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%
127.785707915715675713185707765699245708750.12
227.725723045724775723900.03
单位质量响应值RSD%判断
20549.8620648.990.35数据可信
长期12月-供试品溶液-2024032421批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1194804-19480415.31614.2010.1115.3214.2010.12
2149320-14932011.74011.74
3191600-19160015.06415.06
4192393-19239315.12715.13
5187817-18781714.76714.77
6167440-16744013.16513.16
10min1405498-40549831.88229.867.5331.9129.897.53
2339465-33946526.69026.71
3377646-37764629.69229.72
4417706-41770632.84232.87
5377507-37750729.68129.71
6361069-36106928.38928.41
15min1570817-57081744.88041.524.9844.9641.604.98
2499133-49913339.24439.31
3513187-51318740.34940.42
4547199-54719943.02343.10
5523503-52350341.16041.23
6514890-51489040.48340.55
20min1637887-63788750.15347.453.5550.3147.593.56
2573118-57311845.06145.19
3592064-59206446.55046.69
4609156-60915647.89448.05
5600821-60082147.23947.38
6607804-60780447.78847.92
30min1655530-65553051.54050.421.6151.7850.651.62
2624128-62412849.07149.28
3640415-64041550.35250.57
4645908-64590850.78451.02
5643127-64312750.56550.79
6638811-63881150.22650.44
45min1656769-65676951.63850.881.0451.9651.191.05
2640640-64064050.37050.66
3645706-64570650.76851.07
4652769-65276951.32351.64
5647224-64722450.88751.19
6639770-63977050.30150.60
60min1655318-65531851.52450.960.9551.9351.340.96
2646646-64664650.84251.21
3646404-64640450.82351.21
4654479-65447951.45851.86
5646901-64690150.86251.25
6638774-63877450.22350.61
极限1654088-65408851.42751.100.8751.9251.570.88
2653429-65342951.37551.83
3646919-64691950.86351.34
4656381-65638151.60752.09
5646841-64684150.85751.33
6641615-64161550.44650.91
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%
127.789842519852289850239843029840469845700.06
227.729864239866129865180.02
单位质量响应值RSD%判断
35441.6835588.670.30数据可信
长期12月-供试品溶液-2024032421批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1332465-33246514.32413.2310.5714.3213.2310.57
2251203-25120310.82310.82
3326409-32640914.06314.06
4328716-32871614.16314.16
5319260-31926013.75513.76
6284601-28460112.26212.26
10min1696940-69694030.02828.067.6730.0528.087.67
2580276-58027625.00125.02
3646718-64671827.86427.89
4716915-71691530.88830.91
5646955-64695527.87427.90
6620006-62000626.71326.73
15min1983927-98392742.39239.125.1442.4739.195.14
2856470-85647036.90136.96
3880336-88033637.92938.00
4941815-94181540.57840.65
5899297-89929738.74638.82
6886456-88645638.19338.26
20min11099173-109917347.35844.713.7647.5044.843.76
2981254-98125442.27742.40
31017362-101736243.83343.97
41048020-104802045.15445.30
51033822-103382244.54244.68
61046623-104662345.09445.22
30min11129651-112965148.67147.531.7448.8947.741.76
21070838-107083846.13746.33
31100710-110071047.42447.63
41111078-111107847.87148.09
51107104-110710447.70047.91
61099853-109985347.38747.59
45min11131422-113142248.74747.961.0649.0548.251.08
21100669-110066947.42247.69
31110425-111042547.84348.13
41121358-112135848.31448.61
51113637-111363747.98148.27
61101845-110184547.47347.76
60min11129480-112948048.66448.070.9649.0548.440.98
21110721-111072147.85548.20
31111796-111179647.90248.27
41126552-112655248.53748.92
51114918-111491848.03648.40
61100879-110087947.43147.79
极限11128164-112816448.60748.280.9349.0748.730.93
21127400-112740048.57449.00
31115270-111527048.05148.50
41132241-113224148.78349.24
51115836-111583648.07648.52
61104851-110485147.60248.04
