{"id":10532,"date":"2025-10-08T10:40:12","date_gmt":"2025-10-08T03:40:12","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=10532"},"modified":"2025-10-08T10:40:12","modified_gmt":"2025-10-08T03:40:12","slug":"enalapril-maleate","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/enalapril-maleate\/","title":{"rendered":"Enalapril Maleate"},"content":{"rendered":"

(Ph. Eur. monograph 1420)<\/p>\n

C_{24<\/sub>H_{32<\/sub>N_{2<\/sub>O_{9<\/sub>\u00a0 \u00a0 492.5\u00a0 \u00a076095-16-4<\/p>\n}}}}

Action and use<\/strong><\/p>\n

Angiotensin converting enzyme inhibitor.<\/p>\n

Preparation<\/strong><\/p>\n

Enalapril Tablets<\/p>\n

DEFINITION<\/h2>\n
(2S)-1-[(2S)-2-[[(1S)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]propanoyl]pyrrolidine-2-carboxylic acid hydrogen (Z)-butenedioate.<\/p>\n
Content<\/h3>\n
98.5 per cent to 101.5 per cent (dried substance).<\/p>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
White or almost white, crystalline powder.<\/p>\n
Solubility<\/h3>\n
Sparingly soluble in water, freely soluble in methanol, practically insoluble in methylene chloride. It dissolves in dilute solutions of alkali hydroxides.<\/p>\n
IDENTIFICATION<\/h2>\n
Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison enalapril maleate CRS.<\/p>\n
TESTS<\/h2>\n
Solution S<\/h3>\n
Dissolve 0.25 g in carbon dioxide-free water R and dilute to 25.0 mL with the same solvent.<\/p>\n
Appearance of solution<\/h3>\n
Solution S is clear (2.2.1) and colourless (2.2.2, Method II).<\/p>\n
pH (2.2.3)<\/h3>\n
2.4 to 2.9 for solution S.<\/p>\n
Specific optical rotation (2.2.7)<\/h3>\n
-51 to -48 (dried substance), determined on solution S.<\/p>\n
Related substances<\/h3>\n
Liquid chromatography (2.2.29).<\/p>\n
Buffer solution A: Dissolve 2.8 g of sodium dihydrogen phosphate monohydrate R in 950 mL of water for
\nchromatography R, adjust to pH 2.5 with phosphoric acid R and dilute to 1000 mL with water for chromatography R.<\/p>\n
Buffer solution B: Dissolve 2.8 g of sodium dihydrogen phosphate monohydrate R in 950 mL of water for
\nchromatography R, adjust to pH 6.8 with strong sodium hydroxide solution R and dilute to 1000 mL with water for chromatography R.<\/p>\n
Solvent mixture acetonitrile R1, buffer solution A (5:95 V\/V).<\/p>\n
Test solution (a): Dissolve 30 mg of the substance to be examined in the solvent mixture and dilute to 100.0 mL with the solvent mixture.<\/p>\n
Test solution (b): Dissolve 0.100 g of the substance to be examined in the solvent mixture and dilute to 20.0 mL with the solvent mixture.<\/p>\n
Reference solution (a): Dilute 1.0 mL of test solution (a) to 100.0 mL with the solvent mixture. Dilute 1.0 mL of this solution to 10.0 mL with the solvent mixture.<\/p>\n
Reference solution (b): Dissolve 3 mg of enalapril for system suitability CRS (containing impurity A) in the solvent mixture and dilute to 10.0 mL with the solvent mixture.<\/p>\n
Reference solution (c) Dissolve the contents of a vial of enalapril impurity mixture A CRS (impurities C and H) in 1.0 mL of the solvent mixture.<\/p>\n
Reference solution (d) Dissolve 2.0 mg of enalapril impurity G CRS in the solvent mixture and dilute to 10.0 mL with the solvent mixture. Dilute 1.0 mL of the solution to 20.0 mL with the solvent mixture.<\/p>\n
Column:<\/p>\n
\u2014 size: l = 0.15 m, \u00d8 = 4.1 mm;<\/p>\n
\u2014 stationary phase: styrene-divinylbenzene copolymer R (5 \u03bcm);<\/p>\n
\u2014 temperature: 70 \u00b0C.<\/p>\n
Mobile phase:<\/p>\n
\u2014 mobile phase A: acetonitrile R1, buffer solution B (5:95 V\/V);<\/p>\n
\u2014 mobile phase B: buffer solution B, acetonitrile R1 (34:66 V\/V);<\/p>\n\n\n\n\n\n\n
Time
\n(min)<\/td>\n Mobile phase A
\n(per cent V\/V)<\/td>\n Mobile phase B
\n(per cent V\/V)<\/td>\n<\/tr>\n
0 – 3<\/td>\n 95<\/td>\n 5<\/td>\n<\/tr>\n
3 – 23<\/td>\n \u00a095 \u2192 40<\/td>\n \u00a05 \u2192 60<\/td>\n<\/tr>\n
23 – 30<\/td>\n 40<\/td>\n 60<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
