对乙酰氨基酚布洛芬口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100179-202308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%
1 13.263165148316448431651033164675316403431646890.02
2 13.343161158316463131628940.08
单位质量响应值RSD%判断
238664.33237098.500.47数据可信
供试品溶液-25111802批-布洛芬-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12473342-247334293.48492.172.8393.4892.172.83
22543924-254392496.15296.15
32420216-242021691.47691.48
42334394-233439488.23288.23
52435095-243509592.03892.04
62424173-242417391.62591.63
10min12527155-252715595.51894.592.1396.0495.102.14
22587843-258784397.81298.35
32501612-250161294.55295.06
42427750-242775091.76192.25
52492298-249229894.20094.71
62478488-247848893.67894.19
15min12533424-253342495.75594.682.2196.8095.712.21
22593723-259372398.03499.11
32492206-249220694.19795.23
42427206-242720691.74092.74
52492629-249262994.21395.25
62490071-249007194.11695.15
20min12531524-253152495.68394.352.3397.2695.912.33
22581953-258195397.58999.21
32492819-249281994.22095.78
42408527-240852791.03492.54
52487316-248731694.01295.57
62475506-247550693.56695.12
30min12514170-251417095.02793.992.0897.1496.082.09
22567583-256758397.04699.21
32485413-248541393.94096.02
42412453-241245391.18293.20
52471013-247101393.39695.48
62469448-246944893.33795.41
45min12493460-249346094.24493.492.0396.8996.102.04
22558158-255815896.69099.39
32466892-246689293.24095.84
42406514-240651490.95893.48
52458757-245875792.93395.53
62456661-245666192.85395.44
60min12486186-248618693.96993.262.2197.1396.392.21
22552124-255212496.46199.70
32485950-248595093.96097.08
42390570-239057090.35593.38
52447725-244772592.51695.63
62442750-244275092.32895.43
极限12492284-249228494.20093.072.3097.8996.722.30
22546064-254606496.232100.01
32455513-245551392.81096.45
42373698-237369889.71893.25
52456786-245678692.85896.49
62450268-245026892.61296.23
对乙酰氨基酚布洛芬口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100018-202312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50
标示量(mg)640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%
144.303463005346200734619933462239346172434621940.02
2 44.213455126346218434586550.15
单位质量响应值RSD%判断
78153.3678232.410.08数据可信
供试品溶液-25111802批-对乙酰氨基酚-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12838218-2838218101.985100.132.69101.99100.132.69
22908064-2908064104.495104.49
32767758-276775899.45399.45
42706287-270628797.24497.24
52772943-277294399.64099.64
62726329-272632997.96597.96
10min12867983-2867983103.055101.862.04103.62102.422.05
22929330-2929330105.259105.84
32826930-2826930101.579102.13
42765750-276575099.38199.92
52825721-2825721101.536102.09
62792834-2792834100.354100.90
15min12841736-2841736102.111101.371.98103.25102.491.99
22918025-2918025104.853106.02
32812346-2812346101.055102.17
42752883-275288398.919100.01
52809997-2809997100.971102.09
62791075-2791075100.291101.39
20min12828910-2828910101.651100.771.99103.36102.452.00
22895424-2895424104.041105.79
32800310-2800310100.623102.30
42731176-273117698.13999.78
52801233-2801233100.656102.33
62768796-276879699.491101.15
30min12806805-2806805100.856100.271.83103.13102.521.84
22877774-2877774103.406105.73
32788988-2788988100.216102.45
42726326-272632697.964100.15
52783957-2783957100.035102.27
62759877-275987799.170101.38
45min12786597-2786597100.13099.661.95102.96102.461.95
22867956-2867956103.054105.95
32769203-276920399.505102.30
42706753-270675397.26199.99
52767020-276702099.427102.22
62743769-274376998.591101.35
60min12777712-277771299.81199.131.93103.20102.491.94
22848895-2848895102.369105.84
32759572-275957299.159102.51
42691884-269188496.727100.00
52749677-274967798.804102.15
62725469-272546997.934101.24
极限12770096-277009699.53798.661.96103.48102.571.96
22833661-2833661101.821105.86
32739083-273908398.423102.32
42674611-267461196.10699.92
52741595-274159598.513102.41
62715194-271519497.564101.42
