阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.514607546185459434588145757459680.37
211.414611646271461940.24
单位质量响应值RSD%判断
3993.744048.550.97数据可信
供试品溶液-24022501批-阿齐沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min142343-4234385.10482.522.8985.1082.522.89
240849-4084982.10282.10
339831-3983180.05680.06
439597-3959779.58579.59
542305-4230585.02885.03
641415-4141583.23983.24
10min148824-4882498.13095.743.0498.6096.203.03
248558-4855897.59698.05
348200-4820096.87697.32
444863-4486390.16990.61
547387-4738795.24295.71
647991-4799196.45696.92
15min147040-4704094.54595.132.8395.5696.122.81
247981-4798196.43697.43
348088-4808896.65197.63
444767-4476789.97690.92
547755-4775595.98296.98
648369-4836997.21698.21
20min149290-4929099.06799.643.19100.61101.153.14
246982-4698294.42895.96
349318-4931899.123100.64
449983-49983100.460101.90
551866-51866104.245105.78
650001-50001100.496102.03
30min149399-4939999.286100.912.34101.38102.982.30
248960-4896098.404100.46
349692-4969299.875101.95
450812-50812102.126104.13
552210-52210104.936107.05
650171-50171100.838102.93
45min149617-4961799.724100.521.95102.37103.151.88
248694-4869497.869100.47
350713-50713101.927104.55
451240-51240102.986105.55
549272-4927299.031101.73
650535-50535101.569104.23
60min148507-4850797.49399.012.88100.69102.202.81
247715-4771595.90299.05
347866-4786696.20599.40
450007-50007100.508103.65
551049-51049102.602105.85
650424-50424101.346104.57
极限149839-49839100.171100.380.98103.91104.120.97
249703-4970399.897103.58
349939-49939100.371104.10
450023-50023100.540104.24
550814-50814102.130105.95
649349-4934999.186102.97
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
111.604113094115264121434107284083694108150.36
211.624125154135894130520.19
单位质量响应值RSD%判断
35415.0935546.640.27数据可信
供试品溶液-24022501批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1127215-12721532.17237.3025.0032.1737.3024.99
2168557-16855742.62842.63
395766-9576624.21924.22
4154283-15428339.01839.02
5136111-13611134.42234.42
6203054-20305451.35251.35
10min1247336-24733662.55180.4512.5862.7380.6612.59
2321440-32144081.29181.53
3306131-30613177.42077.55
4363126-36312691.83492.05
5324763-32476382.13282.32
6345905-34590587.47987.76
15min1310547-31054778.53789.508.7079.0690.168.71
2336648-33664885.13885.83
3343139-34313986.77987.34
4394177-39417799.686100.41
5382509-38250996.73697.38
6356447-35644790.14590.92
20min1380311-38031196.18096.875.8697.1498.025.84
2351107-35110788.79489.96
3384199-38419997.16398.21
4404177-404177102.215103.50
5367289-36728992.88794.07
6411178-411178103.986105.26
30min1369529-36952993.45398.747.0194.95100.437.00
2357549-35754990.42392.08
3388466-38846698.24299.83
4427503-427503108.115109.96
5381514-38151496.48498.19
6418035-418035105.720107.57
45min1376586-37658695.23899.427.8997.25101.657.85
2365024-36502492.31494.47
3395621-395621100.052102.18
4432395-432395109.352111.80
5361395-36139591.39693.63
6427618-427618108.144110.58
60min1381507-38150796.48298.717.2699.03101.507.24
2357435-35743590.39593.06
3374882-37488294.80797.50
4425845-425845107.695110.75
5377445-37744595.45598.20
6424716-424716107.410110.45
极限1396225-396225100.204101.683.69103.29105.023.79
2394504-39450499.769102.94
3390223-39022398.687101.90
4426173-426173107.778111.43
5390708-39070898.809102.08
6414598-414598104.851108.49
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.514639646209461674605946078461820.30
211.414645446410464320.07
单位质量响应值RSD%判断
4012.344069.411.00数据可信
供试品溶液-24022502批-阿齐沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min142417-4241784.83780.0219.4284.8480.0219.42
244719-4471989.44189.44
342035-4203584.07384.07
443264-4326486.53186.53
543340-4334086.68386.68
624264-2426448.53048.53
10min147626-4762695.25695.355.0395.7395.805.08
250496-50496100.996101.49
349564-4956499.13299.60
448537-4853797.07897.56
545660-4566091.32491.81
644155-4415588.31388.58
15min149798-4979899.60097.493.53100.6098.463.58
250574-50574101.152102.21
349123-4912398.25099.27
449673-4967399.350100.37
547093-4709394.19095.18
646189-4618992.38293.14
20min150157-50157100.31898.453.85101.8799.973.89
252213-52213104.430106.05
349509-4950999.022100.59
448889-4888997.78299.35
547772-4777295.54897.06
646811-4681193.62694.90
30min149751-4975199.50699.403.92101.62101.473.96
252194-52194104.392106.59
349998-49998100.000102.11
451116-51116102.236104.35
