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%
127.342774832772202771452775232779072774560.11
227.252792042785022788530.18
单位质量响应值RSD%判断
10148.3510233.140.59数据可信
加速6月-供试品溶液-SDR926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%
5min185732-8573213.62510.6315.4013.6310.6315.43
258859-588599.3559.35
367962-6796210.80110.80
467082-6708210.66110.66
556581-565818.9928.99
665132-6513210.35210.35
10min1175069-17506927.82426.354.5627.8526.374.56
2169459-16945926.93226.95
3164364-16436426.12326.14
4158742-15874225.22925.25
5155674-15567424.74124.76
6171420-17142027.24427.26
15min1270865-27086543.04940.007.5243.1240.067.51
2247892-24789239.39839.46
3216618-21661834.42734.49
4260459-26045941.39541.45
5252496-25249640.13040.19
6261709-26170941.59441.66
20min1301840-30184047.97245.748.3848.1145.868.37
2298627-29862747.46147.59
3242961-24296138.61438.73
4311667-31166749.53449.66
5284921-28492145.28345.41
6286614-28661445.55245.68
30min1309712-30971249.22347.477.8149.4447.687.79
2311972-31197249.58249.79
3257418-25741840.91241.10
4324623-32462351.59351.80
5293117-29311746.58546.78
6295327-29532746.93747.14
45min1310866-31086649.40647.877.2449.7148.167.24
2314395-31439549.96750.26
3262964-26296441.79342.04
4325671-32567151.75952.06
5295039-29503946.89147.17
6298302-29830247.41047.70
60min1311045-31104549.43548.106.9649.8248.476.96
2317257-31725750.42250.79
3266795-26679542.40242.72
4326698-32669851.92352.31
5295314-29531446.93547.29
6298947-29894747.51247.88
极限1315877-31587750.20351.143.1150.6751.583.12
2336354-33635453.45753.91
3315533-31553350.14850.54
4332466-33246652.83953.31
5312752-31275249.70650.14
6317477-31747750.45750.90
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%
127.344825294832834827964823214830974828050.09
227.254825364833414829380.12
单位质量响应值RSD%判断
17659.2917722.500.26数据可信
加速6月-供试品溶液-SDR926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%
5min1116056-11605610.0387.7516.4010.047.7616.39
276273-762736.5976.60
391514-915147.9157.92
490796-907967.8537.85
575706-757066.5486.55
687487-874877.5677.57
10min1260968-26096822.57221.304.4322.5921.314.45
2247659-24765921.42121.43
3246516-24651621.32221.34
4238847-23884720.65920.67
5229872-22987219.88319.89
6253501-25350121.92621.94
15min1425964-42596436.84434.177.1836.9034.227.17
2386830-38683033.45933.51
3344513-34451329.79929.85
4407126-40712635.21435.26
5393717-39371734.05434.10
6412222-41222235.65535.70
20min1499209-49920943.17940.848.3243.2940.958.30
2487192-48719242.14042.24
3398628-39862834.47934.58
4508443-50844343.97844.08
5467819-46781940.46440.56
6471899-47189940.81740.93
30min1528076-52807645.67643.778.1245.8643.958.10
2528112-52811245.67945.85
3432816-43281637.43637.59
4550490-55049047.61447.79
5498034-49803443.07743.25
6499048-49904843.16543.34
45min1534036-53403646.19144.367.8546.4644.617.84
2536967-53696746.44546.69
3442493-44249338.27338.49
4556618-55661848.14548.40
5500499-50049943.29143.53
6506799-50679943.83544.08
60min1533250-53325046.12344.657.6846.4644.977.68
2543213-54321346.98547.31
3447228-44722838.68338.96
4559718-55971848.41348.75
5504414-50441443.62943.94
6509617-50961744.07944.40
极限1547895-54789547.39047.843.5247.8148.243.53
2578845-57884550.06750.47
3532002-53200246.01546.36
4575324-57532449.76250.18
5538385-53838546.56746.95
6546284-54628447.25147.65
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%
