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%
128.531193760118631911882451189256118681511888790.25
228.5341208603120757912080910.06
单位质量响应值RSD%判断
41671.1942338.651.13数据可信
供试品溶液-2024032121批-沙库巴曲-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%
5min172091-720912.8312.0958.502.832.0958.37
219487-194870.7650.77
350431-504311.9811.98
421540-215400.8460.85
5101660-1016603.9923.99
654314-543142.1332.13
10min1344499-34449913.52911.2423.5713.5411.2423.59
2194950-1949507.6567.66
3292051-29205111.46911.47
4223505-2235058.7778.78
5369933-36993314.52814.54
6292044-29204411.46911.47
15min1534708-53470820.99920.199.8321.0420.229.87
2446587-44658717.53817.56
3501249-50124919.68519.71
4481282-48128218.90118.92
5593943-59394323.32523.37
6526996-52699620.69620.73
20min1695687-69568727.32127.657.4227.4027.727.44
2652390-65239025.62125.68
3686928-68692826.97727.05
4671672-67167226.37826.44
5800939-80093931.45431.55
6716563-71656328.14128.22
30min1904788-90478835.53337.526.6935.6837.666.69
2944997-94499737.11237.23
3996905-99690539.15039.28
4864021-86402133.93234.05
51037913-103791340.76140.92
6984313-98431338.65638.79
45min11023897-102389740.21142.155.7840.4342.375.78
21102488-110248843.29743.49
31088230-108823042.73742.96
4973746-97374638.24138.44
51137941-113794144.68944.94
61113541-111354143.73143.96
60min11110724-111072443.62044.625.0943.9344.935.09
21168508-116850845.89046.18
31141333-114133344.82245.14
41033728-103372840.59740.88
51195464-119546446.94847.30
61167064-116706445.83346.15
极限11231231-123123148.35348.541.5148.7648.951.54
21240069-124006948.70049.10
31234671-123467148.48848.90
41222644-122264448.01648.39
51269860-126986049.87050.33
61216842-121684247.78848.21
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.532031467202411820249472025815202496720262630.15
228.432043032204296320429980.01
单位质量响应值RSD%判断
71022.1971860.640.83数据可信
供试品溶液-2024032121批-缬沙坦钠-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%
5min189128-891282.1781.6062.082.181.6062.19
220204-202040.4940.49
360599-605991.4811.48
426133-261330.6390.64
5129198-1291983.1583.16
667166-671661.6421.64
10min1450512-45051211.0108.9924.9911.029.0024.98
2242863-2428635.9355.94
3374800-3748009.1609.16
4283842-2838426.9376.94
5480232-48023211.73711.74
6375518-3755189.1789.18
15min1714103-71410317.45216.5810.5817.4816.6010.60
2583681-58368114.26514.28
3656661-65666116.04916.07
4628453-62845315.35915.38
5788513-78851319.27119.30
6698163-69816317.06317.09
20min1947686-94768623.16123.197.9023.2323.257.92
2875838-87583821.40521.45
3916780-91678022.40622.47
4899920-89992021.99422.04
51086545-108654526.55526.63
6966768-96676823.62723.69
30min11266795-126679530.96032.496.9631.0832.606.97
21313993-131399332.11432.21
31377163-137716333.65733.77
41190862-119086229.10429.20
51451785-145178535.48135.62
61375851-137585133.62533.74
45min11501795-150179536.70338.306.1236.8938.486.13
21612504-161250439.40939.57
31579270-157927038.59738.78
41408334-140833434.41934.58
51666210-166621040.72240.94
61633824-163382439.93040.12
60min11683142-168314241.13541.925.5341.4142.195.53
21765038-176503843.13743.39
31710380-171038041.80142.07
41546661-154666137.80038.04
51811818-181181844.28044.58
61775265-177526543.38743.66
极限11942750-194275047.48047.671.5247.8448.041.56
21949943-194994347.65648.00
31936008-193600847.31547.68
41926003-192600347.07147.40
52008838-200883849.09549.50
61940203-194020347.41847.79