548440-4844096.88498.93
646703-4670393.41095.20
45min149247-4924798.49898.422.84101.16101.032.88
251214-51214102.432105.21
348345-4834596.69499.36
450544-50544101.092103.78
547871-4787195.74698.33
648024-4802496.05298.36
60min149419-4941998.84297.773.40102.05100.933.45
251106-51106102.216105.57
349273-4927398.550101.76
449678-4967899.360102.60
546875-4687593.75496.87
646947-4694793.89896.74
极限150515-50515101.03499.412.97104.79103.112.88
251083-51083102.170106.09
349516-4951699.036102.79
449135-4913598.274102.07
547121-4712194.24697.88
650836-50836101.676105.04
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
111.604132004146324126934123784128204131450.22
211.624154254171214162730.29
单位质量响应值RSD%判断
35615.9535823.840.42数据可信
供试品溶液-24022502批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1144119-14411936.20434.3514.9536.2034.3514.95
2148225-14822537.23537.24
3120923-12092330.37730.38
4143870-14387036.14136.14
5159463-15946340.05840.06
6103801-10380126.07626.08
10min1301683-30168375.78576.4210.0075.9976.619.94
2311169-31116978.16878.37
3332109-33210983.42883.60
4271712-27171268.25668.46
5267339-26733967.15767.38
6341263-34126385.72885.87
15min1352850-35285088.63887.894.9789.2688.504.93
2326406-32640681.99582.64
3351028-35102888.18188.81
4334115-33411583.93284.51
5360863-36086390.65191.25
6373878-37387893.92194.54
20min1368851-36885192.65891.275.5493.7792.385.49
2338388-33838885.00586.10
3358825-35882590.13991.26
4345210-34521086.71987.77
5392674-39267498.64299.74
6376087-37608794.47695.62
30min1377209-37720994.75793.926.1796.3995.546.09
2337922-33792284.88886.46
3370425-37042593.05394.68
4376660-37666094.62096.15
5410289-410289103.067104.71
6370819-37081993.15294.82
45min1376764-37676494.64693.676.8496.8095.806.75
2332265-33226583.46785.51
3364847-36484791.65293.79
4377673-37767394.87496.93
5411578-411578103.391105.61
6374174-37417493.99596.18
60min1374977-37497794.19793.346.2696.8895.996.18
2333260-33326083.71786.22
3371703-37170393.37496.02
4373354-37335493.78996.37
5406396-406396102.089104.88
6369736-36973692.88095.59
极限1378826-37882695.16499.244.8198.37102.424.71
2394991-39499199.224102.19
3409214-409214102.797105.97
4387046-38704697.229100.33
5424890-424890106.735110.10
6375464-37546494.31997.54
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.514648046648463834653246295464680.30
211.414698346963469730.04
单位质量响应值RSD%判断
4037.194116.831.39数据可信
供试品溶液-24022801批-阿齐沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141042-4104281.36380.353.8481.3680.353.83
240832-4083280.94780.95
340967-4096781.21581.21
441947-4194783.15883.16
540918-4091881.11881.12
637472-3747274.28674.29
10min146492-4649292.16891.094.3492.6291.534.34
244930-4493089.07189.52
348636-4863696.41896.87
446462-4646292.10892.57
546494-4649492.17292.62
642669-4266984.58985.00
15min146140-4614091.47093.102.4492.4394.052.45
246981-4698193.13794.08
347901-4790194.96195.95
447663-4766394.48995.46
547991-4799195.13996.10
645107-4510789.42290.30
20min146944-4694493.06493.462.8594.5494.922.85
246751-4675192.68194.14
348332-4833295.81597.33
446988-4698893.15194.65
548824-4882496.79198.28
645010-4501089.23090.61
30min147054-4705493.28295.062.7795.2797.052.77
246583-4658392.34894.32
349223-4922397.58299.63
448748-4874896.64098.66
549445-4944598.022100.05
646667-4666792.51594.39
45min147281-4728193.73292.602.9496.2495.112.90
245676-4567690.55093.04
345554-4555490.30892.90
447160-4716093.49296.05
548993-4899397.12699.70
645582-4558290.36492.75
60min147239-4723993.64993.893.1596.6896.923.12
245973-4597391.13994.13
347186-4718693.54496.63
448505-4850596.15899.23
549593-4959398.315101.43
645673-4567390.54493.44
极限146275-4627591.73893.543.0095.2997.102.93
247740-4774094.64298.14
348945-4894597.031100.64
448518-4851896.18499.79
546141-4614191.47295.13
645490-4549090.18193.58
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
111.604163184154544166514137214137424151770.34
211.624195834197504196660.03
单位质量响应值RSD%判断
35791.1236115.830.64数据可信
供试品溶液-24022801批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1226178-22617856.44946.4118.9156.4546.4118.91
2190059-19005947.43447.43
3169548-16954842.31542.32
4208048-20804851.92451.92
5125326-12532631.27931.28
6196579-19657949.06249.06
10min1334317-33431783.43880.467.5583.7580.727.57
2346367-34636786.44586.71
3330058-33005882.37582.61
4311439-31143977.72878.02
