INTRODUCTION
Dimenhydrinate is an antihistamine drug commonly used to prevent and treat motion sickness, nausea, and vertigo. It is a combination of diphenhydramine and 8-chlorotheophylline, where the latter reduces the sedative effects of diphenhydramine. It is available in tablet, liquid, and injectable forms under various brand names.
MANUFACTURE
The synthesis involves the combination of diphenhydramine and 8-chlorotheophylline in a 1:1 molar ratio, typically forming a stable salt. The mixture is purified and crystallized to produce pharmaceutical grade dimenhydrinate.
| Synonyms | N-(2-Diphenylmethoxyethyl)-N,N-dimethylammonium 8-chlorotheophyllinate |
| CAS no. | 523-87-5 |
| EINECS no. | 208-350-8 |
| Molecular formula | C17H21NO · C7H7ClN4O2 |
| Molecular weight | 469.96 |
| Structure |  |
APPLICATIONS
| Motion Sickness & Nausea Relief: |
| Used to prevent and treat nausea, vomiting, and dizziness associated with motion sickness and inner ear disorders. |
| Vertigo Treatment : |
| Helps manage vertigo caused by conditions like Meniere’s disease. |
| Anti-Allergic Uses: |
| Has antihistamine properties and can be used for mild allergic reactions. |
| Sleep Aid: |
| Sometimes used as an over-the-counter sedative due to its drowsiness-inducing effects. |
| Post-Anesthesia & Chemotherapy Support: |
| Used to prevent nausea and vomiting in postoperative and chemotherapy patients. |
SPECIFICATIONS – USP
| Test | Unit | Specification |
|---|---|---|
| Description | – | White, crystalline, odourless powder |
| Solubility | – | Slightly soluble in water, freely soluble in Alcohol and in Chloroform. Sparingly soluble in Ether |
| Identification | ||
| (A) IR Test | – | Should conform to USP monograph |
| B) By HPLC (Dimenhydrinate) | – | Should conform to USP monograph |
| (C) By HPLC (8-Chlorotheophylline) | – | Should conform to USP monograph |
| Melting point | °C | 102.0 – 107.0 |
| Loss on Drying | % | NMT 0.5 |
| Residue on Ignition | % | NMT 0.3 |
| Organic impurities [By HPLC ] | ||
| Theophylline | % | NMT 0.2 |
| Dimenhydrinate related compound E | % | NMT 0.15 |
| Diphenhydramine related compound A | % | NMT 0.2 |
| Any other individual impurity | % | NMT 0.10 |
| Total impurities | % | NMT 0.5 |
| Assay by HPLC (On Dried Basis) | ||
| Diphenhydramine (C17H21NO) | % | NLT 53.0 – NMT 55.5 |
| 8-Chlorotheophylline (C7H7ClN4O2) | % | NLT 44.0 – NMT47.0 |
| Residual solvents [By GC] | ||
| Isopropyl Alcohol | % | NMT 0.5 |
| Microbial Limit Test | ||
| Total aerobic bacterial count | Cfu/g | ≤ 100.0 |
| Total Yeast & mold count | Cfu/g | ≤ 10.0 |
| E. Coli | – | Should be Absent |
| S. Aureus | – | Should be Absent |
| Salmonella Spp. | – | Should be Absent |
| P. Aeruginosa | – | Should be Absent |
PACKING
25 Kg drum
STORAGE
Store in airtight container in a cool, dry place
CERTIFICATIONS
WHO-GMP, EU Written Confirmation
ExSyn offers Dimenhydrinate USP/EP/BP on commercial scales and welcomes enquiries. Our exceptional quality and service will make ExSyn your supplier of choice! If you need any additional information or SDS, please contact us.
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