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%
127.341118633111724211179311118203111764411179310.05
227.251119751111852111191360.08
单位质量响应值RSD%判断
40889.9441069.210.31数据可信
加速6月-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%
5min1134076-1340765.2991.8891.475.301.8891.25
220153-201530.7960.80
328746-287461.1361.14
441397-413971.6361.64
520677-206770.8170.82
639619-396191.5661.57
10min1473077-47307718.69710.4249.4918.7110.4249.49
2120567-1205674.7654.77
3126656-1266565.0065.01
4302623-30262311.96011.96
5281599-28159911.12911.13
6277421-27742110.96410.97
15min1746819-74681929.51619.2834.8129.5619.3034.85
2296910-29691011.73511.74
3300949-30094911.89411.90
4516422-51642220.41020.43
5552696-55269621.84421.86
6512729-51272920.26420.29
20min1948421-94842137.48427.3726.3837.5727.4326.40
2447779-44777917.69717.73
3515275-51527520.36520.39
4734994-73499429.04929.11
5770197-77019730.44030.50
6738995-73899529.20729.26
30min11106827-110682743.74435.9917.4343.9036.0917.47
2672004-67200426.55926.62
3774500-77450030.61030.67
4989629-98962939.11239.22
5979143-97914338.69838.81
6941183-94118337.19837.30
45min11174359-117435946.41340.8513.0946.6441.0113.14
2836655-83665533.06733.17
3894532-89453235.35435.47
41103201-110320143.60143.77
51075911-107591142.52242.69
61116805-111680544.13944.30
60min11213366-121336647.95543.0311.5948.2643.2511.64
2902274-90227435.66035.82
3959543-95954337.92338.10
41149898-114989845.44745.69
51139599-113959945.04045.28
61167137-116713746.12846.37
极限11239681-123968148.99547.712.5749.3848.002.68
21158644-115864445.79246.01
31179734-117973446.62646.86
41222886-122288648.33148.65
51218758-121875848.16848.49
61222626-122262648.32148.64
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%
127.341939601193837119383501938995193976719390170.04
227.251941125193961719403710.06
单位质量响应值RSD%判断
70922.3571206.280.29数据可信
加速6月-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%
5min1176023-1760233.7901.24103.243.791.24103.30
219341-193410.4160.42
333198-331980.7150.71
447252-472521.0171.02
520609-206090.4440.44
648779-487791.0501.05
10min1649521-64952113.9867.4752.8913.997.4752.90
2150992-1509923.2513.25
3157759-1577593.3973.40
4384487-3844878.2798.28
5370877-3708777.9867.99
6366501-3665017.8927.89
15min11054286-105428622.70114.3437.6722.7314.3537.70
2387701-3877018.3488.35
3390706-3907068.4138.42
4704779-70477915.17515.19
5752094-75209416.19416.21
6705205-70520515.18515.20
20min11368570-136857029.46820.8228.9629.5420.8629.00
2600244-60024412.92512.94
3691329-69132914.88614.91
41028197-102819722.13922.18
51071009-107100923.06123.10
61041115-104111522.41722.46
30min11656927-165692735.67728.3219.7335.7928.3919.77
2939291-93929120.22520.27
31085076-108507623.36423.41
41434383-143438330.88530.96
51407975-140797530.31730.40
61367818-136781829.45229.53
45min11824464-182446439.28533.5314.9339.4633.6514.98
21226303-122630326.40526.48
31322455-132245528.47528.56
41672258-167225836.00736.14
51605237-160523734.56434.69
61693179-169317936.45836.58
60min11938109-193810941.73236.3013.5741.9736.4813.62
21350533-135053329.08029.20
31460944-146094431.45731.59
41798622-179862238.72838.92
51746424-174642437.60437.79
61821620-182162039.22339.41
极限12035434-203543443.82741.873.9444.1442.104.04
21827630-182763039.35339.52
31880390-188039040.48940.67
41987254-198725442.79043.04
51955458-195545842.10542.36
61979984-197998442.63342.89
