塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
110.043030085302845530310193031780303519130313060.09
210.143015663301718530164240.04
单位质量响应值RSD%判断
301922.91297477.711.05数据可信
供试品溶液-23004N1批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1687499-68749922.84921.186.7022.8521.186.70
2602542-60254220.02520.03
3587643-58764319.53019.53
4633463-63346321.05321.05
5623741-62374120.73020.73
6689252-68925222.90722.91
10min11209130-120913040.18538.174.8040.2338.224.80
21103222-110322236.66636.71
31100375-110037536.57136.61
41130786-113078637.58237.62
51121271-112127137.26537.31
61226508-122650840.76340.81
15min11639719-163971954.49652.963.5854.6253.083.59
21544025-154402551.31651.43
31542864-154286451.27751.39
41582615-158261552.59852.72
51567188-156718852.08652.20
61684668-168466855.99056.12
20min11974857-197485765.63464.263.0165.8764.493.01
21877161-187716162.38762.60
31882801-188280162.57562.79
41926691-192669164.03464.26
51912397-191239763.55963.78
62027752-202775267.39267.63
30min12392390-239239079.51178.192.1579.8878.552.16
22304270-230427076.58276.92
32310707-231070776.79677.14
42346545-234654577.98778.34
52329360-232936077.41677.76
62433428-243342880.87581.25
45min12637735-263773587.66586.511.2188.1987.021.22
22573469-257346985.52986.02
32582456-258245685.82886.32
42594352-259435286.22386.73
52582869-258286985.84286.34
62646955-264695587.97288.51
60min12660382-266038288.41888.990.8889.1289.670.88
22692487-269248789.48590.15
32672034-267203488.80589.47
42666244-266624488.61389.29
52656480-265648088.28888.96
62717520-271752090.31791.03
极限12729842-272984290.72690.370.9291.6091.230.93
22706475-270647589.95090.79
32713625-271362590.18791.03
42692708-269270889.49290.35
52708508-270850890.01790.87
62763445-276344591.84392.74
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
110.043013867301891230151293013601301154830146110.10
210.143011008300875430098810.06
单位质量响应值RSD%判断
300260.06296832.450.82数据可信
供试品溶液-23004N1批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1601655-60165520.07321.043.5120.0721.043.52
2640168-64016821.35821.36
3635002-63500221.18521.19
4648440-64844021.63421.63
5653391-65339121.79921.80
6604963-60496320.18320.18
10min11143028-114302838.13537.902.0638.1737.942.06
21136258-113625837.90937.95
31102910-110291036.79636.84
41152730-115273038.45838.50
51165451-116545138.88338.93
61115443-111544337.21437.25
15min11545628-154562851.56652.682.6151.6852.802.61
21590534-159053453.06553.18
31576815-157681552.60752.72
41538364-153836451.32451.44
51569366-156936652.35852.48
61653094-165309455.15255.27
20min11871951-187195162.45363.861.8762.6764.081.87
21917971-191797163.98964.21
31927361-192736164.30264.52
41938457-193845764.67264.90
51958097-195809765.32865.55
61870828-187082862.41662.64
30min12339633-233963378.05778.070.8278.4078.420.81
22343767-234376778.19578.55
32325491-232549177.58577.93
42372727-237272779.16179.51
52341262-234126278.11178.47
62317421-231742177.31677.67
45min12585366-258536686.25586.520.9986.7687.030.99
22580799-258079986.10386.61
32619565-261956587.39687.90
42629982-262998287.74388.25
52580432-258043286.09086.60
62564078-256407885.54586.05
60min12668859-266885989.04189.240.5889.7189.920.58
22666198-266619888.95289.63
32666607-266660788.96589.65
42706174-270617490.28590.97
52669818-266981889.07389.76
62671105-267110589.11589.79
极限12696441-269644189.96190.570.8190.8191.430.81
22717892-271789290.67691.54
32696409-269640989.96090.82
42712225-271222590.48791.35
52755550-275555091.93392.80
62710038-271003890.41491.27
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
