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Ribavirin Related Compound A (15 Mg) (1-β-D-Ribofuranosyl-1H-1,2,4-Triazole-3-Carboxylic Acid) CAS NO 39925-19-4
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CAS No.:39925-19-4
Grade:Pharmacy Grade
Content:99.9%
Brand:Customizable
Packaging:Customizable
Description
Ribavirin Related Compound A (15 Mg) (1-β-D-Ribofuranosyl-1H-1,2,4-Triazole-3-Carboxylic Acid) is a high-purity analytical reference standard, essential for pharmaceutical research and quality control. This compound serves as a critical impurity marker and structural analog for the antiviral drug Ribavirin, ensuring the accuracy and reliability of analytical methods. It is primarily used by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in drug development, stability testing, and regulatory compliance.
Application
- Pharmaceutical Impurity Profiling and Control: Used as a certified reference material (CRM) to identify, quantify, and monitor related substances in Ribavirin active pharmaceutical ingredient (API) and finished dosage forms.
- Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and LC-MS methods to ensure specificity, accuracy, and precision.
- Stability Studies and Forced Degradation Testing: Employed to understand degradation pathways and establish shelf-life specifications for Ribavirin-containing products.
- Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization as per ICH Q3A(R2) and Q3B(R2) guidelines.
- Quality Control (QC) Testing: Acts as a system suitability standard and a quantitation marker in routine QC release testing of Ribavirin batches.
- Metabolite and Pharmacokinetic Research: Utilized in research studies investigating the metabolism and pharmacokinetic profile of Ribavirin and its analogs.
Basic Information
| Item | Detail |
|---|---|
| Product Name | Ribavirin Related Compound A (15 Mg) (1-β-D-Ribofuranosyl-1H-1,2,4-Triazole-3-Carboxylic Acid) |
| CAS No. | 39925-19-4 |
| Molecular Formula | C8H11N3O6 |
| Molecular Weight | 245.19 g/mol |
| Synonyms | 1-β-D-Ribofuranosyl-1H-1,2,4-triazole-3-carboxylic acid; Ribavirin Impurity A; Ribavirin Related Substance A; 1-(β-D-Ribofuranosyl)-1,2,4-triazole-3-carboxylic acid; 3-Carboxy-1-β-D-ribofuranosyl-1,2,4-triazole; Ribavirin Carboxylic Acid Impurity; Ribavirin Acid Impurity; Virazole Related Compound A |
| EINECS | Contact for details |
Quality Control
Every batch of Ribavirin Related Compound A is manufactured and tested under strict quality management systems. The product undergoes rigorous analytical testing, including HPLC for purity and identity confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each unit, supporting traceability and compliance with cGMP principles.
Storage
Preserve in the original tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); ensure the container is kept tightly sealed in a low-humidity environment to maintain stability and purity.
Specification
| Item | Specification |
|---|---|
| Appearance | White to off-white powder |
| Identification (IR) | Conforms to structure |
| Identification (HPLC) | Retention time matches reference standard |
| Purity (HPLC) | ≥ 98.0% |
| Water Content (KF) | ≤ 2.0% |
| Residue on Ignition | ≤ 0.1% |
| Heavy Metals | ≤ 20 ppm |
Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.
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