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%
113.474477054468834469364476544474304473220.09
213.494408944398674403800.17
单位质量响应值RSD%判断
33208.7632644.921.22数据可信
供试品溶液-2024102621批-pH4.5(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%
5min132940-329407.4666.4521.057.476.4621.03
217142-171423.8853.89
330870-308706.9977.00
430567-305676.9286.93
532672-326727.4057.41
626637-266376.0376.04
10min1103901-10390123.55022.417.9723.6322.488.01
285684-8568419.42119.46
3105811-10581123.98324.06
4100083-10008322.68422.76
5104404-10440423.66423.75
693363-9336321.16121.23
15min1172131-17213139.01437.924.0939.3638.244.13
2160388-16038836.35336.61
3175541-17554139.78740.13
4165701-16570137.55737.89
5171347-17134738.83739.18
6158625-15862535.95336.26
20min1219611-21961149.77649.933.0150.5550.673.03
2217052-21705249.19649.86
3231652-23165252.50553.29
4216945-21694549.17249.92
5223675-22367550.69751.47
6212806-21280648.23448.94
30min1303931-30393168.88868.652.5270.2269.952.51
2307877-30787769.78270.99
3310768-31076870.43771.81
4295248-29524866.92068.21
5307643-30764369.72971.07
6291921-29192166.16567.40
45min1371352-37135284.16984.401.7686.2786.461.75
2378101-37810185.69987.68
3374915-37491584.97787.13
4363567-36356782.40484.44
5379994-37999486.12888.24
6366162-36616282.99384.97
60min1392540-39254088.97190.361.9992.0093.361.95
2410935-41093593.14196.08
3404998-40499891.79594.89
4394818-39481889.48892.44
5398582-39858290.34193.41
6390219-39021988.44591.34
极限1411385-41138593.24393.761.4797.2697.761.47
2417836-41783694.70598.68
3419548-41954895.09399.21
4416293-41629394.35598.30
5414050-41405093.84797.92
6402770-40277091.29095.17
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%
113.474402854392084389324392324390614393440.13
213.494492464480754486600.19
单位质量响应值RSD%判断
32616.4833258.711.38数据可信
供试品溶液-2024102621批-pH4.5(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%
5min120957-209574.7494.767.254.754.767.27
219351-193514.3854.38
322312-223125.0565.06
421097-210974.7804.78
523049-230495.2235.22
619285-192854.3704.37
10min186368-8636819.57019.591.2919.6219.641.28
286878-8687819.68519.73
388165-8816519.97720.03
484986-8498619.25719.31
586770-8677019.66119.72
685577-8557719.39119.44
15min1152988-15298834.66534.391.9434.9434.661.93
2154264-15426434.95435.22
3154389-15438934.98235.26
4147975-14797533.52933.80
5148138-14813833.56633.84
6152848-15284834.63334.90
20min1201293-20129345.61046.942.6546.2747.602.63
2211095-21109547.83148.49
3212852-21285248.22948.90
4199540-19954045.21345.85
5208145-20814547.16347.81
6210175-21017547.62348.27
30min1294821-29482166.80265.811.4967.9666.981.48
2287021-28702165.03566.22
3295389-29538966.93168.13
4285804-28580464.75965.90
5287038-28703865.03966.21
6292671-29267166.31567.49
45min1360888-36088881.77281.312.9683.6883.222.92
2364533-36453382.59884.51
3364183-36418382.51984.47
4350768-35076879.47981.34
5341846-34184677.45879.35
6370834-37083484.02685.94
60min1393125-39312589.07789.210.6091.8992.020.60
2397721-39772190.11892.95
3393021-39302189.05391.92
4393810-39381089.23291.98
5390504-39050488.48391.24
6394188-39418889.31892.17
极限1416215-41621594.30992.901.4898.1196.701.42
2398470-39847090.28894.12
3410065-41006592.91596.77
4410965-41096593.11996.86
5411000-41100093.12796.87
6413222-41322293.63097.47
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%
