Product Category

Excipient

ICH-Q7 GMP Manufactured Product

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

Low Bioburden, Low Endotoxin, GMP Manufactured

Product Code: LHMM-3250

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

  ANALYSIS SPECIFICATIONS
Color  
White or colorless
Appearance  
Crystalline powder or crystals
Bioburden  
≤ 100 CFU/g
Endotoxin ≤ 100 EU/g
 
 
  ANALYSIS SPECIFICATIONS (EP)
Identity – IR  
Conforms to Reference Standard
Specific Optical Rotation @ 20°C  
+9.2° to +10.6° (on dried basis)
Ninhydrin – Positive Substances For each impurity: ≤ 0.2%
Total: ≤ 0.5%
Ammonium Passes Test
Iron ≤ 10 ppm
Loss on Drying 7.0 – 10.0% 
Sulphated Ash ≤ 0.1%
 
 
  ANALYSIS SPECIFICATIONS (JP)
Clarity and Color of Solution  
Clear and colorless
pH  
3.5 – 4.5
Sulfate ≤ 0.028%
Heavy Metals ≤ 10 ppm
Water 7.2 – 10.0%
Assay (Anhydrous Basis) 99.0 – 101.0%
 
Key Compliance Attributes of BioSpectra Grades Bio Excipient Grade ICH-Q7 Compliant Manufactured
Suitable for Research and Diagnostic  
Yes-image
Each Batch 100% Analyzed  
Yes-image
Management of Change  
Yes-image
Validated Analytical Methods  
Yes-image
Compendial Testing  
Yes-image
Trace Metals Analyzed  
Yes-image
Stability Testing Program  
Yes-image
BioSpectra Supply Chain Audit Trail  
Yes-image
Product Origin Statement  
Yes-image
Customer Quality Audits  
Yes-image
Validated Manufacturing Process  
Yes-image
US Manufactured at BioSpectra  
Yes-image
Customized Additional Specifications  
Yes-image
Multi-Compendial Testing  
Yes-image
Low Bioburden Low Endotoxin (LBLE)  
Yes-image
Enzyme Tested  
Yes-image
Suitable for use as Excipient  
Yes-image
Microbial / Endotoxin Tested  
Yes-image
Manufactured in FDA Registered Facility  
Yes-image
Customized Manufacturing Schedule  
Yes-image
Custom Regulatory Packet  
Yes-image
Accelerated Stability  
Yes-image
Video Conference access to BioSpectra Sites  
Yes-image
Complete access to Product Traceability  
Yes-image
Access to Supply Chain Information  
Yes-image
ICH-Q7 Qualified Utilities  
Yes-image
ICH-Q7 Compliant Manufactured  
Yes-image
Type II Drug Master File  
Yes-image

Yes-imageindicates an attribute or level of compliance which is granted or available based on the purchase of the product grade.
Bio Excipient Grade: Intended for use as ICH-Q7 Compliant Active Pharmaceutical Ingredient 
LBLE: LBLE applies when product specifications include requirements for Bioburden Testing (TAMC/TYMC and/or Endotoxin).
LBLE stands for Low Bioburden, Low Endotoxin non-sterile products suitable for further use in parenteral manufacturing and other sterile applications.

 

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formula-image
formula-image

LHMM-3250

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:

  • The manufacturing of Bio Excipient Grade L-Histidine, Monohydrochloride, Monohydrate, LHMM-3250 is performed at BioSpectra’s Bangor, PA facility and BioSpectra’s Rensselaer, NY facility utilizing multiuse equipment. Equipment used in the manufacturing of Bio Pharma Grade L-Histidine, Monohydrochloride, Monohydrate is cleaned in accordance with BioSpectra’s Cleaning Validation Plan.
  • 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-3250 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 BioSpectra and any raw materials used in the manufacture of LHistidine, Monohydrochloride, Monohydrate at BioSpectra are not subject to genetic modification.
  • Synonyms: L-α-Amino-β-(4-imidazolyl)propionic acidmonohydrochloride; 4-Hydroxy-2-methyl-1,1-dioxo-N-(pyridin-2-yl)-1, 2-dihydro-1lamb; da6,2-benzothiazine-3-carboxamide

 



GMP Compliance:

Bio Excipient Grade L-Histidine, Monohydrochloride, Monohydrate, LHMM-3250 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of L-Histidine, Monohydrochloride, Monohydrate is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.

Retest Date:

The recommended retest period for L-Histidine 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.

Additional Packaging Information

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