对乙酰氨基酚维生素C泡腾片项目信息
介质体积(ml)900取样体积(ml) 1.5补液体积(ml) 1.5
对照品批号100425-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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 11.133641563366899136755433651730367261836620890.41
2 11.133676267364964136629540.52
单位质量响应值RSD%判断
329028.66329106.380.02数据可信
供试品溶液-A9460批-维生素C-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13659199-3659199100.07998.601.17100.0898.601.17
23593248-359324898.27598.28
33648267-364826799.78099.78
43609283-360928398.71498.71
53561883-356188397.41897.42
63559851-355985197.36297.36
10min13556275-355627597.26498.691.7097.4398.851.69
23519414-351941496.25696.42
33607120-360712098.65598.82
43676258-3676258100.546100.71
53626652-362665299.18999.35
63663844-3663844100.206100.37
15min13671874-3671874100.42698.801.58100.7599.131.58
23594903-359490398.32198.64
33525116-352511696.41296.74
43663440-3663440100.195100.53
53642558-364255899.62499.95
63576701-357670197.82398.15
20min13708704-3708704101.433100.041.05101.93100.531.04
23610787-361078798.75599.24
33666564-3666564100.281100.77
43653159-365315999.914100.41
53687399-3687399100.850101.34
63619349-361934998.98999.48
30min13607906-360790698.67698.901.0899.3499.561.08
23609202-360920298.71299.36
33570533-357053397.65498.31
43650296-365029699.836100.50
53673039-3673039100.458101.12
63585130-358513098.05398.71
45min13594410-359441098.30798.570.9499.1499.400.93
23617841-361784198.94899.77
33586927-358692798.10298.92
43602052-360205298.51699.35
53661463-3661463100.141100.97
63562123-356212397.42498.24
60min13573701-357370197.74198.840.9598.7399.830.95
23604887-360488798.59499.58
33624632-362463299.134100.12
43627578-362757899.214100.21
53668349-3668349100.329101.33
63584680-358468098.04199.02
90min13579214-357921497.89297.740.9999.0598.900.98
23607789-360778998.67399.82
33573458-357345897.73498.88
43582027-358202797.96899.13
53593851-359385198.29299.46
63506159-350615995.89397.04
120min13483019-348301995.26197.611.6196.5898.921.59
23561669-356166997.41298.72
33617955-361795598.951100.26
43602224-360222498.52199.85
53625704-362570499.163100.49
63522080-352208096.32997.64
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限13503098-350309895.81098.001.2097.2999.481.19
23588263-358826398.13999.61
33589471-358947198.17299.65
43607864-360786498.675100.16
53629299-362929999.261100.75
63580676-358067697.93299.40
对乙酰氨基酚维生素C泡腾片项目信息
介质体积(ml)900取样体积(ml) 1.5补液体积(ml) 1.5
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(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)330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%
118.067689767774152977595277696714775155377278180.42
218.027759288769449777268920.60
单位质量响应值RSD%判断
427896.90428795.340.15数据可信
供试品溶液-A9460批-对乙酰氨基酚-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17654761-765476197.47697.020.4897.4897.020.48
27611506-761150696.92596.92
37647427-764742797.38297.38
47605717-760571796.85196.85
57637298-763729897.25397.25
67557081-755708196.23296.23
10min17767302-776730298.90997.920.6199.0798.080.61
27658126-765812697.51897.68
37699911-769991198.05198.21
47666102-766610297.62097.78
57710492-771049298.18598.35
67637136-763713697.25197.41
15min17767253-776725398.90897.860.6199.2498.180.61
27670042-767004297.67097.99
37690375-769037597.92998.25
47656837-765683797.50297.83
57691863-769186397.94898.27
67631532-763153297.18097.50
20min17773347-777334798.98697.870.5999.4898.360.59
27664328-766432897.59798.08
37679147-767914797.78698.28
47647368-764736897.38197.87
57685127-768512797.86298.35
67665324-766532497.61098.09
30min17753745-775374598.73697.700.5799.3998.350.57
27656466-765646697.49798.15
37673035-767303597.70898.36
47644404-764440497.34497.99
57673784-767378497.71898.37
67630694-763069497.16997.82
45min17774761-777476199.00497.600.7699.8398.420.76
27639886-763988697.28698.10
37649470-764947097.40898.22
47636668-763666897.24598.06
57675051-767505197.73498.55
67612189-761218996.93397.74
60min17728535-772853598.41597.360.5999.4098.340.59
27611003-761100396.91897.89
37641654-764165497.30998.29
47607487-760748796.87497.85
57660795-766079597.55298.53
67625703-762570397.10698.08
90min17742813-774281398.59797.630.6699.7598.770.66
27645130-764513097.35398.49
37663230-766323097.58398.72
47597679-759767996.74997.88
57701165-770116598.06699.21
67650231-765023197.41898.55
120min17675629-767562997.74197.140.8899.0698.440.87
27668731-766873197.65398.95
37611532-761153296.92598.23
47558544-755854496.25097.55
57708677-770867798.16299.47
67545758-754575896.08897.38
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限17664436-766443697.59996.900.4999.0898.360.49
27619941-761994197.03298.49
37586070-758607096.60198.06
47583501-758350196.56898.02
57635122-763512297.22698.69
67566972-756697296.35897.81