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.531211970121138312100211211240120977412108780.08
228.5341250799124898412498920.11
单位质量响应值RSD%判断
42442.2743803.602.24数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2024032121批-沙库巴曲-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%
5min130340-303401.1612.5733.771.162.5733.75
263830-638302.4422.44
367831-678312.5952.60
4100698-1006983.8533.85
575210-752102.8782.88
664518-645182.4692.47
10min1187494-1874947.17410.5328.497.1810.5328.47
2290864-29086411.12911.13
3184292-1842927.0517.06
4389225-38922514.89214.90
5312139-31213911.94311.95
6286494-28649410.96210.97
15min1381602-38160214.60018.8119.2114.6218.8419.22
2499731-49973119.12019.15
3397315-39731515.20215.22
4630338-63033824.11724.16
5556228-55622821.28221.31
6484067-48406718.52118.55
20min1549843-54984321.03825.6216.1121.0925.6916.14
2657882-65788225.17125.24
3551385-55138521.09721.15
4816307-81630731.23331.33
5759159-75915929.04629.13
6683164-68316426.13926.21
30min1740391-74039128.32834.1613.8528.4334.2813.86
2913082-91308234.93535.06
3738207-73820728.24528.35
4970192-97019237.12037.29
51019963-101996339.02539.17
6974441-97444137.28337.41
45min1893617-89361734.19139.3611.4434.3539.5711.47
21099341-109934142.06242.27
3868417-86841733.22633.39
41081394-108139441.37541.62
51151157-115115744.04444.28
61079048-107904841.28541.50
60min1965765-96576536.95141.8410.5737.1942.1310.60
21177523-117752345.05345.35
3931387-93138735.63635.87
41138470-113847043.55943.90
51206124-120612446.14746.48
61142394-114239443.70944.01
极限11207726-120772646.20946.731.7846.5347.121.85
21233734-123373447.20447.60
31190682-119068245.55745.87
41217529-121752946.58447.02
51253517-125351747.96148.39
61225125-122512546.87447.28
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.532053676205340520527462055102205480320539460.05
228.432094095209543320947640.05
单位质量响应值RSD%判断
71992.5073681.461.64数据可信
供试品溶液-2024032121批-缬沙坦钠-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%
5min135993-359930.8632.0834.420.862.0834.49
279356-793561.9021.90
394165-941652.2572.26
4124787-1247872.9922.99
5103811-1038112.4892.49
681910-819101.9641.96
10min1233301-2333015.5938.4529.685.608.4629.67
2377123-3771239.0419.05
3228824-2288245.4865.49
4498546-49854611.95211.96
5406679-4066799.7509.76
6370320-3703208.8788.88
15min1491146-49114611.77515.4920.1411.7915.5220.15
2668712-66871216.03216.06
3513070-51307012.30012.32
4829112-82911219.87719.91
5739956-73995617.74017.77
6634914-63491415.22115.25
20min1725196-72519617.38621.5416.9917.4321.6017.01
2898011-89801121.52921.59
3727665-72766517.44517.49
41096587-109658726.28926.37
51032112-103211224.74424.81
6912005-91200521.86421.92
30min11016825-101682524.37729.7314.6024.4629.8414.61
21288658-128865830.89431.00
31011231-101123124.24324.33
41350868-135086832.38532.52
51431871-143187134.32734.45
61341240-134124032.15532.26
45min11287074-128707430.85635.9012.2330.9936.0712.26
21619042-161904238.81538.99
31252391-125239130.02530.16
41574286-157428637.74237.95
51695487-169548740.64740.85
61555921-155592137.30137.48
60min11443812-144381234.61439.5711.3734.8239.8211.39
21794087-179408743.01143.27
31392122-139212233.37433.58
41719261-171926141.21741.51
51844503-184450344.22044.51
61709780-170978040.99041.25
极限11895837-189583745.45046.242.2945.7346.582.36
21953911-195391146.84347.20
31872279-187227944.88645.16
41927369-192736946.20646.59
51997760-199776047.89448.28
61925670-192567046.16646.52
