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Product Category

Excipient

GMP Manufactured Product

L-HISTIDINE Monohydrochloride, Monohydrate, LBLE, EP, JP, GMP Excipient Grade

Low Bioburden, Low Endotoxin, GMP Manufactured

Product Code: LHMM-4250

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Intended For Use As An Excipient


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.

Product Specifications

EP COMPENDIA
  ANALYSIS SPECIFICATIONS
Ammonium  
≤ 0.02%
Appearance of Solution  
Passes Test
Assay (Dried Substance)  
99.0 - 101.0%
Identification A, Specific Optical Rotation
(dried substance)		 +9.2° to +10.6°
Identification B, pH 3.0-5.0
Identification C, IR Passes Test
Identification D Passes Test
Identification E Passes Test
Identification F Passes Test
Iron ≤ 10 ppm
Loss on Drying 7.0-10.0%
Ninhydrin-positive substances
Any Individual Impurity
Total Impurities
 ≤0.2%
≤0.5%
Sulfated Ash  ≤0.1%
Sulfates ≤300ppm 
 
 
JP COMPENDIA
  ANALYSIS SPECIFICATIONS (EP)
Ammonium  
≤ 0.02%
Assay (Anhydrous basis)  
99.0-101.0%
Clarity and Color of Solution Clear and Colorless
Identification 1, IR Passes Test
Identification 2, Chloride Passes Test
Heavy Metals ≤ 10ppm
Iron ≤ 10ppm
Loss on Drying NMT 0.20%
Optical Rotation +9.2° to +10.6°
pH 3.5-4.5
Related Substances  Passes test 
Residue on Ignition ≤0.1% 
Sulfate  ≤0.028%
 Water  7.2-10.0%
 
 
ADDITIONAL ANALYSES
  ANALYSIS SPECIFICATIONS (JP)
Appearance and Color White or colorless crystalline powder crystals
Bioburden ≤100CFU/g
Endotoxin ≤100EU/g
 
Printable Version
List of C of As files
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COAs and Tech Docs

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LHMM-4250

CAS #: 5934-29-2

Formula: C6H9N3O2 • H2O

Sol. In H2O (g/L): 149.55

F.W.: 209.64 g/mol

pH @ 20°C: 4.38 - 4.48

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 the IPEC-PQG Joint Good Manufacturing Practice Guide For Excipients. This grade of Bis- Tris HCl 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. 

Additional Packaging Information

https://www.biospectra.us/technical/packaging