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%
110.722228472228872228432228062223392227440.11
210.772224452227192225820.09
单位质量响应值RSD%判断
20778.3620666.850.39数据可信
供试品溶液-2025041521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%
5min1181692-18169278.75379.371.1378.7579.371.13
2183305-18330579.45279.45
3180116-18011678.07078.07
4182915-18291579.28379.28
5185013-18501380.19380.19
6185673-18567380.47980.48
10min1200106-20010686.73587.211.1786.8787.351.17
2201547-20154787.35987.49
3197325-19732585.52985.66
4201231-20123187.22287.35
5203816-20381688.34388.48
6203236-20323688.09188.23
15min1207463-20746389.92390.431.1390.2090.711.13
2209892-20989290.97691.25
3204774-20477488.75889.03
4208285-20828590.28090.56
5209941-20994190.99791.28
6211464-21146491.65891.94
20min1211811-21181191.80892.271.1592.2392.701.15
2213754-21375492.65093.08
3208562-20856290.40090.82
4213098-21309892.36692.79
5214775-21477593.09393.53
6215274-21527493.30993.74
30min1216707-21670793.93094.351.2694.5194.931.25
2218254-21825494.60195.18
3212913-21291392.28692.86
4218159-21815994.55995.14
5218890-21889094.87695.46
6221067-22106795.82096.41
极限1220004-22000495.35995.791.3896.0996.531.38
2222086-22208696.26297.00
3215658-21565893.47594.20
4221302-22130295.92296.66
5222244-22224496.33097.08
6224697-22469797.39398.14
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%
110.722217792217962211142215112213682215140.13
210.772216922221602219260.15
单位质量响应值RSD%判断
20663.6220605.940.20数据可信
供试品溶液-2025041521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%
5min1185680-18568080.82480.751.0580.8280.751.05
2185809-18580980.88080.88
3186956-18695681.37981.38
4185965-18596580.94880.95
5186913-18691381.36081.36
6181726-18172679.10379.10
10min1203819-20381988.71988.760.8488.8588.900.84
2203116-20311688.41388.55
3205972-20597289.65789.79
4204677-20467789.09389.23
5204866-20486689.17589.31
6201053-20105387.51587.65
15min1213301-21330192.84792.101.1593.1392.381.15
2210937-21093791.81892.10
3213612-21361292.98293.27
4212978-21297892.70692.99
5211534-21153492.07892.36
6207142-20714290.16690.44
20min1216641-21664194.30193.830.9394.7494.260.93
2214958-21495893.56894.00
3217169-21716994.53094.97
4216139-21613994.08294.52
5216614-21661494.28994.73
6211799-21179992.19392.62
30min1221992-22199296.63095.751.0897.2296.341.08
2219092-21909295.36895.96
3221920-22192096.59997.20
4220063-22006395.79096.38
5221024-22102496.20996.80
6215710-21571093.89594.48
极限1225078-22507897.97397.171.0798.7397.921.07
2223122-22312297.12297.87
3225061-22506197.96698.72
4222813-22281396.98797.74
5224542-22454297.74098.50
6218789-21878995.23695.97
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%
110.722221602225752225272222852223622223820.08
210.772210662217982214320.24
单位质量响应值RSD%判断
20744.5920560.070.64数据可信
供试品溶液-2025041621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%
5min1175840-17584076.47777.971.4576.4877.971.44
2178285-17828577.54077.54
3178234-17823477.51877.52
4183625-18362579.86379.86
5179826-17982678.21178.21
6179792-17979278.19678.20
10min1194033-19403384.38986.082.1184.5286.212.11
2196655-19665585.53085.66
3193311-19331184.07584.20
4202113-20211387.90488.04
5197962-19796286.09886.23
6203494-20349488.50488.63
15min1200790-20079087.32889.382.3387.6089.652.33
2203575-20357588.53988.81
3201675-20167587.71387.98
4213962-21396293.05793.34
5206490-20649089.80790.08
6206545-20654589.83190.11
20min1205837-20583789.52391.111.7989.9491.531.78
2209158-20915890.96891.39
3205534-20553489.39289.81
4215754-21575493.83694.27
5210385-21038591.50191.92
6210183-21018391.41391.84
30min1211036-21103691.78493.432.0492.3594.002.04
2214079-21407993.10893.68
3209763-20976391.23191.80
4222056-22205696.57797.17
5216239-21623994.04794.62
6215725-21572593.82494.40
极限1215378-21537893.67395.692.1494.3996.422.14
2219315-21931595.38596.11
3215269-21526993.62594.34
4227999-22799999.16299.91
5221437-22143796.30897.04
6220643-22064395.96396.70
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%
