利伐沙班口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号430060-202202对照品来源中检所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1000
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%
115.344879194878134877314879304876044877990.03
215.404883004882724882860.01
单位质量响应值RSD%判断
31799.1531706.880.21数据可信
供试品溶液-第1批-pH4.5jz(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%
5min1261232-26123248.96749.084.0648.9749.084.06
2255537-25553747.90047.90
3248708-24870846.62046.62
4272256-27225651.03451.03
5276526-27652651.83451.83
6256606-25660648.10048.10
10min1364587-36458768.34168.782.7568.4268.862.75
2361794-36179467.81767.90
3351584-35158465.90365.98
4380484-38048471.32171.41
5374052-37405270.11570.20
6369026-36902669.17369.25
15min1402701-40270175.48576.242.2975.6876.442.29
2406713-40671376.23776.43
3391975-39197573.47573.66
4420272-42027278.77978.98
5408440-40844076.56176.76
6410284-41028476.90777.10
20min1419695-41969578.67179.502.2978.9979.822.29
2419037-41903778.54778.87
3411072-41107277.05477.36
4438432-43843282.18382.52
5425435-42543579.74780.08
6430910-43091080.77381.10
30min1439300-43930082.34683.272.0982.8083.732.09
2438898-43889882.27082.72
3432845-43284581.13681.57
4457574-45757485.77186.24
5444347-44434783.29283.76
6452490-45249084.81885.28
45min1454535-45453585.20186.272.0485.7986.862.04
2453780-45378085.06085.65
3451129-45112984.56385.14
4474719-47471988.98589.60
5458543-45854385.95386.56
6468623-46862387.84288.44
60min1462617-46261786.71687.791.6787.4588.531.66
2465509-46550987.25887.99
3460566-46056686.33287.05
4479129-47912989.81190.57
5465305-46530587.22087.97
6477033-47703389.41890.16
极限1477681-47768189.54090.181.5090.4291.061.50
2480850-48085090.13491.01
3472969-47296988.65789.52
4492262-49226292.27393.19
5476122-47612289.24890.14
6486557-48655791.20492.10
利伐沙班口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号430060-202202对照品来源中检所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1000
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%
115.344889044891024892954886844889954889960.05
215.404908384913884911130.08
单位质量响应值RSD%判断
31877.1831890.450.03数据可信
供试品溶液-第2批-pH4.5jz(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%
5min1270751-27075150.54348.962.0750.5448.962.07
2265259-26525949.51849.52
3261264-26126448.77248.77
4255211-25521147.64247.64
5258421-25842148.24148.24
6262806-26280649.06049.06
10min1369972-36997269.06667.911.3669.1567.991.37
2367343-36734368.57568.66
3362278-36227867.62967.71
4356026-35602666.46266.54
5361462-36146267.47767.56
6365596-36559668.24968.33
15min1407319-40731976.03775.381.2076.2475.581.20
2409204-40920476.38976.59
3400947-40094774.84875.04
4396741-39674174.06374.25
5401560-40156074.96275.16
6407160-40716076.00876.20
20min1424188-42418879.18678.961.2179.5179.281.21
2429672-42967280.21080.53
3421058-42105878.60278.92
4415525-41552577.56977.88
5420352-42035278.47078.79
6427078-42707879.72680.05
30min1447035-44703583.45182.811.4183.9183.261.41
2450128-45012884.02984.49
3437942-43794281.75482.20
4435590-43559081.31581.76
5441221-44122182.36682.81
6449752-44975283.95984.41
45min1461398-46139886.13385.601.5386.7386.191.53
2466112-46611287.01387.61
3452414-45241484.45685.04
4449164-44916483.84984.43
5456563-45656385.23085.82
6465666-46566686.92987.52
60min1471746-47174688.06487.281.7388.8188.021.73
2474991-47499188.67089.41
3460895-46089586.03986.77
4456676-45667685.25185.97
5464503-46450386.71287.44
6476526-47652688.95789.70
极限1480197-48019789.64289.511.2790.5390.391.27
2482633-48263390.09790.99
3474216-47421688.52689.40
4473043-47304388.30789.17
5477434-47743489.12690.00
6489543-48954391.38792.27
