奥美沙坦酯片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-201904对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数3333.33
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.062430982421382425812431392427172427350.17
215.102440402454402447400.41
单位质量响应值RSD%判断
16117.8616207.950.40数据可信
中间条件36月-供试品溶液-20210216批-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%
5min1101395-10139542.00640.003.8942.0140.003.90
291536-9153637.92237.92
399381-9938141.17241.17
495841-9584139.70639.71
593193-9319338.60938.61
698013-9801340.60540.61
10min1140392-14039258.16258.732.5558.4058.962.55
2140879-14087958.36458.57
3148145-14814561.37461.60
4138967-13896757.57257.79
5138559-13855957.40357.62
6143683-14368359.52659.75
15min1166128-16612868.82469.481.7569.3870.031.74
2166115-16611568.81969.35
3167184-16718469.26269.83
4165365-16536568.50869.05
5168126-16812669.65270.19
6173339-17333971.81272.37
20min1181832-18183275.33075.401.3576.2776.331.35
2183856-18385676.16977.09
3183248-18324875.91776.87
4178967-17896774.14375.06
5179224-17922474.25075.17
6184827-18482776.57177.53
30min1189184-18918478.37681.112.2679.7382.472.23
2197840-19784081.96283.30
3201715-20171583.56884.94
4193201-19320180.04081.37
5194558-19455880.60381.94
6198267-19826782.13983.52
45min1203847-20384784.45187.352.0686.2489.152.03
2213523-21352388.46090.26
3216137-21613789.54291.38
4208050-20805086.19287.97
5212007-21200787.83189.61
6211452-21145287.60289.44
60min1202738-20273883.99188.862.9386.2591.152.87
2221232-22123291.65393.94
3214167-21416788.72691.06
4216654-21665489.75792.01
5217499-21749990.10792.38
6214623-21462388.91591.24
极限1216000-21600089.48691.511.5792.2194.291.56
2221349-22134991.70294.50
3222255-22225592.07794.91
4221286-22128691.67694.43
5218278-21827890.42993.20
6226092-22609293.66796.48
奥美沙坦酯片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-201904对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数3333.33
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.062434672446772449382434352440422441120.29
215.102447932467912457920.58
单位质量响应值RSD%判断
16209.3016277.620.30数据可信
中间条件36月-供试品溶液-20210217批-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%
5min197904-9790440.35939.504.1040.3639.504.11
299765-9976541.12641.13
394428-9442838.92638.93
493495-9349538.54138.54
599526-9952641.02841.03
689816-8981637.02537.02
10min1139054-13905457.32258.191.6157.5558.411.61
2142309-14230958.66458.89
3141850-14185058.47558.69
4141201-14120158.20758.42
5144378-14437859.51759.74
6138141-13814156.94657.15
15min1158891-15889165.50067.402.7266.0467.942.71
2166541-16654168.65369.21
3163598-16359867.44067.98
4168521-16852169.46970.01
5165990-16599068.42668.98
6157444-15744464.90365.43
20min1175091-17509172.17873.182.2573.0874.102.24
2179123-17912373.84074.78
3182317-18231775.15676.07
4180929-18092974.58475.51
5176024-17602472.56273.50
6171659-17165970.76371.65
30min1195840-19584080.73180.861.9082.0482.181.90
2198937-19893782.00883.35
3200546-20054682.67184.00
4196499-19649981.00382.34
5195331-19533180.52181.86
6189733-18973378.21479.49
45min1202874-20287483.63185.642.4485.3987.412.42
2206821-20682185.25887.06
3212367-21236787.54489.34
4214608-21460888.46890.26
5207965-20796585.72987.52
6201821-20182183.19784.91
60min1198281-19828181.73785.292.9783.9687.532.91
2207529-20752985.55087.82
3209080-20908086.18988.47
4215591-21559188.87391.15
5201627-20162783.11785.38
6209218-20921886.24688.42
极限1214903-21490388.58988.132.4891.2690.852.44
2211376-21137687.13589.89
3216846-21684689.39092.15
4220752-22075291.00193.77
5213665-21366588.07990.81
6205136-20513684.56387.21
