奥利司他胶囊项目信息
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%
113.624568104579334585184583834589234581130.18
213.574569764575084572420.09
单位质量响应值RSD%判断
33635.3233695.060.13数据可信
长期6月-供试品溶液-2024102121批-pH2.0(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%
5min116936-169363.7543.9610.033.753.9610.11
219920-199204.4164.42
318182-181824.0304.03
415221-152213.3743.37
519708-197084.3694.37
617203-172033.8133.81
10min146102-4610210.21910.324.9410.2310.334.95
245518-4551810.09010.10
346416-4641610.28910.30
443424-434249.6269.63
550347-5034711.16011.17
647533-4753310.53710.54
15min175366-7536616.70616.563.3516.7316.583.36
272931-7293116.16616.19
374215-7421516.45116.47
471208-7120815.78515.81
578317-7831717.36017.39
676188-7618816.88816.91
20min1100689-10068922.32022.454.6122.3722.504.60
297711-9771121.65921.71
3100228-10022822.21722.27
496088-9608821.30021.35
5103892-10389223.03023.08
6109069-10906924.17724.23
30min1147696-14769632.74032.212.4832.8332.302.48
2140259-14025931.09131.18
3144882-14488232.11632.20
4141872-14187231.44931.53
5149085-14908533.04733.14
6147961-14796132.79832.89
45min1203548-20354845.12044.132.5645.2644.272.56
2191929-19192942.54542.68
3198597-19859744.02344.16
4194660-19466043.15043.29
5205136-20513645.47245.62
6200485-20048544.44144.59
60min1246891-24689154.72852.972.8954.9553.192.89
2229347-22934750.83951.05
3237184-23718452.57652.79
4233701-23370151.80452.01
5245888-24588854.50654.73
6240840-24084053.38753.61
极限1278241-27824161.67760.172.4961.9960.482.49
2261440-26144057.95358.25
3272572-27257260.42160.72
4265672-26567258.89159.19
5278158-27815861.65961.97
6272594-27259460.42560.74
奥利司他胶囊项目信息
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%
113.624587514569344566694562564549224567060.31
213.574550554564334557440.22
单位质量响应值RSD%判断
33532.0133584.670.12数据可信
长期6月-供试品溶液-2024102121批-pH2.0(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%
5min115634-156343.4773.8014.783.483.8014.79
216554-165543.6813.68
317035-170353.7883.79
417311-173113.8503.85
514259-142593.1713.17
621716-217164.8294.83
10min145921-4592110.21210.426.0310.2210.436.03
248870-4887010.86710.87
345620-4562010.14510.15
444235-442359.8379.84
544932-449329.99210.00
651644-5164411.48411.49
15min176390-7639016.98716.625.8117.0116.645.82
279042-7904217.57717.60
370411-7041115.65815.68
469414-6941415.43615.46
573403-7340316.32316.34
679648-7964817.71217.74
20min1103716-10371623.06422.305.9423.1122.355.94
2106325-10632523.64423.70
393387-9338720.76720.82
492907-9290720.66020.71
599829-9982922.19922.25
6105452-10545223.45023.51
30min1150871-15087133.55031.905.7833.6431.995.77
2151533-15153333.69733.79
3133716-13371629.73529.82
4132851-13285129.54329.63
5144460-14446032.12432.21
6147241-14724132.74332.84
45min1207552-20755246.15443.635.5446.3043.775.53
2205107-20510745.61045.76
3184449-18444941.01741.15
4181382-18138240.33540.47
5200660-20066044.62244.76
6198041-19804144.03944.19
60min1247653-24765355.07252.175.1155.2952.385.10
2245492-24549254.59154.82
3221852-22185249.33449.54
4218691-21869148.63148.83
5236944-23694452.69052.90
6237024-23702452.70852.93
极限1279096-27909662.06459.334.0462.3859.634.04
2277335-27733561.67261.99
3255367-25536756.78757.07
4253283-25328356.32456.60
5268296-26829659.66259.96
6267443-26744359.47259.78
