240947.75548.08
61129364-112936446.00246.31
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%
128.011132912113364411325331131937113135211324760.08
228.021158847115819211585200.04
单位质量响应值RSD%判断
40431.1341346.181.59数据可信
裸放高温-供试品溶液-2024022221批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112770-127700.5151.1846.220.521.1845.98
234655-346551.3981.40
319045-190450.7680.77
425843-258431.0431.04
551423-514232.0752.07
632065-320651.2941.29
10min1196257-1962577.9189.4127.057.929.4227.05
2269117-26911710.85810.86
3155856-1558566.2886.29
4181321-1813217.3167.32
5297334-29733411.99612.00
6300077-30007712.10712.11
15min1423428-42342817.08418.3918.9617.1018.4118.98
2506682-50668220.44320.47
3322061-32206112.99413.01
4409282-40928216.51316.53
5553870-55387022.34722.38
6519264-51926420.95120.98
20min1650685-65068526.25326.7016.8226.3126.7716.83
2720727-72072729.07929.15
3481107-48110719.41119.46
4591527-59152723.86623.92
5760801-76080130.69630.78
6766392-76639230.92131.00
30min1824044-82404433.24734.5511.8233.3634.6711.85
2875288-87528835.31535.45
3728732-72873229.40229.49
4771229-77122931.11731.22
5949574-94957438.31238.46
6988845-98884539.89740.04
45min1909889-90988936.71138.947.6936.9039.147.71
2951913-95191338.40738.62
3937959-93795937.84438.00
4881090-88109035.54935.73
51041573-104157342.02442.26
61068091-106809143.09443.33
60min1957324-95732438.62541.007.5838.9041.287.59
2995815-99581540.17840.48
31020364-102036441.16841.41
4916471-91647136.97737.23
51085753-108575343.80744.13
61120758-112075845.21945.55
极限11172641-117264147.31247.581.7347.6747.961.79
21187850-118785047.92648.32
31177671-117767147.51547.84
41147319-114731946.29046.63
51180994-118099447.64948.07
61209743-120974348.80949.24
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%
128.011136516113697211370981136547113442911363120.10
228.021132510113231411324120.02
单位质量响应值RSD%判断
40568.0840414.420.27数据可信
裸放高湿-供试品溶液-2024022221批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136530-365301.4881.1027.141.491.1027.19
226480-264801.0791.08
319112-191120.7790.78
434808-348081.4181.42
525658-256581.0451.05
619693-196930.8020.80
10min1121824-1218244.9632.4960.494.972.5060.57
270441-704412.8702.87
332399-323991.3201.32
480231-802313.2683.27
538349-383491.5621.56
624054-240540.9800.98
15min1430310-43031017.5308.4393.7517.548.4493.67
2233930-2339309.5309.54
340066-400661.6321.64
4445858-44585818.16318.17
558727-587272.3922.40
632299-322991.3161.32
20min1687281-68728127.99814.5188.5128.0514.5488.51
2541651-54165122.06622.10
345806-458061.8661.87
4689321-68932128.08128.13
582046-820463.3423.35
690980-909803.7063.71
30min1963118-96311839.23523.1274.5039.3523.1874.51
2939360-93936038.26738.35
3119637-1196374.8744.89
4954382-95438238.87938.99
5223514-2235149.1059.12
6205960-2059608.3908.41
45min11044513-104451342.55136.0232.8842.7536.1332.92
21049161-104916142.74042.90
3300283-30028312.23312.26
41034956-103495642.16242.36
5935088-93508838.09338.13
6941331-94133138.34838.38
60min11094026-109402644.56842.198.0244.8742.388.21
21100293-110029344.82345.08
3878901-87890135.80435.85
41081793-108179344.07044.36
51022694-102269441.66241.79
61036384-103638442.22042.34
极限11183743-118374348.22347.013.0048.6247.303.21
21189376-118937648.45248.81
31104730-110473045.00445.13
41177450-117745047.96748.36
51127962-112796245.95146.17
61140619-114061946.46646.68
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%
128.011154396115384011533971153632115221711534960.07
228.021168556116802411682900.04
单位质量响应值RSD%判断
41181.5841694.860.88数据可信
裸放高湿-供试品溶液-2024022221批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min127845-278451.1081.0623.181.111.0623.39
231383-313831.2491.25
324230-242300.9650.96
434395-343951.3691.37
516647-166470.6630.66
625444-254441.0131.01
10min137064-370641.4751.5832.491.481.5932.36
243948-439481.7491.75
332266-322661.2841.29
461445-614452.4462.45
522989-229890.9150.92
640840-408401.6261.63
15min146532-465321.8523.2753.061.863.2752.98
281828-818283.2573.26
343824-438241.7451.75
4104047-1040474.1424.15
5157561-1575616.2726.28
658382-583822.3242.33
20min164033-640332.54910.3885.452.5610.3985.39
2449433-44943317.89117.90
355590-555902.2132.22
4364842-36484214.52414.54
