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(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.323298423300273306753297713301863301000.11
210.243301793296653299220.12
单位质量响应值RSD%判断
31986.4332218.950.52数据可信
供试品溶液-JPS7149批-pH1.2(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1205071-20507157.26358.473.4557.2658.473.46
2218244-21824460.94160.94
3199827-19982755.79855.80
4209356-20935658.45958.46
5217406-21740660.70760.71
6206547-20654757.67557.67
10min1268115-26811574.86676.023.6674.9676.123.66
2281365-28136578.56678.67
3259762-25976272.53472.63
4268241-26824174.90275.00
5286891-28689180.10980.21
6269183-26918375.16575.26
15min1289748-28974880.90782.093.5381.1382.313.53
2302343-30234384.42484.66
3281470-28147078.59678.81
4289842-28984280.93381.16
5310172-31017286.61086.84
6290289-29028981.05881.28
20min1300428-30042883.88985.323.6984.2485.683.69
2315203-31520388.01588.39
3292286-29228681.61681.96
4300704-30070483.96684.32
5322905-32290590.16690.54
6301867-30186784.29184.65
30min1310617-31061786.73488.413.7787.2388.923.77
2325496-32549690.88991.41
3302044-30204484.34184.82
4311135-31113586.87987.38
5335393-33539393.65394.18
6315052-31505287.97388.47
45min1316431-31643188.35889.903.8489.0090.553.84
2332255-33225592.77693.45
3306466-30646685.57586.20
4316437-31643788.36089.00
5340643-34064395.11995.80
6319389-31938989.18489.83
60min1316904-31690488.49090.093.9489.2890.893.93
2332119-33211992.73893.56
3308473-30847386.13686.90
4317385-31738588.62489.41
5343334-34333495.87096.71
6317635-31763588.69489.49
极限1315788-31578888.17890.034.3689.1190.984.35
2334579-33457993.42594.41
3306216-30621685.50586.41
4315360-31536088.05989.00
5343979-34397996.05097.05
6318532-31853288.94589.88
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(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.323316673321663325913329103318443322360.16
210.243292133298503295320.14
单位质量响应值RSD%判断
32193.4132180.860.03数据可信
供试品溶液-JPS7638批-pH1.2(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1216174-21617460.20460.182.5060.2060.182.50
2218326-21832660.80360.80
3224822-22482262.61262.61
4214278-21427859.67659.68
5214607-21460759.76759.77
6208425-20842558.04658.05
10min1274344-27434476.40475.970.7776.5076.070.78
2273523-27352376.17576.28
3275854-27585476.82476.93
4271043-27104375.48475.58
5271282-27128275.55175.65
6270719-27071975.39475.49
15min1294796-29479682.10082.441.5582.3382.671.55
2303695-30369584.57884.81
3298945-29894583.25583.49
4292114-29211481.35381.58
5294927-29492782.13682.36
6291621-29162181.21581.44
20min1310788-31078886.55385.911.0586.9286.281.05
2310273-31027386.41086.78
3312746-31274687.09987.47
4305135-30513584.97985.34
5306854-30685485.45885.82
6305116-30511684.97485.33
30min1320690-32069089.31189.251.0989.8289.761.10
2321637-32163789.57590.09
3326626-32662690.96491.48
4317056-31705688.29988.80
5319244-31924488.90889.41
6317575-31757588.44388.94
45min1329242-32924291.69391.461.1392.3592.111.13
2329393-32939391.73592.40
3334567-33456793.17693.84
4323693-32369390.14790.80
5327505-32750591.20991.86
6325960-32596090.77991.43
60min1331293-33129392.26492.041.1393.0792.851.13
2331226-33122692.24593.06
3336953-33695393.84094.66
4326153-32615390.83291.63
5328151-32815191.38992.19
6329226-32922691.68892.49
极限1332889-33288992.70892.021.1693.6792.981.16
2331548-33154892.33593.30
3335796-33579693.51894.50
4325218-32521890.57291.52
5329645-32964591.80592.76
6327498-32749891.20792.16