奥利司他胶囊项目信息
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%
113.624586994596194597784627334581044597870.39
213.574595704557094576400.60
单位质量响应值RSD%判断
33758.2233724.390.08数据可信
长期6月-供试品溶液-2024102221批-pH2.0(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%
5min114542-145423.2163.5111.623.223.5111.58
216654-166543.6833.68
316189-161893.5803.58
414476-144763.2023.20
514358-143583.1763.18
619083-190834.2214.22
10min143138-431389.5419.754.419.559.764.43
245265-4526510.01110.02
344943-449439.9409.95
442618-426189.4269.43
541730-417309.2299.23
646942-4694210.38210.39
15min169677-6967715.41015.733.6415.4315.743.65
273979-7397916.36216.38
372441-7244116.02216.04
470803-7080315.65915.68
566846-6684614.78414.80
672860-7286016.11416.14
20min193979-9397920.78521.453.7820.8321.493.79
2101190-10119022.38022.43
399665-9966522.04322.09
498284-9828421.73721.78
591377-9137720.21020.25
697313-9731321.52321.57
30min1137657-13765730.44531.333.5330.5331.413.53
2147550-14755032.63332.72
3144800-14480032.02532.11
4145278-14527832.13132.21
5134744-13474429.80129.88
6139850-13985030.93031.02
45min1194202-19420242.95143.562.5343.0843.702.53
2200931-20093144.44044.58
3199618-19961844.14944.29
4199103-19910344.03544.17
5188045-18804541.59041.72
6199911-19991144.21444.35
60min1237481-23748152.52352.522.8052.7352.732.79
2241104-24110453.32553.54
3240000-24000053.08053.29
4246358-24635854.48754.70
5228067-22806750.44150.64
6231778-23177851.26251.47
极限1269797-26979759.67059.061.6659.9659.351.66
2270591-27059159.84660.15
3269271-26927159.55459.86
4269475-26947559.59959.90
5259994-25999457.50257.78
6262984-26298458.16458.46
奥利司他胶囊项目信息
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%
113.624588594583334597414594204596214591950.13
213.574612934569194591060.68
单位质量响应值RSD%判断
33714.7633832.420.25数据可信
长期6月-供试品溶液-2024102221批-pH2.0(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%
5min115044-150443.3242.8910.073.322.8910.08
213821-138213.0543.05
313171-131712.9102.91
413192-131922.9152.91
511644-116442.5732.57
611604-116042.5642.56
10min139529-395298.7348.674.808.748.684.80
240924-409249.0429.05
340725-407258.9989.00
440237-402378.8918.90
537971-379718.3908.39
636082-360827.9737.98
15min163681-6368114.07114.344.9214.0914.354.93
266260-6626014.64114.66
367314-6731414.87414.89
467974-6797415.01915.04
564817-6481714.32214.34
659223-5922313.08613.10
20min194382-9438220.85420.084.8420.9020.124.85
291272-9127220.16720.21
391995-9199520.32720.37
494402-9440220.85920.90
590800-9080020.06320.11
682479-8247918.22418.26
30min1128744-12874428.44729.343.8728.5329.423.87
2133675-13367529.53629.61
3134926-13492629.81329.89
4139314-13931430.78230.86
5135199-13519929.87329.95
6124919-12491927.60227.67
45min1181820-18182040.17440.953.1640.3041.073.16
2186839-18683941.28341.41
3186701-18670141.25341.38
4191537-19153742.32242.45
5189525-18952541.87742.00
6175429-17542938.76238.88
60min1222120-22212049.07949.602.8849.2749.802.88
2225951-22595149.92650.12
3224502-22450249.60549.80
4231349-23134951.11851.32
5229794-22979450.77550.97
6213279-21327947.12647.31
极限1251948-25194855.67056.312.7255.9456.582.72
2257835-25783556.97157.25
3253939-25393956.11056.39
4260964-26096457.66257.95
5261339-26133957.74558.02
6242942-24294253.68053.94
奥利司他胶囊项目信息
