How to Buy Fluralaner API: Grade, Documents and Regulatory

Fluralaner (CAS 864731-61-3) is an active-ingredient raw material, so buying it involves more than price: grade, specification, residual-solvent control and documentation all matter. This page sets out what to fix before you request a quotation.

1. Confirm the grade and form

Item	Specification
Grade	Non-sterile API / intermediate
Assay	98.0 – 102.0% on the anhydrous basis
Form	Powder (as supplied)

State whether you need a non-sterile grade (as here) or a different grade for your process; the grade must match the end use.

2. Fix the specification

Group	Parameters
Assay	98.0 – 102.0% (anhydrous basis)
Residual solvents	Triethylamine 0.5% max; methanol 0.3% max; ethyl acetate 0.5% max; THF 0.072% max
Water	0.2% max
Residue on ignition	0.1% max
Heavy metals	20 ppm max

Residual-solvent limits are usually the parameters buyers focus on, with reference to ICH Q3C. Agree the specification and check the batch COA against it.

3. Confirm the documentation

Document	Note
COA	Per-batch certificate against the agreed specification
SDS	Safety data sheet
GMP	Confirm the relevant GMP certification for the active ingredient
Regulatory support	Additional documents may be needed for market registration – confirm availability

For an active-ingredient raw material, documentation is part of the product. Ask up front which documents you need, because registration requirements vary by market.

4. Packaging and logistics

Item	Standard
Packaging	25 kg fibre drums with inner liner (or as agreed)
Incoterms	FOB and CIF
Storage	Sealed, cool and dry, away from light

5. What drives the price

Price depends on the complexity of the synthesis, the purity and residual-solvent control, and the documentation provided. Committed tonnage gives the best terms.

6. A short enquiry checklist

Product and CAS 864731-61-3; grade (non-sterile or other).
Specification: assay, residual-solvent limits, water, residue on ignition, heavy metals.
Documents needed (COA, SDS, GMP, regulatory support).
Packaging, tonnage and delivery port.
Incoterm (FOB / CIF).

Frequently Asked Questions

What grade of Fluralaner is supplied?

Non-sterile API/intermediate, assay 98.0 – 102.0% on the anhydrous basis.

Do you provide a COA per batch?

Yes – a certificate of analysis for each batch, plus an SDS.

What documents are available?

COA and SDS as standard; GMP and additional regulatory documents on request – confirm what your market requires.

What residual solvents should I check?

Triethylamine, methanol, ethyl acetate and THF against their specification limits, with reference to ICH Q3C.

Is Fluralaner a finished product?

No – it is an active-ingredient raw material for manufacturing, subject to registration and GMP requirements.