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)120供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.474540274540104540214536694534814538420.06
213.494555384543874549620.18
单位质量响应值RSD%判断
33692.8033725.870.07数据可信
供试品溶液-2024102421批-pH6.8(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%
5min121610-216104.78411.0643.864.7811.0643.87
272055-7205515.95115.95
336030-360307.9767.98
459365-5936513.14213.14
574934-7493416.58916.59
635747-357477.9147.91
10min1140431-14043131.08837.4112.6131.1437.5312.71
2194887-19488743.14443.32
3159832-15983235.38335.47
4176514-17651439.07639.22
5188899-18889941.81842.00
6153335-15333533.94534.03
15min1233821-23382151.76357.236.5052.1657.776.63
2275103-27510360.90261.56
3251750-25175055.73256.21
4261840-26184057.96658.55
5278483-27848361.65062.30
6250099-25009955.36655.83
20min1302475-30247566.96170.703.2767.9471.883.42
2329736-32973672.99674.33
3316739-31673970.11971.22
4321392-32139271.14972.37
5330550-33055073.17674.51
6315422-31542269.82770.91
30min1366729-36672981.18685.212.5482.9087.172.64
2385824-38582485.41387.56
3383138-38313884.81886.70
4390340-39034086.41388.43
5394900-39490087.42289.57
6388402-38840285.98487.84
45min1427152-42715294.56294.761.1297.1897.671.06
2420945-42094593.18896.28
3426110-42611094.33197.15
4428418-42841894.84297.82
5430353-43035395.27198.39
6435369-43536996.38199.19
60min1432812-43281295.81596.921.0099.49100.881.01
2434735-43473596.241100.37
3440793-44079397.582101.45
4434414-43441496.170100.20
5440529-44052997.523101.70
6443584-44358498.200102.08
极限1449787-44978799.57398.821.62104.31103.861.43
2433989-43398996.076101.27
3447943-44794399.165104.12
4446744-44674498.899104.00
5444159-44415998.327103.59
6455647-455647100.870105.84
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)120供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.474621014612374613144623254608244615600.14
213.494606024604414605220.03
单位质量响应值RSD%判断
34265.7834138.030.27数据可信
供试品溶液-2024102421批-pH6.8(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%
5min145721-457219.9768.3448.939.988.3448.92
212814-128142.7962.80
351792-5179211.30111.30
451352-5135211.20511.20
515769-157693.4413.44
651860-5186011.31511.32
10min1155555-15555533.94131.4424.7834.0531.5324.85
285881-8588118.73818.77
3172193-17219337.57137.70
4168277-16827736.71636.84
5114281-11428124.93524.97
6168341-16834136.73036.86
15min1243428-24342853.11450.8012.8853.6051.2413.02
2184650-18465040.28940.53
3260949-26094956.93757.48
4248115-24811554.13654.67
5207310-20731045.23345.55
6252413-25241355.07455.61
20min1305490-30549066.65565.187.7667.7366.187.95
2260666-26066656.87557.56
3316729-31672969.10770.28
4316678-31667869.09670.23
5280070-28007061.10961.93
6312623-31262368.21169.36
30min1378364-37836482.55582.322.0384.3784.052.28
2367285-36728580.13881.46
3380251-38025182.96784.91
4384220-38422083.83385.73
5368692-36869280.44581.94
6384964-38496483.99585.90
45min1432744-43274494.42193.391.3597.1696.041.26
2434129-43412994.72396.93
3419780-41978091.59294.46
4431731-43173194.20097.03
5423233-42323392.34594.74
6426537-42653793.06695.90
60min1441133-44113396.25196.741.73100.04100.431.43
2452021-45202198.627101.89
3434514-43451494.80798.69
4443241-44324196.711100.59
5452780-45278098.792102.21
6436622-43662295.26799.14
极限1450225-45022598.23598.822.20103.09103.581.89
2469607-469607102.464106.82
3439205-43920595.830100.77
4451489-45148998.511103.46
5456492-45649299.602104.12
6450455-45045598.285103.21