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(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.323297093292983299613297243295673296520.08
210.243297523294453295980.07
单位质量响应值RSD%判断
31943.0232187.300.54数据可信
供试品溶液-JPS7149批-pH6.8(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1246949-24694969.03769.742.2769.0469.742.27
2239349-23934966.91266.91
3251317-25131770.25870.26
4251089-25108970.19470.19
5255302-25530271.37271.37
6252757-25275770.66170.66
10min1299103-29910383.61786.001.8783.7386.121.87
2306744-30674485.75385.86
3313064-31306487.52087.64
4308275-30827586.18186.30
5314565-31456587.94088.06
6304012-30401284.99085.11
15min1324165-32416590.62392.631.9690.8892.891.96
2329057-32905791.99192.25
3337224-33722494.27494.54
4336692-33669294.12694.39
5337141-33714194.25194.52
6323814-32381490.52590.78
20min1329286-32928692.05595.162.0592.4695.582.05
2339066-33906694.78995.20
3342170-34217095.65796.08
4343913-34391396.14496.56
5350171-35017197.89498.32
6337809-33780994.43894.85
30min1341511-34151195.47398.111.8596.0398.681.85
2348795-34879597.50998.07
3352846-35284698.64299.22
4353730-35373098.88999.47
5360802-360802100.866101.45
6348015-34801597.29197.86
45min1347761-34776197.22099.951.8197.94100.691.81
2358459-358459100.211100.94
3359100-359100100.390101.13
4360144-360144100.682101.42
5366629-366629102.495103.25
6353116-35311698.71799.45
60min1349058-34905897.583100.181.7198.46101.091.71
2358098-358098100.110101.01
3361016-361016100.926101.84
4361866-361866101.163102.07
5366171-366171102.367103.29
6353966-35396698.95599.85
极限1348277-34827797.364100.441.9298.41101.511.92
2358205-358205100.140101.20
3361600-361600101.089102.17
4362713-362713101.400102.48
5368660-368660103.063104.16
6356282-35628299.602100.66
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(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.323291673295483285683289633286963289880.12
210.243291563292803292180.03
单位质量响应值RSD%判断
31878.6832150.200.60数据可信
供试品溶液-JPS7638批-pH6.8(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1248927-24892769.70068.552.0769.7068.552.07
2236487-23648766.21766.22
3247219-24721969.22269.22
4240578-24057867.36367.36
5247993-24799369.43969.44
6247691-24769169.35469.35
10min1302618-30261884.73484.040.8184.8584.160.81
2298179-29817983.49183.60
3303477-30347784.97585.09
4298161-29816183.48683.60
5298176-29817683.49083.61
6300212-30021284.06084.18
15min1321765-32176590.09589.470.7890.3589.720.78
2317907-31790789.01589.26
3323185-32318590.49390.75
4316886-31688688.72988.98
5317926-31792689.02089.28
6319441-31944189.44589.70
20min1331755-33175592.89392.390.5793.3092.800.57
2327366-32736691.66492.06
3332284-33228493.04193.45
4328855-32885592.08192.48
5329257-32925792.19392.60
6330270-33027092.47792.88
30min1345074-34507496.62296.130.7097.1896.690.70
2341168-34116895.52896.08
3346673-34667397.07097.63
4340268-34026895.27695.83
5343532-34353296.19096.75
6343206-34320696.09996.66
45min1352257-35225798.63397.840.8399.3698.560.83
2347293-34729397.24397.95
3353148-35314898.88399.61
4347265-34726597.23597.95
5346279-34627996.95997.68
6350205-35020598.05998.78
60min1354196-35419699.17698.330.87100.0699.210.87
2348664-34866497.62798.50
3355100-35510099.429100.32
4348271-34827197.51798.39
5348647-34864797.62298.50
6352123-35212398.59699.48
极限1355558-35555899.55898.860.82100.6199.900.82
2349656-34965697.90598.94
3357048-35704899.975101.03
4350350-35035098.09999.14
5352481-35248198.69699.74
6353289-35328998.92299.97
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