叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.392601512605742601532601032601852602330.08
210.382603972603372603670.02
单位质量响应值RSD%判断
25046.4925083.530.11数据可信
供试品溶液-24073002批-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%
5min165491-6549121.44619.4110.2121.4519.4110.21
259045-5904519.33519.34
362484-6248420.46220.46
447902-4790215.68615.69
559208-5920819.38919.39
661419-6141920.11320.11
10min193510-9351030.62228.687.1030.8628.897.12
288900-8890029.11229.33
390249-9024929.55429.78
475481-7548124.71824.89
588877-8887729.10429.32
688430-8843028.95829.18
15min1107238-10723835.11733.845.0735.7034.385.11
2104638-10463834.26634.80
3105709-10570934.61635.17
492865-9286530.41030.86
5105127-10512734.42634.96
6104522-10452234.22834.77
20min1114958-11495837.64536.833.9738.6137.744.04
2114745-11474537.57538.49
3114231-11423137.40738.35
4103443-10344333.87434.66
5113297-11329737.10138.02
6114126-11412637.37338.30
30min1124785-12478540.86339.832.6842.2541.152.78
2123166-12316640.33341.67
3122922-12292240.25341.61
4115481-11548137.81638.98
5122530-12253040.12541.46
6120968-12096839.61340.95
45min1126289-12628941.35641.122.1043.2042.882.20
2127943-12794341.89743.68
3126625-12662541.46643.27
4120450-12045039.44441.03
5126576-12657641.45043.23
6125529-12552941.10742.89
极限1128173-12817341.97341.762.0844.2743.982.18
2130105-13010542.60544.86
3128829-12882942.18744.45
4122467-12246740.10442.13
5128254-12825441.99944.24
6127317-12731741.69243.93
叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.391307435130544413061451305796130563713060910.07
210.381308926130316013060430.32
单位质量响应值RSD%判断
125706.54125823.030.07数据可信
供试品溶液-24080501批-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%
5min194181-941816.1477.177.286.157.187.26
2117222-1172227.6507.65
3111976-1119767.3087.31
4112690-1126907.3557.35
5112011-1120117.3107.31
6111531-1115317.2797.28
10min1202619-20261913.22413.923.1813.2914.003.20
2221906-22190614.48314.57
3216180-21618014.10914.19
4210277-21027713.72413.81
5217538-21753814.19814.28
6211076-21107613.77613.86
15min1279006-27900618.20918.722.9318.4218.952.93
2300878-30087819.63719.88
3291748-29174819.04119.28
4281657-28165718.38218.62
5287000-28700018.73118.97
6280371-28037118.29818.53
20min1335533-33553321.89822.472.1722.3222.922.18
2351934-35193422.96923.43
3347218-34721822.66123.11
4335266-33526621.88122.32
5351522-35152222.94223.39
6344701-34470122.49722.93
30min1411197-41119726.83727.041.9527.5027.731.96
2424912-42491227.73228.45
3418177-41817727.29227.99
4406083-40608326.50327.18
5420132-42013227.42028.12
6405084-40508426.43827.12
45min1473943-47394330.93231.431.9131.8932.421.92
2491602-49160232.08433.11
3480745-48074531.37632.38
4473784-47378430.92131.90
5494194-49419432.25333.26
6475110-47511031.00831.99
极限1514168-51416833.55734.121.5034.8635.461.53
2532037-53203734.72336.11
3524994-52499434.26435.62
4516255-51625533.69335.01
5531365-53136534.67936.04
6517969-51796933.80535.13
叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.391307283130747913051341305526130387013058580.12
210.381300672130190213012870.07
单位质量响应值RSD%判断
125684.12125364.840.18数据可信
供试品溶液-24080501批-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%
5min173078-730784.7796.8715.344.786.8715.32
2114124-1141247.4637.46
3115355-1153557.5437.54
4105174-1051746.8776.88
5109399-1093997.1547.15
6113387-1133877.4147.41
10min1179985-17998511.76912.894.9111.8212.974.99
2199714-19971413.05913.14
3203428-20342813.30213.39
4193845-19384512.67512.75
5198308-19830812.96713.05
6207880-20788013.59313.68
15min1262090-26209017.13817.612.8717.3217.832.90
2266629-26662917.43517.66
3275606-27560618.02218.25
4268930-26893017.58517.80
5261455-26145517.09617.32
6281038-28103818.37718.61
20min1318596-31859620.83321.222.2421.2121.632.27
2317336-31733620.75121.17
3327572-32757221.42021.85
4328080-32808021.45321.87
5319490-31949020.89121.30
6335881-33588121.96322.40
30min1399675-39967526.13526.371.6026.7427.021.61
2392412-39241225.66026.31
3407565-40756526.65127.32
4409634-40963426.78627.44
5403099-40309926.35927.00
6407512-40751226.64727.33
45min1470400-47040030.75931.251.1431.6632.191.15
2476863-47686331.18232.12
3473365-47336530.95331.92
4485241-48524131.73032.68
5480102-48010231.39432.33
6481118-48111831.46032.44
极限1514575-51457533.64834.201.5834.8935.491.56
2519119-51911933.94535.23
3513223-51322333.56034.87
4530371-53037134.68135.98
5531022-53102234.72336.01
6529384-52938434.61635.94
叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.391299175129693312968741296378129597212970660.10
210.381318545130301113107780.84
单位质量响应值RSD%判断
124837.92126279.190.82数据可信
供试品溶液-24080501批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11464245-146424595.72494.121.8895.7294.121.88
21438797-143879794.06094.06
31425432-142543293.18693.19
41474767-147476796.41196.41
51399706-139970691.50491.50
61435170-143517093.82393.82
10min11477704-147770496.60396.381.1197.6797.431.11
21498213-149821397.94498.99
31467714-146771495.95096.99
41483900-148390097.00998.08
51450441-145044194.82195.84
61468056-146805695.97397.02
15min11477061-147706196.56196.750.6798.7098.870.66
21499407-149940798.022100.16
31472262-147226296.24898.35
41475251-147525196.44398.59
51480322-148032296.77598.84
61475812-147581296.48098.59
20min11475350-147535096.45096.740.6899.6699.930.66
21497353-149735397.888101.11
31468413-146841395.99699.17
41474935-147493596.42299.64
51483283-148328396.968100.11
61479668-147966896.73299.91
30min11482404-148240496.91196.800.84101.19101.070.82
21503346-150334698.280102.59
31471518-147151896.199100.44
41470903-147090396.159100.45
51483532-148353296.984101.21
61472925-147292596.291100.55
45min11472770-147277096.28196.580.73101.64101.920.72
21497228-149722897.880103.28
31469443-146944396.063101.37
41468749-146874996.018101.38
51481577-148157796.857102.16
61474385-147438596.387101.71
极限11472177-147217796.24296.330.57102.67102.750.57
21488524-148852497.311103.80
31466655-146665595.881102.25
41468577-146857796.007102.43
51477499-147749996.590102.97
61467932-146793295.965102.36
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