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%
127.341118961111850611181961117878111842311183930.04
227.251117780111798611178830.02
单位质量响应值RSD%判断
40906.8441023.230.21数据可信
加速6月-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%
5min147942-479421.8952.4746.111.902.4746.12
2115797-1157974.5784.58
352637-526372.0812.08
434887-348871.3791.38
573118-731182.8912.89
650935-509352.0142.01
10min1123728-1237284.89211.9034.344.8911.9034.36
2417129-41712916.49216.50
3320125-32012512.65712.66
4296663-29666311.72911.73
5383244-38324415.15215.16
6264744-26474410.46710.47
15min1399875-39987515.81021.5816.3015.8221.6016.31
2633425-63342525.04325.08
3574148-57414822.70022.72
4567340-56734022.43022.45
5617770-61777024.42424.45
6481723-48172319.04619.07
20min1615412-61541224.33128.889.1624.3728.959.19
2770896-77089630.47830.56
3776121-77612130.68530.75
4772143-77214330.52830.59
5767013-76701330.32530.40
6681888-68188826.95927.01
30min1835131-83513133.01836.435.4533.1036.545.46
2942165-94216537.25037.38
3900594-90059435.60635.72
4957990-95799037.87537.99
5917280-91728036.26636.39
6975568-97556838.57038.67
45min1926004-92600436.61140.256.7236.7440.426.71
21021839-102183940.40040.59
3985974-98597438.98239.15
41050789-105078941.54441.72
5994892-99489239.33439.52
61128658-112865844.62344.78
60min1973514-97351438.48942.166.4438.6842.406.43
21067887-106788742.22042.48
31044152-104415241.28241.52
41097617-109761743.39643.64
51037047-103704741.00141.25
61178521-117852146.59446.83
极限11189604-118960447.03247.641.3847.2947.941.39
21209316-120931647.81248.14
31206123-120612347.68647.99
41199787-119978747.43547.75
51190031-119003147.04947.37
61234376-123437648.80349.12
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%
127.341939506194020319373011939233193812719388740.06
227.251938335194094319396390.10
单位质量响应值RSD%判断
70917.1271179.410.27数据可信
加速6月-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%
5min156117-561171.2091.6550.201.211.6550.12
2148282-1482823.1943.19
364120-641201.3811.38
440445-404450.8710.87
589892-898921.9361.94
661675-616751.3281.33
10min1157303-1573033.3888.5735.053.398.5735.04
2554822-55482211.94911.95
3427711-4277119.2129.21
4393043-3930438.4658.47
5504740-50474010.87110.87
6349234-3492347.5217.52
15min1534659-53465911.51516.0016.8411.5216.0216.86
2866721-86672118.66718.69
3796970-79697017.16417.18
4767212-76721216.52316.54
5835682-83568217.99818.02
6656960-65696014.14914.16
20min1850360-85036018.31421.999.5918.3422.049.62
21080038-108003823.26123.32
31099143-109914323.67223.72
41072542-107254223.09923.14
51069045-106904523.02423.08
6955958-95595820.58820.63
30min11200454-120045425.85428.715.5525.9128.795.56
21364524-136452429.38829.48
31326244-132624428.56328.65
41377712-137771229.67229.75
51315878-131587828.34028.43
61412987-141298730.43230.50
45min11387216-138721629.87732.987.1129.9833.117.09
21538570-153857033.13633.28
31503680-150368032.38532.52
41568449-156844933.78033.91
51476489-147648931.79931.94
61713763-171376336.90937.03
60min11497873-149787332.26035.497.1032.4135.677.08
21652028-165202835.58035.78
31629264-162926435.09035.28
41683141-168314136.25036.44
51577559-157755933.97634.17
61846027-184602739.75839.94
极限11914275-191427541.22841.731.9941.4341.971.99
21932085-193208541.61141.87
31950301-195030142.00442.25
41922855-192285541.41341.66
51897998-189799840.87741.12
62007160-200716043.22843.48
