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%
128.532934042937492935622927722931802933330.13
228.432961392962752962070.04
单位质量响应值RSD%判断
10281.5610418.820.94数据可信
供试品溶液-2024032721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%
5min1128878-12887820.54018.7817.6820.5418.7817.69
279759-7975912.71212.71
3140256-14025622.35422.35
4122658-12265819.54919.55
5123871-12387119.74219.74
6111767-11176717.81317.81
10min1249266-24926639.72736.1510.6639.7736.1910.67
2180426-18042628.75628.78
3241516-24151638.49238.54
4229616-22961636.59636.64
5227063-22706336.18936.23
6233144-23314437.15837.20
15min1292563-29256346.62846.825.5046.7646.945.52
2262159-26215941.78241.87
3303364-30336448.34948.48
4305933-30593348.75948.88
5298647-29864747.59847.72
6300091-30009147.82847.95
20min1317186-31718650.55252.242.0550.7952.472.05
2325437-32543751.86752.05
3333510-33351053.15453.40
4335828-33582853.52353.76
5329456-32945652.50852.74
6325268-32526851.84052.07
30min1330355-33035552.65153.350.7953.0053.700.79
2334369-33436953.29153.59
3334869-33486953.37153.73
4338373-33837353.92954.28
5336119-33611953.57053.92
6334484-33448453.30953.65
45min1332856-33285653.05053.400.5153.5253.860.52
2334182-33418253.26153.68
3334633-33463353.33353.81
4337909-33790953.85554.33
5335839-33583953.52553.99
6334912-33491253.37753.84
60min1333206-33320653.10653.400.5453.6953.980.54
2333886-33388653.21453.75
3334305-33430553.28153.88
4336598-33659853.64654.24
5337854-33785453.84654.43
6334559-33455953.32153.90
极限1332632-33263253.01453.270.4353.7253.970.44
2333317-33331753.12353.78
3333894-33389453.21553.93
4336707-33670753.66354.37
5334823-33482353.36354.07
6334169-33416953.25953.96
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%
128.535020555018215019435013065017975017840.06
228.435041145042625041880.03
单位质量响应值RSD%判断
17587.9417734.370.59数据可信
供试品溶液-2024032721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%
5min1219093-21909321.65919.7418.6221.6619.7418.61
2131290-13129012.97912.98
3238953-23895323.62323.62
4208836-20883620.64520.65
5210740-21074020.83420.83
6189346-18934618.71918.72
10min1424392-42439241.95538.1110.8742.0038.1510.87
2305066-30506630.15930.19
3410992-41099240.63140.68
4390536-39053638.60838.65
5385567-38556738.11738.16
6396335-39633539.18239.22
15min1498187-49818749.25149.445.6649.3949.565.67
2444603-44460343.95344.05
3516509-51650951.06251.20
4521175-52117551.52351.65
5508682-50868250.28850.42
6511359-51135950.55350.68
20min1539693-53969353.35455.052.1753.6055.292.18
2547923-54792354.16754.36
3567048-56704856.05856.31
4571846-57184656.53256.78
5560991-56099155.45955.70
6553715-55371554.74054.98
30min1562403-56240355.59956.360.8355.9756.720.83
2568810-56881056.23256.55
3570531-57053156.40256.78
4576471-57647156.99057.36
5572928-57292856.63957.01
6569488-56948856.29956.66
45min1566480-56648056.00256.420.5956.4956.900.60
2568253-56825356.17756.62
3570155-57015556.36556.87
4576091-57609156.95257.45
5572159-57215956.56357.06
6570891-57089156.43856.93
60min1567946-56794656.14756.430.6456.7657.040.66
2566658-56665856.02056.58
3569678-56967856.31856.95
4573676-57367656.71357.34
5576271-57627156.97057.59
6570751-57075156.42457.04
极限1566985-56698556.05256.330.4756.7957.070.50
2566913-56691356.04556.73
3569721-56972156.32257.08
4574000-57400056.74557.50
5570895-57089556.43857.18
6570330-57033056.38357.12
