Product Category

GMP Process Chemical

GMP Manufactured Product

L-ARGININE HCl, USP, EP, JP,
GMP Grade

Product Code: LARH-4220

Intended For Use In Pharmaceutical GMP Processes


L-Arginine HCl is the mono, hydro-chlorinated version of the base amino acid, L-Arginine. This product is synthesized and purified under full GMP conditions for use in GMP Pharmaceutical Production. Primary application is as a nutrient to cell culture media along with other GMP Pharma applications.

Product Specifications

USP COMPENDIA

ANALYSIS

SPECIFICATIONS

Assay (dried basis)  

98.5% - 101.0%

Chloride Content  

16.5% - 17.1%

Chromatographic Purity

Passes Test

Impurities

Individual Impurities

Total Impurities 

≤ 0.5%

≤ 2.0%

Identification A, IR

 
Passes Test

Loss on Drying

 

≤ 0.2%

Optical Rotation, Specific Rotation @20°C

+21.4° to +23.6°

Residue on Ignition

 

≤ 0.1%

Sulfate

 

≤ 0.03%

 

EP COMPENDIA

ANALYSIS

SPECIFICATIONS

Appearance

White or almost white crystalline powder or colorless crystals

Ammonium

 

≤ 0.02%

Appearance of Solution

 

Passes Test

Assay (dried substance)

 

98.5% - 101.0%

Identification A, Specific Optical Rotation @20°C

 

+21.0° to +23.5°

Identification B, IR

 

Passes Test

Identification C  
Passes Test

Identification D

Passes Test

Identification E, (Chloride)

Passes Test

Iron

≤ 10 ppm

Loss on Drying

≤ 0.2%

Ninhydrin-positive
Substances

Any Individual Impurity

Total Impurities 

≤ 0.2%

≤ 0.5%

Sulfated Ash

≤ 0.1%

Sulfates  ≤ 300 ppm

 

JP COMPENDIA

ANALYSIS

SPECIFICATIONS

Ammonium

 

≤ 0.02%

Arsenic

 

≤ 2ppm

Assay (dried basis)

 

98.5 – 101.5%

Clarity and Color of Solution

 

Clear and Colorless

Identification 1, IR

 

Passes Test

Identification 2, Chloride  
Passes Test

Heavy Metals

≤ 20ppm

Loss on Drying

≤ 0.20%

Optical Rotation @ 20°C

+21.5 to +23.5°

pH

 

4.7 – 6.2

Related Substances

Passes Test

Residue on Ignition

≤ 0.1%

Sulfate

 ≤ 0.028%

  

ADDITIONAL ANALYSES

ANALYSIS

SPECIFICATIONS

Absorbance (NEED CONCENTRATION)

280nm

400nm

≤ 0.137 a.u.

≤ 0.023 a.u. 

Printable Version

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formula-image

COAs and Tech Docs

formula-image

LARH-4220

CAS #: 1119-34-2

Formula: C6H14N4O2 · HCl

Sol. In H2O (g/L): 40

F.W.: 210.66 g/mol

General Product Description:

  • The manufacturing of L-Arginine HCl LARH- 4220 is performed at BioSpectra’s Bangor, PA facility utilizing multi-use equipment. Equipment used in the manufacturing of LARH-4220 is cleaned in accordance with BioSpectra’s Process Cleaning Validation Master Plan. 
  • L-Arginine HCl is a white or almost white crystalline powder. 
  • Molecular Formula: C6H14N4O2 • HCl 
  • Molecular Weight: 210.66 g/mol. 
  • CAS Number: 1119-34-2 
  • There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product. 
  • BioSpectra certifies that all L-Arginine HCl, LARH-4220 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts. 
  • L-Arginine HCl manufactured at BioSpectra and any raw materials used in the manufacture of L-Arginine HCl at BioSpectra are not subject to genetic modification. 
  • Synonyms: L-Arginine monohydrochloride, (S)-(+)-Arginine hydrochloride, Arg, HCl, (S)- (+)-2-Amino-5-[(aminoiminomethyl)amino] pentanoic acid monohydrochloride


GMP Compliance:

Bio Pharma Grade L-Arginine HCl, LARH-4220 is suitable for use as a process chemical. It is manufactured in accordance with the IPEC-PQG Joint Good Manufacturing Practice Guide. This grade of L-Arginine HCl is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.

Retest Date:

The recommended expiration period for L-Arginine HCl 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