“for system suitability CRS”:我的理解是:在做高效液相色谱时，用于配制system suitability溶液的标准品 (Standards for drug Active or Related Substances/Impurities)。Water R是符合英国药典或欧洲药典中规定的纯化水，具体理化指标要查英国药典或欧洲药典，可以用超纯水Milli-Q Water (达到18.0 megohm-cm)来代替使用。"R" stands for Substance or Solution defined under Reagents in (BP/EP) Pharmacopoeias.R1,R2,R3 或R4加在试剂名称后表示试剂质量级别或要求(例如:液相/气相色谱纯、光谱纯等)不一样。请比较a) 和b):a)在英国药典British Pharmacopoeia Volume IV的附录部分(Appendices)的附录IA(Appendix IA.)的普通试剂( General Reagents)里面:Acetonitrile R1有如下的意思:Acetonitrile R1: Acetonitrile containing not less than 99.9% of C2H3N and complying with the following requirement.Light absorption The absorbance of the reagent being examined at 200 nm, Appendix II B, is not more than 0.10. Use water in the reference cell.b)在EUROPEAN PHARMACOPOEIA 5.0 的4.1.1. Reagents试剂部分参考链接:http://lib.njutcm.edu.cn/yaodian ... 1.1.%20Reagents.pdf)Acetonitrile R1有如下的意思:Complies with the requirements prescribed for acetonitrile R and with the following additional requirements.Content : minimum 99.9 per cent of C2H3N.Absorbance (2.2.25). The absorbance at 200 nm using water R as the compensation liquid is not more than 0.10.Acetonitrile R1不但要满足acetonitrile R的质量要求，还需要满足另外的两个要求(见上面英文的要求)才行。所以acetonitrile R1(如果做液相色谱试验，可以用液相色谱级的ACN来代替;当然如果分析纯ACN的指标达到药典要求，也可使用。)的质量要求与acetonitrile R不同。比较下列试剂:1a)Methanol R1. 1053201.Complies with the requirements prescribed formethanol R and the following additional requirement.Minimum transmittance (2.2.25), determined usingwater R as compensation liquid : 20 per cent at 210 nm,50 per cent at 220 nm, 75 per cent at 230 nm, 95 percent at 250 nm, 98 per cent at 260 nm and at higherwavelengths.1b)Methanol R2. 1053202.Methanol R2 used in liquid chromatography complieswith the following additional requirements.Content : minimum 99.8 per cent of CH4O (Mr 32.04).Absorbance (2.2.25). The absorbance at 225 nm usingwater R as the compensation liquid is not more than 0.17.2a)Water. 1095500. [7732-18-5].See Purified water (0008).2b) Water R1. 1095508.Prepared from distilled water R by multiple distillation.Remove carbon dioxide by boiling for at least 15 minbefore use in a boiling flask of fused silica or borosilicateglass and cool. Any other suitable method may be used.The boiling flask has been already used for the test orhas been filled with water R and kept in an autoclave at121 °C for at least 1 h prior to first use. When testedimmediately before use, water R1 is neutral to methylred solution R, i.e. it shall produce an orange-red (not aviolet-red or yellow) colour corresponding to pH 5.5 ± 0.1when 0.05 ml of methyl red solution R is added to 50 mlof the water to be examined.Conductivity: maximum 1 μS·cm−1, determined at25 °C by an in-line conductivity meter (see Purifiedwater (0008)).3a) Hydrochloric acid, dilute R1. 1043504.Contains 0.37 g/l of HCl.Dilute 1.0 ml of dilute hydrochloric acid R to 200.0 ml with water R.3b) Hydrochloric acid, dilute R2. 1043505.Dilute 30 ml of 1 M hydrochloric acid to 1000 ml with water R; adjust to pH 1.6 ± 0.1.又例如:Iodine Solution R1, A70Iodine Solution R2, A70Iodine Solution R3, A70Iodine Solution R4, A70Iodine Trichloride, A70Iodine Value, A279Iodine VS, A133Methanol, 1415, A79, S85Methanol, Acidifed, A79Methanol, Aldehyde-free, A79Methanol and 2-Propanol,Determination of, A257Methanol, Anhydrous, A79Methanol, Deuterated, A46Methanol, Hydrochloric, A79Methanol R1, A79Methanol R2, A79，