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.532979792978092973212976312976092976700.09
228.433029543028363028950.03
单位质量响应值RSD%判断
10433.5810654.061.48数据可信
供试品溶液-2024032721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%
5min160941-609419.53516.8125.799.5316.8125.80
2129480-12948020.25920.26
392014-9201414.39714.40
4105014-10501416.43116.43
5123348-12334819.29919.30
6133730-13373020.92420.92
10min1155835-15583524.38232.3013.5724.4032.3313.59
2218712-21871234.22034.26
3198528-19852831.06231.09
4207396-20739632.44932.49
5221159-22115934.60334.65
6236902-23690237.06637.11
15min1231769-23176936.26343.999.1936.3444.109.21
2283632-28363244.37744.50
3283104-28310444.29544.40
4289118-28911845.23645.34
5291200-29120045.56145.68
6308064-30806448.20048.33
20min1283042-28304244.28550.185.9644.4450.395.99
2323858-32385850.67150.89
3331669-33166951.89352.09
4328261-32826151.36051.57
5322195-32219550.41150.63
6335470-33547052.48852.72
30min1324233-32423350.73052.061.3250.9852.381.38
2335533-33553352.49852.83
3334144-33414452.28052.60
4333999-33399952.25852.58
5332507-33250752.02452.36
6336148-33614852.59452.95
45min1327315-32731551.21252.031.1051.5852.461.14
2336202-33620252.60253.05
3334210-33421052.29152.72
4333409-33340952.16552.60
5328750-32875051.43651.89
6335388-33538852.47552.94
60min1328783-32878351.44252.200.8151.9252.750.86
2336303-33630352.61853.18
3333334-33333452.15452.70
4333064-33306452.11152.67
5335444-33544452.48453.05
6334827-33482752.38752.97
极限1328131-32813151.34052.061.2251.9352.721.25
2335794-33579452.53953.22
3337831-33783152.85753.52
4332557-33255752.03252.70
5327902-32790251.30451.98
6334256-33425652.29853.00
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%
128.535067465060585060485056345062105061390.08
228.435116565118305117430.03
单位质量响应值RSD%判断
17740.5918000.111.03数据可信
供试品溶液-2024032721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%
5min1100468-1004689.81617.8326.729.8217.8326.71
2221056-22105621.59821.60
3155755-15575515.21815.22
4178057-17805717.39717.40
5210792-21079220.59620.60
6228654-22865422.34122.34
10min1262962-26296225.69334.2313.7825.7134.2613.80
2371015-37101536.25036.30
3336921-33692132.91932.95
4352279-35227934.42034.46
5375882-37588236.72636.77
6402748-40274839.35139.40
15min1392832-39283238.38246.739.3538.4646.849.37
2481989-48198947.09347.22
3481505-48150547.04647.15
4492690-49269048.13948.25
5496087-49608748.47148.60
6524575-52457551.25451.39
20min1480377-48037746.93653.326.0747.1053.546.10
2550726-55072653.80954.04
3563925-56392555.09955.31
4559558-55955854.67254.89
5548231-54823153.56553.80
6571271-57127155.81756.07
30min1551843-55184353.91855.321.3154.1955.661.36
2569825-56982555.67556.03
3568910-56891055.58655.92
4569178-56917855.61255.96
5565481-56548155.25155.60
6572141-57214155.90256.28
45min1557168-55716854.43955.381.1154.8355.841.15
2572096-57209655.89756.37
3570139-57013955.70656.16
4568514-56851455.54756.01
5560877-56087754.80155.28
6571799-57179955.86856.37
60min1559776-55977654.69355.580.8655.2056.160.91
2572828-57282855.96956.57
3568564-56856455.55256.13
4568289-56828955.52556.12
5572805-57280555.96656.57
6570543-57054355.74556.37
极限1559163-55916354.63355.421.2755.2656.121.29
2571816-57181655.87056.59
3577171-57717156.39357.10
4566710-56671055.37156.08
5559022-55902254.62055.34
6569229-56922955.61756.36