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.531200730120373612031381201936120301512025110.10
228.5341247769124335212455600.26
单位质量响应值RSD%判断
42149.0043651.782.48数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2024032221批-沙库巴曲-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%
5min193455-934553.5942.3934.843.592.4034.73
274398-743982.8612.86
340211-402111.5471.55
473250-732502.8172.82
553329-533292.0512.05
638899-388991.4961.50
10min1360340-36034013.85911.9817.3913.8711.9917.39
2324824-32482412.49312.50
3301788-30178811.60711.61
4370814-37081414.26214.27
5290033-29003311.15511.16
6221862-2218628.5338.54
15min1631991-63199124.30720.5011.8424.3520.5311.86
2524759-52475920.18320.22
3538981-53898120.73020.76
4546467-54646721.01821.06
5520847-52084720.03320.06
6434717-43471716.72016.74
20min1836131-83613132.15927.4710.0532.2527.5410.05
2691479-69147926.59526.67
3729946-72994628.07528.15
4706306-70630627.16627.25
5706785-70678527.18427.26
6614309-61430923.62723.69
30min11093884-109388442.07336.1010.2242.2436.2410.21
2843151-84315132.42932.57
31002469-100246938.55738.69
4888449-88844934.17134.32
5943791-94379136.30036.43
6860508-86050833.09733.21
45min11178430-117843045.32439.909.0045.5840.129.00
2937333-93733336.05136.26
31114599-111459942.86943.09
41002075-100207538.54138.76
51035439-103543939.82540.04
6957324-95732436.82037.01
60min11225372-122537247.13042.367.4547.4942.677.46
21002540-100254038.55938.85
31160876-116087644.64944.97
41088537-108853741.86742.17
51097829-109782942.22442.53
61032681-103268139.71939.99
极限11270562-127056248.86847.861.2549.3348.261.30
21223863-122386347.07247.45
31250591-125059148.10048.52
41242962-124296247.80648.21
51238902-123890247.65048.05
61239467-123946747.67248.03
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%
128.532043863204416620478512043711204857120456320.12
228.432092908208887520908920.14
单位质量响应值RSD%判断
71701.0973545.271.80数据可信
供试品溶液-2024032221批-缬沙坦钠-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%
5min1128785-1287853.0972.0135.333.102.0235.36
2101587-1015872.4432.44
359308-593081.4261.43
493096-930962.2382.24
570279-702791.6901.69
649631-496311.1931.19
10min1487922-48792211.7329.8518.6911.749.8618.70
2426252-42625210.24910.25
3399592-3995929.6089.61
4484265-48426511.64411.65
5377681-3776819.0819.09
6282332-2823326.7896.79
15min1873113-87311320.99417.2513.4421.0317.2813.45
2700473-70047316.84316.87
3726877-72687717.47817.50
4732292-73229217.60817.64
5699772-69977216.82616.85
6571434-57143413.74013.76
20min11176177-117617728.28123.5211.6328.3623.5911.64
2942257-94225722.65722.72
3999369-99936924.03024.09
4965594-96559423.21823.29
5961252-96125223.11323.17
6825446-82544619.84819.90
30min11590031-159003138.23232.0111.5038.3732.1311.50
21196854-119685428.77828.89
31419016-141901634.12034.24
41254715-125471530.17030.29
51332865-133286532.04932.16
61195191-119519128.73828.83
45min11783803-178380342.89236.8410.3143.1237.0310.31
21382499-138249933.24233.42
31650162-165016239.67839.87
41470764-147076435.36535.55
51519400-151940036.53436.72
61387154-138715433.35433.51
60min11902895-190289545.75540.188.6746.0840.458.68
21516553-151655336.46636.72
31764194-176419442.42042.70
41644440-164444039.54139.81
51660337-166033739.92340.19
61538281-153828136.98837.22
极限12054361-205436149.39747.462.1949.8247.822.24
21928799-192879946.37846.71
31981828-198182847.65348.03
41959386-195938647.11347.47
51964575-196457547.23847.59
61954053-195405346.98547.30
