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Tramadol Hydrochloride is a centrally acting opioid analgesic used for the management of moderate to moderately severe pain. It combines opioid receptor agonism with inhibition of norepinephrine and serotonin reuptake, offering effective pain relief with a lower risk of respiratory depression compared to traditional opioids.
At Bluepill Express, we manufacture high-purity Tramadol Hydrochloride API under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities, ensuring compliance with IP/BP/USP/EP standards and providing consistent potency, stability, and quality for global pharmaceutical formulations.
Therapeutic Uses
- Management of moderate to moderately severe pain
- Postoperative pain control
- Musculoskeletal pain relief
- Neuropathic pain management in combination therapy
- Used in oral, injectable, and extended-release formulations
Mechanism of Action
Tramadol acts as a mu-opioid receptor agonist and inhibits the reuptake of norepinephrine and serotonin, enhancing the body’s natural pain-modulating pathways.
Key effects include:
- Reduction in pain perception
- Modulation of pain transmission in the central nervous system
- Lower abuse potential compared to stronger opioids
Pharmacological Information
| Parameter | Details |
|---|---|
| Chemical Name | (1R,2R)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride |
| Molecular Formula | C16H25NO2·HCl |
| Molecular Weight | 299.84 g/mol |
| CAS Number | 27203-92-5 |
| Therapeutic Category | Analgesic / Opioid |
| Pharmacopoeial Standards | IP / BP / USP / EP |
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White or almost white crystalline powder |
| Odor | Odorless |
| Melting Point | 170°C – 172°C |
| Solubility | Freely soluble in water; soluble in ethanol |
| Assay (on dried basis) | 98.0% – 102.0% |
| pH (1% solution) | 4.5 – 6.5 |
Technical Specifications
| Test | Specification |
|---|---|
| Appearance | White crystalline powder |
| Identification | IR / UV / HPLC – Complies |
| Assay (Purity) | 98.0% – 102.0% |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Related Substances | ≤ 0.2% (individual), ≤ 0.5% (total) |
| Heavy Metals | ≤ 10 ppm |
| Storage | Store below 25°C, in airtight containers, away from light and moisture |
Applications
- Formulation of tablets, capsules, and injectable solutions for pain management
- Used in acute and chronic pain therapy
- Suitable for generic and branded pharmaceutical products
- Compatible with combination analgesic formulations
Documentation Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Stability Data (ICH guidelines)
- Drug Master File (DMF) – available on request
Packaging & Export Details
| Packaging Type | Net Weight |
|---|---|
| HDPE Drum | 25 kg |
| Fiber Drum | 25 kg |
| LDPE Inner Bag | 1 kg / 5 kg / 10 kg |
Labeling Includes: Product name, batch number, manufacturing & expiry date, net weight, storage instructions.
Shelf Life: 5 years (stored below 25°C)
Export Markets: Africa, Europe, Asia, Middle East, and Latin America