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%
128.532982252983692977302976432978242979580.11
228.433022373023083022720.02
单位质量响应值RSD%判断
10443.6710632.151.27数据可信
供试品溶液-2024032821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%
5min169308-6930810.85013.4325.1910.8513.4225.18
272068-7206811.28211.28
367959-6795910.63910.64
4124655-12465519.51419.51
591778-9177814.36714.37
688800-8880013.90113.90
10min1164544-16454425.75830.1414.8525.7830.1714.85
2189326-18932629.63829.66
3154734-15473424.22324.25
4220637-22063734.53934.58
5201955-20195531.61531.65
6223874-22387435.04635.08
15min1237739-23773937.21741.3910.3737.3041.4810.37
2284530-28453044.54144.63
3222881-22288134.89134.97
4270575-27057542.35742.48
5283445-28344544.37244.47
6287031-28703144.93345.04
20min1289673-28967345.34746.565.8145.5146.745.82
2310815-31081548.65648.85
3266838-26683841.77241.93
4298448-29844846.72046.93
5305425-30542547.81248.01
6313181-31318149.02749.24
30min1329109-32910951.52051.533.3751.7851.823.39
2334311-33431152.33452.63
3307823-30782348.18848.44
4330412-33041251.72452.04
5333918-33391852.27352.58
6339563-33956353.15753.47
45min1335112-33511252.46052.371.5052.8452.781.54
2335471-33547152.51652.93
3324783-32478350.84351.20
4335827-33582752.57253.00
5336940-33694052.74653.17
6339155-33915553.09353.53
60min1336338-33633852.65252.430.9853.1552.951.02
2335131-33513152.46352.99
3328692-32869251.45551.92
4335011-33501152.44452.99
5336139-33613952.62153.16
6338172-33817252.93953.49
极限1335477-33547752.51752.460.4153.1353.100.45
2334009-33400952.28752.93
3333445-33344552.19952.78
4335198-33519852.47353.14
5335060-33506052.45253.11
6337330-33733052.80753.48
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.535072955077005074155064625064205070580.12
228.435112255118215115230.09
单位质量响应值RSD%判断
17772.8017992.370.87数据可信
供试品溶液-2024032821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%
5min1114211-11421111.15114.0226.5711.1514.0226.56
2117862-11786211.50811.51
3112884-11288411.02211.02
4211650-21165020.66520.66
5155620-15562015.19415.19
6149459-14945914.59314.59
10min1277001-27700127.04631.8215.2727.0731.8515.28
2318261-31826131.07431.10
3260884-26088425.47225.50
4374763-37476336.59136.64
5343980-34398033.58533.62
6380534-38053437.15437.19
15min1402134-40213439.26343.7410.4339.3543.8410.44
2478117-47811746.68246.78
3377525-37752536.86136.94
4459480-45948044.86244.99
5482786-48278647.13847.25
6487749-48774947.62347.74
20min1492394-49239448.07649.305.8348.2549.505.84
2525311-52531151.29051.49
3452257-45225744.15744.32
4507416-50741649.54349.77
5520151-52015150.78651.00
6532007-53200751.94452.16
30min1559022-55902254.58254.603.4554.8654.913.47
2563984-56398455.06655.38
3522590-52259051.02451.29
4562128-56212854.88555.22
5568959-56895955.55255.88
6578786-57878656.51156.85
45min1569575-56957555.61255.581.6556.0156.011.69
2567569-56756955.41655.85
3551914-55191453.88854.26
4572816-57281655.92856.39
5575057-57505756.14756.60
6578535-57853556.48756.95
60min1573682-57368256.01355.591.2456.5456.151.27
2562445-56244554.91655.47
3559172-55917254.59655.09
4570563-57056355.70856.29
5573272-57327255.97356.55
6577155-57715556.35256.94
极限1572633-57263355.91055.700.7656.5656.380.76
2562655-56265554.93655.62
3569298-56929855.58556.20
4571624-57162455.81256.52
5571545-57154555.80456.50
6575187-57518756.16056.87
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%