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%
127.341118404111826911173411118254111755211179640.05
227.251118392112100611196990.17
单位质量响应值RSD%判断
40891.1541089.870.35数据可信
加速6月-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%
5min163604-636042.5133.4050.712.513.4150.77
237622-376221.4871.49
343371-433711.7141.71
4128720-1287205.0865.09
5106174-1061744.1954.20
6137561-1375615.4355.44
10min1320300-32030012.65611.9424.1512.6611.9524.17
2199231-1992317.8727.87
3267419-26741910.56610.57
4288711-28871111.40711.42
5317249-31724912.53512.54
6420919-42091916.63116.64
15min1550826-55082621.76421.5413.4221.7921.5613.43
2462312-46231218.26718.28
3542450-54245021.43321.45
4532564-53256421.04321.07
5503603-50360319.89819.93
6679083-67908326.83226.87
20min1740235-74023529.24828.6710.8929.3128.7310.90
2702883-70288327.77227.82
3703535-70353527.79827.85
4665464-66546426.29426.36
5664880-66488026.27126.33
6876076-87607634.61534.70
30min1980676-98067638.74837.229.9738.8637.349.97
2965639-96563938.15438.25
3980340-98034038.73538.84
4820089-82008932.40332.51
5840230-84023033.19933.30
61065704-106570442.10842.25
45min11059185-105918541.85040.928.9742.0341.108.95
21067008-106700842.15942.32
31109987-110998743.85844.02
4907019-90701935.83836.00
5936829-93682937.01637.18
61134201-113420144.81445.02
60min11099382-109938243.43943.027.0843.6843.267.08
21115707-111570744.08444.31
31157501-115750145.73545.98
4991656-99165639.18239.40
5998547-99854739.45439.68
61169660-116966046.21546.50
极限11184936-118493646.81946.951.4647.1447.261.49
21194494-119449447.19747.50
31209816-120981647.80248.12
41161912-116191245.90946.19
51177085-117708546.50946.80
61200700-120070047.44247.80
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%
127.341938832193889419385981939069193898919388760.01
227.251942623194271219426680.01
单位质量响应值RSD%判断
70917.1971290.570.38数据可信
加速6月-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%
5min186591-865911.8632.4950.261.862.4950.25
249723-497231.0701.07
359742-597421.2861.29
4173249-1732493.7283.73
5141884-1418843.0533.05
6183483-1834833.9493.95
10min1430693-4306939.2698.6525.589.278.6525.59
2260232-2602325.6005.60
3353054-3530547.5987.60
4379826-3798268.1748.18
5415932-4159328.9518.96
6571796-57179612.30512.31
15min1765061-76506116.46416.0315.0716.4816.0515.09
2625442-62544213.46013.47
3734048-73404815.79715.81
4719590-71959015.48615.51
5674191-67419114.50914.53
6951247-95124720.47120.50
20min11052545-105254522.65121.8412.5222.7021.8912.53
2970410-97041020.88320.92
3985070-98507021.19921.24
4919820-91982019.79519.84
5909715-90971519.57719.62
61252021-125202126.94427.01
30min11443799-144379931.07129.3511.5231.1529.4311.52
21379306-137930629.68329.75
31416794-141679430.49030.57
41172721-117272125.23725.32
51188917-118891725.58625.66
61580190-158019034.00634.11
45min11620865-162086534.88133.5610.2635.0233.7010.25
21582664-158266434.05934.18
31679072-167907236.13436.26
41349743-134974329.04729.17
51382222-138222229.74629.87
61743469-174346937.52037.68
60min11726794-172679437.16136.278.2937.3536.468.30
21702255-170225536.63336.81
31799590-179959038.72838.92
41516943-151694332.64532.81
51518994-151899432.68932.86
61847924-184792439.76839.99
极限11925058-192505841.42841.262.0941.6841.512.12
21919753-191975341.31441.55
31960593-196059342.19242.44
41863946-186394640.11340.34
51877671-187767140.40840.63
61957653-195765342.12942.42
