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| Name | L-Proline (Ph. Eur., USP) pure, pharma grade |
| Appearance | White crystalline powder |
| Purity | ≥ 98% |
| Cas Number | 147-85-3 |
| Molecular Formula | C5H9NO2 |
| Molecular Weight | 115.13 g/mol |
| Solubility | Soluble in water, slightly soluble in ethanol |
| Melting Point | 228-232°C |
| Boiling Point | 170-173°C |
| Storage Conditions | Store in a cool, dry place away from light |
| Usage | Commonly used in pharmaceutical formulations and as a cell culture supplement |
FAQ
What is L-Proline (Ph. Eur., USP) and what are its pharmaceutical benefits compared to other
grades of proline?
L-Proline (Ph. Eur., USP) is a high-quality pharmaceutical grade form of the amino acid proline. It meets the quality standards set by the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopeia (USP), ensuring its purity and safety for use in pharmaceutical applications. Compared to other grades of proline, L-Proline (Ph. Eur., USP) is tested and certified to meet strict quality standards, making it a reliable choice for pharmaceutical formulations.
How is L-Proline (Ph. Eur., USP) produced and what are the key features of its manufacturing process?
L-Proline (Ph. Eur., USP) is typically produced through fermentation of a suitable carbohydrate source with specialized microorganisms. The production process involves careful monitoring of fermentation conditions, purification steps, and quality control testing to ensure the final product meets the required standards. The key features of the manufacturing process for L-Proline (Ph. Eur., USP) include adherence to Good Manufacturing Practices (GMP), use of high-quality raw materials, and thorough testing at each stage to guarantee purity and quality.
What are the primary applications of L-Proline (Ph. Eur., USP) in the pharmaceutical industry?
L-Proline (Ph. Eur., USP) is commonly used in the pharmaceutical industry for a variety of applications, including as a stabilizer for protein and peptide drugs, a component of cell culture media, and a precursor in the synthesis of pharmaceutical compounds. Its unique properties make it an essential ingredient in formulations where stability, solubility, and bioavailability are critical factors. Additionally, L-Proline (Ph. Eur., USP) is widely used in the production of parenteral nutrition solutions, wound healing products, and dermatological formulations.
What are the key quality control measures in place to ensure the purity and consistency of L-Proline (Ph. Eur., USP)?
L-Proline (Ph. Eur., USP) undergoes rigorous quality control testing throughout the manufacturing process to guarantee its purity and consistency. These measures include identity testing, assay determination, impurity analysis, microbial limits testing, and heavy metals analysis. Additionally, L-Proline (Ph. Eur., USP) is subjected to stability testing to assess its shelf life under various storage conditions. By adhering to these strict quality control measures, manufacturers can ensure that each batch of L-Proline (Ph. Eur., USP) meets the required specifications for pharmaceutical use.
How can pharmaceutical companies benefit from using L-Proline (Ph. Eur., USP) in their formulations?
Pharmaceutical companies can benefit from using L-Proline (Ph. Eur., USP) in their formulations due to its high quality, purity, and compatibility with regulatory standards. By choosing L-Proline (Ph. Eur., USP) for their formulations, companies can ensure the safety and efficacy of their products, as well as meet the quality requirements set by regulatory authorities. Additionally, L-Proline (Ph. Eur., USP) offers a reliable and consistent source of proline for pharmaceutical applications, allowing companies to achieve desired results in their formulations while minimizing risks associated with impurities or variability.
L-Proline (Ph. Eur., USP) is a high-quality pharmaceutical grade form of the amino acid proline. It meets the quality standards set by the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopeia (USP), ensuring its purity and safety for use in pharmaceutical applications. Compared to other grades of proline, L-Proline (Ph. Eur., USP) is tested and certified to meet strict quality standards, making it a reliable choice for pharmaceutical formulations.
How is L-Proline (Ph. Eur., USP) produced and what are the key features of its manufacturing process?
L-Proline (Ph. Eur., USP) is typically produced through fermentation of a suitable carbohydrate source with specialized microorganisms. The production process involves careful monitoring of fermentation conditions, purification steps, and quality control testing to ensure the final product meets the required standards. The key features of the manufacturing process for L-Proline (Ph. Eur., USP) include adherence to Good Manufacturing Practices (GMP), use of high-quality raw materials, and thorough testing at each stage to guarantee purity and quality.
What are the primary applications of L-Proline (Ph. Eur., USP) in the pharmaceutical industry?
L-Proline (Ph. Eur., USP) is commonly used in the pharmaceutical industry for a variety of applications, including as a stabilizer for protein and peptide drugs, a component of cell culture media, and a precursor in the synthesis of pharmaceutical compounds. Its unique properties make it an essential ingredient in formulations where stability, solubility, and bioavailability are critical factors. Additionally, L-Proline (Ph. Eur., USP) is widely used in the production of parenteral nutrition solutions, wound healing products, and dermatological formulations.
What are the key quality control measures in place to ensure the purity and consistency of L-Proline (Ph. Eur., USP)?
L-Proline (Ph. Eur., USP) undergoes rigorous quality control testing throughout the manufacturing process to guarantee its purity and consistency. These measures include identity testing, assay determination, impurity analysis, microbial limits testing, and heavy metals analysis. Additionally, L-Proline (Ph. Eur., USP) is subjected to stability testing to assess its shelf life under various storage conditions. By adhering to these strict quality control measures, manufacturers can ensure that each batch of L-Proline (Ph. Eur., USP) meets the required specifications for pharmaceutical use.
How can pharmaceutical companies benefit from using L-Proline (Ph. Eur., USP) in their formulations?
Pharmaceutical companies can benefit from using L-Proline (Ph. Eur., USP) in their formulations due to its high quality, purity, and compatibility with regulatory standards. By choosing L-Proline (Ph. Eur., USP) for their formulations, companies can ensure the safety and efficacy of their products, as well as meet the quality requirements set by regulatory authorities. Additionally, L-Proline (Ph. Eur., USP) offers a reliable and consistent source of proline for pharmaceutical applications, allowing companies to achieve desired results in their formulations while minimizing risks associated with impurities or variability.
