培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10 供试品稀释倍数2系数1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.413995039940400013997540000399730.08
29.574027440263402680.02
单位质量响应值RSD%判断
4247.934207.730.68数据可信
供试品溶液-24050602批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min140844-4084482.42780.3810.4882.4380.3810.48
245375-4537591.57191.57
333186-3318666.97366.97
442552-4255285.87485.87
538812-3881278.32778.33
638214-3821477.12077.12
10min143822-4382288.43786.106.0189.3586.995.98
245559-4555991.94392.96
344160-4416089.11989.86
443454-4345487.69588.65
539596-3959679.90980.78
639378-3937879.46980.33
15min141381-4138183.51183.744.8985.4185.594.92
244454-4445489.71391.75
340938-4093882.61784.35
443274-4327487.33189.26
539276-3927679.26381.02
639652-3965280.02281.76
20min142938-4293886.65383.615.4589.4886.395.41
245192-4519291.20294.24
341276-4127683.29985.95
439545-3954579.80682.70
539495-3949579.70582.34
640126-4012680.97883.61
30min142378-4237885.52385.513.4889.3189.223.55
244747-4474790.30494.35
341607-4160783.96787.55
443391-4339187.56791.35
540852-4085282.44485.97
641255-4125583.25786.79
45min142564-4256485.89887.052.6390.6491.712.72
244771-4477190.35295.41
342967-4296786.71291.22
444265-4426589.33194.09
542156-4215685.07589.52
642072-4207284.90689.36
极限145570-4557091.96591.811.3397.6697.441.08
244469-4446989.74395.80
346237-4623793.31198.79
445611-4561192.04897.80
545240-4524091.29996.68
645844-4584492.51897.92
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106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8000
标示量(mg)2.5 供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.254203642083420294208042123420700.10
214.164237742363423700.03
单位质量响应值RSD%判断
2952.282992.230.96数据可信
供试品溶液-24050602批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min143529-4352992.47094.832.8092.4794.832.80
245991-4599197.70197.70
344178-4417893.84993.85
444604-4460494.75494.75
546258-4625898.26898.27
643273-4327391.92791.93
10min145700-4570097.08297.081.7698.1198.141.76
246368-4636898.50199.59
345686-4568697.05398.10
445309-4530996.25297.30
546702-4670299.211100.30
644435-4443594.39595.42
15min145196-4519696.01295.981.6198.1298.111.62
245838-4583897.37599.56
344650-4465094.85296.97
445113-4511395.83597.96
546117-4611797.968100.16
644161-4416193.81395.88
20min145015-4501595.62795.201.7298.8098.401.72
245683-4568397.046100.31
344071-4407193.62296.80
444557-4455794.65497.84
545648-4564896.972100.25
643899-4389993.25696.37
30min144773-4477395.11394.741.9899.3598.991.97
245130-4513095.871100.21
343614-4361492.65196.87
444372-4437294.26198.50
545944-4594497.601101.96
643741-4374192.92197.07
45min143906-4390693.27193.952.4498.5699.262.41
245038-4503895.676101.08
343528-4352892.46897.71
444353-4435394.22199.51
545767-4576797.225102.67
642753-4275390.82296.00
极限143847-4384793.14692.771.7899.4799.121.79
244152-4415293.794100.26
343558-4355892.53298.80
443239-4323991.85498.19
544736-4473695.034101.56
642481-4248190.24496.43
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10 供试品稀释倍数2系数1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.413999739980399873998839978399860.02
29.574011740178401480.11
单位质量响应值RSD%判断
4249.314195.190.91数据可信
供试品溶液-24050602批-培哚普利-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%
5min137773-3777376.33280.915.1576.3380.915.15
242581-4258186.04886.05
338530-3853077.86277.86
442577-4257786.04086.04
539262-3926279.34179.34
639505-3950579.83279.83
10min144159-4415989.23785.934.3390.0886.824.30
243544-4354487.99488.95
339914-3991480.65881.52
442970-4297086.83487.79
540525-4052581.89382.77
644012-4401288.94089.83
15min144401-4440189.72686.303.6291.5788.163.60
243370-4337087.64289.58
340334-4033481.50783.27
443078-4307887.05288.97
541346-4134683.55285.34
643710-4371088.32990.20
20min144140-4414089.19886.563.1392.0389.383.11
243015-4301586.92589.83
340252-4025281.34184.01
443080-4308087.05689.94
543025-4302586.94589.67
643505-4350587.91590.77
30min144223-4422389.36687.123.0793.1990.893.03
243158-4315887.21491.09
