PHR1332

L-Proline

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): L-Proline, (S)-Pyrrolidine-2-carboxylic acid
• Empirical Formula (Hill Notation): C₅H₉NO₂
• CAS Number: 147-85-3
• Molecular Weight: 115.13
• Beilstein: 80810
• EC Number: 205-702-2
• MDL number: MFCD00064318
• PubChem Substance ID: 329823317
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to Ph. Eur. P3350000; traceable to USP 1568506
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• mp: 228 °C (dec.) (lit.)
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-30°C
• SMILES string: OC(=O)[C@@H]1CCCN1
• InChI: 1S/C5H9NO2/c7-5(8)4-2-1-3-6-4/h4,6H,1-3H2,(H,7,8)/t4-/m0/s1
• InChI key: ONIBWKKTOPOVIA-BYPYZUCNSA-N

Description

General description

L-Proline is a non-essential amino acid. Peptides bond to proline, making it a useful building block for proteins. It can be used as a cell culture media component for the commercial biomanufacturing of therapeutic recombinant proteins and monoclonal antibodies.
Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Application

L-Proline may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography.

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC3756 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Storage Class Code: 13 - Non Combustible Solids
• WGK: WGK 1
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable