{"id":17406,"date":"2025-10-22T11:08:09","date_gmt":"2025-10-22T04:08:09","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=17406"},"modified":"2025-10-22T11:08:09","modified_gmt":"2025-10-22T04:08:09","slug":"lovastatin","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/lovastatin\/","title":{"rendered":"Lovastatin"},"content":{"rendered":"

(Ph. Eur Monograph 1538)<\/p>\n

C_{24<\/sub>H_{36<\/sub>O_{5\u00a0<\/sub> \u00a0 \u00a0 \u00a0 404.5\u00a0 \u00a0 \u00a0 \u00a0 75330-75-5<\/p>\n}}}

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

HMG Co-A reductase inhibitor; lipid-regulating drug.<\/p>\n

DEFINITION<\/h2>\n
(1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a- hexahydronaphthalen-1-yl (2S)-2-methylbutanoate.<\/p>\n
Content<\/h2>\n
97.0 per cent to 102.0 per cent (anhydrous substance).<\/p>\n
CHARACTERS<\/h2>\n
Appearance<\/h3>\n
White or almost white, crystalline powder.<\/p>\n
Solubility<\/h3>\n
Practically insoluble in water, soluble in acetone, sparingly soluble in anhydrous ethanol.<\/p>\n
IDENTIFICATION<\/h2>\n
A. Specific optical rotation (see Tests).<\/p>\n
B. Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison: lovastatin CRS.<\/p>\n
TESTS<\/h2>\n
Specific optical rotation (2.2.7)<\/h4>\n
+ 325 to + 340 (anhydrous substance).<\/p>\n
Dissolve 0.125 g in acetonitrile R and dilute to 25.0 mL with the same solvent.<\/p>\n
Impurity E<\/h3>\n
Liquid chromatography (2.2.29).<\/p>\n
Test solution: Dissolve 25.0 mg of the substance to be examined in acetonitrile R and dilute to 25.0 mL with the same solvent.<\/p>\n
Reference solution (a): Dilute 5.0 mL of the test solution to 100.0 mL with acetonitrile R. Dilute 5.0 mL of this solution to 50.0 mL with acetonitrile R.<\/p>\n
Reference solution (b): Dissolve 4 mg of lovastatin for peak identification CRS (containing impurities A, B, C, D, E and F) in acetonitrile R and dilute to 10 mL with the same solvent.<\/p>\n
Column:<\/p>\n
\u2014 size: l = 0.25 m, \u00d8 = 4.6 mm;<\/p>\n
\u2014 stationary phase: base-deactivated octylsilyl silica gel for chromatography R (5 \u03bcm);<\/p>\n
\u2014 temperature: 40 \u00b0C.<\/p>\n
Mobile phase: 1.1 g\/L solution of phosphoric acid R, acetonitrile R1 (35:65 V\/V).<\/p>\n
Flow rate: 1.5 mL\/min.<\/p>\n
Detection: Spectrophotometer at 200 nm.<\/p>\n
Injection: 10 \u03bcL.<\/p>\n
Run time: 3 times the retention time of lovastatin.<\/p>\n
Identification of impurities: Use the chromatogram supplied with lovastatin for peak identification CRS and the chromatogram obtained with reference solution (b) to identify the peak due to impurity E.<\/p>\n
Relative retention: With reference to lovastatin (retention time = about 5 min): impurity E = about 1.3.<\/p>\n
System suitability: Reference solution (b):<\/p>\n
\u2014 resolution: minimum 5.0 between the peaks due to lovastatin and impurity E.<\/p>\n
Limit:<\/p>\n
\u2014 correction factor: for the calculation of content, multiply the peak area of impurity E by 1.6;<\/p>\n
\u2014 impurity E: not more than the area of the principal peak in the chromatogram obtained with reference solution (a) (0.5 per cent).<\/p>\n
Related substances<\/h3>\n
Liquid chromatography (2.2.29).<\/p>\n
Test solution: Dissolve 20.0 mg of the substance to be examined in acetonitrile R and dilute to 50.0 mL with the same solvent.<\/p>\n
Reference solution (a): Dissolve 20.0 mg of lovastatin CRS in acetonitrile R and dilute to 50.0 mL with the same solvent.<\/p>\n
Reference solution (b): Dilute 5.0 mL of the test solution to 100.0 mL with acetonitrile R. Dilute 5.0 mL of this solution to 50.0 mL with acetonitrile R.<\/p>\n
