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GMP Biotech Product

ARGININE (L) HYDROCHLORIDE BIOTECH

USP, EP, JP, GMP

COAs Spec Sheet

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Product Code: LARH-6201
Intended for Use in Biopharmaceutical & Biotechnological Applications and Products

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 and meets multicompendial applications.

Formula: C6H14N4O2 · HCl
F.W.: 210.66 g/mol
CAS #: 1119-34-2

Product Specifications:

ANALYSIS

SPECIFICATIONS

Appearance

 

 White or almost white crystalline powder or colorless crystals

Ammonium (EP/JP)

 

 ≤ 0.02%

Appearance of Solution (EP)

 

 Clear, Colorless Solution

Arsenic (JP)

 

 ≤ 2 ppm

Assay (dried basis) (USP/EP/JP)

 

 98.5 – 101.0%

Chloride Content (USP)

16.5% - 17.1%

Clarity and Color of Solution (JP)

 

Passes Test

Heavy Metals (JP)

 

  ≤ 20 ppm

Identification, IR (USP-A/EP-B/JP-1)

 

Conforms to Reference Standard

Identification, Specific Optical Rotation (EP-A/USP/JP)

 

+21.5° to +23.5°

Identification C, TLC (EP)

 

 Passes Test

Identification D, Color

 

 Passes Test

Identification, Chlorides (EP-E/JP-2))

 

  Passes Test

Iron (EP)

 

≤ 10 ppm

Loss on Drying (USP, EP, JP)

 

≤ 0.20%

Ninhydrin-positive Substances (USP/EP)

Each Individual Impurity
Total Impurities

≤ 0.2%
≤ 0.5%

pH (1 in 10) (JP)

 

4.7 – 6.2

Residue on Ignition, Sulfated Ash (USP/EP/JP)

 

 ≤ 0.1%

Sulfate (USP/EP/JP) 

 

 ≤ 0.028%

 

Printable Version

General Product Description:

Molecular Formula: C6H14N4O2 · HCl
Molecular Weight: 210.66 g/mol
CAS Number: 1119-34-2

L-Arginine HCl Biotech:

  • Appears as a white or near white crystalline powder
  • 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-Arginine monohydrochloride, (S)-(+)-Arginine hydrochloride, L Arg. HCl

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 Size:

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.