At Delhi test house, we aim to be a chemistry solutions provider for your small molecule Drug Development needs. We give each project individual attention because every project presents its own challenges and opportunities. We maintain a high level of confidentiality, solve difficult problems and are equipped to handle most aspects of Chemical Development and Manufacturing.

We offer Contract Research & Development services during early stages of Development and Contract Manufacturing for projects that have advanced further into development and are being considered for commercial manufacturing.

The USP defines an impurity profile as "a description of the impurities present in a typical lot of drug substance produced by a given manufacturing process." Each commercial lot should be comparable in purity to this standard release profile, which is developed early on and maintained for each pharmaceutical chemical. We can also call this profile a "Reference Profile" because the quality control unit refers to it
(1) when assessing the purity of each batch of active pharmaceutical ingredient (API), and
(2) when evaluating the viability of proposed process changes.

To illustrate, one of the more critical process changes in the life of a pharmaceutical chemical (both API and key intermediate) is justification of scale-up from smaller development size lots to full-scale production batches. In the absence of a full impurity profile, there would be little support for claims of equivalency of the two process scales.

When reviewing an API impurity profile, the following basic information should be available for impurities present at or above the 0.1% level (or lower based on toxicity of the compound):

• Identity or some identifier (e.g., HPLC retention time)
• Ranges normally (historically) found. Note that some impurities may only be detected sporadically. However, for an impurity profile to be considered complete, it's important to include these as well. 
• Limits 
• Description or type of impurity (e.g., organic solvent, in-process decomposition product, un reacted intermediate, etc.)

Many companies use at least two test methods (e.g., HPLC, GC) for routine purity testing of their pharmaceutical chemicals. It is vital that these methods are of appropriate sensitivity and capable of detecting and quantifying actual and potential impurities. We expect manufacturers to have fully characterized the purity of their pharmaceutical chemicals and consider the failure to perform sufficient impurity profile studies inconsistent with current good manufacturing practice for APIs.