5554998-55499822.09322.11
675459-754593.0043.01
30min1106788-1067884.25120.9574.764.2720.9974.73
2877982-87798234.95135.00
3304518-30451812.12212.14
4847577-84757733.74033.79
5911403-91140336.28136.35
6109583-1095834.3624.38
45min1559327-55932722.26631.9843.2922.2932.0643.31
21050584-105058441.82241.95
3966985-96698538.49438.53
41013076-101307640.32940.45
51029099-102909940.96641.11
6201445-2014458.0198.05
60min11005205-100520540.01540.7110.6240.0940.8610.75
21111695-111169544.25444.48
31049076-104907641.76241.89
41072135-107213542.68042.89
51083922-108392243.14943.39
6813521-81352132.38532.43
极限11142705-114270545.48946.232.1845.6546.482.35
21182432-118243247.07047.39
31140276-114027645.39245.61
41164245-116424546.34646.66
51199729-119972947.75948.09
61139288-113928845.35345.47
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.011152332115159411502581150058114905211506590.12
228.021152228115334711527880.07
单位质量响应值RSD%判断
41080.2941141.610.11数据可信
裸放光照-供试品溶液-2024022221批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150678-506782.0333.2965.182.033.2965.22
274914-749143.0063.01
3180661-1806617.2497.25
465509-655092.6282.63
526265-262651.0541.05
694235-942353.7813.78
10min1159893-1598936.41513.8343.046.4213.8443.05
2520362-52036220.87920.89
3510791-51079120.49520.51
4334254-33425413.41113.42
5213848-2138488.5808.58
6329320-32932013.21313.22
15min1494745-49474519.85124.0519.0019.8724.0919.04
2674285-67428527.05527.11
3782015-78201531.37731.44
4584352-58435223.44623.48
5479438-47943819.23719.26
6581833-58183323.34523.38
20min1678683-67868327.23130.9613.6527.2931.0513.70
2777266-77726631.18731.30
3961903-96190338.59538.73
4727500-72750029.19029.28
5683590-68359027.42827.49
6800958-80095832.13732.23
30min1869782-86978234.89937.688.0935.0237.848.11
2886374-88637435.56435.75
31046917-104691742.00642.22
4868570-86857034.85035.00
5959062-95906238.48138.61
61004423-100442340.30140.46
45min1946211-94621137.96540.727.5338.1740.967.54
2954741-95474138.30838.57
31113832-111383244.69145.00
4940591-94059137.74037.97
51058480-105848042.47042.68
61074821-107482143.12643.38
60min1990642-99064239.74842.616.9040.0342.946.92
2997998-99799840.04340.39
31157296-115729646.43546.84
41002567-100256740.22640.54
51103804-110380444.28844.59
61119362-111936244.91345.26
极限11189295-118929547.71947.971.2248.0948.401.29
21180989-118098947.38547.82
31222794-122279449.06349.58
41192678-119267847.85448.26
51189157-118915747.71348.12
61198752-119875248.09848.54
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%
128.011145779114588511446051143370114368111446640.11
228.021128085112698511275350.07
单位质量响应值RSD%判断
40866.2640240.361.10数据可信
裸放光照-供试品溶液-2024022221批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147922-479221.9492.1536.621.952.1436.66
241656-416561.6941.69
355756-557562.2682.27
423880-238800.9710.97
572590-725902.9532.95
674682-746823.0383.04
10min1292520-29252011.89912.9732.6511.9012.9732.65
2321373-32137313.07313.08
3484814-48481419.72119.73
4160680-1606806.5366.54
5306980-30698012.48712.49
6346085-34608514.07814.08
15min1527006-52700621.43723.3218.1321.4723.3618.14
2581706-58170623.66223.70
3759937-75993730.91230.96
4448795-44879518.25618.27
5537319-53731921.85721.89
6585638-58563823.82223.86
20min1772838-77283831.43731.7910.6431.5231.8810.67
2730583-73058329.71829.80
3942583-94258338.34238.46
4724598-72459829.47529.53
5730129-73012929.70029.78
6788574-78857432.07732.17
30min1940429-94042938.25438.907.5038.4039.057.51
2838595-83859534.11234.26
31039443-103944342.28242.48
4962183-96218339.13939.26
5935417-93541738.05138.20
61021269-102126941.54341.71
45min11047602-104760242.61442.136.4542.8542.376.45
2916781-91678137.29237.52
31099030-109903044.70645.00
41031099-103109941.94342.15
51022373-102237341.58841.82
61097140-109714044.62944.88
60min11093603-109360344.48544.245.3044.8144.585.32
2986037-98603740.11040.42
31139921-113992146.36946.77
41072944-107294443.64543.95
51088888-108888844.29344.62
61144784-114478446.56746.92
极限11221246-122124649.67748.801.7150.1049.231.74
21189925-118992548.40348.80
31211576-121157649.28449.78
41163442-116344247.32647.73
51203271-120327148.94649.37
61208382-120838249.15449.61
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