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L(+)-Histidine monohydrochloride monohydrate 98.5-101.5% (dried basis), Multi-Compendial, Macron Fine Chemicals™

Supplier: MACRON AVANTOR BRAND

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Management of Change (MOC) category = R

4942-06EA 51760.73 INR InStock
4942-06 4942-09 4942-07 MACR4942-05 MACR4942-76
L(+)-Histidine monohydrochloride monohydrate 98.5-101.5% (dried basis), Multi-Compendial, Macron Fine Chemicals™
L(+)-Histidine monohydrochloride monohydrate


Formula: C₆H₉N₃O₂·HCl·H₂O
MW: 209.63 g/mol
Melting Pt: 259
 MDL Number: MFCD00151027
CAS Number: 5934-29-2
Merck Index: 13,04741
https://qa.digitalassets.avantorsciences.com/adaptivemedia/rendition?id=561d2381f930afe618f78d680790ea9a43f6596c&vid=561d2381f930afe618f78d680790ea9a43f6596c&prid=web&clid=SAPDAM
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Specification Test Results
Meets B.P. Chemical Specifications
Meets E.P. Chemical Specifications
Meets J.P. Chemical Specifications
GMP Manufactured Product
CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical
EP/BP - Assay (C₆H₉N₃O₂·HCl) (dried basis) 98.5 - 101.0 %
EP/BP - Identification A Passes Test
EP/BP - Identification B Passes Test
EP/BP - Identification C Passes Test
EP/BP - Identification F Passes Test
EP/BP - Appearance of Solution Passes Test
EP/BP - pH 3.0 - 5.0
EP/BP - Specific Rotation [Å]²º^D (+) 9.2 - 10.6 Degree
EP/BP-Ninhydrin-Positive Substances-Each ≤ 0.2 %
EP/BP-Ninhydrin-Positive Substances-Total Impurities ≤ 0.5 %
EP/BP - Sulfate (SO₄) ≤ 300 ppm
EP/BP - Ammonium (NH₄) ≤ 0.02 %
EP/BP - Iron (Fe) ≤ 10 ppm
EP/BP - Loss on Drying at 150°C 7.0 - 10.0 %
EP/BP - Ash (sulfated) ≤ 0.1 %
JP - Identification Passes Test
JP - Optical Rotation (+) 9.2 - 10.6
JP - pH 3.5 - 4.5
JP - Clarity and Color of Solution Passes Test
JP - Sulfate (SO₄) ≤ 0.028 %
JP - Ammonium (NH₄) ≤ 0.02 %
JP - Heavy Metals (as Pb) ≤ 10 ppm
JP - Iron (Fe) ≤ 10 ppm
JP - Related Substances Passes Test
JP - Water 7.2 - 10.0 %
JP - Residue on Ignition = 0.10 %
JP - Assay (anhydrous basis) 99.0 - 101.0 %
Endotoxin Concentration, IU/mg ,For Information Only Passes Test
No Class 1,2,3 or other solvents are used or produced in the = 0.028 %
manufacturing or purification of the product. = 0.02 %
Metallic Residues: No metal catalysts or metal reagents, as defined by = 10 ppm
EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of = 10 ppm
this material. Passes Test
Endotoxin Concentration, IU/mg For Information Only

 

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