Release Testing

For pharmaceutical products manufactured outside of the European Union, the possession of a product licence does not exempt such products from compliance testing by a laboratory established and accredited within the European Union.

These formalities must be completed before the products can be released for sale.

Eclipse’s Ely facility is able to undertake such testing, using the appropriate methodology – either the clients own protocols or standard ones from the various Pharmacopoeias (BP, EP, USP etc). Common tests include:

	Assay of active ingredients (hplc or glc)
	Disintegration of capsules or tablets
	Dissolution of capsules or tablets
	Identification tests for raw material
	Related substances or impurities
	Uniformity of content of active ingredients

We are regularly inspected by the UK MHRA (Medicines and Healthcare products Regulatory Agency, formerly the MCA - Medicines Control Agency).

Our work will confirm the identity and purity of ingredients for use in pharmaceutical manufacture, as well as levels of active ingredients and, if appropriate, degradation products present in complete formulations.