BioBuffer Solution Brand Product
GMP Amino Acid
GMP Manufactured Product
Arginine(L) HCl
USP, EP, JP, GMP Grade
Minimum Order Quantity: 25kgLead Time: If no stock, 3-6-months
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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 | ||
| 98.5% - 101.0% | ||
| 16.5% - 17.1% | ||
| ≤ 2.0% ≤ 0.5% | ||
| Conforms with Reference | ||
| +21.5° to +23.5° | ||
Loss on Drying | ≤ 0.20% | ||
| ≤ 0.1% | ||
| ≤ 0.028% | ||
Related Substances | Passes Test | ||
| EP COMPENDIA | |||
|---|---|---|---|
ANALYSIS | SPECIFICATIONS | ||
Appearance | White or almost white crystalline powder or colorless crystals | ||
| Ammonium | ≤ 0.02% | ||
| Clear, Colorless Solution | ||
| 98.5% - 101.0% | ||
| +21.5° to +23.5° | ||
| 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% | ||
| ≤ 0.2% ≤ 0.5% | ||
Residue on Ignition, Sulfated Ash | ≤ 0.1% | ||
Sulfates | ≤ 0.028% | ||
| JP COMPENDIA | |||
|---|---|---|---|
ANALYSIS | SPECIFICATIONS | ||
| ≤ 0.02% | ||
| ≤ 2ppm | ||
| 98.5 –101.5% | ||
| Passes Test | ||
| Conforms to Reference Standard | ||
| +21.5 to +23.5° | ||
| Identification, Chlorides | Passes Test | ||
Heavy Metals | ≤ 20ppm | ||
Loss on Drying | ≤ 0.20% | ||
| 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
Tech Docs
Allergen Statement
Animal Origin Statement
BSE/TSE Statement
Catalyst Statement
Elemental Impurity Statement
Genotoxic Impurity Statement
GMO Statement
GMP Statement
Imidazole Statement
Ingredient Declaration
Irgafos Statement
Kosher / Halal Statement
Label Copy
Latex Statement
Melamine Statement
Mycotoxin/Aflatoxin Statement
Nitrosamine Risk Assessment
Phthalate, Bisphenol, Dioxin Statement
Process Flow Diagram
Proposition 65 Statement
Quality Control Testing and Validation
Regulatory Packet
Residual Solvents Statement
Safety Data Sheet
Seal Integrity Statement
Slip Agent Statement
Specifications
Stability Statement
Supply Chain Statement
Testing Methods
COAs
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LARH L02 1124 0008 LARH 4220 LARH 0124 00007 LARH 4220 93 LARH 0124 00006 LARH 4220 93 LARH 0124 00005 LARH 4220 93 LARH 0124 00004 LARH 4220 92 LARH 0124 00003 LARH 4220 92 LARH 0124 00002 LARH 4220 91 LARH 0124 00001 LARH 4220 91 LARH 4220 LARH 0324 00000 S2309003 LARH 4220 LARH 0324 00000 S2309002 LARH 4220 LARH 0324 00000 S2309001
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.
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