替普瑞酮胶囊项目信息
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%
1118.05719525736945714645695635713815716110.26
2117.85732355713515722930.24
单位质量响应值RSD%判断
4844.164858.170.21数据可信
供试品溶液-25073001批-pH6.8(内含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%
5min1269671-26967149.23050.5211.7849.2350.5211.78
2239489-23948943.72043.72
3250655-25065545.75845.76
4294195-29419553.70753.71
5276008-27600850.38650.39
6330496-33049660.33360.33
10min1328804-32880460.02563.259.8660.1163.349.85
2304202-30420255.53355.61
3329269-32926960.10960.19
4374758-37475868.41468.50
5344100-34410062.81762.90
6397699-39769972.60272.70
15min1354422-35442264.70169.098.6764.8869.288.67
2342554-34255462.53562.70
3364058-36405866.46066.64
4409325-40932574.72474.93
5373610-37361068.20468.39
6426660-42666077.88978.11
20min1389945-38994571.18674.797.0571.4875.097.06
2379156-37915669.21769.49
3394331-39433171.98772.27
4443819-44381981.02181.35
5403559-40355973.67173.97
6447224-44722481.64381.99
30min1432483-43248378.95281.275.1879.3681.705.19
2421957-42195777.03077.42
3434344-43434479.29179.70
4475392-47539286.78587.25
5433627-43362779.16079.59
6473229-47322986.39086.88
45min1465735-46573585.02287.384.6885.5687.944.70
2459361-45936183.85884.37
3461558-46155884.25984.80
4508135-50813592.76293.37
5471069-47106985.99686.55
6505897-50589792.35492.99
60min1493070-49307090.01291.843.2390.6992.553.26
2489260-48926089.31789.97
3493519-49351990.09490.77
4522552-52255295.39496.16
5494987-49498790.36291.06
6525250-52525095.88796.67
90min1524027-52402795.66396.432.0996.5097.302.12
2517760-51776094.51995.32
3528802-52880296.53597.37
4539915-53991598.56499.49
5516484-51648494.28695.14
6542480-54248099.03299.98
极限1539362-53936298.46398.101.7599.4599.121.77
2526793-52679396.16897.13
3545538-54553899.590100.58
4542988-54298899.125100.21
5524442-52444295.73996.75
6545115-54511599.513100.62
替普瑞酮胶囊项目信息
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%
1118.05702525690385689395701145698695696420.11
2117.85747225755085751150.10
单位质量响应值RSD%判断
4827.474882.130.80数据可信
供试品溶液-25073001批-pH4.0(内含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%
5min1179055-17905532.66442.7215.6732.6642.7215.68
2224342-22434240.92540.93
3277501-27750150.62350.62
4257642-25764247.00047.00
5209097-20909738.14438.14
6257436-25743646.96246.96
10min1289672-28967252.84348.4449.3852.9048.5149.30
2338063-33806361.67061.74
3332280-33228060.61660.70
41520-15200.2770.36
5294778-29477853.77453.84
6336911-33691161.46061.54
15min1319184-31918458.22764.255.3758.3764.405.35
2358482-35848265.39565.57
3363542-36354266.31866.50
4367303-36730367.00567.08
5340214-34021462.06362.22
6364580-36458066.50866.69
20min1347795-34779563.44668.794.5963.6969.054.57
2380398-38039869.39369.67
3386561-38656170.51870.81
4393215-39321571.73171.92
5365544-36554466.68466.94
6388953-38895370.95471.25
30min1395574-39557472.16275.653.2372.5176.023.22
2411467-41146775.06175.46
3417026-41702676.07576.49
4429354-42935478.32478.63
5405451-40545173.96474.33
6429339-42933978.32178.73
45min1435600-43560079.46382.152.8679.9382.662.84
2445419-44541981.25581.78
3447692-44769281.66982.21
4465836-46583684.97985.42
5441294-44129480.50280.99
6466279-46627985.06085.60
60min1462963-46296384.45586.742.7985.0587.382.78
2468879-46887985.53486.19
3471570-47157086.02586.70
4488226-48822689.06489.65
5465694-46569484.95385.58
6495549-49554990.40091.08
90min1494810-49481090.26592.422.4891.0093.202.48
2503292-50329291.81292.61
3501668-50166891.51692.34
4519046-51904694.68695.42
5495805-49580590.44691.21
6525082-52508295.78796.62
极限1515038-51503893.95595.392.2794.8496.332.25
2519767-51976794.81795.77
3515945-51594594.12095.09
4536963-53696397.95498.84
5511258-51125893.26594.18
6538580-53858098.24999.24
替普瑞酮胶囊项目信息
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%
1118.05985286005185987035986165996685992070.15
2117.86063236040386051800.27
单位质量响应值RSD%判断
5078.035137.350.83数据可信
供试品溶液-25073001批-pH1.2(内含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%
5min1240530-24053041.70638.335.3041.7138.335.30
2207860-20786036.04136.04
3225924-22592439.17339.17
4210713-21071336.53636.54
5220693-22069338.26638.27
6220643-22064338.25838.26
10min1337032-33703258.43858.362.4058.5158.422.40
2323796-32379656.14356.20
3340422-34042259.02659.09
4348417-34841760.41360.47
5334615-33461558.01958.08
6335069-33506958.09858.16
15min1380748-38074866.01866.251.8266.1966.411.81
2376705-37670565.31765.47
3391603-39160367.90168.06
4387705-38770567.22567.39
5382924-38292466.39666.56
6372839-37283964.64764.81
20min1411380-41138071.33072.321.9071.6172.601.90
2406876-40687670.54970.81
3424888-42488873.67273.95
4422750-42275073.30173.57
5424669-42466973.63473.91
6412092-41209271.45371.72
30min1453754-45375478.67779.752.0079.0780.141.99
2450836-45083678.17178.55
3473891-47389182.16982.57
4463308-46330880.33480.73
5465557-46555780.72481.12
6452173-45217378.40378.79
45min1491310-49131085.18985.151.3185.7285.671.31
2483254-48325483.79284.30
3497222-49722286.21486.75
4491734-49173485.26385.79
5498711-49871186.47287.00
6484195-48419583.95584.47
60min1504148-50414887.41587.421.2588.0888.091.25
2492518-49251885.39886.05
3509283-50928388.30588.99
4504152-50415287.41688.09
5510178-51017888.46189.13
6504741-50474187.51888.18
90min1511565-51156588.70187.891.1789.5288.711.17
2496427-49642786.07686.87
3506662-50666287.85188.68
4505139-50513987.58788.40
5512945-51294588.94089.76
6508694-50869488.20389.01
极限1520178-52017890.19488.141.4491.1689.101.44
2499728-49972886.64987.58
3513499-51349989.03690.01
4504346-50434687.44988.41
5506765-50676587.86988.84
6505514-50551487.65288.60
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