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%
113.624540214541544548524542004546474543750.08
213.574599544568304583920.49
单位质量响应值RSD%判断
33360.8733779.810.89数据可信
长期6月-供试品溶液-2024102321批-pH2.0(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%
5min114549-145493.2343.1018.843.233.1018.83
211596-115962.5782.58
317223-172233.8293.83
410166-101662.2602.26
515792-157923.5113.51
614210-142103.1593.16
10min139507-395078.7838.958.908.798.968.89
235811-358117.9617.97
345897-4589710.20310.21
437346-373468.3028.31
541999-419999.3379.34
640987-409879.1129.12
15min163361-6336114.08514.477.2714.1114.497.28
259462-5946213.21913.24
373211-7321116.27516.30
462097-6209713.80413.82
566080-6608014.69014.71
666248-6624814.72714.75
20min184964-8496418.88819.575.9118.9319.615.91
281959-8195918.22018.26
396907-9690721.54321.59
485506-8550619.00819.05
589189-8918919.82719.87
689596-8959619.91719.96
30min1125938-12593827.99628.975.1728.0729.055.17
2121621-12162127.03727.11
3141153-14115331.37931.47
4128228-12822828.50528.58
5132264-13226429.40329.48
6132755-13275529.51229.59
45min1176174-17617439.16440.334.8139.2940.454.81
2168631-16863137.48737.60
3194295-19429543.19243.33
4180102-18010240.03740.16
5184494-18449441.01441.14
6184766-18476641.07441.20
60min1215974-21597448.01248.824.4748.2049.024.47
2202767-20276745.07645.25
3231759-23175951.52151.73
4219627-21962748.82449.01
5223774-22377449.74649.94
6223870-22387049.76749.96
极限1249426-24942655.44855.583.3055.7255.863.31
2235202-23520252.28652.54
3260227-26022757.84958.15
4250414-25041455.66855.94
5253734-25373456.40656.69
6251237-25123755.85156.13
奥利司他胶囊项目信息
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%
113.624550314551124564494576664575764563670.28
213.574542024556034549020.22
单位质量响应值RSD%判断
33507.1233522.620.04数据可信
长期6月-供试品溶液-2024102321批-pH2.0(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%
5min111116-111162.4752.9013.942.482.9013.87
216143-161433.5943.59
313770-137703.0663.07
412759-127592.8412.84
512875-128752.8672.87
611457-114572.5512.55
10min135638-356387.9358.676.107.948.686.09
242749-427499.5199.52
337801-378018.4178.42
438256-382568.5188.52
539631-396318.8248.83
639668-396688.8338.84
15min159512-5951213.25114.016.0513.2714.036.06
268347-6834715.21815.24
359936-5993613.34513.36
463586-6358614.15814.18
566361-6636114.77614.80
659752-5975213.30513.32
20min181027-8102718.04219.166.4218.0819.206.41
293173-9317320.74620.79
380687-8068717.96618.01
487930-8793019.57919.62
591318-9131820.33320.38
682028-8202818.26518.31
30min1122439-12243927.26328.455.9627.3328.525.97
2135378-13537830.14430.23
3118218-11821826.32326.39
4131049-13104929.18029.25
5136579-13657930.41130.49
6122925-12292527.37127.44
45min1172887-17288738.49539.715.2638.6139.835.25
2185460-18546041.29541.43
3165013-16501336.74236.86
4182208-18220840.57140.69
5190451-19045142.40642.53
6173983-17398338.73938.86
60min1211353-21135347.06048.244.8347.2448.434.83
2223531-22353149.77249.97
3200278-20027844.59444.77
4220818-22081849.16849.36
5229986-22998651.20951.41
6213883-21388347.62447.81
极限1241611-24161153.79855.093.6154.0655.363.61
2253018-25301856.33856.62
3235411-23541152.41752.67
4252255-25225556.16856.44
5259368-25936857.75158.04
6242771-24277154.05654.32
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