Flow rate 1.0 mL\/min.<\/p>\n
Detection: Spectrophotometer at 215 nm.<\/p>\n
Injection 50 \u03bcL of test solution (a): and reference solutions (a), (b) and (c); for impurity G, test solution (b) and reference solution (d).<\/p>\n
Identification of impurities: Use the chromatogram obtained with reference solution (b) to identify the peak due to impurity A; use the chromatogram supplied with enalapril impurity mixture A CRS and the chromatogram obtained with reference solution (c) to identify the peaks due to impurities C and H; use the chromatogram obtained with reference solution (d) to identify the peak due to impurity G.<\/p>\n
Relative retention: With reference to enalapril (retention time = about 13 min): maleic acid = about 0.1; impurity C = about 0.2; impurity A = about 1.1; impurity G = about 1.2; impurity H = about 1.3.<\/p>\n
System suitability:<\/p>\n
\u2014 signal-to-noise ratio: minimum 40 for the peak due to enalapril in the chromatogram obtained with reference solution (a); minimum 40 for the peak due to impurity G in the chromatogram obtained with reference solution (d);<\/p>\n
\u2014 peak-to-valley ratio: minimum 10, where Hp = height above the baseline of the peak due to impurity A and Hv = height above the baseline of the lowest point of the curve separating this peak from the peak due to enalapril in the chromatogram obtained with reference solution (b).<\/p>\n
Calculation of percentage contents:<\/p>\n
\u2014 correction factor: multiply the peak area of impurity H by 2.0;<\/p>\n
\u2014 for impurity G, use the concentration of impurity G in reference solution (d);<\/p>\n
\u2014 for impurities other than G, use the concentration of enalapril maleate in reference solution (a).<\/p>\n
Limits:<\/p>\n
\u2014 impurity A: maximum 0.5 per cent;<\/p>\n
\u2014 impurity H: maximum 0.3 per cent;<\/p>\n
\u2014 impurities C, G: for each impurity, maximum 0.2 per cent;<\/p>\n
\u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;<\/p>\n
\u2014 total: maximum 1.0 per cent;<\/p>\n
\u2014 reporting threshold: 0.05 per cent; disregard the peak due to maleic acid.<\/p>\n
Loss on drying (2.2.32)<\/h4>\n
Maximum 1.0 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C for 3 h.<\/p>\n
Sulfated ash (2.4.14)<\/h4>\n
Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n
ASSAY<\/h2>\n
Dissolve 0.100 g in carbon dioxide-free water R and dilute to 50 mL with the same solvent. Titrate with 0.1 M sodium hydroxide, determining the end-point potentiometrically (2.2.20). Titrate to the 2 point of inflexion.<\/p>\n
1 mL of 0.1 M sodium hydroxide is equivalent to 16.42 mg of C_{24<\/sub>H_{32<\/sub>N_{2<\/sub>O_{9<\/sub>.<\/p>\n}}}}
STORAGE<\/h2>\n
Protected from light.<\/p>\n
IMPURITIES<\/h2>\n
Specified impurities A, C, G, H.<\/p>\n
Other detectable impurities (the following substances would, if present at a sufficient level, be detected by one or other of the tests in the monograph. They are limited by the general acceptance criterion for other\/unspecified impurities and\/or by the general monograph Substances for pharmaceutical use (2034). It is therefore not necessary to identify these impurities for demonstration of compliance. See also 5.10. Control of impurities in substances for pharmaceutical use) B, D, E, F, I.<\/p>\n
$\"Enalapril$ <\/p>\n
A. (2S)-1-[(2S)-2-[[(1R)-1-(ethoxycarbonyl)-3-phenylpropyl]amino]propanoyl]pyrrolidine-2-carboxylic acid,<\/p>\n
$\"Enalapril$ <\/p>\n
B. (2S)-2-[[(1S)-1-(ethoxycarbonyl)-3-phenylpropyl]amino]propanoic acid,<\/p>\n
$\"Enalapril$ <\/p>\n
C. (2S)-1-[(2S)-2-[[(1S)-1-carboxy-3-phenylpropyl]amino]propanoyl]pyrrolidine-2-carboxylic acid,<\/p>\n
$\"Enalapril$ <\/p>\n
D. ethyl (2S)-2-[(3S,8aS)-3-methyl-1,4-dioxohexahydropyrrolo[1,2-a]pyrazin-2(1H)-yl]-4-phenylbutanoate,<\/p>\n
$\"Enalapril$ <\/p>\n
E. (2S)-1-[(2S)-2-[[(1S)-3-phenyl-1-[(2-phenylethoxy)carbonyl]propyl]amino]propanoyl]pyrrolidine-2-carboxylic acid,<\/p>\n
