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2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.972206942206332207412221022206672209670.29
29.992217972208612213290.30
单位质量响应值RSD%判断
22163.1922155.060.03数据可信
供试品溶液-24112101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%
5min178003-7800357.78659.802.5357.7959.802.52
281333-8133360.25360.25
381336-8133660.25660.26
484018-8401862.24362.24
580062-8006259.31259.31
679600-7960058.97058.97
10min194527-9452770.02871.912.5070.6772.572.50
295468-9546870.72571.39
396799-9679971.71172.38
4101195-10119574.96875.66
598450-9845072.93473.59
695939-9593971.07471.73
15min1101427-10142775.14077.083.0376.5678.553.02
2103028-10302876.32677.78
3105125-10512577.87979.35
4109511-10951181.12882.65
5104436-10443677.36978.84
6100788-10078874.66676.11
20min1104045-10404577.07979.413.6979.3381.733.66
2104808-10480877.64479.95
3106921-10692179.21081.54
4114889-11488985.11287.54
5107072-10707279.32181.65
6105427-10542778.10380.38
30min1110878-11087882.14183.163.6185.2586.363.57
2108780-10878080.58783.75
3111292-11129282.44885.66
4119583-11958388.59091.96
5113950-11395084.41787.63
6109029-10902980.77183.91
45min1111357-11135782.49684.074.5186.5288.204.43
2111797-11179782.82286.88
3113926-11392684.39988.53
4123457-12345791.46095.82
5111213-11121382.38986.54
6109172-10917280.87784.92
60min1111818-11181882.83784.823.2987.7889.883.28
2111372-11137282.50787.49
3114888-11488885.11290.18
4121689-12168990.15095.52
5114145-11414584.56189.63
6113083-11308383.77588.71
90min1112151-11215183.08485.084.1388.9591.084.07
2111003-11100382.23488.13
3113481-11348184.06990.08
4124089-12408991.92898.30
5115249-11524985.37991.38
6113114-11311483.79889.67
极限1111612-11161282.68585.864.2589.4792.814.18
2113197-11319783.85990.67
3115046-11504685.22992.17
4125489-12548992.965100.36
5115766-11576685.76292.71
6114275-11427584.65891.46
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2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.972208052216792216272201392212392210980.29
29.992195792205112200450.30
单位质量响应值RSD%判断
22176.3322026.530.48数据可信
供试品溶液-24112102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%
5min180790-8079060.00860.711.1260.0160.721.12
281877-8187760.81560.82
382865-8286561.54961.55
481662-8166260.65660.66
582592-8259261.34761.35
680638-8063859.89559.90
10min198363-9836373.06173.460.7673.7374.140.76
299193-9919373.67774.35
399961-9996174.24874.93
499323-9932373.77474.45
598735-9873573.33774.02
697851-9785172.68073.35
15min1104322-10432277.48777.721.0178.9779.210.99
2105634-10563478.46179.96
3103065-10306576.55378.06
4105705-10570578.51480.01
5105139-10513978.09479.59
6103917-10391777.18678.66
20min1106873-10687379.38279.391.3781.7281.751.34
2107908-10790880.15082.52
3107105-10710579.55481.91
4108833-10883380.83783.20
5104662-10466277.73980.10
6105951-10595178.69781.03
30min1108826-10882680.83281.091.1984.0584.321.17
2109574-10957481.38884.64
3109000-10900080.96184.20
4111497-11149782.81686.08
5107780-10778080.05583.28
6108328-10832880.46283.67
45min1112185-11218583.32782.920.7287.4587.050.70
2110860-11086082.34386.50
3111148-11114882.55786.70
4112994-11299483.92888.11
5111277-11127782.65386.77
6111328-11132882.69186.79
60min1110932-11093282.39783.201.1687.4488.261.11
2111168-11116882.57287.65
3114134-11413484.77589.84
4113066-11306683.98289.10
5111131-11113182.54487.58
6111676-11167682.94987.97
90min1112388-11238883.47883.780.7789.4489.760.72
2111468-11146882.79588.79
3114115-11411584.76190.76
4112867-11286783.83489.88
5113003-11300383.93589.89
6112904-11290483.86189.80
极限1110899-11089982.37283.821.1989.2690.731.13
2114441-11444185.00391.92
3113639-11363984.40791.35
4113318-11331884.16991.15
5113214-11321484.09290.98
6111574-11157482.87389.74
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2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.972213712223292213132213182210212214700.23
29.992206812217322212060.34
单位质量响应值RSD%判断
22213.6422142.740.23数据可信
供试品溶液-24112101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%
5min155626-5562641.17441.013.6141.1741.013.61
257972-5797242.91042.91
354358-5435840.23540.24
457211-5721142.34742.35
554783-5478340.55040.55
652483-5248338.84738.85
10min176735-7673556.79856.552.9757.2657.002.97
280152-8015259.32859.80
375614-7561455.96956.42
477480-7748057.35057.82
574024-7402454.79255.24
674373-7437355.05055.48
15min185801-8580163.50963.582.7264.6064.662.72
289999-8999966.61667.75
385256-8525663.10664.17
486133-8613363.75564.86
582804-8280461.29162.35
685364-8536463.18564.23
20min189313-8931366.10866.663.0967.9068.453.08
294176-9417669.70871.58
388453-8845365.47267.24
492656-9265668.58370.40
