盐酸氟西汀胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100513-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数0.8946
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.105064445062565065545062845070735065220.07
212.115049115052065050580.05
单位质量响应值RSD%判断
41861.3241705.860.27数据可信
长期24月-供试品溶液-21241A批-水
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1283828-28382854.58253.987.3054.5853.987.30
2308345-30834559.29759.30
3253539-25353948.75848.76
4294282-29428256.59356.59
5283210-28321054.46454.46
6260837-26083750.16150.16
10min1497884-49788495.74797.081.5496.3597.681.51
2493699-49369994.94295.60
3503451-50345196.81897.36
4510565-51056598.18698.81
5511695-51169598.40399.01
6511618-51161898.38898.95
15min1519087-51908799.82599.402.17101.49101.082.12
2494972-49497295.18796.90
3517431-51743199.506101.12
4520104-520104100.020101.74
5524145-524145100.797102.50
6525654-525654101.088102.74
20min1512918-51291898.638100.031.78101.42102.821.74
2505178-50517897.15099.92
3524183-524183100.805103.53
4522826-522826100.544103.37
5526756-526756101.299104.12
6529176-529176101.765104.54
30min1508221-50822197.73599.582.26101.61103.472.22
2503774-50377496.880100.73
3510488-51048898.171102.01
4524334-524334100.834104.78
5529322-529322101.793105.74
6530702-530702102.058105.96
盐酸氟西汀胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100513-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数0.8946
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.105091805094215103785101445099155098080.10
212.115046275052415049340.09
单位质量响应值RSD%判断
42132.8941695.620.74数据可信
长期24月-供试品溶液-21241A批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1175074-17507433.56424.7840.9533.5624.7840.94
2159768-15976830.63030.63
3192461-19246136.89736.90
499088-9908818.99619.00
581337-8133715.59315.59
667838-6783813.00513.01
10min1453421-45342186.92787.155.3987.3087.435.49
2475331-47533191.12791.47
3492139-49213994.35094.76
4429819-42981982.40282.61
5435123-43512383.41983.59
6441719-44171984.68384.83
15min1492425-49242594.40494.632.3395.7495.872.31
2473816-47381690.83792.19
3507832-50783297.35898.82
4500422-50042295.93797.06
5496395-49639595.16596.27
6490720-49072094.07795.16
20min1509259-50925997.63297.541.99100.0299.841.98
2501117-50111796.07198.43
3513444-51344498.434100.97
4523817-523817100.423102.62
5510616-51061697.892100.05
6494576-49457694.81796.95
30min1517124-51712499.139100.162.06102.61103.541.94
2517300-51730099.173102.60
3515910-51591098.907102.54
4540595-540595103.639106.95
5530424-530424101.689104.93
6513323-51332398.411101.60
盐酸氟西汀胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100513-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数0.8946
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.105077745077765077495077775078665077880.01
212.115132975128785130880.06
单位质量响应值RSD%判断
41965.9542368.950.68数据可信
长期24月-供试品溶液-21241A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%
5min1106091-10609120.21727.0240.6720.2227.0240.67
2119176-11917622.71022.71
393141-9314117.74917.75
4252259-25225948.07148.07
5151411-15141128.85328.85
6128588-12858824.50424.50
10min1497847-49784794.87097.055.0795.0997.355.13
2524201-52420199.892100.14
3476312-47631290.76790.96
4537057-537057102.342102.88
5486543-48654392.71693.04
6533751-533751101.712101.98
15min1514598-51459898.06299.294.7599.34100.674.81
2530004-530004100.998102.36
3483021-48302192.04593.25
4545686-545686103.987105.66
5506219-50621996.46697.82
6546837-546837104.206105.61
20min1518517-51851798.80999.563.50101.18102.043.58
2523503-52350399.759102.24
3496462-49646294.60696.83
4538569-538569102.630105.46
5511022-51102297.38199.80
6546554-546554104.152106.71
30min1518469-51846998.80099.783.05102.27103.373.13
2534329-534329101.822105.42
3497918-49791894.88498.16
4533062-533062101.581105.55
5516215-51621598.371101.88
6541578-541578103.204106.92
盐酸氟西汀胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100513-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数0.8946
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.105047215061405055515057125060465056340.12
212.115142205154645148420.18
单位质量响应值RSD%判断
41787.9342513.791.22数据可信
长期24月-供试品溶液-21241A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%
5min1117024-11702422.31017.9627.2322.3117.9627.23
2130149-13014924.81224.81
397944-9794418.67318.67
463098-6309812.02912.03
579909-7990915.23415.23
677180-7718014.71414.71
10min1464252-46425288.50883.716.5288.7683.916.54
2445477-44547784.92885.20
3477416-47741691.01791.22
4428677-42867781.72681.86
5415142-41514279.14579.31
6403488-40348876.92377.09
15min1501251-50125195.56193.113.9996.7994.244.01
2477737-47773791.07992.30
3520828-52082899.294100.51
4485932-48593292.64193.68
5476946-47694690.92891.98
6467811-46781189.18690.20
20min1512259-51225997.66095.533.2099.9597.693.24
2492527-49252793.89896.13
3528130-528130100.686103.01
4496380-49638094.63396.70
5491556-49155693.71395.77
6485680-48568092.59394.60
30min1520870-52087099.30297.392.63102.68100.612.70
2512623-51262397.730101.00
3529904-529904101.024104.46
4506950-50695096.64899.77
5502402-50240295.78198.88
6492280-49228093.85196.89
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