“for system suitability CRS”:我的理解是:在做高效液相色谱时，用于配制system suitability溶液的标准品 (Standards for drug Active or Related Substances/Impurities)。Water R是符合英国药典或欧洲药典中规定的纯化水，具体理化指标要查英国药典或欧洲药典，可以用超纯水Milli-Q Water (达到18.0 megohm-cm)来代替使用。"R" stands for Substance or Solution defined under Reagents in (BP/EP) Pharmacopoeias.R1,R2,R3 或R4加在试剂名称后表示试剂质量级别或要求(例如:液相/气相色谱纯、光谱纯等)不一样。请比较a) 和b):a)在英国药典British Pharmacopoeia Volume IV的附录部分(Appendices)的附录IA(Appendix IA.)的普通试剂( General Reagents)里面:Acetonitrile R1有如下的意思:Acetonitrile R1: Acetonitrile containing not less than 99.9% of C2H3N and complying with the following requirement.Light absorption The absorbance of the reagent being examined at 200 nm, Appendix II B, is not more than 0.10. Use water in the reference cell.b)在EUROPEAN PHARMACOPOEIA 5.0 的4.1.1. Reagents试剂部分参考链接:http://lib.njutcm.edu.cn/yaodian ... 1.1.%20Reagents.pdf)Acetonitrile R1有如下的意思:Complies with the requirements prescribed for acetonitrile R and with the following additional requirements.Content : minimum 99.9 per cent of C2H3N.Absorbance (2.2.25). The absorbance at 200 nm using water R as the compensation liquid is not more than 0.10.Acetonitrile R1不但要满足acetonitrile R的质量要求，还需要满足另外的两个要求(见上面英文的要求)才行。所以acetonitrile R1(如果做液相色谱试验，可以用液相色谱级的ACN来代替;当然如果分析纯ACN的指标达到药典要求，也可使用。)的质量要求与acetonitrile R不同。比较下列试剂:1a)Methanol R1. 1053201.Complies with the requirements prescribed formethanol R and the following additional requirement.Minimum transmittance (2.2.25), determined usingwater R as compensation liquid : 20 per cent at 210 nm,50 per cent at 220 nm, 75 per cent at 230 nm, 95 percent at 250 nm, 98 per cent at 260 nm and at higherwavelengths.1b)Methanol R2. 1053202.Methanol R2 used in liquid chromatography complieswith the following additional requirements.Content : minimum 99.8 per cent of CH4O (Mr 32.04).Absorbance (2.2.25). The absorbance at 225 nm usingwater R as the compensation liquid is not more than 0.17.2a)Water. 1095500. [7732-18-5].See Purified water (0008).2b) Water R1. 1095508.Prepared from distilled water R by multiple distillation.Remove carbon dioxide by boiling for at least 15 minbefore use in a boiling flask of fused silica or borosilicateglass and cool. Any other suitable method may be used.The boiling flask has been already used for the test orhas been filled with water R and kept in an autoclave at121 °C for at least 1 h prior to first use. When testedimmediately before use, water R1 is neutral to methylred solution R, i.e. it shall produce an orange-red (not aviolet-red or yellow) colour corresponding to pH 5.5 ± 0.1when 0.05 ml of methyl red solution R is added to 50 mlof the water to be examined.Conductivity: maximum 1 μS·cm−1, determined at25 °C by an in-line conductivity meter (see Purifiedwater (0008)).3a) Hydrochloric acid, dilute R1. 1043504.Contains 0.37 g/l of HCl.Dilute 1.0 ml of dilute hydrochloric acid R to 200.0 ml with water R.3b) Hydrochloric acid, dilute R2. 1043505.Dilute 30 ml of 1 M hydrochloric acid to 1000 ml with water R; adjust to pH 1.6 ± 0.1.又例如:Iodine Solution R1, A70Iodine Solution R2, A70Iodine Solution R3, A70Iodine Solution R4, A70Iodine Trichloride, A70Iodine Value, A279Iodine VS, A133Methanol, 1415, A79, S85Methanol, Acidifed, A79Methanol, Aldehyde-free, A79Methanol and 2-Propanol,Determination of, A257Methanol, Anhydrous, A79Methanol, Deuterated, A46Methanol, Hydrochloric, A79Methanol R1, A79Methanol R2, A79，
