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%
111.694593845892458894586045866458890.07
211.734583145808458200.04
单位质量响应值RSD%判断
3925.493906.220.35数据可信
供试品溶液-24042902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%
5min138888-3888880.25983.772.8480.2683.772.84
240662-4066283.92083.92
340195-4019582.95682.96
440236-4023683.04183.04
541228-4122885.08885.09
642333-4233387.36987.37
10min145245-4524593.37994.651.9193.8295.121.91
246595-4659596.16596.63
345855-4585594.63795.10
444620-4462092.08992.55
545828-4582894.58295.05
647024-4702497.05097.54
15min145955-4595594.84495.071.8795.8196.061.87
246339-4633995.63696.64
346075-4607595.09196.08
444597-4459792.04193.01
546164-4616495.27596.27
647264-4726497.54598.57
20min145380-4538093.65794.631.8595.1596.151.85
245425-4542593.75095.28
345937-4593794.80796.32
445013-4501392.90094.38
545948-4594894.82996.36
647417-4741797.86199.43
30min144985-4498592.84294.742.3994.8596.782.38
246250-4625095.45397.51
346252-4625295.45797.50
444506-4450691.85393.85
545815-4581594.55596.61
647619-4761998.278100.39
45min143395-4339589.56093.623.1792.0996.193.14
245165-4516593.21395.80
345885-4588594.69997.27
444175-4417591.17093.68
546155-4615595.25797.84
647389-4738997.803100.46
60min144620-4462092.08993.252.6695.1196.342.64
245683-4568394.28297.38
345744-4574494.40897.51
443354-4335489.47692.49
544817-4481792.49595.60
646869-4686996.73099.93
极限147812-4781298.676101.361.84102.21104.971.80
248520-48520100.138103.76
349072-49072101.277104.90
450094-50094103.386106.90
549040-49040101.211104.83
650136-50136103.473107.21
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(%)99.70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%
111.223955843961193960153955813957403958080.07
211.303955273950603952940.09
单位质量响应值RSD%判断
35277.0134981.770.60数据可信
供试品溶液-24042902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%
5min1132266-13226633.78532.277.4433.7832.277.45
2138268-13826835.31835.32
3112104-11210428.63528.63
4130221-13022133.26333.26
5125649-12564932.09532.09
6119550-11955030.53730.54
10min1289241-28924173.88174.652.4474.0774.832.44
2300513-30051376.76176.96
3287547-28754773.44973.61
4288041-28804173.57573.76
5302069-30206977.15877.34
6285989-28598973.05173.22
15min1312192-31219279.74480.422.6180.3481.022.61
2318296-31829681.30381.93
3311499-31149979.56780.13
4310259-31025979.25079.84
5329857-32985784.25684.86
6307033-30703378.42679.00
20min1317677-31767781.14581.452.4482.1982.492.44
2318761-31876181.42282.50
3314131-31413180.23981.25
4319575-31957581.63082.66
5333012-33301285.06286.14
6310081-31008179.20580.22
30min1324674-32467482.93283.452.2684.4284.942.26
2328544-32854483.92185.45
3321902-32190282.22483.68
4324079-32407982.78084.27
5340594-34059486.99888.55
6320305-32030581.81683.27
45min1326170-32617083.31484.372.6685.2786.332.65
2333617-33361785.21687.21
3325748-32574883.20685.12
4327706-32770683.70685.65
5346481-34648188.50290.53
6322141-32214182.28584.19
60min1331261-33126184.61585.072.4187.0387.492.41
2334284-33428485.38787.85
3327269-32726983.59585.97
4334799-33479985.51887.93
5346889-34688988.60691.13
6323652-32365282.67185.03
极限1379038-37903896.81898.502.3299.70101.402.31
2383730-38373098.017100.96
3382073-38207397.594100.43
4390169-39016999.662102.55
5401420-401420102.535105.55
6377359-37735996.38999.21
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%