113.474491534473204478254471084481874479190.19
213.494480094465794472940.23
单位质量响应值RSD%判断
33253.0833157.450.21数据可信
供试品溶液-M2449M1批-pH4.5(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%
5min125390-253905.7067.4516.375.717.4516.35
232215-322157.2407.24
329536-295366.6386.64
438819-388198.7248.72
539548-395488.8888.89
633467-334677.5217.52
10min1109525-10952524.61526.615.5224.6826.695.55
2118605-11860526.65526.74
3114062-11406225.63425.71
4121791-12179127.37127.47
5128588-12858828.89929.00
6117807-11780726.47626.56
15min1180292-18029240.51942.533.6540.8642.903.67
2189371-18937142.55942.94
3187575-18757542.15542.51
4188651-18865142.39742.80
5201589-20158945.30545.72
6187880-18788042.22442.60
20min1229701-22970151.62353.912.7552.4154.762.79
2239618-23961853.85154.70
3236624-23662453.17954.01
4244074-24407454.85355.73
5249113-24911355.98556.91
6240134-24013453.96754.81
30min1301293-30129367.71268.901.5869.0770.351.62
2303336-30333668.17169.62
3307512-30751269.11070.53
4309012-30901269.44770.93
5314491-31449170.67872.22
6303735-30373568.26169.71
45min1359401-35940180.77181.040.8382.8883.250.88
2357898-35789880.43482.64
3359480-35948080.78982.97
4363590-36359081.71383.97
5365020-36502082.03484.36
6358186-35818680.49882.70
60min1381737-38173785.79186.491.2188.8089.601.22
2379207-37920785.22388.32
3381301-38130185.69388.78
4388888-38888887.39890.56
5387695-38769587.13090.37
6390183-39018387.68990.79
极限1417402-41740293.80693.311.3897.7797.381.34
2403942-40394290.78194.83
3415392-41539293.35597.39
4418324-41832494.01498.15
5416355-41635593.57197.78
6419674-41967494.31798.39
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%
113.474467864457294460734453864463234460590.13
213.494480624467704474160.21
单位质量响应值RSD%判断
33115.0033166.490.11数据可信
供试品溶液-M2449M1批-pH4.5(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%
5min130132-301326.7857.1910.126.797.1910.10
230984-309846.9776.98
334284-342847.7207.72
427353-273536.1596.16
536554-365548.2318.23
632221-322217.2557.26
10min1113261-11326125.50425.704.3725.5825.784.37
2110459-11045924.87324.95
3112103-11210325.24325.33
4109298-10929824.61124.68
5116960-11696026.33726.43
6122762-12276227.64327.72
15min1179871-17987140.50340.713.8540.8641.073.85
2174781-17478139.35739.71
3176300-17630039.69940.06
4176764-17676439.80340.14
5183595-18359541.34141.73
6193435-19343543.55743.94
20min1220815-22081549.72251.143.3150.5351.963.31
2224567-22456750.56751.36
3219788-21978849.49150.30
4226218-22621850.93951.72
5231462-23146252.12052.96
6239865-23986554.01254.88
30min1297224-29722466.92866.082.4868.2967.472.47
2286996-28699664.62565.98
3283813-28381363.90865.27
4298089-29808967.12368.47
5291814-29181465.71067.13
6302944-30294468.21669.69
45min1349800-34980078.76777.851.9580.8779.971.97
2342914-34291477.21679.29
3336339-33633975.73677.80
4342481-34248177.11979.21
5347143-34714378.16880.32
6355783-35578380.11482.34
60min1376810-37681084.84984.111.8987.8387.091.89
2363741-36374181.90684.83
3365309-36530982.25985.17
4379628-37962885.48388.44
5377226-37722684.94287.96
6378399-37839985.20688.33
极限1414747-41474793.39192.061.4897.3195.981.47
2402676-40267690.67394.51
3400787-40078790.24894.07
4415300-41530093.51697.42
5409410-40941092.18996.15
6410054-41005492.33496.40
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