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%
110.192488512488672486572497672495572491400.20
210.192492812491742492280.04
单位质量响应值RSD%判断
24449.4624458.100.03数据可信
供试品溶液-24050904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%
5min122574-2257415.15416.395.7015.1516.395.70
223547-2354715.80715.81
324762-2476216.62316.62
423737-2373715.93515.93
526310-2631017.66217.66
625582-2558217.17317.17
10min139422-3942226.46428.065.8126.6328.245.81
240223-4022327.00227.18
342073-4207328.24428.43
440223-4022327.00227.18
546002-4600230.88131.08
642846-4284628.76328.95
15min149747-4974733.39634.432.4433.8634.922.42
250747-5074734.06734.54
351930-5193034.86135.36
451901-5190134.84235.32
550278-5027833.75234.29
653103-5310335.64836.16
20min157439-5743938.55939.554.4539.3940.424.41
257574-5757438.65039.50
358435-5843539.22840.11
456827-5682738.14839.01
563971-6397142.94443.86
659227-5922739.76040.67
30min166324-6632444.52445.495.0345.7946.804.98
265312-6531243.84445.13
365513-6551343.97945.30
466290-6629044.50145.79
574199-7419949.81051.20
668905-6890546.25647.60
45min173511-7351149.34851.193.7851.1153.023.78
275412-7541250.62552.40
375520-7552050.69752.51
474481-7448150.00051.78
581648-8164854.81156.76
676969-7696951.67053.53
60min178157-7815752.46754.824.9054.7757.214.86
280453-8045354.00956.34
380796-8079654.23956.61
479135-7913553.12455.46
589335-8933559.97162.53
682069-8206955.09457.53
90min185015-8501557.07159.784.6559.9662.784.61
288809-8880959.61862.55
387669-8766958.85361.83
487172-8717258.51961.45
597034-9703465.14068.36
688633-8863359.50062.55
极限189359-8935959.98763.034.3263.5166.694.30
293528-9352862.78666.38
392688-9268862.22265.85
492090-9209061.82165.40
5101400-10140068.07172.01
694294-9429463.30067.01
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%
110.191266611126739712670421267122126699612670340.03
210.191268153126919912686760.06
单位质量响应值RSD%判断
124340.92124502.060.10数据可信
供试品溶液-24051001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%
5min1152959-15295920.18119.857.1120.1819.857.12
2158036-15803620.85120.85
3155276-15527620.48720.49
4151812-15181220.03020.03
5155643-15564320.53520.54
6129101-12910117.03317.03
10min1240861-24086131.77931.826.3832.0032.046.38
2252906-25290633.36833.60
3247697-24769732.68132.91
4244201-24420132.22032.44
5250330-25033033.02833.26
6211059-21105927.84728.04
15min1295610-29561039.00238.634.7039.5839.204.73
2301704-30170439.80640.41
3301064-30106439.72240.31
4293955-29395538.78439.36
5299017-29901739.45240.05
6265412-26541235.01835.52
20min1326827-32682743.12142.904.4044.1343.914.43
2334181-33418144.09145.14
3335075-33507544.20945.24
4327201-32720143.17044.18
5330884-33088443.65644.69
6296877-29687739.17040.06
30min1370006-37000648.81848.583.3750.3150.063.43
2372120-37212049.09750.63
3379317-37931750.04751.57
4369857-36985748.79850.29
5374184-37418449.36950.89
6343949-34394945.38046.70
45min1411834-41183454.33753.832.2956.3755.852.38
2414398-41439854.67556.76
3412585-41258554.43656.52
4407746-40774653.79755.83
5411949-41194954.35256.42
6389484-38948451.38853.22
60min1431169-43116956.88857.112.2859.5259.732.36
2441326-44132658.22860.92
3435042-43504257.39960.08
4437330-43733057.70160.33
5438480-43848057.85260.52
6413990-41399054.62157.02
90min1470834-47083462.12162.591.4765.3965.841.53
2473917-47391762.52865.86
3480598-48059863.40966.73
4470490-47049062.07665.35
5484561-48456163.93267.25
6465984-46598461.48164.49
极限1499825-49982565.94667.502.1869.9071.442.20
2511163-51116367.44271.47
3518954-51895468.47072.50
4519790-51979068.58072.54
5523183-52318369.02873.05
6496589-49658965.51969.21
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%
110.191268389126873612685541268384126858412685290.02
210.191261965126262712622960.04
单位质量响应值RSD%判断
124487.63123875.960.35数据可信
供试品溶液-24051002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%
5min1150043-15004319.83521.223.7519.8321.223.77
2164367-16436721.72821.73
3162243-16224321.44821.45
4157202-15720220.78120.78
5166773-16677322.04622.05
6162386-16238621.46621.47
10min1243637-24363732.20733.322.5332.4333.562.53
2253914-25391433.56633.81
3254299-25429933.61733.86
4245759-24575932.48832.72
5260960-26096034.49734.74
6253928-25392833.56833.81
15min1293301-29330138.77340.382.8239.3540.982.83
2307865-30786540.69841.31
3305918-30591840.44141.05
4297651-29765139.34839.94
5316421-31642141.82942.46
6311420-31142041.16841.78
20min1336167-33616744.43945.051.0845.4546.101.09
2341402-34140245.13146.20
3337011-33701144.55145.61
4342377-34237745.26046.29
5341584-34158445.15546.25
6346061-34606145.74746.82
30min1367406-36740648.56950.042.7750.0751.592.71
2367426-36742648.57250.14
3387780-38778051.26252.82
4381751-38175150.46552.00
5374478-37447849.50451.10
6392215-39221551.84953.43
45min1409260-40926054.10255.712.0656.1457.822.05
2428429-42842956.63658.74
3418694-41869455.34957.47
4414104-41410454.74256.83
5428874-42887456.69558.84
6429255-42925556.74558.90
60min1431714-43171457.07059.342.5559.7162.072.52
2455598-45559860.22762.96
3449624-44962459.43862.18
4438466-43846657.96360.66
5458398-45839860.59863.37
6459589-45958960.75563.54
90min1463545-46354561.27864.392.9064.5667.782.85
2496088-49608865.58068.99
3493420-49342065.22768.63
4475677-47567762.88266.23
5497705-49770565.79469.24
6495992-49599265.56769.03
极限1497697-49769765.79366.931.9569.7571.041.91
2523274-52327469.17473.31
3503167-50316766.51670.64
4499000-49900065.96570.01
5501936-50193666.35370.53
6512750-51275067.78371.97
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