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%
128.531254816125118612490871251092124796812508300.21
228.5341240006123862812393170.08
单位质量响应值RSD%判断
43842.6243432.990.67数据可信
供试品溶液-2024032221批-沙库巴曲-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%
5min143849-438491.6582.8537.491.662.8537.43
251228-512281.9361.94
3104987-1049873.9693.97
4110582-1105824.1804.18
582449-824493.1173.12
659455-594552.2472.25
10min1313835-31383511.86313.2914.4011.8713.2914.41
2298418-29841811.28011.28
3380983-38098314.40214.41
4420679-42067915.90215.91
5385576-38557614.57514.58
6309641-30964111.70511.71
15min1574376-57437621.71221.7711.1321.7421.8011.14
2513097-51309719.39619.42
3568178-56817821.47821.52
4671762-67176225.39325.44
5622857-62285723.54523.58
6504472-50447219.07019.10
20min1718888-71888827.17528.1810.2927.2528.2610.30
2695145-69514526.27726.35
3706800-70680026.71826.81
4867348-86734832.78732.89
5811999-81199930.69430.79
6672137-67213725.40725.48
30min1887798-88779833.56035.397.2033.7035.547.21
2941909-94190935.60535.74
3886084-88608433.49533.64
41061551-106155140.12840.30
5947942-94794235.83335.99
6891756-89175633.70933.84
45min1970237-97023736.67638.875.9836.8939.095.99
21069177-106917740.41640.63
3976183-97618336.90137.12
41129391-112939142.69242.96
51024801-102480138.73838.98
6999125-99912537.76837.97
60min11037985-103798539.23741.204.5739.5341.514.58
21117116-111711642.22842.53
31044907-104490739.49839.80
41172376-117237644.31744.67
51086025-108602541.05341.38
61080993-108099340.86341.15
极限11236482-123648246.74046.850.9647.1247.260.93
21246099-124609947.10447.50
31254723-125472347.43047.82
41234163-123416346.65347.11
51220372-122037246.13146.55
61244661-124466147.04947.43
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%
128.532101362210302721015852104776210375421029010.07
228.432078984207999820794910.04
单位质量响应值RSD%判断
73708.4173144.250.55数据可信
供试品溶液-2024032221批-缬沙坦钠-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%
5min163689-636891.5142.4035.671.512.4035.73
270538-705381.6771.68
3141271-1412713.3593.36
4145756-1457563.4663.47
5104623-1046232.4882.49
678701-787011.8711.87
10min1415088-4150889.87011.0814.639.8711.0814.65
2399434-3994349.4989.50
3512812-51281212.19412.20
4558968-55896813.29113.30
5504800-50480012.00312.01
6403862-4038629.6039.61
15min1782522-78252218.60718.4811.5718.6318.5111.57
2695389-69538916.53516.56
3771647-77164718.34918.38
4911853-91185321.68321.72
5834169-83416919.83519.87
6666701-66670115.85315.88
20min1999188-99918823.75924.3310.5423.8324.4010.54
2958738-95873822.79722.86
3976194-97619423.21223.29
41193362-119336228.37628.46
51109479-110947926.38226.46
6901768-90176821.44321.50
30min11272149-127214930.25031.467.3930.3731.587.40
21332910-133291031.69531.81
31263498-126349830.04430.17
41503558-150355835.75235.90
51336684-133668431.78431.92
61229379-122937929.23329.34
45min11455733-145573334.61535.975.8934.8036.165.89
21574296-157429637.43437.62
31446901-144690134.40534.60
41662130-166213039.52339.75
51499053-149905335.64535.85
61437277-143727734.17634.35
60min11596845-159684537.97139.214.5138.2339.494.52
21699523-169952340.41240.68
31590637-159063737.82338.09
41777034-177703442.25542.57
51626646-162664638.67938.96
61604304-160430438.14838.40
极限11970983-197098346.86746.681.3347.2247.041.31
21984173-198417347.18147.54
31989649-198964947.31147.67
41963020-196302046.67847.09
51917519-191751945.59645.97
61953436-195343646.45046.78
