替普瑞酮颗粒项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1113.65634845680945674585674045661985665280.33
2114.05713275640525676900.91
单位质量响应值RSD%判断
4987.044979.740.11数据可信
供试品溶液-43G01批-pH6.8(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1345848-34584861.46161.851.4161.4661.851.41
2354948-35494863.07863.08
3347948-34794861.83461.83
4345318-34531861.36761.37
5352526-35252662.64862.65
6341716-34171660.72760.73
10min1379965-37996567.52467.991.8367.6368.101.83
2387267-38726768.82168.93
3387173-38717368.80568.91
4383293-38329368.11568.22
5388147-38814768.97869.08
6369831-36983165.72365.82
15min1407638-40763872.44272.271.4972.6672.481.49
2408261-40826172.55272.77
3409483-40948372.76972.99
4405880-40588072.12972.34
5413291-41329173.44673.67
6395439-39543970.27470.48
20min1420138-42013874.66375.171.8175.0075.501.81
2429404-42940476.31076.65
3431617-43161776.70377.04
4420379-42037974.70675.04
5425700-42570075.65175.99
6410573-41057372.96373.29
30min1441947-44194778.53978.851.5079.0079.311.50
2447450-44745079.51779.98
3448916-44891679.77780.24
4438307-43830777.89278.35
5451286-45128680.19880.67
6434211-43421177.16477.61
45min1458755-45875581.52682.261.4582.1282.851.45
2467347-46734783.05283.65
3463830-46383082.42783.03
4463897-46389782.43983.03
5471272-47127283.75084.35
6452179-45217980.35780.94
60min1477827-47782784.91584.881.3585.6485.621.35
2472382-47238283.94784.69
3480264-48026485.34886.09
4479903-47990385.28486.01
5486883-48688386.52487.27
6468633-46863383.28183.99
极限1503358-50335889.45289.640.6390.3290.510.64
2505835-50583589.89290.77
3506161-50616189.95090.83
4503745-50374589.52190.39
5508276-50827690.32691.21
6499106-49910688.69689.55
替普瑞酮颗粒项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1113.65727535723985730645729415683215718950.36
2114.05715175695995705580.24
单位质量响应值RSD%判断
5034.295004.890.42数据可信
供试品溶液-43G01批-pH6.8(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1364289-36428964.27265.182.1464.2765.182.14
2360755-36075563.64863.65
3367927-36792764.91364.91
4365324-36532464.45464.45
5379308-37930866.92166.92
6379105-37910566.88666.89
10min1412882-41288272.84573.261.0872.9573.361.08
2411406-41140672.58472.69
3412889-41288972.84672.95
4412336-41233672.74972.86
5421833-42183374.42474.54
6419959-41995974.09374.20
15min1441366-44136677.87078.021.1178.1078.251.11
2440761-44076177.76477.99
3443288-44328878.20978.44
4433925-43392576.55776.79
5447859-44785979.01679.25
6446076-44607678.70178.94
20min1458255-45825580.85081.490.7181.2181.850.71
2461061-46106181.34581.70
3463258-46325881.73382.09
4458167-45816780.83581.19
5464656-46465681.97982.35
6465851-46585182.19082.56
30min1484097-48409785.40985.910.9385.9086.410.93
2486401-48640185.81686.31
3483075-48307585.22985.73
4484332-48433285.45185.94
5495273-49527387.38187.89
6488519-48851986.19086.69
45min1508193-50819389.66190.170.7190.3090.810.71
2510937-51093790.14590.78
3507912-50791289.61190.25
4508607-50860789.73490.37
5516771-51677191.17491.82
6513920-51392090.67191.32
60min1523840-52384092.42193.290.7793.2194.080.77
2528464-52846493.23794.02
3527301-52730193.03293.82
4528830-52883093.30294.08
5536209-53620994.60395.40
6528019-52801993.15993.96
极限1539040-53904095.10395.920.4896.0496.870.48
2546135-54613596.35597.30
3545532-54553296.24897.19
4542798-54279895.76696.70
5543977-54397795.97496.93
6544626-54462696.08897.04
