THIAMINE

At Chemicea Pharmaceutical, we pride ourselves on delivering top-tier pharmaceutical reference standards, including a comprehensive range of high-quality Thiamine impurities. Thiamine (Vitamin B1) is essential for energy metabolism and neural function, playing a crucial role in maintaining overall health. However, understanding and managing Thiamine impurities is critical to ensuring the safety, stability, and efficacy of Thiamine-based pharmaceutical products. In this blog, we delve into the importance of identifying and managing Thiamine impurities to meet stringent regulatory requirements and ensure product quality

Thiamine Structure

Thiamine Details

• CAS Number: 67-03-8
• Chemical Formula: C12H17N4OS: Cl: HCl
• Molecular Weight: 265.35: 35.45: 36.46
• Chemical Name: 3-((4-Amino-2-methylpyrimidin-5-yl)methyl)-5-(2-hydroxyethyl)-4-methylthiazol-3-ium chloride hydrochloride.
• Synonyms:
• Thiamine Chloride
• Thiamine Mononitrate
• Vitamin B1
• Thio-vitamin
• Aneurin

  Thiamine and Its Impurities Tree Diagram

The Chemistry of Thiamine

Thiamine, with the chemical formula C₁₂H₁₇N₄OS and a molecular weight of 265.35 g/mol, consists of two key components: a pyrimidine ring and a thiazole ring, connected by a methylene bridge. This water-soluble vitamin plays a pivotal role in various metabolic processes, making it an essential nutrient in our diet.

Thiamine’s unique structure allows it to actively participate in enzymatic reactions, particularly those involved in energy metabolism and neurological function. The chemical structure and functionality of Thiamine are not only crucial for its biological activity but also for identifying and understanding its impurities.

Understanding Thiamine Impurities

In pharmaceutical production, impurities can arise from various sources, such as manufacturing processes, environmental conditions, or interactions with other substances. Monitoring and controlling these impurities ensures the safety, efficacy, and stability of Thiamine products.

At Chemicea Pharmaceutical, we specialize in synthesizing and analyzing a range of Thiamine impurities to comply with regulatory standards.

Thiamine impurities fall into the following categories:

Degradation Impurities:

These impurities form when Thiamine chemically breaks down due to environmental factors like heat, light, or pH changes. Controlling these impurities is essential for ensuring stability and shelf life.

Process Impurities:

Arise as by-products during Thiamine synthesis. These impurities need to be minimized and monitored to maintain product safety and quality.

Potential Impurities:

Identified based on Thiamine's chemical structure and synthesis pathway, these impurities may not appear in every batch but still require thorough analysis during quality control.

Key Thiamine Impurities Offered by Chemicea

At Chemicea Pharmaceutical, we offer a diverse range of Thiamine impurities, each with a unique chemical profile. These impurities serve as reference standards for research, development, and quality control in pharmaceutical applications. Some of the most notable Thiamine impurities we provide include:

 Classification and Description of Thiamine Impurities

Below are the primary Thiamine impurities identified during production, storage, and degradation processes. These impurities are monitored to ensure the quality and safety of pharmaceutical products:

1. Thiamine EP Impurity A (CAS No. 2380-61-2)

• Type: Process Impurity
• Description: This impurity arises as a by-product from the synthesis of Thiamine due to incomplete reactions or side reactions during manufacturing. Monitoring this impurity is essential to ensure the purity and efficacy of Thiamine products.
• Role: Used as a reference standard in process control to ensure consistency during Thiamine synthesis.

2. Thiamine EP Impurity B (CAS No. 49614-72-4)

• Type: Degradation Impurity
• Description: Forms from the degradation of Thiamine when exposed to heat, light, or acidic environments. This impurity is key in evaluating Thiamine’s stability under various storage and formulation conditions.
• Role: Crucial for stability testing and determining the shelf life of Thiamine products.

3. Thiamine EP Impurity C (CAS No. 7275-24-3)

• Type: Potential Impurity
• Description: This impurity can form under specific synthesis conditions, especially when there are variations in reagents or pathways. Its possible formation in some, but not all, batches requires careful monitoring during quality control.
• Role: Used in quality control and method development to detect and quantify impurities in Thiamine products.

4. Thiamine EP Impurity D (CAS No. 490-82-4)

• Type: Structural Analogue
• Description: Impurity D is structurally similar to Thiamine but differs slightly in the functional groups attached. It can occur from alternative synthetic pathways or minor structural shifts during chemical reactions.
• Role: Important for characterizing structural by-products and ensuring batch consistency.

5. Thiamine EP Impurity E (CAS No. 299-35-4)

• Type: Process and Degradation Impurity
• Description: Impurity E can form both as a by-product during manufacturing and as a degradation product under certain environmental conditions like high temperatures or humidity.
• Role: Integral to impurity profiling in both production and storage, helping to monitor product stability over time.

6. Thiamine EP Impurity F (CAS No. 6309-04-2)

• Type: Degradation Impurity
• Description: This impurity results from Thiamine breakdown due to oxidative or thermal stress. It is particularly important in assessing the product's oxidative stability and how it degrades over time.
• Role: Used in studying oxidative degradation pathways and developing antioxidant strategies in Thiamine formulations.

7. Thiamine EP Impurity G (CAS No. 1037-29-2)

• Type: Process Impurity
• Description: Impurity G typically forms during Thiamine synthesis, particularly when non-ideal reaction conditions are present. Monitoring this impurity is critical to maintaining the purity of the final product.
• Role: Serves as a marker for process optimization and is used in process validation to ensure consistent synthesis.

8. Thiamine EP Impurity H (CAS No. 89285-03-0)

• Type: Potential Impurity
• Description: This is a hypothetical impurity that could form under certain manufacturing conditions. While it may not always be present, its structural similarity to Thiamine requires its inclusion in comprehensive impurity testing.
• Role: Important for comprehensive screening during production and quality control to ensure the purity of Thiamine products.

 Conclusion

The classification and management of Thiamine impurities are critical to ensuring the quality, safety, and efficacy of pharmaceutical products containing Thiamine. At Chemicea Pharmaceutical, we provide certified reference materials for each of these impurities, enabling rigorous testing, stability assessments, and quality control. Understanding these impurities helps to guarantee that Thiamine products meet the highest industry standards and regulatory requirements.

For more details about our range of Thiamine impurities and how they can be used in your pharmaceutical applications, please contact our team or visit our product catalog.