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%
127.341117735111726611161001117722111782611173300.07
227.251118094111694511175200.08
单位质量响应值RSD%判断
40867.9641009.910.25数据可信
长期6月-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%
5min134165-341651.3521.5843.471.351.5843.46
233270-332701.3161.32
360977-609772.4122.41
430220-302201.1961.20
561864-618642.4472.45
619511-195110.7720.77
10min1153695-1536956.0809.8638.836.089.8738.85
2218756-2187568.6548.66
3367322-36732214.53214.54
4367932-36793214.55614.56
5231138-2311389.1449.15
6157305-1573056.2236.22
15min1387689-38768915.33818.1617.6915.3518.1817.71
2462288-46228818.28918.31
3541596-54159621.42621.45
4548549-54854921.70121.73
5469416-46941618.57118.59
6345282-34528213.66013.67
20min1615972-61597224.36925.577.4524.4125.637.47
2680431-68043126.91926.97
3656513-65651325.97326.04
4693704-69370427.44427.51
5667502-66750226.40726.46
6564565-56456522.33522.37
30min1933851-93385136.94535.047.8937.0235.137.86
2966005-96600538.21738.31
3793618-79361831.39731.50
4940469-94046937.20637.31
5837746-83774633.14233.24
6842891-84289133.34633.42
45min11047883-104788341.45639.918.9441.6040.068.91
21076035-107603542.57042.73
3868182-86818234.34734.51
41092312-109231243.21343.38
5926540-92654036.65536.80
61041796-104179641.21541.34
60min11094404-109440443.29641.988.4843.5142.208.45
21131209-113120944.75244.98
3927891-92789136.70936.93
41142243-114224345.18945.43
5969393-96939338.35138.56
61102193-110219343.60443.80
极限11191642-119164247.14347.211.3647.4247.501.39
21208871-120887147.82548.13
31172086-117208646.36946.65
41215311-121531148.08048.40
51183204-118320446.80947.08
61189025-118902547.04047.31
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
127.341937122193769919357571937657193779319372060.05
227.251938376193692419376500.06
单位质量响应值RSD%判断
70856.1171106.420.25数据可信
长期6月-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%
5min148170-481701.0381.1638.621.041.1638.58
244727-447270.9640.96
378665-786651.6961.70
439856-398560.8590.86
580440-804401.7341.73
630979-309790.6680.67
10min1197908-1979084.2667.0639.824.277.0639.81
2285529-2855296.1556.16
3485166-48516610.45910.46
4487816-48781610.51610.52
5305784-3057846.5926.59
6203186-2031864.3804.38
15min1519505-51950511.19913.3918.6511.2113.4018.67
2621257-62125713.39313.40
3737543-73754315.89915.92
4749751-74975116.16316.18
5640620-64062013.81013.82
6459040-4590409.8969.90
20min1847777-84777718.27619.288.1718.3019.328.19
2942049-94204920.30820.34
3912012-91201219.66119.71
4960178-96017820.69920.74
5936302-93630220.18420.22
6768539-76853916.56816.59
30min11320917-132091728.47527.217.9028.5327.287.88
21384900-138490029.85529.92
31132498-113249824.41424.49
41339008-133900828.86528.95
51207326-120732626.02726.10
61188800-118880025.62725.68
45min11544608-154460833.29832.259.1233.4032.369.08
21611786-161178634.74634.86
31282031-128203127.63727.76
41624079-162407935.01135.14
51379823-137982329.74529.86
61534362-153436233.07733.17
60min11655062-165506235.67934.838.9835.8435.008.95
21739124-173912437.49137.67
31398179-139817930.14130.31
41751383-175138337.75537.94
51476741-147674131.83532.00
61674086-167408636.08936.24
极限11898341-189834140.92341.171.8441.1441.401.87
21948661-194866142.00842.25
31863941-186394140.18240.40
41955382-195538242.15342.40
51895012-189501240.85141.07
61898746-189874640.93241.14
