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
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ANALYSIS |
SPECIFICATIONS (USP) |
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White or almost white crystalline powder |
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98.5% - 101.5% |
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16.5%- 17.1% |
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Chromatographic Purity |
Conforms |
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NMT 0.5% |
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Passes Test | ||
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≤ 0.2% |
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Optical Rotation, Specific Rotation |
+21.4° to +23.6° |
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≤ 0.1% |
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≤ 0.03% |
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ANALYSIS |
SPECIFICATIONS (EP) |
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≤ 0.02% |
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Passes Test |
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98.5% - 101.0% |
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+21.0° to +23.5° |
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Passes Test |
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Passes Test | ||
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Identification D |
Passes Test |
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Identification E- Chlorides |
Passes Test |
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Iron |
≤ 10 ppm |
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Loss on Drying@105°C |
≤ 0.2% | ||
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NMT 0.2% |
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| Sulfated Ash |
≤ 0.1% |
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| Sulfate | ≤ 300 ppm |
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ANALYSIS |
SPECIFICATIONS (JP) |
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NMT 0.02% |
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NMT 2ppm |
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98.5 - 101.5% |
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Passes Test |
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Passes Test |
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Passes Test | ||
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Heavy Metals |
≤ 20ppm |
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Loss on Drying |
NMT0.20% |
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Optical Rotation |
+21.5 to +23.5° |
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4.7 -6.2 |
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Related Substances |
Passes Test |
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Residue on Ignition |
NMT 0.1% |
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Sulfate |
NMT 0.028% |
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ANALYSIS |
SPECIFICATIONS (ADDITIONAL) |
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≤ 0.137 |
| Key Compliance Attributes of BioSpectra Grades | Bio Excipient Grade ICH-Q7 Compliant Manufactured | ||
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| indicates an attribute or level of compliance which is granted or available based on the purchase of the product grade. |
| Bio Excipient Grade: Intended for use as ICH-Q7 Compliant Active Pharmaceutical Ingredient |
| LBLE: LBLE applies when product specifications include requirements for Bioburden Testing (TAMC/TYMC and/or Endotoxin). LBLE stands for Low Bioburden, Low Endotoxin non-sterile products suitable for further use in parenteral manufacturing and other sterile applications. |
| List of C of As files |
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| No files available right now. |
COAs and Tech Docs
- Printable Spec Sheet
- Product Inquiry
- Compliance
- C of As
- SDS
LARH-4220
CAS #: 1119-34-2
Formula: C6H14N4O2 · HCl
Sol. In H2O (g/L): 40
F.W.: 210.66 g/mol
General Product Description:
- The manufacturing of L-Arginine HCl LARH- 4220 is performed at BioSpectra’s Bangor, PA facility utilizing multi-use equipment. Equipment used in the manufacturing of LARH-4220 is cleaned in accordance with BioSpectra’s Process Cleaning Validation Master Plan.
- 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 BioSpectra 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.
Additional Packaging Information
https://www.biospectra.us/technical/packaging