对乙酰氨基酚布洛芬口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100179-202308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%
1 13.263164461315745631560813157383315612731583020.12
2 13.343158636316038431595100.04
单位质量响应值RSD%判断
238182.65236844.830.40数据可信
供试品溶液-25112001批-布洛芬-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12334356-233435688.36781.605.9388.3781.605.93
22277536-227753686.21686.22
32149340-214934081.36381.36
42116224-211622480.11080.11
52014726-201472676.26776.27
62040839-204083977.25677.26
10min12540909-254090996.18690.683.9796.6891.133.98
22484881-248488194.06594.54
32338633-233863388.52988.98
42339298-233929888.55489.00
52301625-230162587.12887.55
62366826-236682689.59690.03
15min12560482-256048296.92791.204.2597.9592.164.25
22513568-251356895.15196.15
32358350-235835089.27590.22
42337109-233710988.47189.41
52311071-231107187.48588.39
62375379-237537989.92090.85
20min12530131-253013195.77891.435.2897.3492.905.27
22617917-261791799.101100.63
32350934-235093488.99490.43
42329327-232932788.17789.61
52303142-230314287.18588.58
62360882-236088289.37190.80
30min12527034-252703495.66190.423.8697.7692.403.87
22480251-248025193.89095.97
32345522-234552288.79090.72
42323227-232322787.94689.86
52302934-230293487.17789.06
62353185-235318589.08091.00
45min12518988-251898895.35692.546.6197.9895.026.48
22483594-248359494.01696.62
32339449-233944988.56090.99
42322569-232256987.92190.33
52288568-228856886.63489.00
62714633-2714633102.762105.18
60min12494819-249481994.44189.883.8097.6092.873.81
22478295-247829593.81696.94
32313624-231362487.58290.50
42343145-234314588.70091.60
52278096-227809686.23789.08
62338064-233806488.50791.50
极限12507646-250764694.92790.113.9198.6193.603.92
22490775-249077594.28897.93
32316180-231618087.67991.08
42321901-232190187.89591.28
52303810-230381087.21190.53
62342685-234268588.68292.16
对乙酰氨基酚布洛芬口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100018-202312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50
标示量(mg)640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%
144.303457330345179534504643451180345095534523450.09
2 44.213450444345243234514380.05
单位质量响应值RSD%判断
77931.0478069.170.13数据可信
供试品溶液-25112001批-对乙酰氨基酚-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12824639-2824639101.74896.264.14101.7596.264.14
22799502-2799502100.843100.84
32609360-260936093.99393.99
42618609-261860994.32794.33
52563097-256309792.32792.33
62617644-261764494.29294.29
10min12856187-2856187102.88497.883.99103.4598.423.99
22854997-2854997102.842103.40
32655841-265584195.66896.19
42651871-265187195.52596.05
52617459-261745994.28594.80
62668019-266801996.10696.63
15min12857548-2857548102.93397.983.99104.0799.063.99
22858229-2858229102.958104.09
32662679-266267995.91496.97
42649971-264997195.45696.51
52617975-261797594.30495.34
62673686-267368696.31097.37
20min12840035-2840035102.30397.543.94104.0199.173.94
22847814-2847814102.583104.29
32647797-264779795.37896.96
42633688-263368894.87096.45
52615858-261585894.22795.79
62662421-266242195.90597.50
30min12827451-2827451101.84997.013.95104.1399.183.95
22827739-2827739101.860104.13
32635079-263507994.92097.04
42612906-261290694.12196.23
52596031-259603193.51395.60
62660050-266005095.81997.94
45min12806371-2806371101.09096.473.87103.9399.173.87
22811992-2811992101.292104.13
32619798-261979894.36997.01
42605493-260549393.85496.49
52582620-258262093.03095.63
62641922-264192295.16697.82
60min12788726-2788726100.45495.853.89103.8699.093.89
22794201-2794201100.652104.05
32601902-260190293.72596.89
42585272-258527293.12696.28
52564536-256453692.37995.50
62630919-263091994.77097.96
极限12780054-2780054100.14295.383.95104.1099.153.95
22781294-2781294100.187104.15
32586244-258624493.16196.85
42573672-257367292.70896.38
52554924-255492492.03295.67
62610303-261030394.02797.74
