依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D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500
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%
19.873293503319313290623288243290203296370.40
29.823290543289923290230.02
单位质量响应值RSD%判断
33397.8733505.400.23数据可信
中间条件6月-供试品溶液-2024012321批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1178494-17849453.35945.5120.8953.3645.5220.89
2105189-10518931.44531.45
3188719-18871956.41656.42
4162989-16298948.72448.72
5152434-15243445.56945.57
6125690-12569037.57437.57
10min1281061-28106184.02075.028.1084.1875.158.12
2225233-22523367.33167.43
3268331-26833180.21580.38
4245442-24544273.37273.52
5246747-24674773.76373.90
6238820-23882071.39371.51
15min1315326-31532694.26387.245.9794.6887.605.98
2288769-28876986.32586.62
3306794-30679491.71392.12
4279764-27976483.63384.00
5292620-29262087.47687.83
6267718-26771880.03280.36
20min1324508-32450897.00891.395.4697.7092.015.47
2307082-30708291.79992.35
3319081-31908195.38696.07
4291707-29170787.20387.82
5311255-31125593.04793.67
6280622-28062283.88984.46
30min1327246-32724697.82794.464.0898.8195.364.10
2319578-31957895.53596.37
3327181-32718197.80798.78
4302088-30208890.30691.18
5322160-32216096.30697.21
6297696-29769688.99389.81
45min1328830-32883098.30095.753.0499.5896.933.07
2322790-32279096.49597.61
3329562-32956298.51999.78
4307085-30708591.80092.95
5324111-32411196.89098.08
6309372-30937292.48493.57
60min1328559-32855998.21996.052.7899.7997.522.81
2323928-32392896.83598.24
3330126-33012698.688100.25
4308849-30884992.32793.75
5324718-32471897.07198.55
6311652-31165293.16594.53
极限1330863-33086398.90899.230.95100.78100.980.98
2330669-33066998.850100.55
3337837-337837100.993102.85
4332976-33297699.540101.24
5329521-32952198.507100.28
6329729-32972998.569100.21
依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D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500
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%
19.873291633292783290843290373292263291580.04
29.823285163286953286060.04
单位质量响应值RSD%判断
33349.3433462.930.25数据可信
中间条件6月-供试品溶液-2024012421批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1151060-15106045.21946.589.8745.2246.589.87
2185036-18503655.39055.39
3147014-14701444.00844.01
4145634-14563443.59543.60
5159394-15939447.71447.71
6145465-14546543.54543.54
10min1278979-27897983.51278.903.3383.6579.043.32
2262089-26208978.45678.62
3255907-25590776.60576.74
4268427-26842780.35380.48
5257815-25781577.17677.32
6258268-25826877.31277.44
15min1322445-32244596.52391.573.6896.9191.943.66
2293473-29347387.85088.25
3301807-30180790.34590.71
4315680-31568094.49894.87
5305501-30550191.45191.83
6296413-29641388.73089.09
20min1329693-32969398.69395.292.8799.3795.942.86
2305923-30592391.57792.24
3317497-31749795.04295.67
4327345-32734597.99098.65
5318162-31816295.24195.89
6311239-31123993.16893.80
30min1333524-33352499.83997.631.85100.8198.571.85
2318072-31807295.21496.15
3325438-32543897.41998.34
4331915-33191599.358100.31
5326983-32698397.88198.82
6320971-32097196.08296.99
45min1334035-33403599.99298.321.29101.2699.551.30
2323343-32334396.79298.02
3327064-32706497.90699.12
4332758-33275899.610100.86
5328402-32840298.30699.53
6325025-32502597.29598.49
60min1333808-33380899.92498.451.16101.5099.981.17
2324115-32411597.02398.54
3327570-32757098.05799.56
4333052-33305299.698101.24
5328235-32823598.25699.78
6326537-32653797.74899.24
极限1334503-334503100.13298.800.90102.00100.620.91
2327219-32721997.95299.76
3327820-32782098.13299.93
4332803-33280399.624101.47
5328307-32830798.278100.10
6329736-32973698.706100.49