340564-4056481.97285.54
443215-4321587.32991.18
544041-4404188.99892.68
643467-4346787.83891.67
45min144568-4456890.06387.982.5194.8892.722.50
243160-4316087.21892.06
341607-4160784.08088.56
444308-4430889.53894.36
544185-4418589.28993.96
643405-4340587.71392.52
极限145809-4580992.57191.722.0898.3997.442.03
245533-4553392.01397.82
344817-4481790.56695.98
446794-4679494.562100.38
545390-4539091.72497.39
643991-4399188.89794.68
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106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8000
标示量(mg)2.5 供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.254210342067421174200642060420710.11
214.164218842192421900.01
单位质量响应值RSD%判断
2952.352979.520.65数据可信
供试品溶液-24050602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%
5min136601-3660177.91774.484.6977.9274.484.69
234327-3432773.07673.08
333031-3303170.31770.32
434151-3415172.70172.70
537354-3735479.52079.52
634467-3446773.37473.37
10min141888-4188889.17286.193.7590.0487.023.76
239593-3959384.28685.10
338586-3858682.14282.92
440281-4028185.75186.56
542667-4266790.83091.71
639922-3992284.98785.80
15min142073-4207389.56687.443.7691.4289.223.77
240138-4013885.44687.19
339515-3951584.12085.81
441069-4106987.42889.19
543617-4361792.85394.75
640022-4002285.19986.96
20min141746-4174688.87087.274.1891.7290.034.17
239683-3968384.47887.18
339400-3940083.87586.50
441277-4127787.87190.60
543930-4393093.51996.44
639939-3993985.02387.73
30min141546-4154688.44487.034.7392.2890.754.69
239595-3959584.29087.93
338661-3866182.30285.86
441374-4137488.07891.79
544128-4412893.94097.90
639976-3997685.10288.75
45min141674-4167488.71686.844.7693.5491.544.72
239314-3931483.69288.27
338937-3893782.89087.36
441358-4135888.04492.73
544004-4400493.67698.68
639475-3947584.03588.63
极限142743-4274390.99288.823.9096.8094.483.91
240838-4083886.93792.44
340235-4023585.65391.05
442332-4233290.11795.78
544153-4415393.994100.04
640029-4002985.21490.74
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10 供试品稀释倍数2系数1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.414009040121400694008740120400970.06
29.574009140172401320.15
单位质量响应值RSD%判断
4261.114193.521.14数据可信
供试品溶液-24050602批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min149208-4920899.323101.801.5899.32101.801.58
251565-51565104.080104.08
350118-50118101.160101.16
450400-50400101.729101.73
550361-50361101.650101.65
650947-50947102.833102.83
10min149213-4921399.333101.781.46100.44102.911.46
251524-51524103.998105.15
350432-50432101.794102.92
450405-50405101.739102.87
550583-50583102.098103.23
650383-50383101.695102.84
15min149093-4909399.091101.381.35101.30103.641.35
251043-51043103.027105.34
350534-50534101.999104.25
450412-50412101.753104.01
549830-49830100.578102.84
650442-50442101.814104.09
20min148692-4869298.281100.031.13101.59103.421.14
250423-50423101.775105.23
349517-4951799.947103.34
449512-4951299.937103.33
549426-4942699.763103.14
649768-49768100.453103.86
30min147871-4787196.62498.391.44101.02102.891.43
249968-49968100.857105.44
348491-4849197.876102.37
448950-4895098.802103.30
548456-4845697.805102.30
648747-4874798.393102.91
45min147355-4735595.58397.261.40101.06102.861.39
249215-4921599.337105.05
348548-4854897.991103.58
448433-4843397.759103.36
547816-4781696.513102.09
647755-4775596.390102.00
极限146681-4668194.22296.682.24100.76103.352.16
249164-4916499.234106.05
347036-4703694.939101.61
448590-4859098.076104.76
547118-4711895.104101.75
648793-4879398.485105.17
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106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8000
标示量(mg)2.5 供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.254204541992421164207942073420610.11
214.164209042070420800.04
单位质量响应值RSD%判断
2951.652971.750.48数据可信
供试品溶液-24050602批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min144188-4418894.20296.331.5694.2096.331.56
246136-4613698.35598.35
344793-4479395.49195.49
444864-4486495.64395.64
545474-4547496.94396.94
645671-4567197.36397.36
10min144675-4467595.24096.611.1196.2997.681.12
