盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
111.062347572352212355152352502361922353870.23
211.092354222351902353060.07
单位质量响应值RSD%判断
21282.7321217.850.22数据可信
供试品溶液-770ABI批-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%
5min1193051-19305181.59881.472.3181.6081.472.31
2190316-19031680.44280.44
3196204-19620482.93182.93
4197285-19728583.38883.39
5185181-18518178.27278.27
6194454-19445482.19182.19
10min1208504-20850488.13087.992.6888.2788.122.68
2205731-20573186.95887.09
3212490-21249089.81589.95
4214057-21405790.47790.62
5198488-19848883.89684.03
6209720-20972088.64488.78
15min1214205-21420590.54090.502.4990.8290.782.49
2211204-21120489.27189.55
3218759-21875992.46592.75
4219421-21942192.74493.03
5205133-20513386.70586.98
6215901-21590191.25791.54
20min1217594-21759491.97292.112.3292.4192.552.32
2215223-21522390.97091.40
3222382-22238293.99694.44
4223509-22350994.47294.92
5209717-20971788.64389.06
6219107-21910792.61293.05
30min1220885-22088593.36393.712.2593.9594.302.25
2219119-21911992.61793.20
3226107-22610795.57096.17
4227118-22711895.99896.60
5213628-21362890.29690.86
6223351-22335194.40595.00
极限1224281-22428194.79994.942.0795.5495.682.07
2222236-22223693.93494.67
3228695-22869596.66497.42
4229873-22987397.16297.92
5217107-21710791.76692.48
6225497-22549795.31396.06
盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
111.062351892347472350862347302344912348490.13
211.092344182350462347320.19
单位质量响应值RSD%判断
21234.0921166.100.23数据可信
供试品溶液-770ABI批-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%
5min1191283-19128381.04281.661.0881.0481.661.08
2194762-19476282.51682.52
3189243-18924380.17880.18
4193892-19389282.14882.15
5193271-19327181.88581.88
6193979-19397982.18582.18
10min1208185-20818588.20488.531.0588.3488.671.04
2211522-21152289.61789.75
3205118-20511886.90487.04
4209498-20949888.76088.90
5209389-20938988.71488.85
6210089-21008989.01089.15
15min1214509-21450990.88390.971.0791.1691.251.07
2216502-21650291.72792.01
3210343-21034389.11889.40
4215612-21561291.35091.64
5214831-21483191.01991.30
6216468-21646891.71392.00
20min1218822-21882292.71092.611.0793.1493.051.08
2220064-22006493.23693.68
3213998-21399890.66691.09
4219050-21905092.80793.24
5219178-21917892.86193.30
6220456-22045693.40293.84
30min1223780-22378094.81194.381.1995.4094.971.18
2224546-22454695.13595.73
3217570-21757092.18092.76
4223078-22307894.51395.11
5223079-22307994.51495.10
6224555-22455595.13995.73
极限1226171-22617195.82495.081.2096.5795.831.19
2227507-22750796.39097.14
3220241-22024193.31194.04
4224775-22477595.23295.98
5225474-22547495.52896.28
6222323-22232394.19394.95
盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
111.062349682346862348722345002348262347700.08
211.092345902348042346970.07
单位质量响应值RSD%判断
21226.9421162.940.22数据可信
供试品溶液-771ABI批-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%
5min1188645-18864579.94480.001.4179.9480.001.41
2190447-19044780.70880.71
3184198-18419878.06078.06
4191617-19161781.20481.20
5187586-18758679.49579.50
6190160-19016080.58680.59
10min1205240-20524086.97786.571.4087.1186.701.40
2206230-20623087.39687.53
3199735-19973584.64484.77
4206142-20614287.35987.49
5201747-20174785.49785.63
6206586-20658687.54787.68
15min1210836-21083689.34889.351.4589.6389.631.45
2212348-21234889.98990.27
3206367-20636787.45487.73
4214219-21421990.78291.06
5208140-20814088.20688.48
6213142-21314290.32690.61
20min1214405-21440590.86190.821.4791.2991.241.47
2216841-21684191.89392.32
3209222-20922288.66489.08
4216761-21676191.85992.29
5211951-21195189.82190.24
6216608-21660891.79492.23
30min1219413-21941392.98392.671.3393.5693.251.33
2220698-22069893.52894.11
3213864-21386490.63291.20
4221182-22118293.73394.32
5216510-21651091.75392.32
6220410-22041093.40693.99
极限1221090-22109093.69493.761.4194.4394.501.41
2223971-22397194.91595.65
3216078-21607891.57092.29
4223783-22378394.83595.58
5219310-21931092.93993.66
6223269-22326994.61795.36
盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