对乙酰氨基酚维生素C泡腾片项目信息
介质体积(ml)900取样体积(ml) 1.5补液体积(ml) 1.5
对照品批号100425-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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 11.133630229365017936468983627832365469236419660.34
2 11.133640900365797036494350.34
单位质量响应值RSD%判断
327220.66327891.730.15数据可信
供试品溶液-A9460批-维生素C-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13030196-303019683.25884.783.4683.2684.783.46
23067775-306777584.29184.29
33279506-327950690.10890.11
43018439-301843982.93582.94
53129290-312929085.98185.98
62988263-298826382.10682.11
10min13374706-337470692.72486.678.5492.8686.818.53
23178561-317856187.33587.48
33227720-322772088.68688.84
43443549-344354994.61694.75
52991977-299197782.20882.35
62709203-270920374.43974.58
15min13120751-312075185.74685.463.6286.0485.743.62
23137278-313727886.20186.49
33243969-324396989.13289.43
43190492-319049287.66387.96
52928418-292841880.46280.74
63040719-304071983.54783.81
20min13073182-307318284.43985.814.8484.8886.244.81
23180201-318020187.38087.81
33339338-333933891.75292.20
42899575-289957579.66980.11
53047416-304741683.73284.15
63197937-319793787.86788.27
30min13004309-300430982.54786.716.4583.1287.286.40
23176704-317670487.28487.86
33077999-307799984.57285.17
43529178-352917896.96997.54
53183976-318397687.48488.04
62963707-296370781.43181.98
45min13144115-314411586.38888.244.9887.1088.964.93
23141894-314189486.32787.05
32991214-299121482.18782.93
43357262-335726292.24592.98
53431350-343135094.28194.98
63203271-320327188.01488.70
60min13170552-317055287.11589.543.0887.9790.403.04
23411672-341167293.74094.60
33228880-322888088.71789.59
43143295-314329586.36687.26
53326115-332611591.38992.25
63272789-327278989.92490.75
90min13087670-308767084.83889.894.1285.8490.904.09
23261448-326144889.61290.63
33316788-331678891.13392.16
43483029-348302995.70196.73
53303798-330379890.77691.79
63176939-317693987.29088.27
120min13083567-308356784.72589.523.9385.8790.683.89
23230575-323057588.76489.93
33356882-335688292.23493.41
43257073-325707389.49290.69
53443037-344303794.60295.76
63176712-317671287.28488.41
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限13138772-313877286.24288.166.6387.5389.486.56
23357716-335771692.25793.58
33391858-339185893.19594.53
43382698-338269892.94494.29
53131282-313128286.03687.35
62849774-284977478.30179.57
对乙酰氨基酚维生素C泡腾片项目信息
介质体积(ml)900取样体积(ml) 1.5补液体积(ml) 1.5
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(%)100对照品水分(%)0对照品稀释倍数50
标示量(mg)330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%
118.067654946769938976937727665504771026076847740.31
218.027682875772106377019690.36
单位质量响应值RSD%判断
425513.51427412.260.32数据可信
供试品溶液-A9460批-对乙酰氨基酚-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17431067-743106795.04596.301.2995.0596.301.29
27650006-765000697.84697.85
37629658-762965897.58597.59
47552276-755227696.59696.60
57480059-748005995.67295.67
67433191-743319195.07295.07
10min17603063-760306397.24597.351.4197.4097.511.41
27685034-768503498.29498.46
37707500-770750098.58198.74
47707328-770732898.57998.74
57480675-748067595.68095.84
67483768-748376895.71995.88
15min17505258-750525895.99497.311.4396.3197.631.43
27736490-773649098.95299.28
37697494-769749498.45398.78
47673804-767380498.15098.48
57477820-747782095.64395.96
67558461-755846196.67596.99
20min17492870-749287095.83697.321.3596.3297.811.35
27712990-771299098.65199.14
37740701-774070199.00699.50
47629403-762940397.58298.07
57520959-752095996.19596.67
67558698-755869896.67897.16
30min17495973-749597395.87597.131.3596.5297.781.35
27673542-767354298.14798.80
37649052-764905297.83398.49
47728327-772832798.84799.50
57486293-748629395.75296.39
67531231-753123196.32696.97
45min17485986-748598695.74897.261.1796.5598.071.17
27680513-768051398.23699.06
37625242-762524297.52998.35
47723295-772329598.78399.60
57555791-755579196.64197.44
67554378-755437896.62297.42
60min17493172-749317295.84097.271.4096.8098.241.40
27739728-773972898.99399.98
37674460-767446098.15899.14
47683672-768367298.27699.26
57530025-753002596.31197.27
67509127-750912796.04497.01
90min17524570-752457096.24197.541.3897.3698.671.38
27680683-768068398.23899.39
37717481-771748198.70999.85
47758694-775869499.236100.38
57548801-754880196.55197.67
67525699-752569996.25697.38
120min17509323-750932396.04697.071.2497.3398.361.24
27643191-764319197.75899.07
37694369-769436998.41399.72
47676341-767634198.18299.49
57543565-754356596.48497.76
67469790-746979095.54196.82
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限17447230-744723095.25296.611.9196.6998.071.90
27660940-766094097.98599.46
37643192-764319297.75899.23
47738960-773896098.983100.46
57414337-741433794.83196.27
67417530-741753094.87296.31
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