127.342794182790842779212778872791172786850.27
227.252785242784362784800.03
单位质量响应值RSD%判断
10193.3110219.450.19数据可信
长期6月-供试品溶液-SDR926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%
5min164095-6409510.1719.307.9010.179.307.91
258878-588789.3439.34
352520-525208.3348.33
462496-624969.9179.92
559852-598529.4989.50
653800-538008.5378.54
10min1148887-14888723.62623.077.1523.6423.097.15
2131452-13145220.86020.88
3143567-14356722.78222.80
4146537-14653723.25323.27
5162528-16252825.79125.81
6139428-13942822.12522.14
15min1203341-20334132.26732.559.0332.3232.619.02
2205887-20588732.67132.72
3190332-19033230.20330.25
4197052-19705231.26931.32
5241001-24100138.24338.30
6193302-19330230.67430.73
20min1234661-23466137.23738.8612.3437.3538.9612.32
2264776-26477642.01642.12
3220564-22056435.00035.10
4228698-22869836.29136.40
5297235-29723547.16747.29
6223249-22324935.42635.53
30min1247974-24797439.35041.5310.7839.5241.7010.76
2284883-28488345.20745.38
3237061-23706137.61837.78
4245829-24582939.00939.18
5308102-30810248.89149.09
6246386-24638639.09839.26
45min1252982-25298240.14542.399.7340.3842.639.72
2288518-28851845.78446.03
3246565-24656539.12639.35
4251187-25118739.86040.09
5310102-31010249.20949.49
6253331-25333140.20040.43
60min1255440-25544040.53542.929.2240.8443.249.22
2291215-29121546.21246.54
3252923-25292340.13540.42
4253842-25384240.28140.58
5311776-31177649.47449.84
6257783-25778340.90641.20
极限1304228-30422848.27750.173.1948.6550.563.20
2332542-33254252.77053.17
3307665-30766548.82249.18
4314646-31464649.93050.30
5320698-32069850.89051.34
6317233-31723350.34050.70
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.344838924830834824734840214831554833250.14
227.254824224822214823220.03
单位质量响应值RSD%判断
17678.3117699.890.09数据可信
长期6月-供试品溶液-SDR926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%
5min186868-868687.5146.739.387.516.739.34
276155-761556.5886.59
370014-700146.0566.06
485651-856517.4097.41
578053-780536.7526.75
670132-701326.0676.07
10min1222575-22257519.25318.657.3419.2718.667.34
2194470-19447016.82216.83
3214096-21409618.52018.53
4218957-21895718.94018.95
5239972-23997220.75820.77
6203406-20340617.59517.61
15min1322613-32261327.90727.918.6327.9527.968.63
2320585-32058527.73227.77
3299967-29996725.94825.99
4313282-31328227.10027.14
5376405-37640532.56032.61
6303204-30320426.22826.27
20min1386005-38600533.39134.4511.9133.4834.5411.89
2423516-42351636.63636.72
3360611-36061131.19431.28
4374982-37498232.43732.53
5482780-48278041.76241.86
6361460-36146031.26731.35
30min1418915-41891536.23737.9910.8536.3838.1410.84
2475893-47589341.16641.31
3397307-39730734.36834.50
4412686-41268635.69935.84
5518941-51894144.89045.06
6411625-41162535.60735.74
45min1427021-42702136.93939.0510.5137.1539.2610.50
2489031-48903142.30342.52
3414692-41469235.87236.07
4421898-42189836.49636.70
5530919-53091945.92646.17
6424982-42498236.76236.96
60min1430491-43049137.23939.4210.1237.5139.6910.10
2493347-49334742.67642.96
3420236-42023636.35236.61
4427026-42702636.93937.20
5532270-53227046.04346.36
6430732-43073237.26037.52
极限1517851-51785144.79646.603.7445.1346.943.76
2569786-56978649.28849.64
3520241-52024145.00345.32
4533990-53399046.19246.52
5554740-55474047.98748.38
6535919-53591946.35946.68
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
127.345567145561195558435567545566375564130.08