$\"Enalapril$ <\/p>\n
F. (2S)-1-[(2S)-2-[[(1S)-1-(butoxycarbonyl)-3-phenylpropyl]amino]propanoyl]pyrrolidine-2-carboxylic acid,<\/p>\n
$\"Enalapril$ <\/p>\n
G. (2S)-2-[[(1S)-3-cyclohexyl-1-(ethoxycarbonyl)propyl]amino]propanoic acid,<\/p>\n
$\"Enalapril$ <\/p>\n
H. (2S)-1-[(2S)-2-[[(1S)-3-cyclohexyl-1-(ethoxycarbonyl)propyl]amino]propanoyl]pyrrolidine-2-carboxylic acid,<\/p>\n
$\"Enalapril$ <\/p>\n
I. 1H-imidazole.<\/p>\n","protected":false},"excerpt":{"rendered":"
(Ph. Eur. monograph 1420) C24H32N2O9\u00a0 \u00a0 492.5\u00a0 \u00a076095-16-4 Action and use Angiotensin converting enzyme inhibitor. Preparation Enalapril Tablets DEFINITION (2S)-1-[(2S)-2-[[(1S)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]propanoyl]pyrrolidine-2-carboxylic acid hydrogen (Z)-butenedioate. Content 98.5 per cent to 101.5 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Sparingly soluble in water, freely soluble in methanol, practically insoluble in methylene chloride….<\/p>\n","protected":false},"author":3,"featured_media":10578,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-10532","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicinal-substances"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/10532","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=10532"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/10532\/revisions"}],"predecessor-version":[{"id":10581,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/10532\/revisions\/10581"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/10578"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=10532"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=10532"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=10532"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Time \n(min)<\/td>\n	Mobile phase A \n(per cent V\/V)<\/td>\n	Mobile phase B \n(per cent V\/V)<\/td>\n<\/tr>\n
0 – 3<\/td>\n	95<\/td>\n	5<\/td>\n<\/tr>\n
3 – 23<\/td>\n	\u00a095 \u2192 40<\/td>\n	\u00a05 \u2192 60<\/td>\n<\/tr>\n
23 – 30<\/td>\n	40<\/td>\n	60<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Flow rate 1.0 mL\/min.<\/p>\n Detection: Spectrophotometer at 215 nm.<\/p>\n Injection 50 \u03bcL of test solution (a): and reference solutions (a), (b) and (c); for impurity G, test solution (b) and reference solution (d).<\/p>\n Identification of impurities: Use the chromatogram obtained with reference solution (b) to identify the peak due to impurity A; use the chromatogram supplied with enalapril impurity mixture A CRS and the chromatogram obtained with reference solution (c) to identify the peaks due to impurities C and H; use the chromatogram obtained with reference solution (d) to identify the peak due to impurity G.<\/p>\n Relative retention: With reference to enalapril (retention time = about 13 min): maleic acid = about 0.1; impurity C = about 0.2; impurity A = about 1.1; impurity G = about 1.2; impurity H = about 1.3.<\/p>\n System suitability:<\/p>\n \u2014 signal-to-noise ratio: minimum 40 for the peak due to enalapril in the chromatogram obtained with reference solution (a); minimum 40 for the peak due to impurity G in the chromatogram obtained with reference solution (d);<\/p>\n \u2014 peak-to-valley ratio: minimum 10, where Hp = height above the baseline of the peak due to impurity A and Hv = height above the baseline of the lowest point of the curve separating this peak from the peak due to enalapril in the chromatogram obtained with reference solution (b).<\/p>\n Calculation of percentage contents:<\/p>\n \u2014 correction factor: multiply the peak area of impurity H by 2.0;<\/p>\n \u2014 for impurity G, use the concentration of impurity G in reference solution (d);<\/p>\n \u2014 for impurities other than G, use the concentration of enalapril maleate in reference solution (a).