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%
128.531223032122240812210841220472121874212211480.14
228.5341251775124895412503640.16
单位质量响应值RSD%判断
42802.2443820.141.67数据可信
供试品溶液-2024032321批-沙库巴曲-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%
5min111023-110230.4202.3973.370.422.3873.44
210310-103100.3930.39
375656-756562.8822.88
475296-752962.8682.87
572061-720612.7452.74
6131483-1314835.0085.01
10min1165722-1657226.3129.7236.626.319.7236.65
2174427-1744276.6446.64
3182022-1820226.9336.94
4314054-31405411.96211.97
5306459-30645911.67311.68
6388109-38810914.78314.79
15min1395258-39525815.05618.9516.4715.0718.9816.51
2426747-42674716.25516.27
3468250-46825017.83617.86
4522712-52271219.91019.94
5564984-56498421.52021.55
6607371-60737123.13523.18
20min1599928-59992822.85226.2012.1522.9026.2612.18
2623000-62300023.73023.78
3669612-66961225.50625.57
4689952-68995226.28126.36
5706996-70699626.93027.01
6836913-83691331.87831.97
30min1874085-87408533.29434.905.5433.3935.035.59
2884594-88459433.69533.80
3901760-90176034.34834.47
4927417-92741735.32635.46
5896970-89697034.16634.31
61013125-101312538.59038.76
45min11002437-100243738.18339.275.4338.3639.485.47
2986444-98644437.57437.75
31011692-101169238.53638.73
41022909-102290938.96339.18
51021026-102102638.89139.11
61141860-114186043.49443.75
60min11071458-107145840.81241.785.5541.0742.075.58
21036718-103671839.48939.75
31064436-106443640.54540.82
41080572-108057241.15941.46
51120316-112031642.67342.98
61208050-120805046.01546.36
极限11224719-122471946.65046.651.7347.0047.041.79
21198295-119829545.64445.99
31224521-122452146.64347.01
41228457-122845746.79247.18
51211278-121127846.13846.53
61261349-126134948.04548.50
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.532059502206186520619522062181206191220614820.06
228.432095604209434620949750.05
单位质量响应值RSD%判断
72256.6473688.881.39数据可信
供试品溶液-2024032321批-缬沙坦钠-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%
5min116794-167940.4021.9170.590.401.9270.61
215299-152990.3660.37
393783-937832.2442.24
494262-942622.2562.26
595391-953912.2832.28
6164458-1644583.9353.94
10min1209228-2092285.0067.8637.455.017.8737.46
2223297-2232975.3435.34
3232554-2325545.5655.57
4403588-4035889.6579.66
5400480-4004809.5839.59
6502884-50288412.03312.04
15min1517175-51717512.37515.8217.1412.3915.8417.17
2565820-56582013.53913.55
3622157-62215714.88714.90
4689323-68932316.49416.52
5763725-76372518.27518.30
6807777-80777719.32919.36
20min1805939-80593919.28522.3512.6119.3222.4012.65
2845189-84518920.22420.27
3909532-90953221.76421.81
4928029-92802922.20622.27
5973769-97376923.30123.37
61140803-114080327.29727.38
30min11217454-121745429.13230.745.9729.2130.856.01
21237335-123733529.60729.70
31254105-125410530.00930.11
41293056-129305630.94131.05
51274804-127480430.50430.62
61431455-143145534.25234.39
45min11457869-145786934.88436.146.0635.0336.316.10
21435123-143512334.34034.49
31472358-147235835.23135.40
41495693-149569335.78935.97
51512027-151202736.18036.37
61688568-168856840.40540.62
60min11601587-160158738.32339.636.6138.5539.896.64
21548690-154869037.05737.29
31592899-159289938.11538.36
41632513-163251339.06339.32
51712733-171273340.98341.25
61849784-184978444.26244.57
极限11928599-192859946.14846.442.2846.4646.782.33
21885288-188528845.11245.42
31929395-192939546.16746.50
41949612-194961246.65147.00
51931411-193141146.21546.57
62019450-201945048.32248.73
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%