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%
127.785740495744015741465735655725645737450.13
227.725760955761465761200.01
单位质量响应值RSD%判断
20653.1720783.550.45数据可信
长期12月-供试品溶液-2024032421批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1190743-19074314.91113.738.5814.9113.738.58
2174575-17457513.64713.65
3179659-17965914.04414.04
4191185-19118514.94614.95
5152383-15238311.91211.91
6165376-16537612.92812.93
10min1386235-38623530.19328.793.9830.2228.813.99
2369702-36970228.90128.92
3359235-35923528.08228.11
4360478-36047828.18028.20
5349651-34965127.33327.35
6384390-38439030.04930.07
15min1522186-52218640.82139.114.2040.9039.184.20
2487329-48732938.09638.17
3501688-50168839.21839.29
4476248-47624837.23037.30
5486294-48629438.01538.08
6528124-52812441.28541.36
20min1594036-59403646.43844.624.0546.5844.754.05
2541223-54122342.30942.44
3593877-59387746.42546.56
4545744-54574442.66242.80
5569230-56923044.49844.63
6580371-58037145.36945.51
30min1637385-63738549.82648.833.0650.0549.043.05
2589335-58933546.07046.28
3639921-63992150.02550.24
4622494-62249448.66248.87
5637231-63723149.81450.02
6621256-62125648.56548.78
45min1645752-64575250.48049.821.5950.7850.111.59
2619240-61924048.40848.69
3644774-64477450.40450.70
4634094-63409449.56949.86
5643942-64394250.33950.62
6635820-63582049.70450.00
60min1646680-64668050.55350.130.9150.9450.510.92
2631800-63180049.39049.75
3645742-64574250.48050.86
4637192-63719249.81150.18
5644645-64464550.39450.76
6641769-64176950.16950.55
极限1648173-64817350.67050.560.8751.1451.020.88
2643851-64385150.33250.78
3646766-64676650.56051.02
4639501-63950149.99250.44
5645677-64567750.47550.93
6656416-65641651.31451.78
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
127.789877529886479880099875659863849876710.09
227.729903699909689906680.05
单位质量响应值RSD%判断
35553.3135738.380.37数据可信
长期12月-供试品溶液-2024032421批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1325184-32518413.95912.818.7813.9612.828.78
2296560-29656012.73012.73
3305053-30505313.09513.10
4325411-32541113.96913.97
5258153-25815311.08211.08
6280649-28064912.04712.05
10min1662037-66203728.41927.064.2028.4427.084.20
2633911-63391127.21227.23
3613430-61343026.33326.35
4616532-61653226.46626.49
5596690-59669025.61425.63
6659887-65988728.32728.35
15min1895830-89583038.45536.844.3038.5336.914.29
2834965-83496535.84335.91
3859383-85938336.89136.96
4816332-81633235.04335.11
5834730-83473035.83335.89
6908422-90842238.99639.06
20min11019131-101913143.74842.104.0843.8842.234.07
2929543-92954339.90340.03
31020351-102035143.80143.93
4936735-93673540.21140.34
5978692-97869242.01242.13
61000237-100023742.93743.07
30min11095942-109594247.04646.093.0847.2546.293.07
21012516-101251643.46443.66
31099846-109984647.21347.41
41070288-107028845.94446.14
51095917-109591747.04547.24
61067674-106767445.83246.04
45min11109827-110982747.64247.061.5847.9347.341.59
21065457-106545745.73746.00
31109825-110982547.64247.92
41090890-109089046.82947.10
51108150-110815047.57047.84
61093431-109343146.93847.22
60min11112669-111266947.76447.370.9448.1347.720.94
21086859-108685946.65647.00
31111085-111108547.69648.05
41095570-109557047.03047.38
51110349-111034947.66448.01
61104238-110423847.40247.76
极限11117924-111792447.98947.860.8448.4348.290.84
21110316-111031647.66348.08
31114641-111464147.84848.29
41102404-110240447.32347.75
51113581-111358147.80348.23
61130554-113055448.53148.97