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%
127.341115561111735311165251116983111678911166420.07
227.251115676111541311155440.02
单位质量响应值RSD%判断
40842.7940937.390.17数据可信
长期6月-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%
5min121904-219040.8682.0575.840.872.0575.81
230173-301731.1951.20
359436-594362.3542.35
461167-611672.4232.42
516265-162650.6440.64
6122263-1222634.8434.84
10min1144104-1441045.7089.1355.045.719.1355.05
2175658-1756586.9586.96
3167333-1673336.6286.63
4315016-31501612.47712.48
5129491-1294915.1295.13
6450956-45095617.86217.87
15min1248444-2484449.84117.0940.089.8517.1040.09
2380322-38032215.06415.08
3284438-28443811.26611.28
4587127-58712723.25523.28
5398757-39875715.79415.80
6689124-68912427.29527.33
20min1483792-48379219.16225.4619.4519.1925.5119.50
2569308-56930822.55022.59
3628892-62889224.91024.94
4782639-78263930.99931.06
5591303-59130323.42123.46
6801156-80115631.73331.82
30min1885830-88583035.08735.007.1635.1535.087.17
2780744-78074430.92431.00
3919206-91920636.40936.48
4968967-96896738.37938.49
5855374-85537433.88033.96
6891173-89117335.29835.43
45min11048645-104864541.53539.596.2641.6539.746.24
2891281-89128135.30235.43
31020844-102084440.43440.57
41055952-105595241.82542.00
51018490-101849040.34140.47
6961891-96189138.09938.29
60min11108594-110859443.91041.945.2644.1042.155.23
2975194-97519438.62638.81
31064430-106443042.16142.36
41104846-110484643.76144.01
51092938-109293843.29043.49
61007154-100715439.89240.15
极限11185482-118548246.95547.170.8847.2247.450.91
21182890-118289046.85347.10
31188570-118857047.07847.35
41210665-121066547.95348.27
51193491-119349147.27347.54
61183745-118374546.88747.21
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%
127.341936444193748019373701937285193740519371970.03
227.251933594193305019333220.02
单位质量响应值RSD%判断
70855.7870947.600.10数据可信
长期6月-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%
5min129486-294860.6361.5271.860.641.5271.94
246799-467991.0101.01
386336-863361.8631.86
480814-808141.7441.74
521020-210200.4540.45
6158810-1588103.4273.43
10min1182432-1824323.9376.5156.383.946.5256.37
2229123-2291234.9454.95
3221361-2213614.7774.78
4419260-4192609.0489.05
5163895-1638953.5373.54
6594968-59496812.84012.85
15min1327782-3277827.07412.5541.587.0812.5641.59
2506497-50649710.93110.94
3379751-3797518.1968.21
4804827-80482717.36917.39
5529934-52993411.43711.44
6940884-94088420.30620.33
20min1654581-65458114.12719.2421.0614.1519.2721.10
2777635-77763516.78316.81
3876817-87681718.92318.95
41102715-110271523.79823.85
5809038-80903817.46017.49
61126848-112684824.31924.38
30min11237378-123737826.70427.328.0926.7527.398.11
21115729-111572924.07924.14
31319401-131940128.47528.53
41416276-141627630.56530.65
51213639-121363926.19226.25
61294375-129437527.93528.04
45min11534119-153411933.10932.166.4433.2032.286.44
21331588-133158828.73828.83
31526652-152665232.94733.05
41608423-160842334.71234.85
51508165-150816532.54832.65
61433001-143300130.92631.07
60min11672029-167202936.08534.975.5636.2335.145.54
21491981-149198132.19932.34
31629455-162945535.16635.32
41724921-172492137.22637.42
51671781-167178136.08036.23
61532399-153239933.07133.27
极限11882630-188263040.63041.111.5440.8341.331.57
21889733-188973340.78340.98
31896080-189608040.92041.14
41961847-196184742.34042.60
51907420-190742041.16541.38
61890653-189065340.80341.06
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%
