L-Arginine HCl, GMP, USP Amino Acid

BioBuffer Solution Brand Product

GMP Amino Acid

GMP Manufactured Product

Arginine(L) HCl

USP, EP, JP, GMP Grade
Product Code: LARH-4220

Minimum Order Quantity: 25kg Lead Time: If no stock, 3-6-months

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UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

1x5kg

1x10kg

Total

Product Code: LARH-4220

Intended For Use In Pharmaceutical GMP Processes 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 for use in GMP Pharmaceutical Production. Primary application is as a nutrient to cell culture media along with other GMP Pharma applications.

CAS #: 1119-34-2
Formula: C₆H₁₄N₄O₂ · HCl
Sol. In H₂O (g/L): 40
F.W.: 210.66 g/mol

Product Specifications:

USP COMPENDIA

ANALYSIS

SPECIFICATIONS

Assay (dried basis)

98.5% - 101.0%

Chloride Content

16.5% - 17.1%

Impurities

Individual Impurities

Total Impurities

≤ 2.0%

≤ 0.5%

Identification, IR

Conforms with Reference

Identification, Optical Rotation, Specific Rotation

+21.5° to +23.5°

Loss on Drying

≤ 0.20%

Residue on Ignition, Sulfated Ash

≤ 0.1%

Sulfate

≤ 0.028%

Related Substances

Passes Test

EP COMPENDIA

ANALYSIS

SPECIFICATIONS

Appearance

White or almost white crystalline powder or colorless crystals

Ammonium

≤ 0.02%

Appearance of Solution

Clear, Colorless Solution

Assay (dried basis)

98.5% - 101.0%

Identification, Specific Optical Rotation

+21.5° to +23.5°

Identification, IR

Conforms to Reference Standard

Identification C, TLC

Passes Test

Identification D, Color

Passes Test

Identification, Chlorides

Passes Test

Iron

≤ 10 ppm

Loss on Drying

≤ 0.20%

Ninhydrin-positive substances

Each Individual Impurity
Total Impurities

≤ 0.2%

≤ 0.5%

Residue on Ignition, Sulfated Ash

≤ 0.1%

Sulfates

≤ 0.028%

JP COMPENDIA

ANALYSIS

SPECIFICATIONS

Ammonium

≤ 0.02%

Arsenic

≤ 2ppm

Assay (dried basis)

98.5 – 101.5%

Clarity and Color of Solution

Passes Test

Identification, IR

Conforms to Reference Standard

Identification, Specific Optical Rotation

+21.5 to +23.5°

Identification, Chlorides

Passes Test

Heavy Metals

≤ 20ppm

Loss on Drying

≤ 0.20%

pH (1 in 10)

4.7 – 6.2

Related Substances

Passes Test

Residue on Ignition, Sulfated Ash

≤ 0.1%

Sulfate

≤ 0.028%

Printable Version

General Product Description:

L-Arginine HCl 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-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 our cGMP Platform in India 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 International Organization for Standardization (ISO) registered Quality Managed Systems. 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.

Country of Origin

India

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.