GMP Process Chemical
GMP Manufactured ProductL-ARGININE HCl, USP, EP, JP,
GMP Grade
Product Code: LARH-4220
Intended For Use In Pharmaceutical GMP Processes
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.
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% |
||
| EP COMPENDIA | |||
|---|---|---|---|
|
ANALYSIS |
SPECIFICATIONS |
||
|
Appearance |
White or almost white crystalline powder or colorless crystals |
||
|
≤ 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% |
||
|
Clear and Colorless |
||
|
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% | ||
COAs and Tech Docs
- Printable Spec Sheet
- Product Inquiry
- C of As
- SDS
- Elemental Impurities
- Regulatory Packet
- Process Flow Diagram
- Animal Origin Statement
- BSE/TSE
- Residual Solvents
- Stability Data Statement
- Supply Chain
- Test Methods
- Nitrosamine Risk Assessment
- Latex Statement
- External Validation Report
- Kosher / Halal Statement
- Quality Control Testing and Validation Statement
- Seal Integrity Statement
LARH-4220
CAS #: 1119-34-2
Formula: C6H14N4O2 · HCl
Sol. In H2O (g/L): 40
F.W.: 210.66 g/mol
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 the IPEC-PQG Joint Good Manufacturing Practice Guide. 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
Additional Packaging Information
https://www.biospectra.us/technical/packaging