111.694634646328463004642946381463570.11
211.734576445782457730.03
单位质量响应值RSD%判断
3965.533902.221.14数据可信
供试品溶液-24042902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%
5min143456-4345689.28183.244.2589.2883.244.25
238921-3892179.96479.96
339621-3962181.40281.40
439461-3946181.07381.07
539940-3994082.05782.06
641691-4169185.65585.65
10min149322-49322101.33394.554.07101.8395.014.07
244735-4473591.90992.35
344362-4436291.14291.59
445802-4580294.10194.55
544919-4491992.28792.74
646981-4698196.52397.00
15min146302-4630295.12894.652.1796.1995.642.17
244929-4492992.30793.26
345759-4575994.01294.97
445253-4525392.97393.95
546479-4647995.49296.46
647708-4770898.01799.03
20min148459-4845999.56094.733.16101.1596.243.16
244519-4451991.46592.93
344924-4492492.29793.78
446151-4615194.81896.31
545574-4557493.63295.13
647021-4702196.60598.16
30min148968-48968100.60595.503.50102.7597.543.49
244870-4487092.18694.16
345481-4548193.44195.43
446704-4670495.95497.97
545139-4513992.73994.76
647740-4774098.082100.18
45min150017-50017102.76094.744.72105.4697.314.68
244022-4402290.44492.93
344929-4492992.30794.82
445981-4598194.46897.02
544744-4474491.92794.46
646989-4698996.53999.18
60min148877-48877100.41894.253.98103.6997.343.97
244134-4413490.67493.66
344322-4432291.06094.09
445955-4595594.41597.49
544934-4493492.31795.36
647023-4702396.60999.78
极限151067-51067104.918100.502.36108.75104.132.40
248358-4835899.352102.85
347858-4785898.325101.86
448638-4863899.927103.53
548298-4829899.229102.79
649291-49291101.269104.98
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(%)99.70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%
111.224002984003404002283998573995454000540.09
211.303946293949423947860.06
单位质量响应值RSD%判断
35655.4434936.811.44数据可信
供试品溶液-24042902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%
5min1125206-12520631.83330.1911.8031.8330.1911.80
2133788-13378834.01534.02
3114809-11480929.19029.19
494369-9436923.99323.99
5115801-11580129.44229.44
6128433-12843332.65432.65
10min1302442-30244276.89573.952.8777.0774.122.89
2292640-29264074.40374.59
3289033-28903373.48673.65
4279533-27953371.07071.20
5284532-28453272.34172.50
6297010-29701075.51475.70
15min1314079-31407979.85480.351.9780.4680.931.98
2314505-31450579.96280.56
3315685-31568580.26280.83
4310193-31019378.86679.39
5313578-31357879.72680.29
6328142-32814283.42984.03
20min1335387-33538785.27182.392.4686.3283.412.45
2316303-31630380.41981.47
3318064-31806480.86781.88
4324746-32474682.56683.53
5318156-31815680.89081.90
6331618-33161884.31385.38
30min1342898-34289887.18184.682.3688.7086.162.34
2327651-32765183.30484.80
3327764-32776483.33384.80
4337976-33797685.92987.35
5323223-32322382.17883.64
6338804-33880486.14087.67
45min1352435-35243589.60685.412.9291.6187.362.89
2328897-32889783.62185.58
3331071-33107184.17486.10
4339044-33904486.20188.10
5325182-32518282.67784.59
6338879-33887986.15988.17
60min1348412-34841288.58386.381.8991.0988.801.88
2336811-33681185.63388.05
3334841-33484185.13287.53
4345120-34512087.74690.13
5331712-33171284.33786.71
6341524-34152486.83189.32
极限1386369-38636998.23397.390.74101.23100.300.76
2379367-37936796.45399.35
3382114-38211497.151100.02
4380670-38067096.78499.65
5383963-38396397.621100.46
6385828-38582898.096101.07
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