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发表于 2021-4-10 10:04:23
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参考链接:http://lib.njutcm.edu.cn/yaodian ... 1.1.%20Reagents.pdf)Acetonitrile R1有如下的意思:Complies with the requirements prescribed for acetonitrile R and with the following additional requirements.Content : minimum 99.9 per cent of C2H3N.Absorbance (2.2.25). The absorbance at 200 nm using water R as the compensation liquid is not more than 0.10.Acetonitrile R1不但要满足acetonitrile R的质量要求，还需要满足另外的两个要求(见上面英文的要求)才行。所以acetonitrile R1(如果做液相色谱试验，可以用液相色谱级的ACN来代替;当然如果分析纯ACN的指标达到药典要求，也可使用。)的质量要求与acetonitrile R不同。比较下列试剂:1a)Methanol R1. 1053201.Complies with the requirements prescribed formethanol R and the following additional requirement.Minimum transmittance (2.2.25), determined usingwater R as compensation liquid : 20 per cent at 210 nm,50 per cent at 220 nm, 75 per cent at 230 nm, 95 percent at 250 nm, 98 per cent at 260 nm and at higherwavelengths.1b)Methanol R2. 1053202.Methanol R2 used in liquid chromatography complieswith the following additional requirements.Content : minimum 99.8 per cent of CH4O (Mr 32.04).Absorbance (2.2.25). The absorbance at 225 nm usingwater R as the compensation liquid is not more than 0.17.2a)Water. 1095500. [7732-18-5].See Purified water (0008).2b) Water R1. 1095508.Prepared from distilled water R by multiple distillation.Remove carbon dioxide by boiling for at least 15 minbefore use in a boiling flask of fused silica or borosilicateglass and cool. Any other suitable method may be used.The boiling flask has been already used for the test orhas been filled with water R and kept in an autoclave at121 °C for at least 1 h prior to first use. When testedimmediately before use, water R1 is neutral to methylred solution R, i.e. it shall produce an orange-red (not aviolet-red or yellow) colour corresponding to pH 5.5 ± 0.1when 0.05 ml of methyl red solution R is added to 50 mlof the water to be examined.Conductivity: maximum 1 μS·cm−1, determined at25 °C by an in-line conductivity meter (see Purifiedwater (0008)).3a) Hydrochloric acid, dilute R1. 1043504.Contains 0.37 g/l of HCl.Dilute 1.0 ml of dilute hydrochloric acid R to 200.0 ml with water R.3b) Hydrochloric acid, dilute R2. 1043505.Dilute 30 ml of 1 M hydrochloric acid to 1000 ml with water R; adjust to pH 1.6 ± 0.1.又例如:Iodine Solution R1, A70Iodine Solution R2, A70Iodine Solution R3, A70Iodine Solution R4, A70Iodine Trichloride, A70Iodine Value, A279Iodine VS, A133Methanol, 1415, A79, S85Methanol, Acidifed, A79Methanol, Aldehyde-free, A79Methanol and 2-Propanol,Determination of, A257Methanol, Anhydrous, A79Methanol, Deuterated, A46Methanol, Hydrochloric, A79Methanol R1, A79Methanol R2, A79，
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，非常感谢！