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%
127.785760055761745760335754335753985758090.07
227.725747225747265747240.01
单位质量响应值RSD%判断
20727.4720733.190.02数据可信
长期12月-供试品溶液-2024032521批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1208650-20865016.30115.6013.5516.3015.6013.55
2246396-24639619.25019.25
3174601-17460113.64113.64
4176903-17690313.82113.82
5185425-18542514.48714.49
6206397-20639716.12516.13
10min1379839-37983929.67630.424.4529.7030.444.46
2401046-40104631.33331.36
3360716-36071628.18228.20
4392202-39220230.64230.66
5391804-39180430.61130.63
6410264-41026432.05332.08
15min1493509-49350938.55639.244.2538.6339.314.25
2496026-49602638.75338.84
3480380-48038037.53137.60
4509705-50970539.82239.90
5492317-49231738.46338.54
6541326-54132642.29242.37
20min1555103-55510343.36943.724.1543.5143.864.14
2540823-54082342.25342.40
3544940-54494042.57542.71
4579067-57906745.24145.38
5541010-54101042.26842.41
6596723-59672346.62046.77
30min1616330-61633048.15247.244.2848.3747.454.27
2578282-57828245.17945.40
3578134-57813445.16845.37
4632802-63280249.43949.65
5589590-58959046.06346.27
6632647-63264749.42749.66
45min1634939-63493949.60649.102.3849.9049.392.39
2615747-61574748.10748.40
3609577-60957747.62447.90
4644148-64414850.32550.62
5621505-62150548.55648.84
6644517-64451750.35450.67
60min1641530-64153050.12149.911.2150.5050.281.22
2633767-63376749.51449.89
3628327-62832749.08949.45
4647139-64713950.55950.94
5634901-63490149.60349.97
6647108-64710850.55750.95
极限1648502-64850250.66650.670.7651.1351.130.76
2651630-65163050.91051.37
3653814-65381451.08151.52
4650341-65034150.80951.28
5639630-63963049.97250.42
6647461-64746150.58451.06
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.789907409907659906859900989902439905060.04
227.729887719891869889780.03
单位质量响应值RSD%判断
35655.3635677.420.05数据可信
长期12月-供试品溶液-2024032521批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1354818-35481815.22214.5813.9415.2214.5813.95
2421640-42164018.08918.09
3294489-29448912.63412.63
4300625-30062512.89712.90
5315856-31585613.55113.55
6351133-35113315.06415.06
10min1649957-64995727.88528.644.5827.9128.674.59
2687526-68752629.49629.53
3616876-61687626.46526.49
4673551-67355128.89728.92
5673516-67351628.89528.92
6703961-70396130.20130.23
15min1845361-84536136.26836.974.4236.3437.044.42
2850474-85047436.48736.57
3822096-82209635.27035.33
4875725-87572537.57037.64
5845324-84532436.26636.34
6931066-93106639.94540.02
20min1950960-95096040.79841.214.2840.9341.354.27
2928215-92821539.82239.96
3933354-93335440.04340.17
4996095-99609542.73542.87
5929013-92901339.85739.99
61026020-102602044.01844.16
30min11057450-105745045.36744.524.4045.5744.724.39
2992317-99231742.57342.78
3989036-98903642.43242.62
41087541-108754146.65846.86
51012537-101253743.44043.64
61087220-108722046.64446.86
45min11089896-108989646.75946.312.3647.0346.582.36
21059181-105918145.44145.72
31046823-104682344.91145.17
41107302-110730247.50647.79
51067183-106718345.78446.05
61106022-110602247.45147.74
60min11101131-110113147.24147.071.2247.5947.421.23
21088595-108859546.70347.06
31078646-107864646.27646.61
41111689-111168947.69448.05
51090792-109079246.79747.14
61111390-111139047.68148.05
极限11117957-111795747.96347.970.7648.4048.400.75
21124228-112422848.23248.66
31126914-112691448.34748.76
41120046-112004648.05248.49
51102961-110296147.31947.74
61115982-111598247.87848.33
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%