Reference solution (c): Dissolve 4 mg of lovastatin for peak identification CRS (containing impurities A, B, C, D, E and F) in acetonitrile R and dilute to 10 mL with the same solvent.<\/p>\n
Column:<\/p>\n
\u2014 size: l = 0.25 m, \u00d8 = 4.6 mm;<\/p>\n
\u2014 stationary phase: base-deactivated octylsilyl silica gel for chromatography R (5 \u03bcm).<\/p>\n
Mobile phase:<\/p>\n
\u2014 mobile phase A: 0.1 per cent V\/V solution of phosphoric acid R;<\/p>\n
\u2014 mobile phase B: acetonitrile for chromatography R;<\/p>\n\n\n\n\n\n\n\n
Time<\/strong>
\n(min)<\/strong><\/td>\n Mobile phase A<\/strong>
\n(per cent V\/V)<\/strong><\/td>\n Mobile phase B<\/strong>
\n(per cent V\/V)<\/strong><\/td>\n<\/tr>\n
0 – 7<\/td>\n 40<\/td>\n 60<\/td>\n<\/tr>\n
7 – 9<\/td>\n 40 \u2192 35<\/td>\n 60 \u2192 65<\/td>\n<\/tr>\n
9 – 15<\/td>\n 35 \u2192 10<\/td>\n 65 \u2192 90<\/td>\n<\/tr>\n
15 – 20<\/td>\n 10<\/td>\n 90<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
Flow rate: 1.5 mL\/min.<\/p>\n
Detection: Spectrophotometer at 238 nm.<\/p>\n
Injection: 10 \u03bcL of the test solution and reference solutions (b) and (c).<\/p>\n
Identification of impurities: Use the chromatogram supplied with lovastatin for peak identification CRS and the chromatogram obtained with reference solution (c) to identify the peaks due to impurities A, B, C, D and F.<\/p>\n
Relative retention: With reference to lovastatin (retention time = about 7 min): impurity B = about 0.6; impurity A = about 0.8; impurity F = about 0.9; impurity C = about 1.6; impurity D = about 2.3.<\/p>\n
System suitability: Reference solution (c):<\/p>\n
\u2014 peak-to-valley ratio: minimum 3.0, where Hp = height above the baseline of the peak due to impurity F and H_{v<\/sub> = height above the baseline of the lowest point of the curve separating this peak from the peak due to lovastatin.<\/p>\n}
Limits:<\/p>\n
\u2014 impurities A, B, C, D: for each impurity, not more than 0.6 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.3 per cent);<\/p>\n
\u2014 impurity F: not more than 0.3 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.15 per cent);<\/p>\n
\u2014 unspecified impurities: for each impurity, not more than 0.2 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.10 per cent);<\/p>\n
\u2014 total: not more than twice the area of the principal peak in the chromatogram obtained with reference solution (b) (1.0 per cent);<\/p>\n
\u2014 disregard limit: 0.1 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.05 per cent).<\/p>\n
Water (2.5.12)<\/h4>\n
Maximum 0.5 per cent, determined on 1.00 g.<\/p>\n
Sulfated ash (2.4.14)<\/h4>\n
Maximum 0.2 per cent, determined on 1.0 g.<\/p>\n
ASSAY<\/h2>\n
Liquid chromatography (2.2.29) as described in the test for related substances with the following modification.<\/p>\n
Injection Test solution and reference solution (a).<\/p>\n
Calculate the percentage content of C_{24<\/sub>H_{36<\/sub>O_{5<\/sub>\u00a0taking into account the assigned content of lovastatin CRS.<\/p>\n}}}
STORAGE<\/h2>\n
Under nitrogen, at a temperature of 2 \u00b0C to 8 \u00b0C.<\/p>\n
IMPURITIES<\/h2>\n
Specified impurities A, B, C, D, E, F.<\/p>\n
$\"Lovastatin\"$ <\/p>\n
A. (1S,7S,8S,8aR)-8-[2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl]-7-methyl-1,2,3,7,8,8a- hexahydronaphthalen-1-yl (2S)-2-methylbutanoate (mevastatin),<\/p>\n
$\"Lovastatin\"$ <\/p>\n
B. (3R,5R)-7-[(1S,2S,6R,8S,8aR)-2,6-dimethyl-8-[[(2S)-2-methylbutanoyl]oxy]-1,2,6,7,8,8a- hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic acid (hydroxyacid lovastatin),<\/p>\n
$\"Lovastatin\"$ <\/p>\n
C. (1S,3R,7S,8S,8aR)-3,7-dimethyl-8-[2-[(2R)-6-oxo-3,6-dihydro-2H-pyran-2-yl]ethyl]-1,2,3,7,8,8a- hexahydronaphthalen-1-yl (2S)-2-methylbutanoate (dehydrolovastatin),<\/p>\n