利伐沙班口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号430060-202202对照品来源中检所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1000
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%
115.344883924886374887174890524883534886300.06
215.404872484871924872200.01
单位质量响应值RSD%判断
31853.3231637.660.49数据可信
供试品溶液-第3批-pH4.5jz(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%
5min1289350-28935054.25152.872.4654.2552.872.46
2280141-28014152.52552.52
3282276-28227652.92552.92
4273006-27300651.18751.19
5290539-29053954.47454.47
6276663-27666351.87251.87
10min1379744-37974471.19971.310.7171.2971.400.71
2378181-37818170.90670.99
3379885-37988571.22671.31
4377670-37767070.81170.90
5385014-38501472.18872.28
6381498-38149871.52871.61
15min1411342-41134277.12477.840.6877.3378.040.68
2414401-41440177.69777.90
3415567-41556777.91678.12
4413002-41300277.43577.64
5418029-41802978.37878.59
6418495-41849578.46578.67
20min1427788-42778880.20780.930.5580.5581.270.54
2431482-43148280.90081.24
3432137-43213781.02381.36
4432379-43237981.06881.40
5434995-43499581.55981.90
6431084-43108480.82581.16
30min1445077-44507783.44984.360.5883.9284.830.57
2451125-45112584.58385.05
3451168-45116884.59185.06
4449273-44927384.23684.70
5452246-45224684.79385.27
6450775-45077584.51784.99
45min1458736-45873686.01087.080.6386.6287.690.63
2466741-46674187.51188.12
3464875-46487587.16187.77
4464421-46442187.07687.68
5466190-46619087.40888.03
6465556-46555687.28987.90
60min1466279-46627987.42488.440.6188.1889.190.61
2474107-47410788.89289.65
3472516-47251688.59489.35
4471209-47120988.34989.10
5472050-47205088.50689.27
6473870-47387088.84789.60
极限1476987-47698789.43290.170.4790.3391.070.46
2482276-48227690.42491.33
3481930-48193090.35991.26
4483172-48317290.59291.49
5481237-48123790.22991.14
6479836-47983689.96690.87
利伐沙班口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号430060-202202对照品来源中检所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1000
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%
115.344892494890904889454888734894934891300.06
215.404961634956134958880.08
单位质量响应值RSD%判断
31885.9232200.520.70数据可信
供试品溶液批-pH4.5jz(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%
5min1347062-34706264.46862.541.7164.4762.541.71
2336605-33660562.52662.53
3333989-33398962.04062.04
4330696-33069661.42861.43
5333426-33342661.93561.94
6338392-33839262.85862.86
10min1405475-40547575.31876.160.8775.4376.260.87
2411785-41178576.49176.59
3409515-40951576.06976.17
4409267-40926776.02376.13
5408117-40811775.80975.91
6415916-41591677.25877.36
15min1430324-43032479.93481.140.9980.1781.380.99
2437390-43739081.24781.48
3437741-43774181.31281.54
4434863-43486380.77781.01
5437149-43714981.20281.43
6443587-44358782.39882.63
20min1442943-44294382.27883.771.0682.6484.141.05
2452620-45262084.07684.44
3451214-45121483.81584.18
4451018-45101883.77884.14
5450506-45050683.68384.05
6457652-45765285.01185.38
30min1458956-45895685.25386.821.1385.7687.331.13
2469321-46932187.17887.69
3467181-46718186.78187.29
4466550-46655086.66387.17
5467034-46703486.75387.26
6475283-47528388.28688.80
45min1469963-46996387.29789.171.2287.9489.821.22
2482155-48215589.56290.21
3480877-48087789.32589.97
4479378-47937889.04689.69
5479836-47983689.13189.78
6488057-48805790.65891.32
60min1475599-47559988.34490.171.2089.1490.971.20
2487545-48754590.56391.37
3485644-48564490.21091.01
4484032-48403289.91190.71
5486146-48614690.30391.10
6493473-49347391.66492.48
极限1479766-47976689.11890.941.1690.0691.881.15
2490479-49047991.10892.06
3489167-48916790.86591.81
4487914-48791490.63291.58
5494723-49472391.89792.84
6495260-49526091.99692.96
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