培哚普利吲达帕胺片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号S2561对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.259844359850159856929858189851099852140.06
210.529996579882819939690.81
单位质量响应值RSD%判断
96118.4494483.751.22数据可信
稳定性考察-长期36月-供试品溶液-202211批-尚未录入-盐酸(pH1.0)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1112491-11249111.80515.4738.6011.8015.4738.61
2217325-21732522.80622.81
3108169-10816911.35111.35
4114803-11480312.04712.05
5107522-10752211.28311.28
6224062-22406223.51323.51
10min1534244-53424456.06357.183.2756.0957.213.29
2556645-55664558.41358.46
3525579-52557955.15355.18
4537037-53703756.35656.38
5541153-54115356.78856.81
6574606-57460660.29860.35
15min1694807-69480772.91273.421.7473.0573.571.76
2706876-70687674.17874.34
3679495-67949571.30571.44
4699750-69975073.43173.57
5701633-70163373.62873.76
6715558-71555875.08975.26
20min1789127-78912782.81082.651.0583.0982.951.07
2788097-78809782.70283.01
3773860-77386081.20881.48
4788490-78849082.74383.03
5786526-78652682.53782.82
6799779-79977983.92784.25
30min1887287-88728793.11093.141.2893.5693.601.29
2893867-89386793.80194.28
3867020-86702090.98491.42
4889199-88919993.31193.76
5886997-88699793.08093.53
6900892-90089294.53895.02
45min1958879-958879100.623100.491.52101.26101.131.52
2966170-966170101.388102.05
3929590-92959097.55098.17
4962652-962652101.019101.65
5957965-957965100.527101.16
6970415-970415101.834102.51
60min1994035-994035104.312103.981.66105.15104.831.67
2999011-999011104.835105.70
3959021-959021100.638101.45
4992068-992068104.106104.94
5994981-994981104.412105.25
61006258-1006258105.595106.47
培哚普利吲达帕胺片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号S2561对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.2599930299982410003279975699991539992350.11
210.521008734100916310089480.04
单位质量响应值RSD%判断
97486.3495907.601.16数据可信
稳定性考察-长期36月-供试品溶液-202211批-尚未录入-盐酸(pH1.2)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1118125-11812512.21714.4846.7312.2214.4846.74
2218770-21877022.62622.63
345748-457484.7314.73
495742-957429.9029.90
5164614-16461417.02517.02
6197264-19726420.40220.40
10min1552571-55257157.14854.4210.7757.1754.4410.78
2567111-56711158.65258.70
3413776-41377642.79442.80
4555194-55519457.42057.44
5539429-53942955.78955.82
6528790-52879054.68954.73
15min1700237-70023772.42070.853.9772.5670.993.99
2700100-70010072.40672.57
3634763-63476365.64965.74
4709046-70904673.33173.47
5691031-69103171.46871.61
6675048-67504869.81569.97
20min1780749-78074980.74779.791.9681.0380.071.97
2774024-77402480.05280.36
3749357-74935777.50177.73
4792455-79245581.95882.24
5771563-77156379.79780.09
6760985-76098578.70378.99
30min1881431-88143191.16090.281.3391.6190.721.32
2863574-86357489.31389.78
3874253-87425390.41890.80
4889463-88946391.99192.44
5870936-87093690.07590.52
6857881-85788188.72489.17
45min1948700-94870098.11797.521.8498.7498.141.81
2928030-92803095.97996.63
3965845-96584599.890100.45
4957632-95763299.04199.67
5935518-93551896.75497.38
6921880-92188095.34395.97
60min1984543-984543101.824101.201.80102.65102.021.77
2958463-95846399.12799.96
31001800-1001800103.609104.37
4993216-993216102.721103.55
5972340-972340100.562101.38
6960840-96084099.373100.19
培哚普利吲达帕胺片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号S2561对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.251004049100467710069161003004100154810040390.20
210.521016281101429610152880.14
单位质量响应值RSD%判断
97955.0296510.271.06数据可信
稳定性考察-长期36月-供试品溶液-202211批-尚未录入-盐酸(pH1.5)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1193151-19315119.86615.4530.0019.8715.4530.00
2165514-16551417.02317.02
3126373-12637312.99813.00
470899-708997.2927.29
5162753-16275316.73916.74
6182724-18272418.79318.79
10min1612863-61286363.03461.397.8763.0761.427.88
2605519-60551962.27962.31
3612898-61289863.03863.06
4502556-50255651.68951.70
5617009-61700963.46063.49
6630535-63053564.85264.89
15min1748359-74835976.97074.883.2077.1475.033.22
2723704-72370474.43474.59
3728693-72869374.94775.10
4685320-68532070.48670.60
5748726-74872677.00877.17
6733152-73315275.40675.57
20min1808426-80842683.14881.352.0183.4781.652.03
2782824-78282480.51580.82
3786858-78685880.93081.23
4766888-76688878.87679.13
5807785-80778583.08283.40
6792695-79269581.53081.85
30min1876068-87606890.10588.311.8390.5988.781.84
2841641-84164186.56487.03
3850748-85074887.50187.96
4843539-84353986.75987.18
5876688-87668890.16990.65
6863016-86301688.76389.24
45min1926155-92615595.25793.721.6495.9294.371.64
2893799-89379991.92992.57
3897297-89729792.28992.93
4903885-90388592.96693.56
5928144-92814495.46196.12
6918221-91822194.44195.10
60min1959690-95969098.70697.151.3199.5697.981.32
2928487-92848795.49796.32
3939589-93958996.63897.46
4937016-93701696.37497.15
5958485-95848598.58299.43
6944155-94415597.10897.96
培哚普利吲达帕胺片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号S2561对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
110.251017258101652610159111014727101567410160190.10
210.521020270102001010201400.02
单位质量响应值RSD%判断
99123.8096971.481.56数据可信
稳定性考察-长期36月-供试品溶液-202211批-尚未录入-盐酸(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%
5min178077-780777.9649.7060.667.969.7060.66
291705-917059.3549.35
3197773-19777320.17420.17
451207-512075.2235.22
536354-363543.7083.71
6115718-11571811.80411.80
10min1533944-53394454.46458.486.3054.4858.506.31
2595471-59547160.74060.76
3620637-62063763.30763.35
4547400-54740055.83755.85
5543364-54336455.42555.43
6598998-59899861.10061.12
15min1705232-70523271.93674.111.9872.0674.241.99
2747330-74733076.23076.37
3725602-72560274.01474.18
4720323-72032373.47573.60
5724092-72409273.86073.98
6736421-73642175.11875.26
20min1782646-78264679.83381.111.4880.1081.401.48
2815715-81571583.20683.50
3784950-78495080.06880.38
4794676-79467681.06081.33
5796042-79604281.19981.47
6796934-79693481.29081.59
30min1854913-85491387.20488.031.4087.6388.481.39
2881141-88114189.87990.34
3846305-84630586.32686.80
4866482-86648288.38488.82
5868690-86869088.60989.04
6860756-86075687.80088.26
45min1908174-90817492.63793.492.1493.2494.122.12
2940507-94050795.93596.57
3882617-88261790.03090.68
4921811-92181194.02894.64
5923127-92312794.16294.77
6923179-92317994.16894.80
60min1943162-94316296.20696.701.8096.9997.511.78
2965515-96551598.48699.32
3916643-91664393.50194.33
4952138-95213897.12197.92
5957615-95761597.68098.47
6953103-95310397.22098.04
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