227.255571925569985570950.03
单位质量响应值RSD%判断
20351.6120443.850.32数据可信
加速6月-供试品溶液-TAWW4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%
5min136514-365142.8995.0543.042.905.0543.07
228017-280172.2252.22
366897-668975.3125.31
486038-860386.8326.83
598604-986047.8297.83
665389-653895.1925.19
10min1217201-21720117.24616.4112.0017.2516.4212.02
2163441-16344112.97712.98
3197281-19728115.66415.67
4223505-22350517.74717.76
5233542-23354218.54418.56
6205326-20532616.30316.31
15min1320259-32025925.42925.779.3625.4625.809.36
2273340-27334021.70421.73
3349200-34920027.72727.76
4359826-35982628.57128.61
5329367-32936726.15226.20
6315162-31516225.02425.06
20min1406829-40682932.30332.889.1032.3832.969.10
2350222-35022227.80827.87
3458590-45859036.41336.49
4430866-43086634.21134.30
5401011-40101131.84131.93
6437135-43713534.70934.79
30min1488622-48862238.79739.406.8638.9339.536.86
2447958-44795835.56835.68
3532174-53217442.25542.40
4506215-50621540.19440.34
5469776-46977637.30137.44
6532300-53230042.26542.40
45min1530210-53021042.09942.796.2942.2942.986.30
2497405-49740539.49539.66
3564047-56404744.78645.00
4553134-55313443.92044.13
5505153-50515340.11040.31
6583290-58329046.31446.52
60min1549261-54926143.61244.395.9643.8844.665.96
2520920-52092041.36241.59
3582927-58292746.28546.57
4574138-57413845.58745.87
5523939-52393941.60141.87
6603284-60328447.90248.18
极限1598658-59865847.53447.744.0447.8748.084.03
2587475-58747546.64646.95
3595758-59575847.30447.67
4628917-62891749.93750.30
5567216-56721645.03845.38
6629321-62932149.96950.33
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.349663569666249651449666409664219662370.07
227.259661339658879660100.02
单位质量响应值RSD%判断
35341.5135449.910.22数据可信
加速6月-供试品溶液-TAWW4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%
5min145817-458171.9813.4445.161.983.4445.17
231498-314981.3621.36
385119-851193.6803.68
4108929-1089294.7094.71
5125706-1257065.4345.43
680935-809353.4993.50
10min1294185-29418512.71811.9912.6312.7211.9912.66
2216335-2163359.3529.35
3263515-26351511.39211.40
4298593-29859312.90812.92
5315779-31577913.65113.66
6275293-27529311.90111.91
15min1448249-44824919.37819.5910.0619.4019.6210.07
2377353-37735316.31316.33
3490588-49058821.20821.23
4506817-50681721.91021.94
5459862-45986219.88019.91
6436135-43613518.85418.88
20min1588505-58850525.44125.769.4325.5025.829.42
2499756-49975621.60521.65
3661905-66190528.61428.67
4624050-62405026.97827.04
5575638-57563824.88524.95
6626025-62602527.06327.12
30min1744543-74454332.18732.237.0232.2932.347.02
2667534-66753428.85828.94
3798484-79848434.51934.63
4767952-76795233.19933.31
5701394-70139430.32130.43
6793851-79385134.31834.42
45min1838151-83815136.23436.416.5036.3936.566.51
2775653-77565333.53233.66
3879558-87955838.02438.19
4872328-87232837.71137.88
5779447-77944733.69633.85
6907706-90770639.24039.40
60min1890361-89036138.49138.786.2438.7038.996.25
2832004-83200435.96836.15
3935459-93545940.44040.67
4930197-93019740.21340.44
5830680-83068035.91136.12
6963412-96341241.64941.87
极限1985972-98597242.62442.604.4942.9042.884.49
2954362-95436241.25741.50
3980537-98053742.38942.69
41036666-103666644.81545.11
5922775-92277539.89240.16
61032574-103257444.63844.93
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%
127.345605835603455599695598545606775602860.07
227.255573005567115570060.08
单位质量响应值RSD%判断
20493.2720440.590.19数据可信
