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%
110.061154467115368711530801151501115019211525850.15
210.001140213113992511400690.02
单位质量响应值RSD%判断
114571.07114006.900.35数据可信
供试品溶液-24050201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%
5min1113520-11352016.30620.1011.5216.3120.1011.51
2152686-15268621.93121.93
3152584-15258421.91721.92
4153367-15336722.02922.03
5130529-13052918.74918.75
6136979-13697919.67519.68
10min1229258-22925832.93035.304.2133.1135.534.25
2249256-24925635.80236.05
3259728-25972837.30637.55
4251455-25145536.11836.36
5242530-24253034.83635.04
6242508-24250834.83335.05
15min1283089-28308940.66242.923.3641.2143.543.37
2310482-31048244.59745.24
3291635-29163541.89042.55
4304465-30446543.73244.38
5298532-29853242.88043.48
6304760-30476043.77544.38
20min1320753-32075346.07248.713.3347.0749.803.35
2342637-34263749.21550.35
3353735-35373550.80951.93
4343602-34360249.35450.49
5332352-33235247.73848.81
6341573-34157349.06250.15
30min1368512-36851252.93256.293.8654.4457.923.85
2391854-39185456.28557.97
3409657-40965758.84260.53
4399448-39944857.37559.06
5380514-38051454.65656.26
6401390-40139057.65459.29
45min1420302-42030260.37163.303.9862.4765.563.97
2440476-44047663.26965.58
3459546-45954666.00868.35
4454930-45493065.34567.66
5418920-41892060.17262.38
6450099-45009964.65166.93
60min1441062-44106263.35366.674.4566.1269.634.41
2463457-46345766.56969.58
3482516-48251669.30772.38
4481378-48137869.14472.19
5437072-43707262.78065.66
6479360-47936068.85471.85
90min1487963-48796370.08972.793.6873.5676.493.68
2509862-50986273.23576.99
3520435-52043574.75478.60
4521381-52138174.88978.70
5479297-47929768.84572.42
6521477-52147774.90378.66
极限1540151-54015177.58679.882.0381.8484.392.12
2560340-56034080.48585.05
3562983-56298380.86585.54
4570867-57086781.99786.64
5546264-54626478.46482.80
6556130-55613079.88184.47
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%
110.061130750113324811354071130315112979611319030.21
210.001123186112236911227780.06
单位质量响应值RSD%判断
112515.21112277.800.15数据可信
供试品溶液-24050202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%
5min159921-599218.75211.8456.438.7511.8456.42
283589-8358912.20912.21
329636-296364.3284.33
456011-560118.1818.18
5161890-16189023.64523.64
695451-9545113.94113.94
10min1170993-17099324.97429.3626.9625.0729.4927.08
2212732-21273231.07031.21
3160938-16093823.50623.55
4147713-14771321.57421.67
5295302-29530243.13043.39
6218417-21841731.90132.06
15min1247294-24729436.11840.4017.8336.4940.8618.00
2289284-28928442.25142.73
3256967-25696737.53137.84
4216766-21676631.66031.99
5360318-36031852.62653.37
6289189-28918942.23742.75
20min1287787-28778742.03346.7814.6042.8147.6914.81
2326379-32637947.66948.62
3307662-30766244.93545.66
4268145-26814539.16439.85
5403276-40327658.90060.23
6328482-32848247.97648.95
30min1341630-34163049.89755.4212.1251.1456.8512.35
2389843-38984356.93858.42
3372561-37256154.41455.64
4328583-32858347.99149.11
5459189-45918967.06769.05
6385077-38507756.24257.75
45min1389151-38915156.83763.9611.3058.6366.0011.51
2448918-44891865.56767.68
3436458-43645863.74765.58
4387427-38742756.58558.24
5522482-52248276.31179.04
6442951-44295164.69566.83
60min1424337-42433761.97668.989.7764.4171.7410.02
2484755-48475570.80173.64
3470675-47067568.74471.28
4427323-42732362.41264.69
5550653-55065380.42584.00
6476105-47610569.53772.39
90min1463078-46307867.63575.048.9270.7578.569.18
2523202-52320276.41680.04
3514690-51469075.17378.48
4467974-46797468.35071.32
5588648-58864885.97590.44
6524946-52494676.67180.30
极限1506219-50621973.93680.336.1577.8084.686.51
2556693-55669381.30885.78
3555742-55574281.16985.31
4525399-52539976.73780.47
5605768-60576888.47593.90
6550192-55019280.35884.84
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%
110.061126928112890111271061124224112684211268000.15
210.001122702112107511218880.11
单位质量响应值RSD%判断
112007.95112188.800.12数据可信
供试品溶液-24050203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%
5min1148481-14848121.74421.4911.4221.7421.4911.41
2153484-15348422.47722.48
3113125-11312516.56616.57
4152310-15231022.30522.30
5156127-15612722.86422.86
6157015-15701522.99422.99
10min1257849-25784937.76034.2811.0238.0034.5211.01
2244413-24441335.79336.04
3183856-18385626.92427.11
4235565-23556534.49734.74
5238097-23809734.86835.12
6244599-24459935.82036.08
15min1313745-31374545.94642.2010.0746.6142.8210.08
2301299-30129944.12344.77
3231743-23174333.93734.42
4287878-28787842.15842.79
5293207-29320742.93843.58
6301147-30114744.10144.75
20min1352284-35228451.58948.258.5552.7649.348.59
2342505-34250550.15751.30
3273741-27374140.08740.95
4332293-33229348.66249.76
5335273-33527349.09850.22
6340613-34061349.88051.02
30min1401546-40154658.80456.455.7460.5558.075.85
2394414-39441457.75959.45
3341264-34126449.97651.28
4394517-39451757.77459.41
5387544-38754456.75358.42
6393484-39348457.62359.32
45min1448287-44828765.64865.212.8468.0567.463.02
2452460-45246066.26068.60
3419863-41986361.48663.35
4453002-45300266.33968.62
5450646-45064665.99468.29
6447322-44732265.50767.85
60min1490401-49040171.81670.461.9874.9473.432.15
2486897-48689771.30374.38
3465634-46563468.18970.73
4488532-48853271.54274.56
5480222-48022270.32573.35
6475020-47502069.56372.63
90min1538139-53813978.80776.822.2482.7380.582.34
2521157-52115776.32080.18
3508688-50868874.49477.80
4534775-53477578.31482.13
5530094-53009477.62881.44
6514412-51441275.33279.17
极限1592070-59207086.70486.321.3391.5190.941.31
2575083-57508384.21788.93
3587623-58762386.05390.18
4597804-59780487.54492.23
5593318-59331886.88791.56
6590816-59081686.52191.20
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