127.341117781111890011180161118213111763111181080.05
227.251116591111689911167450.02
单位质量响应值RSD%判断
40896.4240981.470.15数据可信
长期6月-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%
5min174212-742122.9362.0147.272.942.0047.37
233961-339611.3441.34
314248-142480.5640.56
474166-741662.9342.93
562166-621662.4592.46
645395-453951.7961.80
10min1342322-34232213.54310.2430.3413.5510.2530.35
2219772-2197728.6948.70
3126639-1266395.0105.01
4326666-32666612.92312.93
5274721-27472110.86810.87
6263661-26366110.43110.43
15min1517843-51784320.48720.0412.9320.5120.0612.95
2517542-51754220.47520.49
3377995-37799514.95414.96
4518309-51830920.50520.53
5557485-55748522.05522.08
6550403-55040321.77521.80
20min1666951-66695126.38627.1610.5826.4527.2110.59
2708184-70818428.01728.07
3553190-55319021.88521.92
4742341-74234129.36829.43
5694073-69407327.45827.52
6753996-75399629.82929.89
30min1845854-84585433.46335.028.4233.5735.128.43
2855278-85527833.83633.93
3800116-80011631.65431.72
41013613-101361340.10040.21
5873272-87327234.54834.65
6922911-92291136.51236.62
45min1961251-96125138.02839.156.2338.1939.316.24
2935669-93566937.01637.17
3951473-95147337.64237.77
41104367-110436743.69043.87
5974765-97476538.56338.73
61010348-101034839.97140.14
60min11031386-103138640.80341.455.3541.0341.675.36
2980918-98091838.80639.02
31022753-102275340.46240.65
41149383-114938345.47145.72
51051544-105154441.60141.83
61049969-104996941.53841.77
极限11170662-117066246.31346.961.4746.6147.251.49
21177697-117769746.59146.87
31172479-117247946.38546.64
41210398-121039847.88548.21
51206563-120656347.73348.03
61183930-118393046.83847.14
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%
127.341938832193987119390781940570193892619394550.04
227.251936690193668519366880.01
单位质量响应值RSD%判断
70938.3771071.120.14数据可信
长期6月-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%
5min199549-995492.1451.4845.862.151.4845.88
243662-436620.9410.94
322248-222480.4790.48
4100302-1003022.1622.16
582762-827621.7841.78
663670-636701.3721.37
10min1458425-4584259.8797.4031.139.887.4031.11
2289163-2891636.2326.23
3164513-1645133.5453.55
4435067-4350679.3769.38
5366713-3667137.9037.91
6346863-3468637.4757.48
15min1712564-71256415.35614.8913.5915.3814.9113.61
2706621-70662115.22815.24
3506014-50601410.90510.91
4706821-70682115.23215.25
5764683-76468316.47916.50
6749900-74990016.16016.18
20min1933462-93346220.11620.6411.0520.1620.6811.06
2988799-98879921.30921.35
3759421-75942116.36616.39
41027084-102708422.13422.18
5982758-98275821.17921.22
61056156-105615622.76022.80
30min11224951-122495126.39827.528.3226.4827.598.33
21237133-123713326.66026.73
31136866-113686624.50024.55
41444568-144456831.13131.21
51274839-127483927.47327.55
61343220-134322028.94729.03
45min11439084-143908431.01331.975.9831.1432.095.99
21403457-140345730.24530.36
31417071-141707130.53830.63
41639459-163945935.33135.46
51472276-147227631.72831.85
61529008-152900832.95033.08
60min11585277-158527734.16334.685.0534.3434.865.06
21509066-150906632.52132.69
31564363-156436333.71233.86
41750580-175058037.72537.92
51622374-162237434.96235.14
61624139-162413935.00035.18
极限11884301-188430140.60741.101.5340.8441.331.55
21895360-189536040.84541.07
31874217-187421740.39040.59
41939147-193914741.78942.04
51945307-194530741.92242.16
61904877-190487741.05041.29
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