替普瑞酮颗粒项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1113.65704975693595683395676615673955686500.23
2114.05710965706305708630.06
单位质量响应值RSD%判断
5005.725007.570.03数据可信
供试品溶液-25101701批-pH6.8(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1316678-31667856.01657.563.1956.0257.563.19
2321451-32145156.86056.86
3314243-31424355.58555.58
4325926-32592657.65157.65
5331987-33198758.72358.72
6342067-34206760.50660.51
10min1351742-35174262.21863.952.3962.3164.042.39
2360185-36018563.71163.81
3352672-35267262.38262.47
4361980-36198064.02964.12
5372880-37288065.95766.05
6369614-36961465.37965.48
15min1370769-37076965.58367.422.6165.7867.622.61
2382245-38224567.61367.81
3368314-36831465.14965.35
4383189-38318967.78067.98
5393842-39384269.66569.87
6388526-38852668.72468.93
20min1384428-38442868.00069.191.8468.3169.501.84
2391046-39104669.17069.48
3382075-38207567.58367.89
4391179-39117969.19469.51
5397525-39752570.31670.64
6400571-40057170.85571.18
30min1396974-39697470.21971.622.0070.6472.052.00
2407840-40784072.14172.57
3392869-39286969.49369.91
4408128-40812872.19272.62
5410503-41050372.61273.05
6413186-41318673.08673.53
45min1413238-41323873.09674.502.4673.6375.052.46
2421541-42154174.56475.11
3405523-40552371.73172.26
4433723-43372376.71977.27
5429109-42910975.90376.47
6423965-42396574.99375.56
60min1428282-42828275.75776.822.8976.4277.492.87
2438014-43801477.47878.15
3411863-41186372.85273.51
4446069-44606978.90379.58
5442844-44284478.33279.02
6438532-43853277.57078.26
极限1464768-46476882.21081.961.2083.0082.761.21
2464727-46472782.20383.01
3452182-45218279.98480.76
4465156-46515682.27983.09
5466928-46692882.59383.41
6466253-46625382.47383.29
替普瑞酮颗粒项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1113.65686375690105699895697635700785694950.12
2114.05745925762035753980.20
单位质量响应值RSD%判断
5013.165047.350.49数据可信
供试品溶液-25101701批-pH6.8(内含1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1394406-39440669.43868.102.5969.4468.102.59
2394912-39491269.52769.53
3378909-37890966.70966.71
4372365-37236565.55765.56
5396632-39663269.83069.83
6383735-38373567.55967.56
10min1440682-44068277.58576.391.7577.7076.511.75
2439722-43972277.41677.53
3428886-42888675.50875.62
4422385-42238574.36474.47
5440472-44047277.54877.66
6431379-43137975.94776.06
15min1465797-46579782.00779.642.1682.2579.882.16
2456691-45669180.40480.65
3449038-44903879.05679.29
4438085-43808577.12877.36
5457721-45772180.58580.83
6446816-44681678.66578.90
20min1475701-47570183.75081.522.1084.1381.892.10
2465731-46573181.99582.37
3458442-45844280.71281.08
4448698-44869878.99679.36
5470730-47073082.87583.26
6458860-45886080.78581.16
30min1495671-49567187.26683.852.4887.7984.362.48
2474517-47451783.54284.06
3465010-46501081.86882.37
4468196-46819682.42982.92
5484915-48491585.37385.89
6469126-46912682.59383.10
45min1506157-50615789.11286.612.6289.7887.262.61
2495159-49515987.17687.83
3475871-47587183.78084.42
4481763-48176384.81885.45
5506644-50664489.19889.86
6485984-48598485.56186.20
60min1512647-51264790.25588.661.9591.0789.451.95
2508212-50821289.47490.27
3490881-49088186.42387.20
4494821-49482187.11787.89
5514768-51476890.62891.44
6500120-50012088.04988.83
极限1520769-52076991.68589.961.8892.6590.901.88
2516701-51670190.96991.92
3503107-50310788.57589.50
4497923-49792387.66388.58
5520173-52017391.58092.54
6507127-50712789.28390.22
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