非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.654200676420142142042424205328419809342019520.07
210.774199637419787341987550.03
单位质量响应值RSD%判断
394549.48389856.550.85数据可信
供试品溶液-250601批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1770188-77018817.65716.4316.8617.6616.4316.86
2786712-78671218.03618.04
3764832-76483217.53417.53
4580675-58067513.31213.31
5551290-55129012.63812.64
6847293-84729319.42419.42
10min12012424-201242446.13544.6014.0246.1744.6414.02
22091568-209156847.95047.99
32023858-202385846.39746.44
41707266-170726639.13939.17
51543565-154356535.38635.41
62293773-229377352.58552.63
15min12890943-289094366.27564.857.3666.4264.987.38
22943123-294312367.47267.62
32904797-290479766.59366.74
42708712-270871262.09862.21
52470436-247043656.63556.74
63054130-305413070.01670.18
20min13286617-328661775.34674.793.3475.6475.073.36
23333613-333361376.42476.72
33315783-331578376.01576.30
43244317-324431774.37774.63
53052570-305257069.98170.21
63341079-334107976.59576.91
30min13593488-359348882.38182.841.1282.8483.281.13
23619231-361923182.97183.44
33646523-364652383.59784.06
43658086-365808683.86284.28
53545932-354593281.29181.68
63616919-361691982.91883.40
45min13812186-381218687.39588.090.8688.0388.720.86
23829736-382973687.79788.45
33877029-387702988.88289.53
43889048-388904889.15789.76
53813266-381326687.42087.99
63833929-383392987.89388.56
60min13978586-397858691.21091.030.6892.0491.860.68
23947178-394717890.49091.34
33998072-399807291.65692.50
44005532-400553291.82892.63
53947458-394745890.49691.26
63947932-394793290.50791.37
极限14034345-403434592.48892.970.6893.5294.000.68
24041958-404195892.66393.71
34090126-409012693.76794.81
44090240-409024093.76994.78
54032624-403262492.44993.41
64042508-404250892.67593.74
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.654185731418430041890044190111418830241874900.06
210.774221528421836842199480.06
单位质量响应值RSD%判断
393191.55391824.330.25数据可信
供试品溶液-250601批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1519868-51986811.90813.9326.1611.9113.9326.16
2820181-82018118.78818.79
3363996-3639968.3388.34
4669435-66943515.33415.33
5703538-70353816.11616.12
6571839-57183913.09913.10
10min11481181-148118133.92938.6715.9233.9638.7015.92
21800245-180024541.23841.28
31252824-125282428.69828.72
41881873-188187343.10743.14
51961294-196129444.92744.96
61751012-175101240.11040.14
15min12507641-250764157.44260.787.8457.5460.897.86
22764445-276444563.32463.46
32301145-230114552.71152.79
42708736-270873662.04862.18
52834597-283459764.93165.07
62802514-280251464.19664.31
20min13013329-301332969.02571.913.8869.2572.163.91
23195307-319530773.19473.47
32956669-295666967.72767.93
43211161-321116173.55773.82
53219812-321981273.75574.03
63239571-323957174.20874.47
30min13486817-348681779.87180.811.0680.2581.221.09
23512893-351289380.46880.91
33496071-349607180.08380.43
43564476-356447681.65082.08
53526354-352635480.77781.22
63579971-357997182.00582.43
45min13760081-376008186.13186.600.7786.6987.190.75
23758194-375819486.08786.70
33796887-379688786.97487.50
43799410-379941087.03287.64
53748794-374879485.87286.50
63820395-382039587.51288.12
60min13889387-388938789.09389.530.7789.8490.310.76
23886958-388695889.03789.84
33926701-392670189.94790.67
43924090-392409089.88890.69
53872519-387251988.70689.52
63950555-395055590.49491.30
极限14017604-401760492.03091.790.7592.9892.770.73
23980926-398092691.19092.19
34017924-401792492.03792.96
44018216-401821692.04493.05
53962811-396281190.77591.79
64045239-404523992.66393.67
