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Zolpidem Tartrate API from this US-based supplier is a pharmaceutical-grade active ingredient used in the formulation of insomnia medications. The API is intended for use in 5mg and 10mg immediate or extended-release tablet dosage forms, sourced from GMP-certified manufacturers. This bulk material requires cold chain storage and strict regulatory compliance, including Drug Master File (DMF) and Certificate of Suitability (CEP) documentation.
The API is a non-benzodiazepine hypnotic agent, chemically known as N,N,6-trimethyl-2-(4-methylphenyl)imidazole[1,2-a]pyridine-3-acetamide L-(+)-tartrate. Typical specifications include a purity of at least 99.0%, a moisture content below 1.0%, and compliance with USP or EP monographs. It is a white to off-white crystalline powder, soluble in water and slightly soluble in ethanol, with a molecular weight of 430.56 g/mol.
Primary buyers are pharmaceutical distributors and manufacturers specializing in sleep disorder treatments. The API is used to produce branded and generic versions of insomnia medications, which are prescribed for short-term management of sleep issues. Trade terms such as L/C or T/T may apply, and buyers must ensure compliance with import/export regulations, including controlled substance licenses where applicable.
| API Name | Zolpidem Tartrate |
| Chemical Formula | C19H21N3O · C4H6O6 |
| Molecular Weight | 430.56 g/mol |
| Appearance | White to off-white crystalline powder |
| Solubility | Soluble in water, slightly soluble in ethanol |
| Purity | At least 99.0% (typical for USP/EP grade) |
| Moisture Content | Below 1.0% (standard for API) |
| Storage Conditions | Cold chain (2-8°C), protected from light and moisture |
| Regulatory Documentation | Drug Master File (DMF), Certificate of Suitability (CEP) required |
| Compliance Standards | USP, EP (typical for pharmaceutical APIs) |
The supplier, listed as Buy oxycodone 30 mg tablets online USA, is based in Cadiz, Kentucky, USA, and operates in the pharmaceutical raw materials sector. The profile indicates an organic supplier tier with a voyage trust tier, but response metrics are currently unavailable. The company appears to specialize in controlled substances and APIs, including Zolpidem Tartrate, which is used in insomnia medications.
While the profile does not provide details on production capacity, certifications, or client history, it highlights the need for regulatory compliance and cold chain logistics. Buyers should request documentation such as DMF, CEP, and GMP certificates to verify the supplier’s ability to meet pharmaceutical-grade standards. The address listed is 411 Lafayette St, Cadiz, Kentucky 42211, USA.
Zolpidem Tartrate API serves as the active pharmaceutical ingredient for widely prescribed insomnia medications. This pharmaceutical grade bulk material is sourced from GMP-certified manufacturers and is intended for formulation into 5mg and 10mg immediate or extended-release tablet dosage forms. Ideal for import/export pharmaceutical distributors, the product requires cold chain storage and regulatory compliance documentation including Drug Master File and Certificate of Suitability.
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Before ordering Zolpidem Tartrate API, verify the supplier’s GMP certification and the availability of a Drug Master File (DMF) and Certificate of Suitability (CEP). These documents are essential for regulatory approval in most markets and ensure the API meets pharmaceutical-grade standards. Requesting a certificate of analysis (CoA) for the specific batch can provide additional assurance of purity and compliance.
Confirm logistics details such as cold chain storage capabilities, lead time, and Incoterms (e.g., FOB or CIF) to ensure the API remains stable during transit. The port of shipment and any required import licenses for controlled substances should also be clarified. Payment terms, such as L/C or T/T, should be agreed upon to align with your procurement process.
Quality checks should include testing for purity, moisture content, and solubility to ensure the API meets USP or EP standards. Independent laboratory testing of the first shipment is recommended to validate the supplier’s claims. Documentation such as the DMF, CEP, and CoA should be reviewed thoroughly before finalizing the purchase to avoid compliance issues.
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