利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数800
标示量(mg)15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%
112.384782644779954776754770424770084775970.12
212.464842564840564841560.03
单位质量响应值RSD%判断
38578.1138856.820.51数据可信
长期3月-供试品溶液-2024010711批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1315131-31513160.80160.893.6860.8060.893.68
2312658-31265860.32460.32
3306974-30697459.22759.23
4322839-32283962.28862.29
5334145-33414564.46964.47
6301696-30169658.20958.21
10min1393588-39358875.93875.082.2376.0775.222.23
2383509-38350973.99474.13
3377879-37787972.90773.04
4392956-39295675.81675.95
5401960-40196077.55477.70
6385050-38505074.29174.42
15min1425344-42534482.06581.201.6682.3781.501.66
2418921-41892180.82681.12
3410728-41072879.24579.54
4420007-42000781.03681.34
5431412-43141283.23683.55
6418756-41875680.79481.09
20min1440874-44087485.06284.311.4685.5584.801.46
2435571-43557184.03884.52
3427896-42789682.55883.03
4434067-43406783.74884.24
5446659-44665986.17886.68
6436938-43693884.30284.78
30min1456613-45661388.09887.621.2088.7788.281.20
2455300-45530087.84588.51
3446394-44639486.12786.78
4450112-45011286.84487.52
5462108-46210889.15989.85
6454140-45414087.62188.28
45min1467586-46758690.21589.901.0991.0990.761.10
2467657-46765790.22991.09
3458508-45850888.46489.31
4462420-46242089.21990.08
5473339-47333991.32592.22
6466130-46613089.93590.79
60min1474240-47424091.49991.181.1592.5792.241.16
2473396-47339691.33692.40
3464167-46416789.55690.60
4469585-46958590.60191.67
5480545-48054592.71693.81
6473436-47343691.34492.40
极限1478729-47872992.36591.951.0893.6493.221.08
2478150-47815092.25493.52
3468655-46865590.42291.66
4472754-47275491.21392.48
5483251-48325193.23894.54
6477956-47795692.21693.48
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数800
标示量(mg)15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%
112.384781514780304781004781514782984781460.03
212.464808454810224809340.03
单位质量响应值RSD%判断
38622.4638598.230.05数据可信
长期3月-供试品溶液-2024010811批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1327611-32761163.38363.755.0863.3863.755.08
2348864-34886467.49567.50
3351027-35102767.91467.91
4310567-31056760.08660.09
5319444-31944461.80361.80
6319611-31961161.83661.84
10min1400051-40005177.39878.323.3377.5478.463.33
2420396-42039681.33581.48
3423083-42308381.85482.01
4391120-39112075.67175.80
5396921-39692176.79376.93
6397276-39727676.86277.00
15min1431580-43158083.49884.451.9383.8184.771.94
2446293-44629386.34586.68
3447581-44758186.59486.93
4427182-42718282.64882.95
5431993-43199383.57883.89
6434376-43437684.03984.35
20min1449866-44986687.03687.781.3687.5388.281.38
2460361-46036189.06789.59
3461833-46183389.35289.88
4446724-44672486.42886.91
5449662-44966286.99787.49
6453716-45371687.78188.28
30min1469621-46962190.85891.581.0891.5592.281.09
2478767-47876792.62893.35
3479208-47920892.71393.44
4468476-46847690.63791.31
5468510-46851090.64391.33
6475554-47555492.00692.70
45min1481271-48127193.11293.920.9394.0194.830.94
2489031-48903194.61495.54
3491398-49139895.07296.00
4481416-48141693.14094.02
5481781-48178193.21194.10
6487933-48793394.40195.30
60min1489463-48946394.69795.180.8795.8096.290.88
2495715-49571595.90797.04
3497843-49784396.31897.46
4488658-48865894.54195.63
5487145-48714594.24995.34
6493045-49304595.39096.49
极限1490925-49092594.98095.710.9996.2997.031.01
2498757-49875796.49597.85
3501238-50123896.97598.33
4490516-49051694.90196.20
5489783-48978394.75996.06
6496896-49689696.13597.45
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数800
标示量(mg)15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%
112.384807084806704810374803754803564806290.06
212.464830774833064831920.04
单位质量响应值RSD%判断
38823.0238779.450.08数据可信
长期3月-供试品溶液-2024010911批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1353854-35385468.12462.1010.1268.1262.1010.13
2337401-33740164.95664.96
3329459-32945963.42763.43
4265141-26514151.04551.04
5344414-34441466.30666.31
6305072-30507258.73258.73
10min1413417-41341779.59177.404.8979.7477.534.90
2412637-41263779.44179.59
3408620-40862078.66778.81
4363587-36358769.99870.11
5414623-41462379.82379.97
6399199-39919976.85476.98
15min1436296-43629683.99683.642.9384.3283.952.95
2442568-44256885.20385.52
3437472-43747284.22284.54
4409905-40990578.91579.18
5445671-44567185.80086.13
6434848-43484883.71784.02
20min1451185-45118586.86287.321.8987.3887.821.91
2459455-45945588.45488.96
3455192-45519287.63388.14
4438135-43813584.35084.79
5462636-46263689.06789.58
6454907-45490787.57988.07
30min1467004-46700489.90790.891.0690.6291.581.07
2475618-47561891.56692.27
3471036-47103690.68491.38
4466657-46665789.84190.47
5479485-47948592.31093.02
6472997-47299791.06191.74
45min1477779-47777991.98293.321.0392.8994.221.03
2490486-49048694.42895.34
3483716-48371693.12594.02
4482547-48254792.90093.73
5490579-49057994.44695.36
6483418-48341893.06793.95
60min1481734-48173492.74394.441.1393.8695.541.13
2494799-49479995.25996.38
3489286-48928694.19795.30
4489455-48945594.23095.27
5497887-49788795.85396.98
6490073-49007394.34995.44
极限1483840-48384093.14994.921.1594.4796.231.14
2498778-49877896.02597.36
3489985-48998594.33295.65
4494815-49481595.26296.51
5498380-49838095.94897.29
6492414-49241494.79996.10
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