127.785710775708025703465706725700525705900.07
227.725709525710325709920.01
单位质量响应值RSD%判断
20539.6020598.560.21数据可信
长期12月-供试品溶液-2024032521批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1229415-22941518.06415.4421.4318.0615.4421.42
2160226-16022612.61612.62
3137987-13798710.86510.87
4238862-23886218.80818.81
5181767-18176714.31214.31
6227939-22793917.94817.95
10min1381942-38194230.07429.788.4030.1029.818.40
2378135-37813529.77429.80
3317721-31772125.01725.04
4408723-40872332.18332.21
5384852-38485230.30330.33
6398069-39806931.34431.37
15min1485720-48572038.24538.582.9538.3338.652.96
2509119-50911940.08840.16
3465075-46507536.62036.68
4491503-49150338.70138.79
5493076-49307638.82538.90
6495009-49500938.97739.06
20min1542294-54229442.70043.574.1342.8443.704.11
2598430-59843047.12047.26
3552611-55261143.51243.63
4535314-53531442.15042.30
5545507-54550742.95343.09
6545566-54556642.95843.10
30min1603174-60317447.49448.154.2547.7148.364.23
2648001-64800151.02351.24
3599899-59989947.23647.43
4579818-57981845.65545.87
5637929-63792950.23050.44
6599964-59996447.24147.46
45min1647798-64779851.00750.052.2851.3050.342.28
2651774-65177451.32151.62
3621055-62105548.90249.17
4616499-61649948.54348.84
5643172-64317250.64350.94
6633237-63323749.86150.16
60min1657359-65735951.76050.802.0652.1451.182.06
2654762-65476251.55651.94
3633691-63369149.89750.25
4627292-62729249.39349.77
5657941-65794151.80652.18
6640009-64000950.39450.77
极限1673050-67305052.99651.211.9953.4651.671.98
2655284-65528451.59752.07
3647135-64713550.95551.39
4635512-63551250.04050.50
5642730-64273050.60851.07
6648672-64867251.07651.54
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
127.789842599839469831049837479823799834870.08
227.729833869838599836220.04
单位质量响应值RSD%判断
35402.7035484.200.17数据可信
长期12月-供试品溶液-2024032521批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1393069-39306916.97014.4322.0616.9714.4322.07
2270610-27061011.68311.68
3232574-23257410.04110.04
4409044-40904417.65917.66
5309693-30969313.37013.37
6390219-39021916.84716.85
10min1655513-65551328.30028.008.5328.3328.038.54
2647821-64782127.96827.99
3543361-54336123.45823.47
4701583-70158330.28930.32
5660406-66040628.51128.53
6683397-68339729.50429.53
15min1833907-83390736.00136.302.9536.0836.372.95
2873575-87357537.71437.78
3797974-79797434.45034.51
4842418-84241836.36936.45
5846697-84669736.55436.62
6849784-84978436.68736.76
20min1930723-93072340.18141.014.1940.3241.144.17
21028425-102842544.39944.53
3949260-94926040.98141.09
4917897-91789739.62739.77
5936711-93671140.44040.57
6936381-93638140.42540.56
30min11036367-103636744.74245.344.2744.9445.544.25
21113378-111337848.06748.27
31030262-103026244.47944.66
4995356-99535642.97243.18
51095757-109575747.30647.50
61030609-103060944.49344.70
45min11115112-111511248.14247.192.3448.4247.472.34
21121392-112139248.41348.70
31067205-106720546.07346.33
41059744-105974445.75146.03
51106350-110635047.76348.04
61088592-108859246.99747.28
60min11133049-113304948.91647.942.1949.2748.292.18
21126491-112649148.63349.00
31088823-108882347.00747.34
41078292-107829246.55246.91
51134570-113457048.98249.34
61101316-110131647.54647.90
极限11159584-115958450.06248.391.9750.5048.821.96
21129127-112912748.74749.19
31115684-111568448.16648.58
41095312-109531247.28747.72
51107661-110766147.82048.26
61117857-111785748.26048.70
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%