$\"Lovastatin\"$ <\/p>\n
D. (2R,4R)-2-[2-[(1S,2S,6R,8S,8aR)-2,6-dimethyl-8-[[(2S)-2-methylbutanoyl]oxy]-1,2,6,7,8,8a- hexahydronaphthalen-1-yl]ethyl]-6-oxooxan-4-yl (3R,5R)-7-[(1S,2S,6R,8S,8aR)-2,6-dimethyl-8-[[(2S)-2-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoate (lovastatin dimer),<\/p>\n
$\"Lovastatin\"$ <\/p>\n
E. (1S,3S,4aR,7S,8S,8aS)-8-[2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl]-3,7-dimethyl-1,2,3,4,4a,7,8,8a- octahydronaphthalen-1-yl (2S)-2-methylbutanoate (4,4a-dihydrolovastatin),<\/p>\n
$\"Lovastatin\"$ <\/p>\n
F. (1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a- hexahydronaphthalen-1-yl (2Z)-2-methylbut-2-enoate.<\/p>\n","protected":false},"excerpt":{"rendered":"
(Ph. Eur Monograph 1538) C24H36O5\u00a0 \u00a0 \u00a0 \u00a0 404.5\u00a0 \u00a0 \u00a0 \u00a0 75330-75-5 Action and use HMG Co-A reductase inhibitor; lipid-regulating drug. DEFINITION (1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a- hexahydronaphthalen-1-yl (2S)-2-methylbutanoate. Content 97.0 per cent to 102.0 per cent (anhydrous substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Practically insoluble in water, soluble in acetone, sparingly soluble in…<\/p>\n","protected":false},"author":2,"featured_media":17436,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-17406","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\/17406","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\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=17406"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/17406\/revisions"}],"predecessor-version":[{"id":17438,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/17406\/revisions\/17438"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/17436"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=17406"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=17406"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=17406"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Time<\/strong> \n(min)<\/strong><\/td>\n	Mobile phase A<\/strong> \n(per cent V\/V)<\/strong><\/td>\n	Mobile phase B<\/strong> \n(per cent V\/V)<\/strong><\/td>\n<\/tr>\n
0 – 7<\/td>\n	40<\/td>\n	60<\/td>\n<\/tr>\n
7 – 9<\/td>\n	40 \u2192 35<\/td>\n	60 \u2192 65<\/td>\n<\/tr>\n
9 – 15<\/td>\n	35 \u2192 10<\/td>\n	65 \u2192 90<\/td>\n<\/tr>\n
15 – 20<\/td>\n	10<\/td>\n	90<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n Flow rate: 1.5 mL\/min.<\/p>\n Detection: Spectrophotometer at 238 nm.<\/p>\n Injection: 10 \u03bcL of the test solution and reference solutions (b) and (c).<\/p>\n Identification of impurities: Use the chromatogram supplied with lovastatin for peak identification CRS and the chromatogram obtained with reference solution (c) to identify the peaks due to impurities A, B, C, D and F.<\/p>\n Relative retention: With reference to lovastatin (retention time = about 7 min): impurity B = about 0.6; impurity A = about 0.8; impurity F = about 0.9; impurity C = about 1.6; impurity D = about 2.3.<\/p>\n System suitability: Reference solution (c):<\/p>\n \u2014 peak-to-valley ratio: minimum 3.0, where Hp = height above the baseline of the peak due to impurity F and H_{v<\/sub> = height above the baseline of the lowest point of the curve separating this peak from the peak due to lovastatin.<\/p>\n} Limits:<\/p>\n \u2014 impurities A, B, C, D: for each impurity, not more than 0.6 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.3 per cent);<\/p>\n \u2014 impurity F: not more than 0.3 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.15 per cent);<\/p>\n \u2014 unspecified impurities: for each impurity, not more than 0.2 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.10 per cent);<\/p>\n \u2014 total: not more than twice the area of the principal peak in the chromatogram obtained with reference solution (b) (1.0 per cent);<\/p>\n \u2014 disregard limit: 0.1 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.05 per cent).