Balsalazide USP Related Compound A
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| CAT NO | AQ-B000511 |
|---|---|
| CAS NO | 64896-26-0 |
| Mol.F | C14H10N2O5 |
| Mol.Wt | 286.24 |
| Availability | In Stock |
| Chemical name | 5-(4-Carboxyphenylazo)-salicylic acid |
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Balsalazide USP Related Compound A
Product Description
Balsalazide USP Related Compound A is a high-quality reference standard supplied with comprehensive characterization data, ensuring compliance with regulatory guidelines. This product is essential for analytical method development, method validation (AMV), quality control (QC) applications, and plays a crucial role in Abbreviated New Drug Applications (ANDA).
Balsalazide USP Related Compound A can be used as a reference standard, with possible traceability to pharmacopeial standards such as USP or EP, based on feasibility. AquigenBio products are strictly for analytical purposes and is not intended for human use.
Applications of Balsalazide USP Related Compound A:
1. Pharmaceutical Impurity Profiling
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Used as an official USP-recognized related compound in Balsalazide API and formulation testing.
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Assists in the detection, identification, and quantification of this specific impurity in bulk drug and finished dosage forms.
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Ensures compliance with impurity limits set by the United States Pharmacopeia (USP).
2. Analytical Method Development & Validation
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Serves as a reference standard for developing and validating impurity-specific analytical methods such as:
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HPLC
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LC-MS/MS
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UPLC
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Helps confirm method parameters including:
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Specificity
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LOD (Limit of Detection) and LOQ (Limit of Quantification)
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Linearity, precision, and accuracy
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3. Regulatory Compliance & Submissions
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Required for regulatory filings to demonstrate impurity control according to:
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ICH Q3A/B guidelines
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FDA, EMA, and other international regulatory bodies
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Included in:
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ANDA submissions
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DMF documentation
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Common Technical Dossiers (CTD)
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4. Stability Testing & Forced Degradation Studies
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Used to monitor the formation and behavior of Related Compound A during:
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Forced degradation (heat, light, oxidation, pH conditions)
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Long-term and accelerated stability studies
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Helps evaluate the chemical stability and shelf life of Balsalazide-containing products.
5. Routine Quality Control (QC) Testing
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Applied during:
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Batch release analysis
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In-process quality checks
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Finished product testing
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Ensures that the impurity level of Related Compound A stays within pharmacopeial and regulatory limits.
6. Research & Development
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Used in:
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Synthetic route optimization
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Impurity formation pathway studies
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Reference mapping and structural comparison
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Valuable in pharmaceutical R&D labs, CROs, and academic research involving Balsalazide chemistry.
⚠️ Note: This impurity standard is strictly for analytical, laboratory, and research use only. Not intended for therapeutic or diagnostic use.
Safety & Handling Information for Chemical Products
1. Read the Safety Data Sheet (SDS) : The SDS contains important safety information for handling procedures, first-aid measures, disposal instructions, etc. Read it carefully.
2. Wear Personal Protective Equipment (PPE) : Always wear PPE as indicated in the SDS and by the manufacturer. This may include safety goggles, gloves, lab coats, respirators, and protective clothing.
3. Handle with Care : Be careful with chemical products - prevent spills, splashes, or inhaling fumes or dust. Use secondary trays or spill kits during chemical transfer or dispensing.
4. Work in a Well-Ventilated Area : Use chemical products in well-ventilated spaces to reduce vapour or gas exposure. Indoors, ensure ample ventilation via mechanical systems, fume hoods, or open windows and doors.
5. Avoid Mixing Chemicals : Avoid mixing chemical products unless directed by the manufacturer or a qualified professional. Incompatible mixes can lead to hazardous reactions, toxic gas releases, or explosions.
6. Labeling and Storage : Label chemical containers with product names, hazards, and handling information. Store in original or approved containers.
7. Prevent Contamination : Prevent cross-contamination with dedicated equipment or thorough decontamination. Keep food, drinks, and personal items away from chemical storage or work zones.
8. Emergency Procedures : Learn emergency procedures for spills, leaks, fires, or exposure incidents. Keep spill control materials, fire extinguishers, and emergency eyewash/shower facilities accessible.
9. First Aid : Know first aid for chemical exposure (eye contact, skin contact, inhalation, and ingestion). Ensure accessible supplies and trained personnel for assistance.
10. Proper Waste Disposal : Ensure chemical waste disposal as per local regulations; segregate hazardous from non-hazardous waste for health and environmental protection.
11. Training and Education : Offer thorough training to chemical handlers, covering usage, hazards, safety, and emergency response.
12. Report Incidents and Near Misses : Report incidents, near misses, spills, or safety concerns promptly to authorities and supervisors for investigation and action. By following these safety and handling guidelines, you can minimize risks associated with chemical products and create a safer work environment for yourself and others.
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Wash thoroughly after handling. Remove contaminated clothing and wash before reuse. Avoid contact with eyes, skin, and clothing. Avoid ingestion and inhalation.


