替米沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.163891803889113878053876833876513882460.20
211.183890773895883893320.10
单位质量响应值RSD%判断
34789.0734823.970.08数据可信
供试品溶液-24041901批-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%
5min171644-7164418.52518.352.8618.5318.362.86
271610-7161018.51618.52
367048-6704817.33717.34
471126-7112618.39118.39
572979-7297918.87018.87
671463-7146318.47818.48
10min1101570-10157026.26326.493.1526.3726.603.14
2105719-10571927.33627.44
3106820-10682027.62127.72
499402-9940225.70325.80
5102268-10226826.44426.55
698979-9897925.59325.70
15min1131798-13179834.07934.952.5434.3335.202.52
2135918-13591835.14535.40
3134643-13464334.81535.06
4140291-14029136.27536.52
5137141-13714135.46135.71
6131121-13112133.90434.15
20min1151379-15137939.14240.643.8039.5841.083.76
2154693-15469339.99940.45
3160778-16077841.57342.02
4165933-16593342.90643.35
5150641-15064138.95239.40
6159573-15957341.26141.69
30min1174459-17445945.11045.361.9945.7746.031.96
2169541-16954143.83944.51
3175772-17577245.45046.12
4177009-17700945.77046.45
5175585-17558545.40146.07
6180169-18016946.58747.25
45min1177676-17767645.94246.602.0246.8547.521.99
2175749-17574945.44446.36
3183718-18371847.50448.43
4181929-18192947.04247.98
5177806-17780645.97646.89
6184495-18449547.70548.63
60min1175503-17550345.38045.751.9646.5446.931.90
2179735-17973546.47447.64
3177906-17790646.00247.19
4175816-17581645.46146.66
5181229-18122946.86148.03
6171502-17150244.34645.53
极限1177053-17705345.78146.052.9647.1947.482.88
2179864-17986446.50847.93
3174251-17425145.05646.50
4183205-18320547.37248.82
5183904-18390447.55248.99
6170348-17034844.04745.48
替米沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.163861593857023856763858953861493859160.07
211.183855633854613855120.02
单位质量响应值RSD%判断
34580.2934482.290.21数据可信
供试品溶液-F49232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%
5min195003-9500324.76115.9527.8424.7615.9527.85
252317-5231713.63613.64
353580-5358013.96513.96
457988-5798815.11415.11
559688-5968815.55715.56
648589-4858912.66412.66
10min1111427-11142729.04227.076.1129.1827.166.15
296891-9689125.25325.33
3105904-10590427.60227.68
4106773-10677327.82927.91
5106817-10681727.84027.93
695286-9528624.83524.91
15min1147912-14791238.55136.456.4338.8536.696.44
2139878-13987836.45736.67
3124147-12414732.35732.59
4146801-14680138.26138.50
5144856-14485637.75438.00
6135474-13547435.30935.52
20min1177126-17712646.16544.724.0846.6845.174.11
2174716-17471645.53745.96
3162173-16217342.26842.68
4174418-17441845.45945.91
5177841-17784146.35146.80
6163310-16331042.56442.97
30min1238116-23811662.06157.924.1562.8358.614.16
2220867-22086757.56558.24
3226360-22636058.99759.64
4219450-21945057.19657.90
5217276-21727656.62957.34
6211224-21122455.05255.69
45min1272396-27239670.99669.983.0872.1171.003.08
2265560-26556069.21470.21
3257564-25756467.13068.10
4278565-27856572.60373.62
5275384-27538471.77472.80
6261595-26159568.18069.13
60min1308453-30845380.39372.706.3281.9074.106.27
2277051-27705172.20973.58
3272873-27287371.12072.47
4264039-26403968.81770.24
5289752-28975275.51976.94
6261560-26156068.17169.50
极限1371347-37134796.78692.473.4898.7494.273.44
2344490-34449089.78691.56
3348901-34890190.93592.68
4353753-35375392.20094.01
5342003-34200389.13890.98
6368186-36818695.96297.67
替米沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.163827013832813833523824873831333829910.10
211.183865573853523859540.23
单位质量响应值RSD%判断
34318.1934521.820.42数据可信
供试品溶液-F49232批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1103087-10308726.95527.926.1226.9527.926.12
295634-9563425.00625.01
3109438-10943828.61628.62
4108882-10888228.47028.47
5114427-11442729.92029.92
6109093-10909328.52528.53
10min1188045-18804549.17050.643.6349.3250.793.63
2182949-18294947.83747.98
3197036-19703651.52151.68
4193944-19394450.71250.87
5202022-20202252.82452.99
6197928-19792851.75451.91
15min1264101-26410169.05769.132.8469.4869.572.84
2255847-25584766.89867.30
3265533-26553369.43169.88
4262007-26200768.50968.95
5278076-27807672.71173.17
6260714-26071468.17168.62
20min1317657-31765783.06081.523.6283.8782.343.57
2312925-31292581.82382.60
3327616-32761685.66486.50
4313875-31387582.07182.89
5295479-29547977.26178.12
6302967-30296779.21980.04
30min1350814-35081491.73090.074.3993.0091.344.33
2330878-33087886.51787.75
3341589-34158989.31890.62
4341594-34159489.31990.60
5330693-33069386.46987.76
6371115-37111597.03898.30
45min1368769-36876996.42593.463.9098.2095.243.83
2364215-36421595.23496.95
3368888-36888896.45698.26
4350613-35061391.67893.45
5332676-33267686.98788.76
6359530-35953094.00995.81
60min1362181-36218194.70292.232.6397.0294.522.60
2345545-34554590.35292.59
3360022-36002294.13896.48
4355699-35569993.00895.29
5337911-33791188.35690.61
6355000-35500092.82595.15
极限1349989-34998991.51492.973.8594.3595.783.76
2358159-35815993.65196.39
3381128-38112899.657102.52
4352296-35229692.11894.92
5341154-34115489.20491.95
6350596-35059691.67394.52
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