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.654175240417256641796814173907417184541746480.08
210.774177264417487841760710.05
单位质量响应值RSD%判断
391985.73387750.320.77数据可信
供试品溶液-250602批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1852953-85295319.67117.1610.6519.6717.1610.64
2744092-74409217.16017.16
3614218-61421814.16514.17
4789678-78967818.21218.21
5720660-72066016.62016.62
6741990-74199017.11217.11
10min11891695-189169543.62744.142.7943.6744.182.80
21901392-190139243.85143.89
31876791-187679143.28343.31
41890476-189047643.59943.64
51902863-190286343.88443.92
62021399-202139946.61846.66
15min12807891-280789164.75765.301.0564.9065.441.05
22835233-283523365.38765.52
32830046-283004665.26765.40
42798681-279868164.54464.68
52833595-283359565.34965.48
62883734-288373466.50666.65
20min13154876-315487672.75973.380.6873.0473.660.67
23168320-316832073.06973.35
33216902-321690274.18974.46
43193455-319345573.64973.93
53181133-318113373.36473.64
63175224-317522473.22873.52
30min13463369-346336979.87380.500.8780.3280.950.86
23504664-350466480.82681.27
33535327-353532781.53381.97
43505743-350574380.85181.30
53478576-347857680.22480.67
63455638-345563879.69580.15
45min13681013-368101384.89385.871.5985.5286.501.58
23701486-370148685.36585.99
33758227-375822786.67387.29
43828872-382887288.30388.93
53691241-369124185.12985.75
63680533-368053384.88285.51
60min13808002-380800287.82188.952.1388.6389.762.11
23833494-383349488.40989.22
33894976-389497689.82790.64
44004823-400482392.36193.18
53820002-382000288.09888.91
63780811-378081187.19488.01
极限13909898-390989890.17190.640.8891.1891.650.87
23921183-392118390.43291.44
33981206-398120691.81692.83
43941354-394135490.89791.92
53946332-394633291.01292.02
63880865-388086589.50290.51
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.654233379422751842256494225398421582842255540.15
210.774326284432071443234990.10
单位质量响应值RSD%判断
396765.63401439.090.83数据可信
供试品溶液-250602批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1973781-97378121.93816.6823.2021.9416.6823.21
2822285-82228518.52518.53
3675816-67581615.22515.23
4797997-79799717.97817.98
5461365-46136510.39410.39
6710814-71081416.01416.01
10min12249842-224984250.68640.9017.7550.7440.9417.76
21966698-196669844.30744.35
31761483-176148339.68439.72
41971530-197153044.41644.46
51324861-132486129.84829.87
61617128-161712836.43236.47
15min13018798-301879868.01060.998.9968.1761.129.01
22794802-279480262.96463.10
32671520-267152060.18660.31
42865911-286591164.56664.70
52327687-232768752.44052.53
62563948-256394857.76357.88
20min13294109-329410974.21270.674.1974.5270.944.22
23187009-318700971.80072.08
33137899-313789970.69370.95
43229030-322903072.74673.03
52934256-293425666.10566.31
63040049-304004968.48968.73
30min13573144-357314480.49979.021.1780.9879.441.22
23512190-351219079.12679.56
33490738-349073878.64279.06
43532399-353239979.58180.02
53463770-346377078.03578.39
63472250-347225078.22678.62
45min13787474-378747485.32784.520.7585.9885.120.75
23716799-371679983.73584.35
33743921-374392184.34684.93
43750147-375014784.48685.11
53781592-378159285.19585.72
63729998-372999884.03284.60
60min13911351-391135188.11887.330.8488.9688.110.83
23825401-382540186.18286.98
33854378-385437886.83587.61
43884148-388414887.50588.31
53906698-390669888.01388.73
63876456-387645687.33288.09
极限13999795-399979590.11189.630.8291.1590.610.79
23940241-394024188.76989.76
33956776-395677689.14290.11
43964102-396410289.30790.31
54029653-402965390.78391.69
63980250-398025089.67090.62
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