塞来昔布胶囊项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
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%
19.412794185279720327980002796679279806427968260.06
29.332789816278736027885880.07
单位质量响应值RSD%判断
297218.49298884.030.40数据可信
长期36月-供试品溶液-20211227批-pH12.0(内含1.0%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1474402-47440215.85335.5035.9215.8535.5035.92
2878234-87823429.34829.35
31534824-153482451.29051.29
41221480-122148040.81940.82
51344466-134446644.92844.93
6920934-92093430.77530.78
10min11343867-134386744.90861.2316.9344.9361.2816.94
21538081-153808151.39951.44
32003046-200304666.93667.01
42006497-200649767.05267.11
52029678-202967867.82667.89
62071859-207185969.23669.28
15min11646025-164602555.00676.4615.7955.1076.6015.80
22066514-206651469.05769.18
32473461-247346182.65682.83
42558087-255808785.48485.65
52479413-247941382.85583.02
62504145-250414583.68283.83
20min11935086-193508664.66587.6014.4364.8487.8614.44
22423559-242355980.98981.21
32828566-282856694.52394.82
42903764-290376497.03697.33
52863113-286311395.67895.97
62773759-277375992.69292.97
30min12661299-266129988.934100.036.7089.20100.426.73
23085710-3085710103.116103.46
32949678-294967898.57099.01
43172818-3172818106.027106.46
53191154-3191154106.640107.08
62898716-289871696.86797.28
45min12948599-294859998.534102.134.5598.94102.674.55
23180144-3180144106.272106.77
32945865-294586598.44399.03
43171397-3171397105.980106.57
53194225-3194225106.742107.34
62897443-289744396.82597.38
60min12980160-298016099.589103.344.15100.14104.034.15
23200014-3200014106.936107.60
33020910-3020910100.951101.69
43213528-3213528107.388108.14
53205443-3205443107.117107.87
62933534-293353498.03198.74
极限12968880-296888099.212102.984.4199.91103.834.41
23203898-3203898107.066107.89
32969009-296900999.216100.11
43200223-3200223106.943107.86
53210777-3210777107.296108.21
62936994-293699498.14799.00
塞来昔布胶囊项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
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%
19.412788580278586727857972786289278809227869250.05
29.332786666278701027868380.01
单位质量响应值RSD%判断
296166.31298696.460.61数据可信
长期36月-供试品溶液-20211228批-pH12.0(内含1.0%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11001324-100132433.53235.8826.5433.5335.8826.54
21023003-102300334.25834.26
3628256-62825621.03921.04
41277033-127703342.76442.76
51467024-146702449.12749.13
61031334-103133434.53734.54
10min12057899-205789968.91469.0812.0268.9669.1312.02
22368340-236834079.30979.36
31871127-187112762.65962.69
42258857-225885775.64375.71
52125275-212527571.17071.24
61695714-169571456.78556.84
15min12541486-254148685.10882.7810.9385.2682.9410.94
22758353-275835392.37092.54
32109372-210937270.63770.76
42570496-257049686.07986.26
52683818-268381889.87490.05
62168625-216862572.62172.76
20min12853249-285324995.54892.747.9095.8393.037.91
22999898-2999898100.459100.77
32462505-246250582.46382.69
42853922-285392295.57095.88
52915250-291525097.62497.94
62532493-253249384.80685.05
30min13035800-3035800101.661100.463.71102.09100.883.73
23078547-3078547103.092103.55
32871610-287161096.16396.52
43051593-3051593102.190102.64
53112251-3112251104.221104.68
62850248-285024895.44795.82
45min13029751-3029751101.45899.903.20102.04100.473.23
23091871-3091871103.538104.15
32853858-285385895.56896.07
43044249-3044249101.944102.55
52999574-2999574100.448101.07
62879876-287987696.43996.96
60min13020438-3020438101.14699.982.76101.88100.702.79
23086926-3086926103.373104.14
32910251-291025197.45798.10
43036033-3036033101.669102.42
52993492-2993492100.244101.01
62866962-286696296.00796.67
极限13002602-3002602100.549100.093.98101.43100.964.00
23073991-3073991102.940103.86
32830423-283042394.78395.57
43025904-3025904101.329102.24
53134930-3134930104.980105.90
62864762-286476295.93396.74
