TSS Chemicals · Applications

Pharmaceutical & Nutraceutical Manufacturing

Material entering a medicinal product has to meet the compendial standard of the market that product is sold into. That is the decision this sector makes first, and it is a decision about the grade rather than the compound.

What decides the specification

  1. 01

    The pharmacopoeia follows the market

    USP governs medicines sold in the United States, EP across the member states of the Council of Europe, BP in the United Kingdom. Each sets its own identity, purity and impurity limits for the same substance, so a material that satisfies one does not automatically satisfy another. Specify the pharmacopoeia your finished product answers to, not the one nearest to hand.

  2. 02

    The batch is what you are buying

    A grade describes a standard; a Certificate of Analysis describes the material you actually receive. The CoA is issued against the batch supplied, and it is the document your quality function will hold — check that its assay and impurity results are against the same monograph you specified.

  3. 03

    Documentation travels with the consignment

    A safety data sheet and the export paperwork are issued with the shipment alongside the CoA. What your customs broker needs and what your QA needs are different sets, and both should be settled before despatch rather than chased afterwards.

Where to look

The catalogue is on the TSS storefront and is searchable by name and CAS number.

What to put on the enquiry

These four turn an enquiry into something that can be quoted without a round trip.

  • The pharmacopoeia — USP, BP or EP — that the finished product is sold against.
  • The compound name or CAS number, and the quantity.
  • Any documentation your quality system requires beyond the Certificate of Analysis.
  • The destination country, which decides the export paperwork.
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Common questions

What is the difference between USP, BP and EP grade?
They are the compendial standards of the United States, the United Kingdom and Europe. Each publishes its own monograph for a substance, setting identity tests and limits for assay and impurities. Because the limits differ, the grade you specify should follow the market your finished product is sold into rather than where the material is bought.
Does a Certificate of Analysis come with the order?
Yes — issued for the specific batch supplied, alongside a safety data sheet and the export paperwork your customs broker needs.