对乙酰氨基酚布洛芬口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100179-202308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%
1 13.263166367316728631677593169392316661531674840.04
2 13.343149731314937331495520.01
单位质量响应值RSD%判断
238875.11236098.350.83数据可信
供试品溶液-25120901批-布洛芬-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11166470-116647044.16343.522.1544.1643.522.15
21174778-117477844.47744.48
31163193-116319344.03944.04
41120550-112055042.42442.42
51155232-115523243.73743.74
61116965-111696542.28942.29
10min11545163-154516358.50057.691.3258.7557.931.32
21529414-152941457.90458.15
31527983-152798357.85058.09
41497595-149759556.69956.94
51540960-154096058.34158.58
61500831-150083156.82257.06
15min11781976-178197667.46668.405.9868.0468.965.92
21756881-175688166.51667.08
31755736-175573666.47367.04
42023996-202399676.62977.18
51784497-178449767.56268.13
61737280-173728065.77466.32
20min11940965-194096573.48572.441.5574.4373.381.53
21919356-191935672.66773.61
31917095-191709572.58273.52
41890810-189081071.58772.56
51944565-194456573.62274.56
61867654-186765470.71071.63
30min12116475-211647580.13079.121.5581.4880.461.54
22093380-209338079.25680.60
32096706-209670679.38280.72
42065085-206508578.18579.56
52126498-212649880.51081.86
62039782-203978277.22778.54
45min12272288-227228886.02984.491.6387.8386.281.61
22229239-222923984.40086.18
32236355-223635584.66986.45
42208684-220868483.62185.43
52267235-226723585.83887.64
62176135-217613582.38984.13
60min12344505-234450588.76487.131.5991.0489.381.58
22289822-228982286.69388.94
32299750-229975087.06989.32
42277604-227760486.23188.50
52343127-234312788.71190.99
62253250-225325085.30987.50
极限12382241-238224190.19289.171.3792.9691.901.37
22350556-235055688.99391.73
32367141-236714189.62192.35
42328720-232872088.16690.92
52393306-239330690.61193.38
62308818-230881887.41290.08
对乙酰氨基酚布洛芬口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100018-202312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50
标示量(mg)640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%
144.303458888345880834598443460439345858734593130.03
2 44.213439065344016734396160.03
单位质量响应值RSD%判断
78088.3377801.760.26数据可信
供试品溶液-25120901批-对乙酰氨基酚-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12885343-2885343104.008102.251.61104.01102.251.61
22840294-2840294102.385102.38
32850214-2850214102.742102.74
42781466-2781466100.264100.26
52879896-2879896103.812103.81
62782769-2782769100.311100.31
10min12907122-2907122104.793103.151.69105.37103.721.69
22850832-2850832102.764103.33
32895040-2895040104.358104.93
42805140-2805140101.117101.67
52906053-2906053104.755105.33
62805292-2805292101.123101.68
15min12900018-2900018104.537102.721.51105.70103.871.51
22836742-2836742102.256103.40
32874701-2874701103.625104.78
42805177-2805177101.119102.24
52883864-2883864103.955105.11
62797869-2797869100.855101.97
20min12890714-2890714104.202102.301.69105.94104.021.69
22825243-2825243101.842103.55
32867080-2867080103.350105.08
42791970-2791970100.643102.32
52878195-2878195103.751105.49
62775231-2775231100.039101.72
30min12858567-2858567103.043101.641.69105.36103.921.68
22812305-2812305101.376103.65
32857069-2857069102.989105.29
42771592-277159299.908102.15
52863078-2863078103.206105.52
62755747-275574799.337101.57
45min12850841-2850841102.765101.101.63105.66103.941.63
22791838-2791838100.638103.47
32836626-2836626102.252105.12
42758122-275812299.422102.22
52843381-2843381102.496105.38
62746608-274660899.007101.79
60min12833331-2833331102.134100.501.55105.60103.911.56
22770537-277053799.870103.27
32815719-2815719101.499104.94
42743109-274310998.881102.23
52828457-2828457101.958105.41
62737609-273760998.683102.02
极限12806034-2806034101.15099.841.50105.18103.801.50
22752537-275253799.221103.17
32800972-2800972100.967104.97
42729244-272924498.381102.28
52811082-2811082101.332105.35
62718258-271825897.985101.87