586822-8682264.26566.01
688917-8891765.81567.56
30min194410-9441069.88169.803.0072.4172.332.98
297316-9731672.03274.68
394007-9400769.58372.08
497171-9717171.92574.50
589701-8970166.39668.85
693167-9316768.96171.44
45min1100574-10057474.44473.352.6777.7576.662.67
2102116-10211675.58579.04
398736-9873673.08376.35
4101066-10106674.80878.19
596682-9668271.56374.76
695384-9538470.60273.85
60min1101462-10146275.10174.372.2379.2378.502.22
2102404-10240475.79880.09
3102431-10243175.81879.90
4101030-10103074.78178.99
596893-9689371.71975.71
698665-9866573.03177.06
90min1104394-10439477.27176.913.3382.2481.863.23
2105906-10590678.39083.52
3108549-10854980.34785.27
4104801-10480177.57282.61
599182-9918273.41378.20
6100642-10064274.49479.33
极限1110778-11077881.99780.141.9787.8285.951.97
2109439-10943981.00587.01
3109572-10957281.10486.92
4108452-10845280.27586.18
5105832-10583278.33683.94
6105571-10557178.14283.81
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2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.972217322225002203082205612202742210750.45
29.992205112211162208140.20
单位质量响应值RSD%判断
22174.0222103.500.23数据可信
供试品溶液-24112102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%
5min153229-5322939.47039.372.4839.4739.372.48
254272-5427240.24340.24
354335-5433540.29040.29
453700-5370039.81939.82
551876-5187638.46638.47
651132-5113237.91537.91
10min176295-7629556.57355.621.5357.0156.061.53
274811-7481155.47355.92
376365-7636556.62557.07
474762-7476255.43755.88
574445-7444555.20155.63
673388-7338854.41854.84
15min186310-8631063.99961.743.1465.0762.803.12
282042-8204260.83561.90
386069-8606963.82164.90
482904-8290461.47462.53
582892-8289261.46562.51
679360-7936058.84659.87
20min191590-9159067.91566.442.1069.6968.192.09
290043-9004366.76768.51
390978-9097867.46169.25
490454-9045467.07268.81
587531-8753164.90566.63
687053-8705364.55066.23
30min197433-9743372.24769.963.2074.7872.443.16
295654-9565470.92873.41
396154-9615471.29973.83
495665-9566570.93673.42
591364-9136467.74770.19
689842-8984266.61869.02
45min1102650-10265076.11672.963.6879.4576.223.61
2100769-10076974.72177.99
398737-9873773.21476.54
4100115-10011574.23677.51
594649-9464970.18373.38
693436-9343669.28372.42
60min1104287-10428777.33073.314.1281.5177.384.03
299563-9956373.82777.93
399951-9995174.11478.26
4101118-10111874.98079.08
595172-9517270.57174.55
693134-9313469.05972.97
90min1104565-10456577.53674.723.4682.5879.603.42
2101994-10199475.62980.55
3102734-10273476.17881.14
4102494-10249476.00080.93
596688-9668871.69576.46
696153-9615371.29875.97
极限1105512-10551278.23876.892.2284.1482.602.25
2104780-10478077.69583.46
3105355-10535578.12183.93
4104919-10491977.79883.58
5100157-10015774.26779.83
6101437-10143775.21680.68
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2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.972205022211862215692205152213372210220.23
29.992203232198532200880.16
单位质量响应值RSD%判断
22168.7122030.830.45数据可信
供试品溶液-24112101批-zdyzpH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min182999-8299961.65362.711.0961.6562.711.09
283593-8359362.09562.09
385087-8508763.20463.20
484993-8499363.13563.13
585263-8526363.33563.34
684580-8458062.82862.83
10min198178-9817872.92973.230.6473.6173.920.64
297566-9756672.47473.16
399321-9932173.77874.48
498679-9867973.30174.00
599014-9901473.55074.25
698704-9870473.31974.02
15min1105046-10504678.03076.671.3679.5378.181.33
2103850-10385077.14278.64
3104301-10430177.47779.00
4101367-10136775.29776.81
5102421-10242176.08077.60
6102284-10228475.97977.49
20min1105083-10508378.05878.130.5680.4280.490.54
2105816-10581678.60280.95
3104858-10485877.89180.27
4105540-10554078.39780.75
5104218-10421877.41579.78
6105561-10556178.41380.77
30min1106474-10647479.09178.990.7182.3282.220.70
2105857-10585778.63381.86
3107586-10758679.91783.17
4105534-10553478.39381.62
5106743-10674379.29182.52
6105858-10585878.63381.86
45min1113926-11392684.62781.582.3888.7485.682.28
2106923-10692379.42583.52
3111245-11124582.63586.77
4107238-10723879.65983.75
5110105-11010581.78885.90
6109487-10948781.32985.43
60min1113858-11385884.57682.082.3589.6287.102.24
2106769-10676979.31084.29
3112557-11255783.61088.66
4108504-10850480.59985.58
5110560-11056082.12687.14
6110769-11076982.28187.29
90min1114302-11430284.90682.562.5990.8988.482.48
2108824-10882480.83786.70
3114437-11443785.00690.99
4107522-10752279.87085.74
5109891-10989181.62987.56
6111851-11185183.08589.01
极限1112962-11296283.91083.500.7790.8490.340.77
2111578-11157882.88289.64
3112741-11274183.74690.67
4111465-11146582.79889.56
5113660-11366084.42991.26
6112026-11202683.21590.06
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