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%
1109.85293655290545285835290545282155288540.09
2111.05328405326705327550.03
单位质量响应值RSD%判断
4816.524799.590.25数据可信
供试品溶液-25090801批-pH6.8(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1400307-40030773.73376.512.8173.7376.512.81
2405341-40534174.66074.66
3420413-42041377.43677.44
4429352-42935279.08379.08
5411059-41105975.71475.71
6425895-42589578.44678.45
10min1472002-47200286.93986.251.4487.0686.381.44
2467702-46770286.14786.27
3467532-46753286.11586.24
4475108-47510887.51187.64
5455868-45586883.96784.09
6471512-47151286.84886.98
15min1464383-46438385.53587.521.9785.8087.791.97
2470901-47090186.73687.00
3481576-48157688.70288.97
4488023-48802389.89090.17
5466532-46653285.93186.20
6479646-47964688.34788.62
20min1469136-46913686.41188.021.9186.8288.431.91
2475160-47516087.52087.93
3489239-48923990.11490.53
4486725-48672589.65190.08
5466897-46689785.99886.41
6479972-47997288.40788.83
30min1472044-47204486.94689.111.9087.5089.681.90
2478945-47894588.21888.78
3491884-49188490.60191.17
4495188-49518891.20991.79
5476814-47681487.82588.38
6487846-48784689.85790.43
45min1480256-48025688.45990.631.8089.1691.341.80
2489346-48934690.13390.84
3500132-50013292.12092.84
4502472-50247292.55193.28
5484494-48449489.24089.94
6495466-49546691.26191.98
60min1481853-48185388.75391.361.9089.6092.221.90
2493462-49346290.89191.75
3503004-50300492.64993.52
4507398-50739893.45894.34
5489793-48979390.21691.06
6500443-50044392.17793.05
90min1489062-48906290.08192.711.8891.0893.721.87
2502014-50201492.46793.47
3510299-51029993.99395.02
4515569-51556994.96396.00
5497402-49740291.61792.62
6505518-50551893.11294.14
120min1-0.0000.00-1.141.172.03
2-0.0001.16
3-0.0001.19
4-0.0001.20
5-0.0001.15
6-0.0001.18
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-1.141.172.03
2-0.0001.16
3-0.0001.19
4-0.0001.20
5-0.0001.15
6-0.0001.18
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%
1109.85242035244295238555224665220475234000.21
2111.05398425399515398960.02
单位质量响应值RSD%判断
4766.854863.931.43数据可信
供试品溶液-25090901批-pH6.8(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1429111-42911178.92679.691.2978.9379.691.29
2429260-42926078.95378.95
3429081-42908178.92078.92
4432414-43241479.53479.53
5437009-43700980.37980.38
6442704-44270481.42681.43
10min1475612-47561287.47987.280.9387.6187.420.93
2475990-47599087.54887.68
3467238-46723885.93986.07
4472355-47235586.88087.01
5475729-47572987.50087.63
6480377-48037788.35588.49
15min1484308-48430889.07889.350.8189.3689.630.82
2487637-48763789.69189.97
3481289-48128988.52388.80
4482103-48210388.67388.95
5487886-48788689.73690.02
6491561-49156190.41290.70
20min1491149-49114990.33790.551.0090.7690.981.00
2495406-49540691.12091.55
3485263-48526389.25489.68
4488591-48859189.86690.29
5494638-49463890.97891.41
6498722-49872291.72992.16
30min1499319-49931991.83992.121.1992.4292.701.19
2505806-50580693.03293.61
3494261-49426190.90991.48
4494276-49427690.91291.49
5502704-50270492.46293.04
6508587-50858793.54494.13
45min1508583-50858393.54393.401.2094.2794.131.19
2512020-51202094.17594.91
3500674-50067492.08992.81
4500038-50003891.97292.70
5511061-51106193.99994.73
6514358-51435894.60595.35
60min1511563-51156394.09194.121.1994.9895.001.19
2516485-51648594.99795.89
3503495-50349592.60793.48
4505102-50510292.90393.78
5516844-51684495.06395.95
6516696-51669695.03595.94
90min1515918-51591894.89294.961.2695.9396.001.26
2522882-52288296.17397.22
3509729-50972993.75494.78
4507306-50730693.30894.34
5520343-52034395.70696.76
6521403-52140395.90196.96
120min1-0.0000.00-1.201.201.01
2-0.0001.21
3-0.0001.19
4-0.0001.19
5-0.0001.21
6-0.0001.22
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-1.201.201.01
2-0.0001.21
3-0.0001.19
4-0.0001.19
5-0.0001.21
6-0.0001.22
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%
1109.85387925392875388855388075370595385660.17
2111.05424395416705420540.11
单位质量响应值RSD%判断
4904.974883.370.32数据可信
