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%
128.53 1166287116868811652511169158116546111669690.16
228.43 1182646117759111801180.31
单位质量响应值RSD%判断
40903.2241509.601.05数据可信
供试品溶液-缬沙坦-pH6.8磷酸盐溶液
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
202403212111324291-132429153.0149.575.5146.71%～52.44%
21316607-131660752.71
31226585-122658549.10
41222281-122228148.93
51173378-117337846.97
61167123-116712346.72
202403222111144505-114450545.8246.852.6945.53%～48.17%
21148774-114877445.99
31154836-115483646.23
41152459-115245946.14
51209928-120992848.44
61211172-121117248.49
202403232111285256-128525651.4548.506.2545.32%～51.68%
21278388-127838851.18
31118887-111888744.79
41116523-111652344.70
51236011-123601149.48
61234450-123445049.42
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.53 2019446202126220178182022418201942420200740.09
228.43 2051118204104920460840.35
单位质量响应值RSD%判断
70805.2671969.191.16数据可信
供试品溶液-沙库巴曲-pH6.8磷酸盐溶液
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
202403212112290934-229093456.0352.315.6549.21%～55.41%
22278070-227807055.72
32117619-211761951.79
42109916-210991651.61
52023157-202315749.48
62013334-201333449.24
202403222111972019-197201948.2349.332.7247.92%～50.74%
21978178-197817848.38
31989471-198947148.66
41987807-198780748.62
52084964-208496451.00
62089267-208926751.10
202403232112224161-222416154.4051.236.3047.84%～54.61%
22212926-221292654.13
31934140-193414047.31
41929062-192906247.18
52134242-213424252.20
62132264-213226452.15
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%
128.53 5843275842985856975838665831885842750.16
228.43 5887135897895892510.13
单位质量响应值RSD%判断
20479.3220726.380.85数据可信
供试品溶液-缬沙坦-pH6.8磷酸盐溶液
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240321211650426-65042652.0849.955.7046.96%～52.93%
2650185-65018552.06
3643124-64312451.49
4642798-64279851.47
5579242-57924246.38
6577080-57708046.20
20240322211668393-66839353.5250.098.0745.85%～54.33%
2668102-66810253.49
3646799-64679951.79
4647088-64708851.81
5563003-56300345.08
6560335-56033544.86
20240323211627423-62742350.2348.844.2446.67%～51.00%
2624221-62422149.98
3576688-57668846.17
4576656-57665646.17
5628329-62832950.31
6626317-62631750.15
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%
128.53 1018927101801810207741016337101506910178250.22
228.43 1025972102679610263840.06
单位质量响应值RSD%判断
35675.6036102.150.85数据可信
供试品溶液-沙库巴曲-pH6.8磷酸盐溶液
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
202403212111122414-112241454.6152.355.8449.15%～55.56%
21122351-112235154.60
31110573-111057354.03
41110579-111057954.03
5997227-99722748.52
6993350-99335048.33
202403222111154580-115458056.1752.468.3147.89%～57.03%
21154436-115443656.16
31114590-111459054.23
41116317-111631754.31
5967486-96748647.07
6962379-96237946.82
202403232111078407-107840752.4651.084.2248.82%～53.34%
21074450-107445052.27
3993826-99382648.35
4992098-99209848.27
51082485-108248552.66
61078779-107877952.48
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.53 2914202923042915282928912913572919000.24
228.43 2966082957422961750.21
单位质量响应值RSD%判断
10231.3410417.691.28数据可信
供试品溶液-缬沙坦-pH6.8磷酸盐溶液
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240321211337396-33739653.9151.684.4449.28%～54.09%
2338097-33809754.02
3305978-30597848.89
4306249-30624948.93
5326729-32672952.20
6326338-32633852.14
20240322211305230-30523048.7751.083.5049.21%～52.95%
2306555-30655548.98
3323463-32346351.68
4322676-32267651.56
5330563-33056352.82
6329685-32968552.68
20240323211341568-34156854.5853.930.8953.43%～54.43%
2341036-34103654.49
3336769-33676953.81
4335805-33580553.65
5334965-33496553.52
6335179-33517953.55
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%
128.53 5039625046965042285061305041785046390.18
228.43 5091175092535091850.02
单位质量响应值RSD%判断
17688.0117910.130.89数据可信
供试品溶液-沙库巴曲-pH6.8磷酸盐溶液
批号样品(片)A1A2A平均溶出量(%)平均(%)RSD%置信区间
20240321211583173-58317357.2154.734.6652.06%～57.40%
2584427-58442757.33
3526172-52617251.62
4526961-52696151.69
5563406-56340655.27
6563289-56328955.26
20240322211525816-52581651.5854.063.6152.01%～56.10%
2527161-52716151.71
3557547-55754754.69
4556851-55685154.62
5570062-57006255.92
6569182-56918255.83
20240323211590261-59026157.9057.180.9356.62%～57.73%
2589115-58911557.79
3581435-58143557.04
4579108-57910856.81
5578346-57834656.73
6578785-57878556.78
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