5278419-27841969.48769.66
6333775-33377583.30383.58
15min1365227-36522791.15288.454.9391.9389.154.95
2376989-37698994.08894.83
3361333-36133390.18190.87
4333095-33309583.13383.85
5334542-33454283.49484.05
6355122-35512288.63089.37
20min1378110-37811094.36890.135.6895.6591.325.67
2379605-37960594.74196.01
3377715-37771594.26995.46
4330801-33080182.56183.74
5345864-34586486.32087.34
6354583-35458388.49689.72
30min1391995-39199597.83393.085.2699.6494.785.26
2385950-38595096.32498.12
3388598-38859896.98598.70
4342227-34222785.41287.05
5359022-35902289.60491.11
6369890-36989092.31694.04
45min1392869-39286998.05191.655.62100.4093.865.59
2385644-38564496.24898.58
3370025-37002592.35094.61
4335703-33570383.78485.90
5357966-35796689.34091.34
6361021-36102190.10392.34
60min1387898-38789896.81193.105.2299.7195.825.21
2396240-39624098.893101.76
3385549-38554996.22498.99
4347031-34703186.61189.19
5361342-36134290.18392.68
6360121-36012189.87892.61
极限1378090-37809094.36394.748.0297.8097.987.89
2431788-431788107.765111.18
3393801-39380198.284101.59
4370329-37032992.42695.49
5345984-34598486.35089.35
6357637-35763789.25892.49
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.514686846739469564685046671468170.24
211.414724147388473140.22
单位质量响应值RSD%判断
4067.514146.711.37数据可信
供试品溶液-24022801批-阿齐沙坦-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%
5min149379-4937997.17398.956.5497.1798.956.54
256731-56731111.641111.64
347474-4747493.42493.42
448594-4859495.62895.63
549411-4941197.23697.24
650112-5011298.61698.62
10min150372-5037299.127101.513.7499.67102.063.74
254620-54620107.487108.11
351209-51209100.775101.29
451068-51068100.497101.03
552992-52992104.283104.82
649250-4925096.91997.47
15min151120-51120100.59999.424.45101.69100.544.43
253025-53025104.348105.57
348627-4862795.69396.77
450889-50889100.145101.23
552345-52345103.010104.13
647132-4713292.75193.84
20min148844-4884496.12098.783.3197.77100.453.32
252405-52405103.128104.93
350611-5061199.598101.21
449499-4949997.40999.06
551686-51686101.713103.41
648143-4814394.74196.34
30min146174-4617490.86696.684.9693.0598.894.92
251276-51276100.906103.28
349708-4970897.82199.98
449550-4955097.51099.70
551836-51836102.008104.27
646215-4621590.94793.07
45min147745-4774593.95896.473.9896.6599.233.96
251506-51506101.359104.29
349734-4973497.872100.58
447963-4796394.38797.12
550739-5073999.850102.67
646457-4645791.42394.06
60min147891-4789194.24597.323.5197.46100.603.51
251830-51830101.997105.49
349623-4962397.653100.90
449087-4908796.59999.85
550949-50949100.263103.64
647327-4732793.13596.28
极限146867-4686792.23097.384.6695.96101.214.61
252258-52258102.839106.90
350727-5072799.826103.62
449575-4957597.559101.35
550899-50899100.165104.10
646584-4658491.67395.33
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
111.604180574181834181184183004171674179650.11
211.624237334230694234010.12
单位质量响应值RSD%判断
36031.4736437.260.80数据可信
供试品溶液-24022801批-左氨氯地平-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%
5min17699-76991.9072.1022.321.912.1022.28
211325-113252.8052.80
310144-101442.5122.51
48204-82042.0322.03
56547-65471.6211.62
66881-68811.7041.70
10min126739-267396.6226.3010.296.636.3110.30
228913-289137.1607.18
326805-268056.6386.65
425280-252806.2606.27
521995-219955.4475.46
622854-228545.6605.67
15min138750-387509.5968.895.739.648.935.75
237885-378859.3829.44
335272-352728.7358.79
435599-355998.8168.86
533353-333538.2608.30
634454-344548.5328.57
20min143897-4389710.87110.393.6910.9710.483.73
243322-4332210.72910.84
342213-4221310.45410.55
440582-4058210.05010.14
539876-398769.8759.96
641821-4182110.35710.45
30min148792-4879212.08311.981.3312.2412.131.37
248721-4872112.06612.23
348630-4863012.04312.20
448523-4852312.01712.17
547087-4708711.66111.80
648488-4848812.00812.15
45min155338-5533813.70413.392.3813.9313.612.40
255325-5532513.70113.94
354240-5424013.43213.66
452096-5209612.90113.12
553035-5303513.13413.34
654363-5436313.46313.68
60min159632-5963214.76814.361.9515.0714.661.96
258791-5879114.55914.87
357384-5738414.21114.51
456981-5698114.11114.40
556780-5678014.06114.34
658364-5836414.45414.74
极限159730-5973014.79214.831.6815.1815.211.71
261463-6146315.22115.61
360717-6071715.03615.41
459083-5908314.63215.00
558830-5883014.56914.92
659595-5959514.75815.13
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