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%
110.143367593360823361903364193372143365330.14
210.143382363379343380850.07
单位质量响应值RSD%判断
33188.6633341.720.33数据可信
长期3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%
5min1182991-18299155.01050.4315.7055.0150.4315.69
2189446-18944656.95156.95
3121439-12143936.50736.51
4184874-18487455.57655.58
5151773-15177345.62545.63
6175981-17598152.90352.90
10min1300974-30097490.47885.309.2690.6485.459.27
2314668-31466894.59494.77
3250335-25033575.25575.36
4303923-30392391.36491.53
5260757-26075778.38878.52
6271853-27185381.72381.88
15min1309942-30994293.17492.972.9393.6193.382.95
2324773-32477397.63298.09
3304890-30489091.65591.99
4313458-31345894.23194.67
5302210-30221090.84991.22
6300287-30028790.27190.68
20min1309095-30909592.91994.572.0393.6395.252.03
2324945-32494597.68498.43
3316920-31692095.27195.88
4317024-31702495.30396.03
5311567-31156793.66294.31
6307929-30792992.56893.24
30min1308126-30812692.62895.622.0993.6296.582.07
2325852-32585297.95699.00
3323856-32385697.35698.25
4317915-31791595.57096.58
5319513-31951396.05196.98
6313123-31312394.13095.08
45min1308820-30882092.83696.162.0194.1197.421.99
2327035-32703598.31299.65
3324703-32470397.61198.80
4318894-31889495.86597.16
5321959-32195996.78698.00
6317938-31793895.57796.81
60min1308941-30894192.87396.292.2094.4297.832.17
2328711-32871198.816100.45
3325925-32592597.97899.46
4318841-31884195.84997.43
5322209-32220996.86198.37
6317185-31718595.35196.87
极限1322005-32200596.80098.121.6198.6399.961.62
2335317-335317100.802102.73
3326921-32692198.278100.05
4328951-32895198.888100.76
5323624-32362497.28799.08
6321575-32157596.67198.48
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%
110.143361383383343374883384753384853377840.30
210.143361533376123368820.31
单位质量响应值RSD%判断
33312.0333223.080.19数据可信
长期3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%
5min1151211-15121145.45347.579.4545.4547.579.45
2184488-18448855.45655.46
3141880-14188042.64842.65
4164285-16428549.38349.38
5157946-15794647.47847.48
6149629-14962944.97844.98
10min1288274-28827486.65383.825.5786.7983.965.57
2282626-28262684.95685.12
3261692-26169278.66378.79
4300048-30004890.19390.34
5259977-25997778.14778.29
6280475-28047584.30984.44
15min1309417-30941793.00993.452.8493.4193.852.84
2308097-30809792.61293.03
3308593-30859392.76193.13
4326928-32692898.27398.69
5300143-30014390.22190.60
6312144-31214493.82994.22
20min1310283-31028393.26995.901.9393.9496.571.92
2315554-31555494.85495.55
3319256-31925695.96696.61
4328750-32875098.82099.53
5321381-32138196.60597.25
6318920-31892095.86596.53
30min1314242-31424294.45996.961.8895.4197.921.87
2318675-31867595.79296.78
3321563-32156396.66097.59
4330603-33060399.377100.39
5328317-32831798.69099.63
6321993-32199396.78997.75
45min1318443-31844395.72297.371.4896.9698.631.48
2320529-32052996.34997.62
3322033-32203396.80198.02
4330736-33073699.417100.73
5328625-32862598.783100.02
6323262-32326297.17198.42
60min1319805-31980596.13197.661.4397.6699.201.43
2321049-32104996.50598.07
3322510-32251096.94498.45
4331912-33191299.771101.38
5328220-32822098.661100.19
6325793-32579397.93199.47
极限1326783-32678398.22999.372.55100.04101.212.54
2323240-32324097.16499.01
3325350-32535097.79899.60
4346530-346530104.165106.07
5329356-32935699.002100.83
6332207-33220799.859101.69
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%
110.143365163397943390593385783394553386800.39
210.143367503378883373190.24
单位质量响应值RSD%判断
33400.3933266.170.29数据可信
长期3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%
5min1158771-15877147.63244.8417.1647.6344.8417.16
2142943-14294342.88342.88
3182153-18215354.64654.65
4144890-14489043.46743.47
5162206-16220648.66248.66
6105808-10580831.74331.74
10min1288605-28860586.58280.639.5886.7280.769.59
2229419-22941968.82668.95
3291019-29101987.30687.47
4276732-27673283.02083.15
5282802-28280284.84184.99
6243940-24394073.18273.28
15min1317221-31722195.16791.505.4895.5791.875.49
2272970-27297081.89182.23
3317376-31737695.21395.64
4309350-30935092.80693.18
5311089-31108993.32793.73
6301895-30189590.56990.88
20min1321436-32143696.43194.263.1397.1294.913.14
2296516-29651688.95589.54
3320525-32052596.15896.87
4310472-31047293.14293.80
5314002-31400294.20194.88
6322161-32216196.64997.24
30min1320075-32007596.02395.592.1997.0096.522.17
2312938-31293893.88294.73
3324038-32403897.21298.21
4309496-30949692.84993.79
5316954-31695495.08796.05
6328222-32822298.46799.34
45min1320659-32065996.19896.221.9497.4697.441.92
2320845-32084596.25497.38
3326748-32674898.02599.32
4310731-31073193.22094.44
5317729-31772995.31996.57
6327679-32767998.30499.48
60min1319833-31983395.95096.441.9497.5097.951.92
2322434-32243496.73198.15
3327638-32763898.29299.88
4310793-31079393.23894.73
5320520-32052096.15797.69
6327552-32755298.26699.73
极限1335096-335096100.52999.301.28102.37101.101.26
2336488-336488100.947102.66
3331321-33132199.397101.28
4325361-32536197.60999.38
5329421-32942198.827100.65
6328210-32821098.464100.23
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