128.531244197124205012445821246011124152312436730.15
228.5341263390126303512632120.02
单位质量响应值RSD%判断
43591.7644270.411.10数据可信
供试品溶液-2024032321批-沙库巴曲-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%
5min173685-736852.7672.5531.262.772.5631.30
291073-910733.4203.42
367518-675182.5352.54
472576-725762.7252.73
527773-277731.0431.04
675376-753762.8302.83
10min1312469-31246911.73310.4928.8511.7410.5028.86
2293652-29365211.02711.03
3178663-1786636.7096.71
4299127-29912711.23211.24
5195995-1959957.3607.36
6396380-39638014.88414.89
15min1526325-52632519.76419.6819.0919.8019.7119.09
2568509-56850921.34821.38
3419354-41935415.74715.77
4524814-52481419.70719.74
5419710-41971015.76015.78
6685844-68584425.75325.79
20min1675488-67548825.36526.5416.4625.4426.6216.48
2734799-73479927.59227.67
3592534-59253422.25022.31
4730936-73093627.44727.52
5598966-59896622.49122.54
6908405-90840534.11134.21
30min1858210-85821032.22633.7713.2632.3633.9013.29
2981482-98148236.85537.00
3764462-76446228.70628.81
4914318-91431834.33334.47
5795207-79520729.86029.96
61082039-108203940.63140.80
45min1993447-99344737.30437.8611.8737.5138.0711.89
21120343-112034342.06942.29
3855113-85511332.10932.28
41013843-101384338.07038.28
5903222-90322233.91634.09
61163920-116392043.70543.97
60min11051072-105107239.46840.119.8539.7540.409.89
21165855-116585543.77844.09
3935084-93508435.11235.35
41073750-107375040.31940.62
5976635-97663536.67336.92
61207165-120716545.32945.69
极限11208946-120894645.39645.612.1845.7745.992.26
21237003-123700346.44946.86
31192749-119274944.78845.11
41224443-122444345.97846.36
51177847-117784744.22844.56
61246685-124668546.81347.27
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%
128.532093654209527420971152097708209775420963010.09
228.432115101211793421165180.10
单位质量响应值RSD%判断
73477.0874446.640.93数据可信
供试品溶液-2024032321批-缬沙坦钠-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%
5min193999-939992.2192.0733.412.222.0733.42
2118306-1183062.7932.79
390106-901062.1272.13
490768-907682.1432.14
531805-318050.7510.75
6100672-1006722.3772.38
10min1413377-4133779.7598.6230.619.768.6230.61
2384915-3849159.0879.09
3233413-2334135.5105.51
4383625-3836259.0569.06
5244377-2443775.7695.77
6530681-53068112.52812.53
15min1710413-71041316.77116.5820.2816.8016.6020.29
2763778-76377818.03118.06
3560414-56041413.23013.25
4696537-69653716.44316.47
5548373-54837312.94512.96
6934060-93406022.05022.08
20min1927451-92745121.89422.7717.6221.9622.8417.62
21006578-100657823.76223.83
3804836-80483619.00019.05
4991844-99184423.41423.48
5797890-79789018.83618.88
61259877-125987729.74229.82
30min11211816-121181628.60729.8814.3828.7229.9914.40
21383463-138346332.65932.78
31069182-106918225.24025.33
41280861-128086130.23730.35
51097693-109769325.91326.00
61551520-155152036.62736.78
45min11459025-145902534.44334.9113.1534.6235.0913.17
21650135-165013538.95539.15
31236595-123659529.19229.34
41485580-148558035.07035.25
51301212-130121230.71830.86
61741271-174127141.10641.34
60min11590995-159099537.55938.2011.4337.8138.4511.45
21777710-177771041.96642.24
31383739-138373932.66632.88
41630331-163033138.48738.75
51455708-145570834.36534.58
61869385-186938544.13144.45
极限11913813-191381345.17945.413.2545.5245.763.34
21978528-197852846.70747.08
31871351-187135144.17744.46
41932962-193296245.63145.98
51840757-184075743.45543.74
62005240-200524047.33847.76
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