长期6月-供试品溶液-TAWW4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%
5min175494-754945.9746.9413.745.976.9413.76
272695-726955.7535.75
387780-877806.9466.95
497667-976677.7297.73
589290-892907.0667.07
6103530-1035308.1938.19
10min1198606-19860615.71616.846.9415.7316.866.93
2198612-19861215.71715.73
3207621-20762116.43016.44
4236644-23664418.72618.74
5213228-21322816.87316.89
6222266-22226617.58917.60
15min1333880-33388026.42125.484.9226.4625.524.92
2302625-30262523.94823.98
3317327-31732725.11125.15
4345455-34545527.33727.38
5309319-30931924.47724.52
6323414-32341425.59325.64
20min1403614-40361431.93932.146.7632.0232.226.75
2386656-38665630.59730.67
3446064-44606435.29835.38
4430088-43008834.03434.12
5372174-37217429.45129.53
6398603-39860331.54331.63
30min1481480-48148038.10139.137.8438.2339.277.81
2513279-51327940.61740.74
3552807-55280743.74543.88
4507569-50756940.16540.31
5441051-44105134.90235.03
6470982-47098237.27037.41
45min1525347-52534741.57242.657.2741.7742.857.25
2572861-57286145.33245.53
3591091-59109146.77546.99
4546158-54615843.21943.43
5485312-48531238.40438.59
6512989-51298940.59440.79
60min1542208-54220842.90644.267.0043.1744.536.99
2593291-59329146.94947.22
3611427-61142748.38448.67
4567704-56770444.92445.21
5506184-50618440.05640.31
6534754-53475442.31742.58
极限1602555-60255547.68247.982.5748.0248.332.58
2615028-61502848.66949.02
3631834-63183449.99950.37
4601491-60149147.59847.96
5585857-58585746.36046.68
6601422-60142247.59247.93
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%
127.349732249719449731449731619728799728700.06
227.259664449666039665240.02
单位质量响应值RSD%判断
35584.1335468.770.23数据可信
长期6月-供试品溶液-TAWW4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%
5min198315-983154.2354.9015.244.234.9015.27
290360-903603.8923.89
3111577-1115774.8064.81
4126272-1262725.4395.44
5118736-1187365.1145.11
6136721-1367215.8895.89
10min1265900-26590011.45312.307.6611.4612.317.66
2264867-26486711.40811.41
3277332-27733211.94511.95
4322351-32235113.88413.89
5285517-28551712.29812.31
6297939-29793912.83312.84
15min1470495-47049520.26519.405.7120.2919.435.72
2419018-41901818.04818.07
3442455-44245519.05719.08
4489056-48905621.06421.10
5431557-43155718.58818.62
6449704-44970419.36919.40
20min1587308-58730825.29625.217.0325.3625.277.02
2552227-55222723.78523.84
3638965-63896527.52127.58
4626512-62651226.98527.05
5534279-53427923.01223.07
6572272-57227224.64824.71
30min1733287-73328731.58432.068.0031.6932.167.98
2765131-76513132.95533.05
3829528-82952835.72935.83
4773848-77384833.33133.44
5657001-65700128.29828.40
6706801-70680130.44330.55
45min1830023-83002335.75036.397.4735.9036.557.45
2893501-89350138.48438.63
3924968-92496839.84040.00
4866839-86683937.33637.50
5752051-75205132.39232.54
6802239-80223934.55334.71
60min1874448-87444837.66438.807.3837.8839.027.37
2956535-95653541.19941.41
3984103-98410342.38742.62
4925105-92510539.84540.08
5806387-80638734.73234.93
6858106-85810636.96037.17
极限1992411-99241142.74442.773.3943.0243.053.40
21010160-101016043.50943.79
31043101-104310144.92845.23
4999855-99985543.06543.36
5951444-95144440.98041.24
6960483-96048341.36941.64
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.341116316111631011163491114914111602011159820.06
227.251116848111489811158730.13
单位质量响应值RSD%判断
40818.6540949.470.23数据可信