128.532972222978462956742955242949592962450.42
228.432929522934112931820.12
单位质量响应值RSD%判断
10383.6310312.420.49数据可信
供试品溶液-2024032821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%
5min198363-9836315.68017.218.8115.6817.218.80
2117905-11790518.79518.79
3103400-10340016.48316.48
498969-9896915.77615.78
5108461-10846117.28917.29
6120562-12056219.21819.22
10min1182969-18296929.16635.168.5229.2035.208.52
2220994-22099435.22835.27
3231652-23165236.92736.96
4228929-22892936.49336.53
5229515-22951536.58636.62
6229422-22942236.57136.61
15min1249010-24901039.69445.456.4939.7945.576.50
2299854-29985447.79847.92
3283403-28340345.17645.29
4295051-29505147.03347.15
5291470-29147046.46246.58
6292087-29208746.56046.68
20min1285454-28545445.50350.125.5545.6950.345.55
2329503-32950352.52552.75
3307719-30771949.05249.27
4316500-31650050.45250.67
5312923-31292349.88250.10
6334454-33445453.31453.54
30min1321829-32182951.30153.252.0951.5953.582.10
2332238-33223852.96153.30
3334045-33404553.24953.58
4342715-34271554.63154.96
5336907-33690753.70554.04
6336508-33650853.64153.99
45min1326259-32625952.00853.691.9852.4154.141.99
2332524-33252453.00653.47
3341620-34162054.45654.90
4344919-34491954.98255.44
5338241-33824153.91854.37
6337285-33728553.76554.23
60min1329266-32926652.48753.901.5953.0154.461.60
2337264-33726453.76254.34
3343067-34306754.68755.25
4344341-34434154.89055.47
5337786-33778653.84554.42
6336921-33692153.70754.29
极限1330207-33020752.63753.631.6553.2754.311.65
2331154-33115452.78853.49
3342056-34205654.52655.21
4343627-34362754.77655.47
5336695-33669553.67154.36
6334746-33474653.36054.06
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.535059205055075039125037575030245044240.25
228.435000055003725001880.06
单位质量响应值RSD%判断
17680.4817593.670.35数据可信
供试品溶液-2024032821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%
5min1166131-16613116.44618.068.8416.4518.068.84
2199802-19980219.77919.78
3174705-17470517.29517.29
4167421-16742116.57416.57
5182933-18293318.10918.11
6203559-20355920.15120.15
10min1310196-31019630.70737.048.5730.7437.088.57
2373980-37398037.02237.07
3393979-39397939.00139.04
4389022-38902238.51138.55
5389306-38930638.53938.58
6388381-38838138.44738.49
15min1422403-42240341.81547.986.6141.9248.106.61
2511026-51102650.58850.71
3481634-48163447.67947.80
4502580-50258049.75249.87
5495158-49515849.01749.14
6495160-49516049.01849.15
20min1484481-48448147.96052.915.6448.1653.145.64
2561242-56124255.55955.80
3522662-52266251.74051.97
4538584-53858453.31653.55
5531289-53128952.59452.83
6568460-56846056.27456.51
30min1547513-54751354.20056.262.0854.5056.602.10
2566160-56616056.04656.41
3567364-56736456.16556.51
4583046-58304657.71858.07
5572874-57287456.71157.06
6572796-57279656.70357.07
45min1554478-55447854.89056.742.0455.3157.212.05
2566501-56650156.08056.57
3581527-58152757.56758.04
4587724-58772458.18158.66
5575242-57524256.94557.42
6573439-57343956.76757.26
60min1559700-55970055.40756.971.6355.9557.571.65
2574343-57434356.85657.47
3583629-58362957.77558.37
4586347-58634758.04558.65
5575132-57513256.93457.54
6573836-57383656.80657.42
极限1562258-56225855.66056.751.6856.3357.481.68
2564463-56446355.87856.62
3583221-58322157.73558.46
4585711-58571157.98258.72
5573693-57369356.79257.52
6570283-57028356.45457.20
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%
