How to Buy Paracetamol API: Grades, Specs and Documentation

Paracetamol (acetaminophen, CAS 103-90-2) is a pharmaceutical active ingredient, so buying it involves more than price: grade, specification, impurity control and documentation all matter. This page sets out what to fix before you request a quotation.

1. Choose the grade

Grade	Choose when	Key controls
DC 90 (direct compression)	You compress tablets directly	Particle size, bulk density 0.50-0.70 g/ml, assay 87.5-92.5%
Plain powder	You granulate in-house	Crystalline API; standard assay
Other DC density	Your press needs a different density	Matched bulk density

The grade is the first decision: a DC grade and a plain powder grade are used in different processes and are not freely interchangeable.

2. Fix the specification

Agree which pharmacopoeia (USP, Ph. Eur./BP) or customer specification applies, and check the batch COA against it. The key parameters are:

Group	Parameters
Identity	Identification (chemical reaction; IR vs reference standard)
Assay	87.5 – 92.5% for DC grade
Physical	Loss on drying, bulk density, particle size (sieve analysis)
Related substances	Impurity J (10 ppm max), K (50 ppm max), F (0.05% max), other (0.05% max), total (0.10% max)
Microbial	Aerobic bacteria, mold/yeast, E. coli absent

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 API
Regulatory support	Additional documents (e.g. DMF) may be needed for market registration – confirm availability

For an API, documentation is part of the product. Ask up front which documents you need and confirm they are available, 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 moisture and odours

5. What drives the price

API price depends on the grade (DC vs plain powder), the impurity and microbial control, and the documentation provided. A DC grade costs more than a plain powder but can save a manufacturing step. Committed tonnage gives the best terms.

6. A short enquiry checklist

Product, grade (DC 90 / other) and CAS 103-90-2.
The pharmacopoeia or customer specification you require.
Key parameters (assay, particle size, bulk density, impurity and microbial limits).
Documents needed (COA, SDS, GMP, DMF/regulatory support).
Packaging, tonnage and delivery port.
Incoterm (FOB / CIF).

Frequently Asked Questions

What grade should I buy?

DC 90 if you compress directly; plain powder if you granulate in-house. Confirm the particle size and bulk density against your process.

Do you provide a COA per batch?

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

What documentation is available?

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

Is a DMF available?

Regulatory documents such as a DMF may be required for market registration; ask us about availability for your market.

How is it packed?

Typically 25 kg fibre drums with inner liner, or as agreed.