依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D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500
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%
19.873290853287803287193288863287863288510.05
29.823294123294233294180.01
单位质量响应值RSD%判断
33318.2433545.620.49数据可信
中间条件6月-供试品溶液-2024012521批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1101818-10181830.45637.0318.4130.4637.0318.40
2110179-11017932.95732.96
3125621-12562137.57637.58
4146740-14674043.89343.89
5103333-10333330.90930.91
6155062-15506246.38246.38
10min1260638-26063877.96280.419.8378.0580.529.83
2261138-26113878.11178.21
3262824-26282478.61678.73
4312397-31239793.44493.58
5233563-23356369.86369.96
6282287-28228784.43784.58
15min1308136-30813692.16993.284.9692.4993.634.98
2319673-31967395.62095.95
3314483-31448394.06894.42
4328106-32810698.14398.55
5283265-28326584.73085.03
6317364-31736494.93095.32
20min1320093-32009395.74696.792.3496.3597.422.36
2333011-33301199.610100.23
3324099-32409996.94497.57
4330509-33050998.86199.57
5312096-31209693.35493.91
6321724-32172496.23496.91
30min1326365-32636597.62298.121.5498.5199.041.53
2336767-336767100.733101.65
3327235-32723597.88298.80
4330558-33055898.87699.88
5324398-32439897.03497.87
6322851-32285196.57197.54
45min1328616-32861698.29598.601.3999.4899.821.39
2337210-337210100.866102.09
3327706-32770698.02399.24
4332339-33233999.409100.71
5327964-32796498.10099.23
6323969-32396996.90598.16
60min1328678-32867898.31498.461.4199.7999.981.39
2337671-337671101.004102.53
3326595-32659597.69199.20
4329646-32964698.603100.20
5328465-32846598.25099.67
6323982-32398296.90998.46
极限1332838-33283899.55899.860.69101.33101.670.69
2338428-338428101.230103.06
3333003-33300399.607101.41
4333504-33350499.757101.65
5333181-33318199.661101.38
6332081-33208199.332101.17
依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D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500
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%
19.873280703278453278793277783279053278950.04
29.823283883283413283640.02
单位质量响应值RSD%判断
33221.3833438.290.47数据可信
中间条件6月-供试品溶液-X013576批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1126555-12655537.97135.2127.3037.9735.2127.30
2150131-15013145.04545.04
3157311-15731147.19947.20
485792-8579225.74125.74
599771-9977129.93529.93
684617-8461725.38825.39
10min1268578-26857880.58377.555.8380.7077.655.85
2255781-25578176.74376.88
3274888-27488882.47682.62
4246017-24601773.81473.89
5269091-26909180.73780.83
6236396-23639670.92771.00
15min1302540-30254090.77290.593.0691.1390.933.08
2297179-29717989.16489.53
3311398-31139893.43093.82
4297641-29764189.30389.60
5313567-31356794.08194.41
6289289-28928986.79787.09
20min1309743-30974392.93494.331.4293.5694.941.43
2316884-31688495.07695.71
3315083-31508394.53695.21
4314891-31489194.47895.04
5320832-32083296.26196.87
6308962-30896292.69993.25
30min1312866-31286693.87196.151.5194.7897.051.50
2326833-32683398.06198.98
3320358-32035896.11997.07
4320655-32065596.20897.06
5323983-32398397.20698.11
6318169-31816995.46296.29
45min1314451-31445194.34696.461.4395.5397.641.43
2327222-32722298.17899.39
3321550-32155096.47697.72
4322325-32232596.70997.85
5324988-32498897.50898.70
6318374-31837495.52396.64
60min1315268-31526894.59196.581.3496.0698.051.34
2327344-32734498.21599.72
3321996-32199696.61098.14
4322766-32276696.84198.27
5324976-32497697.50498.99
6319023-31902395.71897.12
极限1317154-31715495.15796.761.0996.9198.521.09
2327472-32747298.253100.05
3322183-32218396.66698.49
4322808-32280896.85498.57
5324595-32459597.39099.17
6320794-32079496.24997.94
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