塞来昔布胶囊项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
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%
19.412791641279322227930292793195279416927930510.04
29.332796387279522727958070.03
单位质量响应值RSD%判断
296817.32299657.770.68数据可信
长期36月-供试品溶液-20211229批-pH12.0(内含1.0%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11258795-125879542.04035.4429.7542.0435.4429.74
21196310-119631039.95339.95
3992803-99280333.15733.16
41452257-145225748.50148.50
5548720-54872018.32618.33
6917689-91768930.64830.65
10min12104805-210480570.29471.1118.6370.3671.1618.64
22374342-237434279.29679.36
32065185-206518568.97169.02
42722164-272216490.91290.98
51543176-154317651.53751.56
61965690-196569065.64865.69
15min12582059-258205986.23390.457.9586.4090.617.97
22857768-285776895.44195.62
32586084-258608486.36786.52
43063425-3063425102.309102.52
52481823-248182382.88582.99
62678297-267829789.44789.59
20min12805206-280520693.68597.514.8593.9897.814.87
23003187-3003187100.297100.62
32863640-286364095.63795.92
43170696-3170696105.892106.25
52855114-285511495.35295.58
62821130-282113094.21794.50
30min12985945-298594599.721101.294.18100.16101.734.21
23125948-3125948104.397104.87
33013016-3013016100.626101.05
43228372-3228372107.818108.34
52978775-297877599.48299.85
62865727-286572795.70796.13
45min12977509-297750999.440101.083.90100.03101.673.92
23120082-3120082104.201104.83
33014208-3014208100.665101.24
43203289-3203289106.980107.66
52972105-297210599.25999.78
62872220-287222095.92396.49
60min12954729-295472998.679100.643.9899.42101.394.00
23093848-3093848103.325104.11
32996725-2996725100.081100.81
43206792-3206792107.097107.94
52962388-296238898.93599.60
62866801-286680195.74296.45
极限12950194-295019498.527100.243.9099.41101.143.93
23078650-3078650102.818103.76
32993634-299363499.978100.86
43188411-3188411106.483107.49
52942459-294245998.26999.09
62855640-285564095.37096.22
塞来昔布胶囊项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
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%
19.412795165280045928034022808475279920728013420.18
29.332790925279217127915480.04
单位质量响应值RSD%判断
297698.41299201.290.36数据可信
长期36月-供试品溶液-DR8010批-pH12.0(内含1.0%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1649101-64910121.66231.7822.2721.6631.7822.28
21314237-131423743.86043.86
3954164-95416431.84331.84
4911925-91192530.43330.43
5946308-94630831.58131.58
6937846-93784631.29831.30
10min12183067-218306772.85573.995.9672.8974.045.96
22162833-216283372.17972.25
32125383-212538370.93070.98
42186874-218687472.98273.03
52482936-248293682.86282.91
62160737-216073772.11072.16
15min12591041-259104186.47087.856.1186.6188.016.10
22417767-241776780.68780.86
32776230-277623092.65092.80
42521836-252183684.16084.32
52852226-285222695.18695.36
62635194-263519487.94388.10
20min12749235-274923591.74993.354.4992.0293.644.48
22632152-263215287.84288.14
32896401-289640196.66196.95
42697862-269786290.03590.32
52961151-296115198.82199.14
62846580-284658094.99895.28
30min12845671-284567194.96897.661.6095.3898.091.60
22919340-291934097.42697.85
32909690-290969097.10497.54
42947837-294783798.37798.79
52973685-297368599.24099.70
62962443-296244398.86599.29
45min12856797-285679795.33997.821.6495.8998.401.64
22908791-290879197.07497.65
32922883-292288397.54498.13
42951946-295194698.51499.08
52999282-2999282100.094100.71
62947226-294722698.35798.93
60min12859752-285975295.43897.621.2996.1398.341.30
22909977-290997797.11497.83
32922735-292273597.53998.27
42948229-294822998.39099.10
52965681-296568198.97399.73
62944729-294472998.27399.00
极限12861971-286197195.51297.531.2196.3598.401.22
22910824-291082497.14298.01
32914807-291480797.27598.15
42948160-294816098.38899.25
52958996-295899698.75099.66
62940527-294052798.13399.01
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