奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号520027-202102对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
113.524579804577154577104583324578624579200.06
213.504594004592304593150.03
单位质量响应值RSD%判断
33869.8234023.330.32数据可信
长期6月-供试品溶液-M2449M1批-pH6.0(内含3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min160509-6050913.30211.8038.9813.3011.8038.99
259722-5972213.12913.13
361222-6122213.45913.46
469194-6919415.21115.21
511608-116082.5522.55
659871-5987113.16213.16
10min1148366-14836632.61631.0314.8832.7631.1614.97
2153373-15337333.71633.86
3147938-14793832.52132.67
4153923-15392333.83734.01
598925-9892521.74721.78
6144380-14438031.73931.89
15min1204916-20491645.04744.189.4145.5644.669.53
2214149-21414947.07747.60
3214694-21469447.19747.71
4207643-20764345.64746.19
5164022-16402236.05736.33
6200455-20045544.06644.57
20min1252873-25287355.59054.697.4256.6055.667.55
2257233-25723356.54857.59
3263721-26372157.97459.01
4256519-25651956.39157.44
5212351-21235146.68247.35
6250097-25009754.97955.97
30min1326065-32606571.67968.195.3173.3169.775.44
2315593-31559369.37771.05
3323526-32352671.12172.80
4307434-30743467.58469.26
5280432-28043261.64862.84
6308178-30817867.74769.35
45min1385609-38560984.76979.564.4787.1981.894.53
2353845-35384577.78680.23
3372961-37296181.98984.46
4366671-36667180.60683.04
5341629-34162975.10176.98
6350768-35076877.11079.46
60min1401444-40144488.25084.823.1691.6288.043.28
2391115-39111585.98089.29
3391141-39114185.98589.37
4389063-38906385.52888.85
5370384-37038481.42284.13
6371962-37196281.76984.98
极限1432184-43218495.00891.663.9599.3695.823.95
2416795-41679591.62595.89
3433630-43363095.32699.66
4421921-42192192.75297.03
5407116-40711689.49793.11
6390078-39007885.75289.87
奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号520027-202102对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
113.524574304574774572634574774572654573820.03
213.504607014607994607500.02
单位质量响应值RSD%判断
33830.0334129.630.63数据可信
长期6月-供试品溶液-M2449M1批-pH6.0(内含3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min161123-6112313.42412.2012.6913.4212.2012.69
263588-6358813.96513.97
353053-5305311.65111.65
453402-5340211.72811.73
558131-5813112.76712.77
643930-439309.6489.65
10min1149848-14984832.91031.184.7733.0631.324.80
2150449-15044933.04233.20
3136695-13669530.02130.15
4137692-13769230.24030.37
5142193-14219331.22831.37
6135009-13500929.65129.76
15min1218931-21893148.08245.493.1148.6045.983.13
2208880-20888045.87446.40
3206425-20642545.33545.80
4203989-20398944.80045.27
5200309-20030943.99244.48
6204293-20429344.86745.30
20min1268161-26816158.89356.052.7959.9457.042.78
2250359-25035954.98456.02
3257692-25769256.59457.56
4248407-24840754.55555.52
5252439-25243955.44156.42
6254244-25424455.83756.77
30min1333171-33317173.17170.052.6574.8771.662.66
2320449-32044970.37772.02
3318459-31845969.94071.54
4306957-30695767.41468.98
5316198-31619869.44371.04
6318487-31848769.94671.50
45min1380329-38032983.52880.802.6286.0483.182.62
2375454-37545482.45784.88
3370240-37024081.31283.68
4358822-35882278.80481.12
5355095-35509577.98680.35
6367496-36749680.70983.04
60min1412456-41245690.58486.562.9894.0389.852.95
2403361-40336188.58691.93
3380204-38020483.50086.78
4388537-38853785.33088.53
5392025-39202586.09689.33
6388255-38825585.26988.50
极限1436113-43611395.77992.872.06100.2397.112.06
2423899-42389993.09797.42
3421915-42191592.66196.86
4415691-41569191.29495.44
5427708-42770893.93398.12
6411742-41174290.42794.60
奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号520027-202102对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
113.524630474625964633834628264625574628820.08
213.504667664666134666900.03
单位质量响应值RSD%判断
34236.8334569.630.69数据可信
中间条件6月-供试品溶液-M2449M1批-pH6.0(内含3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135554-355547.7129.5012.307.719.5012.31
242930-429309.3129.31
339640-396408.5998.60
447711-4771110.34910.35
548306-4830610.47810.48
648639-4863910.55110.55
10min1107305-10730523.27624.854.5623.3624.954.57
2109134-10913423.67323.78
3119057-11905725.82625.92
4118731-11873125.75525.87
5118609-11860925.72825.84
6114409-11440924.81724.93
15min1164549-16454935.69437.053.4136.0437.433.42
2163334-16333435.43035.80
3174178-17417837.78238.16
4172909-17290937.50737.91
5178397-17839738.69739.10
6171423-17142337.18537.58
20min1210635-21063545.69046.323.8046.4347.123.79
2199979-19997943.37944.14
3222317-22231748.22549.03
4215195-21519546.68047.50
5220900-22090047.91748.75
6212227-21222746.03646.84
30min1276855-27685560.05560.451.8161.3061.761.85
2269872-26987258.54059.78
3282568-28256861.29462.63
4280918-28091860.93662.27
5283702-28370261.54062.90
6278222-27822260.35161.67
45min1335835-33583572.84972.221.6674.7674.201.66
2324897-32489770.47672.37
3330446-33044671.68073.70
4340060-34006073.76575.78
5336570-33657073.00875.06
6329932-32993271.56873.56
60min1359133-35913377.90278.801.2680.6381.581.26
2359640-35964078.01280.69
3360915-36091578.28981.10
4365534-36553479.29182.12
5363120-36312078.76781.63
6371221-37122180.52483.31
极限1401421-40142187.07587.351.7290.6791.011.63
2407822-40782288.46492.01
3392180-39218085.07188.76
4410563-41056389.05892.77
5397738-39773886.27690.01
6406413-40641388.15891.84
奥利司他胶囊项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号520027-202102对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
113.524661144657714658874659104656174658600.04
213.504690884692464691670.03
单位质量响应值RSD%判断
34457.1034753.110.61数据可信
中间条件6月-供试品溶液-M2449M1批-pH6.0(内含3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min143461-434619.37210.2119.739.3710.2119.73
250645-5064510.92210.92
332779-327797.0697.07
446284-462849.9819.98
549725-4972510.72310.72
661166-6116613.19113.19
10min1106133-10613322.88825.919.3122.9926.029.34
2125804-12580427.13027.25
3111012-11101223.94024.02
4118202-11820225.49025.60
5122097-12209726.33026.45
6137608-13760829.67529.82
15min1160687-16068734.65238.067.4735.0138.467.50
2178496-17849638.49338.92
3175362-17536237.81738.16
4166675-16667535.94436.34
5178567-17856738.50838.92
6199139-19913942.94543.42
20min1196742-19674242.42846.976.3543.1747.806.37
2216776-21677646.74847.60
3222661-22266148.01748.78
4213950-21395046.13946.93
5217273-21727346.85547.69
6239550-23955051.65952.61
30min1248666-24866653.62560.486.7054.8461.836.71
2285058-28505861.47362.84
3283013-28301361.03262.33
4272615-27261558.79060.10
5288408-28840862.19663.56
6304926-30492665.75867.29
45min1304717-30471765.71371.814.8467.5273.824.88
2329614-32961471.08273.13
3338970-33897073.09975.08
4332571-33257171.71973.68
5338608-33860873.02175.07
6353365-35336576.20478.46
60min1343563-34356374.09079.843.9476.6382.663.99
2372273-37227380.28183.12
3369547-36954779.69382.48
4369616-36961679.70882.46
5385112-38511283.05085.91
6381297-38129782.22785.33
极限1398735-39873585.98888.643.1989.3592.343.24
2398341-39834185.90389.64
3405111-40511187.36391.04
4410385-41038588.50092.14
5424169-42416991.47395.26
6429361-42936192.59296.61
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