<\/p>\n Water (2.5.12)<\/h4>\n Maximum 0.5 per cent, determined on 1.00 g.<\/p>\n Sulfated ash (2.4.14)<\/h4>\n Maximum 0.2 per cent, determined on 1.0 g.<\/p>\n ASSAY<\/h2>\n Liquid chromatography (2.2.29) as described in the test for related substances with the following modification.<\/p>\n Injection Test solution and reference solution (a).<\/p>\n Calculate the percentage content of C_{24<\/sub>H_{36<\/sub>O_{5<\/sub>\u00a0taking into account the assigned content of lovastatin CRS.<\/p>\n}}} STORAGE<\/h2>\n Under nitrogen, at a temperature of 2 \u00b0C to 8 \u00b0C.<\/p>\n IMPURITIES<\/h2>\n Specified impurities A, B, C, D, E, F.<\/p>\n $\"Lovastatin\"$ <\/p>\n A. (1S,7S,8S,8aR)-8-[2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl]-7-methyl-1,2,3,7,8,8a- hexahydronaphthalen-1-yl (2S)-2-methylbutanoate (mevastatin),<\/p>\n $\"Lovastatin\"$ <\/p>\n B. (3R,5R)-7-[(1S,2S,6R,8S,8aR)-2,6-dimethyl-8-[[(2S)-2-methylbutanoyl]oxy]-1,2,6,7,8,8a- hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic acid (hydroxyacid lovastatin),<\/p>\n $\"Lovastatin\"$ <\/p>\n C. (1S,3R,7S,8S,8aR)-3,7-dimethyl-8-[2-[(2R)-6-oxo-3,6-dihydro-2H-pyran-2-yl]ethyl]-1,2,3,7,8,8a- hexahydronaphthalen-1-yl (2S)-2-methylbutanoate (dehydrolovastatin),<\/p>\n $\"Lovastatin\"$ <\/p>\n D. (2R,4R)-2-[2-[(1S,2S,6R,8S,8aR)-2,6-dimethyl-8-[[(2S)-2-methylbutanoyl]oxy]-1,2,6,7,8,8a- hexahydronaphthalen-1-yl]ethyl]-6-oxooxan-4-yl (3R,5R)-7-[(1S,2S,6R,8S,8aR)-2,6-dimethyl-8-[[(2S)-2-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoate (lovastatin dimer),<\/p>\n $\"Lovastatin\"$ <\/p>\n E. (1S,3S,4aR,7S,8S,8aS)-8-[2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl]-3,7-dimethyl-1,2,3,4,4a,7,8,8a- octahydronaphthalen-1-yl (2S)-2-methylbutanoate (4,4a-dihydrolovastatin),<\/p>\n $\"Lovastatin\"$ <\/p>\n F. (1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a- hexahydronaphthalen-1-yl (2Z)-2-methylbut-2-enoate.<\/p>\n","protected":false},"excerpt":{"rendered":" (Ph. Eur Monograph 1538) C24H36O5\u00a0 \u00a0 \u00a0 \u00a0 404.5\u00a0 \u00a0 \u00a0 \u00a0 75330-75-5 Action and use HMG Co-A reductase inhibitor; lipid-regulating drug. DEFINITION (1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a- hexahydronaphthalen-1-yl (2S)-2-methylbutanoate. Content 97.0 per cent to 102.0 per cent (anhydrous substance). CHARACTERS Appearance White or almost white, crystalline powder. Solubility Practically insoluble in water, soluble in acetone, sparingly soluble in…<\/p>\n","protected":false},"author":2,"featured_media":17436,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[174],"tags":[],"class_list":["post-17406","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\/17406","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\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=17406"}],"version-history":[{"count":2,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/17406\/revisions"}],"predecessor-version":[{"id":17438,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/17406\/revisions\/17438"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/17436"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=17406"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=17406"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=17406"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Content<\/h2>\n97.0 per cent to 102.0 per cent (anhydrous substance).<\/p>\n

