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Intended For Use In Pharmaceutical GMP Processes and Products  

• L-Histidine Monohydrochloride, Monohydrate has been manufactured for use as a critical process chemical for downstream biological drug manufacturing. L-Histidine Monohydrochloride, Monohydrate has been manufactured and purified under strict ICH-Q7 guidelines for excipient materials and can be considered an excipient grade product.

General Product Description:

• L-Histidine Monohydrochloride, Monohydrate, LHMM-4250, is produced at our cGMP platform in India and then shipped to our Bangor, PA facility where it is tested and repackaged under cGMP conditions.
• L-Histidine Monohydrochloride, Monohydrate is a White Crystalline product.
• Molecular Formula: C6H9N3O2 •HCl • H2O
• Molecular Weight: 209.64 g/mol.
• CAS Number: 5934-29-2
• There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
• BioSpectra certifies that all L-Histidine Monohydrochloride, Monohydrate, LHMM-4250 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts.
• L-Histidine Monohydrochloride, Monohydrate manufactured at our cGMP platform in India and any raw materials used in the manufacture of L-Histidine Monohydrochloride, Monohydrate at BioSpectra are not subject to genetic modification.
• Synonyms: L-α-Amino-β-(4-imidazolyl)propionic acidmonochloride; 4-Hydroxy-2-methyl-1,1-dioxo-N-(pyridin-2-yl)-1, 2-dihydro-1lamb; da6,2- benzothiazine-3-carboxamide.

GMP Compliance:

• Bio Pharma Grade L-Histidine Monohydrochloride Monohydrate, LHMM-4250, is suitable for use as an excipient. It is manufactured in accordance with International Organization for Standardization (ISO) registered Quality Managed Systems This grade of L-Histidine Monohydrochloride Monohydrate is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.

Retest Date:

• The recommended retest period for L-Histidine, Monohydrochloride, Monohydrate is two years from the date of manufacture.

Storage and Shipping Conditions:

• Ship and Store in ambient temperature.

Package Sizes:

• 10kg, 25kg and 50kg pails.

Country of Origin:

• India

This product is then repacked and retested under cGMP at our Bangor USA cGMP FDA Regulated Facility.