<\/p>\n Limits:<\/p>\n \u2014 impurity A: maximum 0.5 per cent;<\/p>\n \u2014 impurity H: maximum 0.3 per cent;<\/p>\n \u2014 impurities C, G: for each impurity, maximum 0.2 per cent;<\/p>\n \u2014 unspecified impurities: for each impurity, maximum 0.10 per cent;<\/p>\n \u2014 total: maximum 1.0 per cent;<\/p>\n \u2014 reporting threshold: 0.05 per cent; disregard the peak due to maleic acid.<\/p>\n Loss on drying (2.2.32)<\/h4>\n Maximum 1.0 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C for 3 h.<\/p>\n Sulfated ash (2.4.14)<\/h4>\n Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n ASSAY<\/h2>\n Dissolve 0.100 g in carbon dioxide-free water R and dilute to 50 mL with the same solvent. Titrate with 0.1 M sodium hydroxide, determining the end-point potentiometrically (2.2.20). Titrate to the 2 point of inflexion.<\/p>\n 1 mL of 0.1 M sodium hydroxide is equivalent to 16.42 mg of C_{24<\/sub>H_{32<\/sub>N_{2<\/sub>O_{9<\/sub>.<\/p>\n}}}} STORAGE<\/h2>\n Protected from light.<\/p>\n IMPURITIES<\/h2>\n Specified impurities A, C, G, H.<\/p>\n Other detectable impurities (the following substances would, if present at a sufficient level, be detected by one or other of the tests in the monograph. They are limited by the general acceptance criterion for other\/unspecified impurities and\/or by the general monograph Substances for pharmaceutical use (2034). It is therefore not necessary to identify these impurities for demonstration of compliance. See also 5.10. Control of impurities in substances for pharmaceutical use) B, D, E, F, I.<\/p>\n $\"Enalapril$ <\/p>\n A. (2S)-1-[(2S)-2-[[(1R)-1-(ethoxycarbonyl)-3-phenylpropyl]amino]propanoyl]pyrrolidine-2-carboxylic acid,<\/p>\n $\"Enalapril$ <\/p>\n B. (2S)-2-[[(1S)-1-(ethoxycarbonyl)-3-phenylpropyl]amino]propanoic acid,<\/p>\n $\"Enalapril$ <\/p>\n C. (2S)-1-[(2S)-2-[[(1S)-1-carboxy-3-phenylpropyl]amino]propanoyl]pyrrolidine-2-carboxylic acid,<\/p>\n $\"Enalapril$ <\/p>\n D. ethyl (2S)-2-[(3S,8aS)-3-methyl-1,4-dioxohexahydropyrrolo[1,2-a]pyrazin-2(1H)-yl]-4-phenylbutanoate,<\/p>\n $\"Enalapril$ <\/p>\n E. (2S)-1-[(2S)-2-[[(1S)-3-phenyl-1-[(2-phenylethoxy)carbonyl]propyl]amino]propanoyl]pyrrolidine-2-carboxylic acid,<\/p>\n $\"Enalapril$ <\/p>\n F. (2S)-1-[(2S)-2-[[(1S)-1-(butoxycarbonyl)-3-phenylpropyl]amino]propanoyl]pyrrolidine-2-carboxylic acid,<\/p>\n $\"Enalapril$ <\/p>\n G. (2S)-2-[[(1S)-3-cyclohexyl-1-(ethoxycarbonyl)propyl]amino]propanoic acid,<\/p>\n $\"Enalapril$ <\/p>\n H. (2S)-1-[(2S)-2-[[(1S)-3-cyclohexyl-1-(ethoxycarbonyl)propyl]amino]propanoyl]pyrrolidine-2-carboxylic acid,<\/p>\n $\"Enalapril$ <\/p>\n I. 1H-imidazole.<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur. monograph 1420) C24H32N2O9\u00a0 \u00a0 492.5\u00a0 \u00a076095-16-4 Action and use Angiotensin converting enzyme inhibitor. Preparation Enalapril Tablets DEFINITION (2S)-1-[(2S)-2-[[(1S)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]propanoyl]pyrrolidine-2-carboxylic acid hydrogen (Z)-butenedioate. Content 98.5 per cent to 101.5 per cent (dried substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Sparingly soluble in water, freely soluble in methanol, practically insoluble in methylene chloride….<\/p>\n","protected":false},"author":3,"featured_media":10578,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-10532","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicinal-substances"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/10532","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=10532"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/10532\/revisions"}],"predecessor-version":[{"id":10581,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/10532\/revisions\/10581"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/10578"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=10532"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=10532"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=10532"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Content<\/h3>\n98.5 per cent to 101.5 per cent (dried substance).<\/p>\n