供试品溶液-25090801批-pH4.0(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1370959-37095967.12565.114.1167.1365.114.11
2352669-35266963.81663.82
3361727-36172765.45565.45
4333822-33382260.40560.41
5374083-37408367.69167.69
6365535-36553566.14466.14
10min1425137-42513776.92975.751.5477.0475.861.54
2413409-41340974.80774.91
3415767-41576775.23375.34
4416678-41667875.39875.50
5428099-42809977.46577.58
6412679-41267974.67574.78
15min1437384-43738479.14578.551.6979.3978.791.70
2433005-43300578.35378.58
3427458-42745877.34977.58
4432303-43230378.22678.45
5447007-44700780.88681.13
6427565-42756577.36877.60
20min1446539-44653980.80280.281.8581.1780.641.85
2441317-44131779.85780.22
3437360-43736079.14179.50
4443571-44357180.26580.62
5458032-45803282.88183.26
6435018-43501878.71779.08
30min1459744-45974483.19182.292.0483.7082.792.04
2451932-45193281.77782.27
3446757-44675780.84181.34
4455802-45580282.47882.97
5469753-46975385.00285.52
6444510-44451080.43480.93
45min1466978-46697884.50084.022.0185.1584.662.01
2462976-46297683.77684.41
3461170-46117083.44984.08
4465568-46556884.24584.87
5479089-47908986.69287.35
6450288-45028881.48082.11
60min1473762-47376285.72885.221.9386.5186.001.93
2468689-46868984.81085.58
3467663-46766384.62485.39
4471642-47164285.34486.11
5485857-48585787.91688.72
6458142-45814282.90183.67
90min1481410-48141087.11286.411.7888.0487.331.78
2477028-47702886.31987.23
3473070-47307085.60286.51
4478279-47827986.54587.46
5490464-49046488.75089.70
6464974-46497484.13785.04
120min1485250-48525087.80687.192.1288.8888.262.11
2485875-48587587.91988.98
3478104-47810486.51387.57
4480273-48027386.90687.96
5496181-49618189.78490.88
6465468-46546884.22785.27
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1492407-49240789.10188.601.9890.3289.811.97
2491425-49142588.92490.13
3485081-48508187.77688.97
4489677-48967788.60789.81
5504350-50435091.26392.51
6474849-47484985.92487.11
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%
1109.85347355352095353325350595339105348490.11
2111.05500315516595508450.21
单位质量响应值RSD%判断
4871.124962.571.32数据可信
供试品溶液-25090901批-pH4.0(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1377494-37749467.99869.462.3268.0069.462.33
2379897-37989768.43168.43
3378245-37824568.13468.13
4391271-39127170.48070.48
5386347-38634769.59369.59
6400247-40024772.09772.10
10min1433434-43343478.07578.931.0878.1979.051.08
2437055-43705578.72778.84
3432281-43228177.86777.98
4443129-44312979.82179.94
5440130-44013079.28179.40
6443043-44304379.80679.93
15min1446030-44603080.34481.351.2280.5981.601.22
2448454-44845480.78181.03
3445679-44567980.28180.52
4457342-45734282.38282.63
5456418-45641882.21582.46
6455857-45585782.11482.37
20min1459648-45964882.79783.301.0583.1783.691.06
2457975-45797582.49682.88
3456898-45689882.30282.68
4467701-46770184.24884.64
5467344-46734484.18384.57
6465208-46520883.79884.19
30min1470063-47006384.67385.040.3485.1985.560.34
2472825-47282585.17085.69
3471290-47129084.89485.41
4473664-47366485.32285.85
5470778-47077884.80285.33
6473898-47389885.36485.89
45min1472354-47235485.08686.390.9485.7487.050.94
2479742-47974286.41687.08
3477199-47719985.95886.61
4481031-48103186.64987.32
5485579-48557987.46888.13
6481623-48162386.75587.43
60min1477963-47796386.09687.381.0786.8988.181.07
2485928-48592887.53188.33
3480729-48072986.59487.39
4488625-48862588.01788.83
5492152-49215288.65289.46
6484993-48499387.36288.18
90min1485695-48569587.48988.320.9488.4389.270.94
2492966-49296688.79989.75
3487317-48731787.78188.72
4494206-49420689.02289.98
5495977-49597789.34190.30
6485739-48573987.49788.46
120min1491040-49104088.45289.441.4189.5490.541.41
2498099-49809989.72390.82
3492466-49246688.70889.80
4502412-50241290.50091.61
5506503-50650391.23792.35
6488669-48866988.02489.13
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1504140-50414090.81191.080.7592.0592.330.74
2507321-50732191.38492.63
3501212-50121290.28491.52
4507982-50798291.50392.76
5510901-51090192.02993.29
6502137-50213790.45091.71
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