128.533013563013493009413007793007243010300.11
228.433056763059623058190.07
单位质量响应值RSD%判断
10551.3510756.911.37数据可信
供试品溶液-2024032921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%
5min1112953-11295317.48917.1028.0417.4917.1028.06
2143547-14354722.22722.23
3109327-10932716.92816.93
483272-8327212.89412.89
568537-6853710.61210.61
6145039-14503922.45822.46
10min1207964-20796432.20132.3016.6032.2432.3416.60
2234502-23450236.31036.36
3214099-21409933.15133.19
4195315-19531530.24230.27
5150037-15003723.23123.26
6249574-24957438.64438.69
15min1274998-27499842.58042.7511.8442.6942.8611.86
2312222-31222248.34448.47
3289028-28902844.75344.86
4263985-26398540.87540.97
5218917-21891733.89733.97
6297316-29731646.03646.17
20min1321213-32121349.73647.928.8749.9448.128.89
2338764-33876452.45452.69
3319707-31970749.50349.71
4296042-29604245.83946.03
5260867-26086740.39240.54
6320369-32036949.60549.84
30min1332426-33242651.47251.374.2951.7951.684.34
2339367-33936752.54752.90
3336878-33687852.16252.48
4335977-33597752.02252.31
5303558-30355847.00247.24
6342446-34244653.02453.37
45min1335660-33566051.97351.861.9952.4052.292.05
2338787-33878752.45752.93
3336847-33684752.15752.59
4333911-33391151.70252.11
5322616-32261649.95350.30
6341888-34188852.93753.40
60min1333096-33309651.57651.881.4452.1252.421.51
2338070-33807052.34652.93
3336108-33610852.04252.59
4333813-33381351.68752.21
5327568-32756850.72051.18
6341729-34172952.91353.50
极限1332558-33255851.49351.841.0652.1552.491.14
2337723-33772352.29253.00
3335308-33530851.91952.59
4332724-33272451.51852.15
5330474-33047451.17051.74
6339892-33989252.62853.33
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.535101655103135105515106195109755105250.07
228.435157045158805157920.03
单位质量响应值RSD%判断
17894.3218142.530.98数据可信
供试品溶液-2024032921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%
5min1191888-19188818.59418.1328.7118.5918.1228.70
2244693-24469323.71123.71
3185161-18516117.94317.94
4140109-14010913.57713.58
5114050-11405011.05211.05
6246485-24648523.88523.88
10min1353227-35322734.22934.2716.8734.2734.3116.87
2397527-39752738.52138.57
3363330-36333035.20835.25
4331391-33139132.11332.14
5252252-25225224.44424.47
6424250-42425041.11141.16
15min1468209-46820945.37145.4511.9345.4945.5711.95
2528956-52895651.25751.40
3492325-49232547.70747.83
4448358-44835843.44743.55
5370528-37052835.90535.98
6506071-50607149.03949.18
20min1546400-54640052.94750.948.8053.1751.168.83
2571206-57120655.35155.60
3544286-54428652.74352.97
4503397-50339748.78048.98
5442551-44255142.88443.04
6546495-54649552.95753.21
30min1566432-56643254.88954.734.4755.2255.064.51
2575470-57547055.76456.14
3574729-57472955.69356.03
4573498-57349855.57355.88
5514669-51466949.87350.13
6584202-58420256.61156.98
45min1572943-57294355.52055.311.9855.9855.762.05
2575244-57524455.74356.24
3574272-57427255.64856.11
4569851-56985155.22055.65
5549423-54942353.24053.61
6582693-58269356.46456.96
60min1567025-56702554.94655.281.4055.5355.851.46
2572147-57214755.44256.07
3572868-57286855.51256.10
4568551-56855155.09455.65
5558938-55893854.16254.65
6583044-58304456.49857.12
极限1566936-56693654.93755.270.9755.6455.971.04
2571589-57158955.38856.13
3572212-57221255.44956.16
4568039-56803955.04455.72
5563884-56388454.64255.25
6579739-57973956.17856.93
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.533021563022673020073020453019173020780.05
