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GMP Biotech Product

HISTIDINE (L) MONOHYDROCHLORIDE, MONOHYDRATE BIOTECH

EP, JP, LBLE*, GMP

*Low Bioburden, Low Endotoxin

Product Inquiry COAs Spec Sheet
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Price per unit (USD) Price per kilogram (USD)
100g 500g 1kg 2-5kg (1kg ea) 1x5kg 1x10kg
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QUANTITY
Product Code: LHMM-6250
Intended for Use in Biopharmaceutical & Biotechnological Applications and Products

L-Histidine Monohydrochloride, Monohydrate Biotech has been synthesized and purified under full GMP Conditions and meets multicompendial applications.

Formula: C6H9N3O2 •HCl • H2O
F.W.: 209.64 g/mol
CAS #: 5934-29-2

Product Specifications

  ANALYSIS SPECIFICATIONS
Ammonium (EP, JP)  
≤ 0.02%
Appearance of Solution (EP)  
Passes Test
Appearance and Color White crystalline powder or crystals
Assay, Dried Substance (EP)  
98.5 – 101.0%
Assay, Anhydrous Basis (JP) 99.0 – 101.0%
Bioburden < 100 CFU/g
Endotoxin < 100 CFU/g
Identification, Specific Optical Rotation (EP/A) +9.2° to +10.6°
Identification B, pH (EP) 3.0 – 5.0
Identification C, IR (EP-C, JP-1) Conforms to Reference Standard
Identification D (EP) Passes Test
Identification E (EP) Passes Test
Identification F (EP) Passes Test
Identification 2, Chloride (JP) Passes Test
Iron (EP, JP) ≤ 10 ppm
Heavy Metals (JP) ≤ 10 ppm
Loss on Drying (EP) 7.0 – 10.0%
Ninhydrin-positive substances (EP)

Any Individual Impurity

Total Impurities 

≤ 0.2%

≤ 0.5%

Optical Rotation (JP) +9.2° to +10.6°
pH (JP) 3.5 – 4.5
Related Substances (JP) Passes Test
Residue on Ignition/ Sulfated Ash (EP, JP)  ≤ 0.1%
Sulfates (EP) ≤ 300ppm
Sulfates (JP) ≤ 280ppm
Clarity and Color of Solution (JP) Clear and Colorless
Water, KF (JP)  7.2 – 10.0%

 

Printable Version

General Product Description:

Molecular Formula: C6H9N3O2 •HCl • H2O
Molecular Weight: 209.64 g/mol.
CAS Number: 5934-29-2

L-Histidine Monohydrochloride, Monohydrate Biotech:

  • Appears as a white crystalline product.
  • Is manufactured under an ISO Quality Managed cGMP System
  • Manufactured in an enzyme free, hormone free and animal free environment
  • Has no known major food allergens (as defined by FDA and WHO)
  • The final product nor its raw materials are not derived from nor come into contact with animals, animal parts, animal products, and/or animal byproducts or derivatives.
  • Is not subject to genetic modification
  • Synonyms: L-α-Amino-β-(4-imidazolyl) propionic acid monochloride

Shelf Life Policy:

Three-year expiry from the date of manufacture.

Storage and Shipping Conditions:

Please refer to the SDS for storage and shipping conditions.

Package Sizes:

100g, 500g, 1kg, 5kg, 10kg, 25kg, 50kg

Bulk GMP Fine Chemicals exclusively manufactured in North America

American Manufactured - FDA Registered GMP Facilities: Parenteral Excipients, GMP Small Molecule Intermediates, GMP Biological Buffers, Parenteral Carbohydrates, GMP Chlorinated Amino Acids, GMP Solutions in Sterile Single Use Packaging and other Reagent & GMP Fine Chemicals.