111.062351522351832356712351082350322352290.11
211.092345762346492346120.03
单位质量响应值RSD%判断
21268.4421155.280.38数据可信
供试品溶液-771ABI批-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%
5min1185139-18513978.39680.081.8878.4080.081.88
2188430-18843079.79079.79
3184963-18496378.32278.32
4193125-19312581.77881.78
5190697-19069780.75080.75
6192382-19238281.46381.46
10min1203319-20331986.09487.211.4986.2387.341.49
2206796-20679687.56787.70
3201628-20162885.37885.51
4209643-20964388.77288.91
5205809-20580987.14987.28
6208533-20853388.30288.44
15min1209666-20966688.78289.891.2989.0690.171.29
2213031-21303190.20790.49
3208295-20829588.20288.47
4214658-21465890.89691.18
5212922-21292290.16190.44
6215085-21508591.07791.36
20min1213975-21397590.60791.411.1891.0391.841.18
2216747-21674791.78192.21
3212091-21209189.80990.23
4218348-21834892.45892.89
5215541-21554191.27091.70
6218551-21855192.54492.98
30min1218685-21868592.60193.161.1493.1793.741.14
2220735-22073593.46994.05
3215830-21583091.39291.96
4222845-22284594.36394.95
5220049-22004993.17993.76
6221852-22185293.94294.53
极限1221057-22105793.60694.291.2894.3395.031.29
2223511-22351194.64595.38
3217857-21785792.25192.97
4225332-22533295.41696.16
5223021-22302194.43795.17
6225302-22530295.40396.15
盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
111.062352842356182358622351982354702354860.12
211.092346002349902347950.12
单位质量响应值RSD%判断
21291.6821171.780.40数据可信
供试品溶液-790ACE批-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%
5min1177739-17773975.19278.262.2875.1978.262.28
2190752-19075280.69880.70
3185812-18581278.60878.61
4186227-18622778.78378.78
5184402-18440278.01178.01
6185016-18501678.27178.27
10min1195481-19548182.69885.242.1282.8285.372.12
2208025-20802588.00588.14
3201877-20187785.40485.53
4202738-20273885.76885.90
5198416-19841683.94084.07
6202447-20244785.64585.78
15min1200060-20006084.63587.982.5984.9088.252.59
2215232-21523291.05491.33
3210033-21003388.85489.13
4209062-20906288.44488.72
5203464-20346486.07586.35
6209916-20991688.80589.08
20min1204528-20452886.52589.622.3286.9390.042.32
2218810-21881092.56793.00
3213690-21369090.40190.82
4212578-21257889.93190.35
5208330-20833088.13488.55
6213190-21319090.19090.61
30min1209349-20934988.56591.702.1789.1192.262.17
2223010-22301094.34494.93
3218349-21834992.37292.94
4218115-21811592.27392.84
5213602-21360290.36490.92
6218075-21807592.25792.83
极限1212390-21239089.85193.022.1790.5593.742.17
2226640-22664095.88096.62
3221526-22152693.71694.44
4220044-22004493.08993.81
5217382-21738291.96392.67
6221362-22136293.64794.37
盐酸奥洛他定口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101098-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
111.062349352347092350942346762346952348220.08
211.092360802355572358180.16
单位质量响应值RSD%判断
21231.6521264.020.11数据可信
供试品溶液-790ACE批-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%
5min1189997-18999780.31776.224.2480.3276.224.25
2171870-17187072.65472.65
3174013-17401373.56073.56
4176330-17633074.53974.54
5180860-18086076.45476.45
6188748-18874879.78979.79
10min1207678-20767887.79183.943.3887.9284.063.38
2192836-19283681.51781.64
3192540-19254081.39281.51
4194357-19435782.16082.28
5198031-19803183.71383.84
6205961-20596187.06587.20
15min1214571-21457190.70586.723.5090.9886.993.50
2199054-19905484.14584.40
3198527-19852783.92284.18
4201083-20108385.00385.26
5204179-20417986.31286.58
6213510-21351090.25690.53
20min1219693-21969392.87088.513.6293.3088.923.63
2203193-20319385.89586.29
3202812-20281285.73486.13
4204576-20457686.48086.88
5208043-20804387.94588.36
6218018-21801892.16292.59
30min1223912-22391294.65390.303.7095.2490.863.70
2207568-20756887.74488.28
3207225-20722587.59988.14
4207979-20797987.91888.47
5211696-21169689.48990.05
6223234-22323494.36794.95
极限1228348-22834896.52991.773.8597.2792.483.85
2210433-21043388.95589.64
3210175-21017588.84689.53
4211216-21121689.28689.98
5215636-21563691.15591.86
6226737-22673795.84896.59
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