127.785750255750545748725748205745265748590.04
227.725729565731375730460.03
单位质量响应值RSD%判断
20693.2720672.660.08数据可信
长期12月-供试品溶液-2024032621批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1230979-23097918.08715.8711.7818.0915.8711.78
2189026-18902614.80214.80
3210341-21034116.47116.47
4187923-18792314.71614.72
5170830-17083013.37713.38
6226520-22652017.73817.74
10min1380140-38014029.76730.394.8429.8030.424.84
2414134-41413432.42932.45
3381022-38102229.83629.86
4363378-36337828.45528.48
5383478-38347830.02930.05
6406427-40642731.82631.86
15min1480455-48045537.62339.093.5737.7039.173.56
2519089-51908940.64840.73
3496082-49608238.84638.92
4479336-47933637.53537.61
5519877-51987740.70940.78
6500436-50043639.18739.27
20min1540207-54020742.30143.663.7542.4443.803.74
2586455-58645545.92346.07
3540003-54000342.28542.43
4545260-54526042.69742.83
5581129-58112945.50645.65
6552225-55222543.24343.39
30min1578947-57894745.33546.793.2345.5547.013.22
2608135-60813547.62147.84
3580094-58009445.42545.64
4589461-58946146.15846.36
5629599-62959949.30149.52
6599177-59917746.91947.14
45min1617566-61756648.35949.221.7848.6549.511.78
2635173-63517349.73850.04
3622488-62248848.74549.03
4619543-61954348.51448.80
5646944-64694450.66050.96
6629666-62966649.30749.60
60min1634686-63468649.70050.251.4550.0750.621.45
2647281-64728150.68651.07
3638655-63865550.01150.38
4631292-63129249.43449.80
5656836-65683651.43451.82
6641359-64135950.22250.60
极限1649647-64964750.87151.210.9151.3251.670.92
2658605-65860551.57352.04
3655403-65540351.32251.77
4644010-64401050.43050.88
5659184-65918451.61852.09
6656871-65687151.43751.90
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%
127.789900279898429895729899549897059898200.02
227.729880869879209880030.02
单位质量响应值RSD%判断
35630.6735642.240.03数据可信
长期12月-供试品溶液-2024032621批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1394807-39480716.95214.8412.1116.9514.8412.11
2321883-32188313.82113.82
3358911-35891115.41115.41
4319475-31947513.71813.72
5290103-29010312.45612.46
6388421-38842116.67816.68
10min1651084-65108427.95628.574.9027.9828.604.90
2710543-71054330.50930.53
3652381-65238128.01228.04
4623258-62325826.76226.78
5657569-65756928.23528.26
6697863-69786329.96529.99
15min1823972-82397235.38036.783.6235.4536.853.61
2891388-89138838.27538.35
3850601-85060136.52336.60
4822149-82214935.30235.37
5892545-89254538.32438.39
6859069-85906936.88736.96
20min1925966-92596639.75941.053.7639.8941.183.76
21004404-100440443.12743.26
3925315-92531539.73139.86
4935219-93521940.15740.28
5998074-99807442.85542.99
6947735-94773540.69440.83
30min1992732-99273242.62644.033.3242.8344.233.31
21043805-104380544.81945.03
3994250-99425042.69142.89
41010409-101040943.38543.58
51081715-108171546.44746.65
61029012-102901244.18444.39
45min11061085-106108545.56146.371.7345.8346.651.74
21091527-109152746.86847.15
31069162-106916245.90846.18
41065025-106502545.73046.00
51110087-111008747.66547.95
61082750-108275046.49146.77
60min11089954-108995446.80147.301.4247.1547.651.42
21111015-111101547.70548.07
31095774-109577447.05147.40
41083526-108352646.52546.87
51126623-112662348.37548.74
61102084-110208447.32147.68
极限11117973-111797348.00448.350.9248.4348.780.93
21135002-113500248.73549.18
31128378-112837848.45048.88
41109362-110936247.63448.05
51134408-113440848.70949.15
61131452-113145248.58249.02
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%