110.722204372204522200012206202200322203080.13
210.772199032200602199820.06
单位质量响应值RSD%判断
20551.1220425.440.44数据可信
供试品溶液-2025041621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%
5min1180786-18078679.25779.670.7079.2679.670.70
2183333-18333380.37380.37
3182999-18299980.22780.23
4181492-18149279.56679.57
5180020-18002078.92178.92
6181751-18175179.68079.68
10min1201463-20146388.32287.960.9488.4588.100.93
2202071-20207188.58888.72
3202873-20287388.94089.07
4200258-20025887.79387.93
5197797-19779786.71486.85
6199399-19939987.41787.55
15min1209479-20947991.83691.471.0392.1291.741.03
2209937-20993792.03792.32
3211400-21140092.67892.96
4208648-20864891.47291.75
5205562-20556290.11990.39
6206776-20677690.65190.93
20min1213032-21303293.39393.261.2993.8393.691.29
2214845-21484594.18894.62
3216513-21651394.92095.36
4212588-21258893.19993.63
5209559-20955991.87192.30
6209787-20978791.97192.40
30min1217720-21772095.44995.591.0296.0496.181.02
2220095-22009596.49097.08
3221135-22113596.94697.54
4217827-21782795.49696.08
5215837-21583794.62395.20
6215627-21562794.53195.11
极限1222791-22279197.67297.401.1898.4298.141.18
2223771-22377198.10198.85
3226060-22606099.10599.86
4221639-22163997.16797.91
5219151-21915196.07696.81
6219586-21958696.26797.01
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%
110.722218222222322221772217232224232220750.14
210.772215562222052218800.21
单位质量响应值RSD%判断
20715.9520601.670.40数据可信
供试品溶液-2025041821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%
5min1188511-18851181.96182.011.3281.9682.011.32
2187143-18714381.36681.37
3191283-19128383.16683.17
4191761-19176183.37483.37
5187772-18777281.64081.64
6185316-18531680.57280.57
10min1205066-20506689.15989.891.2889.3090.031.28
2205628-20562889.40389.54
3210374-21037491.46791.61
4209637-20963791.14691.29
5205978-20597889.55589.69
6203854-20385488.63288.77
15min1213049-21304992.63093.341.3092.9193.621.30
2213509-21350992.83093.11
3217216-21721694.44194.73
4218910-21891095.17895.47
5213757-21375792.93893.22
6211584-21158491.99392.27
20min1217335-21733594.49395.191.3694.9395.631.36
2217731-21773194.66595.10
3222128-22212896.57797.03
4223051-22305196.97897.43
5217807-21780794.69895.14
6215535-21553593.71194.15
30min1221112-22111296.13597.241.5296.7397.841.51
2222801-22280196.87097.47
3227006-22700698.69899.31
4228211-22821199.22299.83
5223304-22330497.08897.69
6219429-21942995.40496.00
极限1224826-22482697.75098.891.5698.5199.651.56
2227101-22710198.73999.50
3230297-230297100.129100.90
4232798-232798101.216101.99
5226376-22637698.42499.18
6223257-22325797.06897.82
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%
110.722209642217992219272216602217882216280.18
210.772218842219132218980.01
单位质量响应值RSD%判断
20674.2520603.340.25数据可信
供试品溶液-2025041821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%
5min1193107-19310784.04083.111.0684.0483.111.06
2191716-19171683.43583.44
3191123-19112383.17783.18
4192391-19239183.72983.73
5187517-18751781.60881.61
6189932-18993282.65982.66
10min1208919-20891990.92290.351.0691.0690.491.06
2208922-20892290.92391.06
3208579-20857990.77490.91
4209599-20959991.21891.36
5204968-20496889.20289.34
6204649-20464989.06389.20
15min1219098-21909895.35293.771.3895.6494.061.38
2217158-21715894.50794.80
3215811-21581193.92194.21
4216879-21687994.38694.68
5211547-21154792.06592.35
6212269-21226992.38092.67
20min1222085-22208596.65295.571.3197.1096.021.31
2221776-22177696.51796.97
3220284-22028495.86896.31
4221529-22152996.41096.86
5215726-21572693.88494.32
6216260-21626094.11794.56
30min1227427-22742798.97697.641.3099.5998.241.30
2226319-22631998.49499.10
3224555-22455597.72798.33
4226202-22620298.44399.05
5221059-22105996.20596.80
6220553-22055395.98596.58
极限1233381-233381101.56899.781.82102.34100.551.82
2233343-233343101.551102.32
3228447-22844799.420100.19
4231619-231619100.801101.57
5224996-22499697.91898.67
6223898-22389897.44198.20
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