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

ANALYSIS

SPECIFICATIONS (USP)

Appearance

 

White or almost white crystalline powder

Assay (dried basis)  

98.5% - 101.5%

Chloride Content  

16.5%- 17.1%

Chromatographic Purity

Conforms

Impurities

Individual Impurities
Total Impurities 

NMT 0.5%
NMT 2.0%

Identification A (IR)

 
Passes Test

Loss on Drying @ 105°C

 

≤ 0.2%

Optical Rotation, Specific Rotation

+21.4° to +23.6°

Residue on Ignition

 

≤ 0.1%

Sulfate

 

≤ 0.03%

 

ANALYSIS

SPECIFICATIONS (EP)

Ammonium

 

≤ 0.02%

Appearance of Solution

 

Passes Test

Assay (dried substance)

 

98.5% - 101.0%

Identification (A) Specific Optical Rotation

 

+21.0° to +23.5°

Identification B (IR)

 

Passes Test

Identification C  
Passes Test

Identification D

Passes Test

Identification E- Chlorides

Passes Test

Iron

≤ 10 ppm

Loss on Drying@105°C

 ≤ 0.2%

Ninhydrin-positive substances

For each Impurity
Total Impurities
Reporting Threshold 

NMT 0.2%
NMT 0.5%
0.05%

Sulfated Ash

≤ 0.1%

Sulfate  ≤ 300 ppm

 

ANALYSIS

SPECIFICATIONS (JP)

Ammonium

 

NMT 0.02%

Arsenic

 

NMT 2ppm

Assay (dried basis)

 

98.5 - 101.5%

Clarity and Color of Solution

 

Passes Test

Identification 1 (IR)

 

Passes Test

Identification 2  
Passes Test

Heavy Metals

≤ 20ppm

Loss on Drying

NMT0.20%

Optical Rotation

+21.5 to +23.5°

pH (1 in l0)

 

4.7 -6.2

Related Substances

Passes Test

Residue on Ignition

NMT 0.1%

Sulfate

 NMT 0.028%

  

ANALYSIS

SPECIFICATIONS (ADDITIONAL)

UV Absorbance

At 280nm
At 400nm

≤ 0.137
≤ 0.023 

Printable Version

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

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