127.785777865776805780835782565778775779360.05
227.725729065726295727680.04
单位质量响应值RSD%判断
20804.0320662.630.49数据可信
长期12月-供试品溶液-2024032621批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1155230-15523012.12615.0819.7712.1315.0819.77
2233154-23315418.21318.21
3224984-22498417.57517.58
4215774-21577416.85616.86
5141336-14133611.04111.04
6187707-18770714.66314.66
10min1337577-33757726.37029.9910.2726.3930.0210.28
2437103-43710334.14534.18
3400687-40068731.30031.33
4409712-40971232.00532.03
5341410-34141026.67026.69
6377242-37724229.46929.49
15min1492756-49275638.49240.525.1638.5640.595.15
2526746-52674641.14841.23
3536376-53637641.90041.98
4502088-50208839.22139.30
5494742-49474238.64838.71
6559532-55953243.70943.78
20min1575388-57538844.94746.174.9945.0846.324.98
2585187-58518745.71345.87
3595683-59568346.53346.68
4558637-55863743.63943.79
5586069-58606945.78245.91
6645556-64555650.42950.58
30min1630915-63091549.28549.793.1249.4950.013.11
2640999-64099950.07350.30
3643282-64328250.25150.48
4602044-60204447.03047.25
5645787-64578750.44750.65
6661028-66102851.63751.87
45min1646952-64695250.53850.871.5650.8251.171.56
2654439-65443951.12351.44
3655907-65590751.23751.55
4632684-63268449.42349.72
5656665-65666551.29651.58
6660528-66052851.59851.91
60min1651377-65137750.88351.201.1951.2551.591.20
2657612-65761251.37051.77
3659892-65989251.54951.95
4642266-64226650.17250.55
5656752-65675251.30351.68
6664660-66466051.92152.32
极限1654261-65426151.10951.281.6651.5651.761.65
2651632-65163250.90351.39
3675506-67550652.76853.25
4642546-64254650.19450.66
5656443-65644351.27951.74
6658617-65861751.44951.94
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%
127.789972789978199976149968759970569973280.04
227.729882299879959881120.02
单位质量响应值RSD%判断
35900.9435646.180.51数据可信
长期12月-供试品溶液-2024032621批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1262440-26244011.22614.0720.4311.2314.0720.43
2399310-39931017.08017.08
3385950-38595016.50916.51
4368383-36838315.75715.76
5237783-23778310.17110.17
6319656-31965613.67313.67
10min1577207-57720724.69028.1410.4724.7128.1610.48
2750492-75049232.10232.13
3686984-68698429.38529.41
4703517-70351730.09230.12
5583453-58345324.95724.97
6645948-64594827.63027.65
15min1845295-84529536.15738.075.0736.2238.145.07
2904724-90472438.69938.78
3921340-92134039.41039.49
4862395-86239536.88836.96
5848823-84882336.30836.37
6957153-95715340.94141.01
20min1987359-98735942.23343.425.1342.3543.555.12
21003605-100360542.92843.07
31022712-102271243.74643.89
4958631-95863141.00541.14
51007001-100700143.07443.19
61111570-111157047.54647.68
30min11084343-108434346.38246.863.2146.5747.063.21
21101869-110186947.13147.35
31106291-110629147.32147.54
41032799-103279944.17744.38
51110013-111001347.48047.67
61137393-113739348.65148.87
45min11111338-111133847.53747.901.6347.8048.181.63
21126524-112652448.18648.48
31128350-112835048.26448.56
41086992-108699246.49546.78
51128803-112880348.28448.55
61137266-113726648.64648.94
60min11120317-112031747.92148.261.1748.2748.621.18
21131798-113179848.41248.79
31135029-113502948.55048.92
41106679-110667947.33747.69
51130852-113085248.37148.72
61144722-114472248.96449.34
极限11127316-112731648.22048.331.4848.6548.781.48
21122161-112216147.99948.46
31158223-115822349.54250.00
41107447-110744747.37047.81
51130041-113004148.33748.77
61134609-113460948.53248.99
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