沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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100309-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)12.5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 14.033584803570763581643587653583943581760.19
2 14.013556123566553561340.21
单位质量响应值RSD%判断
25529.2925419.990.31数据可信
供试品溶液-24FA489批-氢氯噻嗪-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%
5min183189-8318923.44216.5835.2723.4416.5835.27
268840-6884019.39819.40
345546-4554612.83412.83
445546-4554612.83412.83
531795-317958.9598.96
678216-7821622.04022.04
10min1152165-15216542.87833.5828.3342.9233.6128.34
2156373-15637344.06444.10
3116194-11619432.74232.76
477883-7788321.94621.97
581963-8196323.09623.11
6130392-13039236.74336.78
15min1183981-18398151.84442.0823.7751.9542.1623.78
2183791-18379151.79051.90
3155498-15549843.81743.89
495907-9590727.02527.08
5118670-11867033.44033.49
6158069-15806944.54244.64
20min1201937-20193756.90347.7220.5757.1047.8820.58
2200451-20045156.48556.68
3177476-17747650.01150.16
4109871-10987130.96031.06
5149911-14991142.24342.35
6176525-17652549.74349.91
30min1223117-22311762.87256.6312.2163.1656.8712.25
2221940-22194062.54062.83
3213614-21361460.19460.43
4159387-15938744.91345.07
5187203-18720352.75152.93
6200635-20063556.53656.79
45min1240808-24080867.85764.666.0768.2564.996.13
2238787-23878767.28767.68
3244874-24487469.00269.34
4210103-21010359.20459.43
5220006-22000661.99562.26
6222220-22222062.61962.97
60min1248799-24879970.10868.494.6370.6268.934.67
2247279-24727969.68070.18
3260538-26053873.41673.86
4230239-23023964.87865.21
5237600-23760066.95367.32
6233970-23397065.93066.38
极限1294639-29463983.02684.681.8183.6585.221.76
2300848-30084884.77585.39
3302713-30271385.30185.87
4298195-29819584.02884.46
5309878-30987887.32087.80
6296735-29673583.61684.18
沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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57323100856对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.477
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 22.566155086131246145656151856145406145840.15
222.456006796015276011030.10
单位质量响应值RSD%判断
27242.2026775.191.23数据可信
供试品溶液-24FA489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%
5min1183219-18321913.71810.1319.7013.7210.1319.71
2138214-13821410.34810.35
3116575-1165758.7288.73
4106496-1064967.9737.97
5138720-13872010.38610.39
6128271-1282719.6049.60
10min1378550-37855028.34222.7117.3028.3722.7317.30
2355117-35511726.58826.61
3286388-28638821.44221.46
4239542-23954217.93517.95
5280283-28028320.98521.00
6280216-28021620.98021.00
15min1501613-50161337.55631.3114.6637.6331.3614.67
2483545-48354536.20336.26
3390354-39035429.22629.28
4343851-34385125.74425.79
5385743-38574328.88128.93
6403938-40393830.24330.29
20min1589633-58963344.14637.7114.2444.2837.8214.25
2592842-59284244.38644.51
3456077-45607734.14734.25
4421218-42121831.53731.62
5469085-46908535.12135.22
6493406-49340636.94237.04
30min1665471-66547149.82444.8910.8950.0345.0610.91
2675074-67507450.54350.74
3543725-54372540.70940.86
4525571-52557139.35039.49
5557651-55765141.75241.91
6629651-62965147.14247.31
45min1669188-66918850.10247.595.3950.3947.845.43
2678191-67819150.77651.06
3606896-60689645.43945.66
4593833-59383344.46144.66
5620099-62009946.42746.66
6645895-64589548.35848.60
60min1668696-66869650.06648.323.7850.4448.653.83
2678775-67877550.82051.18
3624826-62482646.78147.08
4621791-62179146.55446.83
5627820-62782047.00547.31
6650712-65071248.71949.04
极限1668929-66892950.08349.961.5750.5450.361.56
2676976-67697650.68651.13
3668094-66809450.02150.40
4679000-67900050.83751.19
5652525-65252548.85549.24
6657829-65782949.25249.66
沙库巴曲缬沙坦钠氢氯噻嗪片项目信息
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57323100856对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)5.8对照品稀释倍数100
标示量(mg)200供试品稀释倍数1系数0.451
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 22.561126698112296211258941127326112498211255720.16
222.451110884111236911116260.10
单位质量响应值RSD%判断
49892.3849515.630.54数据可信
供试品溶液-24FA489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%
5min1331757-33175712.7619.3920.1312.769.3920.13
2249372-2493729.5929.59
3209439-2094398.0568.06
4189912-1899127.3057.30
5251861-2518619.6889.69
6231973-2319738.9238.92
10min1693856-69385626.68821.2917.7526.7121.3117.76
2650980-65098025.03925.06
3521080-52108020.04320.06
4433717-43371716.68316.69
5510794-51079419.64719.66
6510783-51078319.64719.66
15min1919634-91963435.37329.3914.8935.4429.4414.90
2884082-88408234.00534.06
3710952-71095227.34627.39
4625899-62589924.07524.11
5705435-70543527.13427.18
6737993-73799328.38628.43
20min11081661-108166141.60535.4414.4941.7335.5414.49
21087548-108754841.83141.95
3832280-83228032.01332.11
4769311-76931129.59129.67
5855695-85569532.91333.01
6901729-90172934.68434.78
30min11220997-122099746.96442.1911.2547.1642.3511.27
21239710-123971047.68447.87
3990872-99087238.11338.26
4956802-95680236.80236.93
51018642-101864239.18139.33
61154867-115486744.42144.57
45min11231197-123119747.35744.805.7247.6345.045.76
21246078-124607847.92948.19
31106688-110668842.56842.78
41084240-108424041.70441.90
51135453-113545343.67443.89
61185340-118534045.59345.82
60min11230753-123075347.34045.504.0347.6945.804.07
21246906-124690647.96148.30
31141713-114171343.91544.20
41136391-113639143.71043.97
51151109-115110944.27644.56
61190844-119084445.80546.11
极限11231475-123147547.36747.251.6247.8047.641.63
21247275-124727547.97548.40
31228573-122857347.25647.61
41251877-125187748.15248.49
51200672-120067246.18346.54
61211398-121139846.59546.97
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