加速6月-供试品溶液-TYN28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%
5min1146461-1464615.8025.8315.925.805.8315.93
2148318-1483185.8765.88
3175600-1756006.9566.96
4120570-1205704.7764.78
5121269-1212694.8044.80
6170715-1707156.7636.76
10min1414986-41498616.43915.9711.5716.4515.9811.56
2394426-39442615.62515.63
3380068-38006815.05615.07
4366267-36626714.51014.52
5372084-37208414.74014.75
6491495-49149519.47019.48
15min1635112-63511225.16024.768.6625.2024.798.66
2602782-60278223.87923.91
3562117-56211722.26822.30
4586204-58620423.22223.25
5649260-64926025.72025.75
6714315-71431528.29728.34
20min1783394-78339431.03430.888.2131.1130.968.22
2780657-78065730.92531.00
3717132-71713228.40928.48
4724890-72489028.71628.79
5775171-77517130.70830.78
6895989-89598935.49435.59
30min11084500-108450042.96239.337.5743.0939.467.57
2946220-94622037.48437.61
3923025-92302536.56536.69
4923178-92317836.57136.69
5997813-99781339.52839.65
61081618-108161842.84843.00
45min11237571-123757149.02643.876.8449.2344.066.83
21035377-103537741.01641.21
31055510-105551041.81442.00
41066959-106695942.26742.45
51095796-109579643.40943.60
61153065-115306545.67845.90
60min11277214-127721450.59645.536.4950.8845.806.48
21068456-106845642.32642.58
31110809-111080944.00444.26
41113409-111340944.10744.36
51133832-113383244.91645.18
61192481-119248147.24047.54
极限11301222-130122251.54749.522.2951.9249.862.28
21230840-123084048.75949.09
31254491-125449149.69650.02
41258186-125818649.84250.17
51228925-122892548.68349.02
61226707-122670748.59548.97
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
127.341938673193843419374661935549193616419372570.08
227.251938004193592619369650.08
单位质量响应值RSD%判断
70857.9771081.280.23数据可信
加速6月-供试品溶液-TYN28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%
5min1190119-1901194.0994.1016.184.104.1016.18
2193367-1933674.1694.17
3225646-2256464.8654.87
4154340-1543403.3283.33
5155811-1558113.3593.36
6221781-2217814.7824.78
10min1573868-57386812.37311.8610.7112.3811.8610.71
2546387-54638711.78111.79
3511920-51192011.03711.05
4500943-50094310.80110.81
5510152-51015210.99911.00
6656384-65638414.15214.16
15min1924657-92465719.93619.278.3919.9619.298.38
2870388-87038818.76618.79
3788993-78899317.01117.04
4842553-84255318.16618.19
5934813-93481320.15520.18
61000040-100004021.56221.59
20min11172882-117288225.28824.687.3825.3524.747.38
21159808-115980825.00625.06
31036904-103690422.35722.41
41073411-107341123.14423.20
51145538-114553824.69924.76
61278516-127851627.56627.63
30min11673732-167373236.08732.607.1636.1932.707.16
21469373-146937331.68131.78
31389960-138996029.96930.06
41419118-141911830.59730.69
51524553-152455332.87132.97
61594866-159486634.38734.50
45min11993073-199307342.97237.876.9743.1438.026.96
21676624-167662436.14936.30
31659009-165900935.77035.91
41708870-170887036.84536.99
51733719-173371937.38137.53
61766139-176613938.08038.25
60min12114465-211446545.59040.276.7445.8240.496.73
21768983-176898338.14138.35
31791397-179139738.62438.83
41829006-182900639.43539.64
51832596-183259639.51239.73
61869967-186996740.31840.55
极限12193802-219380247.30044.683.3747.6144.963.36
22063654-206365444.49444.77
32056081-205608144.33144.60
42099758-209975845.27345.54
52029119-202911943.75044.03
61991193-199119342.93243.23
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%
127.341116842111572211164811114957111563611159280.07
227.251119310111908911192000.02
