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 14.033500323501253500143492693485693496020.20
2 14.013557673572223564940.29
单位质量响应值RSD%判断
24918.1825445.681.49数据可信
供试品溶液-24FA489批-氢氯噻嗪-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%
5min157680-5768016.44418.1334.3616.4418.1234.36
242342-4234212.07112.07
3102120-10212029.11429.11
458880-5888016.78616.79
573844-7384421.05221.05
646624-4662413.29213.29
10min1124390-12439035.46336.0525.6335.4936.0825.64
288548-8854825.24425.26
3165145-16514547.08247.13
496267-9626727.44527.47
5163471-16347146.60446.64
6120874-12087434.46034.48
15min1149025-14902542.48647.0817.1342.5747.1617.15
2134514-13451438.34938.41
3194480-19448055.44555.57
4140218-14021839.97540.05
5200871-20087157.26757.38
6171621-17162148.92849.01
20min1164951-16495147.02654.7114.5747.1854.8814.58
2159841-15984145.57045.70
3212062-21206260.45760.68
4177597-17759750.63250.77
5226427-22642764.55364.76
6210585-21058560.03660.20
30min1190001-19000154.16865.4212.1254.4065.6812.13
2208572-20857259.46259.66
3235176-23517667.04767.37
4224067-22406763.88064.10
5260505-26050574.26874.58
6258581-25858173.72073.98
45min1212650-21265060.62574.2111.6460.9574.5811.63
2247506-24750670.56270.86
3256013-25601372.98773.42
4259880-25988074.09074.42
5291653-29165383.14883.59
6294186-29418683.87084.25
60min1223497-22349763.71778.8611.7364.1479.3611.71
2267647-26764776.30476.72
3267118-26711876.15376.71
4281493-28149380.25280.71
5307294-30729487.60788.19
6312674-31267489.14189.66
极限1289429-28942982.51489.724.6083.0590.354.63
2314349-31434989.61990.16
3312035-31203588.95989.64
4314866-31486689.76690.35
5328259-32825993.58494.31
6329378-32937893.90394.58
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 22.565920265911195909195908245885145906800.23
222.455960155981915971030.26
单位质量响应值RSD%判断
26182.6226597.021.12数据可信
供试品溶液-24FA489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%
5min1124370-1243709.53010.4318.849.5310.4418.85
2130633-13063310.01010.01
3159709-15970912.23812.24
4116284-1162848.9108.91
5175235-17523513.42713.43
6110829-1108298.4928.49
10min1309170-30917023.69022.5115.5323.7122.5315.53
2280113-28011321.46421.48
3348560-34856026.70926.73
4248287-24828719.02519.04
5337428-33742825.85625.88
6239039-23903918.31618.33
15min1412407-41240731.60129.7210.3731.6629.7810.38
2369802-36980228.33628.39
3441449-44144933.82633.89
4355807-35580727.26427.31
5411724-41172431.54831.61
6336027-33602725.74825.79
20min1525034-52503440.23135.3610.2440.3435.4610.23
2423960-42396032.48632.59
3507676-50767638.90139.02
4433126-43312633.18833.28
5469206-46920635.95336.07
6409524-40952431.38031.47
30min1636688-63668848.78641.4010.8448.9641.5710.83
2501346-50134638.41638.57
3586402-58640244.93345.12
4501028-50102838.39138.54
5525798-52579840.28940.47
6490787-49078737.60737.75
45min1653245-65324550.05544.918.7750.3145.148.77
2557827-55782742.74442.96
3642881-64288149.26149.52
4531494-53149440.72640.94
5586209-58620944.91845.16
6545215-54521541.77741.98
60min1654897-65489750.18246.635.9650.5246.945.99
2585539-58553944.86745.16
3648141-64814149.66450.01
4573368-57336843.93444.21
5613209-61320946.98747.31
6576069-57606944.14144.41
极限1654883-65488350.18150.931.9950.6051.312.01
2652036-65203649.96250.33
3684595-68459552.45752.88
4667792-66779251.17051.52
5674517-67451751.68552.08
6654037-65403750.11650.46
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 22.561091648109238610916571090493108715010906670.20
222.451091562109529410934280.25
单位质量响应值RSD%判断
48345.1748705.030.53数据可信
供试品溶液-24FA489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%
5min1217789-2177898.5819.4519.398.589.4619.39
2230231-2302319.0719.07
3283381-28338111.16511.16
4204284-2042848.0488.05
5310314-31031412.22612.23
6193844-1938447.6377.64
10min1560003-56000322.06320.8715.9422.0820.8815.93
2503527-50352719.83819.85
3630782-63078224.85224.87
4445287-44528717.54417.56
5609890-60989024.02924.05
6428569-42856916.88516.90
15min1748368-74836829.48527.6810.6729.5427.7310.69
2668720-66872026.34726.39
3802784-80278431.62831.69
4643111-64311125.33825.38
5746261-74626129.40229.46
6605887-60588723.87123.91
20min1954179-95417937.59332.9810.4337.6933.0710.44
2768804-76880430.29030.38
3923972-92397236.40336.52
4786070-78607030.97031.05
5849297-84929733.46133.57
6739950-73995029.15329.23
30min11162254-116225445.79138.6211.2345.9538.7711.22
2905991-90599135.69535.84
31064950-106495041.95742.13
4906401-90640135.71135.85
5953937-95393737.58437.75
6887400-88740034.96235.09
45min11194770-119477047.07241.859.3447.3142.079.35
21005528-100552839.61639.82
31169150-116915046.06346.31
4956936-95693637.70237.90
51061283-106128341.81342.04
6985542-98554238.82939.02
60min11197176-119717647.16743.426.4047.4843.706.42
21058179-105817941.69141.96
31175394-117539446.30946.63
41034102-103410240.74241.00
51107250-110725043.62443.92
61040080-104008040.97841.23
极限11202692-120269247.38447.951.8847.7848.311.90
21192246-119224646.97347.31
31252431-125243149.34449.74
41222093-122209348.14948.48
51232126-123212648.54448.91
61200432-120043247.29547.62
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