L-ARGININE HYDROCHLORIDE BIOTECH, Synthetic

GMP Biotech Product

L-ARGININE HYDROCHLORIDE BIOTECH, Synthetic

USP, EP, JP, GMP (Large Batch - Up to 500kg)
Product Code: LARH-6350

Product Inquiry COAs Spec Sheet

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Price per unit (USD)				Price per kilogram (USD)
100g	500g	1kg	2-5kg (1kg ea)	1x5kg	1x10kg
$95 ea.	$270 ea.	$250 ea.	$225 ea.	$205 /kg	$185 /kg

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UNIT SIZE

QUANTITY

100g

500g

1kg

2-5kg

1x5kg

1x10kg

Total

Product Code: LARH-6350

Suitable for use in biological and biotech chemical process applications from R&D through scale cGMP production.

L-Arginine HCl is the mono hydrochlorinated 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 and Color

White or Almost White Crystalline Powder or Colorless Crystals

Ammonium (EP/JP)

< = 200 ppm

Appearance of Solution (EP)

Clear, Colorless Solution

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

Endotoxin

< = 5 EU/g

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 (EP)

Passes Test

Identification D (EP)

Passes Test

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

Passes Test

Loss on Drying (USP/EP/JP)

< = 0.20%

Microbial Content

TAMC

TYMC

< = 100 CFU/g

< = 10 CFU/g

Ninhydrin-positive Substances (USP/EP)

Each Individual Impurity

Total Impurities

< = 0.2%

< = 0.5%

pH (1 in 10) (JP)

4.7 – 6.2

Related Substances (USP/JP)

Passes Test

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

< = 0.1%

Sulfate (USP/EP/JP)

< = 280 ppm

Trace Metals

Arsenic (As)

Iron (Fe) (EP)

Lead (Pb)

< = 2 ppm

< = 10 ppm

< = 20 ppm

Printable Version

Key Product Features:

Appears as a white or almost white crystalline powder or colorless crystals
GMP manufactured in accordance with the QMS
Manufactured in an enzyme free, hormone free and animal free environment
Contains 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; L Arg. HCl; (25)-2-amino-5-(diaminomethylideneamino) pentanoic acid; hydrochloride

Shelf-Life Policy:

Unless otherwise noted on the Shelf-Life Statement and CoA, this product has a 2-year retest date supported by a 3-year ICH Q1 Stability Study (if one is completed).

Storage & Shipping:

Refer to SDS.

Package Sizes:

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.