单位质量响应值RSD%判断
40816.6841071.560.45数据可信
长期6月-供试品溶液-TYN28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%
5min1128922-1289225.1005.7717.865.105.7717.88
2134289-1342895.3125.31
3143036-1430365.6585.66
4151575-1515755.9966.00
5122362-1223624.8404.84
6194595-1945957.6987.70
10min1351829-35182913.91714.4417.9313.9314.4517.92
2330730-33073013.08313.09
3460698-46069818.22418.23
4355425-35542514.05914.07
5274772-27477210.86910.88
6416753-41675316.48516.50
15min1520274-52027420.58021.4410.5520.6121.4810.56
2501762-50176219.84819.88
3634972-63497225.11725.16
4507644-50764420.08120.11
5496825-49682519.65319.68
6590809-59080923.37023.41
20min1731507-73150728.93628.107.1629.0028.177.16
2650676-65067625.73925.80
3772124-77212430.54330.62
4645510-64551025.53425.60
5731545-73154528.93829.00
6731000-73100028.91629.00
30min1954262-95426237.74736.686.1537.8636.796.13
2856989-85698933.90034.01
3922278-92227836.48236.61
4880995-88099534.84934.96
51018961-101896140.30740.41
6929509-92950936.76836.90
45min11100504-110050443.53241.375.4343.7141.555.41
2989858-98985839.15639.32
31026914-102691440.62140.81
4995891-99589139.39439.56
51129119-112911944.66444.84
61032986-103298640.86241.05
60min11170845-117084546.31543.604.9546.5643.844.93
21050103-105010341.53941.77
31069024-106902442.28742.55
41065385-106538542.14342.38
51170926-117092646.31846.57
61086288-108628842.97043.23
极限11270006-127000650.23748.172.5850.5648.482.57
21186240-118624046.92447.22
31204415-120441547.64347.97
41240929-124092949.08749.39
51204526-120452647.64747.97
61200041-120004147.47047.80
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%
127.341937721193787019377021936326193664819372530.04
227.251943005194267919428420.02
单位质量响应值RSD%判断
70857.8371296.950.44数据可信
长期6月-供试品溶液-TYN28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%
5min1161043-1610433.4674.0717.483.474.0817.47
2173051-1730513.7263.73
3190063-1900634.0924.09
4194632-1946324.1904.19
5165648-1656483.5663.57
6251098-2510985.4065.41
10min1474126-47412610.20710.6518.7410.2110.6518.72
2441358-4413589.5029.51
3628357-62835713.52713.53
4490150-49015010.55210.56
5366235-3662357.8847.89
6567395-56739512.21512.22
15min1730366-73036615.72416.3911.0915.7516.4111.08
2696660-69666014.99815.02
3898901-89890119.35219.38
4720469-72046915.51115.54
5690207-69020714.85914.88
6830559-83055917.88117.91
20min11061259-106125922.84722.137.1822.9022.187.19
2935789-93578920.14620.19
31127443-112744324.27224.33
4945411-94541120.35320.40
51048063-104806322.56322.61
61050801-105080122.62222.68
30min11450273-145027331.22229.965.7831.3130.045.77
21288261-128826127.73427.81
31398444-139844430.10630.21
41325704-132570428.54028.62
51508327-150832732.47232.55
61378073-137807329.66829.76
45min11749426-174942637.66235.335.1937.8035.475.16
21566258-156625833.71933.85
31616436-161643634.79934.95
41572602-157260233.85633.99
51747822-174782237.62837.76
61594738-159473834.33234.48
60min11915100-191510041.22938.264.9641.4338.454.94
21713394-171339436.88737.07
31727590-172759037.19237.40
41723117-172311737.09637.28
51861650-186165040.07840.28
61721080-172108037.05237.26
极限12121641-212164145.67543.253.2145.9543.513.20
21969862-196986242.40842.65
31982614-198261442.68242.95
42050562-205056244.14544.40
51972811-197281142.47142.74
61956666-195666642.12442.39
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