对乙酰氨基酚布洛芬口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100179-202308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%
1 13.263160887316132331604573161066316251831612500.03
2 13.343160885316020431605440.02
单位质量响应值RSD%判断
238404.98236922.340.45数据可信
供试品溶液-MXC2401批-布洛芬-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1957687-95768736.23034.146.6136.2334.146.60
2921138-92113834.84834.85
3921754-92175434.87134.87
4911921-91192134.49934.50
5917260-91726034.70134.70
6785578-78557829.71929.72
10min11304223-130422349.34047.995.1149.5448.185.11
21274000-127400048.19748.39
31276078-127607848.27548.47
41260116-126011647.67247.86
51345027-134502750.88451.08
61151496-115149643.56243.73
15min11589012-158901260.11457.244.5360.5957.704.54
21479494-147949455.97156.43
31490013-149001356.36956.83
41507966-150796657.04857.50
51595384-159538460.35560.83
61416880-141688053.60254.01
20min11754588-175458866.37863.604.2667.1964.384.27
21679769-167976963.54864.32
31623350-162335061.41362.19
41658451-165845162.74163.51
51775928-177592867.18568.00
61595213-159521360.34961.05
30min12015750-201575076.25873.233.0777.4474.363.09
21929370-192937072.99074.12
31890807-189080771.53172.65
41929163-192916372.98274.10
51991698-199169875.34876.53
61858161-185816170.29671.34
45min12237681-223768184.65482.083.3586.2683.623.37
22160633-216063381.73983.27
32120603-212060380.22581.74
42166966-216696681.97983.51
52264110-226411085.65487.26
62067875-206787578.23079.66
60min12341509-234150988.58287.582.5090.6589.572.48
22271429-227142985.93187.92
32249264-224926485.09287.05
42285300-228530086.45688.44
52406608-240660891.04593.12
62336131-233613188.37990.24
极限12397391-239739190.69689.354.1693.2691.834.13
22333772-233377288.28990.75
32348293-234829388.83991.27
42361341-236134189.33291.80
52516777-251677795.21397.80
62213878-221387883.75486.11
对乙酰氨基酚布洛芬口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100018-202312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50
标示量(mg)640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%
144.303451728345289534512093450477345371034520040.04
2 44.213453371345191734526440.03
单位质量响应值RSD%判断
77923.3478096.450.16数据可信
供试品溶液-MXC2401批-对乙酰氨基酚-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min12560831-256083192.23490.603.9992.2390.603.99
22521247-252124790.80890.81
32564624-256462492.37092.37
42479365-247936589.30089.30
52628730-262873094.67994.68
62337704-233770484.19784.20
10min12631791-263179194.79093.474.2095.3093.984.20
22593956-259395693.42793.93
32646940-264694095.33595.85
42539485-253948591.46591.96
52740535-274053598.70699.23
62418783-241878387.11887.59
15min12663414-266341495.92894.834.3296.9795.864.32
22605599-260559993.84694.87
32687714-268771496.80497.85
42592572-259257293.37794.38
52794913-2794913100.665101.74
62453732-245373288.37689.33
20min12687468-268746896.79595.894.8398.3797.444.82
22664325-266432595.96197.51
32700505-270050597.26498.84
42611170-261117094.04795.57
52852042-2852042102.722104.36
62458106-245810688.53489.98
30min12711966-271196697.67797.255.3699.7999.335.34
22686370-268637096.75598.83
32760826-276082699.437101.56
42653712-265371295.57997.62
52915933-2915933105.023107.23
62472132-247213289.03990.97
45min12706527-270652797.48197.545.34100.13100.165.32
22693032-269303296.99599.61
32758373-275837399.349102.02
42670163-267016396.17298.75
52933915-2933915105.671108.46
62486401-248640189.55391.98
60min12695333-269533397.07897.145.21100.27100.305.19
22678146-267814696.45999.61
32749187-274918799.018102.24
42667905-266790596.09099.20
52913209-2913209104.925108.30
62478554-247855489.27092.20
极限12678315-267831596.46596.685.14100.20100.385.12
22656532-265653295.68199.37
32729935-272993598.324102.10
42662921-266292195.91199.56
52902553-2902553104.542108.50
62474969-247496989.14192.56
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