110.043007811301411830113423007234302201630125040.20
210.143013358301508330142200.05
单位质量响应值RSD%判断
300050.20297260.360.67数据可信
供试品溶液-24123101批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1492870-49287016.43716.621.5516.4416.621.56
2488772-48877216.30116.30
3500178-50017816.68116.68
4509919-50991917.00617.01
5503802-50380216.80216.80
6495322-49532216.51916.52
10min1978002-97800232.61733.772.2732.6533.802.28
21008439-100843933.63233.66
31020295-102029534.02734.06
41048617-104861734.97235.01
51014625-101462533.83833.87
61004730-100473033.50833.54
15min11455148-145514848.52949.781.6248.6349.881.62
21488004-148800449.62549.73
31511975-151197550.42550.53
41525131-152513150.86350.97
51489719-148971949.68249.78
61485520-148552049.54249.64
20min11852501-185250161.78162.511.0661.9862.721.06
21859971-185997162.03062.23
31892732-189273263.12363.33
41903793-190379363.49263.70
51869970-186997062.36462.56
61867634-186763462.28662.49
30min12323718-232371877.49677.840.3177.8278.160.31
22341077-234107778.07578.40
32335933-233593377.90478.23
42332102-233210277.77678.11
52342055-234205578.10878.43
62328373-232837377.65277.98
45min12623351-262335187.48987.971.1787.9688.451.16
22691160-269116089.75190.23
32642474-264247488.12788.61
42598032-259803286.64587.13
52632791-263279187.80488.29
62638687-263868788.00188.48
60min12724731-272473190.87091.821.6891.5292.481.67
22835863-283586394.57795.24
32744194-274419491.51992.18
42699800-269980090.03990.70
52755706-275570691.90392.56
62758657-275865792.00292.66
极限12823975-282397594.18094.381.7395.0195.221.71
22910311-291031197.05997.91
32818097-281809793.98494.83
42759566-275956692.03292.87
52823463-282346394.16395.00
62844834-284483494.87695.71
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
110.043017815301311330179993009206301300330142270.13
210.143009138301807430136060.21
单位质量响应值RSD%判断
300221.81297199.800.72数据可信
供试品溶液-24123102批-pH12.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1584209-58420919.48019.153.6419.4819.153.64
2567117-56711718.91018.91
3548645-54864518.29418.29
4575479-57547919.18919.19
5561646-56164618.72818.73
6609105-60910520.31020.31
10min11083880-108388036.14135.401.1436.1835.441.14
21054725-105472535.16935.21
31057378-105737835.25735.29
41064022-106402235.47935.52
51049199-104919934.98535.02
61060504-106050435.36235.40
15min11559523-155952352.00151.071.1452.1151.181.14
21517199-151719950.59050.70
31535213-153521351.19051.30
41542644-154264451.43851.55
51517396-151739650.59650.70
61517634-151763450.60450.72
20min11944159-194415964.82664.001.0465.0464.211.04
21891670-189167063.07663.29
31934062-193406264.49064.70
41930351-193035164.36664.58
51909360-190936063.66663.87
61906860-190686063.58363.80
30min12414092-241409280.49680.670.6980.8481.010.68
22392322-239232279.77080.11
32442657-244265781.44881.79
42424821-242482180.85481.19
52417848-241784880.62180.96
62423835-242383580.82181.16
45min12712217-271221790.43790.620.8390.9491.120.82
22691407-269140789.74390.24
32732791-273279191.12391.62
42704750-270475090.18890.69
52754196-275419691.83692.33
62711364-271136490.40890.91
60min12806127-280612793.56893.930.8394.2594.610.82
22790283-279028393.04093.71
32832352-283235294.44295.13
42801623-280162393.41894.10
52854230-285423095.17295.85
62817184-281718493.93794.62
极限12850035-285003595.03295.380.8595.9196.240.85
22837166-283716694.60395.46
32881799-288179996.09196.96
42838347-283834794.64295.51
52897198-289719896.60597.48
62857453-285745395.27996.15
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