Tramadol Hydrochloride (HCL) is a centrally acting synthetic opioid analgesic widely used in the management of moderate to moderately severe pain. As a critical Active Pharmaceutical Ingredient (API), its quality, purity, and regulatory compliance are essential for ensuring safe and effective pharmaceutical formulations. Understanding the detailed specifications, CAS number, and technical characteristics of this API is crucial for pharmaceutical manufacturers and distributors seeking reliable sourcing from the Top Tramadol HCL Manufacturer In Singapore.
Singapore has established itself as a leading pharmaceutical manufacturing hub, known for stringent quality standards and global regulatory compliance. Pharmaceutical companies sourcing Tramadol HCL API require complete technical documentation and assurance of consistent product quality to meet international pharmacopeial standards.
CAS Number and Chemical Identification
Accurate chemical identification is the foundation of pharmaceutical manufacturing. The key identification details of Tramadol HCL API include:
- Chemical Name: (±)-cis-2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride
- CAS Number: 36282-47-0 (Tramadol Hydrochloride)
- Molecular Formula: C16H25NO2·HCl
- Molecular Weight: 299.84 g/mol (hydrochloride salt)
- Category: Synthetic opioid analgesic API
The CAS number ensures global standardization and accurate identification in regulatory documentation, trade processes, and safety data sheets.
Physical and Chemical Properties
Tramadol HCL API typically appears as a white to off-white crystalline powder. It is odorless, highly soluble in water, and soluble in methanol, making it suitable for various pharmaceutical formulations, including tablets, capsules, and injectables.
Key Technical Characteristics:
- Appearance: White crystalline powder
- Solubility: Freely soluble in water
- Melting Point: Approximately 180–184°C
- pH (aqueous solution): As per pharmacopeial standards
- Loss on Drying: Controlled within specified limits
- Residue on Ignition: Within pharmacopeial compliance
These parameters are strictly monitored to ensure consistency in drug formulation and therapeutic performance.
Pharmacopeial Specifications
Tramadol HCL API must comply with recognized pharmacopeial standards such as:
- United States Pharmacopeia (USP)
- British Pharmacopeia (BP)
- European Pharmacopeia (EP)
Typical specification requirements include:
1. Assay (Purity)
The assay value generally ranges between 99.0% and 101.0% on an anhydrous basis, ensuring high purity suitable for pharmaceutical use.
2. Identification Tests
Infrared spectroscopy (IR), High-Performance Liquid Chromatography (HPLC), and chemical identification tests confirm the authenticity of the API.
3. Related Substances
Impurity profiling is conducted using advanced analytical techniques to ensure impurity levels remain within regulatory thresholds.
4. Heavy Metals and Residual Solvents
Compliance with ICH (International Council for Harmonisation) guidelines ensures safety and minimal contamination risks.
Sourcing from the Top Tramadol HCL Manufacturer In Singapore ensures adherence to these stringent pharmacopeial standards, offering pharmaceutical companies reliable and compliant API supply.
Manufacturing and Quality Control Standards
The manufacturing of Tramadol HCL API requires adherence to Good Manufacturing Practices (GMP). Key quality control measures include:
- Controlled synthesis processes
- Batch-to-batch consistency monitoring
- In-process quality checks
- Final product testing with validated analytical methods
- Stability studies under ICH guidelines
Quality assurance teams conduct comprehensive testing to ensure each batch meets predefined specifications. This includes chromatographic analysis, moisture determination, and impurity quantification.
Manufacturers in Singapore are known for operating under internationally recognized regulatory frameworks. Partnering with the Top Tramadol HCL Manufacturer In Singapore provides pharmaceutical companies with confidence in quality, safety, and documentation accuracy.
Packaging and Storage Requirements
Proper packaging and storage are essential to maintain API stability and efficacy.
Standard Packaging:
- Fiber drums with double polyethylene inner lining
- HDPE containers for smaller quantities
- Tamper-evident sealing
Storage Conditions:
- Store in a cool, dry place
- Protect from light and moisture
- Maintain controlled room temperature
Stability testing ensures that the product maintains its specifications throughout its shelf life under recommended storage conditions.
Regulatory and Export Documentation
Given that Tramadol HCL is a regulated substance in many countries, exporters must comply with strict documentation requirements. These may include:
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- GMP certification
- Controlled substance export permits
- Regulatory authority approvals
Singapore’s pharmaceutical export framework ensures that all necessary regulatory approvals and shipping documentation are accurately prepared. Pharmaceutical distributors and formulation companies benefit significantly when sourcing from the Top Tramadol HCL Manufacturer In Singapore, as compliance reduces delays and ensures smooth international trade operations.
Applications in Pharmaceutical Formulations
Tramadol HCL API is widely used in:
- Immediate-release tablets
- Extended-release tablets
- Capsules
- Injectable formulations
- Combination analgesic products
Its balanced analgesic properties and dual mechanism of action make it a preferred choice for pain management therapies globally.
Consistent API quality directly impacts formulation stability, dosage accuracy, and therapeutic efficacy. This underscores the importance of partnering with the Top Tramadol HCL Manufacturer In Singapore for dependable supply and technical support.
Conclusion
Understanding the specifications, CAS number, and technical details of Tramadol HCL API is essential for pharmaceutical manufacturers seeking quality, compliance, and reliability. From purity standards and impurity profiling to packaging and regulatory documentation, every technical aspect plays a vital role in ensuring safe and effective drug production.
With strict adherence to GMP guidelines, pharmacopeial compliance, and advanced quality control systems, sourcing from the Top Tramadol HCL Manufacturer In Singapore ensures global pharmaceutical companies receive high-quality API suitable for regulated markets. Reliable manufacturing practices and comprehensive documentation make Singapore a trusted destination for Tramadol HCL API procurement worldwide.
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