替米沙坦片项目信息
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对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数1250
标示量(mg)80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%
111.124976884974324975364975694974404975330.03
211.204980364971894976120.13
单位质量响应值RSD%判断
44742.1844429.640.50数据可信
供试品溶液-24121601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%
5min1115000-11500023.21423.065.9623.2123.065.95
2118091-11809123.83823.84
3121823-12182324.59124.59
4118527-11852723.92623.93
5106790-10679021.55721.56
6105054-10505421.20621.21
10min1192234-19223438.80438.125.9338.9338.245.93
2192811-19281138.92139.05
3199262-19926240.22340.36
4198892-19889240.14840.28
5174444-17444435.21335.33
6175347-17534735.39635.51
15min1252063-25206350.88149.646.4151.2349.986.40
2250670-25067050.60050.95
3254348-25434851.34351.70
4264465-26446553.38553.74
5222290-22229044.87145.19
6231565-23156546.74447.06
20min1282068-28206856.93858.716.6757.5759.326.65
2289077-28907758.35358.98
3315550-31555063.69764.34
4312708-31270863.12363.78
5267439-26743953.98554.55
6278143-27814356.14656.72
30min1344263-34426369.49372.597.5170.4473.537.46
2365202-36520273.72074.67
3351592-35159270.97271.97
4406527-40652782.06283.06
5326543-32654365.91666.78
6363382-36338273.35274.24
45min1434125-43412587.63292.843.0888.9694.183.03
2465713-46571394.00995.37
3467413-46741394.35295.75
4456088-45608892.06693.53
5461229-46122993.10494.33
6474989-47498995.88197.17
60min1459288-45928892.71290.972.8294.5392.842.71
2433396-43339687.48589.37
3458593-45859392.57294.49
4435775-43577587.96689.94
5455211-45521191.88993.64
6461828-46182893.22595.05
极限1453651-45365191.57489.624.4593.9191.984.32
2407469-40746982.25284.62
3434695-43469587.74890.18
4455064-45506491.85994.32
5455043-45504391.85594.11
6457834-45783492.41894.76
替米沙坦片项目信息
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对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数1250
标示量(mg)80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%
111.124981034980864981104982354978084980680.04
211.204989474990774990120.02
单位质量响应值RSD%判断
44790.2944554.640.38数据可信
供试品溶液-24121701-1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%
5min1120435-12043524.26423.804.4224.2623.804.43
2109768-10976822.11522.11
3118682-11868223.91123.91
4120498-12049824.27624.28
5124748-12474825.13325.13
6114766-11476623.12223.12
10min1211806-21180642.67241.955.0642.8142.085.06
2192294-19229438.74138.86
3202851-20285140.86841.00
4221668-22166844.65944.79
5216198-21619843.55743.70
6204541-20454141.20841.34
15min1281942-28194256.80257.427.0157.1757.786.98
2253972-25397251.16751.51
3296786-29678659.79360.15
4311356-31135662.72863.11
5292338-29233858.89759.28
6273547-27354755.11155.47
20min1340118-34011868.52369.695.6669.2170.385.65
2328786-32878666.24066.86
3347818-34781870.07470.77
4372395-37239575.02675.76
5363969-36396973.32874.04
6322407-32240764.95565.62
30min1407663-40766382.13187.223.1683.2088.303.14
2433281-43328187.29288.28
3440610-44061088.76989.85
4441901-44190189.02990.18
5444787-44478789.61090.73
6429432-42943286.51787.54
45min1465670-46567093.81892.533.0695.3494.082.95
2467145-46714594.11595.59
3454291-45429191.52593.10
4438361-43836188.31689.96
5451777-45177791.01992.63
6478402-47840296.38397.89
60min1446180-44618089.89193.512.2291.9495.582.16
2475229-47522995.74397.74
3465891-46589193.86295.95
4460794-46079492.83594.97
5464340-46434093.55095.67
6472496-47249695.19397.23
极限1463290-46329093.33877.9648.5195.8880.5546.91
2468056-46805694.29896.83
3478340-47834096.37098.97
44464-44640.8993.55
5462346-46234693.14895.79
6445166-44516689.68792.26
替米沙坦片项目信息
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对照品来源原料药对照品使用方法直接使用
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数1250
标示量(mg)80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%
111.124981754982644983164983094977114981550.06
211.204978314977104977700.02
单位质量响应值RSD%判断
44798.1144443.750.57数据可信
供试品溶液-24121701-2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%
5min1106664-10666421.51423.284.5421.5123.284.55
2117169-11716923.63323.63
3111955-11195522.58222.58
4116505-11650523.49923.50
5119274-11927424.05824.06
6120820-12082024.37024.37
10min1174871-17487135.27242.169.3335.3942.299.32
2223565-22356545.09445.22
3196808-19680839.69739.82
4223085-22308544.99745.13
5214865-21486543.33943.47
6220896-22089644.55544.69
15min1247857-24785749.99357.229.7850.3157.599.76
2301877-30187760.88961.27
3252172-25217250.86451.21
4289035-28903558.29958.68
5294553-29455359.41259.79
6316753-31675363.89064.27
20min1304486-30448661.41671.018.8462.0171.698.83
2365734-36573473.76974.49
3322890-32289065.12865.76
4380262-38026276.70077.40
5361443-36144372.90473.61
6377525-37752576.14876.89
30min1388538-38853878.36986.815.9679.3087.895.99
2441242-44124289.00090.13
3409360-40936082.56983.56
4443612-44361289.47890.61
5445172-44517289.79290.90
6454404-45440491.65492.82
45min1464326-46432693.65693.584.1895.0395.144.07
2458610-45861092.50394.13
3479828-47982896.78298.23
4474100-47410095.62797.25
5478730-47873096.56198.17
6428200-42820086.36988.04
60min1464596-46459693.71092.103.7695.6094.183.66
2457187-45718792.21694.35
3449500-44950090.66592.65
4462818-46281893.35195.51
5478158-47815896.44698.59
6427477-42747786.22388.37
极限1451431-45143191.05594.362.2293.4796.952.25
2473337-47333795.47398.12
3461723-46172393.13195.62
4465708-46570893.93496.61
5475125-47512595.83498.51
6479713-47971396.75999.39
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