CHARACTERS<\/h2>\n

Appearance<\/h3>\nWhite or almost white, crystalline powder.<\/p>\n

Solubility<\/h3>\nSparingly soluble in water, freely soluble in methanol, practically insoluble in methylene chloride. It dissolves in dilute solutions of alkali hydroxides.<\/p>\n

IDENTIFICATION<\/h2>\nInfrared absorption spectrophotometry (2.2.24).<\/p>\nComparison enalapril maleate CRS.<\/p>\n

TESTS<\/h2>\n

Solution S<\/h3>\nDissolve 0.25 g in carbon dioxide-free water R and dilute to 25.0 mL with the same solvent.<\/p>\n

Appearance of solution<\/h3>\nSolution S is clear (2.2.1) and colourless (2.2.2, Method II).<\/p>\n

pH (2.2.3)<\/h3>\n2.4 to 2.9 for solution S.<\/p>\n

Specific optical rotation (2.2.7)<\/h3>\n-51 to -48 (dried substance), determined on solution S.<\/p>\n

Loss on drying (2.2.32)<\/h4>\nMaximum 1.0 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C for 3 h.<\/p>\n

Sulfated ash (2.4.14)<\/h4>\nMaximum 0.1 per cent, determined on 1.0 g.<\/p>\n

STORAGE<\/h2>\nProtected from light.<\/p>\n

Content<\/h3>\n
98.5 per cent to 101.5 per cent (dried substance).<\/p>\n

Appearance<\/h3>\n
White or almost white, crystalline powder.<\/p>\n

Solubility<\/h3>\n
Sparingly soluble in water, freely soluble in methanol, practically insoluble in methylene chloride. It dissolves in dilute solutions of alkali hydroxides.<\/p>\n

IDENTIFICATION<\/h2>\n
Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison enalapril maleate CRS.<\/p>\n

Solution S<\/h3>\n
Dissolve 0.25 g in carbon dioxide-free water R and dilute to 25.0 mL with the same solvent.<\/p>\n

Appearance of solution<\/h3>\n
Solution S is clear (2.2.1) and colourless (2.2.2, Method II).<\/p>\n

pH (2.2.3)<\/h3>\n
2.4 to 2.9 for solution S.<\/p>\n

Specific optical rotation (2.2.7)<\/h3>\n
-51 to -48 (dried substance), determined on solution S.<\/p>\n

Loss on drying (2.2.32)<\/h4>\n
Maximum 1.0 per cent, determined on 1.000 g by drying in an oven at 105 \u00b0C for 3 h.<\/p>\n

Sulfated ash (2.4.14)<\/h4>\n
Maximum 0.1 per cent, determined on 1.0 g.<\/p>\n

STORAGE<\/h2>\n
Protected from light.<\/p>\n