228.433125863120043122950.14
单位质量响应值RSD%判断
10588.0810984.702.61数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2024032921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%
5min166983-6698310.24717.4422.7710.2517.4422.76
2115443-11544317.66017.66
3116367-11636717.80117.80
4126963-12696319.42219.42
5145346-14534622.23522.23
6112989-11298917.28517.28
10min1175271-17527126.81232.559.6526.8432.599.66
2232693-23269335.59735.64
3220703-22070333.76333.80
4223348-22334834.16734.21
5220347-22034733.70833.76
6204315-20431531.25631.29
15min1261900-26190040.06541.834.2340.1541.944.23
2273880-27388041.89742.02
3287298-28729843.95044.06
4287399-28739943.96544.08
5266274-26627440.73440.86
6263732-26373240.34540.45
20min1314399-31439948.09647.384.9748.2747.594.95
2298852-29885245.71845.93
3320819-32081949.07849.29
4332427-33242750.85451.07
5292225-29222544.70444.92
6299740-29974045.85346.05
30min1330641-33064150.58150.452.4750.8650.762.47
2331503-33150350.71251.03
3336178-33617851.42851.75
4338986-33898651.85752.19
5316543-31654348.42448.74
6324750-32475049.67949.98
45min1331639-33163950.73351.501.7851.1251.921.80
2338578-33857851.79552.22
3337001-33700151.55351.99
4347330-34733053.13453.58
5331317-33131750.68451.11
6333903-33390351.08051.49
60min1330244-33024450.52051.341.0851.0251.881.10
2338825-33882551.83252.37
3336491-33649151.47552.03
4340057-34005752.02152.58
5334134-33413451.11551.65
6333919-33391951.08251.61
极限1329506-32950650.40751.231.0151.0251.881.04
2337752-33775251.66852.32
3335224-33522451.28251.95
4338985-33898551.85752.54
5333193-33319350.97151.62
6334506-33450651.17251.81
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%
128.535124075125625123315125575131625126040.07
228.435242105246775244440.07
单位质量响应值RSD%判断
17967.1918446.851.87数据可信
供试品溶液-2024032921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%
5min1111387-11138710.68318.5723.4110.6818.5723.42
2197042-19704218.89818.90
3197751-19775118.96618.97
4216039-21603920.72020.72
5248166-24816623.80223.80
6191567-19156718.37318.37
10min1297334-29733428.51834.609.6528.5434.649.66
2395172-39517237.90137.94
3374170-37417035.88735.93
4377824-37782436.23736.28
5373570-37357035.82935.88
6346309-34630933.21533.26
15min1445250-44525042.70444.554.2842.7944.674.29
2465403-46540344.63744.76
3488648-48864846.86746.99
4488295-48829546.83346.96
5451883-45188343.34043.47
6447408-44740842.91143.03
20min1537077-53707751.51150.485.1351.6950.705.11
2506904-50690448.61848.84
3546095-54609552.37652.60
4564517-56451754.14354.37
5495068-49506847.48247.71
6508307-50830748.75248.96
30min1564498-56449854.14153.852.6154.4454.182.61
2564330-56433054.12554.46
3573234-57323454.97955.32
4577077-57707755.34855.70
5537341-53734151.53751.87
6552022-55202252.94553.26
45min1565064-56506454.19654.991.8054.6155.441.82
2577932-57793255.43055.88
3575202-57520255.16855.63
4590734-59073456.65857.13
5563071-56307154.00554.45
6568010-56801054.47854.91
60min1563002-56300253.99854.881.0554.5455.451.07
2577524-57752455.39155.97
3573219-57321954.97855.57
4579212-57921255.55356.15
5568528-56852854.52855.10
6571515-57151554.81455.37
极限1561457-56145753.85054.761.0254.5155.451.05
2575967-57596755.24155.94
3571626-57162654.82555.53
4577655-57765555.40356.13
5568015-56801554.47955.17
6570697-57069754.73655.41
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