ARGININE (L) HYDROCHLORIDE BIOTECH, Synthetic

GMP Biotech Product

ARGININE (L) HYDROCHLORIDE BIOTECH, Synthetic

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

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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

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)

≤ 200 ppm

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

Endotoxin

≤ 5 EU/g

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 (EP)

Passes Test

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

Passes Test

Iron (EP)

≤ 10 ppm

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

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:

Each Certificate of Analysis (CofA) will contain a 2-year retest/recertification date supported by a 3-year ICH Q1 Stability Study (if one is completed).

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.