奥美沙坦酯片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-201904对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数3333.33
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.062450742448522436752428002425162437830.48
215.102438512429202433860.28
单位质量响应值RSD%判断
16187.4516118.280.31数据可信
中间条件36月-供试品溶液-20210218批-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%
5min198915-9891541.00440.497.9241.0040.497.91
2102880-10288042.64842.65
3103524-10352442.91542.92
498432-9843240.80440.80
599799-9979941.37141.37
682492-8249234.19634.20
10min1146101-14610160.56561.673.4960.7961.893.50
2148858-14885861.70861.94
3154371-15437163.99364.23
4152355-15235563.15863.38
5150976-15097662.58662.82
6139933-13993358.00858.20
15min1172200-17220071.38471.841.8471.9572.411.85
2176000-17600072.95973.54
3171138-17113870.94471.54
4173387-17338771.87672.45
5177871-17787173.73574.31
6169218-16921870.14870.66
20min1190334-19033478.90178.461.2179.8679.431.23
2191934-19193479.56580.55
3188008-18800877.93778.93
4190033-19003378.77779.75
5189944-18994478.74079.73
6185390-18539076.85277.75
30min1194049-19404980.44183.512.2081.8484.912.17
2201503-20150383.53184.96
3200226-20022683.00284.42
4204422-20442284.74186.16
5207149-20714985.87287.30
6201321-20132183.45684.78
45min1209996-20999687.05287.801.0288.9089.670.99
2211089-21108987.50589.40
3210978-21097887.45989.34
4215147-21514789.18791.07
5209840-20984086.98788.89
6213746-21374688.60790.40
60min1218238-21823890.46989.831.1692.8092.181.14
2220349-22034991.34493.72
3213800-21380088.62991.00
4216200-21620089.62492.00
5217401-21740190.12292.51
6214191-21419188.79191.08
极限1217643-21764390.22291.150.7893.0594.000.80
2220791-22079191.52794.41
3221211-22121191.70194.56
4221138-22113891.67194.55
5220779-22077991.52294.41
6217725-21772590.25693.03
奥美沙坦酯片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-201904对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数3333.33
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.062419822427072437202434882449702433730.47
215.102444042443042443540.03
单位质量响应值RSD%判断
16160.2316182.380.10数据可信
中间条件36月-供试品溶液-SX026YA批-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%
5min1115336-11533647.75741.7514.4647.7641.7514.47
2105676-10567643.75743.76
379685-7968532.99532.99
4100784-10078441.73141.73
5115530-11553047.83747.84
687988-8798836.43336.43
10min1155044-15504464.19963.492.9964.4663.723.02
2153585-15358563.59563.84
3146240-14624060.55360.74
4155639-15563964.44564.68
5159341-15934165.97866.24
6150183-15018362.18662.39
15min1177007-17700773.29373.832.2073.9174.412.22
2178250-17825073.80874.40
3171736-17173671.11071.63
4181740-18174075.25375.84
5182772-18277275.68076.31
6178336-17833673.84374.39
20min1186329-18632977.15378.602.0778.1879.592.09
2192992-19299279.91280.92
3183634-18363476.03776.95
4190905-19090579.04880.06
5193157-19315779.98081.03
6191906-19190679.46280.42
30min1197717-19771781.86882.601.7983.3384.031.75
2195568-19556880.97882.43
3198386-19838682.14583.48
4198290-19829082.10583.55
5201242-20124283.32884.82
6205745-20574585.19286.59
45min1207539-20753985.93586.380.8387.8588.270.87
2209391-20939186.70288.60
3206487-20648785.50087.29
4208205-20820586.21188.11
5211502-21150287.57689.54
6208553-20855386.35588.23
60min1207252-20725285.81688.452.2388.2190.832.16
2208297-20829786.24988.63
3215347-21534789.16891.44
4214779-21477988.93391.32
5217454-21745490.04192.49
6218599-21859990.51592.87
极限1211120-21112087.41889.221.5790.2892.081.53
2216641-21664189.70492.57
3213371-21337188.35091.11
4220380-22038091.25294.13
5213624-21362488.45591.40
6217639-21763990.11792.97
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