246132-4613298.34699.44
345169-4516996.29397.35
445056-4505696.05297.11
545617-4561797.24898.33
645255-4525596.47697.56
15min144518-4451894.90596.260.9597.0198.400.95
245784-4578497.60499.79
345356-4535696.69298.82
445165-4516596.28598.41
544881-4488195.67997.84
645205-4520596.37098.52
20min144204-4420494.23695.190.6397.4098.410.65
245061-4506196.06399.33
344597-4459795.07498.28
444579-4457995.03598.24
544693-4469395.27898.50
644785-4478595.47498.70
30min142898-4289891.45293.131.3595.6697.401.33
244630-4463095.14499.48
343304-4330492.31796.58
443905-4390593.59897.85
543619-4361992.98997.27
643752-4375293.27297.56
45min142910-4291091.47792.280.9196.7097.580.91
243972-4397293.74199.14
343426-4342692.57797.86
443358-4335892.43297.73
543035-4303591.74497.06
643013-4301391.69797.02
极限142329-4232990.23991.931.9096.4898.261.83
243939-4393993.671100.11
342192-4219289.94796.26
443636-4363693.02599.35
542677-4267790.98197.31
643969-4396993.735100.08
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10 供试品稀释倍数2系数1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.414016540181401774019940233401910.07
29.574014340227401850.15
单位质量响应值RSD%判断
4271.094199.061.21数据可信
供试品溶液-24050602批-培哚普利-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%
5min151477-51477103.713100.612.41103.71100.612.41
251069-51069102.891102.89
348132-4813296.97496.97
449703-49703100.139100.14
549473-4947399.67699.68
649758-49758100.250100.25
10min151062-51062102.877100.491.79104.03101.611.79
250437-50437101.618102.76
348455-4845597.62598.70
450117-50117100.973102.09
549622-4962299.976101.08
649577-4957799.885101.00
15min150491-50491101.72799.151.76104.02101.381.76
249373-4937399.474101.75
347894-4789496.49498.66
449514-4951499.758101.99
548731-4873198.181100.40
649271-4927199.269101.49
20min150251-50251101.24398.741.82104.67102.081.82
249618-4961899.968103.35
347617-4761795.93699.17
448936-4893698.594101.94
548773-4877398.265101.57
648857-4885798.435101.76
30min148889-4888998.49996.361.94103.05100.791.94
248695-4869598.108102.60
346388-4638893.46097.76
448058-4805896.825101.26
547397-4739795.49399.89
647531-4753195.763100.18
45min148149-4814997.00895.341.89102.65100.841.87
247415-4741595.529101.11
345583-4558391.83897.18
447715-4771596.134101.65
547463-4746395.626101.09
647602-4760295.906101.39
极限148208-4820897.12794.642.41103.85101.212.37
247206-4720695.108101.75
344863-4486390.38896.75
447509-4750995.719102.30
546877-4687794.445100.97
647193-4719395.082101.63
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106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8000
标示量(mg)2.5 供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.254200341886420264194342072419860.18
214.164209342063420780.06
单位质量响应值RSD%判断
2946.392971.610.61数据可信
供试品溶液-24050602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%
5min144657-4465795.28995.361.6495.2995.361.64
245662-4566297.43497.43
345472-4547297.02897.03
443817-4381793.49793.50
544268-4426894.45994.46
644264-4426494.45194.45
10min145141-4514196.32295.791.8097.3896.851.79
245271-4527196.59997.68
346205-4620598.59299.67
444115-4411594.13395.17
544436-4443694.81895.87
644189-4418994.29195.34
15min144603-4460395.17494.741.8897.3096.861.87
244614-4461495.19797.35
345819-4581997.76999.94
443565-4356592.95995.04
543618-4361893.07295.18
644183-4418394.27896.37
20min144431-4443194.80794.421.6097.9997.601.61
244827-4482795.65298.87
345250-4525096.55499.81
443387-4338792.57995.70
543835-4383593.53596.67
643781-4378193.42096.56
30min142726-4272691.16991.851.8795.4196.081.86
243924-4392493.72598.00
344210-4421094.33598.67
442373-4237390.41694.56
542499-4249990.68494.86
642553-4255390.80094.98
45min142736-4273691.19091.541.0896.4496.781.10
242968-4296891.68597.00
343778-4377893.41498.79
442460-4246090.60195.75
542751-4275191.22296.41
642702-4270291.11896.31
极限142836-4283691.40391.380.8697.6797.640.90
243084-4308491.93398.27
343391-4339192.58899.01
442645-4264590.99697.15
542626-4262690.95597.15
642365-4236590.39896.60
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