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)120供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.474620224615564619614631244628834623090.15
213.494623774610324617040.21
单位质量响应值RSD%判断
34321.3834225.650.20数据可信
供试品溶液-2024102521批-pH6.8(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%
5min16840-68401.48911.0255.911.4911.0255.90
279616-7961617.33517.34
325471-254715.5465.55
457253-5725312.46612.47
564391-6439114.02014.02
670047-7004715.25215.25
10min1119582-11958226.03735.0916.1226.0535.2116.26
2186591-18659140.62740.82
3139224-13922430.31430.38
4170360-17036037.09337.23
5172836-17283637.63237.79
6178342-17834238.83139.00
15min1218794-21879447.63953.126.0147.9453.636.19
2259568-25956856.51757.16
3235180-23518051.20751.61
4249217-24921754.26354.81
5249034-24903454.22354.80
6252025-25202554.87455.48
20min1281315-28131561.25265.163.7262.0966.273.90
2313075-31307568.16769.44
3292321-29232163.64864.62
4305933-30593366.61267.77
5300688-30068865.47066.65
6302324-30232465.82667.04
30min1375850-37585081.83581.841.4983.3583.671.52
2379906-37990682.71984.75
3372578-37257881.12382.80
4384660-38466083.75485.65
5369468-36946880.44682.35
6372773-37277381.16583.11
45min1420501-42050191.55791.771.2693.9894.501.19
2416373-41637390.65993.61
3425062-42506292.55195.13
4428591-42859193.31996.14
5423506-42350692.21295.01
6414749-41474990.30593.15
60min1450515-45051598.09395.471.86101.5399.231.69
2438081-43808195.38599.34
3436827-43682795.11298.72
4444548-44454896.793100.65
5427503-42750393.08296.90
6433460-43346094.37998.23
极限1451676-45167698.34597.221.80102.88102.031.65
2432388-43238894.14699.16
3446521-44652197.223101.88
4456043-45604399.296104.23
5444506-44450696.784101.64
6447878-44787897.518102.41
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)120供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.474599754593864600704608674609284602450.15
213.494617164594674605920.35
单位质量响应值RSD%判断
34168.1534143.220.06数据可信
供试品溶液-2024102521批-pH6.8(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%
5min123012-230125.0288.1250.445.038.1250.41
219485-194854.2574.26
360976-6097613.32213.32
451434-5143411.23811.24
518975-189754.1464.15
649077-4907710.72310.72
10min1131497-13149728.73031.9413.8628.7932.0313.94
2115175-11517525.16425.21
3163428-16342835.70735.85
4164587-16458735.96036.08
5141489-14148930.91330.96
6160900-16090035.15435.27
15min1219221-21922147.89650.706.6548.2751.156.76
2208743-20874345.60745.93
3243619-24361953.22753.77
4247808-24780854.14254.67
5231129-23112950.49850.89
6241893-24189352.85053.36
20min1288877-28887763.11563.944.3164.0264.944.43
2271558-27155859.33160.16
3300493-30049365.65366.79
4301902-30190265.96167.09
5287630-28763062.84363.79
6305386-30538666.72267.82
30min1361210-36121078.91980.131.3780.5381.841.51
2359646-35964678.57780.07
3369695-36969580.77382.64
4371389-37138981.14383.00
5368468-36846880.50582.15
6369991-36999180.83782.68
45min1407127-40712788.95191.341.6791.4493.951.71
2414476-41447690.55792.92
3415904-41590490.86993.63
4421588-42158892.11194.87
5426086-42608693.09395.64
6423291-42329192.48395.22
60min1425388-42538892.94194.551.6096.4198.181.47
2442390-44239096.656100.03
3426243-42624393.12896.90
4428954-42895493.72097.50
5437613-43761395.61299.19
6435988-43598895.25799.02
极限1428400-42840093.59996.322.1598.11101.002.04
2453767-45376799.141103.59
3431764-43176494.33499.14
4447093-44709397.683102.51
5442007-44200796.572101.21
6442196-44219696.613101.44
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