CHARACTERS<\/h2>\n

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

Solubility<\/h3>\nPractically insoluble in water, soluble in acetone, sparingly soluble in anhydrous ethanol.<\/p>\n

IDENTIFICATION<\/h2>\nA. Specific optical rotation (see Tests).<\/p>\nB. Infrared absorption spectrophotometry (2.2.24).<\/p>\nComparison: lovastatin CRS.<\/p>\n

TESTS<\/h2>\n

Specific optical rotation (2.2.7)<\/h4>\n+ 325 to + 340 (anhydrous substance).<\/p>\nDissolve 0.125 g in acetonitrile R and dilute to 25.0 mL with the same solvent.<\/p>\n

Water (2.5.12)<\/h4>\nMaximum 0.5 per cent, determined on 1.00 g.<\/p>\n

Sulfated ash (2.4.14)<\/h4>\nMaximum 0.2 per cent, determined on 1.0 g.<\/p>\n

STORAGE<\/h2>\nUnder nitrogen, at a temperature of 2 \u00b0C to 8 \u00b0C.<\/p>\n

Content<\/h2>\n
97.0 per cent to 102.0 per cent (anhydrous substance).<\/p>\n

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

Solubility<\/h3>\n
Practically insoluble in water, soluble in acetone, sparingly soluble in anhydrous ethanol.<\/p>\n

IDENTIFICATION<\/h2>\n
A. Specific optical rotation (see Tests).<\/p>\n
B. Infrared absorption spectrophotometry (2.2.24).<\/p>\n
Comparison: lovastatin CRS.<\/p>\n

Specific optical rotation (2.2.7)<\/h4>\n
+ 325 to + 340 (anhydrous substance).<\/p>\n
Dissolve 0.125 g in acetonitrile R and dilute to 25.0 mL with the same solvent.<\/p>\n

Water (2.5.12)<\/h4>\n
Maximum 0.5 per cent, determined on 1.00 g.<\/p>\n

Sulfated ash (2.4.14)<\/h4>\n
Maximum 0.2 per cent, determined on 1.0 g.<\/p>\n

STORAGE<\/h2>\n
Under nitrogen, at a temperature of 2 \u00b0C to 8 \u00b0C.<\/p>\n